Patent Description:
Treatment of wounds or other tissue with reduced pressure may be commonly referred to as "negative -pressure therapy," but is also known by other names, including "negative-pressure wound therapy," "reduced-pressure therapy," "vacuum therapy," "vacuum-assisted closure," and "topical negative-pressure," for example.

There is also widespread acceptance that cleansing a tissue site can be highly beneficial for new tissue growth. For example, a wound or a cavity can be washed out with a liquid solution for therapeutic purposes. These practices are commonly referred to as "irrigation" and "lavage" respectively. "Instillation" is another practice that generally refers to a process of slowly introducing fluid to a tissue site and leaving the fluid for a prescribed period of time before removing the fluid. For example, instillation of topical treatment solutions over a wound bed can be combined with negative-pressure therapy to further promote wound healing by loosening soluble contaminants in a wound bed and removing infectious material. As a result, soluble bacterial burden can be decreased, contaminants removed, and the wound cleansed.

While the clinical benefits of negative-pressure therapy and/or instillation therapy are widely known, improvements to therapy systems, components, and processes may benefit healthcare providers and patients. <CIT> discloses a negative pressure wound treatment (NPWT) dressing system for shoulder incisions, including a wound dressing, an immobilization device, and a negative pressure source. The wound dressing features drape and manifold layers.

The invention is defined by the independent claim. A selection of optional features is set out in the dependent claims.

<FIG> is a block diagram of an example embodiment of a therapy system <NUM> that can provide negative-pressure therapy and instillation treatment in accordance with this specification.

The term "tissue site" in this context broadly refers to a wound, defect, or other treatment target located on or within tissue, including, but not limited to, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. A wound may include chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness bums, ulcers (such as diabetic, pressure, or venous insufficiency ulcers), flaps, and grafts, for example. The term "tissue site" may also refer to areas of any tissue that are not necessarily wounded or defective, but are instead areas in which it may be desirable to add or promote the growth of additional tissue. For example, negative pressure may be applied to a tissue site to grow additional tissue that may be harvested and transplanted.

The therapy system <NUM> may include a source or supply of negative pressure, such as a negative-pressure source <NUM>, and one or more distribution components. A distribution component is preferably detachable and may be disposable, reusable, or recyclable. A dressing, such as a dressing <NUM>, and a fluid container, such as a container <NUM>, are examples of distribution components that may be associated with some examples of the therapy system <NUM>. As illustrated in the example of <FIG>, the dressing <NUM> may include a tissue interface <NUM>, a cover <NUM>, or both in some embodiments.

Distribution components may also include interfaces or fluid ports to facilitate coupling and de-coupling other components.

The therapy system <NUM> may also include a source of instillation solution. For example, a solution source <NUM> may be fluidly coupled to the dressing <NUM>, as illustrated in the example embodiment of <FIG>. The solution source <NUM> may be fluidly coupled to a positive-pressure source such as a positive-pressure source <NUM>, a negative-pressure source such as the negative-pressure source <NUM>, or both in some embodiments. A regulator, such as an instillation regulator, may also be fluidly coupled to the solution source <NUM> and the dressing <NUM> to ensure proper dosage of instillation solution (e.g. saline) to a tissue site. For example, the instillation regulator <NUM> may include a piston that can be pneumatically actuated by the negative-pressure source <NUM> to draw instillation solution from the solution source during a negative-pressure interval and to instill the solution to a dressing during a venting interval. Additionally or alternatively, the controller <NUM> may be coupled to the negative-pressure source <NUM>, the positive-pressure source <NUM>, or both, to control dosage of instillation solution to a tissue site. In some embodiments, the instillation regulator <NUM> may also be fluidly coupled to the negative-pressure source <NUM> through the dressing <NUM>, as illustrated in the example of <FIG>.

Some components of the therapy system <NUM> may be housed within or used in conjunction with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate therapy. For example, in some embodiments, the negative-pressure source <NUM> may be combined with the controller <NUM>, the solution source <NUM>, and other components into a therapy unit.

A negative-pressure supply, such as the negative-pressure source <NUM>, may be a reservoir of air at a negative pressure or may be a manual or electrically-powered device, such as a vacuum pump, a suction pump, a wall suction port available at many healthcare facilities, or a micro-pump, for example. "Negative pressure" generally refers to a pressure less than a local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment. In many cases, the local ambient pressure may also be the atmospheric pressure at which a tissue site is located. Alternatively, the pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. References to increases in negative pressure typically refer to a decrease in absolute pressure, while decreases in negative pressure typically refer to an increase in absolute pressure. While the amount and nature of negative pressure provided by the negative-pressure source <NUM> may vary according to therapeutic requirements, the pressure is generally a low vacuum, also commonly referred to as a rough vacuum, between -<NUM> Hg (-<NUM> Pa) and -<NUM> Hg (-<NUM> kPa). Common therapeutic ranges are between - <NUM> Hg (-<NUM> kPa) and -<NUM> Hg (-<NUM> kPa).

In some embodiments, for example, the controller <NUM> may be a microcontroller, which generally includes an integrated circuit containing a processor core and a memory programmed to directly or indirectly control one or more operating parameters of the therapy system <NUM>.

In some embodiments, the tissue interface <NUM> may include or may be a manifold as further described herein. A manifold in this context may include a means for communicating fluid relative to a tissue site under pressure, such as a means for collecting fluid from or distributing fluid to the tissue site. For example, a manifold may be adapted to receive negative pressure from a source and distribute negative pressure through multiple apertures across the tissue interface <NUM>, which may have the effect of collecting fluid from a tissue site and drawing the fluid toward the source. In some embodiments, the fluid path may be reversed or a secondary fluid path may be provided to facilitate delivering fluid, such as fluid from a source of instillation solution, across a tissue site.

In some illustrative embodiments, a manifold may include a plurality of pathways, which can be interconnected to improve distribution or collection of fluids. In some illustrative embodiments, a manifold may include a porous material having interconnected fluid pathways. Examples of suitable porous material that can be adapted to form interconnected fluid pathways (e.g., channels) may include cellular foam, including open-cell foam such as reticulated foam; porous tissue collections; and other porous material such as gauze or felted mat that generally include pores, edges, and/or walls. Liquids, gels, and other foams may also include or be cured to include apertures and fluid pathways. In some embodiments, a manifold may additionally or alternatively include projections that form interconnected fluid pathways. For example, a manifold may be molded to provide surface projections that define interconnected fluid pathways.

In some embodiments, the tissue interface <NUM> may include reticulated foam having pore sizes and free volume that may vary according to needs of a prescribed therapy. For example, reticulated foam having a free volume of at least <NUM>% may be suitable for many therapy applications, and foam having an average pore size in a range of <NUM>-<NUM> microns (<NUM>-<NUM> pores per inch) may be particularly suitable for some types of therapy. The tensile strength of the tissue interface <NUM> may also vary according to needs of a prescribed therapy. For example, the tensile strength of foam may be increased for instillation of topical treatment solutions. The <NUM>% compression load deflection of the tissue interface <NUM> may be at least <NUM> pounds per square inch, (<NUM> PSI = <NUM>,<NUM> Pascals) and the <NUM>% compression load deflection may be at least <NUM> pounds per square inch. In some embodiments, the tensile strength of the tissue interface <NUM> may be at least <NUM> pounds per square inch. The tissue interface <NUM> may have a tear strength of at least <NUM> pounds per inch. In some embodiments, the tissue interface may be foam including of polyols such as polyester or polyether, isocyanate such as toluene diisocyanate, and polymerization modifiers such as amines and tin compounds. In some examples, the tissue interface <NUM> may be reticulated polyurethane foam such as found in GRANUFOAM™ dressing or V. VERAFLO™ dressing, both available from Kinetic Concepts, Inc.

The thickness of the tissue interface <NUM> may also vary according to needs of a prescribed therapy. For example, the thickness of the tissue interface may be decreased to reduce tension on peripheral tissue. The thickness of the tissue interface <NUM> can also affect the conformability of the tissue interface <NUM>. In some embodiments, a thickness in a range of about <NUM> millimeters to <NUM> millimeters may be suitable.

The tissue interface <NUM> may be either hydrophobic or hydrophilic. In an example in which the tissue interface <NUM> may be hydrophilic, the tissue interface <NUM> may also wick fluid away from a tissue site, while continuing to distribute negative pressure to the tissue site. The wicking properties of the tissue interface <NUM> may draw fluid away from a tissue site by capillary flow or other wicking mechanisms. An example of a hydrophilic material that may be suitable is a polyvinyl alcohol, open-cell foam such as V. WHITEFOAM™ dressing available from Kinetic Concepts, Inc. Other hydrophilic foams may include those made from polyether. Other foams that may exhibit hydrophilic characteristics include hydrophobic foams that have been treated or coated to provide hydrophilicity.

In some embodiments, the tissue interface <NUM> may be constructed from bioresorbable materials. Suitable bioresorbable materials may include, without limitation, a polymeric blend of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blend may also include, without limitation, polycarbonates, polyfumarates, and capralactones. The tissue interface <NUM> may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with the tissue interface <NUM> to promote cell-growth. A scaffold is generally a substance or structure used to enhance or promote the growth of cells or formation of tissue, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, or processed allograft materials.

