Dressings with optional adhesive for use with instillation therapy and negative pressure therapy

Abstract

Disclosed are dressings for treating a tissue site with an instillation therapy, which can include a dressing having a first layer including a polymeric film having a plurality of fluid restrictions through the polymeric film and a second layer including a polymer having a plurality of apertures. The second layer is adjacent to the first layer. The dressing can include an adhesive layer on at least a portion of the first layer. Further, the dressing can include a third layer on the adhesive layer, the third layer being capable of being at least partially removed from the adhesive layer to expose a portion of the adhesive.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 064,216, filed August 11, 2020, the full text of which is incorporated herein by reference. Technical Field

[0003] The invention as set forth in the appended claims relates generally to tissue treatment systems, and more specifically, but not in a limiting way, to dressing materials including optional adhesive portions for use with negative pressure therapy and infusion therapy. Background Technology

[0004] Clinical research and practice have shown that reducing pressure near tissue sites can enhance and accelerate the growth of new tissue at the site. This phenomenon has numerous applications, but it has proven particularly beneficial for wound management. Regardless of the cause of the wound—whether trauma, surgery, or other reasons—proper wound care is crucial for outcome. Treating wounds or other tissues by reducing pressure is commonly referred to as "negative pressure therapy," but it is also known by other names, including "negative pressure wound therapy," "decompression therapy," "vacuum therapy," "vacuum-assisted closure," and "local negative pressure." Negative pressure therapy offers numerous benefits, including the migration of epithelial and subcutaneous tissues, improved blood flow, and microdeformation of tissues at the wound site. These benefits can work together to increase granulation tissue development and reduce healing time.

[0005] It is also widely recognized that cleaning tissue sites is highly beneficial for new tissue growth. For example, for therapeutic purposes, wounds or cavities can be cleaned with liquid solutions. These practices are generally referred to as "irrigation" and "drenching," respectively. "Infusion" is another practice, which typically refers to the slow introduction of fluid into the tissue site and its retention for a specified period of time before removal. For example, infusing a local therapeutic solution into a wound can be combined with negative pressure therapy to further promote wound healing by loosening soluble contaminants and removing infectious material from the wound surface. Thus, the soluble bacterial load is reduced, contaminants are removed, and the wound is cleaned.

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

[0007] The appended claims set forth novel and useful systems, apparatuses, and methods for treating tissues in a negative pressure or infusion therapy setting. Exemplary embodiments are also provided to enable those skilled in the art to make and use the claimed subject matter.

[0008] For example, in some embodiments, a dressing for treating tissue sites with infusion therapy may include a first layer comprising a polymer membrane having multiple channels passing through it. A second layer may comprise a polymer having multiple openings. The second layer may be adjacent to the first layer. The dressing may also include an adhesive layer on at least a portion of the first layer, and a third layer on the adhesive layer. The third layer may be a pad that can be at least partially removable from the adhesive layer. The third layer may be a non-adhesive third layer and may include polyurethane. The third layer may include multiple windows. Furthermore, in some embodiments, the third layer may include multiple regions. The multiple regions may be separable. The multiple regions may be interlocking or concentric rings. Furthermore, the multiple regions may be separable along perforations between adjacent regions within the multiple regions.

[0009] In another embodiment, the system for treating a tissue site may include a dressing and an infusion solution source. The dressing may include a first layer comprising a polymer membrane having a plurality of fluid-restricting portions extending through it. A second layer may include a polymer having a plurality of openings. The second layer may be adjacent to the first layer. The dressing may also include an adhesive layer on at least a portion of the first layer, and a third layer on the adhesive layer. The third layer may be removable at least partially from the adhesive layer. The third layer may be a non-adhesive third layer, which may include polyurethane and may include a plurality of windows. Furthermore, in some embodiments, the third layer may include multiple regions. The multiple regions may be separable. The multiple regions may be interlocking or concentric rings. Furthermore, the multiple regions may be separable along perforations between adjacent regions within the multiple regions.

[0010] The objectives, advantages, and preferred modes of making and using the subject matter protected by the claims can be best understood by referring to the accompanying drawings in conjunction with the following detailed description of exemplary embodiments. Attached Figure Description

[0011] Figure 1 This is a functional block diagram of an exemplary embodiment of a treatment system that can provide negative pressure therapy and infusion therapy according to this specification.

[0012] Figure 2 This is an assembly diagram of an example dressing, showing how it can be used with... Figure 1 Additional details associated with some exemplary implementations of the treatment system.

[0013] Figure 3 yes Figure 2 A schematic diagram of an exemplary layer of dressing.

[0014] Figure 4 This is another example assembly diagram of the dressing, showing its compatibility with... Figure 1 Additional details associated with some exemplary implementations of the treatment system.

[0015] Figure 5 Is it possible to... Figure 4 A schematic diagram of an exemplary configuration of openings in the layers associated with some implementations of the dressing.

[0016] Figure 6 yes Figure 5 A schematic diagram of an exemplary layer, which overlaps with Figure 3 On an exemplary layer.

[0017] Figure 7 This is another example assembly diagram of the dressing, showing its compatibility with... Figure 1 Additional details associated with some exemplary implementations of the treatment system.

[0018] Figure 8 Is it possible to... Figure 7 A schematic diagram of an exemplary configuration of openings in the layers associated with some implementations of the dressing.

[0019] Figure 9 yes Figure 8 A schematic diagram of an exemplary layer, which overlaps with Figure 3 On an exemplary layer.

[0020] Figure 10 Is it possible to... Figure 1 An assembly diagram of the dressing associated with an exemplary implementation of the treatment system.

[0021] Figure 11 yes Figure 10 A top view of the dressing manifold.

[0022] Figure 12 yes Figure 11 A cross-sectional view of the manifold.

[0023] Figure 13 This is an assembly diagram of an example dressing that can be used with... Figure 1 This is related to some implementation schemes of the treatment system.

[0024] Figure 14 This is a schematic diagram of an exemplary layer, which can be used with... Figure 13 This is related to some implementation schemes for dressings.

[0025] Figure 15 yes Figure 14 A side view of an example dressing.

[0026] Figure 16 This is another example assembly diagram of a dressing that can be used with... Figure 1 This is related to some implementation schemes of the treatment system.

[0027] Figure 17 This is a schematic diagram of an exemplary layer, which can be used with... Figure 16 This is related to some implementation schemes for dressings.

