CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of priority to U.S. Provisional Application No.

62/966,638, filed on January 28, 2020, which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] The present invention relates generally to the field of treating wounds (e.g., bums, lacerations, surgical incisions, sores, ulcers, damaged tissue, nerve damage, etc.) and more particularly to negative pressure wound therapy (NPWT) systems with instillation therapy. NPWT refers to the application of negative pressure (relative to atmospheric pressure) to a wound bed to facilitate healing of the wound bed. Negative pressure may be applied in coordination with instillation therapy, in which instillation fluid (e.g., cleansing fluid, medicated fluid, antibiotic fluid, irrigation fluid) is applied to the wound bed. Negative pressure and instillation wound therapy (NPWTi) may facilitate removal of wound exudate and other debris from the wound bed and otherwise support healing.

[0003] One common location for a wound (e.g., a bum) that could benefit from NPWTi is on a patient’s hand. However, standard NPWTi dressings may be challenging to use on a hand due to the shape, size, contours, articulation, etc. of a hand. Accordingly, hand-specific dressings may facilitate improved NPWTi for hand wounds.

SUMMARY

[0004] One implementation of the present disclosure is a dressing for an extremity, according to some embodiments. The dressing can include a manifold layer, a barrier layer, and a fenestrated layer. The barrier layer can be disposed on one side of the manifold layer. The fenestrated layer can be disposed on an opposite side of the manifold layer. The fenestrated layer can include multiple openings, The multiple openings can include multiple slits and multiple slots. The slits are positioned on the fenestrated layer near a negative pressure connection point and the slots are positioned on the fenestrated layer distal from the negative pressure connection point.

[0005] In some embodiments, the slits have a smaller cross-sectional area than the plurality of slots.

[0006] In some embodiments, the negative pressure connection point is configured to receive a conduit communicating with a negative pressure therapy unit.

[0007] In some embodiments, the conduit is configured to deliver instillation fluid from the therapy unit to the manifold layer.

[0008] In some embodiments, the slits are positioned on the fenestrated layer closer to the negative pressure connection point than the plurality of slots. [0009] In some embodiments, a transition between the slots and the slits is continuous such that the openings gradually transition from the slits to the slots with increasing distance from the negative pressure connection point.

[0010] In some embodiments, a transition between the slots and the slits is abrupt such that the openings transition from the slits to the slots at a particular distance from the negative pressure connection point.

[0011] In some embodiments, the slots and the slits have an overall length of about 3 millimeters.

[0012] In some embodiments, a width of the slots is within a range of about 0.5 to 2 millimeters.

[0013] In some embodiments, a width of the openings increases with increased distance from the negative pressure connection point.

[0014] In some embodiments, the slits have a width that is less than a width of the slots.

[0015] In some embodiments, the slots include rounded ends

[0016] In some embodiments, the dressing is formed in the same of a glove and is configured for use on a hand.

[0017] In some embodiments, the negative pressure connection point is positioned at a palm of the glove.

[0018] In some embodiments, the slots are positioned at fingers of the glove and the slits are positioned at the palm of the glove.

[0019] In some embodiments, the dressing includes a vent opening disposed proximate at least one fingertip of the hand. The vent opening can be configured to facilitate a controlled leak of air into the dressing.

[0020] In some embodiments, the dressing includes a hydrophilic or hydrophobic filter disposed proximate the vent opening. The filter can be configured to restrict bacteria from entering the dressing through the vent opening.

[0021] In some embodiments, a pattern of the slits and slots is operable to provide a substantially even negative pressure distribution across the manifold layer.

[0022] In some embodiments, the slits are disposed in a first region proximate the negative pressure connection point and the slots are disposed in a second region adjacent to the first region.

[0023] Another implementation of the present disclosure is a NPWT system, according to some embodiments. The system includes a dressing, a NPWT unit, and a conduit. The dressing is for an extremity and includes a manifold layer, a barrier layer adjacent to one side of the manifold layer, and a fenestrated layer. The fenestrated layer can be adjacent to another side of the manifold layer. The fenestrated layer can include multiple openings. The openings can include multiple slits and multiple slots. The slits are positioned on the fenestrated layer near a negative pressure connection point and the slots are positioned on the fenestrated layer distal from the negative pressure connection point.

The NPWT unit can be configured to draw a negative pressure at the dressing. The conduit can be fluidly coupled to the NPWT unit and the dressing. [0024] The slits can have a smaller cross-sectional area than the slots.

[0025] The negative pressure connection point is configured to receive the conduit to fluidly couple the NPWT unit and the dressing, according to some embodiments.

[0026] The conduit can be configured to deliver an instillation fluid from the therapy unit to the manifold layer.

[0027] The slits are positioned on the fenestrated layer closer to the negative pressure connection point than the slots.

[0028] The transition between the slots and the slits is continuous such that the openings gradually transition from the slits to the slots with increasing distance from the negative pressure connection point.

[0029] The transition between the plurality of slots and the plurality of slits can be abrupt such that the openings transition from the plurality of slits to the plurality of slots at a particular distance from the negative pressure connection point.

[0030] In some embodiments, the slots and the slits have an overall length of about 3 millimeters.

[0031] In some embodiments, a width of the slots is within a range of about 0.5 to 2 millimeters.

[0032] In some embodiments, a width of the openings increases with increased distance from the negative pressure connection point.

[0033] In some embodiments, the slits have a width that is less than a width of the slots.

[0034] In some embodiments, the slots include rounded ends.

[0035] In some embodiments, the dressing is formed in the shape of a glove and is configured for use on a hand.

[0036] In some embodiments, the negative pressure connection point is positioned at a palm of the glove.

[0037] In some embodiments, the slots are positioned at fingers of the glove and the slits are positioned at the palm of the glove.

[0038] In some embodiments, the NPWT system also include a vent opening disposed proximate at least one fingertip of the glove. The vent opening can be configured to facilitate a controlled leak of air into the dressing.

[0039] In some embodiments, the NPWT system includes a hydrophilic or hydrophobic filter disposed proximate the vent opening. The filter can be configured to restrict bacteria from entering the dressing through the vent opening.

[0040] In some embodiments, a pattern of the slits and slots is operable to provide a substantially even negative pressure distribution across the manifold layer.

[0041] In some embodiments, the slits are disposed in a first region proximate the negative pressure connection point and the slots are disposed in a second region adjacent the first region.

[0042] Another implementation of the present disclosure is a method for providing NPWT to an extremity, according to some embodiments. The method can include providing a dressing having a manifold layer, a barrier layer, a fenestrated layer, and a negative pressure connection point. The dressing may define an inner volume configured to receive the extremity. The method can further include drawing a negative pressure at the inner volume of the dressing. The fenestrated layer of the dressing may include multiple slits positioned near the negative pressure connection point and multiple slots positioned a distance away from the negative pressure connection point.