In some embodiments, the cover <NUM> may provide a bacterial barrier and protection from physical trauma. The cover <NUM> may also be constructed from a material that can reduce evaporative losses and provide a fluid seal between two components or two environments, such as between a therapeutic environment and a local external environment. The cover <NUM> may include, for example, an elastomeric film or membrane that can provide a seal adequate to maintain a negative pressure at a tissue site for a given negative-pressure source. The cover <NUM> may have a high moisture-vapor transmission rate (MVTR) in some applications. For example, the MVTR may be at least <NUM> grams per square meter per twenty-four hours in some embodiments, measured using an upright cup technique according to ASTM E96/E96M Upright Cup Method at <NUM> and <NUM>% relative humidity (RH). In some embodiments, an MVTR up to <NUM>,<NUM> grams per square meter per twenty-four hours may provide effective breathability and mechanical properties.

In some example embodiments, the cover <NUM> may be a polymer drape, such as a polyurethane film, that is permeable to water vapor but impermeable to liquid. Such drapes typically have a thickness in the range of <NUM>-<NUM> microns. For permeable materials, the permeability generally should be low enough that a desired negative pressure may be maintained. The cover <NUM> may include, for example, one or more of the following materials: polyurethane (PU), such as hydrophilic polyurethane; cellulosics; hydrophilic polyamides; polyvinyl alcohol; polyvinyl pyrrolidone; hydrophilic acrylics; silicones, such as hydrophilic silicone elastomers; natural rubbers; polyisoprene; styrene butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene vinyl acetate (EVA); co-polyester; and polyether block polymide copolymers. Such materials are commercially available as, for example, Tegaderm® drape, commercially available from <NUM> Company, Minneapolis Minnesota; polyurethane (PU) drape, commercially available from Avery Dennison Corporation, Pasadena, California; polyether block polyamide copolymer (PEBAX), for example, from Arkema S. , Colombes, France; and Inspire <NUM> and Inspire <NUM> polyurethane films, commercially available from Expopack Advanced Coatings, Wrexham, United Kingdom. In some embodiments, the cover <NUM> may include INSPIRE <NUM> having an MVTR (upright cup technique) of <NUM>/m<NUM>/<NUM> hours and a thickness of about <NUM> microns.

An attachment device may be used to attach the cover <NUM> to an attachment surface, such as undamaged epidermis, a gasket, or another cover. The attachment device may take many forms. For example, an attachment device may be a medically-acceptable, pressure-sensitive adhesive configured to bond the cover <NUM> to epidermis around a tissue site. In some embodiments, for example, some or all of the cover <NUM> may be coated with an adhesive, such as an acrylic adhesive, which may have a coating weight of about <NUM>-<NUM> grams per square meter (g. Thicker adhesives, or combinations of adhesives, may be applied in some embodiments to improve the seal and reduce leaks. Other example embodiments of an attachment device may include a double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, or organogel.

In general, exudate and other fluid flow toward lower pressure along a fluid path. Thus, the term "downstream" typically implies a position in a fluid path relatively closer to a source of negative pressure or further away from a source of positive pressure. Conversely, the term "upstream" implies a position relatively further away from a source of negative pressure or closer to a source of positive pressure. Similarly, it may be convenient to describe certain features in terms of fluid "inlet" or "outlet" in such a frame of reference. This orientation is generally presumed, without limitation, for purposes of describing various features and components herein. However, the fluid path may also be reversed in some applications, such as by substituting a positive-pressure source for a negative-pressure source.

Negative pressure applied to the tissue site through the tissue interface <NUM> in the sealed therapeutic environment can induce macro-strain and micro-strain in the tissue site. Negative pressure can also remove exudate and other fluid from a tissue site, which can be collected in container <NUM>.

In some embodiments, the controller <NUM> may receive and process data from one or more sensors, such as the first sensor <NUM>. The controller <NUM> may also control the operation of one or more components of the therapy system <NUM> to manage the pressure delivered to the tissue interface <NUM>. In some embodiments, controller <NUM> may include an input for receiving a desired target pressure and may be programmed for processing data relating to the setting and inputting of the target pressure to be applied to the tissue interface <NUM>. In some example embodiments, the target pressure may be a fixed pressure value set by an operator as the target negative pressure desired for therapy at a tissue site and then provided as input to the controller <NUM>. The target pressure may vary from tissue site to tissue site based on the type of tissue forming a tissue site, the type of injury or wound (if any), the medical condition of the patient, and the preference of the attending physician. After selecting a desired target pressure, the controller <NUM> can operate the negative-pressure source <NUM> in one or more control modes based on the target pressure and may receive feedback from one or more sensors to maintain the target pressure at the tissue interface <NUM>.

In some embodiments, the controller <NUM> may have a continuous pressure mode, in which the negative-pressure source <NUM> is operated to provide a constant target negative pressure for the duration of treatment or until manually deactivated. Additionally or alternatively, the controller may have an intermittent pressure mode. In example embodiments, the controller <NUM> can operate the negative-pressure source <NUM> to cycle between a target pressure and atmospheric pressure. For example, the target pressure may be set at a value of <NUM> mmHg for a specified period of time (e.g., <NUM>), followed by a specified period of time (e.g., <NUM>) of deactivation. The cycle can be repeated by activating the negative-pressure source <NUM>, which can form a square wave pattern between the target pressure and atmospheric pressure.

In some example embodiments, the increase in negative-pressure from ambient pressure to the target pressure may not be instantaneous. For example, the negative-pressure source <NUM> and the dressing <NUM> may have an initial rise time. The initial rise time may vary depending on the type of dressing and therapy equipment being used. For example, the initial rise time for one therapy system may be in a range of about <NUM>-<NUM> mmHg/second and in a range of about <NUM>-<NUM> mmHg/second for another therapy system. If the therapy system <NUM> is operating in an intermittent mode, the repeating rise time may be a value substantially equal to the initial rise time.

In some example dynamic pressure control modes, the target pressure can vary with time. For example, the target pressure may vary in the form of a triangular waveform, varying between a negative pressure of <NUM> and <NUM> mmHg with a rise rate of negative pressure set at a rate of <NUM> mmHg/min. and a descent rate set at <NUM> mmHg/min. In other embodiments of the therapy system <NUM>, the triangular waveform may vary between negative pressure of <NUM> and <NUM> mmHg with a rise rate of about <NUM> mmHg/min. and a descent rate set at about <NUM> mmHg/min.

In some embodiments, the controller <NUM> may control or determine a variable target pressure in a dynamic pressure mode, and the variable target pressure may vary between a maximum and minimum pressure value that may be set as an input prescribed by an operator as the range of desired negative pressure. The variable target pressure may also be processed and controlled by the controller <NUM>, which can vary the target pressure according to a predetermined waveform, such as a triangular waveform, a sine waveform, or a saw-tooth waveform. In some embodiments, the waveform may be set by an operator as the predetermined or time-varying negative pressure desired for therapy.

In some embodiments, the controller <NUM> may receive and process data, such as data related to instillation solution provided to the tissue interface <NUM>. Such data may include the type of instillation solution prescribed by a clinician, the volume of fluid or solution to be instilled to a tissue site ("fill volume"), and the amount of time prescribed for leaving solution at a tissue site ("dwell time") before applying a negative pressure to the tissue site. The fill volume may be, for example, between <NUM> and <NUM>, and the dwell time may be between one second to <NUM> minutes. The controller <NUM> may also control the operation of one or more components of the therapy system <NUM> to instill solution. For example, the controller <NUM> may manage fluid distributed from the solution source <NUM> to the tissue interface <NUM>. In some embodiments, fluid may be instilled to a tissue site by applying a negative pressure from the negative-pressure source <NUM> to reduce the pressure at the tissue site, drawing solution into the tissue interface <NUM>. In some embodiments, solution may be instilled to a tissue site by applying a positive pressure from the positive-pressure source <NUM> to move solution from the solution source <NUM> to the tissue interface <NUM>. Additionally or alternatively, the solution source <NUM> may be elevated to a height sufficient to allow gravity to move solution into the tissue interface <NUM>.

The controller <NUM> may also control the fluid dynamics of instillation by providing a continuous flow of solution or an intermittent flow of solution. Negative pressure may be applied to provide either continuous flow or intermittent flow of solution. The application of negative pressure may be implemented to provide a continuous pressure mode of operation to achieve a continuous flow rate of instillation solution through the tissue interface <NUM>, or it may be implemented to provide a dynamic pressure mode of operation to vary the flow rate of instillation solution through the tissue interface <NUM>. Alternatively, the application of negative pressure may be implemented to provide an intermittent mode of operation to allow instillation solution to dwell at the tissue interface <NUM>. In an intermittent mode, a specific fill volume and dwell time may be provided depending, for example, on the type of tissue site being treated and the type of dressing being utilized. After or during instillation of solution, negative-pressure treatment may be applied. The controller <NUM> may be utilized to select a mode of operation and the duration of the negative pressure treatment before commencing another instillation cycle by instilling more solution.

Some therapy systems may include structures that can interfere with patient comfort and safety. For example, provision of therapy to an area of the patient where force is regularly applied, for example, the dorsal surface of a patient in a supine position, may require special consideration for comfortable and safe application of an appropriate therapy. For some therapy systems, it may be beneficial to increase the surface area of a dressing interface and/or a fluid conductor coupled to the dressing in a plane normal to the force applied to the patient. By increasing the surface area of the dressing interface and/or the fluid conductor, the pressure applied to the patient across an area where the dressing interface and/or the fluid conductor is in direct or indirect contact with the patient may be reduced. However, conventional systems that increase the surface area of a dressing interface are often prohibitively expensive and compromise performance.

These issues and others may be solved by the therapy system <NUM> which provides a pressure-offloading component <NUM>. In some examples, the pressure-offloading component <NUM> may have a height greater than a height of the dressing interface and/or the fluid conductor in a direction parallel with the force applied to the patient, and a surface area greater than the surface area of the dressing interface and/or the fluid conductor in the plane normal to the force applied to the patient. The height of the pressure-offloading component <NUM> may permit the dressing interface and/or fluid conductor to avoid contact with the surface providing the force to the patient. Instead, the force may be provided to the surface area of the pressure-offloading component <NUM> in the plane normal to the force. The surface area of the pressure-offloading component <NUM> reduces the pressure experienced by the patient at any point in direct or indirect contact with the pressure-offloading component <NUM>.

