Improved dressings and systems for negative pressure wound therapy and instillation therapy with low volume manifolds and bypass instillation channels

Abstract

A system for treating a tissue site with negative pressure therapy includes a dressing configured to be placed adjacent the tissue site. The dressing includes a first film layer, a manifold, and a second film layer. A plurality of windows are disposed through the first side and the second side of the first film layer and configured to be exposed to the tissue site. A first side of the manifold is disposed adjacent to the second side of the first film layer, and a first side of the second film layer is disposed adjacent to the second side of the manifold. A negative pressure channel is disposed through the second film layer, and a fluid entry channel is disposed through the second film layer, the manifold, and the first film layer. A negative pressure source is fluidly coupled to the negative pressure passage, and a fluid source is coupled to the fluid inlet passage.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 318,150, filed on March 9, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention as set forth in the appended claims relates generally to tissue treatment systems and more particularly, but not exclusively, to dressings and systems for treating wounds utilizing negative pressure wound therapy and instillation therapy. Background Art

[0004] Clinical studies and practice have shown that reducing the pressure near a tissue site can increase and accelerate the growth of new tissue at the tissue site. The application of this phenomenon is many, but it has been proven to be particularly beneficial for treating wounds. Regardless of the cause of the wound (whether trauma, surgery or other reasons), proper care of the wound is important for the result. Treating wounds or other tissues with reduced pressure is generally referred to as "negative pressure therapy", but is also referred to by other names, including, for example, "negative pressure wound therapy", "reduced pressure therapy", "vacuum therapy", "vacuum assisted closure" and "local negative pressure". Negative pressure therapy can provide many benefits, including migration of epithelial tissue and subcutaneous tissue, improvement of blood flow and micro-deformation of tissue at the wound site. In short, these benefits can increase the development of granulation tissue and reduce healing time.

[0005] It is also generally accepted that cleaning a tissue site can be highly beneficial for new tissue growth. For example, a wound or cavity can be flushed with a liquid solution for therapeutic purposes. These practices are often referred to as "flushing" and "irrigation," respectively. "Instillation" is another practice that generally refers to the process of slowly introducing a fluid into a tissue site and retaining the fluid for a specified period of time before removing the fluid. For example, instillation of a topical therapeutic solution over a wound bed can be combined with negative pressure therapy to further promote wound healing by loosening soluble contaminants in the wound bed and removing infectious materials. Thus, the soluble bacterial burden can be reduced, contaminants removed, and the wound cleaned.

[0006] While the clinical benefits of negative pressure therapy and / or infusion therapy are well known, improvements to therapy systems, components, and processes may benefit healthcare providers and patients. Summary of the invention

[0007] New and useful systems, devices, and methods for detecting the presence of liquid in a fluid pathway of a negative pressure therapy system are set forth in the appended claims. Exemplary embodiments are also provided to enable one skilled in the art to make and use the claimed subject matter.

[0008] A system for treating a tissue site using negative pressure therapy is presented. The system may include a dressing configured to be placed adjacent to the tissue site. The dressing may include a first film layer, a manifold, and a second film layer. The first film layer may have a first side opposite to a second side, and a plurality of fenestrations may be disposed through the first side and the second side and configured to be exposed to the tissue site. The manifold may have a first side opposite to a second side, and the first side of the manifold may be disposed adjacent to the second side of the first film layer. The second film layer may have a first side opposite to a second side, and the first side of the second film layer may be disposed adjacent to the second side of the manifold. A negative pressure channel may be disposed through the second film layer and in direct fluid communication between the second film layer and the manifold. A fluid inlet channel may be disposed through the second film layer, the manifold, and the first film layer. A fluid inlet manifold may be in direct communication with the first side of the first film layer. A negative pressure source may be configured to be fluidically coupled to the negative pressure channel, and a fluid source may be configured to be fluidically coupled to the fluid inlet channel.

[0009] In other features, the first membrane layer may include a fluid inlet hole, the manifold may include a fluid inlet hole, and the second membrane layer may include a fluid inlet hole. The fluid inlet hole of the first membrane layer, the fluid inlet hole of the manifold, and the fluid inlet hole of the second membrane layer may be coaxially aligned to define a fluid inlet channel through the fluid inlet hole of the first membrane layer, the fluid inlet hole of the manifold, and the fluid inlet hole of the second membrane layer. In other features, the portion of the second side of the first membrane layer surrounding the fluid inlet hole of the first membrane layer may be coupled to the portion of the first side of the manifold surrounding the fluid inlet hole of the manifold, and the portion of the first side of the second membrane layer surrounding the fluid inlet hole of the second membrane layer may be coupled to the portion of the second side of the manifold surrounding the fluid inlet hole of the manifold. In other features, the periphery of the second side of the first membrane layer is coupled to the periphery of the first side of the manifold, and the periphery of the first side of the second membrane layer is coupled to the periphery of the second side of the manifold.

[0010] In other features, a first chamber may be defined between the second side of the first membrane layer and the first side of the manifold, the portion of the second side of the first membrane layer being coupled to the portion of the first side of the manifold, and the periphery of the second side of the first membrane layer being coupled to the periphery of the first side of the manifold. A second chamber may be defined between the first side of the second membrane layer and the second side of the manifold, the portion of the first side of the second membrane layer being coupled to the portion of the second side of the manifold, and the periphery of the first side of the second membrane layer being coupled to the periphery of the first side of the manifold. In other features, the first chamber and the second chamber may be fluidically isolated from the fluid entry channel. In other features, the manifold may further include a plurality of windows formed through the manifold. In other features, the first chamber may be in fluid communication with the second chamber through the plurality of windows. In other features, the first side of the first membrane layer may be configured to be in direct contact with the tissue site. In other features, the fluid entry channel may be configured to be in direct fluid communication with the tissue site.

[0011] In other features, the second film layer may include a negative pressure hole. The negative pressure channel may be defined by a fluid passage from the negative pressure hole to the second chamber, and the negative pressure channel may be configured to be positioned to be in fluid communication with the tissue site through the multiple windows, the first chamber, and the multiple fenestrations. In other features, the dressing may also include a sealing layer having a treatment hole and multiple bonding holes surrounding the treatment hole. The first side of the film layer and the multiple fenestrations may be configured to be exposed to the tissue site through the treatment hole. In other features, the dressing may also include a covering layer and a pressure-sensitive adhesive, the covering layer having a first side opposite to the second side, the pressure-sensitive adhesive being disposed on the first side of the covering layer. The pressure-sensitive adhesive may couple the covering layer to the second film layer and the sealing layer. Portions of the pressure-sensitive adhesive may be disposed adjacent to the multiple bonding holes.

[0012] In other features, the first film layer may include a thicker portion and a thinner portion, the thicker portion being between each of the plurality of windows and the thinner portion being proximal to each of the plurality of windows. In other features, the second layer may be substantially coextensive with the manifold and the first film layer. In other features, the second film layer may be substantially coextensive with the sealing layer. In other features, a plurality of legs may be formed on one or both of the first side and the second side of the manifold. In other features, the manifold may include open-cell foam. In other features, the dressing may also include a fluid entry cover configured to be removably coupled to the second side of the second film layer. In other features, the fluid source may be configured to provide an instillation solution to the dressing. In other features, the fluid source may be an oxygen source configured to provide oxygen to the dressing. In other features, the manifold may be fluidically isolated from the fluid entry channel.

[0013] A system for treating a tissue site using negative pressure therapy is also presented. The system may include a dressing configured to be positioned adjacent to the tissue site. The dressing may include a first film layer, a manifold, and a second film layer. The first film layer may include a plurality of fenestrations and a fluid inlet hole. The manifold may include a plurality of windows and a fluid inlet hole. The second film layer may include a negative pressure hole and a fluid inlet hole. The first film layer, the manifold, and the second film layer may be assembled in a stacked relationship to define a first chamber between the first film layer and the manifold and a second chamber between the second film layer and the manifold. The fluid inlet hole of the first film layer, the fluid inlet hole of the manifold, and the fluid inlet hole of the second film layer may define a fluid inlet channel through the dressing. The first chamber and the second chamber may be fluidically isolated from the fluid inlet channel.

[0014] In various embodiments, the system may include a fluid source that is coupled to the fluid entry channel through the fluid entry hole of the second membrane layer. The fluid source may be configured to be in direct fluid communication with the tissue site through the fluid entry channel. In various embodiments, the system includes a negative pressure source coupled to the negative pressure hole of the second membrane layer. The negative pressure source may be configured to provide negative pressure to the tissue site through the multiple fenestrations of the first membrane layer, the first chamber, the multiple windows of the manifold, the second chamber, and the negative pressure hole of the second membrane layer.

[0015] In other features, the system may include a sealing layer comprising a treatment aperture and a plurality of bonding holes surrounding the treatment aperture. The first film layer may be configured to be coupled to the sealing layer such that a plurality of fenestrations of the first film layer are exposed through the treatment aperture. In other features, the system may include a cover comprising a pressure sensitive adhesive. The cover may be coupled to the sealing layer around the manifold. At least a portion of the pressure sensitive adhesive may be exposed through the bonding holes. In other features, the second film layer may be substantially coextensive with the sealing layer. In other features, the first film layer, the manifold, and the second film layer may be substantially coextensive with each other.

[0016] The objects, advantages and preferred modes of making and using the claimed subject matter may be best understood by referring to the accompanying drawings in conjunction with the following detailed description of illustrative embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is a block diagram of an exemplary embodiment of a therapy system that can provide negative pressure therapy and infusion therapy according to the present specification;

[0018] Figure 2 yes Figure 1 An exploded view of an example of a dressing of , illustrating additional details that may be associated with some embodiments suitable for negative pressure wound therapy and infusion therapy and / or oxygen therapy;

[0019] Figure 3 yes Figure 2 Isometric view of the dressing after assembly;

[0020] Figure 4 yes Figure 2 An isometric view of the dressing after assembly with the dressing interface attached;

[0021] Figure 5 is a top view of a dressing assembled according to the present specification;

[0022] Figure 6 is a bottom view of a dressing assembled according to the present specification;

[0023] Figure 7 is a top view illustrating additional details that may be associated with some examples of dressings according to the present specification;

[0024] Figure 8 is a top view illustrating additional details that may be associated with some examples of dressings according to the present specification;

[0025] Fig. 9 is a top view illustrating additional details that may be associated with some examples of dressings according to the present specification;

[0026] Fig.10 is a top view illustrating additional details that may be associated with some examples of dressings according to the present specification;

[0027] Fig.11 is a top view illustrating additional details that may be associated with some examples of dressings according to the present specification;

[0028] Fig.12 is a top view illustrating additional details that may be associated with some examples of dressings according to the present specification;

[0029] Fig.13 is a top view illustrating additional details that may be associated with some examples of dressings according to the present specification;

[0030] Fig.14 is a top view illustrating additional details that may be associated with some examples of dressings according to the present specification;

[0031] Fig.15 is a top view illustrating additional details that may be associated with some examples of dressings according to the present specification;

[0032] Fig.16 is a top view illustrating additional details that may be associated with some examples of dressings according to the present specification;

[0033] Fig.17is a top view illustrating additional details that may be associated with some examples of dressings according to the present specification;

[0034] Fig.18 is a top view illustrating additional details that may be associated with some examples of dressings according to the present specification;

[0035] Fig.19 yes Figure 4 A cross-sectional view of an exemplary dressing of FIG. 1 taken along line 19-19 applied to an exemplary tissue site and illustrating the Figure 1 Additional details associated with some examples of treatment systems;

[0036] Fig.19A is Fig.19 A detailed view taken at 19A in FIG. 1 illustrates a Fig.19 Additional features associated with some examples of dressings;

[0037] Fig.19B It is an example of Fig.19 In some embodiments of the dressing, the Fig.19A A detailed view of an additional feature associated with the detailed view of the

[0038] Fig.19C is Fig.19 A detailed view taken at 19C in FIG. 1 illustrates a Fig.19 Additional features associated with some exemplary embodiments of dressings;

[0039] Fig.19D It is an example of Fig.19 In some embodiments of the dressing, the Fig.19C A detailed view of an additional feature associated with the detailed view of the

[0040] Fig.19E is an example of a method that can be applied to a tissue site having a contour. Fig.19 cross-sectional views with additional details associated with some examples of dressings;

[0041] Fig.19F is an example of a method that can be applied to a tissue site having a contour. Fig.19 cross-sectional views with additional details associated with some examples of dressings;

[0042] Fig. 20 yes Figure 1 An exploded view of an example of a dressing illustrating additional details that may be associated with some embodiments;

[0043] Fig.21 yes Fig. 20An isometric view of an assembly example of a dressing having an attached dressing interface for negative pressure wound therapy and instillation and / or oxygen therapy;

[0044] Fig. 22 yes Fig.21 A cross-sectional view of an exemplary dressing of FIG. 1 taken along line 22-22 applied to an exemplary tissue site and illustrating the Figure 1 Additional details associated with the treatment system;

[0045] Fig.23 yes Figure 1 An exploded view of an example of a dressing illustrating additional details that may be associated with some embodiments;

[0046] Fig.24 yes Fig.23 an isometric view of an assembled example of a dressing; and

[0047] Fig.25 yes Fig.24 A cross-sectional view of an exemplary dressing taken along line 25-25 and applied to an exemplary tissue site. DETAILED DESCRIPTION

[0048] The following description of exemplary embodiments provides information enabling those skilled in the art to make and use the subject matter set forth in the appended claims, but may omit certain details already known in the art. Therefore, the following detailed description is to be regarded as illustrative rather than limiting.

