PREVENTION SYSTEM

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 62/675,385, filed on May 23, 2018, which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] The present disclosure relates generally to a wound dressing and more particularly to a wound dressing for use as part of an audible warning, pressure system for wound treatment and prevention.

[0003] A pressure ulcer is a localized injury to the skin or underlying tissue, usually over a bony prominence, as a result of unrelieved pressure. Exerting pressure on an ulcer will prevent or hinder healing of the pressure ulcer. Once a pressure sore has healed, the area is more susceptible to developing an ulcer again. For example, while tissues are capable of sustaining pressure on the arterial side of around 30-32 mm hg for a small duration of time, an increase in pressure even slightly above the capillary filling pressure can cause

microcirculatory occlusion, which in turn may initiate ischaemia, tissue death, and ulceration. Pressure generated under the ischial tuberosities while a person is seated can reach 300 mm Hg, and sacral pressure can range from 100 to 150 mm Hg while a person lies on a standard hospital mattress. Excess pressure greater than 32 mm Hg results in occlusion of capillary flow, causing ischemic injury and extravasation of fluid, cells, and protein. Patients with a pressure ulcer have a significantly higher mortality rate than those without. One treatment and/or management guidelines for pressure ulcers is the process of reducing or relieving pressure to the skin in and round the pressure ulcer area through the use of visual markers to show when too much pressure is exerted. However, it can be difficult to monitor when a harmful pressure threshold has been reached and exceeded in the area of a pressure ulcer by the patient in many of the most common pressure ulcer sites. It would be desirable to provide a wound therapy system and/or a wound dressing that permits additional functionality to visual sensors. SUMMARY

[0004] One implementation of the present disclosure is a wound dressing including a housing, a biasing member, and a sound valve. The housing includes a top portion, a bottom portion opposite the top portion, and an air chamber between the top portion and the bottom portion. The housing has an inflated state and a collapsing state, the inflated state transitioning to the collapsing state upon application of a collapse force to the housing. The biasing member is within the housing and is configured to laterally collapse upon application of the collapse force and to laterally expand to the inflated state upon removal of the collapse force. The sound valve is coupled to the housing and is in fluid communication with the air chamber and outside of the housing. The sound valve is configured to emit a sound upon receiving air from the air chamber when the housing is in the collapsing state.

[0005] In some embodiments, the wound dressing includes a reinflation valve coupled to the housing. The reinflation valve is in fluid communication with the air chamber and outside of the housing and is configured to draw in air from outside the housing to the air chamber upon removal of the collapse force.

[0006] In some embodiments, the removal of the collapse force causes the housing to transition from a collapsing state to the inflated state due to air through the reinflation valve.

[0007] In some embodiments, the reinflation valve is configured to restrict air flow from the air chamber to the outside of housing to be less than one-tenth the air that flows from the air chamber to the outside of the housing through the sound valve.

[0008] In some embodiments, the reinflation valve comprises a hydrophobic bacterial filter element therethrough.

[0009] In some embodiments, the sound valve is a one way valve, whereby air is impeded to flow from outside of the housing into the air chamber through the sound valve.

[0010] In some embodiments, the sound valve is located around a periphery of the housing where the top portion and the bottom portion meet.

[0011] In some embodiments, the collapse force is a first collapse force, and wherein the sound valve is tunable such that a first sound is emitted when the first collapse force is applied and a second sound is emitted when a second collapse force is applied. [0012] In some embodiments, the housing and biasing member are configured to cause the housing to controllably collapse from the inflated state to a deflated state, the deflated state wherein the air chamber is substantially without air.

[0013] In some embodiments, the biasing member is integrally formed with the housing.

[0014] In some embodiments, the top portion and bottom portion of the housing each have a thickness within a range of 500 microns to 1 mm in thickness.

[0015] In some embodiments, the collapse force is related to a force that causes damage to a wound of a patient, the wound dressing covering the wound of the patient.

[0016] In some embodiments, the top portion is a wound contact layer and the bottom portion is a backing film, the wound contact layer having osmotic membrane that draws water through the wound contact layer.

[0017] In some embodiments, an adhesive drape extends along the top portion of the housing.

[0018] Another implementation of the present disclosure is a wound dressing array that includes a first wound dressing and a second wound dressing. A first wound dressing includes a first housing, a first biasing member, and a first sound valve. The first housing includes a first top portion, a first bottom portion opposite the first top portion, and a first air chamber between the first top portion and the first bottom portion. The first housing has a first inflated state and a first collapsing state, the first inflated state transitioning to the first collapsing state upon application of a first collapse force to the first housing. The first biasing member is within the first air chamber and is configured to laterally collapse upon application of the first collapse force and to laterally expand to the first inflated state upon removal of the first collapse force. The first sound valve is coupled to the first housing and is in fluid communication with the first air chamber and outside of the first housing. The first sound valve is configured to emit a sound upon receiving air from the first air chamber when the first housing is in the first collapsing state. A second wound dressing includes a second housing, a second biasing member, and a second sound valve. The second housing includes a second top portion, a second bottom portion opposite the second top portion, and a second air chamber between the second top portion and the second bottom portion. The second housing has a second inflated state and a second collapsing state, the second inflated state transitioning to the second collapsing state upon application of a second collapse force to the second housing. The second biasing member is within the second air chamber and is configured to laterally collapse upon application of the second collapse force and to laterally expand to the second inflated state upon removal of the second collapse force. The second sound valve is coupled to the second housing and is in fluid communication with the second air chamber and outside of the second housing. The second sound valve is configured to emit a sound upon receiving air from the second air chamber when the second housing is in the second collapsing state.

[0019] In some embodiments, the wound dressing includes a first reinflation valve coupled to the first housing and in fluid communication with the first air chamber and outside of the first housing. The first reinflation valve is configured to draw in air from outside the first housing to the first air chamber upon removal of the first collapse force. A second reinflation valve is coupled to the second housing and in fluid communication with the second air chamber and outside of the second housing. The second reinflation valve is configured to draw in air from outside the second housing to the second air chamber upon removal of the second collapse force.