[0043] In some embodiments, the inner volume has a shape configured to receive a hand.

[0044] In some embodiments, the inner volume has a shape configured to receive a foot.

[0045] In some embodiments, the method further includes drawing air into the dressing through a vent opening in the dressing. The dressing can further include a filter positioned at the vent opening to restrict bacteria from entering the dressing with the air.

[0046] In some embodiments, the vent opening is positioned at a fingertip of the dressing.

[0047] Those skilled in the art will appreciate that the summary is illustrative only and is not intended to be in any way limiting. Other aspects, inventive features, and advantages of the devices and/or processes described herein, as defined solely by the claims, will become apparent in the detailed description set forth herein and taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0048] FIG. 1 is a perspective view of a negative pressure and instillation wound therapy (NPWTi) system, according to an exemplary embodiment.

[0049] FIG. 2 is a block diagram of the NPWTi system of FIG. 1, according to an exemplary embodiment.

[0050] FIG. 3 is a top view of dressing for treating a hand wound and for use with the NPWTi system of FIGS. 1-2, according to an exemplary embodiment.

[0051] FIG. 4 is a first cross-section view of the dressing of FIG. 3, according to an exemplary embodiment.

[0052] FIG. 5 is a second cross-section view of the dressing of FIG. 3, according to an exemplary embodiment.

[0053] FIG. 6 is a third cross-section view of the dressing of FIG. 3, according to an exemplary embodiment.

[0054] FIG. 7 is a top view of a perforated layer that is usable with the dressing of FIG. 3, including both slits and slots, according to an exemplary embodiment.

[0055] FIG. 8 is a view of one of the slots of the perforated layer of FIG. 7, according to an exemplary embodiment.

[0056] FIG. 9 is a view of one of the slots of the perforated layer of FIG. 7, according to an exemplary embodiment.

[0057] FIG. 10 is a diagram of a NPWT system that is usable with the dressing of FIG. 3 and the perforated layer of FIG. 7, according to an exemplary embodiment. [0058] FIG. 11 is a diagram of a gradual transition between the slits and the slots of the perforated layer of FIG. 7, according to an exemplary embodiment.

[0059] FIG. 12 is a diagram of an abrupt transition between the slits and the slots of the perforated layer of FIG. 7, according to an exemplary embodiment.

[0060] FIG. 13 is a block diagram of a process for performing NPWT using the dressing of FIG. 3 and the perforated layer of FIG. 7, according to an exemplary embodiment.

DETAILED DESCRIPTION

Overview

[0061] Referring generally to the FIGURES, a hand dressing for NPWT includes a barrier layer, a manifold layer, and a fenestrated or perforated layer. The barrier layer can be a fdm layer that encloses the manifold layer and the fenestrated layer onto a wound surface or onto tissue surrounding a wound. The manifold layer can be configured to receive and transport fluid along the hand dressing to a negative pressure contact point. The fenestrated or perforated layer can abut or be in direct contact with the manifold layer on a first side of the manifold layer. The barrier layer can abut or be in direct contact with the manifold layer on a second side of the manifold layer that is opposite the first side of the manifold layer.

[0062] The perforated layer can include multiple regions with openings that cover substantially an entire surface area of the perforated layer. For example, the perforated layer may include a first region, a proximate region, a palm region, etc., that is proximate the negative pressure contact point. The perforated layer can also include a second region or an outer region(s) that is/are adjacent the first region.

[0063] The first region includes multiple slits that extend through the perforated layer. The slits can have a negligible width and may have a length of up to 3 millimeters. The second region includes multiple slots that extend through the perforated layer, similar to the slits in the first region. The slots that extend through the perforated layer may have a width, a length, or an overall cross-sectional area that is greater than the width, length, and/or overall cross-sectional area of the slits. The slots and the slits may function as valves that selectively open/close in response to fluidic contact (e.g., fluid exuded by a wound or by the patient’s tissue). The fluid can then be transferred to the manifold layer and transported to the negative pressure contact point.

[0064] The slots and the slits can facilitate a more uniform pressure differential across the dressing. For example, regions that are further away from the negative pressure contact point may result in a pressure drop or less negative pressure. However, providing slots with an increased area may reduce the pressure drop at regions distal from the negative pressure contact point, thereby improving the uniformity of the pressure differential across the dressing. Negative Pressure and Instillation Wound Therapy System

[0065] Referring to FIGS. 1 and 2, a negative pressure and instillation wound therapy (NPWTi) system 100 is shown, according to exemplary embodiments. FIG. 1 shows a perspective view of the NPWTi system 100, according to an exemplary embodiment. FIG. 2 shows a block diagram of the NPWTi system 100, according to an exemplary embodiment. The NPWTi system 100 is shown to include a therapy unit 102 fluidly coupled to a dressing 104 via a vacuum tube 106 and an instillation tube 108. In the embodiments described herein, the dressing 104 is configured for use in treating one or more wounds on a patient’s hand. The NPWTi system 100 is also shown to include an instillation fluid source 110 fluidly coupled to the instillation tube 108. The NPWTi system 100 is configured to provide NPWT at a wound bed by reducing the pressure at the dressing 104 relative to atmospheric pressure. The NPWTi system 100 is also configured to provide instillation therapy by providing instillation fluid to the dressing 104. By providing both NPWT and instillation therapy, the NPWTi system 100 is configured to facilitate wound healing. As described in detail below, the NPWTi system 100 is also configured to provide a physiotherapy mode that facilitates mobility, articulation, etc. of a patient’s hand during treatment by the NPWTi system 100. The NPWTi system 100 thereby facilitates wound healing while also allowing for functional rehabilitation of the hand and reducing the risk of contractures.

[0066] Although the examples described herein show a NPWTi system 100 configured to provide both NPWT and instillation therapy, in other embodiments the system 100 is configured to provide NPWT without instillation therapy.

[0067] The dressing 104 is coupleable to a wound bed, i.e., a location of a wound (e.g., sore, laceration, bum, etc.) on a patient. In the examples herein, the dressing 104 is configured to be placed on a hand of a patient to cover a wound bed located on the hand. The dressing 104 may be substantially sealed over/around the wound bed such that a pressure differential may be maintained between the atmosphere and the wound bed (i.e., across the dressing 104). The dressing 104 may be coupled to the vacuum tube 106 and the instillation tube 108, for example to place the vacuum tube 106 and/or the instillation tube 108 in fluid communication with the wound bed. Embodiments of the dressing 104 are shown in FIGS. 3-9 and described in detail with reference thereto.