[0028] Figure 18 yes Figure 17 A schematic diagram of an exemplary layer, which overlaps with Figure 14 On an exemplary layer.

[0029] Figure 19 Is it possible to... Figure 1 Another example assembly diagram of the dressing associated with some implementation schemes of the treatment system.

[0030] Figure 20 Is it possible to... Figure 1 A side sectional view of an example of an tissue interface associated with some implementations of the treatment system.

[0031] Figure 21 Is it possible to... Figure 1 An exploded side sectional view of another example of the tissue interface associated with some exemplary implementations of the treatment system.

[0032] Figure 22 Is it possible to... Figure 1 An exploded side sectional view of another example of the tissue interface associated with some exemplary implementations of the treatment system. Detailed Implementation

[0033] The following description of exemplary embodiments provides information that enables those skilled in the art to make and use the subject matter set forth in the appended claims, but certain details well known in the art may be omitted. Therefore, the following detailed description should be considered exemplary and not restrictive.

[0034] This document may also describe exemplary embodiments with reference to the spatial relationships between various elements or the spatial orientations of various elements depicted in the accompanying drawings. Generally, such relationships or orientations are assumed to be consistent with or relative to the patient in the location to be treated. However, as those skilled in the art will recognize, this frame of reference is merely descriptive convenience and not a strict specification.

[0035] Figure 1 This is a simplified functional block diagram of an exemplary embodiment of a treatment system 100 according to this specification, which can provide negative pressure therapy in conjunction with the infusion of a local treatment solution to a tissue site.

[0036] In this context, the term "tissue site" broadly refers to a wound, defect, or other therapeutic target located on or within a tissue, including but not limited to bone, adipose tissue, muscle tissue, nerve tissue, dermis, vascular tissue, connective tissue, cartilage, tendons, or ligaments. Wounds can include, for example, chronic wounds, acute wounds, traumatic wounds, subacute wounds, and dehiscences, partial skin burns, ulcers (such as diabetic ulcers, pressure ulcers, or venous insufficiency ulcers), flaps, and grafts. The term "tissue site" can also refer to an area of ​​any tissue that is not necessarily injured or defective, but rather an area where it may be desirable to add or promote the growth of additional tissue. For example, negative pressure can be applied to a tissue site to encourage the growth of additional tissue, which can then be harvested and transplanted.

[0037] Treatment system 100 may include a negative pressure source or negative pressure supply device such as negative pressure source 105, and one or more dispensing components. The dispensing components are preferably removable and may be disposable, reusable, or recyclable. Dressings (such as dressing 110) and fluid containers (such as container 115) are examples of dispensing components that may be associated with some examples of treatment system 100. Figure 1 As shown in the examples, in some embodiments, dressing 110 may include tissue interface 120, cover 125 or both, or substantially consist of tissue interface, cover or both.

[0038] A fluid conductor is another exemplary example of a dispensing component. In this context, "fluid conductor" broadly includes tubes, pipes, hoses, conduits, or other structures having one or more lumens or open paths suitable for conveying fluid between two ends. Typically, a tube is an elongated cylindrical structure with a degree of flexibility, but its geometry and stiffness can vary. Furthermore, some fluid conductors may be molded into other components or otherwise integrally combined with other components. Dispensing components may also include or contain interfaces or fluid ports to facilitate attachment and disengagement from other components. In some embodiments, for example, a dressing interface may facilitate attachment of the fluid conductor to the dressing 110. For example, such a dressing interface may be SENSAT.RAC, available from Kinetic Concepts, Inc., San Antonio, Texas. TM pad.

[0039] The treatment system 100 may also include a regulator or controller, such as controller 130. Additionally, the treatment system 100 may include sensors to measure operating parameters and provide feedback signals indicative of these operating parameters to controller 130. Figure 1 As shown, for example, the treatment system 100 may include a first sensor 135 and a second sensor 140 connected to the controller 130.

[0040] The treatment system 100 may also include an infusion solution source. For example, the solution source 145 may be fluidly coupled to the dressing 110, such as... Figure 1 The exemplary embodiments are shown. In some embodiments, solution source 145 may be fluidly coupled to a positive pressure source such as positive pressure source 150, a negative pressure source such as negative pressure source 105, or both. A regulator such as drip regulator 155 may also be fluidly coupled to solution source 145 and dressing 110 to ensure appropriate dosage of infusion solution (e.g., saline) to tissue site. For example, drip regulator 155 may include a piston that may be pneumatically actuated by negative pressure source 105 to draw infusion solution from solution source during negative pressure intervals and drip solution into dressing during discharge intervals. Additionally or alternatively, controller 130 may be coupled to negative pressure source 105, positive pressure source 150, or both to control the dosage of infusion solution to tissue site. In some embodiments, drip regulator 155 may also be fluidly coupled to negative pressure source 105 via dressing 110, such as... Figure 1 As shown in the example.

[0041] Some components of the treatment system 100 may be housed within or combined with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or further user interfaces that facilitate treatment. For example, in some embodiments, the negative pressure source 105 may be combined with the controller 130, the solution source 145, and other components to form a treatment unit.

[0042] Generally, components of the treatment system 100 can be directly or indirectly coupled. For example, a negative pressure source 105 can be directly coupled to a container 115 and indirectly coupled to a dressing 110 via the container 115. Couplings can include fluid couplings, mechanical couplings, thermal couplings, electrical couplings, or chemical couplings (such as chemical bonds), or in some cases, a combination of couplings. For example, the negative pressure source 105 can be electrically coupled to a controller 130 and fluidly coupled to one or more dispensing components to provide a fluid pathway to the tissue site. In some embodiments, components may also be coupled by means of physical proximity, integral integration with a single structure, or formation from the same material.

[0043] For example, a negative pressure supply device such as negative pressure source 105 may be a reservoir of air under negative pressure, or it may be a manual or electric device such as a vacuum pump, a suction pump, a wall suction port, or a micropump available in many healthcare facilities. "Negative pressure" generally refers to a pressure less than the local ambient pressure, such as the ambient pressure in a local environment outside a sealed treatment environment. In many cases, the local ambient pressure may also be the atmospheric pressure at the tissue site. Alternatively, the pressure may be less than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise specified, the pressure values ​​described herein are gauge pressures. A reference to 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 negative pressure source 105 may vary depending on the treatment requirements, the pressure is typically a low vacuum (often also referred to as a rough vacuum) between -5 mmHg (-667 Pa) and -500 mmHg (-66.7 kPa). Common treatment ranges are between -50 mmHg (-6.7 kPa) and -300 mmHg (-39.9 kPa).