[0020] In some embodiments, the removal of the first collapse force from the first housing causes the first housing to transition from the first collapsing state to the first inflated state due to air through the first reinflation valve.

[0021] In some embodiments, the first reinflation valve is adjacent to the first sound valve, the second reinflation valve is adjacent to the second sound valve, and the first sound valve and the second sound valve are coplanar.

[0022] In some embodiments, the first reinflation valve is configured to restrict air flow from the first air chamber to the outside of first housing to be less than one-tenth the air that flows from the first air chamber to the outside of the first housing through the first sound valve.

[0023] In some embodiments, the first reinflation valve comprises a hydrophobic bacterial filter element therethrough. [0024] In some embodiments, the first sound valve is a one way valve, whereby air is impeded to flow from outside of the first housing into the first air chamber through the first sound valve.

[0025] In some embodiments, the first sound valve is located around a periphery of the first housing where the first top portion and the first bottom portion meet and the second sound valve is located around a periphery of the second housing where the second top portion and the second bottom portion meet.

[0026] In some embodiments, the first sound valve is formed by a slit between the first top portion and the first bottom portion of the first housing and configured to have a thickness to produce the first sound with a first frequency when the first housing is in the first collapsing state and the second sound valve is formed by a slit between the second top portion and the second bottom portion of the second housing and configured to have a thickness to produce the second sound with a second frequency when the second housing is in the second collapsing state.

[0027] In some embodiments, the first housing and first biasing member are configured to cause the first housing to controllably collapse from the first inflated state to a first deflated state, the first deflated state wherein the first air chamber is substantially without air.

[0028] In some embodiments, the first biasing member is integrally formed with the housing.

[0029] In some embodiments, the first top portion and first bottom portion of the first housing each have a thickness within a range of 500 microns to 1 mm in thickness.

[0030] In some embodiments, the first collapse force is related to a force that causes damage to a wound of a patient, the first wound dressing covering the wound of the patient.

[0031] In some embodiments, the first top portion is a wound contact layer and the first bottom portion is a backing film, the wound contact layer having osmotic membrane that draws water through the wound contact layer.

[0032] In some embodiments, an adhesive drape extends along the first top portion of the first housing. [0033] 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

[0034] FIG. 1 is a top perspective view of a wound dressing including a top portion of a housing, a bottom portion of a housing, and a sound valve, according to an exemplary embodiment.

[0035] FIG. 2 is a perspective cross-sectional view of the wound dressing of FIG. 1, according to an exemplary embodiment.

[0036] FIG. 3 is a top perspective view of wound dressings including inflating material, a sound valve, and adhesive coating, according to an exemplary embodiment.

[0037] FIG. 4 is another top perspective view of wound dressings of FIG. 3 including an adhesive drape, according to an exemplary embodiment.

[0038] FIG. 5 is another top perspective view of wound dressings of FIG. 3 including a backing film and a wound contact layer, according to an exemplary embodiment.

[0039] FIG. 6 is a top perspective view of a wound dressing array including a plurality of wound dressings that include a top portion of a housing, a bottom portion of a housing, and a sound valve, according to an exemplary embodiment.

DET AIDED DESCRIPTION

Overview

[0040] Referring generally to the FIGFTRES, a wound dressing system is shown, according to various exemplary embodiments. Pressure ulcers are a type of wound that is a localized injury to the skin or underlying tissue as a result of unrelieved pressure. The wound dressing is a type of recovery component that reduces pressure to the wound site and provides an audible“warning” to the patient when pressure is exerted on or around the pressure ulcer (e.g., wound). This warning alerts the patient when a harmful pressure threshold has been reached or exceeded on a wound or wound site. The wound dressing includes an air- filled housing, a biasing member that facilitates re-inflation, and a sound valve to emit a noise when a harmful pressure threshold is reached. The wound dressing is controllably collapsible at a wide variety of collapse forces to accommodate a plethora of wound sizes, wound severities, patient weights, patient sizes, and other treatment considerations. The wound dressing is sealable to a patient’s skin surrounding a wound site. As will be appreciated, the wound dressing may be configured to have rigidity and a“softness” that provides additional protection to the wound and buffering from pressured contact on and around the wound site.

[0041] As used herein a“harmful pressure” describes a pressure on an existing pressure ulcer (e.g., wound) that will hinder or prevent healing, as well as pressure on an area of a healed pressure ulcer that will cause re-occurrence of a pressure ulcer on that area. For example, in some instances underlying and surrounding tissues become anoxic with an applied external pressure greater than 33 mm Hg on the capillaries, while in other instances muscle can be damaged by pressures exceeding 60 mm Hg for more than an hour. A “collapse force” describes a pressure that is equal to or less than the harmful pressure and causes the biasing member, and in turn the wound dressing, to collapse. A“lateral collapse” describes the collapse of the top housing portion toward the bottom housing portion or the collapse of the bottom housing portion toward the top housing portion. The“inflated state” of the wound dressing describes the wound dressing having a pressure applied to it that is less than the collapse force such that the wound dressing includes air within an air chamber of the wound dressing housing. The“collapse state” of the wound dressing describes the wound dressing having a pressure applied to it that is equal to or greater than the collapse force, thereby causing air from the air chamber to travel through the sound valve and emit a warning noise.

[0042] The housing includes a top portion, a bottom portion opposite the top portion, and an air chamber between the top portion and the bottom portion. The housing includes an inflated state and a collapsing state that corresponds to a harmful pressure threshold being reached. As will be appreciated, the housing transitions from the inflated state to the collapsing state upon application of a collapse force, which is associated with the harmful pressure threshold, to the housing. The biasing member is disposed within the housing. The biasing member is configured to laterally collapse upon application of the collapse force and to laterally expand to the inflated state upon removal of the collapse force. In other words, the biasing member facilitates the reinflation of the air chamber after a collapse force has been applied and removed. The sound valve is coupled to the housing and is in fluid communication with the outside of the housing and the air chamber within the housing. The sound valve is configured to emit a sound when the housing is in the collapsing state as a result of the flow of air from the air chamber, through the sound valve, and out to the outside of the housing. These and other features of the wound dressing are described in greater detail below.