[0068] The dressing 104 includes one or more sensors 204. The one or more sensor(s) 204 are configured to measure one or more physical parameters at the dressing and provide the measurements to the control circuit 202, for example by transmitting the measurements via wireless communications (e.g., via a wireless network such as Bluetooth, WiFi, etc.). In the embodiments shown herein, the one or more sensor(s) 104 include a humidity sensor configured to measure humidity at the dressing 104, a moisture sensor configured to measure moisture at the dressing 104, and a strain sensor configured to measure a strain on the dressing 104. In some embodiments, the one or more sensor(s) 204 include one or more pH sensors to measure tissue pH or fluid pH. [0069] The therapy unit 102 includes a negative pressure pump 112 (shown in FIG. 2 and obscured within the therapy unit 102 in the perspective view of FIG. 1) configured to pump air, wound exudate, and/or other debris (e.g., necrotic tissue) and/or fluids (e.g., instillation fluid) out of the dressing 104 via the vacuum tube 106, thereby creating a negative pressure at the dressing 104. The negative pressure pump 112 is fluidly communicable with the vacuum tube 106 and the dressing 104. Wound exudate and/or other debris and/or fluids removed from the wound bed by the negative pressure pump 112 may be collected in a canister 114 located on the therapy unit 102. The canister 114 may be removable from the therapy unit 102 to allow canister 114 to be emptied or replaced when the canister 114 fdls with fluid and debris.

[0070] Operating the negative pressure pump 112 may therefore both create a negative pressure at the wound bed and remove undesirable fluid and debris from the wound bed. In some cases, operating the negative pressure pump 112 may cause deformation of the wound bed and/or provide other energy to the wound bed to facilitate debridement and healing of the wound bed. In various embodiments, the negative pressure pump 112 may be operated to provide various levels (amounts, values, etc.) of negative pressure at the wound bed (e.g., 30 mmHg, 60 mmHg, 75 mmHg, 125 mmHg, 150 mmHg, etc.) for example varying over time as part of a dynamic pressure control approach. In the embodiments described below, the negative pressure pump 112 is configured to operate, as controlled by the control circuit 202, to provide a first level of negative pressure at the wound bed corresponding to a wound therapy mode (e.g., 125 mmHg) and a second level of negative pressure at the wound bed corresponding to a physiotherapy mode (e.g., 60 mmHg), where the second level is closer to ambient air pressure than the first level.

[0071] The therapy unit 102 also includes an instillation pump 116. The instillation pump 116 is configured to selectively provide instillation fluid from the instillation fluid source 110 to the dressing 104. The instillation pump 116 is operable to control the timing and amount (volume) of instillation fluid provided to the dressing 104. The instillation pump 116 may be controlled in coordination with the negative pressure pump 112 to provide one or more wound treatment cycles that may facilitate wound healing. In some embodiments, the amount of fluid provided by the instillation pump is automatically determined using a wound volume estimation process executed by the therapy unit 102. [0072] The therapy unit 102 is also shown to include an input/output device 118. The input/output device 118 is configured to provide information relating to the operation of the NPWTi system 100 to a user and to receive user input from the user. The input/output device 118 may display status information relating to the NPWTi system 100, for example including measurements obtained from the sensor(s) 204 of the dressing 104 or the sensor(s) 200 of the therapy unit 102. The input/output device 118 may allow a user to input various preferences, settings, commands, etc. that may be used in controlling the negative pressure pump 112 and the instillation pump 116 as described in detail below. The input/output device 118 may include a display (e.g., a touchscreen), one or more buttons, one or more speakers, and/or various other devices configured to provide information to a user and/or receive input from a user.

[0073] As shown in FIG. 2, the therapy unit 102 is also shown to include one or more sensors 200 and a control circuit 202. The sensor(s) 200 may be configured to monitor one or more of various physical parameters relating to the operation of the NPWTi system 100. For example, the sensor(s) 200 may measure pressure at the vacuum tube 106, which may be substantially equivalent and/or otherwise indicative of the pressure at the dressing 104. As another example, the sensor(s) 200 may measure an amount (e.g., volume) of instillation fluid provided to the dressing 104 by the instillation pump 116. The sensor(s) 200 may provide such measurements to the control circuit 202.

[0074] The control circuit 202 is configured to control the operation of the therapy unit 102, including by controlling the negative pressure pump 112, the instillation pump 116, and the input/output device 118. The control circuit 202 may receive measurements from the sensor(s) 200 and the sensor(s) 204 and/or user input from the input/output device 118 and use the measurements and/or the user input to generate control signals for the instillation pump 116 and/or the negative pressure pump 112. For example, the control circuit 202 may control the negative pressure pump 112 and the instillation pump 116 to provide various combinations of various instillation phases, soak periods, and negative pressure phases (i.e., various pressures and instillation amounts over various durations) to support and encourage wound healing. As another example, as described in detail below with reference to FIG. 10, the control circuit 202 is configured to automatically initiate a wound therapy mode in response to strain measurements from the sensor(s) 204 by controlling the negative pressure pump 112 to reduce the negative pressure at the dressing 104, thereby allowing increased mobility, flexion, articulation, etc. of the hand treated by the dressing 104.

Hand Dressing for NPWTi or NPWT

[0075] Referring now to FIGS. 3-5, various views of a first embodiment of the dressing 104 is shown. FIG. 3 shows a top view of the dressing 104 and FIGS. 4-6 show various cross-sectional views of the dressing 104.

[0076] In FIGS. 3-5, the dressing 104 is shown to include a first manifold layer 300, a second manifold layer 302, a first barrier layer 304 that is adjacent to (e.g., abuts) the first manifold layer 300, and a second barrier layer 306 abuts the second manifold layer 302. The first manifold layer 300 and the second manifold layer 302 are positioned between the first barrier layer 304 and the second barrier layer 306. In some embodiments, the first manifold layer 300 is coupled to the first barrier layer 304 by an adhesive and/or the second manifold layer 302 is coupled to the second barrier layer 306 by an adhesive.

[0077] The dressing 104 is also shown to includes a first fenestrated film layer 308 that abuts the first manifold layer 300 with and a second fenestrated film layer 308 that abuts the second manifold layer 302. The first manifold layer 300 is positioned between the first fenestrated film layer 308 and the first barrier layer 304, and the second manifold layer 302 is positioned between the second fenestrated film layer 310 and the second barrier layer 306. In some embodiments, the first fenestrated film layer 308 is coupled to the first manifold layer 300 by an adhesive and/or the second fenestrated film layer 310 is coupled to the second manifold layer 302 by an adhesive. In preferred embodiments, the first fenestrated film layer 308 is configured to be easily separated from the second fenestrated film layer 310. That is, the first fenestrated film layer 308 and the second fenestrated film layer 310 are configured to not adhere to one another.