<FIG> is an exploded view of an example pressure-offloading component <NUM> which may be used with the therapy system <NUM> of <FIG>. The pressure-offloading component <NUM> may include a sealing layer, such as film layer <NUM>, a thermoformed layer, such as embossed layer <NUM>, and a cover layer, such as film layer <NUM>. The film layer <NUM> may be substantially sheet-like having a first end <NUM> and a second end <NUM> opposite the first end <NUM>. In some embodiments, the film layer <NUM> may be substantially rectangular having the first end <NUM> and the second end <NUM> comprise a width of the film layer <NUM> and the first end <NUM> and the second end <NUM> being separated by a length of the film layer <NUM>. In some embodiments, the first end <NUM> may be semi-circular or curved. The second end <NUM> may be angular or squared-off. In other embodiments, the first end <NUM> and the second end <NUM> may have a same shape. The first end <NUM> and the second end <NUM> may have other shapes such as ovular, square, or amorphous.

In some embodiments, the film layer <NUM> can include a first surface <NUM> and a second surface <NUM> opposite the first surface <NUM>. In some embodiments, the first surface <NUM> may be configured to be oriented to face a tissue site, and the second surface <NUM> may be configured to be oriented to face away from the tissue site. The first surface <NUM> and the second surface <NUM> may be substantially planar surfaces. In some examples, the first surface <NUM> and the second surface <NUM> may be substantially parallel. In some examples, the film layer <NUM> may have a uniform thickness between the first surface <NUM> and the second surface <NUM>. In some examples, the film layer <NUM> may have a thickness in a range of between about <NUM> micrometers to about <NUM> micrometers.

The film layer <NUM> may include an edge or perimeter, such as a periphery <NUM>. For example, the periphery <NUM> may be defined by an outer perimeter of the first surface <NUM> or the second surface <NUM>. In some examples, the periphery <NUM> may define a substantially rectangular shape having a first, semi-circular or curved end and a second, angular or squared-off end. In some examples, the first end of the periphery <NUM> may be separated from the second end of the periphery <NUM> by a length. In other examples, the first end of the periphery <NUM> and the second end of the periphery <NUM> may have a same shape. The periphery <NUM> may define other shapes, such as an ovular, a square, or an amorphous shape.

In some examples, an opening, such as aperture <NUM>, may be formed through the film layer <NUM> near the first end <NUM>. In some examples, the periphery <NUM> may define the aperture <NUM>. In some examples, the aperture <NUM> may be circular. In other embodiments, the aperture <NUM> have other shapes, such as elliptical, square, triangular, or amorphous shapes. In some examples, as shown in <FIG>, the aperture <NUM> may be concentric with the first end <NUM>. For example, the film layer <NUM> may have a uniform width between the aperture <NUM> and the periphery <NUM> at the first end <NUM>. In other embodiments, the aperture <NUM> may not be concentric with the first end <NUM> or the aperture <NUM> and the first end <NUM> may be differently shaped, causing a width between the aperture <NUM> and the periphery <NUM> at the first end <NUM> to be variable.

The film layer <NUM> may also include a cutaway portion, such as notch <NUM>. In some examples, the periphery <NUM> may define the notch <NUM>. In some examples, as shown in <FIG>, the notch <NUM> may extend from the second end <NUM> of the film layer <NUM> to the aperture <NUM>. In some examples, the notch <NUM> may be a slot, extending into the film layer <NUM> from the second end <NUM> parallel to the length of the film layer <NUM> between the first end <NUM> and the second end <NUM>. In some examples, a portion of the periphery <NUM> may define the aperture <NUM> and the notch <NUM>.

The film layer <NUM> may be formed from a material capable of providing a fluid seal between two components and/or two environments. In some examples, the film layer <NUM> may be formed from any of the materials previously described with respect to cover <NUM>. In some examples, the film layer <NUM> may be a flexible material capable of providing a fluid seal, such as polymer drape. In some examples, the film layer <NUM> may include one or more of the following materials: polyurethane; cellulosics; hydrophilic polyamides; polyvinyl alcohol; polyvinyl pyrrolidone; hydrophilic acrylics; silicones; natural rubbers; polyisoprene; styrene butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene vinyl acetate; co-polyester; and/or polyether block polymide copolymers.

In some examples, the film layer <NUM> may include an attachment device, such as an adhesive. The attachment device can be disposed on some or all of the first surface <NUM>. In some examples, the attachment device of the film layer <NUM> may be any attachment device previously described with respect to the attachment device of the cover <NUM>. For example, the attachment device may be a medically-acceptable, pressure sensitive adhesive, an acrylic adhesive, such as an acrylic adhesive with a coating weight of about <NUM>-<NUM>. , a double-sided tape, a paste, a hydrocolloid, a hydrogel, a silicone gel, or an organogel.

The embossed layer <NUM> may be a substantially sheet-like structure with three-dimensional features suitable for forming a cavity. When assembled, the embossed layer <NUM> and the film layer <NUM> may define a cell. The embossed layer <NUM> may have a first end <NUM> and a second end <NUM> opposite the first end <NUM>. In some examples, outer periphery 224the embossed layer <NUM> may generally define a substantially rectangular shape with the first end <NUM> and the second end <NUM> being separated by a length of the embossed layer <NUM>. In some examples, the first end <NUM> may be substantially semi-circular or substantially curved. In some examples, the second end <NUM> may be substantially angular or squared-off. In some examples, the first end <NUM> and the second end <NUM> may have substantially the same shape. In some examples, the first end <NUM> and/or the second end <NUM> may have other shapes, such as ovular, squared, or amorphous shapes.

The embossed layer <NUM> may also include a planar portion <NUM>. The planar portion <NUM> may include a first surface <NUM> opposite a second surface <NUM>. In some examples, the first surface <NUM> may be configured to be oriented to face the tissue site, and the second surface <NUM> may be configured to face away from the tissue site. The first surface <NUM> and the second surface <NUM> may be substantially planar surfaces. In some examples, the first surface <NUM> and the second surface <NUM> may be substantially parallel. In some examples, the planar portion <NUM> may have a substantially uniform thickness between the first surface <NUM> and the second surface <NUM>. In some examples, the planar portion <NUM> may have a uniform thickness in a range of between about <NUM> micrometers to about <NUM>,<NUM> micrometers. For example, the planar portion <NUM> may have a uniform thickness in a range of about <NUM> micrometers to about <NUM>,<NUM> micrometers. In some examples, the planar portion <NUM> may have a uniform thickness in a range of about <NUM> micrometers to about <NUM>,<NUM> micrometers. In some examples, the planar portion <NUM> may have a uniform thickness in a range of about <NUM> micrometers and about <NUM>,<NUM> micrometers. In some examples, the planar portion <NUM> may have a uniform thickness of about <NUM> micrometers. The planar portion <NUM> may have an outer edge or perimeter, such as an outer periphery <NUM>. The outer periphery <NUM> may define an outline or a shape of the planar portion <NUM>.

The embossed layer <NUM> may include an opening, such as aperture <NUM>, near the first end <NUM>. In some examples, the outer periphery <NUM> of the planar portion <NUM> may define the aperture <NUM>. In some examples, the aperture <NUM> may be circular. In some examples, the aperture <NUM> may have other shapes, such as elliptical, triangular, rectangular, polyhedral, or amorphous shapes. In some examples, as shown in <FIG>, the aperture <NUM> may be concentric with the first end <NUM>. For example, the embossed layer <NUM> may have a uniform width between the aperture <NUM> and the portion of the outer periphery <NUM> at the first end <NUM>. In some examples, the aperture <NUM> may not be concentric with the first end <NUM>. In some examples, the aperture <NUM> may not have a similar shape to the shape of the first end <NUM>. In some examples, the width between the aperture <NUM> and the portion of the outer periphery <NUM> at the first end <NUM> may be variable.

The embossed layer <NUM> may also include a cutaway portion, such as a notch <NUM>. In some examples, the outer periphery <NUM> of the planar portion <NUM> may define the notch <NUM>. In some examples, as shown in <FIG>, the notch <NUM> may extend from the second end <NUM> to the aperture <NUM>. In some examples, the notch <NUM> may be a slot, extending into the embossed layer <NUM> from the second end <NUM> parallel to the length of the embossed layer <NUM>. In some examples, a portion of the outer periphery <NUM> may define the aperture <NUM> and the notch <NUM>.

The planar portion <NUM> may have an inner edge or perimeter, such as an inner periphery <NUM>. In some examples, the planar portion <NUM> may be defined as the material between the first surface <NUM>, the second surface <NUM>, the outer periphery <NUM>, and the inner periphery <NUM>. In some examples, the inner periphery <NUM> may be substantially geometrically similar to the outer periphery <NUM>, and scaled to contain a smaller area. In some examples, the inner periphery <NUM> may be substantially parallel to the outer periphery <NUM>. In some examples, a distance between the inner periphery <NUM> and the outer periphery <NUM> may remain constant. In some examples, the inner periphery <NUM> and the outer periphery <NUM> may define dissimilar or different shapes.

