Device for negative pressure wound therapy

Abstract

Disclosed herein are several embodiments of negative pressure systems and methods of using negative pressure systems during wound treatment. Some embodiments are directed to systems utilizing wound dressings having at least three layers. These embodiments are directed to improved distribution of negative pressure to the wound and the surrounding peri-wound area. Some embodiments are directed to fixation strips for sealing the wound dressing to the wound and the peri-wound area. The fixation strips may comprise multiple layers, including an adhesive layer, a wound sealing layer, and at least one protective liner.

Description

[Technical Field]

[0001]

[0002] Embodiments of the present disclosure relate to methods and apparatus for dressing and treating wounds using reduced pressure or topical negative pressure (TNP) therapy. Specifically, but not exclusively, embodiments disclosed herein relate to negative pressure treatment devices, methods for controlling the operation of TNP systems, and methods of using TNP systems. [Background technology]

[0002] 2. Description of Related Art Many different types of wound dressings are known to aid in the healing process in humans and animals. These different types of wound dressings include many different types of materials and layers, such as gauze, pads, foam pads, or multi-layer wound dressings. Topical negative pressure (TNP) therapy, sometimes referred to as vacuum-assisted closure therapy, negative pressure wound therapy (NPWT), or reduced pressure wound therapy, is widely recognized as a beneficial mechanism for improving wound healing rates. Such therapy is applicable to a wide range of wounds, including surgical wounds, open wounds, and abdominal wounds.

[0003] TNP treatment may aid wound closure and healing by reducing tissue edema, promoting blood flow, granulation tissue formation, and removing excess exudate, reducing bacterial load and, therefore, wound infection. Furthermore, TNP treatment allows for less external trauma to the wound and promotes more rapid healing. Summary of the Invention

[0004] The embodiments of the invention disclosed herein are directed to apparatus, systems, devices, and methods for use in negative pressure wound therapy. Those skilled in the art will understand that the application of the materials, devices, methods, and systems described herein is not limited to any particular tissue or to any particular injury.

[0005] Some of the embodiments described herein provide a device for sealing a wound site. The device may include a fixation strip. The fixation strip may include a wound sealing layer and an adhesive layer. The wound sealing layer may include a first adhesive. For example, the wound sealing layer may include a first adhesive surface including the first adhesive. The adhesive layer may overlie and extend beyond the wound sealing layer. The adhesive layer may include a second adhesive. For example, the adhesive layer may include a second adhesive surface including the second adhesive. The fixation strip may include at least one protective liner removably adhered to the first adhesive surface of the wound sealing layer and / or the second adhesive surface of the adhesive layer.

[0006] In some embodiments, the fixation strip may be configured to fit over an edge of the wound dressing. The fixation strip may have a width and a length. The second adhesive may extend along the entire width of the fixation strip. The first adhesive may extend along a portion of the entire width of the fixation strip.

[0007] In some embodiments, the at least one protective liner may further include a first protective liner and a second protective liner. The first protective liner may be removably adhered to a first adhesive surface of the wound sealing layer, and the second protective liner may be removably adhered to a second adhesive surface of the adhesive layer. The first protective liner may include a peel handle that may be configured to remove the first protective liner from the wound sealing layer when activated. The second protective liner may include a peel handle that may be configured to remove the second protective liner from the adhesive layer when activated.

[0008] In some embodiments, the at least one protective liner may further include a first outer protective liner, a second outer protective liner, and a central protective liner. The first outer protective liner may be removably adhered to an outer edge portion of the first adhesive surface of the wound sealing layer. The second outer protective liner may be removably adhered to a portion of the second adhesive surface of the adhesive layer that extends outward beyond the wound sealing layer. The central protective liner may be removably adhered to the first adhesive surface of the wound sealing layer between the first outer protective liner and the second outer protective liner.

[0009] In some embodiments, at least one of the first outer protective liner, the second outer protective liner, and the central protective liner may include a peel handle configured to, upon actuation, detach the respective liner from the wound sealing layer and / or the adhesive layer.

[0010] In some embodiments, the first outer protective liner, the second outer protective liner, and the central protective liner may each have a width extending across the width of the fastening strip so as to removably adhere to the first adhesive surface of the wound sealing layer and a portion of the second adhesive surface of the adhesive layer extending outwardly beyond the wound sealing layer.

[0011] In some embodiments, the device for sealing a wound site may further comprise a carrier layer that may be removably adhered to the non-adhesive surface of the adhesive layer.

[0012] In some embodiments, the first adhesive comprises a silicone adhesive configured to adhere to the wound site or the skin surrounding the wound site. In some embodiments, the second adhesive comprises an acrylic adhesive configured to adhere to the wound dressing. In some embodiments, the wound sealing layer comprises a flexible polymer. In some embodiments, the adhesive layer comprises a flexible film.

[0013] Some embodiments described herein provide a negative pressure wound therapy kit. The negative pressure wound therapy kit may include a wound dressing and a fixation strip. The wound dressing may include a cover. The fixation strip may include a wound sealing layer and an adhesive layer. The wound sealing layer may include a first adhesive. For example, the wound sealing layer may include a first adhesive surface including the first adhesive. The adhesive layer may overlie the wound sealing layer and extend outward beyond the wound sealing layer. The adhesive layer may include a second adhesive. For example, the adhesive layer may include a second adhesive surface including the second adhesive. The fixation strip may include at least one protective liner removably adhered to the first adhesive surface of the wound sealing layer and / or the second adhesive surface of the adhesive layer.

[0014] In some embodiments, the at least one protective liner may further include a first protective liner and a second protective liner. The first protective liner may be removably adhered to a first adhesive surface of the wound sealing layer. The second protective liner may be removably adhered to a second adhesive surface of the adhesive layer.

[0015] In some embodiments, a portion of the second adhesive surface of the adhesive layer extending outward beyond the wound sealing layer may be configured to adhere to the cover of the wound dressing during use. In some embodiments, the at least one protective liner may further include a first outer protective liner, a second outer protective liner, and a central protective liner. The first outer protective liner may be removably adhered to an outer edge portion of the first adhesive surface of the wound sealing layer. The second outer protective liner may be removably adhered to the second adhesive surface of the adhesive layer extending outward beyond the wound sealing layer. The central protective liner may be removably adhered to the first adhesive surface of the wound sealing layer between the first outer protective liner and the second outer protective liner. The outer edge portion of the first adhesive surface of the wound sealing layer may face the portion of the adhesive layer extending outward beyond the wound sealing layer.

[0016] In some embodiments, the first outer protective liner, the second outer protective liner, and the central protective liner may each have a width extending across the width of the fastening strip so as to removably adhere to the first adhesive surface of the wound sealing layer and a portion of the second adhesive surface of the adhesive layer extending outwardly beyond the wound sealing layer.

[0017] In some embodiments, the fastening strip may further comprise a carrier layer that may be removably adhered to the non-adhesive surface of the adhesive layer.

[0018] Some of the embodiments described herein provide a method for sealing a wound dressing. The method may include positioning the wound dressing over a wound site and a peri-wound area surrounding the wound site, removing the central protective liner and the first outer protective liner from the first adhesive surface of the wound sealing layer and / or the second adhesive surface of the adhesive layer of the fixing strip, positioning the fixing strip over the peri-wound area and partially over the wound dressing, removing the second outer protective liner from the first adhesive surface of the wound sealing layer and / or the second adhesive surface of the adhesive layer of the fixing strip, adhering the contact layer of the fixing strip to a cover of the wound dressing, positioning a negative pressure applicator on the cover of the wound dressing, and applying negative pressure through the wound dressing to the wound site and the peri-wound area for a period of time. The wound dressing may include a cover. The fixation strip may include a wound sealing layer, an adhesive layer, a central protective liner, a first outer protective liner, and a second outer protective liner. The wound sealing layer of the fixation strip may include a first adhesive surface including a first adhesive. The adhesive surface may overlie and extend outward beyond the wound sealing layer. The adhesive layer of the fixation strip may include a second adhesive surface including a second adhesive.

[0019] In some embodiments, the disclosed methods may further include cutting the wound dressing along a side portion of the wound dressing prior to positioning the wound dressing over the wound site and perilous area.

[0020] Some of the embodiments described herein provide a method for sealing a wound dressing. The method may include cutting the wound dressing along a side portion of the wound dressing, using a peel handle of the first protective liner to remove the first protective liner from a first adhesive surface of the wound sealing layer of the fixation strip, positioning the fixation strip over a peri-wound area surrounding the wound site, inserting the side portion of the wound dressing into the fixation strip between the wound sealing layer and the adhesive layer, positioning the wound dressing over the wound site and peri-wound area, using a peel handle of the second protective liner to remove the second protective liner from the second adhesive surface of the adhesive layer, adhering the adhesive layer of the fixation strip to the wound dressing, positioning a negative pressure applicator on the wound dressing, and applying negative pressure through the wound dressing to the wound site and peri-wound area for a period of time. The wound dressing may include a cover. The fixation strip may include a wound sealing layer, an adhesive layer, a first protective liner, and a second protective liner. The wound sealing layer of the fixation strip may include a first adhesive surface including a first adhesive. The adhesive surface may overlie the wound sealing layer and extend outward beyond the wound sealing layer. The adhesive layer of the fixation strip may include a second adhesive surface including a second adhesive. The first protective liner of the fixation strip may include a peel handle. The second protective liner of the fixation strip may include a peel handle.

[0021] In some embodiments, the fixation strip may further comprise a carrier layer that may be removably adhered to the non-adhesive surface of the adhesive layer. The disclosed methods may further include removing the carrier layer from the fixation strip prior to applying negative pressure to the wound site and perilous area.

[0022] Some of the embodiments described herein provide a device for sealing a wound site. The device includes a sheet having a plurality of fastening strips and perforated portions. Each of the perforated portions may be positioned between adjacent fastening strips. Each of the perforated portions may include two perforated sections and a continuous cut section positioned between the two perforated sections. The two perforated sections may include a plurality of perforations separated by a bridge portion extending between adjacent fastening strips. Each of the plurality of fastening strips may include an adhesive layer, a first outer protective liner, a second outer protective liner, and a central protective liner. Each of the protective liners may be removably adhered to the adhesive layer. The continuous cut section may extend along at least the entire length of the central protective liner.

[0023] In some embodiments, each of the plurality of fixation strips may be configured to be placed over a portion of the wound dressing, which may include an edge of the wound dressing.

[0024] In some embodiments, the adhesive layer of each of the plurality of fixation strips may comprise an adhesive surface. In some embodiments, the adhesive surface may comprise a silicone adhesive configured to adhere to the wound site or the skin surrounding the wound site. In some embodiments, the adhesive may comprise an acrylic adhesive configured to adhere to a wound dressing.

[0025] In some embodiments, the first outer protective liner of each of the plurality of fixation strips can include a first peel handle and the second outer protective liner can include a second peel handle. In some embodiments, the central protective liner of each of the plurality of fixation strips can be positioned over the first peel handle and the second peel handle.

[0026] In some embodiments, each of the plurality of fixation strips may include a wound sealing layer including a first adhesive. In some embodiments, the adhesive layer may overlie the wound sealing layer and extend outwardly beyond the wound sealing layer. In some embodiments, the adhesive layer may include a second adhesive. In some embodiments, the first adhesive may include a silicone adhesive and the second adhesive may include an acrylic adhesive.

[0027] In some embodiments, each of the plurality of fastening strips may comprise a carrier layer removably adhered to a non-adhesive surface of the adhesive layer. In some embodiments, the plurality of fastening strips may be removably attached. In some embodiments, the length of each of the perforated portions may extend the length of each of the plurality of fastening strips. [Brief explanation of the drawings]

[0028] [Figure 1] 1 illustrates a reduced pressure wound therapy system according to some embodiments. [Figure 2] 1 illustrates a pump assembly and canister, according to some embodiments. [Figure 3] FIG. 1 illustrates a schematic diagram of electrical components of a pump assembly according to some embodiments. [Figure 4A] 1 illustrates an embodiment of a negative pressure wound therapy system including a pump and a flexible suction adapter being applied to a wound. [Figure 4B] 4B illustrates the embodiment of FIG. 4A with the flexible suction adapter placed over the wound. [Figure 5A] 1 illustrates an isometric view of a flexible suction adapter that may be used in a negative pressure wound therapy system. [Figure 5B] 5B illustrates an exploded view of the flexible suction adapter of FIG. 5A. [Figure 5C] 5C illustrates a close-up view of the proximal end of the flexible suction adapter of FIG. 5B. [Figure 5D] 2B illustrates an enlarged cutaway view of the proximal end of the flexible suction adapter of FIG. 2A. [Figure 5E]5B illustrates a top view of the flexible suction adapter of FIG. 5A. [Figure 5F] 5B illustrates a side view of the flexible suction adapter of FIG. 5A. [Figure 5G] 5B illustrates a bottom view of the flexible suction adapter of FIG. 5A. [Figure 6] 10 illustrates an exploded view of an alternative flexible suction adapter. [Figure 7A] 1 illustrates an embodiment of a negative pressure wound therapy system using a pump, a flexible fluid connector, and a wound dressing capable of absorbing and storing wound exudate. [Figure 7B] 1 illustrates an embodiment of a negative pressure wound therapy system using a flexible fluid connector and a wound dressing capable of absorbing and storing wound exudate. [Figure 7C] 1 illustrates a cross section of one embodiment of a fluid connector connected to a wound dressing. [Figure 8A] 1 illustrates an embodiment of a wound dressing in which a negative pressure source and / or other electronic components are integrated into the wound dressing. [Figure 8B] 1 illustrates an embodiment of the layers of the wound dressing in which the pump and electronic components are offset from the absorbent area of ​​the dressing. [Figure 9A] 1 illustrates a cross-sectional side view along the length of one embodiment of a fastening strip. [Figure 9B] 9B illustrates a cross-sectional side view along the width of one embodiment of the fastening strip shown in FIG. 9A. [Figure 10A] 1 illustrates a top view of the dressing before application of the fastening strips. [Figure 10B] FIG. 10B illustrates a top view of the dressing shown in FIG. 10A with fastening strips. [Figure 11A] 1 illustrates a cross-sectional side view of one embodiment of a fastening strip as it is being applied to a dressing. [Figure 11B] 1 illustrates a cross-sectional side view of one embodiment of a fastening strip as it is being applied to a dressing. [Figure 11C] 1 illustrates a cross-sectional side view of one embodiment of a fastening strip as it is being applied to a dressing. [Figure 11D] 1 illustrates a cross-sectional side view of one embodiment of a fastening strip as it is being applied to a dressing. [Figure 11E] 1 illustrates a cross-sectional side view of one embodiment of a fastening strip as it is being applied to a dressing. [Figure 11F] 1 illustrates a cross-sectional side view of one embodiment of a fastening strip as it is being applied to a dressing. [Figure 12A] 1 illustrates a top view of one embodiment of a sheet of multiple fastening strips. [Figure 12B] 12B illustrates a cross-sectional side view of the fastening strip shown in FIG. 12A. [Figure 12C] 12B illustrates a close-up view of the perforation pattern of the perforated section of the sheet shown in FIG. 12A. [Figure 13A] 1 illustrates an exploded view and a perspective view of one embodiment of a drape according to certain aspects of the present disclosure. [Figure 13B] 1 illustrates an exploded view and a perspective view of one embodiment of a drape according to certain aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0029]

[0003] Embodiments disclosed herein relate to apparatus, systems, devices, and methods for treating wounds with reduced pressure. As used herein, a reduced pressure or negative pressure level, such as -X mmHg, refers to a pressure level relative to normal ambient air pressure, which may correspond to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Thus, a negative pressure value of -X mmHg reflects an absolute pressure that is X mmHg less than 760 mmHg, or in other words, an absolute pressure of (760-X) mmHg. Furthermore, a negative pressure "lower" or "smaller" than X mmHg corresponds to a pressure closer to atmospheric pressure (e.g., -40 mmHg is lower than -60 mmHg). A negative pressure "higher" or "larger" than -X mmHg corresponds to a pressure further from atmospheric pressure (e.g., -80 mmHg is higher than -60 mmHg). In some embodiments, the local ambient pressure is used as a reference point, and such local pressure may not necessarily be, for example, 760 mmHg.

[0030] Embodiments of the present disclosure are generally applicable for use in topical negative pressure (TNP) or reduced pressure therapy systems. Briefly, negative pressure wound therapy can assist in the closure and healing of many forms of "difficult-to-heal" wounds by reducing tissue edema, promoting blood flow and granulation tissue formation, and removing excessive exudate, reducing bacterial load (and therefore infection risk). Additionally, treatment can reduce wound unrest, leading to faster healing. TNP treatment systems can also assist in the healing of surgically closed wounds by removing fluid. In some embodiments, TNP treatment helps stabilize tissues in opposition to closure. Further beneficial uses of TNP treatment can be found in grafts and flaps, where removal of excess fluid is important and graft proximity to tissue is required to ensure tissue viability.

[0031] Embodiments described herein relate to materials, devices, methods, and systems that incorporate, comprise, or utilize a wound contact layer ("WCL") for positioning in contact with a wound. The WCL may be utilized as a stand-alone component for separate positioning at the wound site, or may be incorporated into any number of multi-layer wound dressings and wound treatment devices, such as those described below with respect to Figures 1-9. Embodiments of the present disclosure are generally applicable for use in negative or reduced pressure therapy systems, or compression therapy systems, under ambient conditions.

[0032] Some of the preferred embodiments described herein incorporate, comprise, or utilize a multicare wound contact layer. Such multicare WCL possesses two or more of the following functional characteristics: antimicrobial activity, ease of application and / or removal as one piece, ease of cutting with scissors, conformability to the three-dimensional contours of the wound surface, abrasion resistance, compatibility with negative pressure wound therapy and / or pressure wound therapy, exudate management, ability to facilitate autolytic debridement of the wound, ability to promote wound healing, and self-representation of compositional or functional changes.

[0033] Certain embodiments described herein provide a wound treatment system. Such a wound treatment system may include a stand-alone layer of a multicare WCL configured to be sized for placement on a wound. The wound treatment system may further include a secondary wound dressing configured to be separately positioned on the multicare WCL. The multicare WCL may have an adhesive attached to its underside, the adhesive configured to place the multicare WCL adjacent to the wound. The secondary wound dressing, when used, can adhere to the skin surrounding the wound and may be the same size as the multicare WCL or larger than the multicare WCL so that the multicare WCL contacts or is placed adjacent to the wound. Alternatively or additionally, the secondary wound dressing may be configured to form a seal against the skin surrounding the wound so that the multicare WCL contacts or is placed adjacent to the wound. The wound treatment system may further include a negative pressure source configured to supply negative pressure to the wound through the secondary wound dressing and through the multicare wound contact layer.