[0049] Figure 1 is a block diagram of an exemplary embodiment of a treatment system 100 that can provide negative pressure therapy as well as instillation of a localized therapeutic solution to a tissue site in accordance with the present specification.

[0050] In this article, the term "tissue site" refers broadly to a wound, defect or other treatment target located on or in a tissue, including but not limited to bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon or ligament. Wounds may include, for example, chronic wounds, acute wounds, traumatic wounds, subacute wounds and dehiscence wounds, partial thickness burns, ulcers (such as diabetic ulcers, pressure sores or venous insufficiency ulcers), flaps and grafts. The term "tissue site" may also refer to an area of ​​any tissue that is not necessarily injured or defective, but rather an area in which it may be desirable to add additional tissue or promote the growth of additional tissue. For example, negative pressure may be applied to the tissue site to allow additional tissue to grow, and then the additional tissue may be removed and transplanted.

[0051] The treatment system 100 may include a negative pressure source or negative pressure supply device (such as negative pressure source 102) and one or more dispensing components. The dispensing components are preferably detachable and can be disposable, reusable, or recyclable. Dressings (such as dressing 104) and fluid containers (such as container 106) are examples of dispensing components that may be associated with some examples of the treatment system 100. Figure 1 As illustrated in the example of , in some embodiments, the dressing 104 can include or consist essentially of a tissue interface 108, a cover 110, or both.

[0052] A fluid conductor is another illustrative example of a distribution component. As used herein, a "fluid conductor" broadly includes a tube, pipe or hose, conduit, or other structure having one or more lumens or open passages suitable for conveying fluid between two ends. Typically, a tube is an elongated cylindrical structure with a certain flexibility, but the geometry and rigidity may vary. In addition, some fluid conductors may be molded into other components or otherwise integrally combined with other components. The distribution component may also include or include an interface or fluid port to facilitate the connection and separation of other components. In some embodiments, for example, a dressing interface may facilitate the connection of the fluid conductor to the dressing 104. For example, such a dressing interface may be a SENSAT.RAC available from Kinetic Concepts, Inc., San Antonio, Texas. TM pad.

[0053] The treatment system 100 may also include a regulator or controller, such as controller 112. In addition, the treatment system 100 may include sensors to measure operating parameters and provide feedback signals indicative of the operating parameters to the controller 112. Figure 1 As illustrated, for example, treatment system 100 may include a first sensor 114 and a second sensor 116 coupled to a controller 112 .

[0054] The treatment system 100 may also include an instillation solution source. For example, the solution source 118 may be fluidly coupled to the dressing 104, such as Figure 1As illustrated in the exemplary embodiment of . In some embodiments, the solution source 118 may be fluidly connected to a positive pressure source (such as positive pressure source 120), a negative pressure source (such as negative pressure source 102), or both. A regulator (such as a drip regulator 122) may also be fluidly connected to the solution source 118 and the dressing 104 to ensure that an appropriate dose of infusion solution (e.g., saline) is delivered to the tissue site. For example, the drip regulator 122 may include a piston that can be pneumatically actuated by the negative pressure source 102 to draw the infusion solution from the solution source during the negative pressure interval and drip the solution into the dressing during the ventilation interval. Additionally or alternatively, the controller 112 may be connected to the negative pressure source 102, the positive pressure source 120, or both to control the dose of the infusion solution to the tissue site. In some embodiments, the drip regulator 122 may also be fluidly connected to the negative pressure source 102 through the dressing 104, such as Figure 1 as shown in the example.

[0055] Some components of the treatment system 100 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 treatment. For example, in some embodiments, the negative pressure source 102 may be combined with the controller 112, the solution source 118, and other components into a treatment unit.

[0056] In general, the components of the treatment system 100 may be coupled directly or indirectly. For example, the negative pressure source 102 may be directly coupled to the container 106 and may be indirectly coupled to the dressing 104 through the container 106. The coupling may include a fluid coupling, a mechanical coupling, a thermal coupling, an electrical coupling, or a chemical coupling (such as a chemical bond), or in some cases some combination of couplings. For example, the negative pressure source 102 may be electrically coupled to the controller 112 and may be fluidly coupled to one or more distribution components to provide a fluid path to the tissue site. In some embodiments, the components may also be coupled by means of physical proximity, integration into a single structure, or formation from the same piece of material.

[0057] Negative pressure supply device (such as negative pressure source 102) can be a reservoir of air at negative pressure, or can be a manual or electric device, such as a vacuum pump, a suction pump, a wall suction port available in many healthcare facilities, or a micro pump. "Negative pressure" generally refers to a pressure less than the local ambient pressure, such as the ambient pressure in the local environment outside the sealed treatment environment. In many cases, the local ambient pressure may also be the atmospheric pressure where the tissue site is located. Alternatively, the pressure may be less than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise specified, the values ​​of the pressures stated herein are gauge pressures. Mentioning an increase in negative pressure generally refers to a decrease in absolute pressure, while a decrease in negative pressure generally refers to an increase in absolute pressure. Although the amount and nature of the negative pressure provided by the negative pressure source 102 may vary according to treatment requirements, the pressure is generally a low vacuum between -5mm Hg (-667Pa) and -500mm Hg (-66.7kPa), which is also generally referred to as a rough vacuum. The common treatment range is between -50 mm Hg (-6.7 kPa) and -300 mm Hg (-39.9 kPa).

[0058] Container 106 represents a container, canister, pouch, or other storage component that can be used to manage exudate and other fluids drawn from a tissue site. In many environments, a rigid container may be preferred or required for collecting, storing, and disposing of fluids. In other environments, fluids may be properly disposed of without rigid container storage, and reusable containers may reduce waste and costs associated with negative pressure therapy.

[0059] A controller, such as controller 112, may be a microprocessor or computer programmed to operate one or more components of the treatment system 100, such as the negative pressure source 102. In some embodiments, for example, the controller 112 may be a microcontroller, which typically includes an integrated circuit containing a processor core and a memory programmed to directly or indirectly control one or more operating parameters of the treatment system 100. For example, the operating parameters may include the power applied to the negative pressure source 102, the pressure generated by the negative pressure source 102, or the pressure distributed to the tissue interface 108. The controller 112 is also preferably configured to receive one or more input signals, such as feedback signals, and is programmed to modify one or more operating parameters based on the input signals.

[0060] The sensor (such as the first sensor 114 and the second sensor 116) may be any device operable to detect or measure a physical phenomenon or characteristic, and generally provides a signal indicating the detected or measured phenomenon or characteristic. For example, the first sensor 114 and the second sensor 116 may be configured to measure one or more operating parameters of the treatment system 100. In some embodiments, the first sensor 114 may be a transducer configured to measure the pressure in the pneumatic passage and convert the measurement result into a signal indicating the measured pressure. In some embodiments, for example, the first sensor 114 may be a piezoresistive strain gauge. In some embodiments, the second sensor 116 may optionally measure an operating parameter of the negative pressure source 102, such as voltage or current. Preferably, the signals from the first sensor 114 and the second sensor 116 are suitable as input signals to the controller 112, but in some embodiments, some signal conditioning may be appropriately performed. For example, before the signal can be processed by the controller 112, it may be necessary to filter or amplify the signal. Typically, the signal is an electrical signal, but can be represented in other forms, such as an optical signal.

[0061] The tissue interface 108 may generally be adapted to partially or completely contact a tissue site. The tissue interface 108 may take a variety of forms and may have a variety of sizes, shapes, or thicknesses, depending on various factors, such as the type of treatment being performed or the nature and size of the tissue site. For example, the size and shape of the tissue interface 108 may be adapted to the contours of a deep and irregularly shaped tissue site. Any or all surfaces of the tissue interface 108 may have an uneven, rough, or jagged profile.

[0062] In some embodiments, the tissue interface 108 may include or consist essentially of a manifold. The manifold herein may include or consist essentially of a device for collecting or distributing fluids passing through the tissue interface 108 under pressure. For example, the manifold may be adapted to receive negative pressure from a source and distribute the negative pressure through a plurality of holes through the tissue interface 108, which may have the effect of collecting fluids from the tissue site and drawing the fluids toward the source. In some embodiments, the fluid path may be reversed or may be provided to facilitate a secondary fluid path for delivering fluids (such as fluids from an instillation solution source) to the tissue site.

[0063] In some exemplary embodiments, the manifold may include a plurality of passages that may be interconnected to improve the distribution or collection of fluids. In some exemplary embodiments, the manifold may include or be substantially composed of a porous material having interconnected fluid passages. Examples of suitable porous materials that may be suitable for forming interconnected fluid passages (e.g., channels) may include: porous foams, including open-cell foams, such as reticulated foams; porous tissue collections; and other porous materials that typically include pores, edges, and / or walls, such as gauze or felt pads. Liquids, gels, and other foams may also include or be cured to include pores and fluid passages. In some embodiments, the manifold may additionally or alternatively include projections that form interconnected fluid passages. For example, the manifold may be molded to provide surface projections that define interconnected fluid passages.

[0064] In some embodiments, the tissue interface 108 may include or be substantially composed of a reticulated foam having a pore size and free volume that may vary according to the needs of the prescribed treatment. For example, a reticulated foam having at least 90% free volume may be suitable for many therapeutic applications, and a foam having an average pore size (40-50 pores / inch) in the range of 400 microns-600 microns may be particularly suitable for some types of treatment. The tensile strength of the tissue interface 108 may also vary according to the needs of the prescribed treatment. For example, for the instillation of a local treatment solution, the tensile strength of the foam may be increased. The 25% compressive load deflection of the tissue interface 108 may be at least 0.35 pounds per square inch, and the 65% compressive load deflection may be at least 0.43 pounds per square inch. In some embodiments, the tensile strength of the tissue interface 108 may be at least 10 pounds per square inch. The tissue interface 108 may have a tear strength of at least 2.5 pounds per inch. In some embodiments, the tissue interface can be a foam composed of a polyol (such as a polyester or a polyether), an isocyanate (such as toluene diisocyanate), and a polymerization modifier (such as an amine and a tin compound). In some examples, the tissue interface 108 can be a reticulated polyurethane foam, such as GRANUFOAM®, both available from Kinetic Concepts, Inc., San Antonio, Texas. TM Dressing or VACVERAFLO TM Found in dressings.

[0065] The thickness of the tissue interface 108 may also vary depending on the needs of the prescribed treatment. For example, the thickness of the tissue interface may be reduced to reduce tension on the surrounding tissue. The thickness of the tissue interface 108 may also affect the conformability of the tissue interface 108. In some embodiments, a thickness in the range of about 5 mm to 10 mm may be suitable.

[0066] The tissue interface 108 can be hydrophobic or hydrophilic. In examples where the tissue interface 108 can be hydrophilic, the tissue interface 108 can also wick fluid away from the tissue site while continuing to distribute negative pressure to the tissue site. The wicking properties of the tissue interface 108 can wick fluid away from the tissue site by capillary flow or other wicking mechanisms. Examples of materials that may be suitable hydrophilic materials are polyvinyl alcohol, open-cell foams such as VACWHITEFOAM available from Kinetic Concepts, Inc. of San Antonio, Texas. TM Dressings. Other hydrophilic foams may include those made from polyethers. Other foams that may exhibit hydrophilic characteristics include hydrophobic foams that have been treated or coated to render them hydrophilic.

[0067] In some embodiments, the tissue interface 108 may be composed of a bioabsorbable material. Suitable bioabsorbable materials may include, but are not limited to, polymer blends of polylactic acid (PLA) and polyglycolic acid (PGA). Polymer blends may also include, but are not limited to, polycarbonate, polyfumarate, and caprolactone. The tissue interface 108 may also be used as a scaffold for new cell growth, or a scaffold material may be used in conjunction with the tissue interface 108 to promote cell growth. A scaffold is typically a material or structure used to enhance or promote cell growth or tissue formation, 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 hydroxyapatite, carbonate, or treated allograft material.