The embossed layer <NUM> may further include a wall or a walled portion <NUM>. The walled portion <NUM> may be a substantially sheet-like structure including a first surface (not shown) opposite a second surface <NUM>. In some examples, the first surface of the walled portion <NUM> may be configured to be oriented to face substantially towards the cavity defined by the embossed layer <NUM>, and the second surface <NUM> of the walled portion <NUM> may be configured to be oriented to face substantially away from the cavity defined by the embossed layer <NUM>. In some examples, the first surface of the walled portion <NUM> may be substantially planar. In some examples, the first surface of the walled portion <NUM> may include substantially flat planar portions and substantially curved planar portions. In some examples, the second surface <NUM> may be substantially planar. In some examples, the second surface <NUM> may include substantially flat planar portions and substantially curved planar portions. In some examples, the first surface of the walled portion <NUM> and the second surface <NUM> of the walled portion <NUM> may be substantially parallel. In some examples, the walled portion <NUM> may have a uniform thickness in a range of between about <NUM> micrometers to about <NUM>,<NUM> micrometers. For example, the walled portion <NUM> may have a uniform thickness in a range of about <NUM> micrometers to about <NUM>,<NUM> micrometers. In some examples, the walled portion <NUM> may have a uniform thickness in a range of about <NUM> micrometers to about <NUM>,<NUM> micrometers. In some examples, the walled portion <NUM> may have a uniform thickness in a range of about <NUM> micrometers and about <NUM>,<NUM> micrometers. In some examples, the walled portion <NUM> may have a uniform thickness of about <NUM> micrometers.

The walled portion <NUM> may include a base at an edge of the first surface and/or the second surface <NUM> proximate to the second surface <NUM> of the planar portion <NUM>. In some examples, the walled portion <NUM> may include a top at the edge of the first surface and/or the second surface <NUM> distal from the second surface <NUM> of the planar portion <NUM>. In some examples, the walled portion <NUM> may be joined to the planar portion <NUM> at the base. The base of the walled portion <NUM> may follow a path defined by the inner periphery <NUM> of the planar portion <NUM>. In some examples, the plane defined by the first surface of the walled portion <NUM> may extend in a direction different from the plane defined by the second surface <NUM> of the planar portion <NUM>. For example, the plane defined by the first surface of the walled portion <NUM> may be substantially orthogonal to the plane defined by the second surface <NUM> of the planar portion <NUM> where the walled portion <NUM> is joined to the planar portion <NUM>. In some examples, the plane defined by the second surface <NUM> of the walled portion <NUM> may extend in a direction different from the plane defined by the second surface <NUM> of the planar portion <NUM>. For example, the plane defined by the second surface <NUM> of the walled portion <NUM> may be substantially orthogonal to the plane defined by the second surface <NUM> of the planar portion <NUM> where the walled portion <NUM> is joined to the planar portion <NUM>.

The embossed layer <NUM> may further include a second planar portion, such as planar portion <NUM>. The planar portion <NUM> may be a substantially sheet-like structure, including a first surface (not shown) opposite a second surface <NUM>. The first surface of the planar portion <NUM> may be configured to be oriented to face the tissue site, and the second surface <NUM> of the planar portion <NUM> may be configured to be oriented to face away from the tissue site. In some examples, the first surface and the second surface <NUM> of the planar portion <NUM> may be substantially planar surfaces. In some examples, the first surface of the planar portion <NUM> may be parallel to the second surface <NUM> of the planar portion <NUM>. In some examples, the planar portion <NUM> may have a uniform thickness between the first surface and the second surface <NUM>. In some examples, the planar portion <NUM> may have a uniform thickness in a range of between about <NUM> micrometers to about <NUM>,<NUM> micrometers. For example, the planar portion <NUM> may have a uniform thickness in a range of about <NUM> micrometers to about <NUM>,<NUM> micrometers. In some examples, the planar portion <NUM> may have a uniform thickness in a range of about <NUM> micrometers to about <NUM>,<NUM> micrometers. In some examples, the planar portion <NUM> may have a uniform thickness in a range of about <NUM> micrometers and about <NUM>,<NUM> micrometers. In some examples, the planar portion <NUM> may have a uniform thickness of about <NUM> micrometers.

The planar portion <NUM> may include an edge or perimeter, such as a periphery <NUM>. In some examples, the periphery <NUM> may be defined by an outer perimeter of the first surface or the second surface <NUM> of the planar portion <NUM>. In some examples, the periphery <NUM> of the planar portion <NUM> may be joined to the walled portion <NUM> at the top of the walled portion <NUM>. In some examples, the plane defined by the first surface of the planar portion <NUM> may be substantially parallel to the plane defined by the second surface <NUM> of the planar portion <NUM>. In some examples, the plane defined by the second surface <NUM> of the planar portion <NUM> may be substantially parallel to the plane defined by the second surface <NUM> of the planar portion <NUM>. In some examples, the embossed layer <NUM> may define a cavity or a partially enclosed space between the first surface of the walled portion <NUM> and the first surface of the planar portion <NUM>.

In some examples, the outer periphery <NUM> of the planar portion <NUM> may be substantially geometrically similar to the periphery <NUM> of the film layer <NUM>. In some examples, the outer periphery <NUM> of the planar portion <NUM> may be substantially parallel to the periphery <NUM> of the film layer <NUM>. In some examples, the outer periphery <NUM> may be substantially coextensive with the periphery <NUM> of the film layer <NUM>.

In some examples, a cross-section of the first surface and/or the second surface <NUM> of the walled portion <NUM> taken in a plane parallel to the second surface <NUM> of the planar portion <NUM> may be substantially geometrically similar to the path defined by the inner periphery <NUM> of the planar portion <NUM>. In some examples, a cross-section of the first surface and/or the second surface <NUM> of the walled portion <NUM> taken in a plane parallel to the second surface <NUM> of the planar portion <NUM> may be substantially parallel to the path defined by the inner periphery <NUM> of the planar portion <NUM>. In some examples, a cross-section of the second surface <NUM> of the walled portion <NUM> taken in a plane parallel to the second surface <NUM> of the planar portion <NUM> may be substantially coextensive with the path defined by the inner periphery <NUM> of the planar portion <NUM>. In some examples, the cross-section of the first surface/and or the second surface <NUM> of the walled portion <NUM> taken in a plane parallel to the second surface <NUM> of the planar portion <NUM> may define an aperture and a notch substantially geometrically similar to the aperture <NUM> and the notch <NUM> formed through the planar portion <NUM>. In some examples, the cross-section of the first surface/and or the second surface <NUM> of the walled portion <NUM> taken in a plane parallel to the second surface <NUM> of the planar portion <NUM> may define an aperture and a notch substantially parallel to the aperture <NUM> and the notch <NUM> formed through the planar portion <NUM>.

In some examples, the embossed layer <NUM> may include an attachment device, such as an adhesive. The attachment device may be disposed on some or all of the first surface <NUM> of the planar portion <NUM>. In some examples, the attachment device of the embossed layer <NUM> may be any attachment device previously described with respect to the attachment devices of the cover <NUM> and/or the film layer <NUM>. For example, the attachment device may be a medically-acceptable, pressure sensitive adhesive, an acrylic adhesive, such as an acrylic adhesive with a coating weight of about <NUM>-<NUM>. , a double-sided tape, a paste, a hydrocolloid, a hydrogel, a silicone gel, or an organogel.

In some examples, the embossed layer <NUM> may be formed from any of the materials previously described with respect to cover <NUM>. In some examples, the embossed layer <NUM> may be formed from a non-porous polymeric film which may include any flexible material that can be manipulated to form a defined shape which may enclose a space, including thermoplastics. Non-limiting examples of suitable thermoplastics include polyethylene homopolymers (such as low-density polyethylene (LDPE) or high-density polyethylene (HDPE)) and/or polyethylene copolymers (such as ionomers, EVA, EMA, heterogeneous (Zeigler-Natta catalyzed) ethylene/alpha-olefin copolymers, and homogenous (metallocene, single-site catalyzed) ethylene/alpha olefin copolymers). Ethylene/alphaolefin copolymers are copolymers are copolymers of ethylene with one or more comonomers selected from C<NUM> to C<NUM> alpha-olefins, such as <NUM>-butene, <NUM>-pentene, <NUM>-hexene, <NUM>-octene, methyl pentene in which the polymer molecules include long chains with relatively few side chain branches. Examples of suitable ethyle/alpha-olefin copolymers include linear low-density polyethylene (LLDPE), linear medium-density polyethylene (LMDPE), very-low-density polyethylene (VLDPE), and ultra-low-density polyethylene (ULDPE). In some examples, the embossed layer <NUM> may be formed from or include polypropylene homopolymers, polypropylene copolymers, polyesters, polystyrenes, polyamides, and polycarbonates. In some examples, the embossed layer <NUM> may be formed from an HDPE material with an ultimate tensile strength of about <NUM> MPa and a yield strength in a range of about <NUM>-<NUM> MPa. In some examples, the embossed layer <NUM> may be formed from a thermoplastic polyurethane film, such PLATILON® thermoplastic films available from Convestro AG. For example, a thermoplastic polyurethane film having an ultimate tensile strength of about <NUM> MPa and a yield strength of greater than about <NUM> MPa may be used.

The film layer <NUM> may be substantially sheet-like having a first end <NUM> opposite a second end <NUM>. In some examples, the film layer <NUM> may be substantially rectangular having the first end <NUM> and the second end <NUM> define a width of the film layer <NUM>. In some examples, the first end <NUM> and the second end <NUM> may be separated by a length of the film layer <NUM>. In some examples, the first end <NUM> may be semi-circular or curved. The second end <NUM> may be angular or squared-off. In other embodiments, the first end <NUM> and the second end <NUM> may have a same shape. The first end <NUM> and the second end <NUM> may have other shapes, such as ovular, square, or amorphous.