[0034] Certain other embodiments described herein provide multi-layer wound dressings as described herein with respect to Figures 1-9. Such multi-layer wound dressings can incorporate a Multicare WCL as a component layer thereof, or alternatively, can comprise a composite or laminate including a Multicare WCL as part of one of its component layers. The multi-layer wound dressing can comprise a Multicare wound contact layer as described above or elsewhere herein, a transmission layer and / or absorbent layer over the Multicare wound contact layer, and a cover layer over the transmission layer and / or absorbent layer. The wound dressing can further comprise an adhesive layer on the underside of the Multicare wound contact layer. The wound dressing can further comprise a negative pressure port positioned on or above the cover layer. The Multicare wound contact layer can have a perimeter that is substantially the same as the perimeter of the cover layer. Alternatively, the Multicare wound contact layer can have a perimeter that is smaller than the perimeter of the cover layer.

[0035] Some embodiments described herein provide methods for treating wounds or loci. Such methods may include placing a multicare WCL on the wound, either separately or by placing a multi-layer wound dressing with the multicare WCL. The method may include adhering the separate multicare WCL and / or the multi-layer wound dressing with the multicare WCL to healthy skin surrounding the wound. The method may further include one or more of the following steps: An additional wound dressing may be placed on the separate multicare WCL or the multi-layer wound dressing with the multicare WCL placed on the wound. Wound exudate, or any moist or aqueous medium other than wound exudate, may be provided to reach and / or contact the multicare WCL. Wound exudate, or any moist or aqueous medium other than wound exudate, may be diffused or wicked into the wound dressing incorporating the multicare WCL or into the wound dressing provided on the multicare WCL. Negative pressure can be applied to a separate Multicare WCL or a multi-layer wound dressing with a Multicare WCL, so that wound exudate is drawn directly into the Multicare WCL, or into a wound dressing incorporating the Multicare WCL, or into a wound dressing provided on top of the Multicare WCL.

[0036] Negative pressure system FIG. 1 illustrates an embodiment of a negative pressure or reduced pressure wound therapy (or TNP) system 100 including a wound cavity 110 and a wound packing material 130 disposed within the wound cavity sealed by a wound cover 120. The wound packing material 130 in combination with the wound cover 120 may be referred to as a wound dressing. A flow path 140, such as a single or multiple lumen tube or conduit, connects the wound cover 120 to a negative pressure wound therapy device, e.g., a pump assembly 150, configured to provide reduced pressure. The wound cover 120 may be in fluid communication with the wound cavity 110. In some system embodiments disclosed herein, such as the embodiment shown in FIG. 1, the pump assembly may be a canisterless pump assembly (meaning that exudate is collected in the wound dressing or conveyed via the tube 140 for collection at another location). However, some pump assembly embodiments disclosed herein may be configured to include or support a canister. Additionally, in some system embodiments disclosed herein, some pump assembly embodiments may be attached to, supported by, or adjacent to a dressing. The wound packing material 130 may be of any suitable type, such as hydrophilic or hydrophobic foam, gauze, an inflatable bag, etc. The wound packing material 130 may conform to the wound cavity 110 so that it substantially fills the cavity. The wound cover 120 may provide a substantially fluid-impermeable seal over the wound cavity 110. The wound cover 120 may have a top surface and a bottom surface, with the bottom surface adhesively sealing (or in any other suitable manner) the wound cavity 110. The conduit 140 or lumen or any other conduit or lumen disclosed herein may be formed from polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.

[0037] Some embodiments of the wound cover 120 may have a port (not shown) configured to receive the end of the conduit 140. In other embodiments, the conduit 140 may otherwise pass through or beneath the wound cover 120 to supply reduced pressure to the wound cavity 110 to maintain a desired level of reduced pressure within the wound cavity. The conduit 140 may be any suitable article configured to provide at least a substantially sealed fluid flow path between the pump assembly 150 and the wound cover 120 to supply the reduced pressure provided by the pump assembly 150 to the wound cavity 110. The wound cover 120 and the wound packing material 130 may be provided as a single article or an integral single unit. In some embodiments, no wound packing material may be provided, and the wound cover may be considered a wound dressing in its own right. The wound dressing may then be connected to a negative pressure source, such as the pump assembly 150, via the conduit 140. The pump assembly 150 may be miniaturized and portable, although larger, conventional such pumps may also be used.

[0038] The wound cover 120 may be positioned over the wound site to be treated. The wound cover 120 may form a substantially sealed cavity or enclosed space over the wound site. In some embodiments, the wound cover 120 may be configured with a highly water vapor permeable film to allow evaporation of excess fluid and may have a superabsorbent material included therein to safely absorb wound exudate. It will be understood that references to wounds are made throughout this specification. In this regard, it should be understood that the term wound is to be broadly interpreted to encompass open and closed wounds where the skin is torn, incised, or punctured, or where trauma has caused a bruise, or any other surface or other condition or defect in the skin of a patient or other person who would benefit from reduced pressure treatment. A wound is therefore broadly defined as any damaged area of ​​tissue that may or may not produce fluid. Examples of such wounds include, but are not limited to, acute wounds, chronic wounds, surgical incisions and other incisions, subacute and dehiscence wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, traumatic ulcers and venous ulcers, etc. The components of the TNP system described herein may be particularly suitable for surgical wounds that exude small amounts of wound exudate.

[0039] Some embodiments of the system are designed to operate without the use of an exudate canister. Some embodiments may be configured to support an exudate canister. In some embodiments, configuring the pump assembly 150 and tubing 140 so that the tubing 140 can be quickly and easily removed from the pump assembly 150 can facilitate or improve the process of replacing the coating or the pump, if necessary. Some pump embodiments disclosed herein may be configured with any suitable connection between the tubing and the pump.

[0040] In some embodiments, pump assembly 150 can be configured to deliver a negative pressure of approximately −80 mmHg, or between about −20 mmHg and −200 mmHg. Note that these pressures are relative to normal ambient atmospheric pressure; i.e., −200 mmHg may practically be approximately 560 mmHg. The pressure range can be between about −40 mmHg and −150 mmHg. Alternatively, a pressure range up to −75 mmHg, up to −80 mmHg, or above −80 mmHg can be used. Pressure ranges below −75 mmHg can also be used. Alternatively, a pressure range of approximately −100 mmHg or even above 150 mmHg can be provided by pump assembly 150. In some embodiments, pump assembly 150 is configured to provide continuous or intermittent negative pressure therapy. Continuous therapy can be delivered above -25mmHg, -25mmHg, -40mmHg, -50mmHg, -60mmHg, -70mmHg, -80mmHg, -90mmHg, -100mmHg, -120mmHg, -140mmHg, -160mmHg, -180mmHg, -200mmHg, or below -200mmHg. Intermittent therapy can be delivered between low and high negative pressure settings. The low setting can be set to above 0 mmHg, 0 mmHg, −25 mmHg, −40 mmHg, −50 mmHg, −60 mmHg, −70 mmHg, −80 mmHg, −90 mmHg, −100 mmHg, −120 mmHg, −140 mmHg, −160 mmHg, −180 mmHg, or below −180 mmHg. The high setting can be set to above −25 mmHg, −40 mmHg, −50 mmHg, −60 mmHg, −70 mmHg, −80 mmHg, −90 mmHg, −100 mmHg, −120 mmHg, −140 mmHg, −160 mmHg, −180 mmHg, −200 mmHg, or below −200 mmHg. During intermittent therapy, negative pressure at a low setting can be delivered for a first duration, and at the end of the first duration, negative pressure at a higher setting can be delivered for a second duration. At the end of the second duration, negative pressure at the lower setting can be delivered. The first and second durations can be the same or different.The first and second durations can be selected from the following ranges: less than 2 minutes, 2 minutes, 3 minutes, 4 minutes, 6 minutes, 8 minutes, 10 minutes, or more than 10 minutes. In some embodiments, switching between the low and high settings can be performed according to a step waveform, a square wave, a sine waveform, etc.

[0041] In some embodiments, the TNP system 100 may include multiple wound dressings connected to the pump assembly 150. The performance and wound healing capabilities (such as fluid management) of a TNP system with multiple wound dressings with pump assembly 150 can match or exceed the performance and wound healing capabilities of a standard single wound dressing with a single pump setup.

[0042] In operation, the wound packing 130 is inserted into the wound cavity 110 and the wound cover 120 is placed to seal the wound cavity 110. The pump assembly 150 provides a source of negative pressure to the wound cover 120 that permeates through the wound packing 130 and into the wound cavity 110. Fluid (e.g., wound exudate) may be drawn through the conduit 140 and stored in the canister. In some embodiments, the fluid is absorbed by the wound packing 130 or one or more absorbent layers (not shown).

[0043] Wound dressings that may be utilized with the pump assembly and other embodiments of the present application include Renasys-F, Renasys-G, Renasys AB, and Pico dressings available from Smith & Nephew. Any of the dressings described herein may be used with Smith & Nephew's Renasys soft port connector, or interface between the dressing and the pump assembly. For example, a Renasys soft port connector may be positioned in the flow path 140 and serve as a port for the wound dressing. In other embodiments, other suitable wound dressings may be utilized.

[0044] Pump Assembly and Canister FIG. 2 illustrates a front view 200 of a pump assembly 230 and canister 220 according to some embodiments. As illustrated, the pump assembly 230 and canister are connected, thereby forming a TNP device or system. The pump assembly 230 includes one or more indicators, such as a visual indicator 202 configured to indicate an alarm and a visual indicator 204 configured to indicate the status of the TNP system. The indicators 202 and 204 can be configured to alert a user, such as a patient or healthcare provider, of various operational or fault conditions of the system, including alerting the user of a normal or proper operating condition, a pump fault, power supplied to the pump or a power failure, detection of a leak in the wound cover or flow path, a suction blockage, a no-flow condition, a canister-full condition, or any other similar or suitable condition, or combination thereof. The pump assembly 230 can include additional indicators. The pump assembly can use a single indicator or multiple indicators. Any suitable indicator can be used, for example, a visual indicator, an audio indicator, a tactile indicator, etc. The indicator 202 may be configured to indicate a warning condition, such as, for example, a full canister, low power, a disconnected conduit 140, or a broken seal in the wound seal 120. The indicator 202 may be configured to display a red flashing light to attract the user's attention. The indicator 204 may be configured to indicate the status of the TNP system, such as, for example, that therapy delivery is normal, that a leak has been detected, or the like. The indicator 204 may be configured to display one or more different colored lights, such as, for example, green, yellow, etc. For example, a green light may be emitted when the TNP system is operating properly, and a yellow light may be emitted to indicate a warning.

[0045] Pump assembly 230 includes a display or screen 206 mounted in a recess 208 formed within the pump assembly's case. Display 206 may be a touchscreen display. Display 206 can support playback of audiovisual (AV) content, such as instructional videos. As described below, display 206 may be configured with several screens or graphical user interfaces (GUIs) for configuring, controlling, and monitoring the operation of the TNP system. Pump assembly 230 includes a grip portion 210 formed within the pump assembly's case. Grip portion 210 may be configured to assist a user in holding pump assembly 230, for example, during removal of canister 220. Canister 220 may be replaced with another canister, for example, when canister 220 is filled with fluid.

[0046] The pump assembly 230 may include one or more keys or buttons 212 configured to allow a user to operate and monitor the operation of the TNP system. As illustrated, buttons 212a, 212b, and 212c are included. Button 212a may be configured as a power button for turning the pump assembly 230 on and off. Button 212b may be configured as a play / pause button for the delivery of negative pressure therapy. For example, pressing button 212b may start therapy, and then pressing button 212b may pause or end therapy. Button 212c may be configured to lock the display 206 or buttons 212. For example, pressing button 212c may prevent a user from unintentionally altering therapy delivery. Pressing button 212c may release control. In other embodiments, additional buttons may be used, or one or more of the illustrated buttons 212a, 212b, or 212c may be omitted. Multiple key presses or sequential key presses can be used to operate the pump assembly 230 .

[0047] The pump assembly 230 may include one or more latch recesses 222 formed in the cover. In an exemplary embodiment, two latch recesses 222 may be formed on opposite sides of the pump assembly 230. The latch recesses 222 may be configured to allow attachment and detachment of the canister 220 using one or more canister latches 221. The pump assembly 230 includes an air outlet 224 for removing and venting air from the wound cavity 110. Air entering the pump assembly may pass through one or more suitable filters, such as an antibacterial filter. This may maintain the reusability of the pump assembly. The pump assembly 230 includes one or more strap attachments 226 for connecting a carrying strap to the pump assembly 230 or for attaching a cradle. In an exemplary embodiment, two strap attachments 226 may be formed on opposite sides of the pump assembly 230. In some embodiments, various of these features are omitted, or various additional features are added to the pump assembly 230.

[0048] The canister 220 may be configured to hold fluid (e.g., exudate) removed from the wound cavity 110. The canister 220 includes one or more latches 221 for attaching the canister to the pump assembly 230. In an exemplary embodiment, the canister 220 includes two latches 221 on either side of the canister. The exterior of the canister 220 may be formed from a matte plastic such that the canister is substantially opaque and the contents of the canister are substantially hidden in a plan view. The canister 220 includes a grip portion 214 formed within the canister's casing. The grip portion 214 may be configured to allow a user to hold the pump assembly 220, such as during removal of the canister from the device 230. The canister 220 includes a substantially transparent window 216, which may also include volumetric graduations. For example, the 300 mL canister 220 shown includes graduations of 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, and 300 mL. Other embodiments of the canister can hold different amounts of fluid and include different graduation scales. For example, the canister can be an 800 mL canister. The canister 220 includes a tubing channel 218 for connecting to the conduit 140. In some embodiments, one or more features, such as the grip portion 214, are omitted, or various additional features are added to the canister 220. Any of the disclosed canisters may include a solidifying agent or may omit a solidifying agent.

[0049] Electronics and Software FIG. 3 illustrates an electrical component schematic 300 of a pump assembly, such as pump assembly 230, according to some embodiments. The electrical components can operate to accept user input, provide output to a user, operate the pump assembly and TNP system, provide network connectivity, and the like. The electrical components can be mounted on one or more printed circuit boards (PCBs). As illustrated, the pump assembly can include multiple processors. Utilizing multiple processors can be advantageous to apportion or assign various tasks to the various processors. A first processor can be responsible for user activity, and a second processor can be responsible for controlling the pump. In this manner, pump control activities that may require a higher level of responsiveness (corresponding to a higher risk level) can be offloaded to a dedicated processor and thereby not be interrupted by user interface tasks that may take longer to complete due to user interaction.

[0050] The pump assembly may include a user interface processor or controller 310 configured to operate one or more components, such as the display 206, buttons 212, etc., to accept user input and provide output to the user. Inputs to and outputs from the pump assembly may be controlled by an input / output (I / O) module 320. For example, the I / O module may receive data from one or more ports, such as serial, parallel, or hybrid ports. The processor 310 also receives data and provides it to one or more expansion modules 360, such as one or more USB ports, SD ports, compact disc (CD) drives, DVD drives, FireWire ports, Thunderbolt ports, PCI Express ports, etc. The processor 310, along with other controllers or processors, stores data in one or more memory modules 350, which may be internal or external to the processor 310. Any suitable type of memory may be used, including volatile or non-volatile memory, such as RAM, ROM, magnetic memory, solid-state memory, or magnetoresistive random access memory (MRAM).

[0051] In some embodiments, processor 310 may be a general-purpose controller, such as a low-power processor. In other embodiments, processor 310 may be an application-specific processor. Processor 310 may be configured as a "central" processor within the electronic architecture of the pump assembly, where processor 310 may coordinate the operations of other processors, such as pump control processor 370, communications processor 330, and one or more additional processors 380 (e.g., a processor for controlling display 206, a processor for controlling buttons 212, etc.). Processor 310 may run a suitable operating system, such as Linux, Windows CE, VxWorks, etc.

[0052] The pump control processor 370 may be configured to control the operation of the negative pressure source or pump 390. The pump 390 may be a suitable pump, such as a membrane pump, a peristaltic pump, a rotary pump, a rotary vane pump, a scroll pump, a screw pump, a liquid ring pump, a pump operated by a piezoelectric transducer (e.g., a diaphragm pump), or a voice coil pump. The pump control processor 370 may use data received from one or more pressure sensors to measure the pressure within the fluid flow path, calculate the fluid flow rate, and control the pump. The pump control processor 370 may control an actuator, such as a pump motor, to achieve a desired level of negative pressure within the wound cavity 110. The desired level of negative pressure may be selected by a pressure setting or by a user. In various embodiments, the pump control processor 370 controls the pump actuator (e.g., the pump motor) using pulse width modulation (PWM). The control signal for driving the pump actuator may be a 0-100% duty cycle PWM signal. The pump control processor 370 may perform flow rate calculations and detect various conditions within the fluid flow path. Pump control processor 370 may communicate information to processor 310. Pump control processor 370 may include internal memory or may utilize memory 350. Pump control processor 370 may be a low power processor.

[0053] The communications processor 330 may be configured to provide wired or wireless connectivity. The communications processor 330 may utilize one or more antennas 340 to transmit and receive data. The communications processor 330 may provide one or more connection types, such as global positioning system (GPS) technology, cellular connectivity (e.g., 2G, 3G, LTE, 4G), Wi-Fi connectivity, or Internet connectivity. The connectivity may be used for various activities, such as pump assembly location tracking, asset tracking, compliance monitoring, remote selection, uploading logs, alerts, and other operational data, adjusting therapy settings, and software or firmware upgrades. The communications processor 330 may provide dual GPS / cellular functionality. The cellular functionality may be, for example, 3G functionality. In such cases, if the GPS module is unable to establish a satellite connection due to various factors, such as atmospheric conditions, building or terrain interference, satellite geometry, or the like, the device's location may be determined using a 3G network connection, such as by using cellular authentication, triangulation, forward link timing, or the like. The pump assembly may include a SIM card, allowing SIM-based location information to be obtained.

[0054] The communications processor 330 may communicate information to the processor 310. The communications processor 330 may include internal memory or may utilize memory 350. The communications processor 330 may be a low-power processor.

[0055] In some embodiments, the pump assembly can track and store various data, such as one or more of positioning data, therapy parameters, logs, device data, etc. The pump assembly can track and log therapy and other operational data. The data can be stored in memory 350, for example.

