BORDER

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 62/876,223, filed on July 19, 2019, which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] The present disclosure relates generally to the field of wound therapy, and more particularly to dressings for use in negative pressure wound therapy.

[0003] Negative pressure wound therapy (NPWT) is a type of wound therapy that involves applying negative pressure (relative to atmospheric pressure) to a wound bed to promote wound healing.

Typically, a dressing is sealed over a wound bed and air is pumped out of the dressing to create a negative pressure at the wound bed. In some NPWT systems, wound exudate and other fluid is pumped out of the dressing and collected by a therapy system. In other NPWT systems, air is pumped out of the dressing while the dressing is used to absorb fluid from the wound.

[0004] To facilitate the establishment of negative pressure, the dressing may include a silicone adhesive that is suitable for creating a substantially air-tight seal between the dressing and the patient’s skin. However, in some cases, it may be desirable to provide adhesives having longer-term retention of the dressing in a substantially fixed position on the patient.

SUMMARY

[0005] One implementation of the present disclosure is a dressing. The dressing includes a dressing core, a first border coupled to the dressing core and including a silicone adhesive border that surrounds the dressing core, a second border coupled to the first border and including an acrylic adhesive border that at least partially surrounds the silicone adhesive border.

[0006] In some embodiments, the silicone adhesive border is configured to seal the dressing to skin of a patient surrounding a wound bed and the acrylic adhesive border is configured to reinforce a coupling between the silicone adhesive border and the skin of the patient by adhering to the skin. The dressing may include a tube coupled to the dressing core and configured to be coupled to a pump configured to operate to establish a negative pressure at the dressing core when the silicone adhesive border is sealed to the skin. The dressing core may include a wound contact film, a manifolding foam, and an absorbent material. [0007] In some embodiments, the dressing includes a first release liner coupled to the dressing and removable to expose the silicone adhesive border and a second release liner coupled to the dressing and removable to expose the acrylic adhesive border. The first release liner can include a first material configured to release from the silicone adhesive border, and the second the second release liner can include a second material configured to release from the acrylic adhesive border. The second material is different from the first material. The second release liner may be configured to be removed from the acrylic adhesive border in two or four sections.

[0008] In some embodiments, the acrylic adhesive border includes a light-deactivated adhesive.

[0009] In some embodiments, the silicone adhesive border radially extends from the dressing core by approximately 20 to 25 millimeters and the acrylic adhesive border radially extends from the silicone adhesive border by approximately 10 to 20 millimeters.

[0010] In some embodiments, the second border comprises a top support layer removeably coupled to the second border.

[0011] Another implementation of the present disclosure is a wound therapy system. The wound therapy system includes a pump, a tube coupled to the pump, a dressing core coupled to the tube, a first border coupled to the dressing core and including a silicone adhesive border that surrounds the dressing core, a second border coupled to the first border and including an acrylic adhesive border that at least partially surrounds the silicone adhesive border.

[0012] In some embodiments, the silicone adhesive border is configured to establish a seal between the first border and a patient. The acrylic adhesive border may be configured to adhere to the patient. The acrylic adhesive border can reinforce a bond between the silicone adhesive border and the patient.

[0013] In some embodiments, the dressing core includes a wound contact film, a manifolding film, and an absorbent material. The pump is operable to remove air from the manifolding foam via the tube.

[0014] In some embodiments, the wound therapy system includes a first release liner coupled to dressing and removable to expose the silicone adhesive border and a second release liner coupled to the dressing and removable to expose the acrylic adhesive border. The first liner can include a first material configured to release from the silicone adhesive border and the second release liner can include a second material configured to release from the acrylic adhesive border. The second material is different from the first material. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 is a cross-sectional diagram of a negative pressure wound therapy (NPWT) system with an absorbent dressing, according to an exemplary embodiment.

[0016] FIG. 2 in an exploded cross-sectional side view of the dressing of FIG. 1, according to an exemplary embodiment.

[0017] FIG. 3 is an exploded perspective view of the dressing of FIG. 1, according to an exemplary embodiment.

[0018] FIG. 4 is a bottom view of the dressing of FIG. 1, according to an exemplary embodiment.