[0078] As illustrated in FIG. 5, the first manifold layer 300, the second manifold layer 302, the first barrier layer 304, the second barrier layer 306, the first fenestrated film layer 308, and the second fenestrated film layer 310 are hand-shaped. That is, each of the layers 302-310 includes a central region 312 and five peninsular projections 314 that extend from the central region 312 in the shape of a hand. Each of the five peninsular projections 314 corresponds to one finger or thumb of a patient. The dressing 104 may be made available in various sizes corresponding to different hand sizes (i.e., different dimensions of the central region 312 and the peninsular projections 314 of the layers 300- 310). For example, the dressing 104 may be available in a small size, a medium size, a large size, etc. to allow fitting to various patients without requiring individual/patient-specific customization.

[0079] The first barrier layer 304 is coupled to the second barrier layer 306 along a hand portion of a perimeter of the dressing 104 and separated from the second barrier layer 306 along a wrist portion 320 of the perimeter of the dressing 104. The first barrier layer 304 is not coupled to the second barrier layer 306 along the wrist portion 320 of the perimeter of the dressing 104, which creates an opening that allows a patient’s hand to be inserted into the dressing 104. In other words, the dressing 104 is formed as a glove. The dressing 104 is thereby configured to receive a patient’s hand between the first fenestrated film layer 308 and the second fenestrated film layer 310.

[0080] In the example shown, the first barrier layer 304 is coupled to the second barrier layer 306 along edges of the peninsular regions 314 and the central region 312 by film welds 316, and along a portion of the perimeter of the central region by anchor welds 318. FIG. 4 shows a cross-section view of the dressing 104 including film welds 316. The film welds 316 couple the first barrier layer 304 to the second barrier layer 306 and substantially prevent air from passing between the first barrier layer 304 and the second barrier layer 306 at the film welds. For example, the first barrier layer 304 may be thermally bonded to the second barrier layer 306 at the film welds 316.

[0081] FIG. 5 shows a cross-section view of the dressing includes film welds 316 and anchor welds 318. The anchor welds 318 couple the first manifold layer, the second manifold layer 302, the first barrier layer 304, the second barrier layer 306, the first fenestrated film layer 308, and the second fenestrated film layer 310 together along portions of the perimeter of the dressing where the anchor welds 318 are present. In the example shown, the anchor welds 318 include structures (e.g., staples, pins, etc.) extending through the layers 300-310 to restrict (e.g., substantially prevent) movement of the layers 300-310 relative to one another at the anchor welds 318. In other examples, adhesive is used along the anchor welds 318 to restrict movement of the layers 300-310 relative to one another at the anchor welds 318.

[0082] The dressing 104 is also shown to include an adhesive cuff 322. Adhesive cuff 322 includes an adhesive (or multiple adhesives) configured to seal the adhesive cuff 322 to the first barrier layer 304 and the second barrier layer 306 along the wrist portion 320 of the perimeter of the dressing and to skin of a patient. The adhesive cuff 322 extends from the first barrier layer 304 and the second barrier layer 306 such that the adhesive cuff 322 is configured to be coupled to a wrist of a patient when the patient’s hand is inserted into the dressing 104. When the adhesive cuff 322 is sealed to a patient’s wrist, the first barrier layer 304, and the second barrier layer 306, the adhesive cuff 322 substantially prevents air from flowing between an ambient environment and the interior of dressing 104 (e.g., the manifold layers 300, 302) via the opening at the wrist portion 320 of the dressing 104. The adhesive cuff 322 may be produced as an integrated piece of the dressing 104 or may be distributed as a separate piece of a dressing kit (e.g., as an adhesive strip).

[0083] The barrier layers 304, 306 are configured to substantially prevent airflow therethrough.

The barrier layers 304, 306 may include a polyurethane drape material, for example a drape material as used in a V.A.C.® Drape by Acelity. As mentioned above, the barrier layers 304, 306 are sealed with a substantially-airtight seal by film welds 316. Accordingly, when the adhesive cuff 322 is sealed around the wrist of a patient and the barrier layers 304, 306, a substantially airtight volume is created within the dressing 104, i.e., between the barrier layers 304, 306 and the patient’s hand. The barrier layers 304, 306 may each have a thickness in a range between approximately 80 and 120 microns.

[0084] As shown in FIGS. 3, the first barrier layer 304 includes knuckle flexion points 324 arranged at positions that correspond to knuckles/joints within a typical hand that may be inserted into the dressing 104. In the example shown, each peninsular portion 314 corresponding to a finger includes three knuckle flexion points 324, while the peninsular portion 314 corresponding to a thumb includes two knuckle flexion points. FIG. 6 shows cross sectional views of a knuckle flexion point 324, includes a first view 600 of the knuckle flexion point 324 in an unflexed state and a second view 602 of the knuckle flexion point 324. As illustrated by FIG. 6, each knuckle flexion point 324 includes a series of folds (e.g., three folds) which, in the unflexed state, draw the barrier layer 304 away from the manifold layer 300. In the flexed state, the series of folds are extended (unfolded) to facilitate curvature (bending) of the dressing 104 at the knuckle flexion point 324 by increasing an effective length of the barrier layer 304. Accordingly, the knuckle flexion points 324 are configured to facilitate articulation, movement, etc. of a patient’s fingers confined in the dressing 104. The fenestrated film layers 308, 310 and the manifolding film layers 300, 302 may be configured to resiliently stretch and/or flex to accommodate articulation, movement, etc. of a hand in the dressing 104 as shown in FIG. 6. [0085] The fenestrated film layers 308, 310 are made of a non-adherent film and are configured to provide a non-adherent interface between the dressing 104 and a hand of a patient, including a wound bed located on the hand. The fenestrated film layers 308, 310 are also configured to prevent ingrowth of skin to the dressing (e.g., healing into the manifold layers 300, 302). The fenestrated film layer 308, 310 thereby facilitate easy insertion of a hand into the dressing 104 and removal of the hand from the dressing 104. Additionally, the fenestrated film layers 308, 310 have fenestrations (perforations, holes, airways, windows, etc.) extending therethrough that allow air and fluid to pass between the hand (e.g., a wound bed) and the manifold layers 300, 302. The fenestrated film layers 308 may each have a thickness of approximately 30 microns.

[0086] The manifold layers 300, 302 are configured to allow air and fluid to flow therethrough.

The manifold layers are made of an open-cell foam, for example a reticulated polyurethane open cell foam. In some embodiments, the manifold layers 300, 302 are made of an open-cell foam marketed as GRANUFOAM™ by ACELITY™. The manifold layers 300, 302 may each have a thickness in a range between approximately 6mm and 10mm. Accordingly, the manifold layers 300, 302 may be thinner than in conventional bulky dressings. The reduced thickness of the manifold layers 300, 302 facilitates flexion of the dressing 104 to allow for physiotherapy for the hand in the dressing 104 in a way not previously achieved.