Molded Wound Dressing

[0043] Referring now to FIGS. 1-2, a wound dressing 100 is shown, according to an exemplary embodiment. The wound dressing 100 is shown to include a top housing portion 102, a bottom housing portion 104, a periphery portion 106 between the periphery of the top housing portion 102 and the periphery of the bottom housing portion 104, an air chamber 116, a biasing member 118 within the air chamber 116, a sound valve 108, and a reinflation valve 110. The top housing portion 102 or the bottom housing portion 104 of the wound dressing 100 can be sealed to a patient’s skin surrounding a wound site and, in some embodiments, may provide an airtight seal over the wound. The air chamber is formed between the top housing portion 102, the bottom housing portion 104, and the periphery portion such that air flow is possible through the sound valve 108 and reinflation valve 110.

A biasing member 118 can be configured to facilitate the lateral collapse of the wound dressing 100 such that a certain pressure (e.g., collapse force) applied to the wound dressing 100 will cause the biasing member 118, and in turn the wound dressing 100, to contra llably collapse. The biasing member 118 can be configured to laterally expand after the wound dressing 100 has entered a collapse state and the collapse force has been removed. In various embodiments, the biasing member 118 is a spring, a foam member, a flexible protrusion, a semi-rigid membrane, or any other member that functions as a biasing member.

[0044] Generally, the wound dressing 100 can be formed as a substantially flat sheet for topical application to wounds or contoured for application to body surfaces having high curvature. The size of wound dressing 100 can vary depending on the size of the wound to be dressed. For example, it is contemplated that the size of wound dressing 100 can range from 1 cm ² to 200 cm ² . However, other shapes and sizes of wound dressing 100 are also possible depending on the intended use. The wound dressing 100 may be made of polyurethane or other suitable polymeric materials and may include an elastomeric film or membrane that can provide a seal around the wound site. Beneficially, the wound dressing may be made of a breathable, anti- microbial material in order to facilitate healing and user experience. The wound contact layer of the wound dressing 100 may have an osmotic membrane that draws water through the wound contact layer and into the wound dressing 100. The wound dressing 100 may have an absorbent member within the housing portions or inside the wound dressing 100 to facilitate and capture water drawn into the wound dressing 100. In some embodiments, substantially all or all of the wound dressing 100 is optically transparent to allow for the patient or caregiver to view the wound site while the wound dressing 100 is applied to the wound site.

[0045] The top housing portion 102 and the bottom housing portion 104 are injection molded separately and formed together at the periphery portion 106 to form the housing of the wound dressing 100. The periphery portion 106 may be distinct (e.g., a clearly defined top housing portion 102 and bottom housing portion 104) or it may be ambiguous (e.g., the top housing portion 102 and bottom housing portion 104 meld together and are obscure). The top housing portion 102 and the bottom housing portion 104 may be formed as two separate components that are welded and formed together. As shown in FIG. 2, the bottom housing portion 104 has an outer surface 124 that forms with a corresponding outer surface (not shown) on the top housing portion 102. In some embodiments, the top housing portion 102 and the bottom housing portion 104 each have a thickness within a range of 500 microns to 1 mm. While FIGS. 1 & 2 show the top housing portion 102 as the wound site interface layer, either the top housing portion 102 or the bottom housing portion 104 may be configured to be the layer that interfaces with the wound site.

[0046] The bottom housing portion 104 includes a first indention on the outer surface 124 that forms the sound valve 108 with a corresponding indention on an outer surface of the top housing portion 102. In some embodiments, the sound valve 108 is formed by a slit between the top housing portion 102 and the bottom housing portion 104 by overlapping one of the housing portions over the other. The slit is configured to have a thickness to produce a sound with a desired frequency when the wound dressing 100 is in the collapsing state. The bottom housing portion 104 includes a second indention on the outer surface 124 that forms the reinflation valve 110 with a corresponding indention on an outer surface of the top housing portion 102. As shown in FIG. 2, the reinflation valve 110 is adjacent the sound valve 108, however, other orientations along or near the periphery portion 106 are feasible locations for either valve. For example, the reinflation valve 110 may be disposed on an opposite end or diagonal from the sound valve 108.

[0047] The sound valve 108 is in fluid communication with the air chamber 116 and the outside of the wound dressing 100. The sound valve 108 may be a one-way valve such that air flow is only able to travel from the air chamber 116 to the outside of the wound dressing. The sound valve 108 will be disposed on the wound dressing 100 in a location that allows it to emit noise and not be sealed shut under compression, preferably at a location around the periphery portion 106 of the wound dressing. The sound valve 108 may be tuned (e.g., configured) to emit a desired frequency and/or volume of a noise when a collapse force is applied. In some embodiments, the sound valve may be tuned to emit a wide variety of noises with distinct frequencies, with each frequency corresponding to a different pressure. For example, the sound valve 108 may emit a lower frequency noise at a low pressure as a warning that a harmful pressure is approaching, with higher frequency or volume as the pressure applied to the wound dressing 100 increases.