In some examples, the film layer <NUM> can include a first surface <NUM> opposite a second surface <NUM>. In some examples, the first surface <NUM> may be configured to be oriented to face a tissue site, and the second surface <NUM> may be configured to be oriented to face away from a tissue site. The first surface <NUM> and the second surface <NUM> may be substantially planar surfaces. In some examples, the first surface <NUM> and the second surface <NUM> may be substantially parallel. In some examples, the film layer <NUM> may have a uniform thickness between the first surface <NUM> and the second surface <NUM>. In some examples, the film layer <NUM> may have a thickness in a range of between about <NUM> micrometers to about <NUM> micrometers.

The film layer <NUM> may include an outer edge or perimeter, such as periphery <NUM>. For example, the periphery <NUM> may be defined by an outer perimeter of the first surface <NUM> or the second surface <NUM>. In some examples, the periphery <NUM> may define a substantially rectangular shape having a first, semi-circular or curved end and a second, angular or squared-off end. In some examples, the first end of the periphery <NUM> may be separated from the second end of the periphery <NUM> by a length. In other examples, the first end of the periphery <NUM> and the second end of the periphery <NUM> may have a same shape. The periphery <NUM> may define other shapes, such as an ovular, square, or amorphous shape.

In some examples, an opening, such as aperture <NUM>, may be formed through the film layer <NUM> near the first end <NUM>. In some examples, the periphery <NUM> may define the aperture <NUM>. In some examples, the aperture <NUM> may be circular. In other embodiments, the aperture <NUM> may have other shapes, such as elliptical, square, triangular, or amorphous shapes. In some examples, as shown in <FIG>, the aperture <NUM> may be concentric with the first end <NUM>. For example, the film layer <NUM> may have a uniform width between the aperture <NUM> and the periphery <NUM> at the first end <NUM>. In some examples, the aperture <NUM> may not be concentric with the first end <NUM> or the aperture <NUM> and the first end <NUM> may be differently shaped, causing a width between the aperture <NUM> and the periphery <NUM> at the first end <NUM> to be variable.

The film layer <NUM> may also include a cutaway portion, such as notch <NUM>. In some examples, the periphery <NUM> may define the notch <NUM>. In some examples, as shown in <FIG>, the notch <NUM> may extend from the second end <NUM> of the film layer <NUM> to the aperture <NUM>. In some examples, the notch <NUM> may be a slot, extending into the film layer <NUM> from the second end <NUM> parallel to the length of the film layer <NUM> between the first end <NUM> and the second end <NUM>. In some examples, a portion of the periphery <NUM> may define the aperture <NUM> and the notch <NUM>. In some examples, the film layer <NUM> may include an interior edge or inner perimeter, such as periphery <NUM>. For example, as shown in <FIG>, the periphery <NUM> may define an opening in the film layer <NUM>, such as aperture <NUM>.

In some examples, the periphery <NUM> may be substantially geometrically similar to the outer periphery <NUM> of the embossed layer <NUM> and/or the periphery <NUM> of the film layer <NUM>. In some examples, the periphery <NUM> may be substantially parallel to the outer periphery <NUM> of the embossed layer <NUM> and/or the periphery <NUM> of the film layer <NUM>. In some examples, the periphery <NUM> may extend past the outer periphery <NUM> of the embossed layer <NUM> and/or the periphery <NUM> of the film layer <NUM>. In some examples, the outline of the aperture <NUM> defined by the periphery <NUM> may be substantially geometrically similar to the outline of the inner periphery <NUM>. In some examples, the outline of the aperture <NUM> defined by the periphery <NUM> may be substantially parallel to the outline of the inner periphery <NUM>. In some examples, the outline of the aperture <NUM> defined by the periphery <NUM> may be substantially coextensive with the outline of the inner periphery <NUM>. In some examples, the periphery <NUM> may be substantially geometrically similar to the path defined by a cross-section of the second surface <NUM> of the walled portion <NUM> of the embossed layer <NUM> taken in a plane substantially orthogonal to the second surface <NUM>. In some examples, the periphery <NUM> may be substantially parallel to the path defined by a cross-section of the second surface <NUM> in a plane substantially orthogonal to the second surface <NUM>. In some examples, the periphery <NUM> may be substantially coextensive with the path defined by a cross section of the second surface in a plane substantially orthogonal to the second surface <NUM>. In some examples, the periphery <NUM> may be substantially geometrically similar to the path defined by a cross-section of the second surface <NUM> taken in a plane substantially parallel to the plane defined by the second surface <NUM> of the planar portion <NUM> of the embossed layer <NUM>. In some examples, the periphery <NUM> may be substantially parallel to the path defined by a cross-section of the second surface <NUM> taken in a plane substantially parallel to the plane defined by the second surface <NUM>. In some examples, the periphery <NUM> may be substantially coextensive with the path defined by a cross-section of the second surface <NUM> taken in a plane substantially parallel to the plane defined by the second surface <NUM>.

In some examples, the film layer <NUM> may be formed from a material capable of providing a fluid seal between two components and/or two environments. For example, the film layer <NUM> may be formed from any of the materials previously described with respect to cover <NUM> or film layer <NUM>. In some examples, the film layer <NUM> may be a flexible material capable of providing a fluid seal, such as a polymer drape. In some examples, the film layer <NUM> may include one or more of the following materials: polyurethane; cellulosics; hydrophilic polyamides; polyvinyl alcohol; polyvinyl pyrrolidone; hydrophilic acrylics; silicones; natural rubbers; polyisoprene; styrene butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene vinyl acetate; co-polyester; and/or polyether block polyamide copolymers.

In some examples, the film layer <NUM> may include an attachment device, such as an adhesive. The attachment device can be disposed on some or all of the first surface <NUM>. In some examples, the attachment device of the film layer <NUM> may be any attachment previously described with respect to the attachment device of the cover <NUM> or the attachment device of the film layer <NUM>. For example, the attachment device may be a medically-acceptable, pressure sensitive adhesive, an acrylic adhesive, such as an acrylic adhesive with a coating weight of about <NUM>-<NUM>. , a double-sided tape, a paste, a hydrocolloid, a hydrogel, a silicone gel, or an organogel.

The pressure-offloading component <NUM> may also include one or more securing tabs <NUM>. In some examples, the securing tabs <NUM> may be elongated strips formed from any of the materials previously described with respect to the cover <NUM>. In some examples, the securing tabs <NUM> may have an attachment device, such as an adhesive, disposed on some or all of a surface of the securing tab <NUM>, such as the surface of the securing tab <NUM> configured to face the second surface <NUM> of the planar portion <NUM> of the embossed layer <NUM>.

The pressure-offloading component <NUM> may further include one or more release liners, such as release liner <NUM>, release liner <NUM>, and/or release liner <NUM>. In some examples, the release liner <NUM>, the release liner <NUM>, and/or the release liner <NUM> may protect any or all of the adhesives disposed on the first surface <NUM>, the first surface <NUM>, and/or the first surface <NUM> prior to the application of the pressure-offloading component <NUM>. The release liner <NUM>, the release liner <NUM>, and/or the release liner <NUM> may also provide stiffness to assist with the deployment of the pressure-offloading component <NUM>. In some examples, the release liner <NUM>, the release liner <NUM>, and/or the release liner <NUM> may be a casting paper or a film, such as a polyethylene film. In some examples, the release liner <NUM>, the release liner <NUM>, and/or the release liner <NUM> may be formed from a polyester material, such as polyethylene terephthalate (PET), or a similar polar semi-crystalline polymer. The use of a polar semi-crystalline polymer for the release liner <NUM>, the release liner <NUM>, and/or the release liner <NUM> may substantially prevent the wrinkling or other deformation of the pressure-offloading component <NUM>. For example, the polar semi-crystalline polymer may be highly orientated and resistant to softening, swelling, or other deformation that may occur when brought into contact with the components of the pressure-offloading component <NUM>, or when subjected to temperature of environmental variations, or sterilization. In some examples, a release agent may be disposed on a side of the release liner <NUM>, the release liner <NUM>, and/or the release liner <NUM> configured to face any or all of the adhesives disposed on the first surface <NUM>, the first surface <NUM>, and/or the first surface <NUM>. In some examples, the release agent may be a silicone coating and may have a release factor suitable to facilitate the removal of the release liner <NUM>, the release liner <NUM>, and/or the release liner <NUM> by hand without damaging or deforming the pressure-offloading component <NUM>. In some examples, the release agent may be a fluorocarbon or a fluorosilicone. In some examples, the release liner <NUM>, the release liner <NUM>, and/or the release liner <NUM> may be uncoated or otherwise used without a release agent.

In some examples, as shown in <FIG>, the release liner <NUM> may include a contact portion <NUM> configured to contact any or all of the adhesives disposed on the first surface <NUM>, the first surface <NUM>, and/or the first surface <NUM>, a first handling portion <NUM> configured to extend away from the pressure-offloading component <NUM>, and/or a second handling portion <NUM> configured to extend away from the pressure-offloading component <NUM>. In some examples, the release liner <NUM> may include a contact portion <NUM> configured to contact any or all of the adhesives disposed on the first surface <NUM>, the first surface <NUM>, and/or the first surface <NUM>, and a handling portion <NUM> configured to extend away from the pressure-offloading component <NUM>. In some examples, the release liner <NUM> may include a contact portion <NUM> configured to contact any or all of the adhesives disposed on the first surface <NUM>, the first surface <NUM>, and/or the first surface <NUM>, and a handling portion <NUM> configured to extend away from the pressure-offloading component <NUM>.