[0044] Container 115 refers to a container, canister, pouch, or other storage component used to manage exudates and other fluids aspirated from tissue sites. In many settings, rigid containers may be preferred or necessary for the collection, storage, and disposal of fluids. In other settings, fluids may be properly disposed of without rigid container storage devices, and reusable containers can reduce waste and costs associated with negative pressure therapy.

[0045] A controller, such as controller 130, may be a microprocessor or computer programmed to operate one or more components of the treatment system 100, such as the negative pressure source 105. In some embodiments, for example, controller 130 may be a microcontroller that typically includes an integrated circuit, comprising a processor core and memory programmed to directly or indirectly control one or more operating parameters of the treatment system 100. Operating parameters may include, for example, power applied to the negative pressure source 105, pressure generated by the negative pressure source 105, or pressure distributed to the tissue interface 120. Controller 130 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.

[0046] Sensors such as the first sensor 135 and the second sensor 140 are generally known in the art as any device capable of operating to detect or measure a physical phenomenon or characteristic, and typically provide a signal indicating the detected or measured phenomenon or characteristic. For example, the first sensor 135 and the second sensor 140 may be configured to measure one or more operating parameters of the treatment system 100. In some embodiments, the first sensor 135 may be a transducer configured to measure pressure in a pneumatic passage and convert the measurement into a signal indicating the measured pressure. In some embodiments, for example, the first sensor 135 may be a piezoresistive strain gauge. In some embodiments, the second sensor 140 may optionally measure operating parameters of the negative pressure source 105, such as voltage or current. Preferably, the signals from the first sensor 135 and the second sensor 140 are suitable as input signals to the controller 130, but in some embodiments, some signal conditioning may be appropriate. For example, the signals may need to be filtered or amplified before they can be processed by the controller 130. Typically, the signals are electrical signals, but may be represented in other forms, such as optical signals.

[0047] The tissue interface 120 is typically adapted to partially or completely contact the tissue site. The tissue interface 120 can take many forms and can have various sizes, shapes, or thicknesses, depending on 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 120 can be adapted to the contours of deeper and irregularly shaped tissue sites. Any or all surfaces of the tissue interface 120 can have an uneven, rough, or serrated profile.

[0048] In some embodiments, the tissue interface 120 may include or be substantially composed of a manifold. In this context, the manifold may include or be substantially composed of means for collecting or distributing fluid at the tissue interface 120 under pressure. For example, the manifold may be adapted to receive negative pressure from a source and distribute negative pressure at the tissue interface 120 through a plurality of openings, which may have the effect of collecting fluid from the tissue site and drawing fluid toward the source. In some embodiments, the fluid path may be reversed or an auxiliary fluid path may be provided to facilitate the delivery of fluid, such as fluid from an infusion solution source, to the tissue site.

[0049] In some exemplary embodiments, the manifold may include multiple passages that can be interconnected to improve fluid distribution or collection. 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 suitable for forming interconnected fluid passages (e.g., channels) may include honeycomb foams, including open-cell foams such as mesh 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 orifices and fluid passages. In some embodiments, the manifold may additionally or alternatively include protrusions forming interconnected fluid passages. For example, the manifold may be molded to provide surface protrusions defining interconnected fluid passages.

[0050] In some embodiments, tissue interface 120 may comprise or be substantially composed of a mesh foam having a pore size and free volume that can vary depending on the requirements of the prescribed treatment. For example, a mesh foam with a free volume of at least 90% is suitable for many therapeutic applications, and foam with an average pore size in the range of 400 to 600 micrometers (40 to 50 pores / inch) is particularly suitable for some types of treatment. The tensile strength of tissue interface 120 may also vary depending on the requirements of the prescribed treatment. For example, the tensile strength of the foam may be increased for use with infusion of topical treatment solutions. The 25% compressive load flexure of tissue interface 120 may be at least 0.35 psi, and the 65% compressive load flexure may be at least 0.43 psi. In some embodiments, the tensile strength of tissue interface 120 may be at least 10 psi. Tear strength of tissue interface 120 may be at least 2.5 psi. In some embodiments, the interface 120 may be a foam composed of polyols (such as polyesters or polyethers), isocyanates (such as toluene diisocyanate), and polymerization modifiers (such as amines and tin compounds). In some examples, the interface 120 may be a reticulated polyurethane foam, such as that found in Granufoam. TM Dressing or VACVERAFLO TM Both the mesh polyurethane foam in the dressing and the other material were available from Kinetic Concepts in San Antonio, Texas.

[0051] The thickness of the tissue interface 120 can also be varied according to the needs of the prescribed treatment. For example, the thickness of the tissue interface 120 can be reduced to decrease tension on the surrounding tissues. The thickness of the tissue interface 120 can also affect its conformability. In some embodiments, a thickness in the range of about 5 mm to about 10 mm may be appropriate.

[0052] The tissue interface 120 can be hydrophobic or hydrophilic. In an example where the tissue interface 120 is hydrophilic, the tissue interface 120 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 120 can draw fluid away from the tissue site through capillary flow or other wicking mechanisms. An example of a potentially suitable hydrophilic material is open-cell polyvinyl alcohol foam, such as VACWHITEFOAM, available from Kinetic Concepts, San Antonio, Texas. TM Dressings. Other hydrophilic foams may include those made of polyether. Other foams that may exhibit hydrophilic properties include hydrophobic foams that have been treated or coated to provide hydrophilicity.

[0053] In some embodiments, the tissue interface 120 may be constructed of a bioresorbable material. Suitable bioresorbable materials may include, but are not limited to, polymer blends of polylactic acid (PLA) and polyglycolic acid (PGA). The polymer blend may also include, but is not limited to, polycarbonate, polyfumarate, and caprolactone. The tissue interface 120 may also serve as a scaffold for new cell growth, or a scaffold material may be used in conjunction with the tissue interface 120 to promote cell growth. Scaffolds are typically substances or structures used to enhance or promote cell growth or tissue formation, such as three-dimensional porous structures that provide a template for cell growth. Exemplary examples of scaffold materials include calcium phosphate, collagen, PLA / PGA, coral hydroxyapatite, carbonates, or processed allogeneic graft materials.