[0056] In some embodiments, using the connection provided by the communications processor 330, the device can upload any data stored, maintained, and / or tracked by the pump assembly. Information can be uploaded to a remote computer or server, including, for example, an activity log containing therapy delivery information, such as therapy duration; an alarm log containing alarm types and times of occurrence; an error log containing internal error information, transmission errors, etc.; therapy duration information, which may be calculated by hour, day, etc.; total therapy time, including the duration of therapy since a particular therapy program or programs were first applied; lifetime therapy information; device information, such as serial number, software version, battery level, etc.; device location information; patient information; and the like. The device can also download therapy selections and various operational data, such as parameters, firmware and software patches and upgrades. The pump assembly can provide internet browsing capabilities using one or more browser programs, email programs, application software (e.g., apps), etc.

[0057] In some embodiments, the communications processor 330 may use the antenna 340 to communicate the location of the pump assembly, such as the location of the pump assembly housing, to other devices in close proximity (e.g., within 10, 20, or 50 meters) of the pump assembly. The communications processor 330 may communicate one-way or two-way with other devices, depending on the implementation. Communications transmitted by the communications processor 330 may also include identification information to uniquely identify the pump assembly relative to one or more other pump assemblies in the vicinity of the pump assembly. For example, the identification information may include a serial number or a value derived from the serial number. The signal strength of communications transmitted by the communications processor 330 may be controlled (e.g., maintained at a constant or substantially constant level) to allow another device to determine the distance to the pump assembly, such as the distance between the device and the pump assembly.

[0058] In some embodiments, the communications processor 330 can communicate with other devices in the vicinity of the pump assembly so that the communications processor 330 itself can determine the distance from the pump assembly to the other devices. In such embodiments, the communications processor 330 can track and store the distance from the pump assembly to the other devices or provide an indication of changes in distance over time, and the communications processor 330 can later provide this information to the other devices. For example, the communications processor 330 can determine the length of time the pump assembly has been removed from the device's coverage area and then report this time to the device when it returns to the coverage area.

[0059] Flexible Suction Adapter 4A-6 illustrate an embodiment of a negative pressure wound therapy system 5501 similar to the embodiment illustrated in FIG. 1. Here, the system 5501 may include a flexible suction adapter 5500 having a bridge portion 5502 including a proximal end 5503 and a distal end 5505, and an applicator 5520 at the distal end 5505 of the bridge portion 5502 forming the flexible suction adapter 5500. A connector 5504 is preferably disposed at the proximal end 5503 of the bridge portion 5502 to connect to at least one of the channels 5512 and / or 5516, as shown in FIG. 4B. A cap 5536 may be provided with the system 5501 (and in some cases, may be attached to the connector 5504, as illustrated). The cap 5536 may be useful in preventing fluid from leaking out of the proximal end 5503. The system 5501 may include a source of negative pressure, such as a pump or negative pressure unit 5534 capable of supplying negative pressure. The pump may preferably comprise a canister or other container that stores wound exudate and other fluids that may be removed from the wound. In some embodiments, the pump 5534 may be the pump 200 described in connection with FIG. 2. In some embodiments, the pump 5534 may be a RENASYS GO pump sold by Smith & Nephew. The pump 5534 may be connected to the connector 5504 via tubing 5540. In use, the applicator 5520 is placed across a gap 5535 formed in a drape 5531, which is placed over a suitably prepared wound 5530, which in some cases may be filled with wound packing material such as foam or gauze. The pump 5534, which is connected to the connector 5504 via tubing 5540, then activates the pump, thereby supplying negative pressure to the wound. The application of negative pressure may be continued until a desired level of healing of the wound 5530 is achieved.

[0060] In some embodiments, the bridge portion 5502 may include a top channel layer 5512 positioned between the top layer 5510 and the middle layer 5514, and a bottom channel layer 5516 positioned between the middle layer 5514 and the bottom layer 5518. Preferably, the layers 5510, 5514, and 5518 have elongated portions extending between their proximal and distal ends and may comprise a fluid-impermeable material, e.g., a polymer such as polyurethane. Of course, the layers 5510, 5514, and 5518 may each be constructed from different materials, including semi-permeable materials. In some embodiments, one or more of the layers 5510, 5514, and 5518 may be at least partially transparent. As shown in FIG. 5B, the top layer 5510 and the bottom layer 5518 may be curved, curled, or convex outwardly along most of their lengths. During assembly, for example, layers 5510, 5514, and 5518 may be sandwiched together and the layers welded or glued together. In doing so, the proximal ends of channels 5512 and 5516 may be sandwiched between these layers, thus partially compressing the proximal ends of channels 5512, 5516 and stretching layers 5510, 5514, 5518 over these aforementioned proximal ends. Of course, the proximal ends of the material used in bridge portion 5502 are not necessarily rounded or curved; they can be substantially squared and kept straight, as shown in FIG. 6 .

[0061] The upper channel layer 5512 and the lower channel layer 5516 are preferably elongated layers extending from the proximal end 5503 to the distal end 5505 and each preferably comprise a porous material including, for example, an open-cell foam such as polyethylene or polyurethane. In some embodiments, one or more of the upper channel layer 5512 and the lower channel layer 5516 may be comprised of, for example, a knitted or woven spacer fabric (such as a knitted polyester 3D fabric, Baltex 7970®, or Gehring 879®) or a nonwoven material. Suitable materials may also include terry or loop pile materials. The fibers are not necessarily woven and may include felt and flock fiber materials (including materials such as Flotex®). The material selected preferably directs wound exudate away from the wound, allows negative pressure and / or exhaled air to pass to the wound site, and may also provide a degree of kink or occlusion resistance to the channel layers 5512 and 5516, as described below. In one embodiment, the upper channel layer 5512 may comprise an open-cell foam such as polyurethane, and the lower channel layer may comprise a fabric as described herein. In another embodiment, the upper channel layer is optional, and the system may instead be provided with an open upper channel. In the embodiment shown in FIG. 5B, the upper channel layer 5512 may have a curved, rounded, or upwardly convex upper surface and a substantially flat lower surface, and the lower channel layer 5516 may have a curved, rounded, or downwardly convex lower surface and a substantially flat upper surface.

[0062] In some embodiments, the fabric may have a three-dimensional (3D) structure, with one or more types of fibers forming a fibrous structure in all three dimensions. Such fabrics may aid in wicking, fluid transport, and / or transmission of negative pressure in some cases. To prevent channels 5512 and / or 5516 from shifting or twisting while contained within system 5501, which may impair the performance of each channel under negative pressure, in some embodiments, it may be preferable to adhere or otherwise secure channels 5512 and / or 5516 to one or more of layers 5510, 5514, and 5518. In certain embodiments, these materials remain open and are capable of transmitting negative pressure to the wound area under typical pressures used in negative pressure treatment, e.g., 40-150 mmHg, although higher and lower values ​​are possible. In some embodiments, the fabric may comprise several layers of material stacked or laminated on top of each other, which may be useful in some cases to prevent the channel 5516 from collapsing under negative pressure. In other embodiments, the fabric used for the channel 5516 may be 1.5 mm to 6 mm thick, and more preferably, the fabric may be 3 mm to 6 mm thick and may consist of one or several individual fabric layers. In other embodiments, the channel 5512 may be 1.2 mm to 3 mm thick, and preferably thicker than 1.5 mm. Additionally, as previously mentioned, the materials used for the system 5501 are preferably comfortable and soft, which may help avoid pressure sores and other complications that may result from a wound treatment system being pressed against a patient's skin.

[0063] In some embodiments, the distal ends of layers 5510, 5514, and 5518, as well as channel layers 5512 and 5516, may be expanded at their distal ends (placed over the wound site) to form a "teardrop" or other expanded shape. The distal ends of at least layers 5512, 5514, 5516, and 5518 may also be provided with at least one through gap. This gap may be useful not only for drainage of wound exudate and application of negative pressure to the wound, but also during manufacturing of the device, as the gaps may be used to properly align their respective layers.

[0064] 5B and 5C, and with additional reference to FIG. 6, a channel connector 5506 may be provided at the proximal end 5503 of the bridge portion 5502, the channel connector 5506 preferably configured to be embedded in the lower channel layer 5516 to create a secure fluid connection. The channel connector 5506, in some embodiments, may be inserted into a pre-made cavity formed in the channel 5516, which may be cut out or in the form of a tongue and groove joint, as shown in FIG. 6. With one end of the channel connector 5506 embedded in the lower channel layer 5516, the other end of the channel connector 5506, in one embodiment, may connect or communicate with a connector tube 5507, although in some embodiments, the channel connector 5506 may be directly connected to a connector 5504 or a tube 5540 that is otherwise connected to a negative pressure source. If a connector tube 5507 is used, the resulting assembly may have the connector 5504 attached to the connector. The cap 5536 may be secured to the suction adapter via, for example, a cap leash 5527 secured by a ring disposed on the exterior surface of the connector tube 5507. The cap 5536 may be used, for example, to cover the end of the suction adapter with the connector 5504 to prevent exudate and other wound fluids from leaking out. The connector 5504 is preferably configured to connect with a tube 5540 connected to a negative pressure source. The connector 5504 may include, for example, a lip or other such structure to help secure the connector 5504 to the tube 5540 and / or cap 5536, although it will be understood that other connector types are possible, including quick-disconnect couplings, luer locks, Christmas trees, and other such connectors.

[0065] The top layer 5510 may include additional material extending downward, preferably at least below the thickness of the bridge portion 5502, which may be used to bond or weld to other layers to form a fluid-tight seal. More specifically, during assembly, the top layer 5510 may be attached to the bottom layer 5518 to form a fluid-tight seal (with the exception of gaps at the distal and proximal ends), for example, using melting, welding, or adhesives. The middle layer 5514 is preferably attached to the top layer 5510 and the bottom layer 5518. In some embodiments, it may be preferable to attach or glue the connectors 5504 and / or 5506, and the tube 5507 to at least one of the layers 5510, 5514, 5518, thereby creating a fluid-tight connection. To provide a more secure connection, some embodiments may also be provided with weld points 5532 made on the bottom layer 5518. The lower channel 5516 may have a hole or gap made therethrough which may be used to weld it to the lower layer 5518 via weld points 5532. This welding of the lower channel 5516 to the lower layer 5518 via weld points 5532 made through holes 5533 may thus help to prevent the various layers and channels from shifting or displacing. Of course, it will be understood that other fastening means may be used, such as, for example, adhesives, and that such arrangements may also be used with the upper channel 5512.

[0066] 5A-6, a controlled air leak 5524 may be disposed on the bridge portion 5502, e.g., at its proximal end. The air leak 5524 may include an opening or channel extending through the upper layer 5510 such that the air leak 5524 is in fluid communication with the upper channel 5512. Upon application of suction to the suction adapter 5500, air will enter through the air leak 5524 and travel from the proximal end 5503 along the upper channel 5512 to the distal end 5505. The air will then be drawn into the lower channel 5516 by passing through gaps through the distal ends of layers 5512, 5514, 5516, and 5518. The air leak 5524 preferably includes a filter 5525. Preferably, the air leak 5524 is located at the proximal end of the bridge portion 5502 to minimize the possibility of wound exudate or other fluids contacting and blocking or obstructing the air leak 5524 or its filter 5525. In some embodiments, the filter 5525 is a microporous membrane capable of excluding microorganisms and bacteria and filtering particles larger than 45 μm. Preferably, the filter 5525 is capable of filtering out particles larger than 1.0 μm, and more preferably, particles larger than 0.2 μm. Advantageously, some embodiments may provide a filter 5525 that is at least partially chemically resistant to, for example, water, common household liquids such as shampoo, and other surfactants. In some embodiments, reapplication of vacuum to the suction adapter 5500 and / or wiping the exposed outer portion of the filter 5525 may be sufficient to remove any foreign matter blocking the filter 5525. The filter 5525 may be constructed of a suitably resistant polymer, such as acrylic, polyethersulfone, or polytetrafluoroethylene, and may be oil-resistant and / or hydrophobic. In some embodiments, the filter 5525 may also include a support backing layer, such as a nonwoven polyester support. Preferably, the air leak 5524 will provide a relatively constant airflow that does not increase significantly when additional negative pressure is applied to the system 5501.In embodiments of the suction adapter 5500, when additional negative pressure is applied, the air flow through the air leak portion 5524 increases, but preferably this increased air flow is minimized and does not increase proportionally to the negative pressure applied thereto.

[0067] The filter 5525 provided in the controlled air leak 5524 in certain embodiments may be useful in system 5501 for use with more ambulatory and active patients. For example, a chemical-resistant filter may allow the patient to bathe or shower without impairing the function of the filter when reconnected to the negative pressure source. Any blockage or fluid blocking the air leak 5524 may then be removed, for example, by wiping the filter 5525 or reapplying negative pressure to the suction adapter 5500. Such a system also has the advantage that the system 5501 and any associated wound dressing, if present, do not need to be removed and then reapplied if the patient needs to be disconnected from the negative pressure source, for example, as associated with bathing. This entails significant benefits in improving the cost-effectiveness and ease of use of the present treatment system.

[0068] The suction adapter 5500 can be constructed to provide constant fluid flow even when the suction adapter 5500 is twisted or weighted. For example, when used on a patient, the bridge portion 5502 may fold over on itself, or the patient may roll over and thus rest their weight on at least a portion of the suction adapter 5500. Typically, prior art dressings and fluid connectors may block or become ineffective in such situations, potentially contributing to complications such as pressure ulcers. However, certain embodiments now provide improved occlusion resistance when twisted or weighted. By using the channel layers 5512 and 5516 as described above, and by using the foam channel layer 5512 and the fabric channel layer 5516, the suction adapter 5500 may be able to maintain a flow rate through the air leak 5524 of at least 0.08 L / min, preferably 0.12 L / min, while negative pressure is applied through a negative pressure source. Further embodiments also enable the suction adapter 5500 to handle at least 10 L / day, or 6.9 ml / min, of fluid exudate drainage from the wound site through the lower channel 5516. Certain embodiments provide the suction adapter 5500 to maintain these flow rates even with a 12 kg weight, for example, pushing down on the bridge portion through a 1-inch diameter rod. In some embodiments, these flow rates are maintained while the bridge portion 5502 is twisted on itself with the same weight, or, for example, with a 4.75 kg weight placed directly on the folded area. The suction adapter 5500 can preferably withstand being folded and twisted even over extended periods, for example, 40 hours or more, without exhibiting any degradation in performance (e.g., flow rate) compared to its performance before being folded and twisted. Preferably, embodiments of the suction adapter 5500 are also capable of delivering and maintaining negative pressure to the wound at a level close to the negative pressure level of the negative pressure source. For example, an acceptable level of pressure maintained at the wound may be within +-.25 mmHg of the negative pressure set by the negative pressure source, and this pressure is preferably maintained at this level within 95% of the time that the suction adapter 5500 is applying negative pressure.Acceptable pressure levels can include a pressure range of 40 to 120 mmHg, although a level of 200 mmHg has been used successfully.

[0069] 4A-5B and 6, the suction adapter 5500 may include an applicator 5520 designed for placement on a wound site. The applicator 5520 may include a flexible layer 5550, such as polyethylene or polyurethane, with a layer of adhesive on its lower (wound-facing) side. Optionally, a protective release layer 5529 may be placed over the adhesive layer, which is removable prior to use. In some embodiments, due to the flexibility of the layer 5550, a more rigid, removable backing layer 5552 may be provided on the upper side of the applicator 5520 to facilitate handling of the applicator 5520. The applicator 5520 preferably includes an attachment point for the bridge 5502 at its distal end 5505, such as, for example, using a section of double-sided adhesive tape 5528. The double-sided adhesive tape 5528 may be protected by an additional protective release layer that is removed before adhering the bridge 5502 to the applicator 5520. As will be appreciated, different attachment methods are contemplated, such as, for example, heat sealing, welding, or a suitable adhesive. Some embodiments may also allow for manufacture of the bridge 5502 and applicator 5520 as a single unit without the need for separate attachment means. The applicator 5520 preferably includes at least one aperture 5526 through which it is designed to be placed over the wound site and which can fluidly connect the wound site to a source of negative pressure and an air leak, while also functioning as a conduit for drawing wound exudate from the wound site.

[0070] 4A and 4B, the system 5501 may be used in a manner similar to other embodiments previously disclosed herein, such as the system 100 described in connection with FIG. 1. The wound site 5530 is cleaned and prepared in a suitable manner, and wound packing material is placed at the wound site, if necessary, preferably followed by a drape 5531. A gap 5535 through the drape to the wound site is then created, although some embodiments may have a pre-made gap 5535. The operator may then position the applicator portion 5520 over the gap 5535. After removing the backing layer 5529 (if present) from the adhesive layer underneath the applicator portion 5520, the applicator is sealed to the drape 5531, and the backing layer 5552 (if present) is also removed from the applicator portion 5520. A fluid conduit, such as a tube 5540, may then be connected to the connector 5504. The tube 5540 may also be connected to the connector 5504 prior to applying the applicator to the wound site. The fluid conduit is preferably connected to a negative pressure source 5534, having a container suitable for containing wound exudate interposed therebetween. Application of negative pressure may then be performed on the wound site 5530 until the wound site has progressed to a desired level of healing.

[0071] During use of the system 5501, wound exudate from the wound site 5530 can be drawn by negative pressure through the lower channel layer 5516. The air leak 5524 allows air to pass through the upper channel layer 5512 and into gaps through the distal ends of layers 5512, 5514, 5516, and 5518. The negative pressure draws air passing through the upper channel layer into the lower channel layer 5516 toward a negative pressure source or pump. In some embodiments, the controlled air leak 5524 provides a constant flow of air through the suction adapter 5500, which can then be used to determine whether a blockage or leak exists. Causes of blockages can include, for example, a situation in which the lower channel 5516 becomes blocked with wound debris. Causes of leaks can include, for example, improper sealing of a drape over the wound site or physical damage to the suction adapter 5500 resulting in excessive air leakage into the system. A blockage or leak may be determined in certain embodiments by measuring the speed of the pump while it functions to maintain a constant negative pressure. Pump speed may also be measured indirectly by measuring the amount of voltage or signal sent to the pump.