DETAILED DESCRIPTION

[0019] Referring now to FIGS. 1-4, a negative pressure wound therapy (NPWT) system 100 and a dressing 104 for use therewith are shown, according to exemplary embodiments. The NPWT system 100 includes a pump 102 pneumatically communicable with a dressing 104 via tube 106. FIG. 1 shows a cross-sectional side-view of the NPWT system 100 in which the dressing 104 is sealed over a wound bed. The wound bed is a tissue wound of a patient, for example a laceration, bum, sore, trauma wound, chronic wound, etc. FIG. 2 shows an exploded, cross-sectional, side view of the NPWT system 100 before the dressing 104 is sealed over the wound bed. FIG. 3 shows an exploded perspective view of the dressing 104. FIG. 4 shows a bottom view of the dressing 104. The various views show various features of the NPWT system 100 and are described concurrently in the following. Advantageously, as described in detail below, the dressing 104 provides a silicone adhesive that facilitates an initial seal between the dressing 104 and the patient in addition to an acrylic adhesive that reinforces the bond between the dressing 104 and the patient and facilitates long term (e.g., approximately 7 days) fixation of the dressing 104 to the patient. As detailed below, this dual-adhesive dressing design is configured to be highly-intuitive and easy-to-use for a caregiver.

[0020] The dressing 104 allows a negative pressure to be maintained at the wound bed while absorbing fluid from the wound bed. The dressing 104 is shown to include a drape 112, a dressing core 120, a first border 121, and a second border 122. The drape 112 is configured to provide a barrier between the ambient environment and the dressing core 120 and wound bed. The drape 112 may include a material that substantially prevents leaking of air therethrough to facilitate creation and maintenance of a negative pressure at the dressing core 120 (i.e., in a volume between the drape 112 and the wound bed). The drape 112 may also include a material with a high moisture vapor transfer rate to facilitate evaporation of fluid from the dressing core 120 to the ambient air through the drape 112. The first border 121 is configured to provide a substantially air-tight seal between the drape 112 and the patient’s skin around the wound bed, and the second border 122 is configured to adhere to the skin to retain the dressing 104 in a substantially-fixed location on the patient (i.e., to reinforce the bond between the first border 121 and the skin). The first border 121 and the second border 122 are described in further detail below.

[0021] The dressing core 120 is configured to facilitate communication of negative pressure across the wound bed while also absorbing fluid from the wound bed. Various dressing cores 120 are possible in various embodiments. For example, the dressing core 120 may be the same as or similar to that included with the absorbent negative pressure dressing sold under the trade name PICO by Smith and Nephew. In the example shown, the dressing core 120 includes a manifold layer 110, a wound contact layer 114, and an absorbent 116. The dressing core 120 may have a rectangular shape, a circular shape, an elliptical shape, a pentagonal shape, an octagonal shape, etc.

[0022] The wound contact layer 114 provides an interface between the dressing 104 and a wound.

In some embodiments, the wound contact layer 114 is configured to prevent ingrowth of the wound bed to the dressing and to facilitate removal of the dressing 104 while minimizing damage to the healing tissue of the wound bed. The wound contact layer 114 includes a film, for example a silicone film. The wound contact layer 114 may be perforated, fenestrated, or otherwise formed to allow for the flow of air and fluid therethrough.

[0023] The manifold layer 110 is configured to allow airflow therethrough to facilitate the distribution of negative pressure across the wound bed. In some embodiments, the manifold layer 110 may include an open-celled foam, for example a foam material marketed as GRANUFOAM™by ACELITY™. The manifold layer 110 is also configured to allow fluid to flow therethrough, for example from the wound bed to the absorbent 116.

[0024] The absorbent 116 (e.g., absorbent deposits, absorbent layer) is configured to absorb fluid, for example wound exudate from the wound bed. The absorbent 116 may include a superabsorbent material. Various arrangements and configurations of absorbent 116 are included in various embodiments. For example, in some embodiments, the absorbent 116 is formed as a superabsorbent laminate positioned between the drape 112 and the manifold layer 110, with channels extending therethrough to allow airflow therethrough. As another example, in some embodiments, the absorbent 116 is printed or deposited in a pattern on a non-wound-facing surface of the manifold layer 110 (i.e., adjacent the drape 112). It should be understood that various configurations of the dressing core 120 are contemplated by the present disclosure.