[0054] In some embodiments, the cover 125 provides a bacterial barrier and protection against physical trauma. The cover 125 may also be constructed of a material that reduces evaporation loss and provides a fluid seal between two components or two environments, such as between a treatment environment and a local external environment. The cover 125 may include, for example, an elastomeric membrane or film, or be composed of therein, which provides a seal sufficient to maintain negative pressure at the tissue site against a given negative pressure source. In some applications, the cover 125 may have a high moisture vapor transmission rate (MVTR). For example, in some embodiments, the MVTR may be at least 250 g / m² / 24h, a value measured using the upright cup technique at 38°C and 10% relative humidity (RH) according to the ASTM E96 / E96M positive cup method. In some embodiments, an MVTR of up to 5,000 g / m² / 24h provides effective breathability and mechanical properties.

[0055] In some exemplary embodiments, the cover 125 may be a water vapor-permeable but liquid-impermeable polymer sterilizing cover, such as a polyurethane membrane. Such sterilizing covers typically have a thickness in the range of 25 to 50 micrometers. For permeable materials, the permeability should generally be low enough to maintain the desired negative pressure. The cover 125 may include one or more of the following materials: polyurethane (PU), such as hydrophilic polyurethane; cellulose; hydrophilic polyamide; polyvinyl alcohol; polyvinylpyrrolidone; hydrophilic acrylic resins; silicone, such as hydrophilic silicone elastomers; natural rubber; polyisoprene; styrene-butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene-vinyl acetate (EVA); copolyester; and polyether block polyamide copolymers. Such materials are commercially available, for example, from 3M Company, Minneapolis, Minnesota. Disinfecting cover; a polyurethane (PU) disinfecting cover commercially available from Avery Dennison Corporation, Pasadena, California; a polyether block polyamide copolymer (PEBAX) commercially available, for example from Arkema SA, Colombes, France; and Inspire 2301 and Inpsire 2327 polyurethane films commercially available from Expopack Advanced Coatings, Wrexham, United Kingdom. In some embodiments, the cover 125 may include a 2600 g / m² polyurethane film. 2 INSPIRE 2301 features 24-hour MVTR (Vertical Cup Technology) and a thickness of approximately 30 micrometers.

[0056] Attachment devices can be used to attach the cover 125 to an attachment surface, such as undamaged epidermis, a gasket, or another cover. Attachment devices can take many forms. For example, an attachment device can be a medically acceptable pressure-sensitive adhesive configured to bond the cover 125 to the epidermis surrounding the tissue site. In some embodiments, for example, some or all of the cover 125 may be coated with an adhesive, such as an acrylic, silicone, or polyurethane adhesive, with a coating weight of about 25 g / m² to 65 g / m². In some embodiments, a thicker adhesive or combination of adhesives may be applied to improve sealing and reduce leakage. Other exemplary embodiments of the attachment device may include double-sided tape, paste, aqueous colloid, hydrogel, silicone gel, or organic gel.

[0057] Solution source 145 may also refer to a container, canister, pouch, bag, or other storage component that can provide a solution for infusion therapy. The composition of the solution may vary depending on the prescribed therapy, but examples of some prescribed solutions include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanide, cation solutions, and isotonic solutions.

[0058] During operation, the tissue interface 120 can be placed within, above, on, or otherwise close to the tissue site. For example, if the tissue site is a wound, the tissue interface 120 can partially or completely fill the wound, or it can be placed above the wound. The covering 125 can be placed above the tissue interface 120 and sealed to the attachment surface near the tissue site. For example, the covering 125 can be sealed to the undamaged epidermis surrounding the tissue site. Thus, the dressing 110 provides a sealed therapeutic environment close to the tissue site and substantially isolated from the external environment, and the negative pressure source 105 reduces the pressure within the sealed therapeutic environment.

[0059] The fluid dynamics of using a negative pressure source to reduce pressure in another component or location (such as within a sealed treatment environment) can be mathematically complex. However, the basic principles of fluid dynamics applicable to negative pressure therapy and infusion are generally well known to those skilled in the art, and the process of reducing pressure can be exemplarily described herein as, for example, “delivering,” “distributing,” or “generating” negative pressure.

[0060] Generally, exudates and other fluids flow towards lower pressure along the fluid path. Therefore, the term "downstream" typically means something relatively closer to a negative pressure source or further away from a positive pressure source within the fluid path. Conversely, the term "upstream" means something relatively further away from a negative pressure source or closer to a positive pressure source. Similarly, certain features can conveniently be described according to the fluid's "inlet" or "outlet" in this frame of reference. This orientation is generally assumed for the purpose of describing the various features and components described herein. However, in some applications, the fluid path can be reversed, such as by replacing the negative pressure source with a positive pressure source, and this descriptive convention should not be construed as restrictive.

[0061] The negative pressure applied to the tissue site by the tissue interface 120 within the sealed treatment environment can induce macro- and micro-strains within the tissue site. The negative pressure can also remove exudates and other fluids from the tissue site, which can be collected in container 115.

[0062] In some embodiments, controller 130 may receive and process data from one or more sensors, such as first sensor 135. Controller 130 may also control the operation of one or more components of treatment system 100 to manage pressure delivered to tissue interface 120. In some embodiments, controller 130 may include input for receiving a desired target pressure and may be programmed to process data associated with the setting and input of the target pressure to be applied to tissue interface 120. In some exemplary embodiments, the target pressure may be a fixed pressure value set by the operator as the desired negative pressure for treatment at the tissue site and then provided as input to controller 130. The target pressure may vary depending on the tissue site, based on the type of tissue forming the tissue site, the type of injury or wound (if any), the patient's medical condition, and the attending physician's preference. After selecting the desired target pressure, controller 130 may operate negative pressure source 105 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 tissue interface 120.

[0063] Figure 2 yes Figure 1 An assembly diagram of an example dressing 110 shows additional details that can be associated with some embodiments in which the tissue interface 120 includes more than one layer. Figure 2In the example, the tissue interface 120 includes a first layer 205, a second layer 210, and a third layer 215. In some embodiments, the first layer 205 may be disposed adjacent to the second layer 210, and the third layer 215 may also be disposed adjacent to the first layer 205. For example, the first layer 205 and the second layer 210 may be stacked such that the first layer 205 contacts the second layer 210. In some embodiments, the first layer 205 may also be bonded to the second layer 210. In some embodiments, the second layer 210 may coexist with the surface of the first layer 205.