[0072] Multilayer wound dressings for NPWT FIG. 7A illustrates one embodiment of a negative pressure wound therapy system 70 using a wound dressing 700 with a fluid connector 710. Additional examples of negative pressure wound therapy including wound dressings combined with the pumps described herein may be used in combination with or in addition to those described in U.S. Patent No. 9,061,095, the entirety of which is incorporated by reference. Here, the fluid connector 710 may comprise an elongated conduit, more preferably a bridge 720 having a proximal end 730 and a distal end 740, and an applicator 780 at the distal end 740 of the bridge 720. The system 70 may include a negative pressure source, such as a pump or negative pressure unit 750, capable of providing negative pressure. The pump may include a canister or other container for storing wound exudate and other fluids that may be removed from the wound. The canister or container may also be provided separately from the pump. In some embodiments, pump 750 can be a canisterless pump, such as a PICO™ pump sold by Smith & Nephew. Pump 750 can be connected to bridge 720 via tubing, or pump 750 can be connected directly to bridge 720. During use, dressing 700 is placed over a suitably prepared wound, which in some cases may be filled with a wound packing material, such as foam or gauze, as described above. Applicator 780 of fluid connector 710 has a sealing surface that is placed over the gap in dressing 700 and sealed to the top surface of dressing 700. Either before, during, or after connecting fluid connector 710 to dressing 700, pump 750 is connected to coupler 760 via tubing or directly to bridge 720. The pump is then activated, thereby providing negative pressure to the wound. Application of negative pressure may be performed until a desired level of wound healing is achieved.

[0073] As shown in FIG. 7B , the fluid connector 710 preferably includes an enlarged distal end or head 740 in fluid communication with the dressing 700, as described in more detail below. In one embodiment, the enlarged distal end has a rounded or circular shape. The head 740 is illustrated here as being positioned near an edge of the dressing 700, but can be positioned anywhere on the dressing. For example, some embodiments may be provided in a central or off-center location that is not on or near an edge or corner of the dressing 700. In some embodiments, the dressing 70 may include two or more fluid connectors 710, each with one or more heads 740 in fluid communication therewith. In a preferred embodiment, the heads 740 may be 30 mm along their widest edge. The heads 740 at least partially form the applicator 780, described above, configured to seal against the top surface of the wound dressing.

[0074] FIG. 7C illustrates a cross-section of a wound dressing 700 similar to the wound dressing 70 described in International Patent Application Publication No. 2013175306(A2), which is incorporated by reference in its entirety, along with a fluid connector 710. Alternatively, the wound dressing 700, which may be any wound dressing embodiment disclosed herein or any combination of any number of features of the wound dressing embodiments disclosed herein, may be placed over the wound site to be treated. The dressing 700 may be installed to form a sealed cavity over the wound site. In a preferred embodiment, the dressing 700 comprises a backing layer 820 attached to a top or cover layer, or optional wound contact layer 822, both of which are described in more detail below. These two layers 820, 822 are preferably joined or sealed together to define an interior space or chamber. This interior space or chamber may comprise additional structures that may be adapted to distribute or transmit negative pressure, store wound exudate and other fluids removed from the wound, and other functions that will be described in more detail below. Examples of such structures described below include a transmission layer 826 and an absorbent layer 821.

[0075] As used herein, the top, uppermost, or upper layer refers to the layer that is furthest from the surface of the skin or wound while the dressing is in use and positioned over the wound, and the bottom, lower, lowermost, or lower layer thus refers to the layer that is closest to the surface of the skin or wound while the dressing is in use and positioned over the wound.

[0076] As shown in FIG. 7C, the wound contact layer 822 may be a polyurethane layer, a polyethylene layer, or other flexible layer that has been perforated or otherwise rendered liquid and gas permeable, for example, via a hot pin process, laser ablation process, ultrasonic process, or some other method. The wound contact layer 822 has a lower surface 824 and an upper surface 823. Perforations 825 preferably comprise through-holes in the wound contact layer 822, allowing fluid to flow through the layer 822. The wound contact layer 822 serves to prevent tissue ingrowth into other materials of the wound dressing. The perforations are preferably small enough to meet this requirement while allowing fluid to flow therethrough. For example, perforations formed as slits or holes having dimensions in the range of 0.025 mm to 1.2 mm are believed to be small enough to help prevent tissue ingrowth into the wound dressing while allowing wound exudate to flow into the dressing. In some configurations, the wound contact layer 822 may help maintain the integrity of the entire dressing 700 while also creating an airtight seal around the absorbent pad to maintain negative pressure at the wound.

[0077] Some embodiments of the wound contact layer 822 may also serve as a carrier for optional upper and lower adhesive layers (not shown). For example, a lower pressure-sensitive adhesive may be provided on the lower surface 824 of the wound dressing 700, while an upper pressure-sensitive adhesive layer may be provided on the upper surface 823 of the wound contact layer. The pressure-sensitive adhesive, which may be a silicone, hot melt, hydrocolloid, or acrylic-based adhesive, or other such adhesive, may be formed on both sides of the wound contact layer, or on an optionally selected side, or on neither side of the wound contact layer. Utilizing a lower pressure-sensitive adhesive layer may help adhere the wound dressing 700 to the skin around the wound site. In some embodiments, the wound contact layer may comprise a perforated polyurethane film. The lower surface of the film may be provided with a silicone pressure-sensitive adhesive, and the upper surface may be provided with an acrylic pressure-sensitive adhesive, which may help the dressing maintain its integrity. In some embodiments, the polyurethane film layer may be provided with adhesive layers on both its top and bottom surfaces, and all three layers may be perforated together.

[0078] A transmission layer 826 may be positioned above the wound contact layer 822. In some embodiments, the transmission layer may be a porous material. As used herein, the transmission layer may be referred to as a spacer layer, and the terms may be used interchangeably to refer to the same components as described herein. This transmission layer 826 allows fluids, including liquids and gases, to permeate away from the wound site into the upper layers of the wound dressing. In particular, the transmission layer 826 preferably ensures that open air channels are maintained to transmit negative pressure over the wound area even when the absorbent layer absorbs a significant amount of exudate. As described above, the layer 826 should preferably remain open under the normal pressures that would be applied during negative pressure wound therapy, thereby ensuring that the entire wound site experiences equal negative pressure. The layer 826 may be formed from a material having a three-dimensional structure. For example, a knitted or woven spacer fabric (e.g., Baltex 7970 weft knit polyester) or a nonwoven fabric may be used. The three-dimensional material may include a 3D spacer fabric material similar to the materials described in International Publication Nos. WO2013 / 175306(A2) and WO2014 / 020440, the disclosures of which are incorporated by reference in their entireties.

[0079] In certain embodiments, the wound dressing 700 may incorporate or comprise a multicare WCL as described herein or elsewhere herein. Those skilled in the art will understand that the wound dressing 700 may incorporate any of the multicare WCLs disclosed herein or elsewhere herein. Those skilled in the art will also understand that the multicare WCL may be incorporated as an entire component layer or as part of a component layer. In some embodiments, the multicare WCL layer may be provided below the transmission layer 826. In some embodiments, the multicare WCL layer may be provided above the wound contact layer 822. In some embodiments, the multicare WCL layer may replace the transmission layer 826, such that the multicare WCL layer is provided between the absorbent layer 221 (described further below) and the wound contact layer 822. In some embodiments, the multicare WCL layer may complement or replace the absorbent layer 821. In some embodiments, the wound dressing 700 does not have a wound contact layer 822, and the Multicare WCL layer may be the bottom layer of the wound dressing 700. The Multicare WCL may have the same or substantially similar size and shape as the transmission layer 826 and / or the absorbent layer 821.

[0080] The Multicare WCL layer can be constructed to be flexible yet rigid enough to withstand negative pressure so that the Multicare WCL does not collapse excessively, and thereby sufficiently transmits negative pressure to the wound when negative pressure is supplied to the wound dressing 700. The Multicare WCL layer can be constructed to include pores of a sufficient number or size to allow transmission of negative pressure therethrough. Additionally, the Multicare WCL layer can have a thickness suitable for transmitting sufficient negative pressure to the wound. For example, the Multicare WCL layer can have a thickness of 1 mm to 10 mm, or 1 mm to 7 mm, or 1.5 mm to 7 mm, or 1.5 mm to 4 mm, or 2 mm to 3 mm. In some embodiments, the Multicare WCL can have a thickness of approximately 2 mm.

[0081] In some embodiments, an absorbent layer 821 is provided above the transmission layer 826. The absorbent, which may comprise a foam or nonwoven natural or synthetic material, and may optionally include a superabsorbent, forms a reservoir for fluids, particularly liquids, that are removed from the wound site. In some embodiments, layer 821 may also help draw fluids toward the backing layer 220.

[0082] The material of the absorbent layer 821 may also prevent fluid collected within the wound dressing 700 from flowing freely within the dressing and preferably acts to contain any collected fluid within the dressing. The absorbent layer 821 also helps distribute fluid throughout the layer by wicking, so that fluid is drawn from the wound site and stored throughout the absorbent layer. This helps prevent clumping within the absorbent layer area. The capacity of the absorbent material must be sufficient to manage the rate at which wound exudate flows when negative pressure is applied. During use, the absorbent layer experiences negative pressure, so the material of the absorbent layer is selected to absorb fluid under such conditions. Several materials exist that can absorb fluid when under negative pressure, such as superabsorbent materials. The absorbent layer 821 may typically be made from ALLEVYN™ foam Freudenberg 114-224-4 or Chem-Posite™ 11C-450. In some embodiments, the absorbent layer 821 may comprise a composite including superabsorbent powder, a fibrous material such as cellulose, and bonding fibers. In a preferred embodiment, the composite is an airlaid thermally bonded composite.

[0083] In some embodiments, the absorbent layer 821 is a layer of nonwoven cellulose fibers with superabsorbent material in the form of dry particles dispersed throughout the layer. The use of cellulose fibers introduces a fast wicking element that helps quickly and evenly distribute liquid absorbed by the dressing. The parallel arrangement of many strand-like fibers leads to strong capillary action in the fibrous pad, which helps distribute the liquid, thus efficiently delivering liquid to the superabsorbent material. The wicking action also helps bring liquid into contact with the upper cover layer, which helps increase the dressing's evaporation rate.

[0084] A gap, hole, or orifice 827 is preferably provided in the backing layer 820 so that negative pressure can be applied to the dressing 700. A fluid connector 710 is preferably attached or sealed to the top of the backing layer 820 over the orifice 827 made in the dressing 700 and transmits the negative pressure through the orifice 827. A long tube may be connected at a first end to the fluid connector 710 and at a second end to a pump unit (not shown) to enable pumping of fluid from the dressing. If the fluid connector is to be adhered to the top layer of the wound dressing, the long tube may be connected at a first end of the fluid connector such that the tube or conduit extends parallel to, or substantially toward, the top surface of the dressing. The fluid connector 710 can be adhered and sealed to the backing layer 820 using an adhesive such as an acrylic, cyanoacrylate, epoxy, UV-curable, or hot-melt adhesive. The fluid connector 710 may be formed from a soft polymer, such as polyethylene, polyvinyl chloride, silicone, or polyurethane, having a hardness of 30 to 90 on the Shore A scale. In some embodiments, the fluid connector 710 may be made from a soft or compliant material.

[0085] Optionally, the absorbent layer 821 includes at least one through-hole 828 positioned to underlie the fluid connector 710. The through-hole 828 may, in some embodiments, be the same size as the opening 827 in the backing layer, or may be larger or smaller. As illustrated in FIG. 2C , a single through-hole may be used to provide an opening under the fluid connector 710. It will be understood that multiple openings may alternatively be utilized. Additionally, if one or more ports are to be utilized in accordance with certain embodiments of the present disclosure, one or more openings may be made in the absorbent layer in registration with each respective fluid connector. While not required for certain embodiments of the present disclosure, the use of through-holes in the superabsorbent layer may provide a fluid flow path that remains unobstructed, particularly when the absorbent layer is near saturation.

[0086] As illustrated in FIG. 2C , a gap or through-hole 828 is preferably provided in the absorbent layer 821 below the orifice 827 such that the orifice directly connects to the permeable layer 826. This allows negative pressure applied to the fluid connector 710 to be transmitted to the permeable layer 826 without passing through the absorbent layer 821. This ensures that negative pressure applied to the wound site is not inhibited by the absorbent layer as it absorbs wound exudate. In other embodiments, no gap may be provided in the absorbent layer 821, or alternatively, multiple gaps may be provided below the orifice 827. In further alternative embodiments, additional layers, such as another permeable layer, or a shielding layer as described with reference to FIGS. 6A and 6B in International Patent Application Publication No. WO 2014 / 020440, the entire contents of which are incorporated herein by reference, may be provided above the absorbent layer 821 and below the backing layer 820.

[0087] The backing layer 820 is preferably impermeable to gases but permeable to water vapor and may extend across the width of the wound dressing 700. The backing layer 820, which may be, for example, a polyurethane film (e.g., Elastollan SP9109) with a pressure-sensitive adhesive on one side, is impermeable to gases; therefore, it covers the wound and acts to seal the wound cavity over which the wound dressing is placed. In this manner, an effective chamber is created between the backing layer 820 and the wound site, within which negative pressure can be established. The backing layer 820 is preferably sealed to the wound contact layer 822 within the dressing's perimeter boundary region, for example, via adhesive or welding techniques, to prevent air from being drawn into the boundary region. The backing layer 820 protects the wound from external bacterial contamination (a bacterial barrier) and allows liquid from wound exudate to migrate through the layer and evaporate from the film's outer surface. The backing layer 820 preferably includes two layers: a polyurethane film and an adhesive pattern spread over the film. The polyurethane film is preferably breathable and may be made from a material that becomes more breathable when wet. In some embodiments, the breathability of the backing layer increases when the backing layer becomes wet. The breathability of the wet backing layer may be up to about 10 times that of the dry backing layer.

[0088] The absorbent layer 821 may be of a larger area than the transmission layer 826 so that the absorbent layer overlaps the edges of the transmission layer 826, thereby ensuring that the transmission layer does not contact the backing layer 820. This provides an outer channel in the absorbent layer 821 that is in direct contact with the wound contact layer 822, aiding in more rapid absorption of exudate into the absorbent layer. Furthermore, this outer channel ensures that fluid cannot pool around the perimeter of the wound cavity, which could otherwise seep through the seal around the dressing and lead to the formation of a leak. As illustrated in FIG. 7C , the absorbent layer 821 may define a perimeter that is smaller than the perimeter of the backing layer 820, such that a border or boundary area is defined between the edge of the absorbent layer 821 and the edge of the backing layer 820.

[0089] 7C , one embodiment of the wound dressing 700 includes a gap 828 in the absorbent layer 821 positioned directly below the fluid connector 710. During use, therefore, for example, when negative pressure is applied to the dressing 700, the wound-facing portion of the fluid connector may contact the transmission layer 826 and thus help transmit negative pressure to the wound site even when the absorbent layer 821 is filled with wound fluid. In some embodiments, the backing layer 820 may be at least partially adhered to the transmission layer 826. In some embodiments, the gap 828 is at least 1-2 mm larger than the diameter of the wound-facing portion or orifice 827 of the fluid connector 710.

[0090] In particular, in some embodiments involving a single fluid connector 710 and through-hole, it may be preferable for the fluid connector 710 and through-hole to be located in an off-center position, as illustrated in FIG. 7B. Such a location may allow the dressing 700 to be positioned on the patient such that the fluid connector 710 is elevated relative to the remainder of the dressing 700. In such a positioning, the fluid connector 710 and filter 814 may be less likely to come into contact with wound fluid that could prematurely block the filter 814, reducing the transmission of negative pressure to the wound site.

[0091] Similar to the wound dressing embodiments described above, some wound dressings include a perforated wound contact layer with a silicone adhesive on the skin-contacting surface and an acrylic adhesive on the backside. In some embodiments, the wound contact layer may be constructed from polyurethane, polyethylene, or polyester. Above this bordered layer is a transmission layer. Above the transmission layer is an absorbent layer. The absorbent layer may include a superabsorbent nonwoven (NW) pad. The absorbent layer may contact the transmission layer approximately 5 mm beyond the perimeter. The absorbent layer may have gaps or perforations toward one end. The gaps may be approximately 10 mm in diameter. Above the transmission and absorbent layers is a backing layer. The backing layer may be a high moisture vapor transmission rate (MVTR) film that is patterned and coated with an acrylic adhesive. The high MVTR film and wound contact layer encapsulate the transmission and absorbent layers, creating a peripheral boundary of approximately 20 mm. The backing layer may have a 10 mm gap that overlaps the gap in the absorbent layer. Above the hole, a fluid connector may be coupled, comprising a liquid-impermeable, gas-permeable semi-permeable membrane (SPM) or filter that overlies the aforementioned gap.

[0092] Multi-layer wound dressing with integrated negative pressure source In some embodiments, the negative pressure source (e.g., a pump) and some or all other components of the TNP system, such as power sources, sensors, connectors, user interface components (buttons, switches, speakers, screens, etc.), may be integrated with the wound dressing. Additionally, some embodiments relating to wound treatment comprising the wound dressings described herein may be used in combination with or in addition to those described in International Application No. WO 2016 / 174048 and International Patent Application No. PCT / EP2017 / 055225, filed March 6, 2017, entitled "WOUND TREATMENT APPARATUSES AND METHODS WITH NEGATIVE PRESSURE SOURCE INTEGRATED INTO THE WOUND DRESSING," the disclosures of which are incorporated herein by reference in their entireties, including further details regarding wound dressing embodiments, wound dressing components and principles, and materials used for wound dressings and wound dressing components.

[0093] In some embodiments, the pump and / or other electronic components may be configured to be positioned adjacent to or next to the absorbent and / or permeable layer of the wound dressing so that the pump and / or other electronic components are still part of a single device that will be applied to the patient, with the pump and / or other electronics positioned away from the wound site. FIG. 8A illustrates a wound dressing in which a negative pressure source and / or other electronic components are incorporated within the wound dressing. FIG. 8A illustrates a wound dressing 1200 in which the pump and / or other electronics are positioned away from the wound site. The wound dressing may include an electronics area 1261 and an absorbent area 1260. The dressing may include a wound contact layer (not shown) and a moisture-permeable film, i.e., cover layer 1213, positioned over the contact layer and other layers of the dressing. The wound dressing layer and the components of the electronics area and absorbent area may be covered by one continuous cover layer 1213, as shown in Figure 8A.

[0094] The electronics area 1261 may include a negative pressure source (e.g., a pump) and some or all other components of the TNP system that may be integrated with the wound dressing, such as a power source, sensors, connectors, user interface components (buttons, switches, speakers, screens, etc.), etc. For example, the electronics area 1261 may include a button or switch 1211, as shown in FIG. 8A. The button or switch 1211 may be used to operate the pump (e.g., turn the pump on / off).