[0048] As shown in FIG. 2, the sound valve 108 includes a sounder 114 that is configured to sealably engage inside the sound valve 108 and facilitate emitting a noise when the wound dressing 100 is in the collapsing state. The sounder 114 may be a hollow plastic tube molded to produce a tone, frequency, and volume for air traveling therethrough during the collapsing state of the wound dressing 100. Alternatively, the sounder 114 may be a flap sounder that is formed by two layers of housing material formed over each other (e.g., overlapped) and thinned to achieve the right tone, frequency, and volume for the collapsing state of the wound dressing 100. As will be appreciated, the air pressure from the air chamber 116 causes the flap sounder to open and air to travel outside, thereby emitting the noise. When the collapse force is removed, the flap sounder no longer has internal pressure keeping it open and will therefore close and prevent air flow back into the wound dressing 100 until it is re-inflated through the reinflation valve 110. [0049] The reinflation valve 110 is in fluid communication with the air chamber 116 and the outside of the wound dressing 100. The reinflation valve 110 is configured to allow air to flow, relatively unrestricted, from the outside of the wound dressing 100 back into the air chamber 116 when the collapse force has been removed from the wound dressing 100 and the wound dressing transitions from a collapsing state to an inflating state. Beneficially, the reinflation valve 110 would be configured as a semi“one way” valve, meaning that the flow from inside the air chamber 116 to the outside (e.g., wound dressing 100 is in a collapsing state) is restricted to force air leaving the air chamber 116 to flow through the sound valve 108. In some embodiments, the reinflation valve 110 is configured to receive less than 5% of the mass flow rate leaving the air chamber 116, with preferably 95% or more of the mass flow rate of the air traveling through, and activating, the sound valve 108. Similar to the sound valve 108, the reinflation valve is disposed on the wound dressing 100 in a location that allows it to emit noise and not be sealed shut under compression, preferably at a location around the periphery portion 106 of the wound dressing. The reinflation valve 110 may include a filter element 112 therethrough to prevent contamination within the air chamber 116 and inside the wound dressing 100. The filter element 112 may be a hydrophobic bacterial filter with filter member holes having a diameter less than 0.2 microns, for example, a GORE™ MMT 314 medical membrane. In some embodiments, the reinflation valve 110 is a micro-perforation having a diameter of 5 mm and a given flow rate.

[0050] The biasing member 118 includes a base portion 120 integrally formed with the bottom housing portion 104 and a flexible protrusion 122 that functions as a spring. The flexible protrusion 122 is configured to laterally and controllably collapse when the collapse force is applied to the wound dressing 100, and in turn, the biasing member 118. In other words, the collapse force acting on the biasing member 118 causes the sudden collapse of the flexible protrusion 122 and air escapes from the air chamber 116 through the sound valve 108. Preferably, the flexible protrusion 122 collapses at a pressure that is equal to or less than the harmful pressure. The rigidity and configuration of the flexible protrusion 122 can affect the collapse force of the biasing member 118. In some embodiments, for example as shown in FIGS. 3-5, the biasing member may be integrally formed with the material of the top housing portion 102 and the bottom housing portion 104 such that the top housing portion 102 and the bottom housing portion 104 are the biasing member. By way of example, the collapse force may be less than or equal to 32 mm Hg, the force at which occlusion of capillary flow can occur, or within the range of 25-35 mm Hg.

[0051] In one exemplary use case, the wound dressing 100 is applied to a wound site by applying an adhesive to the top housing portion 102 and applying it to the wound site. The wound dressing 100 is configured such that the size and shape of the wound dressing is tailored to the type, location, and size of the wound. The wound dressing 100 remains inflated due to the rigidity of the biasing member 118 in the air chamber 116. The wound dressing remains substantially silent up until a harmful pressure is applied to the wound dressing 100. The flexible protrusion 122 is configured to collapse at a collapse force equal to the harmful pressure. The flexible protrusion 122 gives way laterally toward the bottom housing portion 104, contracting the air chamber 116 and causing air to evacuate the air chamber 116. Due to the flow restriction in the reinflation valve 110, the majority of the air flows through the sound valve 108 and causes the sounder 114 to emit a sound having a frequency and tone associated with the harmful pressure. The sound acts as a warning to the patient of a pressure threshold being breached at the wound site, either due to a continuous pressure (e.g., the patient has moved to a position that puts pressure on the wound site) or a brief pressure (e.g., the wound site has bumped an object with a force that is harmful). The patient is aware of what the noise corresponds to and can rectify the issue, for example, by re positioning to alleviate the pressure on the wound site or by traveling to a medical professional to assess damage to the wound site from the contact with a harmful pressure.

The noise provides the patient with specific instances of harmful pressure being applied to the wound suite, thereby allowing the patient to alter behavior and actions to promote healing of the wound and limit re-occurrence at the wound site.

Wound Covering and Wound Surrounding Dressings

[0052] Referring now to FIGS. 3-5, a wound covering dressing 300 and a wound surrounding dressing 350 are shown, according to an exemplary embodiment. The wound covering dressing 300 is similar to the wound dressing 100 of FIGS. 1 & 2. Notably, the wound covering dressing 300 and the wound dressing 100 are both in contact with and cover the wound (e.g., through the top housing portion 102, 302). Differences between the wound covering dressing 300 and the wound dressing 100 include the wound covering dressing 300 having a more continuous periphery portion 306, the wound covering dressing 300 having a slit-style sound valve 308, and the top housing portion 302 and the bottom housing portion 304 having the biasing member formed within. Accordingly, similar numbering to the wound dressing 100 will be used in describing the wound covering dressing 300. Similarly, the collapse force of the biasing member may be less than or equal to 32 mm Hg, the force at which occlusion of capillary flow can occur, or within the range of 25-35 mm Hg.

[0053] The wound covering dressing 300 is shown to include a top housing portion 302, a bottom housing portion 304, a periphery portion 306 between the periphery of the top housing portion 302 and the periphery of the bottom housing portion 304, an air chamber (not shown due to the opaque housing), a sound flap valve 308, and a reinflation valve 310. The top housing portion 302 or the bottom housing portion 304 of the wound covering dressing 300 can be sealed to a patient’s skin surrounding a wound site and, in some embodiments, may provide an airtight seal over the wound site. The air chamber is formed between the top housing portion 302, the bottom housing portion 304, and the periphery portion such that air flow is possible through the sound flap valve 308 and reinflation valve 310. A biasing member is formed within the top housing portion 302 and the bottom housing portion 304 and is configured to facilitate the lateral collapse of the wound covering dressing 300 such that a certain pressure (e.g., collapse force) applied to the wound covering dressing 300 will cause the biasing member, and in turn the wound covering dressing 300, to controllably collapse. The biasing member can be configured to laterally expand after the wound covering dressing 300 has entered a collapse state and the collapse force has been removed.

[0054] Generally, the wound covering dressing 300 can be formed as a substantially flat sheet for topical application to wounds or contoured for application to body surfaces having high curvature. The size of wound covering dressing 300 can vary depending on the size of the wound to be dressed. For example, it is contemplated that the size of wound covering dressing 300 can range from 1 cm ² to 200 cm ² . However, other shapes and sizes of wound covering dressing 300 are also possible depending on the intended use. The wound covering dressing 300 may be made of polyurethane or other suitable polymeric materials and may include an elastomeric film or membrane that can provide a seal around the wound site.