[0064] In some embodiments, at least a portion of the third layer 215 may be bonded to the first layer 205 by adhesive 240. Adhesive 240 may be, for example, a medically acceptable pressure-sensitive adhesive extending around, partially, or entirely around the periphery of the first layer 205. In some embodiments, adhesive 240 may be, for example, an acrylic adhesive with a coating weight between 25 g / m² and 65 g / m². In some embodiments, adhesive 240 may be a polyurethane adhesive or a silicone adhesive. In some embodiments, adhesive 240 may comprise or be substantially composed of a sealing layer formed of a soft, flexible material (such as an adhesive gel) suitable for providing a fluid seal with the tissue site, and may have a substantially flat surface. For example, adhesive 240 may include, but is not limited to, silicone gels, soft silicones, aqueous colloids, hydrogels, polyurethane gels, polyolefin gels, hydrogenated styrene copolymer gels, or foamed gels. In some embodiments, a thicker adhesive or combination of adhesives may be applied to improve sealing and reduce leakage. In some embodiments, such an adhesive 240 layer may be continuous or discontinuous. Interruptions in adhesive 240 may be provided by openings or holes (not shown) in adhesive 240. Openings or holes in adhesive 240 may be formed after adhesive 240 is applied or by patterning adhesive 240 onto a carrier layer (such as, for example, first layer 205).

[0065] The first layer 205 may include or be substantially composed of means for controlling or managing fluid flow. In some embodiments, the first layer 205 may be a fluid control layer comprising or substantially composed of a liquid-impermeable elastomeric material. For example, the first layer 205 may include or be substantially composed of a polymer film (such as a polyurethane film). In some embodiments, the first layer 205 may include or be substantially composed of the same material as the cover 125. In some embodiments, the first layer 205 may also have a smooth or matte surface texture. A glossy or bright surface, preferably or equal to B3 grade according to SPI (Plastics Industry Association) standards, may be particularly advantageous for some applications. In some embodiments, variations in surface height may be limited to acceptable tolerances. For example, the surface of the first layer 205 may have a substantially flat surface, where variations in height are limited to 0.2 mm per centimeter.

[0066] In some embodiments, the first layer 205 may be hydrophobic. The hydrophobicity of the first layer 205 may vary, but in some embodiments, it may have a contact angle with water of at least ninety degrees. In some embodiments, the first layer 205 may have a contact angle with water of no more than 150 degrees. For example, in some embodiments, the contact angle of the first layer 205 may be in the range of at least 90 degrees to about 120 degrees, or in the range of at least 120 degrees to 150 degrees. The water contact angle can be measured using any standard apparatus. While manual goniometers can be used to visually approximate the contact angle, contact angle measuring instruments may generally include integrated systems involving water platforms, liquid droplets such as syringes, cameras, and software designed to calculate the contact angle more accurately and precisely. Non-limiting examples of such integrated systems may include all commercially available from First Ten Angstroms, Inc., Portsmouth, VA. and The system, as well as the DTA25, DTA30, and DTA100 systems, are all commercially available from Kruss GmbH, Hamburg, Germany. Unless otherwise specified, the water contact angles described herein were measured using deionized and distilled water in air at 20°C to 25°C and 20% to 50% relative humidity for fixative droplets added from a height not exceeding 5 cm onto a horizontal sample surface. The contact angles described herein represent the average of 5 to 9 measurements, discarding the highest and lowest measurements. The hydrophobicity of the first layer 205 can be further enhanced with hydrophobic coatings of other materials such as silicone resins and fluorocarbons, such as hydrophobic coatings applied by liquid coating or plasma coating.

[0067] The first layer 205 can also be used to weld to other layers, including the second layer 210. For example, the first layer 205 can be adapted to be welded to polyurethane foam using thermal, radio frequency (RF) welding, or other heat-generating methods such as ultrasonic welding. RF welding is particularly suitable for materials with higher polarity, such as polyurethane, polyamide, polyester, and acrylate. Sacrificial polar interfaces can be used to facilitate RF welding of membrane materials with lower polarity, such as polyethylene. Highly polar membranes suitable for lamination onto polyethylene membranes include polyamide, copolyester, ionomer, and acrylic resins. To facilitate adhesion between polyethylene and the polar membrane, bonding layers, such as ethylene-vinyl acetate or modified polyurethane, can be used. For some constructions, methyl acrylate (EMA) membranes may also possess suitable hydrophobicity and weldability.

[0068] The areal density of the first layer 205 can vary depending on the prescribed treatment or application. In some embodiments, an areal density of less than 40 g / m² may be suitable, and an areal density of about 20 g / m² to 30 g / m² may be particularly advantageous for some applications.

[0069] In some embodiments, for example, the first layer 205 may comprise or be substantially composed of a hydrophobic polymer such as a polyethylene film. The simple and inert structure of polyethylene provides a surface with minimal (if any) interaction with biological tissues and fluids, thus providing a surface that promotes free flow of liquids and low adhesion, which can be particularly advantageous for many applications. Other suitable polymer films include polyurethanes, acrylic resins, polyolefins (such as cyclic olefin copolymers), polyacetates, polyamides, polyesters, copolyesters, PEBAX block copolymers, thermoplastic elastomers, thermoplastic vulcanizates, polyethers, polyvinyl alcohol, polypropylene, polymethylpentene, polycarbonate, styrene resins, silicones, fluoropolymers, and acetates. Thicknesses between 20 micrometers and 100 micrometers are suitable for many applications. The film can be translucent, colored, or printed. More polar films suitable for lamination onto polyethylene films include polyamides, copolyesters, ionomers, and acrylic resins. To facilitate adhesion between the polyethylene and the polar film, a bonding layer, such as ethylene-vinyl acetate or modified polyurethane, can be used. For some constructions, methyl acrylate (EMA) films can also possess suitable hydrophobicity and weldability.

[0070] In some embodiments, the first layer 205 may comprise a polymeric membrane of polylactic acid, carboxymethyl cellulose, or polycaprolactone. In other embodiments, the first layer 205 may comprise a xanthan gum membrane mixed with at least one of collagen, oxidized regenerated cellulose, and alginate. In some embodiments, the first layer 205 comprises a membrane of xanthan gum and citric acid mixed with at least one of collagen, oxidized regenerated cellulose, and alginate. In some embodiments, the first layer 205 may comprise a membrane copolymerized with dialkylcarbamoyl chloride.