[0095] The absorbent area 1260 may include absorbent material 1212 and may be positioned over the wound site. The electronics area 1261 may be positioned away from the wound site, such as by being offset laterally from the absorbent area 1260. As shown in Figure 8A, the electronics area 1261 may be positioned adjacent to and in fluid communication with the absorbent area 1260. In some embodiments, the electronics area 1261 and the absorbent area 1260 may each be rectangular and positioned adjacent to one another.

[0096] In some embodiments, additional layers of dressing material may be provided in the electronics area 1261, the absorbent area 1260, or both areas. In some embodiments, the dressing may include one or more spacer or transmission layers, and / or one or more absorbent layers positioned above the contact layer and below the cover layer 1213 of the dressing.

[0097] The dressing may include a Multicare WCL as described above or elsewhere herein, a transmission layer (not shown), an absorbent layer 1212 over the transmission layer, and a moisture-permeable film or cover layer 1213 positioned over the wound contact layer, transmission layer, absorbent layer, or other layer of the dressing. The wound contact layer may be configured to contact the wound. The wound contact layer may include adhesive on the side facing the patient to secure the dressing to the surrounding skin, or on the upper side to secure the wound contact layer to the cover layer or other layer of the dressing. In operation, the wound contact layer may be configured to provide unidirectional flow to facilitate removal of exudate from the wound while inhibiting or substantially preventing exudate from returning to the wound. One or more transmission layers distribute negative pressure over the wound site, helping to facilitate transport of wound exudate and fluids into the wound dressing. In some embodiments, the transmission layer may be at least partially formed from three-dimensional (3D) fibers. Additionally, an absorbent layer (such as layer 1212) may be utilized to absorb and retain exudate drawn from the wound. In some embodiments, a superabsorbent material may be used for absorbent layer 1212. In some embodiments, the absorbent body comprises a shaped superabsorbent layer configuration. The wound dressing layer and absorbent layer of the electronics area may be covered by a single continuous cover layer 1213. In some embodiments, the cover layer may comprise a breathable material that allows the passage of gases while preventing the passage of liquid exudate and other liquids removed from the wound.

[0098] FIG. 8B illustrates an embodiment of a wound dressing layer in which the pump and electronic components are offset from the absorbent area of ​​the dressing. As illustrated in FIG. 8B, the dressing may include a wound contact layer 1310 for placement against the wound. Lower spacer or transmission layers 1311 and 1311′ are provided above the wound contact layer 1310. In some embodiments, as shown in FIG. 8B, the transmission layer 1311 may be a separate layer from the spacer layer 1311′. The lower transmission layers 1311 and / or 1311′ may evenly distribute pressure on the wound surface and / or assist in wicking fluid away from the wound. An absorbent layer 1322 may be positioned above the lower transmission layer 1311.

[0099] In embodiments, the dressing layer 1351 may include a cutout or recess 1328 for embedding the electronic component 1350 within the layer 1351. In some embodiments, the cutout or recess 1328 may be sized or shaped to embed the pump 1327, the power source 1326, and / or other electronic components. In some embodiments, the layer 1351 may include multiple spacer or transmission layers stacked together. In some embodiments, the layer 1351 may include multiple spacer or transmission layers spliced ​​together to surround the electronic component 1350. An upper transmission layer 1317 may be provided above the absorber layer 1322, the layer 1351, and / or the electronic component 1350.

[0100] The wound dressings 1200, 1300 may incorporate or comprise a multicare WCL as described herein or elsewhere herein. Those skilled in the art will understand that the wound dressings 1200, 1300 may incorporate any of the multicare WCLs disclosed herein or elsewhere herein. In some embodiments, a multicare WCL layer may be provided below the transmission layer 1311. In some embodiments, a multicare WCL layer may be provided below the wound contact layer 1310. In some embodiments, the multicare WCL layer may replace the transmission layer 1311, 1311′ such that the multicare WCL layer is provided between the absorbent layer 1322 and the wound contact layer 1310. In some embodiments, the multicare WCL layer may complement or replace the absorbent layer 1212, 1322. In some embodiments, the multicare WCL layer may be the bottom layer of the wound dressing. The Multicare WCL layer may have the same or substantially similar size and shape as the transmission and / or absorption layers described herein in this section or elsewhere herein.

[0101] The Multicare WCL layer can be constructed to be flexible yet rigid enough to withstand negative pressure so that the Multicare WCL layer does not collapse excessively, and thereby allows sufficient transmission of negative pressure to the wound when negative pressure is supplied to the wound dressing 1200. The Multicare WCL layer can be constructed to include pores of a sufficient number or size to allow transmission of negative pressure therethrough. Furthermore, the Multicare WCL layer can have a thickness suitable to allow sufficient negative pressure to be transmitted to the wound. For example, the Multicare WCL layer can have a thickness of 1 mm to 10 mm, 1 mm to 7 mm, 1.5 to 7 mm, 1.5 to 4 mm, or 2 mm to 3 mm. In some embodiments, the Multicare WCL layer can have a thickness of approximately 2 mm.

[0102] A cover or backing layer 1313 may be positioned over the upper transmission layer 1317. The backing layer 1313 may form a seal against the wound contact layer 1310 in a peripheral area surrounding the transmission layers 1311, 1311′, and 1317, the absorbent layer 1322, the layer 1351, and the electronic component 1350. In some embodiments, the backing layer 1313 may be a sheet of flexible material that forms and molds around the dressing component when it is applied to the wound. In other embodiments, the backing layer 1313 may be a pre-formed or pre-molded material to fit around the dressing component, as shown in FIG. 8B.

[0103] Fixing strip 9A and 9B illustrate one embodiment of a fastening strip 900 that may be used with any of the system configurations, devices, apparatus, and / or dressings disclosed herein, as well as elsewhere herein, such as in FIGS. 1-8B, 10A and 10B, 11A and 11B, or 13A and 13B. For example, such a fastening strip may be used with dressings 700, 1200, and / or drapes 5531 described above, or drapes 1400 described below. FIG. 9A illustrates a cross-sectional side view of fastening strip 900 along the length of strip 900, and FIG. 9B illustrates a cross-sectional side view of fastening strip 900 along the width of strip 900.

[0104] As shown in FIGS. 9A and 9B , the fixation strip 900 may comprise multiple layers. The multiple layers may include a top layer 910, an adhesive layer 920, a wound sealing layer 930, and one or more protective liners 940, 950. The adhesive layer 920, in some embodiments, may comprise a flexible film material provided with a pressure-sensitive adhesive (e.g., an acrylic adhesive) on the underside of the adhesive layer 920. In some embodiments, the pressure-sensitive adhesive of the adhesive layer 920 may extend the entire width of the fixation strip. One skilled in the art will appreciate that the adhesive layer may be constructed from any suitable material disclosed herein, such as a cover layer and / or drape disclosed herein. The adhesive layer 920 may be thinner in some areas of the fixation strip 900, thereby allowing the fixation strip 900 to fold or self-adhere as needed. In some embodiments, the adhesive layer 920 may be covered by the top layer 910 on top of the adhesive layer 920.

[0105] In certain examples, the top layer 910 may have the same length and width as the adhesive layer 920. The top layer 910 may also have different dimensions than the adhesive layer 920, e.g., the top layer 910 may be longer or shorter than the adhesive layer 920 in terms of width and / or length. In some configurations, as shown in FIG. 9A, the top layer 910 may have a greater length than the adhesive layer 920. In some configurations, as shown in FIG. 9B, the top layer 910 may have the same width as the adhesive layer 920.

[0106] In some configurations, the adhesive layer 920 may have the same length and width as the wound sealing layer 930. The adhesive layer 920 may also have different dimensions than the wound sealing layer 930; for example, the adhesive layer 920 may be longer or shorter in width and / or length than the wound sealing layer 930. In some configurations, as shown in FIG. 9B, the adhesive layer 920 may have a width that is the same as or similar to the width of the wound sealing layer 930. In some embodiments, as shown in FIG. 9B, the adhesive layer 920 may have a width that is greater than the wound sealing layer 930, such that the adhesive layer 920 may extend beyond the wound sealing layer 930 on a side 920a of the fixation strip 900. The extending surface 920a may be configured to secure the fixation strip 900 to the wound dressing. In certain embodiments, the adhesive layer 920 may extend beyond the wound sealing layer 930 on one, two, three, or four sides of the layer 930. Those skilled in the art will appreciate that by extending adhesive layer 920 beyond wound sealing layer 930, adhesive layer 920 may be placed in contact with and / or adhered to a different surface than wound sealing layer 930. For example, wound sealing layer 930 may be placed over the wound or an area surrounding the wound, such as the peri-wound area, while adhesive layer 920 is placed over a wound dressing as disclosed herein. Such an arrangement allows for sealing of the wound dressing without exposing the wound or skin to adhesive surface 920, which may be less suitable for skin or wound contact than wound sealing layer 930.

[0107] In certain embodiments, the wound sealing layer 930 may comprise a flexible, biocompatible material, such as silicone or any suitable material disclosed herein. The wound sealing layer 930 may further be constructed in the same manner as any wound contact layer disclosed herein, such as the wound contact layer of FIGS. 7A-8B. The wound sealing layer 930 may further comprise a silicone adhesive on the skin-contacting surface and an acrylic adhesive on the upper surface. In some embodiments, the silicone adhesive may extend along a portion of the entire width of the fastening strip. The wound sealing layer 930 may be constructed entirely from silicone. In some embodiments, the wound sealing layer 930 may be constructed from polyurethane, polyethylene, or polyester. The layer 930 may further comprise a plurality of gaps, which may be created, for example, via a hot pin process, a laser ablation process, an ultrasonic process, or another suitable method that allows for liquid and gas permeability. The gaps may comprise through-holes in the wound sealing layer 930, which allow fluid to flow through the layer 930. The arrangement of gaps may include shapes selected from the group consisting of circles, ellipses, triangles, squares, rectangles, hexagons, octagons, and any other polygonal shapes. The wound sealing layer 930 can prevent tissue ingrowth into the other materials of the fixation strip 900. The gaps may be small enough to meet this requirement while allowing fluid flow therethrough. For example, gaps formed as slits or holes having sizes ranging from 0.025 mm to 1.2 mm are considered small enough to help prevent tissue ingrowth into the fixation strip 900 while allowing wound exudate to flow into the fixation strip 900. However, in certain embodiments, the gaps may be sized at least 0.5 mm, 0.5-5 mm, or 1-3 mm. The space between two adjacent holes may be within the range of 0.5-5 mm, 0.5-3.5 mm, or 1-3 mm. The thickness of the wound sealing layer 930 may be in the range of 1 to 10 mm, or 1 to 7 mm, or preferably 1.5 to 7 mm, or 1.5 to 4 mm, or 2 to 3 mm, or approximately 2 mm.In some configurations, the wound sealing layer 930 may help maintain the integrity of the entire fixation strip 900 while also creating an airtight seal around the periphery of the fixation strip 900 to maintain negative pressure at the wound.

[0108] In some embodiments, the fixation strip 900 may be manufactured with an adhesive layer 920 and a wound sealing layer 930 laminated together via an adhesive layer (not shown). In embodiments, the adhesive layer 920 may be laminated (e.g., heat laminated) directly to the wound sealing layer 930 without the need for an adhesive layer.

[0109] In certain embodiments, the fixation strip 900 may also be provided with one or more protective liners 940, 950 on the lower adhesive surface of the fixation strip 900. Those skilled in the art will understand that such protective liners may be the same as or similar to the protective release layers disclosed herein and may be constructed in any suitable manner and from any suitable materials disclosed herein. In certain embodiments, such liners serve to protect the adhesive surface during handling and transportation prior to use. The one or more protective liners 940, 950 may be configured to protect the adhesive surfaces of the wound sealing layer 930 and the adhesive layer 920. The one or more protective liners 940, 950 may include one or more outer protective liners 940 and / or one or more central protective liners 950. The one or more outer protective liners may include a first outer protective liner and a second outer protective liner 940 that may be provided on both ends of the fixation strip 900, thereby covering both ends of the strip 900. For example, one outer protective liner 940 may protect the adhesive surface of the extending surface 920a of the adhesive layer 920, and the other outer protective liner 940 may protect the adhesive surface of the wound sealing layer 930 opposite the extending surface 920a. In some configurations, as shown in FIG. 9A , the outer protective liners 940 may protect the adhesive surface of the wound sealing layer 930 on both sides of the wound sealing layer 930. A central protective liner 950 may be provided over a central portion of the fixation strip 900. For example, the central protective liner 950 may be positioned between both ends of the fixation strip 900, partially overlapping the outer protective liners 940, and underlying the outer protective liners 940.

[0110] In some embodiments, the outer protective liner 940 may have an outer edge positioned beyond the extended surface 920a of the adhesive layer 920 and the edge of the wound sealing layer 930, and may also include a folded handle that is covered by the central protective liner 950. Thus, the folded handle of the protective liner 940 is not in direct contact with the adhesive surface of the adhesive layer 920 or the wound sealing layer 930, thereby facilitating removal of the outer protective liner 940. Similarly, the portion of the central protective liner 950 that overlaps the outer protective liner 940 is not in direct contact with the adhesive surface of the wound sealing layer 930 and is not adhered to the outer protective liner 940, thereby forming a handle that facilitates removal of the central protective liner 950.

[0111] In some configurations, as shown in FIG. 9A , the protective liners 940, 950 each include a length less than the entire length of the fixation strip 900 and may be positioned longitudinally along the fixation strip 900. In some configurations, the protective liners 940, 950 may each include a width extending the entire width of the fixation strip 900. For example, as shown in FIG. 9B , the outer protective liner 940 may extend from the extending surface 920 a of the adhesive layer 920 to the outer edge of the wound sealing layer 930, such that the outer protective liner 940 covers the adhesive surfaces of both the adhesive layer 920 and the wound sealing layer 930. In these configurations, the other outer protective liner 940 and the central protective liner 950 may similarly extend from the extending surface 920 a of the adhesive layer 920 to the outer edge of the wound sealing layer 930, covering the adhesive surfaces of both layers 920, 930. In some configurations, each protective liner 940, 950 may include at least two liners. 9B , the outer protective liner 940 may include a first liner 940a and a second liner 940b. Similarly, the other outer protective liner 940 and the central protective liner 950 may include a first liner and a second liner, which may be configured to removably adhere to the adhesive surface of the extended surface 920a of the adhesive layer 920 and the adhesive surface of the wound sealing layer 930, respectively. During use, a user can remove the first liner, adhere the extended surface 920a of the adhesive layer 920 to a wound dressing, and then remove the second liner and adhere the wound sealing layer 930 to the patient's skin.

[0112] The top layer 910, which may be provided on top of the adhesive layer 920, may be configured to releasably attach to the non-adhesive surface of the adhesive layer 920 and may comprise a sheet of paper or film having relatively more rigidity than the adhesive layer 920. Peel tabs (not shown) may be provided on one or both ends of the top layer 910 to facilitate removal of the top layer 910 from the adhesive layer 920. The peel tabs may extend outward from the adhesive layer 920 and top layer 910 to an outer edge that is aligned with the outer edge of the outer protective liner 940. In some embodiments, graphical and / or numbered instructions for removing the protective liner and top layer 910 may be provided on one or both of the protective liner and top layer 910. In certain embodiments, there may be a protective liner adhered to the entire adhesive surface of the adhesive layer 920.

[0113] In some configurations, the fastening strips 900 may be part of a sheet of fastening strips 900. For example, multiple fastening strips 900 may be removably attached along the longitudinal sides of each strip 900 to form a sheet. The sheet of fastening strips 900 may include two, three, four, five, six, or more fastening strips 900. Advantageously, a user can remove a suitable number of individual fastening strips 900 from the sheet of fastening strips 900 as the user applies the wound dressing to a patient.

[0114] 10A and 10B show top views of a wound dressing 800 before and after application of a fastening strip 900. The wound dressing 800 may be any suitable dressing, such as those disclosed in FIGS. 7A-8B. As shown in FIG. 10A, the wound dressing 800 may first be cut along one side 801 of the dressing 800. As described above, the extending surface 920a of the adhesive layer 920 may extend beyond the wound sealing layer 930, such that the extending surface 920a of the adhesive layer 920 adheres to the top surface of the dressing 800, as described above.

[0115] As described above, to utilize the fixation strip 900, the central protective liner 950 can be removed using the non-adhesive portion of the central protective liner 950, which serves as a handle, to expose the central adhesive surface of the wound sealing layer 930. The adhesive surface can then be applied to the skin and / or a dressing, or any desired location, or the adhesive surface can be applied after one or both of the outer protective liners 940 have been removed. The folded handle of the outer protective liner 940 can be grasped to remove the outer protective liner 940, exposing the lower adhesive surface of the wound sealing layer 940 and the entire extended surface 920a of the adhesive layer 920. The outer edge of the adhesive surface of the wound sealing layer 930 and the extended surface 920a of the adhesive layer 920 can be placed in a desired location. For example, the extended surface 920a of the adhesive layer 920 can be placed on a wound dressing. After sealing the fixation strip 900, the top layer 910 can be removed from the adhesive layer 920 using the peel tab(s). This can be repeated with as many fastening strips as needed. As will be appreciated by those skilled in the art, additional fastening strips can be added around the perimeter of the dressing as needed to secure and maintain a seal as negative pressure is applied.

[0116] In some embodiments, each fastening strip 900 may have a width of 40 mm or approximately 40 mm, or a width in the range of 20 mm to 80 mm or approximately 20 mm to 80 mm. The width of the fastening strip 900 may be approximately 30 mm to 70 mm, or approximately 40 mm to 60 mm. Alternatively, widths less than 20 mm or greater than 80 mm can be used. The overall length of each fastening strip 900 may be approximately 250 mm or 300 mm, or approximately 250 mm or approximately 300 mm, or may range from 100 mm to 400 mm or approximately 100 mm to 400 mm, in some embodiments. The overall length of the fastening strip 900 may be approximately 150 mm to 350 mm, or approximately 200 mm to 300 mm. Alternatively, overall lengths less than 100 mm or greater than 400 mm can be used.