Beneficially, the wound covering dressing may be made of a breathable, anti- microbial material in order to facilitate healing and user experience. The wound contact layer of the wound covering dressing 300 may have an osmotic membrane that draws water through the wound contact layer and into the wound covering dressing 300. The wound covering dressing 300 may have an absorbent member within or inside the wound covering dressing 300 to facilitate and capture water drawn into the wound covering dressing 300. In some embodiments, substantially all or all of the wound covering dressing 300 is optically transparent to allow for the patient or caregiver to view the wound site while the wound covering dressing 300 is applied to the wound site.

[0055] As shown in FIG. 3, the top housing portion 302 is the wound site interface layer and includes an adhesive coating 312. However, either the top housing portion 302 or the bottom housing portion 304 may be configured to be the layer that interfaces with the wound site and has an adhesive coating 312. The top housing portion 302 and the bottom housing portion 304 may be formed by overlapping one portion over the other portion in a way to form a sound flap valve 308 along the periphery portion 306 of the wound covering dressing 300. The periphery portion 306 is ambiguous such that the top housing portion 302 and bottom housing portion 304 meld together and the periphery portion 306 is more obscure compared to, for example, the periphery portion 106 of the wound dressing 100 of FIGS. 1 & 2. In some embodiments, the top housing portion 302 and the bottom housing portion 304 may be formed as two separate components that are welded and formed together. In some embodiments, the top housing portion 302 and the bottom housing portion 304 each have a thickness within a range of 500 microns to 1 mm.

[0056] The top housing portion 302 and the bottom housing portion 304 are a molded structure that includes a biasing member within one or both of the housing portions 302, 304. In other words, the biasing member may be in the construction of the top housing portion 302 and/or in the construction of the bottom housing portion 304. For example, the materials used to form the top housing portion 302 and the bottom housing portion 304 may have a specific resiliency or structure that causes the housing portions to exhibit spring-like behavior (e.g., compress when a collapse force is applied and reform when the collapse force is removed). The top housing portion 302 and the bottom housing portion 304 may be formed with a plurality of flexible ribs, a resilient web, a spring skeleton, or any other support material that includes a resilient springiness. The biasing member within the housing portions is configured to laterally and controllably collapse when the collapse force is applied to the wound covering dressing 300, and in turn, the biasing member. In other words, the collapse force acting on the biasing member within the housing portions causes the sudden collapse of the wound covering dressing 300 and air to escapes from the air chamber through the sound flap valve 308. Preferably, the biasing member collapses at a pressure that is equal to or less than the harmful pressure. The rigidity and configuration of the biasing member can affect the collapse force of the biasing member. In some embodiments, a biasing member may be disposed within the top housing portion 302 and/or the bottom housing portion 304. For example, the biasing member may be a foam-based structure, a polymer spring material, a semi-rigid membrane, or any other membrane that functions as a biasing structure (e.g., deform and reform under pressure conditions) that is internal to a part of the housing portions.

[0057] The sound flap valve 308 is in fluid communication with the air chamber and the outside of the wound covering dressing 300. The sound valve 308 may be a one-way valve such that air flow is only able to travel from the air chamber to the outside of the wound covering dressing 300. The air pressure from the air chamber causes the sound flap valve 308 to open and air to travel outside, thereby emitting the noise. When the collapse force is removed, the sound flap valve 308 no longer has internal pressure keeping it open and will therefore close and prevent air flow back into the wound covering dressing 300 until it is re inflated through the reinflation valve 310. As shown in FIG. 3, the sound flap valve 308 is disposed on the wound covering dressing 300 in a location that allows it to emit noise and not be sealed shut under compression.

[0058] The sound flap valve 308 is configured to have a thickness to produce a sound with a desired frequency when the wound covering dressing 300 is in the collapsing state. The sound flap valve 308 may be tuned (e.g., configured) to emit a desired frequency and/or volume of a noise when a collapse force is applied. In some embodiments, the sound valve may be tuned to emit a wide variety of noises with distinct frequencies, with each frequency corresponding to a different pressure. For example, the sound flap valve 308 may emit a lower frequency noise at a low pressure as a warning that a harmful pressure is approaching, with higher frequency or volume as the pressure applied to the wound covering dressing 300 increases. [0059] The reinflation valve 310 is in fluid communication with the air chamber and the outside of the wound covering dressing 300. The reinflation valve 310 is configured to allow air to flow, relatively unrestricted, from the outside of the wound covering dressing 300 back into the air chamber when the collapse force has been removed from the wound covering dressing 300 and the wound covering dressing 300 transitions from a collapsing state to an inflating state. Beneficially, the reinflation valve 310 would be configured as a semi“one way” valve, meaning that the flow from inside the air chamber to the outside (e.g., wound covering dressing 300 is in a collapsing state) is restricted to force air leaving the air chamber to flow through the sound flap valve 308. In some embodiments, the reinflation valve 310 is configured to receive less than 5% of the mass flow rate leaving the air chamber, with preferably 95% or more of the mass flow rate of the air traveling through and activating the sound flap valve 308. Similar to the sound flap valve 308, the reinflation valve is disposed on the wound covering dressing 300 in a location that allows it to emit noise and not be sealed shut under compression, preferably at a location around the periphery portion 306 of the wound covering dressing 300. The reinflation valve 310 may include a filter element therethrough to prevent contamination within the air chamber and inside the wound covering dressing 300.