[0071] In some embodiments, the first layer 205 may be a film coated with petrolatum gel. The petrolatum gel may have a viscosity of at least 10,000 mPa·s. In some embodiments, the petrolatum gel contains an antimicrobial compound.

[0072] In some embodiments, instead of silicone and polyethylene membranes, the first layer 205 may comprise a long-staying bioresorbable polymer membrane formed of polylactic acid, carboxymethyl cellulose, polycaprolactone, or other crosslinkable polymers, such that functionality is maintained for more than about 7 days and reabsorption occurs over more than 12 days. In other embodiments, the first layer may comprise a highly crosslinked biopolymer, such as collagen or alginate, mixed with xanthan gum at a 20% gum-to-biological ratio, and plasma-treated to achieve hydrophobicity within a desired range. The membrane may also include citric acid to help reduce biofilm and limit concerns about bacterial buildup. In some embodiments, the membrane is formed of polyethylene, polyurethane, EMA, or a biopolymer incorporating a texture (such as "Sharklet") that helps reduce biofilm formation on the dressing. In other embodiments, the membrane is copolymerized with a highly hydrophobic dialkylcarbamoyl chloride and may help prevent biofilm and bacterial adhesion.

[0073] The first layer 205 may have one or more channels, which may be uniformly or randomly distributed on the first layer 205. The channels may be bidirectional and pressure-responsive. For example, each channel may typically comprise or consist of a generally unstrained elastic channel to significantly reduce fluid flow, and may expand or open in response to a pressure gradient. Figure 2 As illustrated in the examples, the channel may include or substantially consist of a perforation 220 in the first layer 205. The perforation can be formed by removing material from the first layer 205. For example, the perforation can be formed by cutting through the first layer 205. Where there is no pressure gradient across the perforation, the perforation can be small enough to form a seal or fluid restriction that significantly reduces or prevents fluid flow. Additionally or alternatively, one or more channels in the channel may be, or can be used as, an elastomeric valve that is normally closed when unstrained to substantially prevent fluid flow and can open in response to a pressure gradient. In some examples, the channel may include or substantially consist of a window in the first layer 205. Typically, a window is a perforation and can also be formed by removing material from the first layer 205. The amount of material removed and the resulting size of the window can be up to an order of magnitude smaller than that of the perforation.

[0074] In some embodiments, the perforation can be formed as a slot, slit, or a combination of slots and slits in the first layer 205. In some examples, the perforation may comprise or consist of linear slots, the length of which is less than 4 mm and the width less than 1 mm. In some embodiments, the length may be at least 2 mm and the width may be at least 0.4 mm. A length of about 3 mm and a width of about 0.8 mm are particularly suitable for many applications, and a tolerance of about 0.1 mm is also acceptable. Such dimensions and tolerances can be achieved, for example, using a laser cutting machine. Such a constructed slot can function as an imperfect elastomeric valve, which significantly reduces fluid flow in a normally closed or stationary state. For example, such a slot can form a flow restriction without completely closing or sealing. The slot can expand or open wider in response to a pressure gradient to allow increased fluid flow.

[0075] The second layer 210 typically includes or is substantially composed of a manifold or manifold layer that provides means for collecting or distributing fluid across the tissue interface 120 under pressure. For example, the second layer 210 may be adapted to receive negative pressure from a source and distribute negative pressure across the tissue interface 120 through multiple openings, which can have the effect of collecting fluid at the tissue site and drawing fluid toward the source. In some embodiments, the fluid path may be reversed or an auxiliary fluid path may be provided to facilitate the delivery of fluid, such as fluid from an infusion solution source, across the tissue interface 120.

[0076] In some exemplary embodiments, the pathways of the second layer 210 may be interconnected to improve fluid distribution or collection. In some exemplary embodiments, the second layer 210 may comprise or be substantially composed of a porous material having interconnected fluid pathways. Examples of suitable porous materials that include interconnected fluid pathways (e.g., channels) or can be adapted to form interconnected fluid pathways may include cellular foams, including open-cell foams such as mesh 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 pathways. In some embodiments, the second layer 210 may additionally or alternatively include protrusions forming interconnected fluid pathways. For example, the second layer 210 may be molded to provide surface protrusions defining interconnected fluid pathways.

[0077] In some embodiments, the second layer 210 may comprise or be substantially composed of a mesh foam having a pore size and free volume that can be varied according to the needs of the prescribed treatment. For example, a mesh foam with a free volume of at least 90% is suitable for many therapeutic applications, and foams with an average pore size in the range of 400 to 600 micrometers are particularly suitable for certain types of treatment. The tensile strength of the second layer 210 may also be varied according to the needs of the prescribed treatment. For example, the tensile strength of the foam may be increased for use with infusion of topical treatment solutions. The 25% compressive load flexure of the first layer 205 may be at least 0.35 psi, and the 65% compressive load flexure may be at least 0.43 psi. In some embodiments, the tensile strength of the first layer 205 may be at least 10 psi. The second layer 210 may have a tear strength of at least 2.5 psi. In some embodiments, the second layer 210 may be a foam composed of polyols such as polyesters or polyethers, isocyanates such as toluene diisocyanate, and polymerization modifiers such as amines and tin compounds. In some examples, the first layer 205 may be a mesh polyurethane foam, such as that used in Granufoam. TM Dressing or VACVERAFLO TM Both the mesh polyurethane foam in the dressing and the material were available from KCI, a company based in San Antonio, Texas.

[0078] Other suitable materials for the second layer 210 may include, for example, nonwoven fabrics (Libeltex, Freudenberg), three-dimensional (3D) polymer structures (molded polymers, embossed and shaped films and fusion-bonded films [Supracore]), and mesh.