[0117] The length of the adhesive layer 920 and carrier layer 910, in some embodiments, may be 280 mm or 330 mm, or approximately 280 mm or approximately 330 mm, or may range from 90 mm to 380 mm, or approximately 90 mm to approximately 380 mm. The length of the adhesive layer 920 and carrier layer 910 may be approximately 120 mm to 350 mm, approximately 150 mm to 320 mm, approximately 180 mm to 290 mm, approximately 150 mm to 260 mm, or approximately 180 mm to 230 mm. Alternatively, lengths less than 90 mm and greater than 380 mm can be used. The length of the central protective liner 950, in some embodiments, may be 210 mm or 260 mm, or approximately 210 mm or approximately 260 mm, or may range from 100 mm to 300 mm, or approximately 100 mm to approximately 300 mm. The length of the central protective liner 950 may be approximately 125 mm to 275 mm, approximately 150 mm to 250 mm, or approximately 175 mm to 225 mm. Alternatively, lengths less than 100 mm or greater than 300 mm can be used.

[0118] The length of the wound sealing layer 940 may, in some embodiments, be 140 mm or 165 mm, or approximately 140 mm or approximately 165 mm, or may range from 45 mm to 190 mm, or approximately 45 mm to approximately 190 mm. The length of the wound sealing layer 940 may be approximately 60 mm to 175 mm, approximately 75 mm to 160 mm, approximately 90 mm to 145 mm, approximately 75 mm to 130 mm, or approximately 90 mm to 115 mm. Alternatively, lengths less than 45 mm and greater than 190 mm can be used.

[0119] The length of the outer protective liner 940 (not including the folded portion) may be 85 mm or 110 mm, or approximately 85 mm or approximately 110 mm, or may range from 50 mm to 200 mm, or approximately 50 mm to approximately 200 mm, in some embodiments. The length of the outer protective liner 940 may be approximately 75 mm to 175 mm, or approximately 100 mm to 150 mm. Alternatively, lengths less than 50 mm or greater than 200 mm can be used. The length of the folded portion or handle of the outer protective liner 940 may be 20 mm plus or minus 5 mm, or approximately 20 mm plus or minus 5 mm, in some embodiments. Alternatively, lengths greater than 25 mm can be used. The distance from the outer edge of the folded tab to the outer edge of the central protective liner 950 may be 20 mm plus or minus 5 mm, or approximately 20 mm plus or minus 5 mm, in some embodiments. Alternatively, distances greater than 25 mm can be used.

[0120] 11A-11F illustrate a method of using one embodiment of a retention strip 1000. The retention strip 1000 may be used with any of the system configurations, devices, apparatuses, and / or dressings disclosed herein or elsewhere herein, such as in FIGS. 1-8B and 13A-13B. For example, such a retention strip 1000 may be used with a drape 5531 or suitable dressing 700, 1200, as described above. As illustrated in FIG. 11C, the retention strip 1000 may comprise multiple layers. In some embodiments, the multiple layers may include a first protective liner 1030, a wound sealing layer 1020, a second protective liner 1035, and an adhesive layer 1010. The adhesive layer 1010 may, in some embodiments, comprise a flexible film material provided with a pressure-sensitive adhesive (e.g., an acrylic adhesive) on the underside of the adhesive layer 1010. In some embodiments, the pressure-sensitive adhesive may extend the entire width of the retention strip. The adhesive layer 1010 may be thinner in some areas of the fastening strip 1000, as described above in connection with Figures 7-8B. Thus, the adhesive layer 1010 may be provided with a top layer (not shown) on an upper non-adhesive surface having the same length and width as the adhesive layer 1010.

[0121] In certain embodiments, the wound sealing layer 1020 may comprise a flexible, biocompatible material, such as silicone. The layer 1020 may further comprise a silicone adhesive on the skin-contacting surface and an acrylic adhesive on the top surface. In some embodiments, the silicone adhesive may extend a portion of the entire width of the fixation strip. In some embodiments, the wound sealing layer 1020 may be constructed from polyurethane, polyethylene, or polyester. The layer 1020 may further comprise a plurality of gaps, which may be created, for example, via a hot pin process, a laser ablation process, an ultrasonic process, or another suitable method that allows liquid and gas permeability. The gaps may comprise through-holes in the wound sealing layer 1020, allowing fluid to flow through the layer 1020. The arrangement of gaps may include a shape selected from the group consisting of a circle, an oval, a triangle, a square, a rectangle, a hexagon, an octagon, and any other polygonal shape. The wound sealing layer 1020 may prevent tissue ingrowth into the other materials of the fixation strip 1000. The gaps may be small enough to meet this requirement while allowing fluid flow therethrough. For example, gaps formed as slits or holes having sizes ranging from 0.025 mm to 1.2 mm are considered small enough to allow wound exudate to flow into the fixation strip 1000 while helping to prevent tissue ingrowth into the fixation strip 1000. However, in certain embodiments, the gaps may be sized at least 0.5 mm, 0.5-5 mm, or 1-3 mm. The space between two adjacent holes may be within the range of 0.5-5 mm, 0.5-3.5 mm, or 1-3 mm. The thickness of the wound sealing layer 1020 may be in the range of 1-10 mm, or 1-7 mm, or preferably 1.5-7 mm, or 1.5-4 mm, or 2-3 mm, or approximately 2 mm. In some configurations, the wound sealing layer 1020 may help maintain the integrity of the entire fixation strip 1000 while also creating an airtight seal around the periphery of the fixation strip 1000 to maintain negative pressure at the wound.

[0122] In certain embodiments, the wound sealing layer 1020 may have a smaller footprint than the top layer 1010. In some embodiments, the fixation strip 1000 may be manufactured with the top layer 1010 and the wound sealing layer 1020 laminated together along one side of the retention strip 1000 via an adhesive layer (not shown). In other embodiments, the top layer 1010 may be laminated (e.g., heat laminated) directly to the wound sealing layer 1020 along one side of the retention strip 1000 without the need for an adhesive layer.

[0123] In certain embodiments, the fixation strip 1000 may also be provided with one or more protective liners 1030, 1035, which may be configured to protect the adhesive surface of the adhesive layer 1010 or the wound sealing layer 1020. A first protective liner 1030 may be provided over the adhesive surface of the wound sealing layer 1020. In some embodiments, the first protective liner 1030 may cover the entire lower adhesive surface of the wound sealing layer 1020. A second protective liner 1035 may partially cover the lower adhesive surface of the adhesive layer 1010. As illustrated, the protective liners 1030, 1035 may have outer edges (shown on the left side of FIG. 9C ) positioned beyond the outer edges of the adhesive layer 1010 or the wound sealing layer 1020, and may also include peel handles 1030 a, 1035 a that do not directly contact the adhesive surface of the adhesive layer 1010 or the wound sealing layer 1020 to facilitate removal of the protective liners 1030, 1035.

[0124] In some configurations, the fastening strip 1000 may be part of a sheet of fastening strips 1000. For example, multiple fastening strips 1000 may be removably attached along the longitudinal sides of each strip 1000 to form a sheet. The sheet of fastening strips 1000 may include two, three, four, five, six, or more fastening strips 900. Advantageously, a user can remove a suitable number of individual fastening strips 1000 from the sheet of fastening strips 1000 as the user applies the wound dressing to a patient.

[0125] As described above, the dressing 1100 can be cut to utilize the fastening strips 1000. The dressing 1100 can include a wound sealing layer 1130, a middle layer 1120, and a top layer 1110. The first protective liner 1030 can be removed using a peel handle 1035 to expose the adhesive surface of the wound sealing layer 1020. The adhesive surface can then be applied to the skin 1200 and / or the dressing, or any desired location, or the adhesive surface can be applied after the second contact layer 1035 is removed. The cut wound dressing 1100 can be positioned between the wound sealing layer 1020 and the adhesive layer 1010. The peel handle 1035 of the second protective liner 1035 can be grasped to remove the second protective liner 1035 and expose the lower adhesive surface of the adhesive layer 1010. The adhesive layer 1010 can then be placed in the desired location. For example, adhesive layer 1010 can be placed on the top layer 1110 of wound dressing 1100. After sealing the fixation strip 1000, peel tab(s) can be used to remove the top layer (not shown) from adhesive layer 1010. This can be repeated with as many fixation strips as needed, as described above.

[0126] 12A-12C show one embodiment of a fastening strip 1502 that may be used with any of the system configurations, devices, apparatus, and / or dressings disclosed herein and elsewhere herein, such as in FIGS. 1-8B, 10A and 10B, 11A and 11B, or 13A and 13B. FIG. 12A is a top view of a sheet 1500 of multiple fastening strips 1502 with the bottom layer shown in dashed lines. FIG. 12B is a cross-sectional side view of the fastening strip 1502. FIG. 12C is a close-up view of the perforation pattern between each of the multiple fastening strips 1502, as described further below.

[0127] The fastening strip 1502 may have one or more layers. For example, as shown in FIG. 12B, the fastening strip 1502 may have a top layer 1504, an adhesive layer 1506, and one or more protective liners 1508, 1510, 1512. The top layer 1504 may be the same as or similar to the top layers 910, 1010, the adhesive layer 1506 may be the same as or similar to the adhesive layers 920, 1010, and the one or more protective liners 1508, 1510, 1512 may be the same as or similar to one or more protective liners 940, 950, 1030, 1035 shown and described in connection with FIGS. 9A and 9B and 11C-11E. In some configurations, the fixation strip 1502 may include a wound sealing layer that may be the same as or similar to the wound sealing layers 930, 1020 shown and described in connection with Figures 9A and 9B, and Figures 11C-11F.

[0128] As shown in FIG. 12A , the sheet 1500 can include multiple fastening strips 1502. The sheet 1500 can include, for example, six fastening strips 1502. In some configurations, the sheet 1500 can include fewer than six or more than six fastening strips 1502 (e.g., two, three, four, five, seven, eight, or more strips). In some configurations, the sheet 1500 can include a sheet width 1514. The sheet width 1514 can be about 100 mm to about 500 mm, 150 mm to about 450 mm, about 200 mm to about 400 mm, or about 250 mm to about 350 mm. In some configurations, the fastening strips 1502 can include a strip width 1516. Strip width 1516 may be from about 10 mm to about 100 mm, from about 20 mm to about 90 mm, from about 30 mm to about 80 mm, from about 40 mm to about 70 mm, or from about 50 mm to about 60 mm.

[0129] 12B, the fastening strip 1502 can include multiple layers 1504, 1506, 1508, 1510, 1512, which can have the same or different lengths and / or widths. For example, the top layer 1504 can have a length 1520 that can be about 100 mm to about 500 mm, 150 mm to about 450 mm, about 200 mm to about 400 mm, or about 250 mm to about 350 mm. The adhesive layer 1506 can have a length 1518 that can be about 100 mm to about 500 mm, 150 mm to about 450 mm, about 200 mm to about 400 mm, or about 250 mm to about 350 mm.

[0130] In some configurations, the one or more protective liners 1508, 1510, 1512 may include three protective liners 1508, 1510, 1512. In some configurations, the one or more protective liners may include less than three or more than three protective liners (e.g., one, two, four, five, six, seven, or more liners). The three protective liners 1508, 1510, 1512 may include two outer protective liners 1508, 1510 and a central protective liner 1512. At least one of the two outer protective liners 1508, 1510 may include an outer edge that may extend beyond the adhesive layer 1506. For example, the distance 1524 between the outer edge of the adhesive layer 1506 and the outer edge of at least one of the outer protective liners 1508, 1510 may be about 1 mm to about 30 mm, about 5 mm to about 25 mm, or about 10 mm to about 20 mm. In some configurations, at least one of the outer edges of the outer protective liners 1508 , 1510 can be substantially aligned with the outer edge of the top layer 1504 .

[0131] In some configurations, at least one of the outer protective liners 1508, 1510 may include a folded handle. The folded handle may be positioned at or near the inner edge of the outer protective liners 1508, 1510. The inner edge of the outer protective liners 1508, 1510 may be opposite the outer edge of the outer protective liners 1508, 1510. The folded handle may include a length 1522 that may be about 10 mm to about 50 mm, about 15 mm to about 45 mm, about 20 mm to about 40 mm, or about 25 mm to about 35 mm. In some configurations, the folded handle may be spaced apart such that the outer protective liners 1508, 1510 do not cover the entire length of the adhesive layer 1506. In some configurations, a central protective liner 1512 may be positioned over at least one of the folded handles. For example, the central protective liner 1512 may overlap the folded handle such that at least one of the outer edges of the central protective liner 1512 extends beyond at least one of the outer edges of the folded handle. The distance 1526 between the outer edge of the central protective liner 1512 and the outer edge of the folded handle may be from about 1 mm to about 20 mm, or from about 5 mm to about 15 mm.

[0132] 12A , the multiple fastening strips 1502 can be removably attached to one another. For example, the sheet 1500 can include a perforated portion 1528 between each of the multiple fastening strips 1502, allowing a user to tear along the perforated portion 1528 to remove the fastening strip 1502 from the sheet 1500. The perforated portion 1528 can extend through each of the layers 1504, 1506, 1508, 1510, 1512 of the fastening strip 1502. In some configurations, the perforated portion 1528 can include a continuous cut 1528a along the middle of the perforated portion 1528 and two perforated portions 1528b, 1528c on either side of the cut 1528a. For example, the continuous cut 1528a can have a length of about 50 mm to about 350 mm, about 100 mm to about 300 mm, or about 150 mm to about 250 mm. In some configurations, the continuous cut 1528a can have a length equal to or greater than the length of the central protective liner 1512. The two perforated sections 1528b, 1528c can include a plurality of perforations, each separated by an attached or bridge portion connecting adjacent strips 1502. The length of one or both of the two perforated sections can be about 10 mm to about 100 mm, about 20 mm to about 90 mm, about 30 mm to about 80 mm, about 40 mm to about 70 mm, or about 50 mm to about 60 mm. As shown in FIG. 12C, the attached or bridge portion can include a length 1530, and the perforations can include a length 1532. The length 1530 of each attached or bridge portion may be about 0.1 mm to about 2.0 mm, about 0.5 mm to about 1.5 mm, or about 0.5 mm. The length 1532 of each perforation may be about 1.0 mm to about 4.0 mm, about 1.5 mm to about 3.5 mm, about 2.0 mm to about 3.0 mm, or about 2.5 mm. Advantageously, if a user removes a central protective liner 1512 without first separating adjacent fastening strips 1502, only that central protective liner 1512 will be removed instead of all respective central protective liners 1512 of the fastening strips 1502.

[0133] To utilize the fastening strips 1502, the dressing can be applied to the wound site. A single fastening strip 1502 can be removed from the sheet 1500 by tearing along the perforated portion of the sheet 1500. The central protective liner 1512 can be removed. The outer protective liners 1508, 1510 can be removed using folded handles to expose the adhesive surface of the adhesive layer 1506. The adhesive surface can be applied to the user's skin and / or the dressing, or any desired location. After the fastening strips 1502 are sealed along the edges of the dressing and / or the user's skin, the top layer 1504 can be removed from the adhesive layer 1506. This can be repeated with as many fastening strips 1502 as needed.

[0134] Multi-layer drape optionally configured with handles 13A and 13B, wound dressing or drape 1400, 1400' configurations are shown. Wound dressing or drape 1400, 1400' may be used with any of the system configurations disclosed herein or elsewhere herein, such as in FIGS. 1-6. For example, such a drape may be incorporated as drape 5531 described above. Any component or step disclosed herein in any configuration may be used in any other configuration.

[0135] FIG. 13A shows a configuration of a drape 1400 comprising a square-like shape. In other configurations, the drape 1400 may comprise any of several shapes, such as a rectangle, an oval, a circle, or any geometric or non-geometric shape. For example, FIG. 13B illustrates a drape 1400′ having a rectangular shape, which may be the same as or similar to the drape 1400 shown in FIG. 13B. The drape 1400 may include four layers and at least one protective layer 1450. For example, the drape 1400 may include a top layer 1410, an intermediate layer 1420 (also referred to herein as a protective construction layer or PCL), a transmission layer 1440, and a wound contact layer 1430. The top layer 1410 may be positioned on top of the intermediate layer 1420, with the transmission layer 1440 positioned between the intermediate layer 1420 and the wound contact layer 1430. Although FIG. 13A shows a drape 1400 having four layers and a particular positioning of the layers, the drape 1400 may include less than or more than four layers, and the layers may be arranged in a different order.

[0136] The top layer 1410 of the drape 1400 may be formed from a breathable film, such as polyurethane, that allows fluid evaporation. The film may be transparent so that the other layers immediately below the top layer 1410 can be seen from a top view of the dressing 1400. The top layer 1410 may include an adhesive for securing the top layer 1410 to the middle layer 1420 and the wound contact layer 1430. Additionally or alternatively, the adhesive of the top layer 1410 can secure the dressing 1400 to the peri-wound area, as described above. For example, the top layer 1410 may include an acrylic adhesive on the underside of the top layer 1410 (i.e., the surface facing the other layers 1420, 1430, 1440).

[0137] In some configurations, the top layer 1410 may include a width and a length. The width may be approximately 220 mm, approximately 270 mm, or approximately 420 mm. The width may be approximately 150 mm to approximately 500 mm, approximately 200 mm to approximately 450 mm, approximately 250 mm to approximately 400 mm, approximately 300 mm to approximately 350 mm, or any suitable width. The length may be approximately 170 mm or approximately 270 mm. The length may be approximately 100 mm to approximately 300 mm, approximately 125 mm to approximately 275 mm, approximately 150 mm to approximately 250 mm, approximately 175 mm to approximately 225 mm, or any suitable length.

[0138] In some configurations, the top layer 1410 may include a larger width and length than the other layers 1420, 1430, 1440, such that the top layer 1410 includes a top border (not shown) that extends beyond the perimeter of the other layers 1420, 1430, 1440. In this configuration, the top border can be adhered to the peri-wound area in use. In some configurations, the top layer 1410 and the wound contact layer 1430 may have the same length and width, such that the top layer 1410 adheres to the wound contact layer 1430 in a manner that sandwiches the other layers 1420, 1440 between the two layers 1410 and 1430. In this configuration, the wound contact layer 1430 can be adhered to the wound site and peri-wound area in use. The top border can include a width that can be measured from the edge of the PCL 1420 to the edge of the top layer 1410. The width may be approximately 30 mm. The width may be approximately 10 mm to approximately 50 mm, approximately 15 mm to approximately 45 mm, approximately 20 mm to approximately 40 mm, approximately 25 mm to approximately 35 mm, or any suitable width.