[0087] The manifold layers 300, 302 allow for the communication of air pressure, for example negative pressure (relative to ambient air pressure), through the manifold layers 300, 302 and to the hand and the wound bed (via the fenestrated fdm layers 308, 310. The dressing 104 is configured such that air and fluid can flow between the first manifold layer 300 and the second manifold layer 302 proximate the film welds 316 and anchor welds 318, i.e., through the fenestrated film layers 308, 310 and around a hand positioned in the dressing 104. Negative pressure can thereby be communicated across both manifold layers 300, 302 (i.e., such that both manifold layers 300, 302 are maintained at approximately equal pressures).

[0088] The dressing 104 is configured to be coupled to a vacuum (negative pressure) tube 106 and, in some embodiments, an instillation tube 108. For example, a hole may be cut in the first barrier layer 304 (e.g., with a diameter in a range between approximately 3-20mm) and a connection pad may be coupled to the barrier layer 304 over the hole. The connection pad is coupled to the vacuum tube 106 and/or instillation tube 108. In some embodiments, multiple holes and/or connection pads are used. For example, the connection pad may be a SENSAT.R.A.C.™ connection pad marketed by ACELITY™.

[0089] The manifold layers 300, 302 can thereby be put in fluid communication with the vacuum tube 106 and/or instillation tube 108. As described above with reference to FIGS. 1-2, the negative pressure pump 112 can be controlled to remove air from the manifold layers 300, 302 to establish a negative pressure at the manifold layers 300, 302. The negative pressure at the manifold layers 300, 302 is communicated to the hand/wound via the fenestrations in the fenestrated film layers 308, 310. Instillation fluid may also be provided to the wound via the manifold layers 300, 302 and the fenestrated film layers 308. Wound exudate, instillation fluid, other debris, etc. may also be removed from the wound and manifold layers via the vacuum tube 106 as described above with reference to FIGS. 1-2. The dressing 104 thereby facilitates treatment of a hand wound using NPWTi.

[0090] Still referring to FIGS. 3-6, the dressing 104 is also shown to include one or more sensor(s) 204. positioned on the first barrier layer 304. In the embodiment shown, the one or more sensor(s) include a humidity sensor and a moisture sensor, which may be positioned extending through the first barrier layer 304 to measure humidity and moisture in the first manifold layer 300. In some embodiments, the one or more sensor(s) include one or more pH sensor(s) configured to measure tissue pH and/or fluid pH. In the embodiment shown, the one or more sensor(s) also include a strain sensor 326. The strain sensor 326 is positioned on or in the first barrier layer 304 and extends along a length of the dressing from proximate the wrist portion 320 to a tip of one of the peninsular regions 314 (e.g., corresponding to a middle finger). The strain sensor 326 is configured to measure (e.g., generate an electrical signal indicative of) a strain on the dressing 104 (i.e., on the strain sensor 326), which may correspond to a curvature of the dressing 104 and/or a force applied by the hand inside the dressing 104. For example, a strain measured by the strain sensor 326 may increase when a patient attempts to clench the hand (e.g., in a fist) or otherwise bend one or more fingers in the dressing 104. The strain may decrease when the patient moves the hand in the dressing 104 to an open or neutral pose. The one or more sensors 204 include a wireless communications circuit (e.g., WiFi transceiver, Bluetooth transceiver, etc.) configured to facilitate wireless transmission of measurements from the one or more sensors to the control circuit 202 of the therapy unit 102.

Hand Dressing with Varying Slot Width

[0091] Referring now to FIGS. 7-12, the dressing 104 can include a perforated or fenestrated layer 710. The perforated layer 710 can be any of the manifold layers 300, 302, the barrier layers 304-306, and/orthe fenestrated film layers 308, 310. The perforated layer 710 may be configured for use on an extremity such as a foot or a hand and may have an overall shape that resembles a food or hand. In some embodiments, the perforated layer 710 includes multiple openings, holes, perforations, apertures, windows, etc., shown as openings 711. The openings 711 can cover substantially an entire surface area of the perforated layer 710.

[0092] The perforated layer 710 can be made from any of the materials of the manifold layers 300, 302, the barrier layers 304, 306, and/or the fenestrated film layers 308, 310. The perforated layer 710 can be configured to abut or be adjacent either of the manifold layers 300, 302. The perforated layer 710 includes a first portion, a first area, a first region, etc., shown as palm region 712, and a second portion, a second area, a second region, etc., shown as outer regions 718. The openings 711 can extend over the palm region 712 and the outer regions 718. In some embodiments, the openings 711 that extend or are positioned about the palm region 712 are slits 720. Likewise, the openings 711 that extend or are positioned about the outer regions 718 are slots 722. [0093] The slits 720 can cover substantially the entire palm region 712 and may be spaced apart. The slits 720 can be generally straight or may be curved (e.g., to match a curvature of a hand). The slits 720 can have an overall length 726. The overall length 726 may be 2-4 millimeters. In an exemplary embodiment, the overall length 726 of the slits 720 and/or the slots 722 is 3 millimeters. The slits 720 can have a negligible width (e.g., less than 1 millimeter, less than half a millimeter, etc.). [0094] The slits 720 can cover substantially the entire palm region 712 and may be spaced apart from each other laterally and/or longitudinally. For example, the overall length 726 of the slit 720 can define a longitudinal direction, while a direction that is perpendicular to the longitudinal direction may be a lateral direction. The slits 720 can be laterally and or longitudinally offset from each other. In some embodiments, the slits 720 are patterned along and spaced apart along a circular path. In other embodiments, the slits 720 extend generally in a straight direction. In other embodiments, the slits 720 extend along any curved path. The slits 720 can be spaced apart longitudinally along the path uniformly, non-uniformly, or otherwise. Likewise, the slits 720 can be spaced apart laterally from each other (e.g., uniformly, non-uniformly, etc.).

[0095] The slots 722 can cover substantially the entire outer regions 718. For example, the slots 722 can be laterally and/or longitudinally spaced apart from each other throughout the outer regions 718. The slots 722 can have an overall longitudinal length 730 that defines a longitudinal direction of the slots 722. Likewise, the slots 722 can have a lateral width 728 that defines a lateral direction of the slot 722. The slots 722 and/or the slits 720 may extend through an entire thickness of the perforated layer 710. The outer regions 718 can include various digit portions 714 (e.g., finger portions). Specifically, the outer regions 718 can include a first digit portion 714a (e.g., a thumb portion), a second digit portion 714b (e.g., an index or pointer finger portion), athird digit portion 714c (e.g., a middle finger portion), a fourth digit portion 714d (e.g., a ring finger portion), and a fifth digit portion 714e (e.g., a pinky finger portion). The slots 722 can cover substantially an entire surface area of any of the digit portions 714.