<FIG> is an isometric view of an assembled example of the pressure-offloading component <NUM> of <FIG>. As shown in the example of <FIG>, the components may be assembled in a stacked relationship. The embossed layer <NUM> may be disposed over the film layer <NUM>. In some examples, at least a portion of the first surface <NUM> (not shown) of the planar portion <NUM> (not shown) of the embossed layer <NUM> may be coupled, such as by an adhesive or by welding, to at least a portion of the second surface <NUM> (not shown) of the film layer <NUM>. The film layer <NUM> may be disposed over the embossed layer <NUM> and the film layer <NUM>. In some examples, at least a portion of the first surface <NUM> (not shown) of the film layer <NUM> may be coupled, such as by an adhesive or by welding, to at least a portion of the second surface <NUM> (not shown) of the planar portion <NUM> and/or to at least a portion of the second surface <NUM>. In some examples, as shown in <FIG>, the walled portion <NUM> of the embossed layer <NUM> may be received through the aperture <NUM> defined by the inner periphery <NUM> of the film layer <NUM>.

In some examples, the outer periphery <NUM> of the planar portion <NUM> of the embossed layer <NUM> may bound an area smaller than an area bound by the periphery <NUM> of the of the film layer <NUM>. In some examples, the outer periphery <NUM> may be contained within the periphery <NUM>. In some examples, the outer periphery <NUM> may bound an area larger than the periphery <NUM>, and the periphery <NUM> may be contained within the outer periphery <NUM>. In some examples, the outer periphery <NUM> may be substantially coextensive with the periphery <NUM>. In some examples, the periphery <NUM> may be substantially coextensive with the inner inner periphery <NUM> of the planar portion <NUM> forming the base of the walled portion <NUM>. In some examples, at least a portion of the periphery <NUM> of the film layer <NUM> may be substantially similar to, parallel to, or coextensive with at least a portion of with the periphery <NUM> of the film layer <NUM> such that the notch <NUM> of the film layer <NUM> may be substantially aligned or coextensive with the notch <NUM> of the embossed layer <NUM> and/or the notch <NUM> of the film layer <NUM>. In some examples, the aperture <NUM> of the film layer <NUM> may be substantially aligned or coextensive with the aperture <NUM> of the embossed layer <NUM> and/or the aperture <NUM> of the film layer <NUM>.

In some examples, a portion of the profile of the second surface <NUM> of the walled portion <NUM> may define an annular region <NUM>. In some examples, a portion of the second surface of the walled portion <NUM> taken in a plane parallel to the second surface <NUM> of the film layer <NUM>, the first surface <NUM>, the second surface <NUM>, and/or the first surface <NUM> (not shown) may define an annular region <NUM> substantially geometrically similar to the path define by the aperture <NUM> and/or the aperture <NUM>. In some examples, a portion of the profile of the second surface <NUM> taken in a plane parallel to the second surface <NUM>, the first surface <NUM>, the second surface <NUM>, and/or the first surface <NUM> may define an annular region <NUM> substantially parallel to the path defined by the aperture <NUM> and/or the aperture <NUM>.

In some examples, a portion of the profile of the second surface <NUM> may define a slotted region <NUM>. In some examples, a portion of the profile of the second surface <NUM> taken in a plane parallel to the second surface <NUM>, the first surface <NUM>, the second surface <NUM>, and/or the first surface <NUM> may define a slotted region <NUM> substantially geometrically similar to the path defined by the notch <NUM> and/or the notch <NUM>. In some examples, a portion of the profile of the second surface <NUM> taken in a plane parallel to the second surface <NUM>, the first surface <NUM>, the second surface <NUM>, and/or the first surface <NUM> may define a slotted region <NUM> substantially parallel to the path defined by the notch <NUM> and/or the notch <NUM>.

As shown in the example of <FIG>, the one or more securing tabs <NUM> may be coupled, such as by adhesive, to at least a portion of the second surface <NUM> of the planar portion <NUM> of the embossed layer <NUM>. In some examples, the one or more securing tabs <NUM> may form a bridge over at least a portion of the slotted region <NUM> and/or the annular region <NUM>.

<FIG> is a cross-sectional view of an example pressure-offloading component <NUM> of <FIG>, taken at line <NUM>-<NUM>, illustrating additional details associated with some embodiments. In some examples, the film layer <NUM> may be coupled to the embossed layer <NUM> near the periphery <NUM> of the film layer <NUM> to define a cavity or cell, such as interior space <NUM>, between the film layer <NUM> and the embossed layer <NUM>. In some examples, the film layer <NUM> and the embossed layer <NUM> may form a fluid seal between the layers, substantially fluidly isolating the interior space <NUM> from the external environment. In some examples, the interior space <NUM> may be defined as the space enclosed by the second surface <NUM> of the film layer <NUM>, the first surface <NUM> of the walled portion <NUM> of the embossed layer <NUM>, and the first surface <NUM> of the planar portion <NUM> of the embossed layer <NUM>. In some examples, the interior space <NUM> may be filled with a gas, such as air from the atmosphere, or an inert gas, such as nitrogen or argon. In some examples, the interior space <NUM> may be filled with a liquid, such as water or a saline solution.

<FIG> is a cross-sectional view, illustrating additional details that may be associated with some embodiments of the pressure-offloading component <NUM> shown in <FIG>. In some examples, the interior space <NUM> may be filled with a material suitable for distributing the weight of a patient, such as a foam or gel material.

<FIG> is an exploded view of an example embodiment of the pressure-offloading component <NUM> of <FIG> which further includes an additional thermoformed layer. As shown in <FIG>, some examples of the pressure-offloading component <NUM> may include a second thermoformed layer suitable for forming a cavity or cell, such as embossed layer <NUM>. The embossed layer <NUM> may be a substantially sheet-like structure with three dimensional features suitable for forming a cavity or a plurality of cavities. When assembled, the embossed layer <NUM> and the film layer <NUM> may define a cell or a plurality of cells. In some examples, the embossed layer <NUM> may have a first end <NUM> opposite a second end <NUM>. In some examples, the embossed layer <NUM> may generally define a substantially rectangular shape with the first end <NUM> and the second end <NUM> being separated by a length of the embossed layer <NUM>. In some examples, the first end <NUM> may be substantially semi-circular or substantially curved. In some examples, the second end <NUM> may be substantially angular or squared-off. In some examples, the first end <NUM> and the second end <NUM> may have substantially the same shape. In some examples, the first end <NUM> and/or the second end <NUM> may have other shapes, such as ovular, squared, or amorphous shapes.

The embossed layer <NUM> may have a planar portion <NUM>. The planar portion <NUM> may include a first surface <NUM> opposite a second surface <NUM>. In some examples, the first surface <NUM> may be configured to be oriented to face the tissue site, and the second surface <NUM> may be configured to face away from the tissue site. The first surface <NUM> and the second surface <NUM> may be substantially planar surfaces. In some examples, the first surface <NUM> and the second surface <NUM> may be substantially parallel. In some examples, the planar portion <NUM> may have a substantially uniform thickness between the first surface <NUM> and the second surface <NUM>. In some examples, the planar portion <NUM> may have a uniform thickness in a range of between about <NUM> micrometers to about <NUM>,<NUM> micrometers. For example, the planar portion <NUM> may have a uniform thickness in a range of about <NUM> micrometers to about <NUM>,<NUM> micrometers. In some examples, the planar portion <NUM> may have a uniform thickness in a range of about <NUM> micrometers to about <NUM>,<NUM> micrometers. In some examples, the planar portion <NUM> may have a uniform thickness in a range of about <NUM> micrometers and about <NUM>,<NUM> micrometers. In some examples, the planar portion <NUM> may have a uniform thickness of about <NUM> micrometers. The planar portion <NUM> may have an outer edge or perimeter, such as a periphery <NUM>. The periphery <NUM> may define an outline or a shape of the planar portion <NUM>.

The embossed layer <NUM> may include an opening, such as aperture <NUM> formed near the first end <NUM>. In some examples, the periphery <NUM> may define the aperture <NUM>. In some examples, the aperture <NUM> may be circular. In some examples, the aperture <NUM> may have other shapes, such as elliptical, triangular, rectangular, polyhedral, or amorphous shapes. In some examples, as shown in <FIG>, the aperture <NUM> may be concentric with the first end <NUM>. For example, the embossed layer <NUM> may have a uniform width between the aperture <NUM> and the portion of the periphery <NUM> defining the first end <NUM>. In some examples, the aperture <NUM> may not be concentric with the first end <NUM>. In some examples, the aperture <NUM> may not have a similar shape to the shape of the first end <NUM>. In some examples, the width between the aperture <NUM> and the portion of the periphery <NUM> defining the first end <NUM> may be variable.

The embossed layer <NUM> may also include a cutaway portion, such as a notch <NUM>. In some examples, the periphery <NUM> may define the notch <NUM>. In some examples, as shown in <FIG>, the notch <NUM> may extend from the second end <NUM> of the planar portion <NUM> to the aperture <NUM>. In some examples, the notch <NUM> may be a slot, extending into the planar portion <NUM> from the second end <NUM> parallel to the length of the planar portion <NUM>. In some examples, a portion of the periphery <NUM> may define the aperture <NUM> and the notch <NUM>.