[0139] The size of the top layer 1410 can correspond to the size of the dressing, such as small, medium, or large. The table below shows example dimensions of the top layer 1410 that can correspond to a small, medium, or large size. [Table 1]

[0140] The middle layer 1420 may be a protective construction layer (PCL) 1420 configured to provide support to the dressing 1400 and protect the top layer from the transmission layer 1440 (e.g., from being penetrated by the monofilaments of the transmission layer 1440, if the transmission layer comprises monofilaments). For example, the PCL 1420 may provide a support layer between the top layer 1410 and the transmission layer 1440. The PCL 1420 may be configured to act as a blinding or shielding layer to help reduce the unsightly appearance of the drape 1400 in use due to absorption of wound exudate. The PCL 1420 may be a colored portion of the transmission layer 1440 or may be a separate layer that covers the transmission layer 1420. The PCL 1420 may be one of a variety of colors, such as blue, orange, yellow, green, or any color suitable for concealing the presence of wound exudate within the drape 1400. For example, blue PCL1420 may be a shade of blue similar to those commonly used in medical gowns, scrubs, and drapes. Some configurations of PCL1420 may include a polypropylene spunbond material. For example, PCL1420 may be made from or include Glatfelter Vizorb® 3055 MBAL90, Daltex® REPEL, and / or sterilizable thermally bonded nonwoven viscose and polypropylene nonwovens (e.g., Freudenberg M1556N, Vilene). Additionally, some configurations of PCL1420 may include hydrophobic additives or coatings. Some configurations may include thin fibrous sheets of 60, 70, or 80 gsm.

[0141] The PCL 1420 may include at least one viewing window configured to allow visual determination of the saturation level of the transmission layer 1440. The at least one viewing window may include at least one gap created through the PCL 1420. The at least one viewing window may include at least one uncolored region of the PCL 1420. Some configurations of the PCL 1420 may include multiple viewing windows or an array of viewing windows.

[0142] The blinding capability of PCL1420 may be partial or less than 100% occlusion, thereby allowing the clinician to access the information they need by observing the spread of exudate across the dressing surface. The blinding capability of PCL1420 may be partial due to material properties that allow wound exudate to slightly alter the appearance of the dressing 1400, or due to the presence of at least one viewing window in a fully occluding material. The partially blinding nature of PCL1420 may allow a skilled clinician to visually assess and monitor the extent of spread across the dressing by being able to perceive different colors caused by exudate, blood, by-products, etc. within the dressing. However, the change in color of the dressing from clean to containing exudate may be so subtle that the patient is unlikely to notice any aesthetic difference. Reducing or eliminating the visual indicators of wound exudate from a patient is likely to have a positive effect on the patient's health, for example, by reducing stress.

[0143] The PCL 1420 may include a width and a length. For example, the length and width of the PCL 1420 may be less than the width and length of the top layer 1410, as described above. The width of the PCL 1420 may be approximately 160 mm, approximately 210 mm, or approximately 360 mm. The width may be approximately 100 mm to approximately 400 mm, approximately 125 mm to approximately 375 mm, approximately 150 mm to approximately 350 mm, approximately 200 mm to approximately 325 mm, approximately 225 mm to approximately 300 mm, approximately 250 mm to approximately 300 mm, or any suitable width. The length of the PCL 1420 may be approximately 110 mm or approximately 210 mm. The length may be approximately 50 mm to approximately 300 mm, approximately 75 mm to approximately 275 mm, approximately 100 mm to approximately 250 mm, approximately 125 mm to approximately 225 mm, approximately 150 mm to approximately 200 mm, or any suitable length.

[0144] In some configurations, the PCL 1420 may include a larger width and a larger length than the transmission layer 1440, such that the PCL 1420 includes a PCL boundary 1420a that extends beyond the perimeter of the transmission layer 1440. The PCL boundary 1420a may include a width that may be measured from the edge of the transmission layer 1440 to the edge of the PCL 1420. The width may be approximately 5 mm. The width may be between approximately 5 mm and approximately 20 mm, or any suitable width.

[0145] The size of the PCL 1420 can correspond to a dressing size, such as small, medium, or large. The table below shows example dimensions of the PCL 1420 that can correspond to a small, medium, or large size. [Table 2]

[0146] The transmission layer 1440 can be configured to act as a transmission layer. In some embodiments, the transmission layer 1440 can be a porous material. The transmission layer 1440 can allow the transmission of fluids, including liquids and gases, away from the wound site and into the upper layer of the drape 1400. In particular, the transmission layer 1440 can assist in distributing negative pressure evenly to the wound and peri-wound area. This layer 1440 can be formed from a material having a three-dimensional structure; for example, a knitted or woven spacer fabric (e.g., Baltex 7970 weft knit polyester) or a nonwoven fabric can be used. The three-dimensional material can include a 3D spacer fabric material similar to the materials described in International Publication Nos. WO 2013 / 175306(A2) and WO 2014 / 020440, the disclosures of which are incorporated by reference in their entireties. The three-dimensional material may also be the same as or similar to the materials described above for the upper channel layer 5512 and the lower channel layer 5516, and may be composed of, for example, a knitted or woven spacer fabric (such as a knitted polyester 3D fabric, Baltex 7970®, or Gehring 879®), or a nonwoven material. Suitable materials may also include terry or loop pile materials. The fibers are not necessarily woven and may include felt and flock fiber materials (including materials such as Flotex®).

[0147] Some configurations of the transmission layer 1440 may additionally or alternatively include a wicking or acquisition distribution layer (ADL). An ADL is another type of transmission layer that may be provided to conduct fluids through the drape 1400. The ADL may be configured to wick fluids, such as wound exudate, horizontally as they are absorbed upward through the layers of the drape 1400. Wicking fluids laterally can advantageously increase water vapor transmission and the efficient delivery of negative pressure to the wound site. Some ADL embodiments may include viscose, polyester, polypropylene, polyethylene, cellulose (e.g., polysaccharides or repeating disaccharides), or a combination of some or all of these, and the material may be needle-pierceable. Some ADL configurations may include polyethylene in the range of 40 to 150 grams per square meter (gsm). Some ADL configurations may include a heavy fibrous melt material. Some ADL configurations may be relatively porous to allow the passage of fluids, including gases, therethrough. An example of an ADL may include a lightweight, felt-like viscose material, which may be 80 gsm (or approximately 80 gsm). Some embodiments of the ADL may include cellulose in the range of 40 to 160 gsm (or approximately 40 to approximately 160 gsm), e.g., 80 gsm (or approximately 80 gsm). The ADL may be constructed from a material that withstands compression under the levels of negative pressure typically applied during negative pressure therapy. The ADL may be constructed to advantageously wick fluids, such as wound exudate, vertically. It is desirable to facilitate rapid movement of wound exudate from the permeable layer to, for example, a port on the top layer 1410. Furthermore, judicious material selection can reduce rewetting of fluids downward from the upper layer to the lower layer, a phenomenon known as "backwetting" or "rewetting." Suitable materials that exhibit this enhanced effect include Slimcore TL4 (150 gsm) from Libeltex BVBA or equivalent.

[0148] Some configurations of ADLs may include several internal layers. For example, one material suitable for use as an ADL includes a lower wicking or acquisition layer with substantially vertically extending fibers for wicking fluid vertically, and further includes an upper distribution layer with substantially horizontally extending fibers for wicking fluid horizontally. Some ADL materials may include three or more layers, for example, a lower wicking layer and two upper distribution layers. Other configurations may have one or more distribution layers positioned between the upper and lower acquisition layers.

[0149] In some embodiments, the transmission layer may additionally or alternatively comprise an absorbent material; in other embodiments, the transmission layer may not have any absorbent material. If an absorbent material is utilized, it may be a foam or nonwoven natural or synthetic material, and may optionally include or be a superabsorbent material. The absorbent material forms a reservoir for fluids, particularly liquids removed from the wound site. The material of the transmission layer 1440 also prevents liquids collected within the drape 1400 from flowing in a sloshing manner. The transmission layer 1440 may help distribute fluids throughout the layer 1440 by wicking, so that fluids are drawn from the wound site and stored throughout the transmission layer 1440. This may help prevent clumping in the area of ​​the transmission layer 1440. The capacity of the absorbent material must be sufficient to manage the rate at which wound exudate flows when negative pressure is applied. During use, the transmission layer 1440 experiences negative pressure, and the material of the transmission layer 1440 is selected to absorb liquid under such conditions. Several materials exist, such as superabsorbent materials, that can absorb liquid when under negative pressure. In addition to the materials mentioned above, the transmission layer 1440 can be made from or include ALLEVYN™ foam, Freudenberg 114-224-4, and / or Chem-Posite™ 11C-450.

[0150] In some configurations, the transmission layer 1440 can include nonwoven cellulose fibers with superabsorbent material in the form of dry particles dispersed throughout. The use of cellulose fibers introduces a fast wicking element that helps quickly and evenly distribute liquid absorbed by the dressing. The parallel arrangement of many strand-like fibers can lead to strong capillary action in the fibrous pad, which helps distribute liquid, thus efficiently delivering liquid to the superabsorbent material. Additionally, all areas of the transmission layer 1440 are provided with liquid. Wicking also helps bring liquid into contact with the top layer 1410, which helps increase the transpiration rate of the drape 1400. Wicking can also help transport liquid downward toward the wound bed once exudation slows or stops. This delivery process may help to keep the transmission layer 1440 and the underlying wound bed area moist, which helps to prevent crusting within the drape 1400, which can lead to blockage, and helps to maintain an optimized environment for wound healing.

[0151] In some configurations, the transmission layer 1440 may comprise an airlaid material or any suitable material disclosed herein. Optionally, heat-fusible fibers may be used to help hold the structure of the drape 1400 together. It will be appreciated that instead of, or in addition to, using superabsorbent particles, superabsorbent fibers may be utilized in accordance with certain configurations of the present disclosure. An example of a suitable material is Product Chem-Posite™ 11C, available from Emerging Technologies Inc. (ETi) of the United States.

[0152] According to certain configurations of the present disclosure, the transmission layer 1440 may optionally include synthetic and / or bicomponent stable fibers and / or natural and / or superabsorbent fibers. The fibers of the transmission layer 1440 may be secured together by latex bonding, thermal bonding, hydrogen bonding, or any combination of bonding techniques or other securing mechanisms. In some configurations, the transmission layer 1440 may be formed with fibers that operate to lock the superabsorbent particles within the transmission layer 1440. Such an arrangement may help ensure that the superabsorbent particles do not migrate out of the transmission layer 1440 and toward the underlying wound bed. This may improve function because, when negative pressure is applied, the transmission layer 1440 tends to collapse downward, which can push the superabsorbent particulate matter toward the wound bed if it were not trapped by the fibrous structure of the transmission layer 1440.

[0153] The transmission layer 1440 may include a plurality of fibers. The fibers may be strand-like and may be made from cellulose, polyester, viscose, etc. Dry absorbent particles may be distributed throughout the ready-to-use transmission layer 1440. In some configurations, the transmission layer 1440 includes a pad of cellulose fibers and a plurality of superabsorbent particles. In an additional configuration, the transmission layer 1440 may be a nonwoven layer of randomly oriented cellulose fibers.

[0154] The transmission layer 1440 may include a length and a width. The width of the transmission layer 1440 may be approximately 150 mm, approximately 200 mm, or approximately 350 mm. The width may be approximately 100 mm to approximately 400 mm, approximately 150 mm to approximately 350 mm, approximately 200 mm to approximately 300 mm, or any suitable width. The length of the transmission layer 1440 may be approximately 100 mm or approximately 200 mm. The length may be approximately 50 mm to approximately 300 mm, approximately 75 mm to approximately 275 mm, approximately 100 mm to approximately 250 mm, approximately 125 mm to approximately 225 mm, approximately 150 mm to approximately 200 mm, or any suitable length.

[0155] The size of the transmission layer 1440 can correspond to the size of the dressing, such as small, medium, or large. The following table shows example dimensions of the transmission layer 1440 that can correspond to a small, medium, or large size: [Table 3]

[0156] The wound contact layer 1430 may include a length and a width. The width of the wound contact layer 1430 may be approximately 220 mm, approximately 270 mm, or approximately 420 mm. The width may be approximately 200 mm to approximately 500 mm, approximately 250 mm to approximately 450 mm, approximately 300 mm to approximately 400 mm, or any suitable width. The length of the wound contact layer 1430 may be approximately 170 mm or approximately 270 mm. The length may be approximately 100 mm to approximately 300 mm, approximately 125 mm to approximately 275 mm, approximately 150 mm to approximately 250 mm, approximately 175 mm to approximately 225 mm, or any suitable length.

[0157] In some configurations, the wound contact layer 1430 may be the same size as the top layer 1410. In this configuration, the wound contact layer 1430 can adhere to the wound site and peri-wound area during use. For example, the wound contact layer 1430 may be the same as or similar to any of the wound contact layers described herein. The wound contact boundary 1430 may include a wound contact boundary (not shown). The wound contact boundary may be the same size as the top boundary or a different size. The wound contact boundary may include a width that may be measured from the edge of the PCL 1420 to the edge of the wound contact layer 1430. The width may be approximately 30 mm. The width may be approximately 10 mm to approximately 50 mm, approximately 15 mm to approximately 45 mm, approximately 20 mm to approximately 40 mm, approximately 25 mm to approximately 35 mm, or any suitable width.

[0158] The size of the wound contact layer 1430 may correspond to the size of the dressing, such as small, medium, or large. The table below shows example dimensions of the wound contact layer 1430 that may correspond to a small, medium, or large size. [Table 4]

[0159] 13A and 13B, the layers 1410, 1420, 1430, 1440 can overlap the peri-wound area to enable NPWT to that area. For example, the wound contact layer 1430 can be positioned over the wound site, and the transmission layer 1440 can be positioned over the wound contact layer 1430. The wound contact layer 1430 can adhere to the peri-wound area surrounding the wound site. The PCL 1420 can be positioned over the transmission layer 1440, so that the PCL 1420 can reduce the risk of material from the transmission layer 1440 penetrating through the top layer 1410. The top layer 1410 can be positioned above the PCL 1420, so that the portion of the top layer 1410 extending beyond the PCL 1420 and transmission layer 1440 can adhere to the wound contact layer 1430 and / or the peri-wound area. When these overlapping layers 1410, 1420, 1430, 1440 are placed over the peri-wound area, negative pressure can be applied to the top layer 1410 and through the other layers 1420, 1430, 1440 to the peri-wound area, as described in further detail below. Openings or gaps can be provided in the top layer 1410 and the PCL 1420, such as in the center of the top layer 1410 and the PCL 1420, to provide negative pressure to the wound site and peri-wound area through the drape, such as through a port or suction adapter described herein.

[0160] The drape 1400 may include at least one protective release layer 1450. The at least one protective release layer 1450 may comprise a single, integral component or several overlapping components. The configuration illustrated in FIG. 13A has three overlapping components (a central release strip 1450b and first and second side release strips 1450a and 1450c). Although three release strips are shown, the drape 1400 may include more or fewer than three release strips (e.g., one, two, four, five, six, or more release strips). The at least one protective release layer 1450 may be removable prior to use. For example, each of the release strips 1450a, 1450b, 1450c may include a handle and / or a pair of handles that may be configured to remove the strip upon actuation of 1450a, 1450b, 1450c. For example, a user can pull a handle to remove the strips 1450a, 1450b, 1450c. At least one protective release layer 1450 can be removably attached to the underside of the wound contact layer 1430 and / or the top layer 1410 to maintain the adhesiveness of the silicone adhesive of the wound contact layer 1430 and / or the acrylic adhesive of the top layer 1410. As shown in FIG. 12A , the first release strip 1450a and the second release strip 1450c can be positioned on either side of the central release strip 1450b. The first release strip 1450a and the second release strip 1450c can overlap either side of the central release strip 1450b.

[0161] Methods for treating wounds with multi-layer drapes Some embodiments described herein provide methods of treating a wound using the wound dressings and drapes described herein, such as the wound dressing or drape 800 described above in connection with FIGS. 13A and 13B. The method of treating a wound may include removing the central release strip 1450b from the drape 1400. The drape 1400 may be positioned over the wound such that the wound contact layer 1430 contacts the wound and / or the peri-wound area surrounding the wound. The wound contact layer 1430 may be adhered to the wound and / or peri-wound area. The drape 1400 may optionally be repositioned over the wound and peri-wound area until the drape 1400 is in the proper position to provide effective treatment to the wound. The second side release strips 1450a, 1450c may be removed from the adhesive surface of the top layer 1410. The portion of the top layer 1410 extending over the wound contact layer 1430 may be adhered to the peri-wound area so that the drape 1400 is secured to the patient and negative pressure may be applied to the wound and peri-wound area through the drape 1400. Optionally, one or more fastening strips 900, 1000 may be applied around the periphery of the drape 1400.

[0162] Some embodiments described herein provide methods of treating a wound using the wound dressings and drapes described herein, such as the drape 1400 described above in connection with FIGS. 13A and 13B. The method of treating a wound may include removing at least one protective release layer 1450. The drape 1400 may be positioned over the wound such that the wound contact layer 1430 contacts the wound and / or the peri-wound area surrounding the wound. The wound contact layer 1430 may be adhered to the wound and / or peri-wound area. The drape 1400 may optionally be repositioned over the wound and peri-wound area until the drape 1400 is in the proper position to provide effective treatment to the wound. Negative pressure may be supplied to the drape 1400 utilizing a port or suction adapter described elsewhere herein. The port or suction adapter may be pre-applied to the drape over the opening in the top layer 1410 before the drape is positioned over the wound, or may be applied after the drape is positioned over the wound.

[0163] In some alternative configurations, a method of treating a wound may include using the drape 1400 under ambient conditions not associated with a negative pressure wound therapy system described above or elsewhere in this specification.

[0164] term The above patents and specifications and other references, including those that may be described in accompanying applications, are incorporated herein by reference. Aspects of the present disclosure can be modified, if necessary, to provide still further implementations using the systems, functions, and concepts of the various references described herein.

[0165] It should be understood that a feature, material, characteristic, or group described in connection with a particular aspect, embodiment, or example can be applied to any other aspect, embodiment, or example described herein, unless it is inconsistent with the other aspect, embodiment, or example. All features disclosed in this specification (including any accompanying claims, abstract, and drawings), or all steps of any similarly disclosed method or process, may be combined in any combination, except combinations in which at least some of such features or steps are mutually exclusive. Protection is not limited to the details of any of the foregoing embodiments. Protection extends to any novel, or any novel combination, of features disclosed in this specification (including any accompanying claims, abstract, and drawings), or any novel, or any novel combination of steps of any similarly disclosed method or process.