[0096] Referring still to FIG. 7, the dressing 104 can include a negative pressure connection, a fluid connection, a coupler, an aperture, etc., shown as negative pressure connection point 706. In some embodiments, the negative pressure connection point 706 includes an aperture or a hole that extends through the perforated layer 710. The negative pressure connection point 706 may facilitate fluidly coupling the therapy unit 102 with the dressing 104. In some embodiments, the negative pressure connection point 706 fluidly couples the therapy unit 102 with an inner volume of the dressing 104 or an inner volume of the perforated layer 710.

[0097] The negative pressure connection point 706 may be positioned (e.g., centrally) on a palm or a back of the palm. For example, the negative pressure connection point 706 can be positioned in the palm region 712. The negative pressure connection point 706 may be positioned on the back or front of the palm that is above a patient’s wrist to facilitate wrist mobility while the patient is wearing the dressing 104. [0098] Referring still to FIG. 7, the openings 711 can transition from the slits 720 to the slots 722 at transitional regions that are between the palm region 712 and the outer regions 718. The openings 711 can transition from the slits 720 to the slots 722 abruptly, suddenly, discontinuously, etc., or may gradually transition from the slits 720 to the slots 722. For example, as shown in FIG. 7, the openings 711 may gradually increase in width at the transitional regions from the palm region 712 to the outer regions 718.

[0099] In some embodiments, the width of the openings 711 increases linearly from the palm region 712 to the outer regions 718. For example, the width of the openings 711 can increase by a constant amount between consecutive openings 711: wk = ^w k- 1 + ^c width where w _k is a width of a kt opening 711, w _k- is a width of a previous opening 711 (e.g., a k — 1 opening 711) and c _width is an amount that consecutive openings 711 increase. For example, the first openings 711 at the transition may have a width of 0.5 millimeters (e.g., being slits 720), the next openings 722 may have a width of 0.7 millimeters, the next openings 722 may have a width of 0.9 millimeters, etc.

[0100] In some embodiments, the transition of the openings 711 from the slits 720 to the slots 722 is gradual but non-linear. For example, the width of the openings 711 may transition (e.g., increase) according to a parabolic function, an exponential function, a polynomial, etc. For example, the amount c _width that consecutive openings 711 increase may be a non-constant value.

[0101] In some embodiments, the width of the openings 711 as the openings 711 transition from slits 720 to slots 722 increases or is based on a distance that each openings 711 is from the negative pressure connection point 706. For example, a first opening 711 at the transitional area/region that is most proximate the negative pressure connection point 706 may be positioned a distance 734 (e.g., CZ- _L ) from a center of the negative pressure connection point 706. Likewise, a final or distal opening 711 (e.g., a first slot 722) can be positioned a distance 736 (e.g., d ₂ ) from the center of the negative pressure connection point 706. The transitional region or area can be from the distance d _± (i.e., distance 734) to the distance d ₂ (i.e., the distance 736). The width of the openings 711 can transition (e.g., increase) from the distance d _± to the distance d ₂ . For example, the width of the openings 711 can be a function of a distance d from the negative pressure connection point 706. The width of the openings 711 can increase or decrease linearly, non-linearly, according to a polynomial, suddenly, abruptly, etc., based on the distance d of the openings 711 from the negative pressure connection point 706.

[0102] For example, the openings 711 may be spaced a distance 738 (e.g., Ad). The distance 738 may be a uniform value, a non-uniform value, etc. In some embodiments, the distance 738 is a scalar quantity that indicates a lateral distance between neighboring or adjacent openings 711. The openings 711 can be uniformly spaced, or non-uniformly spaced as the openings 711 transition from the slits 720 to the slots 722. For example, the spacing between the openings 711 may decrease linearly or non-linearly with respect to the distance d from the negative pressure connection point 706 such that openings 711 that are further away from the negative pressure connection point 706 are closer together or more closely spaced. Likewise, the spacing between the openings 722 may increase linearly or non-linearly with respect to the distance d from the negative pressure connection point 706 such that openings 711 that are further away from the negative pressure connection point 706 are further apart.

[0103] In this way, the transition of the openings 711 between the slits 720 and the slots 722 may be gradual. Advantageously, a gradual transition of the openings 711 between the slits 720 and the slots 722 can distribute negative pressure more uniformly across an area of the perforated layer 710. [0104] In other embodiments, the transition between the slits 720 and the slots 722 is abrupt or sudden. For example, a transitional line 740 can extend along a border between the palm region 712 and the outer regions 718. The transitional line 740 can define the transition between the slits 720 and the slots 722 such that openings 722 that are on the palm region 712 side of the transitional line 740 are slits 720, whereas openings 722 that are on the outer regions 718 side of the transitional line 740 are slots 722. For example, the transitional line 740 can define a range of distance values d _trans for various angular positions Q relative to the negative pressure connection point 706. Regions or areas of the perforated layer 710 that are beyond the transitional line 740 (e.g., d at a specific angular value Q is greater than a corresponding d _trans value) may include slots 722, whereas regions or areas of the perforated layer 710 that are within or on an opposite side of the transitional line 740 (e.g., d at a specific angular value Q is less than a corresponding d _trans value) may include slits 720. In this way, the transitional line 740 can define the transition between the slits 720 and the slots 722 such that the openings 711 abruptly switch or transition from the slits 720 to the slots 722.

[0105] It should be understood that while the transition between the slits 720 and the slots 722 is described with reference to changing (e.g., increasing) the width of the openings 711, the length may also change. For example, the length of the openings 711 may increase or decrease (e.g., linearly or non-linearly) gradually or abruptly as the openings 711 transition from the slits 720 to the slots 722. Likewise, the lateral and/or longitudinal spacing of the openings 711 may increase or decrease (e.g., linearly or non-linearly), gradually or abruptly, as the openings 711 transition from the slits 720 to the slots 722. In this way, the length, longitudinal spacing, lateral spacing, etc., of the openings 711 can transition similar to the transition of the width of the openings 711 as described in greater detail above. A cross-sectional shape of the openings 711 can also change as the openings 711 transition from the slits 720 to the slots 722.

[0106] Referring particularly to FIGS. 8-9, one of the slots 722 is shown in greater detail, according to some embodiments. Opposing ends 732 of the slots 722 may be rounded (as shown in FIG. 8) or square (as shown in FIG. 9). In some embodiments, the slits 720 can also have rounded or square ends. The radius of the rounds shown in FIG. 8 may be substantially equal to half of the width 728 of the slot 722. In other embodiments, the rounds at the opposing ends 732 of the slots 722 are elliptical. [0107] Referring particularly to FIGS. 11 and 12, the transition of the openings 711 from the slits 720 to the slots 722 can be gradual (as shown in FIG. 11) or sudden/abrupt (as shown in FIG. 12).