The embossed layer <NUM> may further include a first plurality of standoffs formed in the embossed layer <NUM>, such as a plurality of standoffs <NUM>. In some examples, the embossed layer <NUM> may also include a second plurality of standoffs, such as a plurality of standoffs <NUM>. In some examples, as shown in <FIG>, each standoff of the plurality of standoffs <NUM> may include a base portion connected to the planar portion <NUM>, and a center portion connecting the base portion to an end portion. In some examples, the base portion of each standoff of the plurality of standoffs <NUM> may have a substantially spherical segment shape. In some examples, the center portion of each standoff of the plurality of standoffs <NUM> may be substantially cylindrical in shape. In some examples, the end portion of each standoff of the plurality of standoffs <NUM> may have a substantially spherical segment shape or a hemispherical shape. In some examples, each standoff of the plurality of standoffs <NUM> may have a substantially hemispherical, spherical segment, cylindrical, cuboidal, polyhedral or amorphous shape. In some examples, each standoff of the plurality of standoffs <NUM> may be hollow, and have a same thickness as the thickness of the embossed layer <NUM>. In some examples, each standoff of the plurality of standoffs <NUM> may be hollow and define a cavity or cell formed in the first surface <NUM> of the planar portion <NUM>. In some examples, each standoff of the plurality of standoffs <NUM> may be substantially filled such that the first surface <NUM> of the planar portion <NUM> remains a substantially planar surface without cavities or cells.

In some examples, as shown in <FIG>, each standoff of the plurality of standoffs <NUM> may include a base portion connected to the planar portion <NUM>, and a center portion connecting the base portion to an end portion. In some examples, the base portion of each standoff of the plurality of standoffs <NUM> may have a substantially spherical segment shape. In some examples, the center portion of each standoff of the plurality of standoffs <NUM> may be substantially cylindrical in shape. In some examples, the end portion of each standoff of the plurality of standoffs <NUM> may have a substantially spherical segment shape or a hemispherical shape. In some examples, each standoff of the plurality of standoffs <NUM> may have a substantially hemispherical, spherical segment, cylindrical, cuboidal, polyhedral or amorphous shape. In some examples, each standoff of the plurality of standoffs <NUM> may be hollow, and have a same thickness as the thickness of the embossed layer <NUM>. In some examples, each standoff of the plurality of standoffs <NUM> may be hollow and define a cavity or cell formed in the first surface <NUM> of the planar portion <NUM>. In some examples, each standoff of the plurality of standoffs <NUM> may be substantially filled such that the first surface <NUM> of the planar portion <NUM> remains a substantially planar surface without cavities or cells.

In some examples, the plurality of standoffs <NUM> may be arranged in a pattern near the first end <NUM> of the planar portion <NUM>. In some examples, the plurality of standoffs <NUM> may be arranged in a pattern of substantially annular rows. In some examples, the plurality of standoffs <NUM> may be arranged in a pattern of substantially concentric substantially annular rows. In some examples, each row of the plurality of standoffs <NUM> may be substantially concentric with the aperture <NUM>. In some examples, each row of the standoffs <NUM> may be substantially concentric with a portion of the periphery <NUM> defining the curved portion of the first end <NUM>. In some examples, the plurality of standoffs <NUM> may be arranged in a pattern near the second end <NUM> of the planar portion <NUM>. In some examples, the plurality of standoffs <NUM> may be arranged in a pattern of rows. In some examples, the plurality of standoffs <NUM> may be arranged in a pattern of rows, wherein each row substantially extends along a length of the notch <NUM>. In some examples, the plurality of standoffs <NUM> may be arranged in a pattern of substantially parallel rows. In some examples, each row of the plurality of standoffs <NUM> may be substantially parallel with each other row. In some examples, each row of the plurality of standoffs <NUM> may be substantially parallel with an edge of the notch <NUM>. In some examples, each standoff of the plurality of standoffs <NUM> may be substantially smaller than each standoff of the plurality of standoffs <NUM>. In some examples, each standoff of the plurality of standoffs <NUM> may be the substantially the same size as each standoff of the plurality of standoffs <NUM>.

In some examples, the periphery <NUM> may be substantially geometrically similar to the periphery <NUM> of the film layer <NUM> and/or the outer periphery <NUM> of the planar portion <NUM> of the embossed layer <NUM>. In some examples, the periphery <NUM> may be substantially parallel to the periphery to the periphery <NUM> and/or the outer periphery <NUM>. In some examples, the periphery <NUM> may be substantially coextensive with one or both of the periphery <NUM> and/or the outer periphery <NUM>.

In some examples, the embossed layer <NUM> may be formed from any of the materials previously described with respect to the embossed layer <NUM>. In some examples, the embossed layer <NUM> may be formed from a non-porous polymeric film which may include any flexible material that can be manipulated to form a defined shape which may enclose a space, including thermoplastics. Non-limiting examples of suitable thermoplastics include polyethylene homopolymers (such as low-density polyethylene (LDPE) or high-density polyethylene (HDPE)) and/or polyethylene copolymers (such as ionomers, EVA, EMA, heterogeneous (Zeigler-Natta catalyzed) ethylene/alpha-olefin copolymers, and homogenous (metallocene, single-site catalyzed) ethylene/alpha olefin copolymers). Ethylene/alphaolefin copolymers are copolymers are copolymers of ethylene with one or more comonomers selected from C<NUM> to C<NUM> alpha-olefins, such as <NUM>-butene, <NUM>-pentene, <NUM>-hexene, <NUM>-octene, methyl pentene in which the polymer molecules include long chains with relatively few side chain branches. Examples of suitable ethyle/alpha-olefin copolymers include linear low-density polyethylene (LLDPE), linear medium-density polyethylene (LMDPE), very-low-density polyethylene (VLDPE), and ultra-low-density polyethylene (ULDPE). In some examples, the embossed layer <NUM> may be formed from or include polypropylene homopolymers, polypropylene copolymers, polyesters, polystyrenes, polyamides, and polycarbonates. In some examples, the embossed layer <NUM> may be formed from an HDPE material with an ultimate tensile strength of about <NUM> MPa and a yield strength in a range of about <NUM>-<NUM> MPa. In some examples, the embossed layer <NUM> may be formed from a thermoplastic polyurethane film, such PLATILON® thermoplastic films available from Convestro AG. For example, a thermoplastic polyurethane film having an ultimate tensile strength of about <NUM> MPa and a yield strength of greater than about <NUM> MPa may be used.

<FIG> is an isometric cutaway view of an assembled example of the pressure-offloading component <NUM> of <FIG> with a portion of the embossed layer <NUM> removed to show a portion of the embossed layer <NUM>. As shown in the example of <FIG>, the components may be assembled in a stacked relationship. The embossed layer <NUM> may be disposed over the film layer <NUM>. In some examples, at least a portion of the first surface <NUM> of the planar portion <NUM> of the embossed layer <NUM> may be coupled, such as by an adhesive or welding, to at least a portion of the second surface <NUM> (not shown) of the film layer <NUM>. The embossed layer <NUM> may be disposed over the embossed layer <NUM> and the film layer <NUM>. In some examples, at least a portion of the first surface <NUM> (not shown) of the planar portion <NUM> (not shown) of the embossed layer <NUM> may be coupled, such as by an adhesive or by welding, to at least a portion of the second surface <NUM> of the planar portion <NUM> of the embossed layer <NUM> and/or the second surface <NUM>. The film layer <NUM> may be disposed over the embossed layer <NUM>, the embossed layer <NUM>, and the film layer <NUM>. In some examples, at least a portion of the first surface <NUM> (not shown) of the film layer <NUM> may be coupled, such as by an adhesive or by welding, to at least a portion of the second surface <NUM> (not shown) of the planar portion <NUM>, to at least a portion of the second surface <NUM>, and/or to at least a portion of the second surface <NUM>.

In some examples, the periphery <NUM> (not shown) of the planar portion <NUM> of the embossed layer <NUM> may bound an area smaller than an area bound by the periphery <NUM> of the film layer <NUM>. In some examples, the periphery <NUM> may be contained within the periphery <NUM>. In some examples, the periphery <NUM> may bound an area larger than the periphery <NUM>, and the periphery <NUM> may be contained within the periphery <NUM>. In some examples, the periphery <NUM> may be substantially coextensive with the periphery <NUM>. In some examples, the outer periphery <NUM> (not shown) of the planar portion <NUM> may bound an area smaller than an area bound by the periphery <NUM>. In some examples, the outer periphery <NUM> may be substantially coextensive with the periphery <NUM>. In some example, the outer periphery <NUM> may bound an area larger than an area bound by the periphery <NUM>.

In some examples, as shown in <FIG>, at least a portion of the periphery <NUM> may be substantially similar to, parallel to, or coextensive with at least a portion of the periphery <NUM>, outer periphery <NUM>, and/or periphery <NUM> such that the notch <NUM> of the embossed layer <NUM> may be substantially aligned or coextensive with the notch <NUM> of the film layer <NUM>, the notch <NUM> of the embossed layer <NUM>, and/or the notch <NUM> of the film layer <NUM>. In some examples, the aperture <NUM> of the embossed layer <NUM> may be substantially aligned or coextensive with the aperture <NUM> of the film layer <NUM>, the aperture <NUM> of the embossed layer <NUM>, and/or the aperture <NUM> of the film layer <NUM>.