[0025] The connection assembly 108 is configured to couple the dressing 104 to a tube 106, which is coupled to a pump 102. The connection assembly 108 is configured to allow airflow between the manifold layer 110 and the pump 102, while restricting the flow of fluid therethrough. For example, the connection assembly 108 may include a filter or membrane that allows airflow therethrough while preventing the flow of fluid therethrough.

[0026] The pump 102 is operable to pump air out of the dressing 104 via the tube 106 to create and maintain a negative pressure at the wound bed. In some embodiments, the pump 102 is electrically powered (e.g., battery powered) and the NPWT system 100 includes power systems and control circuitry to power and control operation of the pump 102. For example, the NPWT system 100 may include one or more pressure sensors or various other sensors that collect data used to control the pump 102 to maintain a negative pressure at the wound bed. In some embodiments, the pump 102 is manually-powered, such that a user may manipulate the pump 102 to draw air out of the dressing 104 as desired by the user. For example, the pump 102 may be spring-loaded to gradually pull air from the dressing 104 for a duration of time following a compression of the pump 102 by the user.

[0027] The NPWT system 100 is thereby configured to provide a negative pressure at the wound bed while also facilitating absorption of fluid from the wound bed by the dressing 104.

[0028] In order for the negative pressure to be maintained over a lifetime of the dressing 104 (e.g., 7 days), it is desirable that the seal between the drape 112 and the patient’s skin remain intact. As mentioned above, the first border 121 is configured to provide a substantially airtight seal between the drape 112 and the skin. The first border 121 includes a silicone adhesive border that surrounds the dressing core 120. That is, the first border 121 includes a patient-facing surface that includes a silicone adhesive and surrounds the dressing core 120. The silicone adhesive can seal the first border 121 to a patient’s skin. In the example shown, the first border 121 extends radially from the wound contact layer 114 of the dressing core 120 by a breadth in the range of approximately 20 millimeters to 25 millimeters.

[0029] In some embodiments, the first border 121 is formed as an integral part of the drape 112, such that the drape 112 extends beyond the dressing core 120 to provide the patient-facing surface which is coated with the silicone adhesive. In other embodiments, the first border 121 is formed as a separate piece of material which is coupled to the drape 112 and/or the dressing core 120 (e.g., adhered to the wound contact layer 114).

[0030] The second border 122 is coupled to the first border 121 and includes an acrylic adhesive border that at least partially surrounds the silicone adhesive border. The second border 122 has an inner portion that defines (borders, surrounds, delineates) a central opening 300. The central opening 300 is shaped and sized to be aligned with and placed over the dressing core 120 such that the inner portion of the second border 122 overlaps the first border 121 and can be coupled to the first border 121. That is, as shown in FIG. 1, the inner portion of the second border 122 is configured to be adhered to the non-patient facing surface of the first border 121.

[0031] The second border 122 also includes an outer portion that extends radially from the inner portion such that the outer portion extends radially from the first border 121 when the second border 122 is coupled to the first border 121. The second border 122 may extend from the first border 121 with a breadth in a range of approximately 10 millimeters to 20 millimeters.

[0032] The outer portion includes an acrylic adhesive on a patient-facing surface to form the acrylic adhesive border. The acrylic adhesive is configured to adhere to the patient and substantially fix the dressing 104 in position on the patient. In the example shown, the acrylic adhesive border is configured to adhere to the patient for a duration of at least seven days. In some embodiments, the acrylic adhesive is a light-deactivated adhesive that is configured to release (i.e., lose the ability to adhere) when exposed to a particular wavelength of light (e.g., ultraviolet light). In such a case, the acrylic adhesive border may adhere to the patient until a caregiver applies light of the corresponding wavelength to deactivate the adhesive. For example, a light-deactivated adhesive marketed as Adhelight by Lumina may be included with the second border 122.

[0033] In some embodiments, the dressing 104 is manufactured with the second border 122 coupled to the first border 121 during the manufacturing process. In other embodiments, the second border 122 is manufactured and distributed as a separate piece from the first border 121, the drape 113, the dressing core 120. In such embodiments, the second border 122 is configured to allow a user to couple the second border 122 to the first border 121 when applying the dressing.