[0079] In some examples, the second layer 210 may comprise a 3D textile, such as various textiles commercially available from Baltex, Muller, and Heathcoates. For some embodiments, a 3D textile of polyester fibers may be particularly advantageous. For example, the second layer 210 may comprise or be substantially composed of a three-dimensional fabric of polyester fibers. In some embodiments, the fibers may be elastic in at least two dimensions. For some embodiments, a puncture-resistant fabric of polyester and cotton fibers having a weight of about 650 g / m² and a thickness of about 1 mm to 2 mm may be particularly advantageous. In some embodiments, such a puncture-resistant fabric may have a warp tensile strength of about 330 kg to 340 kg and a weft tensile strength of about 270 kg to 280 kg. In some embodiments, another particularly suitable material may be a polyester insulating fabric having a weight of about 470 g / m² and a thickness of about 4 mm to 5 mm. Such an insulating fabric may have a compressive strength of about 20 kPa to 25 kPa (at 40% compression). Additionally or alternatively, the second layer 210 may comprise or be composed of a material having substantially linear tensile properties, such as a polyester insulating fabric having biaxial tensile strength and a weight of approximately 380 g / m². In some embodiments, a suitable insulating fabric may have a thickness of approximately 3 mm to 4 mm and may have a warp and weft tensile strength of approximately 30 kg to 40 kg. In some examples, the fabric may have a tightly woven polyester layer on one or more opposing surfaces. In some embodiments, the woven layer may advantageously be positioned on the second layer 210 facing the tissue site.

[0080] The second layer 210 typically has a first flat surface and a second flat surface opposite to the first flat surface. The thickness of the second layer 210 between the first and second flat surfaces can also be varied according to the needs of the prescribed treatment. For example, the thickness of the second layer 210 can be reduced to reduce stress on other layers and tension on surrounding tissues. The thickness of the second layer 210 can also affect its conformability. In some embodiments, suitable foams may have a thickness in the range of about 5 mm to 10 mm. Fabrics, including suitable 3D textiles and insulating fabrics, may have a thickness in the range of about 2 mm to about 8 mm.

[0081] The third layer 215 may be a release liner and may be at least partially removable to expose at least a portion of the adhesive 240 on the first layer 205. The third layer 215 may also provide stiffness to facilitate, for example, the deployment of dressing 110. The third layer 215 may be, for example, cast paper, film, or polyethylene. Furthermore, in some embodiments, the third layer 215 may be a polyester material, such as polyethylene terephthalate (PET) or a similar polar semi-crystalline polymer. Using a polar semi-crystalline polymer in the third layer 215 can substantially eliminate wrinkles or other deformations of dressing 110. For example, the polar semi-crystalline polymer may be highly oriented and resistant to softening, swelling, or other deformations that may occur when in contact with components of dressing 110, or when subjected to temperature or environmental changes or sterilization. Additionally, a release agent may be disposed on the side of the third layer 215 configured to contact the first layer 205. For example, the release agent may be a silicone coating and may have a peel coefficient suitable for easy removal by hand from the adhesive 240 of the third layer 215 without damaging the dressing 110 or deforming the dressing. In some embodiments, the release agent may be, for example, a fluorocarbon compound or a fluorosiloxane. In other embodiments, the third layer 215 may be uncoated or otherwise used without a release agent.

[0082] In some embodiments, the third layer 215 is formed of polyurethane and includes one or more channels 250, which may be uniformly or randomly distributed on the third layer 215 and may restrict fluid transport across or through the third layer 215. The channels 250 are aligned with perforations in the first layer 205. In some embodiments, the channels 250 may be fluid confinement portions. The channels 250 may be bidirectional and pressure-responsive. For example, each channel in the channels 250 may typically include or be substantially composed of a generally unstrained elastic channel to significantly reduce liquid flow and may expand or open in response to a pressure gradient. In some embodiments, the channels 250 may include or be substantially composed of perforations in the third layer 215. Perforations may be formed by removing material from the third layer 215. For example, perforations may be formed by cutting through the third layer 215, which in some embodiments may also deform the edges of the perforations. In some embodiments, the length of the perforation may be about 3 mm and the width may be about 0.8 mm. Where there is no pressure gradient across the perforation, the channels can be small enough to form a seal or fluid confinement that significantly reduces or prevents fluid flow. Additionally or alternatively, one or more channels in channel 250 can be elastomeric valves that are normally closed when unstrained to substantially prevent fluid flow and can open in response to a pressure gradient. The apertures in the third layer 215 can be suitable valves for some applications. The apertures can also be formed by removing material from the third layer 215, but the amount of material removed and the resulting aperture size can be up to an order of magnitude smaller than the perforation, and without causing edge deformation. Therefore, the third layer 215 can be a stripper gasket for the perforation.

[0083] For example, some embodiments of channel 250 may include one or more windows, perforations, or combinations of windows and perforations in the third layer 215, or substantially consist thereof. In some examples, channel 250 may include or consist of linear slots with a length less than 4 mm and a width less than 1 mm. In some embodiments, the length may be at least 2 mm and the width may be at least 0.4 mm. A length of about 3 mm and a width of about 0.8 mm are particularly suitable for many applications, and a tolerance of about 0.1 mm is also acceptable. Such dimensions and tolerances can be achieved, for example, using a laser cutting machine. Such a constructed slot can act as an imperfect valve, significantly reducing fluid flow in a normally closed or quiescent state. For example, such a slot can form a flow restriction without completely closing or sealing. The slot can expand or open wider in response to a pressure gradient to allow increased fluid flow.

[0084] In some embodiments, the third layer 215 may include a plurality of separable regions 270, such that one or more of the separable regions 270 are removable. Therefore, in cases where, for example, only one of the separable regions 270 is removed, only a portion of the adhesive 240 on the first layer 205 may be exposed. Figure 2 As illustrated in the examples, in some embodiments, the plurality of separable regions 270 may be concentric rings or ellipses. In other examples, the separable regions 270 may be configured as a mosaic pattern. The plurality of separable regions 270 may be separated by perforations 280 to allow easy removal of one or more of the plurality of separable regions 270. Thus, one or more of the concentric rings or ellipses may be removed to expose only the generally annular portion of the adhesive 240. Each separable region of the third layer 215 and / or the plurality of separable regions 270 may also include a tab 275 to allow easy removal of the third layer 215 or at least one of the plurality of separable regions 270 to expose at least a portion of the adhesive 240.