[0068] In some embodiments, the cover 110 can provide a bacterial barrier and prevent physical trauma. The cover 110 can also be made of a material that can reduce evaporative losses and provide a fluid seal between two components or two environments (such as between a treatment environment and a local external environment). The cover 110 may include or be composed of, for example, an elastomeric film or diaphragm that can provide a seal sufficient to maintain negative pressure at the tissue site for a given negative pressure source. In some applications, the cover 110 may have a high moisture vapor transmission rate (MVTR). For example, in some embodiments, the MVTR may be at least 250 grams per cubic meter per twenty-four hours, which is measured using a cup technique at 38°C and 10% relative humidity (RH) according to ASTM E96 / E96M cup method. In some embodiments, an MVTR of up to 5,000 grams per square meter per twenty-four hours can provide effective breathability and mechanical properties.

[0069] In some exemplary embodiments, the cover 110 may be a polymer drape that is permeable to water vapor but impermeable to liquids, such as a polyurethane film. Such a drape typically has a thickness in the range of 25 microns to 50 microns. For permeable materials, the permeability should generally be low enough so that the desired negative pressure can be maintained. The cover 110 may include, for example, one or more of the following materials: polyurethane (PU), such as hydrophilic polyurethane; cellulose; hydrophilic polyamide; polyvinyl alcohol; polyvinyl pyrrolidone; hydrophilic acrylic resin; silicone, such as hydrophilic silicone elastomer; natural rubber; polyisoprene; styrene-butadiene rubber dichloroprene; polybutadiene; nitrile rubber; butyl rubber; ethylene-propylene rubber; ethylene-propylene-diene monomer dichlorosulfonated polyethylene; polysulfide rubber; ethylene-vinyl acetate (EVA); copolyesters; and polyether block polyamide copolymers. Such materials are, for example, commercially available items: commercially available from 3M Company, Minneapolis Minnesota drape; polyurethane (PU) drape commercially available from Avery Dennison Corporation, Pasadena, California; polyether block polyamide copolymer (PEBAX), available, for example, from Arkema SA, Colombes, France; and Inspire 2301 and Inpsire 2327 polyurethane films commercially available from Transcontinental Advanced Coatings, Wrexham, United Kingdom. In some embodiments, cover 110 may include a 2600 g / m 2 / 24 hours MVTR (stand-up cup technology) and a thickness of approximately 30 microns for INSPIRE 2301.

[0070] Attachment means can be used to attach cover 110 to an attachment surface, such as an undamaged epidermis, a gasket, or another cover. Attachment means can take many forms. For example, attachment means can be a medically acceptable pressure-sensitive adhesive that is configured to bond cover 110 to the epidermis around the tissue site. In some embodiments, for example, some or all of cover 110 may be coated with an adhesive, such as an acrylic adhesive, that may have a coating amount of about 25 grams per square meter to 65 grams per square meter (gsm). In some embodiments, a thicker adhesive or a combination of adhesives may be applied to improve sealing and reduce leakage. Other exemplary embodiments of attachment means may include double-sided tape, paste, aqueous colloid, hydrogel, silicone gel, or organogel.

[0071] Solution source 118 may also be representative of a container, canister, pouch, bag, or other storage component that may provide a solution for infusion therapy. The composition of the solution may vary depending on the prescribed therapy, but examples of solutions that may be suitable for some prescriptions include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanides, cationic solutions, and isotonic solutions.

[0072] In operation, the tissue interface 108 can be placed in, above, on, or otherwise close to a tissue site. For example, if the tissue site is a wound, the tissue interface 108 can partially or completely fill the wound, or the tissue interface can be placed above the wound. The cover 110 can be placed above the tissue interface 108 and sealed to an attachment surface near the tissue site. For example, the cover 110 can be sealed to the undamaged epidermis around the tissue site. Therefore, the dressing 104 can provide a sealed treatment environment close to the tissue site that is substantially isolated from the external environment, and the negative pressure source 102 can reduce the pressure in the sealed treatment environment.

[0073] The process of reducing pressure may be illustratively described herein as, for example, "delivering," "distributing," or "generating" negative pressure. Typically, exudates and other fluids flow along a fluid path in the direction of lower pressure. Thus, the term "downstream" typically means a location in a fluid path that is relatively closer to a source of negative pressure or farther from a source of positive pressure. Conversely, the term "upstream" means a location that is relatively farther from a source of negative pressure or closer to a source of positive pressure.

[0074] Negative pressure applied across a tissue site through tissue interface 108 in a sealed treatment environment can induce macro- and micro-strains in the tissue site. Negative pressure can also remove exudate and other fluids from the tissue site that may be collected in container 106.

[0075] In some embodiments, the controller 112 may receive and process data from one or more sensors (such as the first sensor 114). The controller 112 may also control the operation of one or more components of the treatment system 100 to manage the pressure delivered to the tissue interface 108. In some embodiments, the controller 112 may include an input for receiving a desired target pressure, and may be programmed to process data related to the setting and input of the target pressure to be applied to the tissue interface 108. In some exemplary embodiments, the target pressure may be a fixed pressure value set by an operator as the target negative pressure desired for treatment at the tissue site and then provided as an input to the controller 112. The target pressure may vary from tissue site to tissue site based on the type of tissue forming the tissue site, the type of injury or wound (if any), the medical condition of the patient, and the preferences of the attending physician. After selecting the desired target pressure, the controller 112 may operate the negative pressure source 102 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 108.

[0076] In some embodiments, the controller 112 may have a continuous pressure mode, wherein the negative pressure source 102 is operated to provide a constant target negative pressure during the treatment duration or until manual deactivation. Additionally or alternatively, the controller may have an intermittent pressure mode. In an exemplary embodiment, the controller 112 may operate the negative pressure source 102 to cycle between the target pressure and the atmospheric pressure. For example, the target pressure may be set to a value of 135 mmHg for a specified period of time (e.g., five minutes), followed by deactivation of a specified period of time (e.g., two minutes). The cycle may be repeated by activating the negative pressure source 102, which may form a square wave pattern between the target pressure and the atmospheric pressure.

[0077] In some exemplary embodiments, the increase in negative pressure from ambient pressure to target pressure may not be instantaneous. For example, the negative pressure source 102 and the dressing 104 may have an initial rise time. The initial rise time may vary depending on the type of dressing and treatment device used. For example, the initial rise time of one treatment system may be in the range of about 20 mmHg / second-30 mmHg / second, and the initial rise time of another treatment system may be in the range of about 5 mmHg / second-10 mmHg / second. If the treatment system 100 is operated in an intermittent mode, the repetitive rise time may be a value substantially equal to the initial rise time.

[0078] In some exemplary dynamic pressure control modes, the target pressure may vary over time. For example, the target pressure may vary in the form of a triangular waveform, varying between a negative pressure of 50 mmHg to 135 mmHg, wherein the rising rate of the negative pressure is set at a rate of 25 mmHg / minute, and the falling rate is set at 25 mmHg / minute. In other embodiments of the treatment system 100, the triangular waveform may vary between a negative pressure of 25 mmHg to 135 mmHg at a rising rate of about 30 mmHg / minute, and the falling rate is set at about 30 mmHg / minute.

[0079] In some embodiments, the controller 112 can control or determine a variable target pressure in a dynamic pressure mode, and the variable target pressure can vary between a maximum pressure value and a minimum pressure value, which can be set as a range of desired negative pressures as input specified by the operator. The variable target pressure can also be processed and controlled by the controller 112, which can change the target pressure according to a predetermined waveform (such as a triangular waveform, a sine waveform, or a sawtooth waveform). In some embodiments, the waveform can be set by the operator to a predetermined or time-varying negative pressure desired for treatment.

[0080] In some embodiments, the controller 112 may receive and process data, such as data related to the instillation solution provided to the tissue interface 108. Such data may include the type of instillation solution specified by the clinician, the volume of the fluid or solution to be instilled into the tissue site ("fill volume"), and the amount of time specified for leaving the solution at the tissue site before applying negative pressure to the tissue site ("residence time"). The fill volume may be, for example, between 10mL and 500mL, and the residence time may be between one second and 30 minutes. The controller 112 may also control the operation of one or more components of the treatment system 100 to instill the solution. For example, the controller 112 may manage the fluid distributed to the tissue interface 108 from the solution source 118. In some embodiments, the fluid may be instilled into the tissue site by applying negative pressure from the negative pressure source 102 to reduce the pressure at the tissue site, and the solution may be sucked into the tissue interface 108. In some embodiments, the solution may be instilled into the tissue site by applying positive pressure from the positive pressure source 160 to move the solution from the solution source 118 to the tissue interface 108. Additionally or alternatively, the solution source 118 may be elevated to a height sufficient to allow gravity to move the solution into the tissue interface 108 .

[0081] The controller 112 can also control the fluid dynamics of the instillation by providing a continuous flow of solution or an intermittent flow of solution. Negative pressure can be applied to provide a continuous flow of solution or an intermittent flow. The application of negative pressure can be implemented to provide a continuous pressure operating mode to achieve a continuous flow rate of the instillation solution across the tissue interface 108, or the application of negative pressure can be implemented to provide a dynamic pressure operating mode to change the flow rate of the instillation solution across the tissue interface 108. Alternatively, the application of negative pressure can be implemented to provide an intermittent operating mode to allow the instillation solution to stay at the tissue interface 108. In the intermittent mode, a specific fill volume and residence time can be provided, which depends on, for example, the type of tissue site being treated and the type of dressing being utilized. Negative pressure therapy can be applied after or during the instillation of the solution. The controller 112 can be used to select the operating mode and the duration of the negative pressure therapy before starting another instillation cycle by instilling more solution.

[0082] Figure 2 yes Figure 1 An exploded view of an example of a dressing 104 of , illustrating additional details that may be associated with some embodiments for use with negative pressure wound therapy and drip therapy and / or oxygen therapy. Figure 2 In the example of, the dressing 104 may include a sealing layer 202, a first film layer 204, a manifold layer 206, a second film layer 208 and a cover 110. The sealing layer 202 may be formed of a soft, pliable material (such as a suitable gel material) suitable for providing a fluid seal with a tissue site, and may have a substantially flat surface. In various embodiments, the sealing layer 202 may include, but is not limited to, silicone gel, soft silicone, hydrocolloid, hydrogel, polyurethane gel, polyolefin gel, hydrogenated styrene copolymer gel, foaming gel, soft closed-cell foam (such as, polyurethane and polyolefin coated with an adhesive), polyurethane, polyolefin or hydrogenated styrene copolymer. In various embodiments, the sealing layer 202 may have a thickness in the range of about 200 microns to about 1,000 microns. In various embodiments, the sealing layer 202 may be formed of a hydrophobic or hydrophilic material.

[0083] In various embodiments, the sealing layer 202 may include or be formed of a hydrophobic material or a hydrophobic coating material. For example, the sealing layer 202 may be formed by coating a spacer material (such as a woven mesh, a nonwoven mesh, a molded mesh, or an extruded mesh) with a hydrophobic material (such as soft silicone).

[0084] The sealing layer 202 can have a top surface 210 opposite the bottom surface 212, a perimeter 214 defined by the outer perimeter of the sealing layer 202, and a treatment hole 216 formed through the sealing layer 202. In various embodiments, the treatment hole 216 can have a contour that is complementary or corresponding to the outer perimeter of the manifold 206. The sealing layer 202 can also include a plurality of holes 218 formed through the sealing layer 202. In various embodiments, the plurality of holes 218 can be formed through an area of ​​the sealing layer 202 between the treatment hole 216 and the perimeter 214.

[0085] In various embodiments, the holes 218 can be formed by cutting, perforating, or applying localized radio frequency or ultrasonic energy through the sealing layer 202. In various embodiments, the holes 218 can be formed by other suitable techniques for forming openings or perforations in the sealing layer 202. In various embodiments, the holes 218 can have a uniform distribution pattern, or can be randomly distributed. In various embodiments, the holes 218 can have any combination of many shapes, including circles, squares, stars, ovals, polygons, slits, complex curves, straight lines, or triangles.

[0086] In various embodiments, each of the holes 218 may have uniform or similar geometric characteristics. For example, each of the holes 218 may be a circular hole and have substantially the same diameter. In various embodiments, each of the holes 218 may have a diameter in the range of about 1 mm to about 20 mm.

[0087] In various embodiments, the geometric characteristics of the holes 218 may vary. For example, the diameter of the holes 218 may vary depending on the positioning of the corresponding holes 218 in the sealing layer 202. In various embodiments, at least some of the holes 218 may have a diameter in the range of about 5 mm to about 10 mm. In various embodiments, at least some of the holes 218 may have a diameter in the range of about 7 mm to about 9 mm. In various embodiments, the sealing layer 202 may include corners, and the holes 218 disposed at or near these corners may have a diameter in the range of about 7 mm to about 8 mm.

[0088] In various embodiments, at least some of the holes 218 positioned near the periphery 214 may have interiors that are cut or exposed at the periphery 214 and that are laterally connected to the periphery 214 in a lateral direction (relative to the top surface 210 and / or the bottom surface 212). In various embodiments, the lateral direction may refer to a direction that is in the same plane as the top surface 210 and / or the bottom surface 212 and extends toward the periphery 214. In various embodiments, at least some of the holes 218 positioned near or at the periphery 214 may be substantially equally spaced around the periphery 214. Alternatively, in various embodiments, the spacing of the holes 218 near or at the periphery 214 may be irregularly spaced.