[0060] In one exemplary use case, the wound covering dressing 300 is applied to a wound site by applying the adhesive coating 312 on the top housing portion 302 to the wound site. The wound covering dressing 300 is configured such that the size and shape of the wound covering dressing is tailored to the type, location, and size of the wound. The wound covering dressing 300 remains inflated due to the rigidity of the biasing member in the housing portions 302, 304. The wound covering dressing remains substantially silent up until a harmful pressure is applied to the wound covering dressing 300. The biasing member is configured to collapse at a collapse force equal to the harmful pressure. The biasing member gives way laterally toward the bottom housing portion 304, contracting the air chamber and causing air to evacuate the air chamber. Due to the flow restriction in the reinflation valve 316, the majority of the air flows through the sound flap valve 308 resulting in an emission of a sound having a frequency and tone associated with the harmful pressure. The sound acts as a warning to the patient of a pressure threshold being breached at the wound site, either due to a continuous pressure (e.g., the patient has moved to a position that puts pressure on the wound site) or a brief pressure (e.g., the wound site has bumped an object with a force that is harmful). The patient is aware of what the noise corresponds to and can rectify the issue, for example, by re-positioning to alleviate the pressure on the wound site or by traveling to a medical professional to assess damage to the wound site from the contact with a harmful pressure. The noise provides the patient with specific instances of harmful pressure being applied to the wound suite, thereby allowing the patient to alter behavior and actions to promote healing of the wound and limit re-occurrence at the wound site.

[0061] Referring now to the wound surrounding dressing 350, the wound surrounding dressing 350 is similar to the wound dressing 100 of FIGS. 1 & 2. Differences between the wound surrounding dressing 350 and the wound dressing 100 include the wound surrounding dressing 350 having a more continuous periphery portion 356, the wound surrounding dressing 350 having a slit-style sound valve 358, and the top housing portion 302 and the bottom housing portion 304 having the biasing member formed within. Additionally, the wound surrounding dressing 350 is similar to the wound covering dressing 300. Differences between the wound surrounding dressing 350 and the wound covering dressing 300 include the wound surrounding dressing having a circular shape and including a wound opening configured to surround the wound. Accordingly, similar numbering to the wound covering dressing 300 will be used in describing the wound surrounding dressing 350

[0062] The wound surrounding dressing 350 is shown to include a top housing portion 352, a bottom housing portion 354, a periphery portion 356 between the periphery of the top housing portion 352 and the periphery of the bottom housing portion 354, an air chamber (not shown due to the opaque housing), a sound flap valve 358, a reinflation valve 360, and a wound opening 364. The top housing portion 352 or the bottom housing portion 354 of the wound surrounding dressing 350 can be affixed to a patient’s skin to surround a wound. As will be appreciated, the wound opening 364 provides minimal contact with the wound and may be implemented on pressure ulcers that are sensitive or at a greater risk of injury than pressure ulcers that have a wound covering dressing 300. The air chamber is formed between the top housing portion 352, the bottom housing portion 354, and the periphery portion such that air flow is possible through the sound flap valve 358 and reinflation valve 360. A biasing member is formed within the top housing portion 352 and the bottom housing portion 354 and is configured to facilitate the lateral collapse of the wound surrounding dressing 350 such that a certain pressure (e.g., collapse force) applied to the wound surrounding dressing 350 will cause the biasing member, and in turn the wound surrounding dressing 350, to controllably collapse. The biasing member can be configured to laterally expand after the wound surrounding dressing 350 has entered a collapse state and the collapse force has been removed.

[0063] Generally, the wound surrounding dressing 350 can be formed as a substantially round disc for topical application around a wound (e.g., substantially not contacting a wound). The size of wound surrounding dressing 350 can vary depending on the size of the wound to be dressed. For example, it is contemplated that the size of wound surrounding dressing 350 can range from a diameter of 1 cm ² to 200 cm ² . However, other shapes and sizes of wound surrounding dressing 350 are also possible depending on the intended use.

The wound surrounding dressing 350 may be made of polyurethane or other suitable polymeric materials and may include an elastomeric film or membrane that can provide a seal around the wound site. Beneficially, the wound surrounding dressing 350 may be made of a breathable, anti- microbial material in order to facilitate healing and user experience. The wound contact layer of the wound surrounding dressing 350 may have an osmotic membrane that draws water through the wound contact layer and into the wound surrounding dressing 350. The wound surrounding dressing 350 may have an absorbent member within or inside the wound surrounding dressing 350 to facilitate and capture water drawn into the wound surrounding dressing 350. In some embodiments, substantially all or all of the wound surrounding dressing 350 is optically transparent to allow for the patient or caregiver to view the wound site while the wound surrounding dressing 350 is applied to the wound site.

[0064] As shown in FIG. 3, the top housing portion 352 is the wound site interface layer and includes an adhesive coating 362. However, either the top housing portion 352 or the bottom housing portion 354 may be configured to be the layer that interfaces with the wound site and has an adhesive coating 362. The top housing portion 352 and the bottom housing portion 354 may be formed by overlapping one portion over the other portion in a way to form a sound flap valve 358 along the periphery portion 356 of the wound surrounding dressing 350. While the sound flap valve 358 and the reinflation valve 360 are shown around the outer circumference (e.g., periphery portion 356) of the wound surrounding dressing 350, the sound flap valve 358 and the reinflation valve 360 may be disposed inwardly facing on the inner circumference (e.g., wound opening 364) of the wound surrounding dressing 350. The periphery portion 356 is ambiguous such that the top housing portion 352 and bottom housing portion 354 meld together and the periphery portion 356 is obscure compared to, for example, the periphery portion 106 of the wound dressing 100 of FIGS. 1 & 2. In some embodiments, the top housing portion 352 and the bottom housing portion 354 may be formed as two separate components that are welded and formed together. In some embodiments, the top housing portion 352 and the bottom housing portion 354 each have a thickness within a range of 500 microns to 1 mm.