[0034] As shown in FIGS. 2 and 4, the dressing 104 can include release liners that cover the adhesive surfaces and the wound contact layer 114 until the dressing 104 is applied to the wound by a user (caregiver, patient, etc.). In the example shown, the dressing 104 includes a first release liner 200 configured to cover and release from the first border 121 (i.e., the silicone adhesive border) and a second release liner 208 configured to cover and release from the second border 122 (i.e., the acrylic border). The first release liner 200 includes a first material suitable to allowing the first release liner 200 to be easily removed from a silicone adhesive, while the second release liner 208 includes a second material suitable to allowing the second release liner 208 to be easily removed from an acrylic adhesive. The first material may be different from the second material.

[0035] The first release liner 200 includes a central release liner 202 positioned to cover and release from the wound contact layer 114 and longitudinally-central portions of the first border 121, a first end release liner 204 configured to cover and release from a first end of the first border 121 and a portion of the wound contact layer 114 proximate the first end, a second end release liner 206 configured to cover and release from a second end of the first border 121 and a portion of the wound contact layer 114 proximate the second end. The central release liner 202, the first end release liner 204, and the second end release liner 206 includes folds 210 at which the release liners 202-206 fold away from the wound contact layer 114 and the first border 121. The folds 210 provide a gripping area for a user to grab and pull on the release liners 202-206 to facilitate removal of the release liners 202-206 from the first border and the wound contact layer 114.

[0036] As shown in FIGS. 2 and 4, the second release liner 208 is shaped to cover the outer portion of the second border 122, i.e., the portion that extends beyond the first border 121. The second release liner 208 surrounds and is aligned with the first release liner 200 such that a patient-facing side of the dressing is substantially covered by the combination of the first release liner 200 and the second release liner 208. The second release liner 208 may be formed as one piece, in two portions, in three portions, in four portions, etc. In the example of FIG. 4, the second release liner 208 is formed in four portions. Each portion includes a tab 400 that can extend away from the second border 122 and is configured to be gripped by a user to facilitate the user in removing the second release liner 208 from the second border 122.

[0037] In some embodiments, for example as shown in FIG. 2, a top support layer 212 is included with the dressing 104 and is removeably coupled to the second border 122. The top support layer 212 is at least partially rigid and provides structure support to the second border 122, which is made of a flexible material configured to conform to a patient’s anatomy. The top support layer 212 can thereby protect the second border 122 from being folded, curled, deformed, etc. during distribution and storage of the dressing 104. The top support layer 212 can then be removed from the dressing 104 (i.e., from the second border 122) during application of the dressing 104 to a patient.

[0038] To apply the dressing 104 and to initiate wound therapy with the NPWT system 100, a user may first remove the first release liner 200 to expose the silicone adhesive border and the wound contact layer 114. The wound contact layer 114 and the dressing core 120 can be aligned with a wound and the silicone adhesive border can be sealed to the patient around the wound. The tube 106 can then be used to connect the dressing core 120 to the pump 102, and the pump 102 operated to test whether the seal is satisfactorily established between the silicone adhesive border and the patient. The first border 121 is configured to be shifted in location relative to the patient several times to facilitate a caregiver in achieving a desired location of the dressing 104 relative to the wound. Once the first border 121 is placed as desired and such that a seal between the first border 121 and the patient can be verified using the pump 102, a user can remove the second release liner 208 to expose the acrylic adhesive border of the second border 122. In an embodiment that includes the support layer 210, the user also removes the support layer 210 at this step. The acrylic adhesive can then be positioned against the patient around the first border 121 to couple the second border 122 in a substantially-fixed position on the patient.

[0039] In some cases, the silicone adhesive may provide a sufficient bond between the dressing 104 and the patient over the timespan of the dressing being applied that a caregiver may be inclined to believe that further retention structures are not necessary. However, the silicone adhesive may not provide sufficient retention over longer time spans. Accordingly, in some embodiments, the dressing 104 described herein advantageously includes the second border 122 as an integral part of the dressing 104, which may substantially prevent users from mistakenly omitting the acrylic adhesive. In some cases, the second release liner 208 includes brightly-colored tabs or other visual indications configured to substantially prevent a user from failing to remove the second release liner 208. The dressing 104 is thereby configured to reduce the risk of improper application of the dressing 104.

[0040] 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.

[0041] 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.