For example, the width of the openings 711 can increase with increasing distance from the negative pressure connection point 706 (e.g., with increasing d) as shown in FIG. 11. In other embodiments, the openings 711 transition from the slits 720 to the slots 722 at the transitional line 740 which is positioned a distance away from the negative pressure connection point 706.

[0108] Referring particularly to FIG. 10, a NPWT system 1000 includes the dressing 104, and the therapy unit 102. The therapy unit 102 is configured to draw a negative pressure at the dressing 104 through the vacuum tube 106. The therapy unit 102 can also be configured to provide instillation fluid to an inner volume of the dressing 104 through the instillation tube 108. The vacuum tube 106 can fluidly couple with the inner volume of the dressing 104 through the negative pressure connection point 706. In this way, the negative pressure drawn within the dressing 104 originates at the negative pressure connection point 706 and is distributed throughout the dressing 104. A pressure distribution across the dressing 104 may be substantially uniform or may vary. In some embodiments, the slots 722 have a cross-sectional area that is greater than a cross-sectional area of the slits 720. Advantageously, the slots 722 are positioned at increased distances from the negative pressure connection point 706, thereby improving a uniformity of the pressure distribution throughout the dressing 104 and improving manifolding of the dressing 104.

[0109] The therapy unit 102 can be configured to draw negative pressure at the dressing 104 to facilitate improved healing of a wound on the patient’s hand. In some embodiments, the therapy unit 102 is configured to draw away fluid or wound exudate from the patient’s hand (e.g., wound exudate or fluid that is within the dressing 104). The therapy unit 102 can draw the fluid or the wound exudate through the vacuum tube 106. The therapy unit 102 can collect the fluid or the wound exudate in a container, a capsule, a tank, a storage container, etc., which can later be disposed of when the container is full. The therapy unit 102 can produce the negative pressure within the dressing 104 such that the wound exudate or fluid flows at 5 cc/minute or less to the therapy unit 102.

[0110] Referring still to FIG. 10, the dressing 104 can include barrier layers 304 and 306 that sealingly couple with each other. The barrier layers 304 and 306 can include an opening, a pin-hole, an aperture, etc., shown as vent opening 750. The vent opening 750 may have a very small or a negligible cross-sectional area to facilitate a controlled or small leakage amount. In some embodiments, the vent opening 750 results in a negligible pressure drop in the dressing 104 for which the therapy unit 102 can compensate. The vent opening 750 can be positioned at one or several or all of the digit portions 714 of the dressing 104. For example, the vent openings 750 can be positioned at the fingertips of the dressing 104. The vent openings 750 may fluidly couple the inner volume of the dressing 104 with external surroundings, an external environment, etc. In this way, the therapy unit 102 may produce a pressure differential between the inner volume of the dressing 104 and the external environment. Air may flow into the inner volume of the dressing 104 through the vent opening 750 due to the pressure differential between the inner volume of the dressing 104 and the external environment. The vent opening 750 can be a micro-perforation in the barrier layers 304 and/or 306.

[0111] The dressing 104 can also include a fdter 752 that is positioned along a fluid flow path from the external environment to the inner volume of the dressing 104, defined by the vent opening 750.

The filter 752 can be a hydrophilic or hydrophobic filter. In some embodiments, the filter 752 is a bacterial filter. In this way, the air that enters the inner volume of the dressing 104 may be filtered (e.g., for bacteria) by the filter 752, thereby ensuring that only sterile air is introduced into the inner volume of the dressing 104. The filter 752 can be manufactured from GORE® MMT 314. In other embodiments, the filter 752 is manufactured from a sterile and/or porous filter material.

[0112] Referring particularly to FIGS. 7 and 10, the openings 711 can function as or similar to valves in the perforated layer 710. The perforated layer 710 can be a tissue or wound interfacing layer (e.g., a layer that directly engages, directly contacts, is disposed directly upon, etc., the patient’s tissue). In some embodiments, the perforated layer 710 is an inner most layer of the dressing 104. [0113] The perforated layer 710 can include the slits 720 and the slots 722 which are approximately 3 millimeters in length. The perforated layer 710 can be a polyurethane film layer. The slits 720 and the slots 722 can function as valves that allow fluid to push through the perforated layer into a manifolding structure (e.g., the manifold layers 300, 302). The slits 720 and the slots 722 may maintain a closed or substantially sealed configuration when engaging skin or tissue. In this way, fluids may “open” the valves in the perforated layer 710 (e.g., open the slits 720 and the slots 722), thereby allowing the manifolding structure to interact with the skin or tissue. This can be due, at least in part, to the compressive force of the negative pressure of the vacuum drawn in the dressing 104 by the therapy unit 102. The compressive or vacuum force exerted by the therapy unit 102 may ensure that the perfbrations/valves (e.g., the slits 720 and the slots 722) remain sealed with the skin or the tissue.

[0114] On a smooth or flat wound surface (such as a hand) exuded fluids may still push through the valve (e.g., the slits 720) and into the manifolding structure (e.g., the manifold layers 300, 302) such that the exuded fluid is removed by the therapy unit 102 even if the dressing 104 does not deform into a space and mechanically open the valves (e.g., the slits 720). In some embodiments, if only the slits 720 are used, a pressure drop may occur with increased distance from the negative pressure contact point 706. Using the slots 722 in addition to the slits 720 can reduce the uneven distribution of the negative pressure across the dressing 104. In particular, using the slots 722 at the outer regions 718 may reduce the pressure drop at the outer regions 718, thereby facilitating an even pressure distribution across the dressing 104. The slots 722 may have width 728 that is within the range of approximately 1-2 millimeters. [0115] The slots 722 can be positioned at regions of the dressing 104 associated with the highest pressure drops (e.g., at the digits of a patient’s hand), with the rest of the perforated layer 710 (e.g., the palm region 712) being covered in the slits 720. Fluids that are exuded in the main body of the patient’s hand (e.g., at the palm region 712) are not driven to move into the fingers (e.g., into the outer regions 718), thereby ensuring that these fluids are not exposed to fluids from other regions of the patient’s extremity. Fluid exuded in each digit may be guided to flow through the manifold structure (e.g., the manifold layers 300, 302) to the main body of the hand (e.g., the palm region 712) where the slits 720 can prevent exposure of the fluid to palm tissues. Advantageously, the dressing 104, and more particularly the perforated layer 710, facilitate optimized manifolding and even pressure distribution of the negative pressure across the patient’s hand while facilitating preventing the exposure of fluids (e.g., exuded fluids) to non-damaged skin.