[0089] The first film layer 204 may include a suitable structure for controlling or managing fluid flow. In various embodiments, the first film layer 204 may be a fluid control layer, which includes an elastomeric material that is impermeable to liquid and permeable to steam. In various embodiments, the first film layer 204 may be formed by a polymer film or include a polymer film. For example, in various embodiments, the first film layer 204 may be formed by a polyolefin film or include a polyolefin film, such as a polyethylene film. In various embodiments, the first film layer 204 may be substantially transparent or optically transparent. In various embodiments, the first film layer 204 may be formed by the same material as the cover 110 or include the same material as the cover. In various embodiments, the first film layer 204 may be formed by or include a biocompatible polyurethane film tested and certified according to the USPVI grade standard. In various embodiments, the first film layer 204 may also have a smooth or matte surface texture. In various embodiments, the first film layer 204 may have a smooth or glossy finish equal to or exceeding the B3 grade according to the Plastics Industry Association (SPI) standard. In various embodiments, the surface of the first film layer 204 can be a substantially flat surface with a height variation in a range of about 0.2 millimeters to about 1 centimeter.

[0090] In various embodiments, the first film layer 204 may be hydrophobic. The hydrophobicity of the first film layer 204 may vary, but in some examples may have a contact angle with water of at least 90 degrees. In various embodiments, the first film layer 204 may have a contact angle with water of no more than 150 degrees. In various embodiments, the contact angle of the first film layer 204 with water may be in the range of about 90 degrees to about 120 degrees, or in the range of about 120 degrees to about 150 degrees. The water contact angle can be measured using any standard equipment. Although manual goniometers can be used to visually approximate the contact angle, contact angle measurement instruments can typically involve integrated systems that include a level, a liquid dropper (such as a syringe), a camera, and software designed to more accurately and precisely calculate the contact angle. Non-limiting examples of such integrated systems include and Systems, all commercially available from First Ten Angstroms, Inc., Portsmouth, Virginia, and DTA25, DTA30 and DTA100 systems, all commercially available from Kruss GmbH, Hamburg, Germany. Unless otherwise specified, the water contact angles herein are measured in air at 20°C-25°C and 20%-50% relative humidity using deionized water and / or distilled water on a horizontal sample surface added from a stationary drop of no more than five centimeters. The contact angles herein represent the average of five to nine measurements, with the highest and lowest measurements discarded. In various embodiments, the hydrophobicity of the first film layer 204 can be further enhanced with a hydrophobic coating of other materials, such as silicones and fluorocarbons.

[0091] The first film layer 204 may also be suitable for welding to other layers, including the manifold layer 206 and the second film layer 208. In various embodiments, the first film layer 204 may be suitable for welding to polymers (such as polyurethanes, polyurethane films, and polyurethane foams) using heat welding, radio frequency (RF) welding, ultrasonic welding, or other methods. RF welding may be particularly suitable for more polar materials such as polyurethanes, polyamides, polyesters, and acrylates. Sacrificial polar interfaces may be used to facilitate RF welding of less polar film materials (such as polyethylene).

[0092] The surface density of the first film layer 204 can vary depending on the treatment or application specified. In various embodiments, a surface density of less than 40 grams per square meter may be suitable. In various embodiments, the surface density of the first film layer 204 can be in the range of about 20 grams per square meter to about 30 grams per square meter.

[0093] In various embodiments, the first film layer 204 may be formed by a hydrophobic polymer or include a hydrophobic polymer, such as a polyethylene film. The simple and inert structure of polyethylene provides a surface that hardly interacts (if at all) with biological tissue and fluid, and provides a surface that can promote free flow of liquid and show low adhesion to tissue and fluid, and these characteristics may be particularly advantageous for many applications. In various embodiments, the first film layer 204 may be formed by other polymer films, such as polyurethane, acrylic, polyolefin (such as cyclic olefin copolymer), polyacetate, polyamide, polyester, copolyester, PEBAX block copolymer, thermoplastic elastomer, thermoplastic vulcanizate, polyether, polyvinyl alcohol, polypropylene, polymethylpentene, polycarbonate styrene, silicone, fluoropolymer and acetate. In various embodiments, the first film layer 204 may have a thickness in the range of about 20 microns to about 500 microns. In various embodiments, the first film layer 204 may have a thickness of about 23 microns, about 25 microns, about 100 microns, about 250 microns, about 300 microns and about 500 microns. In various embodiments, the first film layer 204 may include a polar film suitable for lamination to a polyethylene film, such as polyamides, copolyesters, ionomers, and acrylics. In various embodiments, the first film layer 204 may include a tie layer to improve the bonding between the polyethylene and polar film layers. In various embodiments, the tie layer may include ethylene vinyl acetate or modified polyurethane. In various embodiments, the first film layer 204 may include ethyl methyl acrylate (EMA) film.

[0094] like Figure 2 As illustrated, the first film layer 204 may have a top surface 220 opposite the bottom surface 222 and a perimeter 224 defined by the outer perimeter of the first film layer 204. In various embodiments, the perimeter 224 may be stadium-shaped, discorectangular, or oblong. The first film layer 204 may also include one or more fluid channels 226 formed through the first film layer 204, and they may be evenly or randomly distributed across the first film layer 204. In various embodiments, the first film layer 204 may include a fluid entry hole or a drip hole, such as hole 228.

[0095] In various embodiments, the fluid channel 226 can be used as a bidirectional and fluid responsive valve. For example, each fluid channel 226 can be an elastic channel that is stress-free under normal circumstances to prevent or substantially reduce fluid flow through the fluid channel 226, and can expand or open in response to a pressure gradient applied across the fluid channel 226 to allow fluid to flow through the fluid channel 226. In various embodiments, the fluid channel 226 may include perforations formed in the first film layer 204. The perforations can be formed by removing material from the first film layer 204 or cutting through the first film layer 204. In various embodiments, cutting through the first film layer 204 can deform the edges of the perforations. In various embodiments, the fluid channel 226 can be narrow enough to form a seal or fluid restriction, thereby significantly reducing or preventing fluid from flowing through the fluid channel 226, especially in the absence of a pressure difference. In various embodiments, one or more fluid channels in the fluid channel 226 can be an elastic valve that is usually closed when unstrained to prevent liquid from flowing through the valve, and can be opened in response to a pressure gradient. In various embodiments, the fluid channel 226 may include a fenestration formed through the first film layer 204. The fenestration may be formed by removing material from the first film layer 204, but the amount of material removed and the resulting size of the fenestration may be at most an order of magnitude smaller than a perforation and may not deform the edges.

[0096] In various embodiments, the fluid channel 226 may include one or more slits, slots, or a combination of slits and slots in the first film layer 204. In various embodiments, the fluid channel 226 may include a linear slot having a length less than about five millimeters and a width less than about two millimeters. In various embodiments, the length may be at least about two millimeters, and the width may be at least about 0.5 millimeters. In various embodiments, the length may be in the range of about two millimeters to about five millimeters, and the width may be in the range of about 0.5 millimeters to about two millimeters, wherein the tolerance is about 0.1 millimeters. In various embodiments, the length may be about three millimeters. Such dimensions and tolerances may be realized, for example, with a laser cutter. In various embodiments, the slot of such a structure may be used as an imperfect valve that significantly reduces the flow of liquid in a normally closed or static state. Such a slot may form a flow restriction without being completely closed or sealed. The slot may expand or open wider in response to the pressure gradient applied across the slot to allow increased liquid to flow through the slot.

[0097] In various embodiments, the fluid passage 226 may include a linear slit having a length less than about five millimeters. In various embodiments, the length of the linear slit may be at least about two millimeters. In various embodiments, the length of the linear slit may be in the range of about two millimeters to about five millimeters, with a tolerance of about 0.1 millimeters. In various embodiments, the length of the linear slit may be about three millimeters.

[0098] In various embodiments, the manifold layer 206 can be formed as a substantially sheet-like structure having a top surface 230 opposite the bottom surface 232 and a perimeter 234 defined by the outer perimeter of the manifold layer 206. In various embodiments, the perimeter 234 of the manifold layer 206 can be substantially similar to or coextensive with the perimeter 224 of the first membrane layer 204. In various embodiments, the manifold layer 206 can be formed of a polyurethane sheet, such as a vacuum-formed polyurethane sheet having a thickness of about 0.5 millimeters. In various embodiments, the manifold layer 206 can be formed of a substantially transparent or optically clear polymer material, thereby allowing a user to see through the manifold layer 206.

[0099] In various embodiments, the windows 236 may be removed from the manifold layer 206 and formed into a grid pattern. For example, the plurality of windows 236 may be arranged in a pattern of rows and columns. The center of each window 236 may be aligned with the center of each other window 236 in the row, and the center of each window 236 may be aligned with the center of each other window 236 in the column. In various embodiments, a plurality of legs 238 may be formed on the bottom surface 232 of the manifold layer 206. In various embodiments, the plurality of legs 238 may form a grid pattern. For example, the plurality of legs 238 may be arranged in a pattern of rows and columns. The center of each leg 238 may be aligned with the center of each other leg 238 in the row, and the center of each leg 238 may be aligned with the center of each other leg 238 in the column. In various embodiments, each row of the plurality of windows 236 may be disposed adjacent to a row of the plurality of legs 238, and each column of the plurality of windows 236 may be disposed adjacent to a column of the plurality of legs 238. In various embodiments, the plurality of windows 236 and the plurality of legs 238 may be arranged in a pattern such that the rows of the pattern alternate between rows of the plurality of windows 236 and rows of the plurality of legs 238 and the columns of the pattern alternate between columns of the plurality of windows 236 and columns of the plurality of legs 238.

[0100] In various embodiments, the profile of each window 236 in the plane of the top surface 230 of the manifold layer 206 may be substantially circular. In various embodiments, the profile of each leg 238 may be substantially circular and protrude outwardly from the plane of the bottom surface 232 of the manifold layer 206 in a substantially orthogonal manner. In various embodiments, the diameter of each window 236 may be greater than the diameter of each leg 238. For example, each window 236 may have a diameter of about eight millimeters, and each leg 238 may have a diameter of about three millimeters. In various embodiments, each leg 238 may have a height in the range of about 0.5 millimeters to about 3 millimeters. In various embodiments, each leg 238 may have a height of about 2.5 millimeters. In various embodiments, each leg 238 may have a height of about 3 millimeters. In various embodiments, each leg 238 in a row may be spaced apart from adjacent legs 238 in the row by a distance of about four millimeters on center, and each leg 238 in a column may be spaced apart from adjacent legs 238 in the column by a distance of about four millimeters on center. In various embodiments, the plurality of legs 238 may be right circular cylinders with hemispherical ends, such as a half-capsule shape, and may be formed on and substantially protrude away from the bottom surface 232 of the manifold layer 206 in a direction substantially perpendicular to the bottom surface 232. In various embodiments, each leg of the plurality of legs 238 may have a height in a range of about 2.5 millimeters to about three millimeters.

[0101] like Figure 2As shown, an example of the manifold layer 206 may include a raised portion, such as a lip or protrusion 240. In various embodiments, the protrusion 240 may protrude outward from the plane of the top surface 230 of the manifold layer 206 in a substantially orthogonal manner. In various embodiments, the protrusion 240 may have a scaled-down profile or outline similar to the shape of the perimeter 234. In various embodiments, the manifold layer 206 may also have a border area 242 between the protrusion 240 and the perimeter 234, and the border area 242 may not include any windows 236 or legs 238. The manifold layer 206 may also include a fluid entry or drip hole (such as hole 239) and an area around the hole 239 that does not have any windows 236 or legs 238 (such as a connection area 243). In various embodiments, the first membrane layer 204 may include a connection area (such as a connection area 241) around the hole 228 for connecting the area around the hole 228 to the connection area 243. In various embodiments, the coupling region 241 may include an area of ​​the top surface 220 of the first membrane layer 204 surrounding the hole 228. In various embodiments, the coupling region 241 may be an area of ​​the top surface 220 defined by the area between a circle having a diameter greater than the diameter of the hole 228 and concentric with the hole 228 and the hole 228 itself. In various embodiments, the coupling region 241 may be convex such that it is offset a certain distance from the top surface 220 toward the manifold layer 206.