[0065] The top housing portion 352 and the bottom housing portion 354 are a molded structure that includes a biasing member within one or both of the housing portions 352, 354. In other words, the biasing member may be in the construction of the top housing portion 352 and/or in the construction of the bottom housing portion 354. For example, the materials used to form the top housing portion 352 and the bottom housing portion 354 may have a specific resiliency or structure that causes the housing portions to exhibit spring-like behavior (e.g., compress when a collapse force is applied and reform when the collapse force is removed). The top housing portion 352 and the bottom housing portion 354 may be formed with a plurality of flexible ribs, a resilient web, a spring skeleton, or any other support material that includes a resilient springiness. The biasing member within the housing portions is configured to laterally and controllably collapse when the collapse force is applied to the wound surrounding dressing 350, and in turn, the biasing member. In other words, the collapse force acting on the biasing member within the housing portions causes the sudden collapse of the wound surrounding dressing 350 and air to escapes from the air chamber through the sound flap valve 358. Preferably, the biasing member collapses at a pressure that is equal to or less than the harmful pressure. The rigidity and configuration of the biasing member can affect the collapse force of the biasing member. In some embodiments, a biasing member may be disposed within the top housing portion 352 and/or the bottom housing portion 354. For example, the biasing member may be a foam-based structure, a polymer spring material, a semi-rigid membrane, or any other membrane that functions as a biasing structure (e.g., deform and reform under pressure conditions) that is internal to a part of the housing portions. [0066] The sound flap valve 358 is in fluid communication with the air chamber and the outside of the wound surrounding dressing 350. The sound valve 358 may be a one-way valve such that air flow is only able to travel from the air chamber to the outside of the wound surrounding dressing 350. The air pressure from the air chamber causes the sound flap valve 358 to open and air to travel outside, thereby emitting the noise. When the collapse force is removed, the sound flap valve 358 no longer has internal pressure keeping it open and will therefore close and prevent air flow back into the wound surrounding dressing 350 until it is re-inflated through the reinflation valve 360. As shown in FIG. 3, the sound flap valve 358 is disposed on the wound surrounding dressing 350 in a location that allows it to emit noise and not be sealed shut under compression.

[0067] The sound flap valve 358 is configured to have a thickness to produce a sound with a desired frequency when the wound surrounding dressing 350 is in the collapsing state. The sound flap valve 358 may be tuned (e.g., configured) to emit a desired frequency and/or volume of a noise when a collapse force is applied. In some embodiments, the sound valve may be tuned to emit a wide variety of noises with distinct frequencies, with each frequency corresponding to a different pressure. For example, the sound flap valve 358 may emit a lower frequency noise at a low pressure as a warning that a harmful pressure is approaching, with higher frequency or volume as the pressure applied to the wound surrounding dressing 350 increases.

[0068] The reinflation valve 360 is in fluid communication with the air chamber and the outside of the wound surrounding dressing 350. The reinflation valve 360 is configured to allow air to flow, relatively unrestricted, from the outside of the wound surrounding dressing 350 back into the air chamber when the collapse force has been removed from the wound surrounding dressing 350 and the wound surround dressing 350 transitions from a collapsing state to an inflating state. Beneficially, the reinflation valve 360 would be configured as a semi“one way” valve, meaning that the flow from inside the air chamber to the outside (e.g., wound surrounding dressing 350 is in a collapsing state) is restricted to force air leaving the air chamber to flow through the sound flap valve 358. In some embodiments, the reinflation valve 360 is configured to receive less than 5% of the mass flow rate leaving the air chamber, with preferably 95% or more of the mass flow rate of the air traveling through and activating the sound flap valve 358. Similar to the sound flap valve 358, the reinflation valve is disposed on the wound surrounding dressing 350 in a location that allows it to emit noise and not be sealed shut under compression, preferably at a location around the periphery portion 356 of the wound surrounding dressing 350. The reinflation valve 360 may include a filter element therethrough to prevent contamination within the air chamber and inside the wound surrounding dressing 350.

[0069] In one exemplary use case, the wound surrounding dressing 350 is applied to a wound site by applying the adhesive coating 362 on the top housing portion 352 to the wound site. The wound surrounding dressing 350 is configured such that the size and shape of the wound surrounding dressing 350 is tailored to the type, location, and size of the wound. The wound surrounding dressing 350 remains inflated due to the rigidity of the biasing member in the housing portions 352, 354. The wound surrounding dressing 350 remains substantially silent up until a harmful pressure is applied to the wound surrounding dressing 350. The biasing member is configured to collapse at a collapse force equal to the harmful pressure. The biasing member gives way laterally toward the bottom housing portion 354, contracting the air chamber and causing air to evacuate the air chamber. Due to the flow restriction in the reinflation valve 366, the majority of the air flows through the sound flap valve 358 resulting in an emission of a sound having a frequency and tone associated with the harmful pressure. The sound acts as a warning to the patient of a pressure threshold being breached at the wound site, either due to a continuous pressure (e.g., the patient has moved to a position that puts pressure on the wound site) or a brief pressure (e.g., the wound site has bumped an object with a force that is harmful). The patient is aware of what the noise corresponds to and can rectify the issue, for example, by re-positioning to alleviate the pressure on the wound site or by traveling to a medical professional to assess damage to the wound site from the contact with a harmful pressure. The noise provides the patient with specific instances of harmful pressure being applied to the wound suite, thereby allowing the patient to alter behavior and actions to promote healing of the wound and limit re-occurrence at the wound site.

[0070] FIG. 4 shows the wound covering dressing 300 and the wound surrounding dressing 350 with an adhesive drape 410. The adhesive drape 410 may be applied to further ensure that wound covering dressing 300 or the wound surrounding dressing 350 adheres to the patient’s skin and remains in place throughout the wear time. The adhesive drape 410 may extend beyond (e.g., circumscribes) the perimeter of the wound covering dressing 300 or the wound surrounding dressing 350 to provide an adhesive-coated margin for adhering to the skin of a patient adjacent to the wound being treated. The adhesive-coated margin may extend around all sides of the wound covering dressing 300 or the wound surrounding dressing 350 such that wound dressing is a so-called“island dressing.”

[0071] FIG. 5 shows the wound covering dressing 300 and the wound surrounding dressing 350 with an adhesive drape 410 and a backing film 510. The backing film 510 may be provided to cover and further protect the wound. In some embodiments, the backing film 510 may be an absorbent layer that absorbs and entraps liquid. In other embodiments, the backing film 510 may be a hydrophilic foam that is laminated or otherwise coupled to the superab sorbent material via a fusible fiber.