[0116] Referring generally to FIGS. 3-12, the perforated layer 710 can be configured for use with various dressing structures where various regions may be smooth and flush with surrounding tissues but may be damaged and require local manifolding/pressure distribution optimization. For example, the perforated layer 710 can be configured for use on other extremity dressings such as amputation dressings, diabetic foot ulcer dressings, breast dressings, etc. In the example of diabetic foot ulcer dressings, the slots 722 may be created in the areas that are further away from the negative pressure connection point 706 (e.g., the negative pressure source, at the base of the foot) to ensure that there is an even pressure distribution across the foot. Exuded fluid can be removed to avoid maceration for any of the dressings described herein. Moving closer to the negative pressure source (e.g., the negative pressure connection point 706 at the base of the foot), the slots 722 may transition to the slits 720 to better control the negative pressure distribution and thereby reduce the risk of over macerating the wound site and key areas of the foot.

[0117] Advantageously, the perforated layer 710 can be used to optimize manifolding and provide an even distribution of negative pressure across smooth, non-deficit wounds. Additionally, another advantage of the perforated layer 710 is that the perforated layer 710 (or a dressing which uses the perforated layer 710) does not expose exuded wound fluid to other regions of the dressing 104.

Rather, the fluid is directed into a canister or container of the therapy unit 102 where it may be disposed of. The addition of the controlled leak through the vent opening 750 ensures flow for fluids in a desired direction without drying the wound due to limited flow and the presence of the tissue contacting the perforated layer 710 or exposing the wound to bacteria.

Negative Pressure Wound Therapy Process

[0118] Referring particularly to FIG. 13, a flow diagram of a process 1300 for performing NPWT is shown, according to some embodiments. The process 1300 includes steps 1302-1308 and can be performed using a dressing 104 including the perforated layer 710 as described in greater detail above with reference to FIGS. 7-12. [0119] Referring still to FIG. 13, the process 1300 includes providing a wound dressing with a perforated layer including slits at a first region and slots at a second region (step 1302), according to some embodiments. In some embodiments, the wound dressing is the wound dressing 104 with the perforated layer 710. The perforated layer 710 includes the slits 720 and the slots 722 that are positioned as described in greater detail above with reference to FIGS. 7-12. The first region may be areas that are proximate a negative pressure therapy unit interface (e.g., the negative pressure connection point 706). In some embodiments, the negative pressure therapy unit interface is a connection pad. Step 1302 can be performed by a clinician, a technician, a user, a patient, a caregiver, etc.

[0120] The process 1300 includes fluidly coupling the wound dressing with a therapy unit using a conduit and a connection pad at the wound dressing (step 1304), according to some embodiments.

The therapy unit can be the therapy unit 102. The therapy unit 102 can be fluidly coupled with an inner volume of the wound dressing through the vacuum tube 106 and/or the instillation tube 108.

The step 1304 can be performed by a clinician, a caregiver, a patient, etc.

[0121] The process 1300 includes operating the therapy unit to draw a uniform negative pressure at the wound dressing (step 1306), according to some embodiments. The negative pressure can be drawn at the wound dressing (e.g., the wound dressing 104) by operating the negative pressure pump 112. The negative pressure may be uniform due to the slots 722 and the slits 720. Step 1306 can be performed by the therapy unit 102.

[0122] The process 1300 includes drawing exuded wound fluid into a canister of the therapy unit without the exuded fluid contacting other tissue, or while guiding the exuded fluid to avoid other tissue (step 1308), according to some embodiments. Step 1308 can be performed by the therapy unit 102 and facilitated by the perforated layer 710. For example, the slots 722 and slits 720 may facilitate guiding the exuded wound fluid to be drawn into the canister of the therapy unit 102 while guiding the exuded fluid through the manifolding structure (e.g., through the manifold layers 300, 302) to avoid other tissue.

Configuration of Exemplary Embodiments

[0123] As utilized herein, the terms “approximately,” “about,” “substantially,” and similar terms are intended to have a broad meaning in harmony with the common and accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure pertains. It should be understood by those of skill in the art who review this disclosure that these terms are intended to allow a description of certain features described and claimed without restricting the scope of these features to the precise numerical ranges provided. Accordingly, these terms should be interpreted as indicating that insubstantial or inconsequential modifications or alterations of the subject matter described and claimed are considered to be within the scope of the disclosure as recited in the appended claims. [0124] It should be noted that the term “exemplary” and variations thereof, as used herein to describe various embodiments, are intended to indicate that such embodiments are possible examples, representations, and/or illustrations of possible embodiments (and such terms are not intended to connote that such embodiments are necessarily extraordinary or superlative examples).

[0125] The term “coupled,” as used herein, means the joining of two members directly or indirectly to one another. Such joining may be stationary (e.g., permanent or fixed) or moveable (e.g., removable or releasable). Such joining may be achieved with the two members coupled directly to each other, with the two members coupled to each other using a separate intervening member and any additional intermediate members coupled with one another, or with the two members coupled to each other using an intervening member that is integrally formed as a single unitary body with one of the two members. Such members may be coupled mechanically, electrically, and/or fluidly.

[0126] The term “or,” as used herein, is used in its inclusive sense (and not in its exclusive sense) so that when used to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is understood to convey that an element may be either X, Y, Z; X and Y ; X and Z; Y and Z; or X, Y, and Z (i.e., any combination of X, Y, and Z). Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y, and at least one of Z to each be present, unless otherwise indicated.

[0127] References herein to the positions of elements (e.g., “top,” “bottom,” “above,” “below,” etc.) are merely used to describe the orientation of various elements in the FIGURES. It should be noted that the orientation of various elements may differ according to other exemplary embodiments, and that such variations are intended to be encompassed by the present disclosure.

[0128] It is important to note that the construction and arrangement of the dressing 104 as shown in the various exemplary embodiments is illustrative only. Although only a few embodiments have been described in detail in this disclosure, many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.). For example, the position of elements may be reversed or otherwise varied and the nature or number of discrete elements or positions may be altered or varied. Accordingly, all such modifications are intended to be included within the scope of the present disclosure. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions and arrangement of the exemplary embodiments without departing from the scope of the present disclosure.

[0129] Additionally, any element disclosed in one embodiment may be incorporated or utilized with any other embodiment disclosed herein. For example, the configuration and construction of the perforated layer 710 of the exemplary embodiment described in at least paragraph [0090] may be incorporated in the dressing 104 of the exemplary embodiment described in at least paragraph [0064] Although only one example of an element from one embodiment that can be incorporated or utilized in another embodiment has been described above, it should be appreciated that other elements of the various embodiments may be incorporated or utilized with any of the other embodiments disclosed herein.