[0102] The second film layer 208 may have a top surface 244 opposite the bottom surface 246 and a perimeter 248 defined by the perimeter of the second film layer 208. Negative pressure holes (such as holes 250) and fluid entry or drip holes (such as holes 252) may be formed through the second film layer 208. In various embodiments, the second film layer 208 may be formed of or include any of the materials previously described with respect to the cover 110 and / or the first film layer 204. In various embodiments, the second film layer 208 may include a connection area (such as a connection area 253) around the hole 252 for connecting the area around the hole 252 to the connection area 241. In various embodiments, the connection area 253 may include an area of ​​the bottom surface 246 of the second film layer 208 surrounding the hole 252. In various embodiments, the connection area 253 may be an area of ​​the bottom surface 246 defined by an area between a circle having a diameter greater than the diameter of the hole 252 (and concentric with the hole 252) and the hole 252 itself. In various embodiments, the coupling region 253 may be raised such that it is offset a distance from the bottom surface 246 toward the manifold layer 206 .

[0103] like Figure 2As shown in , an example of a dressing 104 may include a cover 110 having a top surface 254 opposite a bottom surface 256 and a perimeter 258 defined by an outer perimeter of the cover 110. A central aperture 260 may be formed through the cover 110.

[0104] In various embodiments, the perimeter 214 of the sealing layer 202 can be substantially coextensive with the perimeter 258 of the cover 110. In various embodiments, the perimeter 224 of the first film layer 204, the perimeter 234 of the manifold layer 206, and the perimeter 248 of the second film layer 208 can be substantially coextensive. In various embodiments, the contour of the treatment hole 216 of the sealing layer 202 can be substantially coextensive with the contour of the central hole 260 of the cover 110. In various embodiments, the contours of the treatment hole 216 and the central hole 260 can be substantially similar to the contours of the perimeter 224, the perimeter 234, and the perimeter 248. In various embodiments, the contours of the treatment hole 216 and the central hole 260 can be substantially similar to the contours of the perimeter 224, the perimeter 234, and the perimeter 248, but scaled down from the contours of these perimeters. In assembled form, the sealing layer 202, the first membrane layer 204, the manifold layer 206, the second membrane layer 208, and the cover 110 can be stacked such that the perimeter 214 is aligned with the perimeter 258, and the perimeter 224 is aligned with the perimeters 234 and 248. In various embodiments, the treatment hole 216 can be aligned with the central hole 260, and the perimeters 224, 234, and 248 are positioned such that they are aligned with and extend uniformly across the contours of the treatment hole 216 and the central hole 260.

[0105] In various embodiments, a portion of the top surface 220 of the first membrane layer 204 near the perimeter 224 may be coupled to a portion of the bottom surface 232 of the manifold layer 206 at a boundary region 242, and a portion of the top surface 220 at a coupling region 241 may be coupled to a portion of the bottom surface 232 at a coupling region 243 to define a first chamber 245 between the first membrane layer 204 and the manifold layer 206. In various embodiments, a portion of the bottom surface 246 of the second membrane layer 208 near the perimeter 248 may be coupled to a portion of the top surface 230 of the manifold layer 206 at a boundary region 242, and a portion of the bottom surface 246 at a coupling region 253 may be coupled to a portion of the top surface 230 at a coupling region 243 to define a second chamber 247 between the second membrane layer 208 and the manifold layer 206. In various embodiments, the apertures 228 of the first membrane layer 204, the apertures 239 of the manifold layer 206, and the apertures 252 of the second membrane layer 208 may be substantially coaxially aligned. In various embodiments, the fluid access channel can be defined as a fluid passage through the aperture 252, the aperture 239, and the aperture 228. In various embodiments, as a result of the coupling regions 241 and 253 being coupled to the coupling region 243, the fluid access channel can be substantially isolated from the first chamber 245 and the second chamber 247 formed in the interior of the dressing 104.

[0106] In various embodiments, a portion of the top surface 210 of the sealing layer 202 surrounding the treatment hole 216 may be coupled to a portion of the bottom surface 222 of the first film layer 204 near the perimeter 224, and a portion of the bottom surface 256 of the cover 110 surrounding the central hole 260 may be coupled to a portion of the top surface 244 of the second film layer 208 near the perimeter 248. In various embodiments, a portion of the top surface 210 of the sealing layer 202 between the perimeter 214 and the treatment hole 216 may be coupled to a portion of the bottom surface 256 of the cover 110 between the perimeter 258 and the central hole 260.

[0107] Some examples of the dressing 104 also include a dressing interface 262 and a fluid conductor 264. In various embodiments, the fluid conductor 264 can be a flexible tube, one end of which can be fluidly coupled to the dressing interface 262. In various embodiments, the dressing interface 262 can be an elbow connector that can be placed over the hole 260 to provide a fluid path between the fluid conductor 264 and the interior of the dressing 104. In various embodiments, the dressing 104 includes a fluid entry or drip port cover, such as the cover 266. In various embodiments, the cover 266 can be formed of or include any of the materials previously described with respect to the cover 110, the first film layer 204, and / or the second film layer 208. In various embodiments, the cover 266 can be releasably coupled to a portion of the top surface 244 of the second film layer 208 and / or a portion of the top surface 254 of the cover 110 to cover the aperture 252, and can be removed by the user to expose the aperture 252 before the dressing 104 is used for instillation or oxygen therapy. For example, the bottom surface 267 of the cover 266 can be coated with an adhesive having a release factor suitable for facilitating manual removal of the cover 266 without damaging or deforming the dressing 104.

[0108] like Figure 2 As illustrated, some examples of the dressing 104 may include a release liner 268 to protect the sealing layer 202 and the adhesive coated on the bottom surface 256 of the cover 110 before use. The release liner 268 may also provide rigidity to assist, for example, in the deployment of the dressing 104. In various embodiments, the release liner may include polyethylene terephthalate (PET) or a similar polar semi-crystalline polymer. Using a polar semi-crystalline polymer for the release liner 268 may substantially prevent the dressing 104 from wrinkling or other deformation. The polar semi-crystalline polymer may be highly oriented and resist softening, swelling, or other deformation that may occur when an object contacts the layers and / or components of the dressing 104 or when the dressing 104 is subjected to temperature or environmental changes or during sterilization. In addition, a release agent may be disposed on the top surface 270 of the release liner 268, which is configured to contact the bottom surface 212 of the sealing layer 202 and the adhesive disposed on the bottom surface 256 of the cover 110. For example, the release agent may be a silicone coating and may have a release coefficient suitable for facilitating manual removal of the release liner 268 without damaging or deforming the dressing 104. In various embodiments, the release agent may be a fluorocarbon or a fluorosilicone. In various embodiments, the release liner 268 may be uncoated or may otherwise be used without a release agent.

[0109] Figure 3 yes Figure 2 An isometric view of an example of an assembled dressing 104. Figure 3, in some examples, the cover 110, the second film layer 208, the manifold layer 206, and / or the first film layer 204 can be substantially transparent or optically transparent, thereby allowing visualization of the layers of the dressing 104 and visualization of the window 236 through the manifold layer 206. In various embodiments, the cover 266 can be coupled to the top surface 244 and / or the top surface 254, thereby fluidly isolating the fluid passage between the interior of the dressing 104 and the external environment via the aperture 252. In such a configuration, the dressing 104 can be used for negative pressure wound therapy without the need for instillation or oxygen therapy.

[0110] Figure 4 yes Figure 2 and Figure 3 An isometric view of an assembled dressing 104 with a dressing interface attached for negative pressure wound therapy and instillation and / or oxygen therapy. Figure 3 As shown, in some examples, dressing interface 262 and fluid conductor 264 can be attached to top surface 244 and / or top surface 254 and fluidly coupled to the interior of dressing 104 via aperture 250, and dressing interface 402 and fluid conductor 404 can similarly be attached to top surface 244 and / or top surface 254 and fluidly coupled to fluid access channel via aperture 252. In various embodiments, fluid conductor 264 can be connected to negative pressure source 102, and fluid conductor 404 can be connected to solution source 118 and / or oxygen source.

[0111] Figure 5 yes Figure 2-Figure 4 A top view of an assembled dressing 104 illustrating details that may be associated with some examples. Figure 6 yes Figure 2-Figure 5 A bottom view of a dressing 104 is provided, illustrating details that may be associated with some embodiments. Figure 5 and Figure 6 As illustrated, in some examples of the dressing 104, the perimeter 258 of the cover 110 can be coextensive with the perimeter 214 of the sealing layer 202. In various embodiments, the perimeter 224 of the first film layer 204 can be coextensive with the perimeter 234 of the manifold layer 206 and the perimeter 248 of the second film layer 208. In various embodiments, the perimeter or outline of the central aperture 260 of the cover 110 can be coextensive with the perimeter or outline of the treatment aperture 216 of the sealing layer 202 in a plane defined by the top surface 254 of the cover 110 or the bottom surface 212 of the sealing layer 202.

[0112] As previously referenced Figure 2As described, the perimeters or contours of the treatment aperture 216 and the central aperture 260 may be similar in shape to the perimeters or contours of the perimeters 224, 234, and 248 but scaled down such that, in an assembled form, a portion of the sealing layer 202 surrounding the treatment aperture 216 overlaps a portion of the first film layer 204 surrounding the perimeter 224, and a portion of the cover 110 surrounding the central aperture 260 overlaps a portion of the second film layer 208 surrounding the perimeter 248, for example, at the border region 242. Figure 5 As shown and in some examples, the outlines or perimeters of the apertures 252 of the second membrane layer 208 , the apertures 239 of the manifold layer 206 , and the apertures 228 of the first membrane layer 204 may be coextensive.

[0113] Figure 7-Figure 18 is a top view illustrating additional details that may be associated with some examples of first film layer 204. For example, Figure 7 As illustrated, the fluid channel 226 may include a first plurality of perforations 702 and a second plurality of perforations 704. Each of the first plurality of perforations 702 and the second plurality of perforations 704 may be a linear or curved perforation, such as a slot or slit. In some embodiments where the perforations are linear slots or slits, each of the first plurality of perforations 702 may have a length L1, and each of the second plurality of perforations 704 may have a length L2. In some embodiments, where the perforations are curved slots or slits, each of the first plurality of perforations may have a length L1 measured from one end of the curved slot or slit to the other end of the curved slot or slit, and each of the second plurality of perforations may have a length L2 measured from one end of the curved slot or slit to the other end of the curved slot or slit. In some embodiments, the length L1 may be equal to the length L2. The first plurality of perforations 702 and the second plurality of perforations 704 may be distributed across the second layer in one direction or in different directions in one or more rows.

[0114] In an exemplary embodiment, each perforation in the first plurality of perforations 702 may have a first major axis. In some embodiments, the first major axis may be parallel to a first reference line 706 extending in a first direction. In an illustrative example, each perforation in the second plurality of perforations 704 may have a second major axis. In an exemplary embodiment, the second major axis may be parallel to a second reference line 708 extending in a second direction. In some embodiments, one or both of the first reference line 706 and the second reference line 708 may be defined relative to an edge 710 or a line of symmetry of the first film layer 204. For example, one or both of the first reference line 706 and the second reference line 708 may be parallel to or coincide with the edge 710 or the line of symmetry of the first film layer 204. In some exemplary embodiments, one or both of the first reference line 706 and the second reference line 708 may be rotated by a certain angle relative to the edge 710 of the first film layer 204. In an exemplary embodiment, the angle α may define the angle between the first reference line 706 and the second reference line 708.

[0115] In some exemplary embodiments, the centroid of each perforation in the first plurality of perforations 702 in a row may intersect a third reference line 712 extending in a third direction. In an exemplary embodiment, the centroid of each perforation in the second plurality of perforations 704 in a row may intersect a fourth reference line 714 extending in a fourth direction. Generally speaking, the centroid refers to the centroid of a geometric object. In the case of a substantially two-dimensional object such as a linear slit, the centroid of the linear slit will be the midpoint.

[0116] The pattern of fluid channels 226 may also be characterized by a pitch, which indicates the spacing between corresponding points on the fluid channels 226 within the pattern. In an exemplary embodiment, the pitch may indicate the spacing between the centroids of the fluid channels 226 within the pattern. Some patterns may be characterized by a single pitch value, while other patterns may be characterized by at least two pitch values. For example, if the spacing between the centroids of the fluid channels 226 is the same in all orientations, the pitch may be characterized by a single value indicating the spacing between the centroids in adjacent rows. In an exemplary embodiment, a pattern including a first plurality of perforations 702 and a second plurality of perforations 704 may be characterized by two pitch values ​​P1 and P2, where P1 is the spacing between the centroids of each perforation in the first plurality of perforations 702 in adjacent rows, and P2 is the spacing between the centroids of each perforation in the second plurality of perforations 704 in adjacent rows.