<FIG> is a cross-sectional view of an example pressure-offloading component <NUM> of <FIG>, taken at line <NUM>-<NUM>, illustrating additional details associated with some embodiments. In some examples, the film layer <NUM> may be coupled to the embossed layer <NUM> near the periphery <NUM> of the film layer <NUM> to define one or more cavities or cells, such as interior spaces <NUM>, between the film layer <NUM> and the embossed layer <NUM>. In some examples, the film layer <NUM> and the embossed layer <NUM> may form a fluid seal between the layers, substantially isolating the interior spaces <NUM> from the external environment. In some examples, the interior spaces <NUM> may be defined as the spaces enclosed by the second surface <NUM> of the film layer <NUM> and the interior surfaces <NUM> of the first plurality of standoffs <NUM> and/or the interior surfaces of the second plurality of standoffs <NUM> (not shown). In some examples, the embossed layer <NUM> may be coupled to the embossed layer <NUM> near the outer periphery <NUM> of the embossed layer <NUM> to define a cavity or cell, such as interior space <NUM> between the embossed layer <NUM> and the embossed layer <NUM>. In some examples, the embossed layer <NUM> and the embossed layer <NUM> may form a fluid seal between the layers, substantially isolating the interior space <NUM> from the external environment. In some examples, the interior space <NUM> may be defined as the space enclosed by a portion of the second surface <NUM> of the planar portion <NUM> of the embossed layer <NUM>, the exterior surfaces <NUM> of the first plurality of standoffs <NUM> and/or the exterior surfaces of the second plurality of standoffs <NUM> (not shown), the first surface <NUM> of the walled portion <NUM> of the embossed layer <NUM>, and the first surface <NUM> of the planar portion <NUM> of the embossed layer <NUM>. In some examples, the interior spaces <NUM> may be filled with a gas, such as air from the atmosphere, or an inert gas, such as nitrogen or argon. In some examples, the interior spaces <NUM> may be filled with a liquid, such as water or a saline solution. In some examples, the interior space <NUM> may be filled with a gas, such as air from the atmosphere, or an inert gas, such as nitrogen or argon. In some examples, the interior space <NUM> may be filled with a liquid, such as water or a saline solution.

<FIG> is a cross-sectional view, illustrating additional details that may be associated with some embodiments of the pressure-offloading component <NUM> shown in <FIG>. As shown in <FIG>, the interior space <NUM> may be filled with a material suitable for distributing the weight of a patient, such as a foam or gel material, while the interior space <NUM> may be filled with a liquid or a gas. In some examples (not shown), the interior space <NUM> may be filled with a material suitable for distributing the weight of a patient, such as a foam or gel material, while the interior space <NUM> may be filled with a liquid or a gas. In some examples (not shown), the interior space <NUM> and the interior space <NUM> may be filled with a material suitable for distributing the weight of a patient, such as a foam or gel material.

<FIG> is an exploded view of an example embodiment of a therapy system <NUM> of <FIG> including a pressure-offloading component <NUM> in accordance with this specification. In some embodiments, the system <NUM> may include a dressing interface as previously described, such as dressing interface <NUM>, and a fluid conductor as previously described, such as tube <NUM>. In some examples, the dressing interface <NUM> may include an elbow connector <NUM> configured to be fluidly coupled to the tube <NUM>. In some examples, the dressing interface <NUM> may include a drape <NUM> with an adhesive disposed on a side of the drape <NUM> configured to face the cover <NUM>. The drape <NUM> may be configured to couple or adhere the elbow connector <NUM> to the cover <NUM>. The cover <NUM> may be configured to be disposed over a tissue interface as previously described, such as tissue interface <NUM>. The tissue interface <NUM> may be configured to be in fluid communication with the tube <NUM> through the elbow connector <NUM> and an aperture <NUM> formed through the cover <NUM>.

<FIG> is an isometric view of an assembled example of the therapy system <NUM> of <FIG>. As shown in <FIG>, the cover <NUM> may be disposed over the tissue interface <NUM> (not shown), and the elbow connector <NUM> may be coupled to the cover <NUM>, such as with the drape <NUM> as previously described. The tube <NUM> may be coupled to the elbow connector <NUM>. The pressure-offloading component <NUM> may be coupled to the cover <NUM>. In some examples, at least a portion of the first surface <NUM> (not shown) of the film layer <NUM> of the pressure-offloading component <NUM> may be coupled, such as adhered using an adhesive disposed on the first surface <NUM>, to the cover <NUM>. As shown in <FIG>, the elbow connector <NUM> may be received through the aperture <NUM> (not shown) of the film layer <NUM> and the aperture <NUM> of the embossed layer <NUM>. In some examples, the elbow connector <NUM> may be disposed in the annular region <NUM> between a portion of the second surface <NUM> of the walled portion <NUM> of the embossed layer <NUM> at the first end. At least a portion of the tube <NUM> may be received through the notch <NUM> (not shown) of the film layer <NUM>, the notch <NUM> (not shown) of the embossed layer <NUM>, and the notch <NUM> (not shown) of the film layer <NUM> to be disposed in the slotted region <NUM> between a portion of the second surface <NUM> of the walled portion <NUM> of the embossed layer <NUM> at the second end. In some examples, as shown in <FIG>, the notch <NUM>, the notch <NUM>, and/or the notch <NUM> may be narrower than a diameter of the tube <NUM>, and the tube <NUM> may be disposed on top of the second surface <NUM> of the film layer <NUM> and between two portions of the second surface <NUM> at the slotted region <NUM>. In some examples, the notch <NUM>, the notch <NUM>, and the notch <NUM> may be wider than a diameter of the tube <NUM>, and the tube <NUM> may be disposed on the cover <NUM> between the portions of the periphery <NUM> of the film layer <NUM> defining the notch <NUM>, the portions of the outer periphery <NUM> (not shown) defining the notch <NUM>, the portions of the periphery <NUM> defining the notch <NUM>, and between two portions of the second surface <NUM> at the slotted region <NUM>.

In some examples, a height of the elbow connector <NUM> and a height of the tube <NUM> may be less than a height of the second surface <NUM> of the planar portion <NUM> of the embossed layer <NUM> in a direction normal to the surface of the cover <NUM> on which the pressure-offloading component <NUM> is disposed. The one or more securing tabs <NUM> may be coupled to a portion of the second surface <NUM> to be disposed over the tube <NUM> and/or the elbow connector <NUM>, substantially securing the tube <NUM> relative to the pressure-offloading component <NUM>.

The systems, apparatuses, and methods described herein may provide significant advantages. For example, in some embodiments of the system <NUM> where the height of the second surface <NUM> of the planar portion <NUM> of the embossed layer <NUM> is greater than a height of the elbow connector <NUM> and a height of the tube <NUM> in a direction normal to the surface of the cover <NUM> on which the pressure-offloading component <NUM> is disposed, the relatively large second surface <NUM> may come into contact with an opposing surface, such as a surface of a bed. The normal force resulting from the contact of the second surface <NUM> with the opposing surface will be distributed across a relatively large area of the second surface <NUM>, lowering the pressure exerted by the pressure-offloading component <NUM> on the cover <NUM>, and lowering the force exerted by the pressure-offloading component <NUM> on the cover <NUM> at any given point. In examples of the system <NUM> without the pressure-offloading component <NUM>, the normal force resulting from the contact of the relatively small surface areas of the tube <NUM> and the elbow connector <NUM> will be distributed across a relatively small surface area of the tube <NUM> and elbow connector <NUM> in a plane substantially parallel with the surface of the cover <NUM> on which the tube <NUM> and elbow connector <NUM> are disposed, resulting in an increased pressure exerted by the tube <NUM> and/or the elbow connector <NUM> on the cover <NUM> and an increased force exerted by the tube <NUM> and/or the elbow connector <NUM> on the cover <NUM> at any given point in comparison to examples of the system <NUM> including the pressure-offloading component <NUM>. By including a pressure-offloading component <NUM> to reduce the pressure and force exerted on the cover <NUM> at any given point or area, the overall comfort of a patient undergoing negative-pressure wound therapy may be increased, particularly where the patient is undergoing negative-pressure wound therapy in a region of the body which may experience prolonged contact with another surface.

Additionally or alternatively, by including a conformable material such as a liquid, foam, and/or gel in the interior space <NUM>, the interior spaces <NUM>, and/or the interior space <NUM> as previously described, the overall ability of the pressure-offloading component <NUM> to resist deformation in a direction substantially normal to the second surface <NUM> may be increased, increasing the force that may be distributed across the pressure-offloading component <NUM> before the height of the pressure-offloading component <NUM> in a direction normal to the surface of the cover <NUM> may be reduced to become equal with the height of the tube <NUM> and/or the elbow connector in the direction normal to the surface of the cover <NUM>.

Additionally or alternatively, by providing a central release liner, such as release liner <NUM>, and one or more release liners at the edges of the pressure-offloading component <NUM>, such as release liner <NUM> and/or release liner <NUM>, the release liners may be used to aid the user in easily and precisely positioning the pressure-offloading component <NUM> on the cover <NUM>. For example, the user may initially remove the central release liner <NUM>, while leaving the release liner <NUM> and the release liner <NUM> attached to the pressure-offloading component <NUM>. In such a configuration, only the adhesive disposed on central portions of the first surface <NUM> of the film layer <NUM> and/or the first surface <NUM> of the film layer <NUM> may be exposed. The user may handle or maneuver the pressure-offloading component <NUM> without contacting or compromising any of the adhesive by grasping the release liner <NUM> and/or the release liner <NUM>, precisely placing the pressure-offloading component <NUM> against the desired surface. Once the pressure-offloading component <NUM> is in place, the release liner <NUM> and/or the release liner <NUM> may be removed, exposing the additional adhesive, which may more securely adhere the pressure-offloading component <NUM> to the desired surface.

Claim 1:
An apparatus for distributing force across a tissue site, comprising:
a first film layer (<NUM>) having a first end (<NUM>) and a second end (<NUM>), the first film layer (<NUM>) having an aperture (<NUM>) near the first end (<NUM>) and a notch (<NUM>) extending from the second end (<NUM>) to the aperture (<NUM>); and
an embossed layer (<NUM>) coupled to the first film layer (<NUM>) near a periphery of the first film layer (<NUM>) to define an interior space (<NUM>);
wherein the first film layer (<NUM>) and the embossed layer (<NUM>) form a fluid seal between those layers (<NUM>, <NUM>) to fluidly isolate the interior space (<NUM>) from the external environment.