Wound Dressing Array

[0072] FIG. 6 shows a top perspective view of a wound dressing array 600 that includes a plurality of wound dressings 650. Each wound dressing 650 in the wound dressing array 600 may be configured to emit different frequencies such that a compression on a first wound dressing 650 results in a frequency that is different and distinct from a frequency caused by the compression on a second wound dressing 650. Each wound dressing 650 or a group of wound dressings may have different collapse forces to accommodate different trigger pressures. Beneficially, the wound dressing array 600 provides greater flexibility in configuration of wound dressings and in satisfying the needs of the patient. The wound dressing array 600 may include a variety of different shaped individual wound dressings. For example, a wound dressing array 600 may include a wound covering dressing 300 and a wound surrounding dressing 350 formed together by molding, sewing, adhesive, or other connection methods. Similarly, the collapse force of the biasing member within a single wound dressing may be less than or equal to 32 mm Hg, the force at which occlusion of capillary flow can occur, or within the range of 25-35 mm Hg.

[0073] The wound dressing array 600 may be formed using one or more of the wound dressings described above, for example, the wound dressing 100 of FIGS. 1 & 2 or the wound covering dressing 300 and wound surrounding dressing 350 of FIGS. 3-5. The wound dressing 650 shown in FIG. 6 is similar to the wound dressings 100, 300 of FIGS. 1-5. A difference between the wound dressing 650 and the wound dressings 100, 300 is that the wound dressing 650 includes a sound flap valve 608 is disposed on a corner of the wound dressing above the connecting surface 606 between the wound dressings 650. In some embodiments, each wound dressing 650 has a distinct air chamber while in other

embodiments, each wound dressing’s air chamber is in fluid communication with the air chambers of adjacent wound dressings.

[0074] Each wound dressing 650 is shown to include a top housing portion 602, a bottom housing portion 604, a connecting surface 606 between the periphery of the top housing portion 602 and the periphery of the bottom housing portion 604, an air chamber (not shown due to the opaque housing), a sound flap valve 608, and a reinflation valve 610. The top housing portion 602 and the bottom housing portion 604 are substantially similar to the housing portion and the bottom housing portion of the wound dressings 100, 300, 350 described above. The biasing member may be disposed within the air chamber or formed within the housing portions and is configured to laterally expand after the wound dressing 650 has entered a collapse state and the collapse force has been removed. The connecting surface 606 is the surface shared by a wound dressing 650 and the adjacent wound dressings. In some embodiments, each air chamber within a wound dressing is in fluid communication with the air chambers of the adjacent wound dressings 650 through an opening within each connecting surface 606. In those embodiments, reinflation valves are only disposed along the outer most periphery of the wound dressing array 600 (e.g., only on the wound dressings 650 that form the circumference/perimeter) to ensure air can be captured from outside the wound dressing array into the collective air chamber.

[0075] The sound flap valve 608 is in fluid communication with the air chamber and the outside of the wound dressing array 600 and is similar to the sound flap valve 308 in FIGS. 3- 5. However, due to the connection between multiple wound dressings limiting the surface area around the periphery of each wound dressing, the sound flap valve 608 is disposed on a corner of each wound dressing 650 and above the connecting surface 606 to allow for air to flow through. In other words, the sound flap valve 608 is disposed on the wound dressing 650 in a location that allows it to emit noise and not be sealed shut under compression or by an adjacent wound dressing 650. As will be appreciated, the air pressure from the air chamber causes the sound flap valve 608 to open and air to travel outside, thereby emitting the noise. When the collapse force is removed, the sound flap valve 608 no longer has internal pressure keeping it open and will therefore close and prevent air flow back into the wound dressing 650 until it is re-inflated through the reinflation valve 610.

[0076] The reinflation valve 610 is in fluid communication with the air chamber and the outside of the wound dressing array 600. The reinflation valve 610 is configured to allow air to flow, relatively unrestricted, from the outside of the wound dressing array 600 back into the air chamber when the collapse force has been removed from the wound dressing 650 and the wound dressing 650 transitions from a collapsing state to an inflating state. In some embodiments, each wound dressing 610 has a reinflation valve 610 disposed on each wound dressing 350 above the connecting surface 606. In other embodiments, each air chamber of the wound dressing is in fluid communication with the air chambers of adjacent wound dressings, thereby reducing the need for reinflation valves 610 on each wound dressing 650. In those embodiments, the reinflation valves 610 are disposed on the periphery of the wound dressings 650 that form the circumference/perimeter of the wound dressing array 600 to ensure air can be captured from outside the wound dressing array into the collective air chamber.

[0077] Each wound dressing 650 is configured to have a respective biasing member.

Beneficially, this allows for the wound dressing array 600 to be tuned via the configuration and collapse force of each respective wound dressing 650 in the wound dressing array. In other words, each wound dressing 650 may have a distinct frequency and/or tone to specifically identify the location of the pressure. Additionally, adjacent wound dressings 650 may have different collapse forces, thereby allowing customization and accommodation for a wide variety of wounds.

Configuration of Exemplary Embodiments

[0078] The construction and arrangement of the elements of the wound as shown in the exemplary embodiments are illustrative only. Although only a few embodiments of the present disclosure have been described in detail, those skilled in the art who review this disclosure will readily appreciate that 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.) without materially departing from the novel teachings and advantages of the subject matter recited. For example, elements shown as integrally formed may be constructed of multiple parts or elements.

[0079] The elements and assemblies may be constructed from any of a wide variety of materials that provide sufficient strength or durability, in any of a wide variety of colors, textures, and combinations. Additionally, in the subject description, the word“exemplary” is used to mean serving as an example, instance, or illustration. Any embodiment or design described herein as“exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments or designs. Rather, use of the word“exemplary” is intended to present concepts in a concrete manner. 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 preferred and other exemplary embodiments without departing from the scope of the appended claims.

[0080] The order or sequence of any process or method steps may be varied or re sequenced according to alternative embodiments. Any means-plus-function clause is intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures. Other substitutions, modifications, changes and omissions may be made in the design, operating configuration, and arrangement of the preferred and other exemplary embodiments without departing from the scope of the appended claims.