[0117] In an exemplary embodiment, within each row of the first plurality of perforations 702, each perforation may be separated from an adjacent perforation by a distance D1. In some embodiments, within each row of the second plurality of perforations 704, each perforation may be separated from an adjacent perforation by a distance D2. In some patterns, the rows may be staggered. Staggering may be characterized by the orientation of corresponding points in consecutive rows relative to an edge or other reference line associated with the first film layer 204. In some embodiments, the rows of the first plurality of perforations 702 may be staggered. For example, the fifth reference line 716 in the fifth direction passes through the centroid of the corresponding perforations of the adjacent rows of the first plurality of perforations 702. In some exemplary embodiments, the staggering of the rows of the first plurality of perforations 702 may be characterized by an angle β formed between the first reference line 706 and the fifth reference line 716. In additional exemplary embodiments, the rows of the second plurality of perforations 704 may also be staggered. For example, the sixth reference line 718 in the sixth direction passes through the centroid of the corresponding perforations of the adjacent rows of the second plurality of perforations 704. In some implementations, the staggering of the rows of the second plurality of perforations 704 can be characterized by an angle γ formed between the first reference line 706 and the sixth reference line 718 .

[0118] Figure 7 Examples of patterns that may be associated with some embodiments of fluid channels 226 are illustrated. Figure 7 In the example of , each of the first plurality of perforations 702 and the second plurality of perforations 704 can be a linear slot or slit. The first reference line 706 can be parallel to the edge 710, and the second reference line 708 can be orthogonal to the edge 710. In an exemplary embodiment, the third reference line 712 is orthogonal to the first reference line 706, and the fourth reference line 714 is orthogonal to the second reference line 708. For example, the third reference line 712 can be incident with the centroid of the corresponding perforations in the second plurality of perforations 704 in alternating rows, and the fourth reference line 714 can intersect with the centroid of the corresponding perforations in the first plurality of perforations 702 in alternating rows. Figure 7 In the example of , the fluid channels 226 are arranged in a cross-pitch pattern, wherein each of the first plurality of perforations 702 along its first long axis is orthogonal to each of the second plurality of perforations 704 along its second long axis. Figure 7 , P1 is equal to P2 (within acceptable manufacturing tolerances), and the cross-pitch pattern can be characterized by a single pitch value. In addition, L1 and L2 can be substantially equal, and D1 and D2 can also be substantially equal, all within acceptable manufacturing tolerances. The rows of the first plurality of perforations 702 and the rows of the second plurality of perforations 704 can be characterized as staggered. For example, in some exemplary embodiments illustrated, α can be about 90°, β can be about 135°, γ can be about 45°, P1 can be about 4 mm, P2 can be about 4 mm, L1 can be about 3 mm, L2 can be about 3 mm, D1 can be about 5 mm, and D2 can be about 5 mm.

[0119] Figure 8 is a schematic diagram of another exemplary pattern that may be associated with some exemplary embodiments of fluid channel 226. Fig.21 In the illustrative example of, each of the first plurality of perforations 702 and the second plurality of perforations 704 may be a linear slit. The first reference line 706 may be parallel to the edge 710, and the second reference line 708 may be orthogonal to the edge 710. In some exemplary embodiments, the third reference line 712 is orthogonal to the first reference line 706, and the fourth reference line 714 is orthogonal to the second reference line 708. Fig.21 In the example of the embodiment of the present invention, the third reference line 712 does not intersect or contact any of the second plurality of perforations 704, and the fourth reference line 714 can intersect the centroids of corresponding perforations in alternating rows of the first plurality of perforations 702. In an exemplary embodiment, the third reference line 712 can be equidistant from the centroids of corresponding adjacent perforations within each row of the second plurality of perforations 704. Fig.21 The pattern can also be characterized as a cross-pitch pattern, where P1 is not equal to P2. Fig.21 In the example, P1 is greater than P2. Fig.21 In the example of , L1, L2, D1, and D2 are substantially equal. In some embodiments, α may be about 90°, β may be about 0°, so that the first reference line 706 coincides with the fifth reference line 740, γ may be about 90°, P1 may be about 6 mm, P2 may be about 3 mm, L1 may be about 3 mm, L2 may be about 3 mm, D1 may be about 3 mm, and D2 may be about 3 mm.

[0120] Fig. 9 Additional examples of patterns that may be associated with some embodiments of fluid channels 226 are illustrated. Fig. 9 In the example of , each of the first plurality of perforations 702 and the second plurality of perforations 704 can be a linear slit. The first reference line 706 can be parallel to the edge 710, and the second reference line 708 can be orthogonal to the edge 710. In an exemplary embodiment, the third reference line 712 is orthogonal to the first reference line 706, and the fourth reference line 714 is orthogonal to the second reference line 708. Fig. 22 In the example of , the third reference line 712 does not intersect or contact any of the second plurality of perforations 704, and the fourth reference line 714 does not intersect or contact any of the first plurality of perforations 702. In an exemplary embodiment, the third reference line 712 can be equidistant from the centroids of corresponding adjacent perforations within each row of the second plurality of perforations 704, and the fourth reference line 714 can be equidistant from the centroids of corresponding adjacent perforations within each row of the first plurality of perforations 702. Fig. 22 The pattern can be characterized as a cross-pitch pattern, where P1 is substantially equal to P2. Fig. 9 In the example of , L1, L2, D1, and D2 are substantially equal. In some embodiments, α may be about 90°, β may be about 0°, so that the first reference line 706 coincides with the fifth reference line 740, γ may be about 90°, P1 may be about 6 mm, P2 may be about 6 mm, L1 may be about 3 mm, L2 may be about 3 mm, D1 may be about 3 mm, and D2 may be about 3 mm.

[0121] Fig.10 Additional embodiments of patterns that may be associated with some embodiments of fluid channels 226 are illustrated. Fig.10 In the example of , each of the first plurality of perforations 702 and the second plurality of perforations 704 can be a linear slit. The first reference line 706 can form an angle θ with the edge 710, and the second reference line 708 can form an angle θ with the edge 710. In an exemplary embodiment, the third reference line 712 is orthogonal to the first reference line 706, and the fourth reference line 714 is orthogonal to the second reference line 708. Fig.10 In the example of , the third reference line 712 does not intersect or contact any of the second plurality of perforations 704, and the fourth reference line 714 does not intersect or contact any of the first plurality of perforations 702. In an exemplary embodiment, the third reference line 712 can be equidistant from the centroids of corresponding adjacent perforations within each row of the second plurality of perforations 704, and the fourth reference line 714 can be equidistant from the centroids of corresponding adjacent perforations within each row of the first plurality of perforations 702. Fig.10 The pattern can be characterized as a cross-pitch pattern, where P1 is substantially equal to P2. Fig.10 In the example of , L1 may be substantially equal to L2, and D1 may be substantially equal to D2. In some embodiments, β may be approximately 0°, so that the first reference line 706 coincides with the fifth reference line 716, γ may be approximately 90°, θ may be approximately 45°, and It can be about 135°.

[0122] Fig.11 Examples are illustrated that may be associated with some embodiments of fluid channel 226. Fig.11 In some embodiments, each perforation in the first plurality of perforations 702 and the second plurality of perforations 704 may be a linear slit. The first reference line 706 may be parallel to the edge 710, and the second reference line 708 may be orthogonal to the edge 710. In an exemplary embodiment, the third reference line 712 is orthogonal to the first reference line 706, and the fourth reference line 714 is orthogonal to the second reference line 708. For example, the third reference line 712 may be incident on the centroid of corresponding perforations in alternating rows of the second plurality of perforations 704, and the fourth reference line 714 may be incident on the centroid of corresponding perforations in alternating rows of the first plurality of perforations 702. Fig.11 In the example of , the centroid of each perforation in the first plurality of perforations 702 is incident with the centroid of a perforation in the second plurality of perforations 704. The fluid channels 226 are arranged in a cross-pitch pattern, wherein each perforation in the first plurality of perforations 702 along its first major axis is orthogonal to each perforation in the second plurality of perforations 704 along its second major axis. Fig.11 , P1 is substantially equal to P2, and the cross-spacing pitch may be characterized by a single pitch value. Additionally, L1 and L2 may be substantially equal, and D1 and D2 may also be substantially equal, all within acceptable manufacturing tolerances. The rows of the first plurality of perforations 702 and the rows of the second plurality of perforations 704 may be characterized as staggered. Fig.11 In some exemplary embodiments, α may be about 90°, β may be about 135°, and γ may be about 45°.

[0123] Fig.12 Additional embodiments are shown in association with certain exemplary embodiments of fluid passage 226. Fig.12 In the example of FIG. 7 , each of the first plurality of perforations 702 and the second plurality of perforations 704 may be a linear slit. The first reference line 706 may form an angle θ with the edge 710. The second reference line 708 may form an angle θ with the edge 710. exist Fig.12 In the exemplary embodiment of , the third reference line 712 and the fourth reference line 714 can be orthogonal to the edge 710. Fig.12 In the example of , the rows of the first plurality of perforations 702 and the rows of the second plurality of perforations 704 can be characterized as mirror-image rows running in a direction parallel to the edge 710 of the first film layer 204. For example, within acceptable manufacturing tolerances, L1 and L2 can be substantially equal, D1 and D2 can be substantially equal, and P1 and P2 can be substantially equal. In some embodiments, θ can be approximately 45°, and It can be about 135°. Fig.12 The pattern can be characterized as a herringbone pattern.

[0124] Fig.13 Additional exemplary embodiments are shown in association with certain exemplary embodiments of fluid channel 226. Fig.13 In the example of FIG. 7 , each of the first plurality of perforations 702 and the second plurality of perforations 704 can be a curved slit. The first reference line 706 can form an angle θ with the edge 710. The second reference line 708 can form an angle θ with the edge 710. exist Fig.13 In an exemplary embodiment of , the third reference line 712 and the fourth reference line 714 may be parallel to the edge 710. Fig.13In the example of FIG. 1 , the rows of the first plurality of perforations 702 and the rows of the second plurality of perforations 704 can be characterized as mirror images running in a direction parallel to the edge 710 of the first film layer 204. The rows of the first plurality of perforations 702 and the rows of the second plurality of perforations 704 can be characterized as Fig.13 For example, within acceptable manufacturing tolerances, L1 and L2 may be substantially equal, D1 and D2 may be substantially equal, and P1 and P2 may be substantially equal. In some embodiments, θ may be approximately 45°, and It can be about 225°.

[0125] Fig.14 Additional embodiments are shown in association with certain embodiments of fluid channel 226. Fig.14 In the example of , each perforation in the first plurality of perforations 702 and the second plurality of perforations 704 may be characterized as a V-shaped slit. Each V-shaped slit may be formed by two orthogonal straight slits of the same length that coincide at endpoints. The V-shaped slits may be characterized as pointing in a direction defined by a vector drawn from the centroid of the V-shaped slits to the coincident endpoints. Within each row of the first plurality of perforations 702, the V-shaped slits point in the same direction. Within each row of the second plurality of perforations 704, the V-shaped slits point in the same direction. In an exemplary embodiment, the V-shaped slits of the first plurality of perforations 702 and the V-shaped slits of the second plurality of perforations 704 point in opposite directions. In an exemplary embodiment, the first reference line 706 and the second reference line 708 may be parallel to the edge 710. In an exemplary embodiment, the third reference line 712 and the fourth reference line 714 may be orthogonal to the first reference line 706. In Fig.14 In the example of FIG. 7 , the rows of the first plurality of perforations 702 and the rows of the second plurality of perforations 704 can be characterized as mirror-image rows that run in a direction orthogonal to the edge 710 of the first film layer 204 .

[0126] Fig.15Also illustrated are exemplary embodiments that may be associated with some embodiments of the fluid channel 226. Certain patterns of the fluid channel 226 may include a third plurality of perforations 1502, a fourth plurality of perforations 1504, a fifth plurality of perforations 1506, and a sixth plurality of perforations 1508. Each perforation in the third plurality of perforations 1502 may be a linear slit having a major axis substantially orthogonal to the edge 710. Each perforation in the fourth plurality of perforations 1504 may be a linear slit having a major axis substantially orthogonal to the major axis of the third plurality of perforations 1502. Each perforation in the fifth plurality of perforations 1506 may be a curved slit having a major axis rotated to form a 45° angle with the edge 710. Each perforation in the sixth plurality of perforations 1508 may be a curved slit having a major axis rotated to form a 225° angle with the edge 710. Within each row, the pattern of fluid channels 226 can be a repeating pattern of one perforation in the fifth plurality of perforations 1506, one perforation in the third plurality of perforations 1502, one perforation in the sixth plurality of perforations 2820, one perforation in the fifth plurality of perforations 1506, one perforation in the third plurality of perforations 1502, and one perforation in the sixth plurality of perforations 1508 (in order). Each alternating row in the pattern of fluid channels 226 can be shifted by three positions in either direction.

[0127] Figures 16 to 18 is a schematic diagram illustrating additional details that may be associated with some embodiments of fluid channel 226. For example, Fig.17 As illustrated, the fluid channels 226 can be distributed across the first film layer 204 in a row pattern. In some embodiments, each fluid channel 226 along a row can be rotated about 90° relative to an adjacent fluid channel 226. Each fluid channel 226 along a row can be rotated about 90° clockwise or about 90° counterclockwise relative to a previous adjacent fluid channel 226 in the row. In an exemplary embodiment of the pattern of fluid channels 226, every second row can be offset by one fluid channel 226 relative to the previous row. Figures 16 to 18 The pattern can be characterized as a pattern of offset rows. Figures 16 to 18 Exemplary embodiments of the pattern may further be characterized as a pattern of rotating fluid channels 22 .