[0166] While certain embodiments have been described, these embodiments are presented by way of example only and are not intended to limit the scope of the protected subject matter. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Additionally, various omissions, substitutions, and changes may be made in the form of the methods and systems described herein. Those skilled in the art will appreciate that, in some embodiments, the actual steps performed in the illustrated or disclosed processes may differ from those shown in the drawings. In some embodiments, certain of the steps described above may be omitted, while others may be added. For example, the actual steps or order of steps performed in the disclosed processes may differ from those shown in the drawings. In some embodiments, certain of the steps described above may be omitted, while others may be added. Furthermore, the features and characteristics of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which are within the scope of the present disclosure.

[0167] While the present disclosure includes certain specific embodiments, examples, and applications, those skilled in the art will recognize that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments or uses, and obvious variations and equivalents thereof, including embodiments that may not provide all of the features and advantages described herein. Accordingly, the scope of the present disclosure is not intended to be limited by the described embodiments, but may be defined by the claims presented herein or hereafter.

[0168] Conditional language such as "can," "could," "might," or "may," unless specifically stated otherwise or interpreted otherwise within the context of use, is typically intended to convey that certain embodiments include certain features, elements, or steps, while other embodiments do not. Thus, such conditional language is not generally intended to imply that features, elements, or steps are required in any way for one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without user input or instruction, whether those features, elements, or steps are included in or should be performed in any particular embodiment. Terms such as "comprise," "include," and "have" are synonymous and used in an inclusive, open-ended manner and do not exclude additional elements, features, acts, operations, etc. The term "or" is also used in an inclusive sense (rather than an exclusive sense), such that, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Similarly, the term "and / or," in reference to a list of two or more items, encompasses all of the following interpretations of the word: any one of the items in the list, all items in the list, and any combination of items in the list. Additionally, the term "each," as used herein, in addition to having its ordinary meaning, can also refer to any subset of the list of elements to which the term "each" is applied. Furthermore, as used herein, the words "herein," "above," "below," and similar words, when used in this application, are meant to refer to the specification as a whole, and not to specific portions of the specification.

[0169] Conjunctive phrases such as "at least one of X, Y, and Z," unless specifically stated otherwise, are to be construed otherwise in accordance with the context in which they are generally used to suggest that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive phrases are generally not intended to suggest that a particular embodiment requires the presence of at least one X, at least one Y, and at least one Z.

[0170] As used herein, degree-expressing phrases, such as "approximately," "about," "generally," and "substantially," refer to values, amounts, or characteristics that approximate a given value, amount, or characteristic that still performs a desired function or produces a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is within 10%, 5%, 1%, 0.1%, and 0.01% of a given amount. As another example, in certain embodiments, the terms "generally parallel" and "substantially parallel" refer to a value, amount, or characteristic that deviates from exactly parallel by no more than 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degrees.

[0171] The scope of the present disclosure is not intended to be limited by the description of particular embodiments, but may be defined by the claims, which claim language should be interpreted broadly based on the language used in the claims and not limited to the examples described herein or during the prosecution of this application, which examples should be interpreted as non-exclusive.

[0172] Various modifications to the implementations described in this disclosure may be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other implementations without departing from the spirit or scope of the disclosure. Thus, the disclosure is not intended to be limited to the implementations shown herein, but is to be accorded the widest scope consistent with the principles and features described herein. Certain embodiments of the disclosure are covered by the set of claims listed below or presented below. [Additional note 1] 1. A device for sealing a wound site, said device comprising: a fixing strip, the fixing strip comprising: a wound sealing layer having a first adhesive surface, the first adhesive surface comprising a first adhesive; an adhesive layer overlying and extending outwardly beyond the wound sealing layer, the adhesive layer comprising a second adhesive surface comprising a second adhesive; and at least one protective liner removably adhered to the first adhesive surface of the wound sealing layer and / or the second adhesive surface of the adhesive layer. [Additional note 2] 10. The device of claim 1, wherein the fixation strip is configured to be placed over the edge of the wound dressing. [Additional note 3] 10. The device of any one of the preceding clauses, wherein the fixing strip has a width and a length, and the second adhesive extends along the width of the fixing strip. [Additional note 4] 4. The device of claim 3, wherein the first adhesive extends along a portion of the width of the fixing strip. [Additional note 5] 5. The device of claim 4, wherein the at least one protective liner further comprises a first protective liner and a second protective liner, the first protective liner being removably adhered to the first adhesive surface of the wound sealing layer, and the second protective liner being removably adhered to the second adhesive surface of the adhesive layer. [Additional note 6] 6. The device of claim 5, wherein the first protective liner comprises a peeling handle configured to remove the first protective liner from the wound sealing layer when actuated, and the second protective liner comprises a peeling handle configured to remove the second protective liner from the adhesive layer when actuated. [Additional note 7] 10. The device of claim 1, wherein the at least one protective liner further includes a first outer protective liner, a second outer protective liner, and a central protective liner. [Additional note 8] 8. The device of claim 7, wherein the first outer protective liner is removably adhered to an outer edge portion of the first adhesive surface of the wound sealing layer, the second outer protective liner is removably adhered to a portion of the second adhesive surface of the adhesive layer that extends outward beyond the wound sealing layer, and the central protective liner is removably adhered to the first adhesive surface of the wound sealing layer between the first outer protective liner and the second outer protective liner. [Additional note 9] 9. The device of claim 7 or 8, wherein at least one of the first outer protective liner, the second outer protective liner, and the central protective liner comprises a peeling handle configured, upon actuation, to detach the respective liner from the wound sealing layer and / or the adhesive layer. [Additional Note 10] 8. The device described in claim 7, wherein the first outer protective liner, the second outer protective liner, and the central protective liner each have a width extending across the width of the fixing strip so as to removably adhere to the first adhesive surface of the wound sealing layer and to a portion of the second adhesive surface of the adhesive layer extending outward beyond the wound sealing layer. [Additional Note 11] The device of any one of the preceding clauses, further comprising a carrier layer removably adhered to a non-adhesive surface of the adhesive layer. [Additional Note 12] 10. The device of any one of the preceding clauses, wherein the first adhesive comprises a silicone adhesive configured to adhere to the wound site or skin surrounding the wound site. [Additional Note 13] 10. The device of any one of the preceding clauses, wherein the second adhesive comprises an acrylic adhesive configured to adhere to a wound dressing. [Additional Note 14] The device of any one of the preceding clauses, wherein the wound sealing layer comprises a flexible polymer. [Additional Note 15] The device of any one of the preceding claims, wherein the adhesive layer comprises a flexible film. [Additional Note 16] 1. A negative pressure wound therapy kit comprising: a wound dressing comprising a cover; a fixing strip, the fixing strip comprising: a wound sealing layer having a first adhesive surface, the first adhesive surface comprising a first adhesive; an adhesive layer overlying and extending outwardly beyond the wound sealing layer, the adhesive layer comprising a second adhesive surface comprising a second adhesive; and at least one protective liner removably adhered to the first adhesive surface of the wound sealing layer and / or the second adhesive surface of the adhesive layer. [Additional Note 17] The negative pressure wound therapy kit described in Appendix 16, wherein the at least one protective liner further includes a first protective liner and a second protective liner. [Additional Note 18] 18. The negative pressure wound therapy kit of claim 17, wherein the first protective liner is removably adhered to the wound sealing layer and the second protective liner is removably adhered to the adhesive layer. [Additional Note 19] A negative pressure wound therapy kit as described in Appendix 16, wherein a portion of the second adhesive surface of the adhesive layer extending outward beyond the wound sealing layer is configured to adhere to the cover of the wound dressing during use. [Additional Note 20] The negative pressure wound therapy kit of claim 16, wherein the at least one protective liner further includes a first outer protective liner, a second outer protective liner, and a central protective liner. [Additional Note 21] 21. A negative pressure wound therapy kit as described in Appendix 20, wherein the first outer protective liner is removably adhered to an outer edge portion of the first adhesive surface of the wound sealing layer, the second outer protective liner is removably adhered to a portion of the second adhesive surface of the adhesive layer that extends outward beyond the wound sealing layer, and the central protective liner is removably adhered to the first adhesive surface of the wound sealing layer between the first outer protective liner and the second outer protective liner. [Additional Note 22] A negative pressure wound therapy kit as described in Appendix 21, wherein the outer edge portion of the first adhesive surface of the wound sealing layer faces a portion of the adhesive layer that extends outward beyond the wound sealing layer. [Additional Note 23] A negative pressure wound therapy kit as described in Appendix 20, wherein the first outer protective liner, the second outer protective liner, and the central protective liner each have a width extending to the width of the fixing strip so as to removably adhere to the first adhesive surface of the wound sealing layer and a portion of the second adhesive surface of the adhesive layer extending outward beyond the wound sealing layer. [Additional note 24] A negative pressure wound therapy kit according to any one of claims 16 to 23, wherein the fixing strip further comprises a carrier layer removably adhered to the non-adhesive surface of the adhesive layer. [Additional note 25] 1. A method for sealing a wound dressing, said method comprising: positioning a wound dressing over the wound site and a peri-wound area surrounding the wound site, the wound dressing comprising a cover; removing the central protective liner and the first outer protective liner from the first adhesive surface of the wound sealing layer and / or the second adhesive surface of the adhesive layer of the fixation strip; the fixation strip comprises the wound sealing layer having the first adhesive surface comprising a first adhesive, the adhesive layer overlying the wound sealing layer and extending outwardly beyond the wound sealing layer, the central protective liner, the first outer protective liner, and the second outer protective liner; removing the adhesive layer, the second adhesive surface comprising a second adhesive; positioning the fixation strip over the peri-wound area and partially over the wound dressing; removing the second outer protective liner from the first adhesive surface of the wound sealing layer and / or the second adhesive surface of the adhesive layer; adhering the adhesive layer of the fixation strip to the cover of the wound dressing; Positioning a negative pressure applicator on the cover of the wound dressing; applying negative pressure to the wound site and the peri-wound area through the wound dressing for a period of time. [Additional note 26] 26. The method of claim 25, further comprising cutting the wound dressing along a side portion thereof before positioning the wound dressing over the wound site and the pericown area. [Additional note 27] 1. A method for sealing a wound dressing, said method comprising: cutting a wound dressing along a side portion of the wound dressing, the wound dressing comprising a cover; using a peel handle of a first protective liner to remove said first protective liner from a first adhesive surface of the wound sealing layer of the fixation strip; the fixation strip comprises the wound sealing layer with the first adhesive surface comprising a first adhesive, an adhesive layer overlying and extending outwardly beyond the wound sealing layer, the first protective liner comprising the first protective liner peel handle, and the second protective liner comprising the second protective liner peel handle; removing the adhesive layer, wherein the adhesive layer comprises a second adhesive surface comprising a second adhesive; Positioning the fixation strip over a peri-wound area surrounding a wound site; inserting the side portion of the wound dressing into the fixing strip between the wound sealing layer and the adhesive layer; positioning the wound dressing over the wound site and the peri-wound area; removing the second protective liner from the second adhesive surface of the adhesive layer using the peel handle of the second protective liner; adhering the adhesive layer of the fixation strip to the wound dressing; Positioning a negative pressure applicator on the wound dressing; applying negative pressure to the wound site and the peri-wound area through the wound dressing for a period of time. [Additional note 28] 28. The method of claim 27, wherein the fixing strip further comprises a carrier layer removably adhered to a non-adhesive surface of the adhesive layer. [Additional note 29] 29. The method of claim 27 or 28, further comprising removing the carrier layer from the fixation strips before applying negative pressure to the wound site and the peri-wound area. [Additional note 30] 1. A device for sealing a wound site, said device comprising: a sheet comprising a plurality of fastening strips and perforated portions, each of the perforated portions being positioned between adjacent fastening strips, each of the perforated portions comprising two perforated sections and a continuous cut section positioned between the two perforated sections, the two perforated sections comprising a plurality of perforations separated by a bridge portion extending between adjacent fastening strips; Each of the plurality of fastening strips is an adhesive layer; a first outer protective liner, a second outer protective liner, and a central protective liner, each removably adhered to the adhesive layer, wherein the continuous cut section extends along at least the entire length of the central protective liner. [Additional note 31] 31. The device of claim 30, wherein each of the plurality of fixation strips is configured to be placed over a portion of the wound dressing. [Additional note 32] 32. The device of claim 31, wherein the portion of the wound dressing includes an edge of the wound dressing. [Additional note 33] 33. The device of any one of clauses 30 to 32, wherein the adhesive layer of each of the plurality of fixing strips comprises an adhesive surface. [Additional note 34] 34. The device of claim 33, wherein the adhesive surface comprises a silicone adhesive configured to adhere to the wound site or the skin surrounding the wound site. [Additional note 35] 34. The device of claim 33, wherein the adhesive surface comprises an acrylic adhesive configured to adhere to a wound dressing. [Additional note 36] The device described in any one of appended claims 30 to 35, wherein the first outer protective liner of each of the plurality of fixing strips includes a first peel handle and the second outer protective liner includes a second peel handle. [Additional note 37] 37. The device of claim 36, wherein the central protective liner of each of the plurality of fixing strips is positioned over the first peel handle and the second peel handle. [Additional note 38] 38. The device of any one of clauses 30 to 37, wherein each of the plurality of fixing strips further comprises a wound sealing layer comprising a first adhesive, the adhesive layer overlying and extending outwardly beyond the wound sealing layer, and the adhesive layer comprising a second adhesive. [Additional note 39] 39. The device of claim 38, wherein the first adhesive comprises a silicone adhesive and the second adhesive comprises an acrylic adhesive. [Additional note 40] 40. The device of any one of clauses 30 to 39, wherein each of the plurality of fixing strips further comprises a carrier layer removably adhered to a non-adhesive surface of the adhesive layer. [Additional note 41] The device according to any one of claims 30 to 40, wherein the plurality of fixing strips are removably attached. [Additional note 42] 42. The device of any one of clauses 30 to 41, wherein the length of each of the perforated portions extends the length of each of the plurality of fixing strips.

Claims

1. 1. A device for sealing a wound site, said device comprising a fixation strip; The fixing strip a wound sealing layer having a first adhesive surface, the first adhesive surface comprising a first adhesive; an adhesive layer overlying and extending outwardly beyond the wound sealing layer, the adhesive layer comprising a second adhesive surface comprising a second adhesive; at least one protective liner removably adhered to the first adhesive surface of the wound sealing layer and / or the second adhesive surface of the adhesive layer; a top layer releasably attached to the adhesive layer on a side opposite the second adhesive surface; An apparatus comprising:

2. The device of claim 1 , wherein the fixation strip is configured to fit over an edge of a wound dressing.

3. The device of claim 1 or 2, wherein the fastening strip has a width and a length, and the second adhesive extends along the width of the fastening strip.

4. The device of claim 3 , wherein the first adhesive extends along a portion of the width of the fastening strip.

5. 5. The device of claim 4, wherein the at least one protective liner further comprises a first protective liner and a second protective liner, the first protective liner being removably adhered to the first adhesive surface of the wound sealing layer and the second protective liner being removably adhered to the second adhesive surface of the adhesive layer.

6. 6. The device of claim 5, wherein the first protective liner comprises a peel handle configured to, when actuated, detach the first protective liner from the wound sealing layer, and the second protective liner comprises a peel handle configured to, when actuated, detach the second protective liner from the adhesive layer.

7. The device of claim 1 , wherein the at least one protective liner further comprises a first outer protective liner, a second outer protective liner, and a central protective liner.

8. 8. The device of claim 7, wherein the first outer protective liner is removably adhered to an outer edge portion of the first adhesive surface of the wound sealing layer, the second outer protective liner is removably adhered to a portion of the second adhesive surface of the adhesive layer that extends outwardly beyond the wound sealing layer, and the central protective liner is removably adhered to the first adhesive surface of the wound sealing layer between the first outer protective liner and the second outer protective liner.

9. 9. The device of claim 7 or 8, wherein at least one of the first outer protective liner, the second outer protective liner, and the central protective liner comprises a peeling handle configured, upon actuation, to detach the respective liner from the wound sealing layer and / or the adhesive layer.

10. 8. The device of claim 7, wherein the first outer protective liner, the second outer protective liner, and the central protective liner each have a width extending across the width of the securing strip so as to removably adhere to the first adhesive surface of the wound sealing layer and to a portion of the second adhesive surface of the adhesive layer that extends outwardly beyond the wound sealing layer.

11. 11. The device of any one of claims 1 to 10, wherein the first adhesive comprises a silicone adhesive configured to adhere to the wound site or to the skin surrounding the wound site.

12. 12. The device of any one of claims 1 to 11, wherein the second adhesive comprises an acrylic adhesive configured to adhere to a wound dressing.

13. 1. A device for sealing a wound site, comprising: the device comprises a seat; the sheet comprises a plurality of fastening strips and perforated portions, each of the perforated portions being positioned between adjacent fastening strips, each of the perforated portions comprising two perforated sections and a continuous cut section positioned between the two perforated sections, the two perforated sections comprising a plurality of perforations separated by a bridge portion extending between the adjacent fastening strips; Each of the plurality of fastening strips comprises: an adhesive layer; a first outer protective liner, a second outer protective liner, and a central protective liner, each removably adhered to the adhesive layer; a top layer of the adhesive layer releasably attached to a surface opposite to a surface to which the first outer protective liner, the second outer protective liner, and the central protective liner are adhered; Equipped with The apparatus wherein the continuous cut section extends along at least the entire length of the central protective liner.

14. 14. The device of claim 13, wherein each of the plurality of fixation strips is configured to be placed over a portion of a wound dressing.

15. the adhesive layer of each of the plurality of fastening strips comprises an adhesive surface; 14. The device of claim 13, wherein the adhesive surface comprises a silicone adhesive configured to adhere to the wound site or to the skin surrounding the wound site.

16. the adhesive layer of each of the plurality of fastening strips comprises an adhesive surface; 14. The device of claim 13, wherein the adhesive surface comprises an acrylic adhesive configured to adhere to a wound dressing.

17. 17. The device of claim 13, wherein the first outer protective liner of each of the plurality of fixation strips comprises a first peel handle and the second outer protective liner comprises a second peel handle.

18. 18. An apparatus according to any one of claims 13 to 17, wherein each of the plurality of fixing strips further comprises a wound sealing layer comprising a first adhesive, the adhesive layer overlying and extending outwardly beyond the wound sealing layer, the adhesive layer comprising a second adhesive.

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