[0128] Fig.16 Exemplary embodiments are illustrated in which the fluid channels 226 include curved slits. In some exemplary embodiments, the fluid channels 226 within a row alternate between being parallel to the edge 710 of the first film layer 204 along the long axis of the fluid channels 226 and being orthogonal to the edge 710 of the first film layer 204 along the long axis.

[0129] Fig.17Some embodiments are shown where the fluid channels 226 include V-shaped slits. In some exemplary embodiments, the fluid channels 226 within a row alternate between being parallel to the edge 710 of the first film layer 204 along the long axis of the fluid channels 226 and being orthogonal to the edge 710 of the first film layer 204 along the long axis.

[0130] Fig.18 Also depicted are exemplary embodiments in which the fluid channels 226 include split V-shaped slits. Each split V-shaped slit can be formed by two orthogonal non-incidental linear slits that are mirrored about an axis that bisects the angle formed by the intersection of the orthogonal long axes of the linear slits. In some exemplary embodiments, the fluid channels 226 within a row alternate between being parallel to the edge 710 of the first film layer 204 along the long axis of the fluid channel 226 and being orthogonal to the edge 710 of the second layer along the long axis.

[0131] In other embodiments, P1 may be in the range of about 4 mm to about 6 mm, and P2 may be in the range of about 3 mm to about 6 mm. In an exemplary embodiment, D1 may be in the range of about 3 mm to about 5 mm, and D2 may be in the range of about 3 mm to 5 mm. In some embodiments, the number of fluid channels 226 in the first plurality of perforations 702 may be equal to the number of fluid channels 226 in the second plurality of perforations 704.

[0132] Fig.19 yes Figure 4 A cross-sectional view of an exemplary dressing 104 applied to an exemplary tissue site 1902 taken along line 19-19 and illustrating Figure 1 Additional details associated with the treatment system 100 are provided. Fig.19 As shown, in various embodiments, the bottom surface 256 of the cover 110 can be coated with an adhesive layer 1903, and at least a portion of the cover 110 can be coupled to at least a portion of the top surface 220 of the sealing layer 202 using the adhesive layer 1903. The adhesive layer 1903 can be the adhesive layer 256 of the cover 110. Figure 1Any of the attachment means discussed. At least a portion of the bottom surface 256 of the cover 110 can be coupled to at least a portion of the top surface 244 of the second film layer 208 via the adhesive layer 1903, for example, at the border region 242. In various embodiments, at least a portion of the bottom surface 222 of the first film layer 204 can be coupled to at least a portion of the top surface 210 of the sealing layer 202 (e.g., at the border region 242). In various embodiments, the perimeters or contours of the apertures 228, 239, and 252 can be aligned, and a portion of the first film layer 204 surrounding the apertures 228 can be coupled to the coupling region 241 of the manifold layer 206, and a portion of the second film layer 208 surrounding the apertures 252 can be coupled to the coupling region 241 to define a fluid entry channel through the apertures 228, 239, and 252. In various embodiments, the fluid entry channel is substantially isolated from the interior of the dressing 104.

[0133] In some applications, dressing 104 can be applied to tissue site 1902 and cover wound 1904. Tissue site 1902 can be or include a defect or targeted treatment site, such as wound 1904, which can be partially or completely filled or covered by dressing 104. In some examples, wound 1904 can be in epidermis 1906. In some examples, wound 1904 can extend through epidermis 1906 and into dermis 1908. In some examples, such as Fig.19 As shown, wound 1904 can extend through epidermis 1906 and dermis 1908 and into subcutaneous tissue 1910. In some applications, at least a portion of bottom surface 212 of sealing layer 202 can be in contact with a portion of epidermis 1906 surrounding wound 1904, and at least a portion of bottom surface 222 of first film layer 204 can be placed in, above, on, against, or otherwise proximate to wound 1904.

[0134] In operation, negative pressure may be provided to the wound 1904, and / or fluid may be removed from the wound 1904 by the negative pressure source 102. For example, fluid may travel from the wound 1904 through at least one of the fluid channels 226 into the first chamber 245 between the top surface 220 of the first membrane layer 204, the bottom surface 232 of the manifold layer 206, and the legs 238. The fluid may then travel through the window 236 of the manifold layer 206 and into the second chamber 247 between the top surface 230 of the manifold layer 206 and the bottom surface 246 of the second membrane layer 208. The fluid may then travel through the aperture 250 and into the dressing interface 262, and from the dressing interface 262 through the fluid conductor 264 and / or the container 106 to the negative pressure source 102.

[0135] In operation, an instillation solution may be provided to the wound 1904 by the solution source 118, and / or oxygen may be provided to the wound by the oxygen source. For example, the instillation solution and / or oxygen may travel from the solution source 118 and / or the oxygen source to the dressing interface 402 via the fluid conductor 404. The instillation solution and / or oxygen may then travel from the dressing interface 402 to the dressing via the fluid entry channel formed by the holes 252 of the second film layer 208, the holes 239 of the manifold layer 206, and the holes 228 of the first film layer 204. In such a configuration, the instillation solution and / or oxygen bypasses the interior space of the dressing 104 (such as the first chamber 245 and the second chamber 247) by traveling directly to the wound 1904 via the fluid entry channel, which may be substantially isolated from the interior space of the dressing 104.

[0136] Fig.19A is Fig.19 A detailed view taken at 19A in FIG. 1 illustrates a Fig.19 Detailed information associated with some exemplary embodiments of the exemplary dressing 104 of the present invention is provided. In various embodiments, the sealing layer 202 may be sufficiently tacky at the bottom surface 212 to hold the dressing 104 in place relative to the epidermis 1906 and / or the wound 1904 while allowing the dressing 104 to be removed or repositioned without causing trauma to the tissue site 1902. In various embodiments, the sealing layer 202 may be formed of a silicone polyurethane material that may form a sealed connection with the epidermis 1906 at the bottom surface 212. In various embodiments, the bond strength or tack of the sealed connection may have a peel adhesion or resistance to peeling from the stainless steel material between about 0.5 N / 25 mm and about 1.5 N / 25 mm based on ASTM D3330 at about 25° C. and about 50% relative humidity on a stainless steel substrate. The sealing layer 202 may achieve this bond strength after a contact time of less than about 60 seconds. Tackiness may be considered to be the bond strength of the adhesive after a very low contact time between the adhesive and the substrate. In various embodiments, sealing layer 202 may have a thickness in the range of about 200 microns to about 1,000 microns. Removing release liner 268 may also expose adhesive layer 1903 through holes 218 of sealing layer 202. In an assembled state, the thickness of sealing layer 202 may create a gap between adhesive layer 1903 and skin 1906 through holes 218 of sealing layer 202, so that adhesive 1903 does not contact skin 1906.

[0137] Fig.19B It is an example of Fig.19 Some embodiments of the dressing 104 may be Fig.19A A detail view that associates additional details with the detail view. Fig.19BThe adhesive layer 1903 is illustrated after a portion thereof has been brought into contact with the epidermis 1906 by a force vector 1912 applied to the top surface 254 of the cover 110 at the apertures 218. In use, if the assembled dressing 104 is in a desired position, the force vector 1912 may be applied to the top surface 254 at the apertures 218 so that at least a portion of the adhesive layer 1903 is pressed into at least partial contact with the epidermis 1906 through at least one or more of the apertures 218 to form an adhesive connection. The adhesive connection may provide a secure, releasable mechanical fixation of the dressing 104 to the epidermis 1906. In various embodiments, the sealing connection may not be as mechanically secure as the adhesive connection. The adhesive connection may anchor the dressing 104 to the epidermis 1906, thereby inhibiting and / or substantially preventing migration of the dressing 104.

[0138] Fig.19C is Fig.19 A detailed view taken at 19C in FIG. 1 illustrates a Fig.19 Features associated with some embodiments of the exemplary dressing 104. Fig.19C As shown, in some examples, the first film layer 204 may include a plurality of micro features to ensure that the bottom surface 222 of the first film layer 204 is smooth when negative pressure is applied to the dressing 104 but is patterned in the absence of negative pressure. For example, the first film layer 204 may include a plurality of thickened areas 1914 and a plurality of thinner areas 1916 surrounding the thickened areas 1914. Fig.19C , in the absence of negative pressure, the thin region 1916 can be shaped such that portions of the bottom surface 222 of the first film layer 204 are biased away from the wound 1904 to define a plurality of voids 1918. In various embodiments, these voids 1918 can provide additional space for instillation solution and / or oxygen to flow in, so as to provide increased saturation of the wound 1904 during instillation and / or oxygen therapy.

[0139] Fig.19D It is an example of Fig.19 Some embodiments of the dressing 104 may be Fig.19C The detailed view of the additional features associated with the detailed view of Fig.19D As illustrated, in various embodiments, the thinner region 1916 may deform after negative pressure is applied to the dressing 104 such that the void 1918 disappears and the bottom surface 222 lies substantially flat against the surface of the wound 1904 , thereby minimizing surface stress against the wound 1904 by evenly distributing the pressure of the bottom surface 222 across a larger surface area of ​​the wound 1904 .

[0140] Fig.19E and Fig.19F is an example of Fig.19A cross-sectional view of additional details associated with dressing 104. Fig.19E and Fig.19F An example of a dressing 104 applied to a contoured tissue site 1902 is illustrated. Fig.19E In the example of FIG. 1 , negative pressure has been applied to the dressing 104. Due to the pressure difference between the negative pressure in the dressing and the external surrounding environment, a force is applied to the top surface 244 of the second film layer 208 by the atmosphere, and the dressing 104 is biased toward the tissue site 1902, so that the bottom surface 222 of the first film layer 204 can substantially contact the contour of the wound site 1902. Fig.19F An example of the dressing 104 is illustrated after negative pressure has been released from the dressing 104. In various embodiments, after the negative pressure is released, the dressing 104 can rebound from the tissue site 1902, such that a void 1920 is created between the bottom surface 222 of the first film layer 204 and the tissue site 1902. In various embodiments, the presence of the void 1920 can be beneficial during instillation therapy because the void creates additional volume between the bottom surface 222 and the surface of the tissue site 1902 for saturation with instillation solution and / or oxygen.

[0141] Fig. 20 yes Figure 1 An exploded view of an example of a dressing 104 is provided, illustrating additional details that may be associated with some embodiments. In various embodiments, Fig. 20 The dressing 104 may be substantially similar to Figure 2-Figure 4 and Fig.19 The present invention relates to a dressing 104 of the present invention, except that the first film layer 204 does not include the hole 228, the manifold layer 206 is formed of an open-cell foam, the second film layer 208 is omitted, and the cover does not include the central hole 260. In various embodiments, the open-cell foam manifold layer 206 may have a height in the range of about 50 mm to about 250 mm, such as a height of about 50 mm, 100 mm, 150 mm, 200 mm, or 250 mm. In various embodiments, the cover 110 may include a negative pressure channel (such as the hole 2102) and a fluid entry channel (such as the hole 2104). In various embodiments, the adhesive layer 1903 may coat substantially all of the bottom surface 256 of the cover 110. When assembled, at least a portion of the bottom surface 256 of the cover 110 may be coupled to at least a portion of the top surface of the manifold layer 206 by the adhesive layer 1903, and at least another portion of the bottom surface 256 of the cover 110 may be coupled to the area of ​​the sealing layer 202 between the perimeter 214 and the treatment hole 216. In various embodiments, at least a portion of the top surface 220 of the first membrane layer 204 may be coupled to at least a portion of the bottom surface 232 of the manifold layer 206 .

[0142] A fluid inlet channel, such as a hole 2106, may be formed through the top surface 230 of the manifold layer 206 and extend from the top surface to the bottom surface 246 of the manifold layer. A fluid isolation member, such as a fluid isolation member 2108, may be received within the hole 2106 and / or the first membrane layer 204. In various embodiments, the fluid isolation member 2108 may be a cylinder having a hollow interior, such as a tube. The fluid isolation member 2108 may have a height extending from the top surface 230 of the manifold layer 206 to the bottom surface 222 of the first membrane layer 204. In various embodiments, the outer diameter of the fluid isolation member 2108 may be smaller than the diameter of the hole 2106 and the diameter of the hole 228, and the inner diameter of the fluid isolation member 2108 may be smaller than the outer diameter. In an assembled form, the hole 228, the hole 2106, the fluid isolation member 2108, and the hole 2104 may be substantially coaxial.

[0143] Fig.21 yes Fig. 20 An isometric view of an assembled example of a dressing 104 with an attached dressing interface for negative pressure wound therapy and instillation and / or oxygen therapy. Fig.21 As shown, in some examples, the dressing interface 262 and the fluid conductor 264 can be attached to the top surface 254 and fluidly coupled to the interior of the dressing 104 through the hole 2102. Similarly, in some examples, the dressing interface 402 can be attached to the top surface 254 and fluidly coupled to the fluid access channel through the hole 2104.

[0144] Fig. 22 yes Fig.21 A cross-sectional view of an exemplary dressing 104 applied to an exemplary tissue site 1902 taken along line 22-22 and illustrating the Figure 1 Additional details associated with the treatment system 100 are provided. Fig. 22 As illustrated, in some examples, the bottom surface 256 of the cover 110 can be coated with an adhesive layer 1903, and at least a portion of the bottom surface 256 of the cover 110 can be coupled to at least a portion of the top surface 220 of the sealing layer 202 using the adhesive layer 1903, and at least a portion of the bottom surface 256 can be coupled to at least a portion of the top surface 230 of the manifold layer 206. In various embodiments, the aperture 228, the aperture 2106, the fluid isolation member 2108, and the aperture 2104 can be coaxially aligned and define a fluid entry channel through the interior or interior space of the inner diameter of the aperture 2104 and the fluid isolation member 2108. In various embodiments, the fluid entry channel is substantially isolated from the interior of the dressing 104, such as the space occupied by the first membrane layer 204 and the manifold layer 206 between the top surface 210 of the sealing layer 202 and the bottom surface 256 of the cover 110.

[0145] In operation, negative pressure may be provided to the wound 1904, and / or fluid may be removed from the wound 1904 by the negative pressure source 102. For example, fluid may travel from the wound 1904 through at least one of the fluid channels 226 into the open pores of the foam manifold layer 206, and exit the dressing 104 to enter the dressing interface 262 through the apertures 2102. In operation, an instillation solution and / or oxygen may enter the dressing 104 from the dressing interface 402 through the apertures 2104 and travel through the fluid entry channels defined by the apertures 2104, the fluid isolation member 2108, and / or the apertures 228 to enter the wound 1904 without entering the interior of the dressing 104. In various embodiments, to ensure that the fluid isolation member 2108 effectively isolates the interior of the dressing 104 from the instillation solution and / or oxygen, the fluid isolation member 2108 may extend past the top surface 230 of the manifold layer 206 and contact the base of the dressing interface 402.

[0146] Fig.23 yes Figure 1 An exploded view of an example of a dressing 104 is provided, illustrating additional details that may be associated with some embodiments. In various embodiments, Fig. 20 The dressing 104 may be substantially similar to Figure 2-Figure 4 and Fig.19 The dressing 104 is described above, except that the first film layer 204 does not include the aperture 228 or the coupling region 241 , the manifold layer 206 does not include the aperture 239 or the coupling region 243 , and the second film layer 208 does not include the coupling region 253 .

[0147] Fig.24 yes Fig.23 An isometric view of an assembled example of the dressing 104. Fig.25 yes Fig.24 A cross-sectional view of an exemplary dressing taken along line 25-25 and applied to an exemplary tissue site 1902. Fig.25 As shown, in various embodiments, the dressing interface 262 and the fluid conductor 264 can be attached to the top surface 254 and fluidly coupled to the interior of the dressing through the hole 250. In various embodiments, the dressing interface 402 and the fluid conductor 404 can be attached to the top surface 254 and fluidly coupled to the interior of the dressing through the hole 252. In operation, an instillation solution and / or oxygen can be provided to the wound 1904 and / or the surrounding wound area via the dressing interface 402. In various embodiments, the instillation solution and / or oxygen can be provided by the dressing interface 402 to the hole 252 and flow from the hole 252 through the window 236, and from the window 236 through the fluid channel 226 to the wound 1904 and / or the surrounding wound area.

[0148] The systems, devices, and methods described herein may provide significant advantages. For example, a conventional open-cell foam manifold used in a negative pressure wound therapy system may have a free volume in the range of about 50%-90%. The instillation solution and / or oxygen may typically be provided to the foam manifold after the negative pressure has been released from the open-cell foam manifold, or simultaneously with the release of the negative pressure (using the negative pressure at the manifold to draw the instillation solution and / or oxygen into the manifold and tissue site until the pressure at the manifold reaches approximately ambient pressure). Therefore, typically, the amount of instillation solution and / or oxygen required may be equal to the free volume of the open-cell foam manifold plus the volume that needs to be filled at the wound site. In conventional systems, a large amount of instillation solution and / or oxygen may therefore be wasted in filling the free volume of the open-cell foam manifold, thereby requiring a larger negative pressure wound therapy, instillation therapy, and / or oxygen therapy device and system. In addition, the user may need to manage a larger volume of instillation solution and / or oxygen. By providing fluid access channels that bypass the interior of a wound dressing and / or a dressing having a low internal volume, the improved systems described herein can significantly reduce the volume of instillation solution and / or oxygen required to treat a wound.

[0149] Although shown in several exemplary embodiments, it will be appreciated by those skilled in the art that the systems, apparatuses, and methods described herein are susceptible to various changes and modifications, and that these changes and modifications fall within the scope of the appended claims. In addition, unless the context clearly requires otherwise, descriptions of various alternatives using terms such as "or" do not need to be mutually exclusive, and unless the context clearly requires otherwise, the indefinite article "a" or "an" does not limit the subject matter to a single instance. Components may also be combined or removed in various configurations for the purpose of sale, manufacture, assembly, or use. For example, in some configurations, the dressing 104, the container 106, or both may be removed or separated from the other components for manufacture or sale. In other exemplary configurations, the controller 112 may also be manufactured, constructed, assembled, or sold independently of the other components.

[0150] The appended claims set forth novel and inventive aspects of the subject matter described above, but the claims may also include additional subject matter not specifically described in detail. For example, certain features, elements, or aspects may be omitted from the claims if it is not necessary to distinguish novel and inventive features from features known to those of ordinary skill in the art. Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced by alternative features that serve the same, equivalent, or similar purposes without departing from the scope of the invention as defined by the appended claims.

Claims

1. A system for treating a tissue site using negative pressure therapy, the system comprising: A dressing configured to be placed adjacent to the tissue site, the dressing comprising: a first film layer having a first side opposite to a second side, a plurality of fenestrations disposed through the first side and the second side, the plurality of fenestrations being configured to be exposed to the tissue site; a manifold having a first side opposite a second side, the first side of the manifold being disposed adjacent to the second side of the first membrane layer; a second membrane layer having a first side opposite a second side, the first side of the second membrane layer being disposed adjacent the second side of the manifold; a negative pressure channel disposed through the second membrane layer, the negative pressure channel being in direct fluid communication between the second membrane layer and the manifold; and a fluid inlet channel disposed through the second membrane layer, the manifold, and the first membrane layer, the fluid inlet channel being in direct fluid communication with the first side of the first membrane layer; a negative pressure source configured to be fluidly coupled to the negative pressure channel; and A fluid source is configured to be fluidly coupled to the fluid inlet passage.

2. The system of claim 1, wherein: The first membrane layer further comprises a fluid inlet hole; The manifold further includes a fluid inlet port; The second membrane layer further comprises a fluid inlet hole; and The fluid inlet holes of the first membrane layer, the fluid inlet holes of the manifold, and the fluid inlet holes of the second membrane layer are coaxially aligned to define a fluid inlet channel through the fluid inlet holes of the first membrane layer, the fluid inlet holes of the manifold, and the fluid inlet holes of the second membrane layer.

3. The system of claim 2, wherein: a portion of the second side of the first membrane layer surrounding the fluid entry hole of the first membrane layer coupled to a portion of the first side of the manifold surrounding the fluid entry hole of the manifold; and A portion of the first side of the second membrane layer surrounding the fluid entry aperture of the second membrane layer is coupled to a portion of the second side of the manifold surrounding the fluid entry aperture of the manifold.

4. The system of claim 3, wherein: A perimeter of the second side of the first membrane layer is coupled to a perimeter of the first side of the manifold; and A perimeter of the first side of the second membrane layer is coupled to a perimeter of the second side of the manifold.

5. The system of claim 4, wherein: a first chamber defined between the second side of the first membrane layer and the first side of the manifold, the portion of the second side of the first membrane layer coupled to the portion of the first side of the manifold, and the perimeter of the second side of the first membrane layer coupled to the perimeter of the first side of the manifold; and A second chamber is defined between the first side of the second membrane layer and the second side of the manifold, the portion of the first side of the second membrane layer is coupled to the portion of the second side of the manifold, and the periphery of the first side of the second membrane layer is coupled to the periphery of the first side of the manifold.

6. The system of claim 5, wherein the first chamber and the second chamber are fluidly isolated from the fluid inlet passage.

7. The system of claim 6, wherein the manifold further comprises a plurality of windows formed through the manifold.

8. The system of claim 7, wherein the first chamber is in fluid communication with the second chamber through the plurality of windows.

9. The system of claim 8, wherein the first side of the first film layer is configured to be in direct contact with the tissue site.

10. The system of claim 8, wherein the fluid access channel is configured to be in direct fluid communication with the tissue site.

11. The system of claim 8, wherein: The second film layer further comprises negative pressure holes; and The negative pressure channel is defined by a fluid passage from the negative pressure hole to the second chamber, and is configured to be positioned in fluid communication with the tissue site through the plurality of windows, the first chamber, and the plurality of fenestrations.

12. The system of claim 1, further comprising a sealing layer comprising a treatment hole and a plurality of bonding holes surrounding the treatment hole, wherein the first side of the membrane layer and the plurality of fenestrations are configured to be exposed to the tissue site through the treatment hole.

13. The system of claim 12, further comprising a covering layer having a first side opposite to a second side, a pressure-sensitive adhesive disposed on the first side of the covering layer, the pressure-sensitive adhesive coupling the covering layer to the second film layer and the sealing layer, a portion of the pressure-sensitive adhesive being disposed adjacent to the plurality of bonding holes.

14. The system of claim 1, wherein the first film layer comprises a thicker portion and a thinner portion, the thicker portion being between each of the plurality of fenestrations and the thinner portion being adjacent to each of the plurality of fenestrations.

15. The system of claim 1, wherein the second membrane layer is substantially coextensive with the manifold and the first membrane layer.

16. The system of claim 12, wherein the second film layer is substantially coextensive with the sealing layer.

17. The system of claim 1, further comprising a plurality of standoffs formed on one or both of the first side and the second side of the manifold.

18. The system of claim 1, wherein the manifold comprises open cell foam.

19. The system of claim 1, wherein the dressing further comprises a fluid entry cover configured to be removably coupled to the second side of the second film layer.

20. The system of claim 1, wherein the fluid source is configured to provide an instillation solution to the dressing.

21. The system of claim 1, wherein the fluid source is an oxygen source configured to provide oxygen to the dressing.

22. The system of claim 1, wherein the manifold is fluidly isolated from the fluid inlet passage.

23. A system for treating a tissue site using negative pressure therapy, the system comprising: A dressing configured to be positioned adjacent to the tissue site, the dressing comprising: A first film layer, the first film layer having a plurality of openings and fluid inlet holes; a manifold having a plurality of windows and fluid inlet ports; and A second membrane layer, wherein the second membrane layer has a negative pressure hole and a fluid inlet hole; wherein the first membrane layer, the manifold, and the second membrane layer are assembled in a stacked relationship to define a first chamber between the first membrane layer and the manifold and a second chamber between the second membrane layer and the manifold; wherein the fluid access apertures of the first film layer, the fluid access apertures of the manifold, and the fluid access apertures of the second film layer define a fluid access channel through the dressing; and Wherein the first chamber and the second chamber are fluidly isolated from the fluid inlet passage.

24. The system of claim 23, further comprising: a fluid source, the fluid source being coupled to the fluid inlet channel through the fluid inlet hole of the second membrane layer; Wherein the fluid source is configured to be in direct fluid communication with the tissue site through the fluid access channel.

25. The system of claim 23, further comprising: a negative pressure source, the negative pressure source being connected to the negative pressure hole of the second membrane layer; The negative pressure source is configured to provide negative pressure to the tissue site through the multiple fenestrations of the first membrane layer, the first chamber, the multiple windows of the manifold, the second chamber, and the negative pressure holes of the second membrane layer.

26. The system of claim 23, further comprising: a sealing layer, the sealing layer comprising a treatment hole and a plurality of bonding holes surrounding the treatment hole; The first membrane layer is configured to be coupled to the sealing layer such that the plurality of fenestrations of the first membrane layer are exposed through the treatment aperture.

27. The system of claim 26, further comprising: a cover comprising a pressure sensitive adhesive; wherein the cover is coupled to the sealing layer around the manifold and at least a portion of the pressure sensitive adhesive is exposed through the bonding hole.

28. The system of claim 26, wherein the second film layer is substantially coextensive with the sealing layer.

29. The system of claim 26, wherein the first membrane layer, the manifold, and the second membrane layer are substantially coextensive with each other.

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