[0085] like Figure 2 As shown in the example, dressing 110 may also include attachment devices, such as adhesive 285. Adhesive 285 may be a medically acceptable pressure-sensitive adhesive, for example, extending around the periphery, a portion, or the entire surface of cover 125. In some embodiments, for example, adhesive 285 may be an acrylic adhesive with a coating weight between 25 g / m² and 65 g / m². In some embodiments, a thicker adhesive or combination of adhesives may be applied to improve sealing and reduce leakage. In some embodiments, such an adhesive 285 layer may be continuous or discontinuous. Interruptions in adhesive 285 may be provided by openings or holes (not shown) in adhesive 285. Openings or holes in adhesive 285 may be formed after the application of adhesive 285 or by patterning adhesive 285 onto a carrier layer (such as, for example, one side of cover 125). In some exemplary embodiments, the size of the openings or holes in adhesive 285 may also be set to enhance the MVTR of dressing 110.

[0086] Figure 2 An example of the fluid conductor 290 and the dressing interface 295 is also shown. Figure 2 As shown in the example, the fluid conductor 290 can be a flexible tube that is fluidly connected at one end to the dressing interface 295. The dressing interface 295 can be an elbow connector, such as... Figure 2 As shown in the example, the elbow connector can be placed over the opening 297 in the cover 125 to provide a fluid path between the fluid conductor 290 and the tissue interface 120.

[0087] Figure 3 This is a schematic diagram of an example of layer 205, showing additional details that can be associated with some implementation schemes. For example... Figure 3 As shown in the examples, the perforations 220 may each consist essentially of one or more linear slots, windows, or perforations having a length L. A length L of approximately 3 mm may be particularly suitable for some examples. Figure 3 Another example of a uniformly distributed pattern of perforations 220 is shown. Figure 3 In this structure, the perforations 220 are substantially co-extended with the first layer 205 and are distributed on the first layer 205 in a grid of parallel rows and columns, wherein the perforations 220 are also parallel to each other. These rows may be spaced apart by a distance D1, and the perforations 220 within each row may be spaced apart by a distance D2. For example, a distance D1 of approximately 3 mm at the center and a distance D2 of approximately 3 mm may be suitable for some embodiments. The perforations 220 in adjacent rows may be aligned or offset. For example, adjacent rows may be offset, such as... Figure 3 As shown, the perforations 220 are aligned in alternating rows spaced apart by a distance D3. A distance D3 of approximately 6 mm is suitable for some examples. In some embodiments, the spacing of the perforations 220 can be varied to increase the density of the perforations 220 as needed for treatment.

[0088] Figure 4 yes Figure 1 Another example assembly diagram of dressing 110 shows additional details that can be associated with some embodiments. In some embodiments, such as Figure 4 As shown, the tissue interface 120 may further include a fourth layer 400. The fourth layer 400 may include or be substantially composed of a sealing layer formed of a flexible material (such as a suitable gel material) suitable for providing a fluid seal with the tissue site, and may have a substantially flat surface. For example, the fourth layer 400 may include, but is not limited to, silicone gels, soft silicones, aqueous colloids, hydrogels, polyurethane gels, polyolefin gels, hydrogenated styrene copolymer gels, foamed gels, soft closed-cell foams (such as polyurethanes and polyolefins coated with adhesives), polyurethanes, polyolefins, or hydrogenated styrene copolymers. In some embodiments, the fourth layer 400 may have a thickness between about 200 micrometers (μm) and about 1000 micrometers (μm). In some embodiments, the fourth layer 400 may have a hardness between about 5 Shore A00 and about 80 Shore A00. Furthermore, the fourth layer 400 may be composed of a hydrophobic or hydrophilic material.

[0089] In some embodiments, the fourth layer 400 may be a material with a hydrophobic coating. For example, the fourth layer 400 may be formed by coating spaced materials (such as, for example, woven, nonwoven, molded, or extruded meshes) with a hydrophobic material. The hydrophobic material used for coating may be, for example, a soft silicone.

[0090] The fourth layer 400 may have a periphery 405 surrounding or surrounding the treatment opening 410 and an opening 415 in the periphery 405 surrounding the treatment opening 410. In some examples, the treatment opening 410 may be complementary to or correspond to a surface region of the first layer 205. For example, the treatment opening 410 may form a frame, window, or other opening surrounding the surface of the first layer 205. The fourth layer 400 may also have a corner 420 and an edge 425. The corner 420 and the edge 425 may be part of the periphery 405. The fourth layer 400 may have an internal boundary 430 surrounding the treatment opening 410, which may substantially not contain, for example, an opening 415. Figure 4 The example shows an opening 415. In some examples, such as... Figure 2 As shown, the treatment opening 410 can be symmetrical and centrally located in the fourth layer 400, thus forming an open central window.

[0091] The opening 415 may be formed by cutting, perforating, applying, for example, localized RF or ultrasonic energy, or other suitable techniques for forming openings or perforations in the fourth layer 400. The opening 415 may have a uniform distribution pattern or may be randomly distributed on the fourth layer 400. The opening 415 in the fourth layer 400 may have many shapes, including, for example, circular, square, star-shaped, elliptical, polygonal, slit, complex curve, straight line shape, triangle, or some combination of such shapes.

[0092] Each opening in aperture 415 may have uniform or similar geometric characteristics. For example, in some embodiments, each opening in aperture 415 may be a circular opening having substantially the same diameter. In some embodiments, each opening in aperture 415 may have a diameter of about 1 mm to about 50 mm. In other embodiments, the diameter of each opening in aperture 415 may be about 1 mm to about 20 mm.

[0093] In other embodiments, the geometry of the opening 415 may vary. For example, the diameter of the opening 415 may vary depending on its location within the fourth layer 400. For instance, in some embodiments, the opening 415 located in the perimeter 405 may have a diameter between about 5 mm and about 10 mm. A range of about 7 mm to about 9 mm may be applicable in some examples. In some embodiments, the opening 415 located in the corner 420 may have a diameter between about 7 mm and about 8 mm.

[0094] At least one of the openings 415 in the periphery 405 of the fourth layer 400 may be located at an edge 425 of the periphery 405 and may have an internal cutout that opens or exposes at the edge 425, the internal cutout being in lateral communication with the edge 425. The lateral direction may refer to a direction toward the edge 425 and coplanar with the fourth layer 400. As shown, the openings 415 in the periphery 405 may be located near or at the edge 425 and in lateral communication with the edge 425. The openings 415 located near or at the edge 425 may be spaced substantially equidistantly around the periphery 405, such as... Figure 4 As shown in the example. Alternatively, the spacing of the openings 415 near or at the edge 425 may be irregular.

[0095] like Figure 4 As illustrated in the examples, in some embodiments, dressing 110 may include a third layer 215 to protect adhesive 240 prior to use. The third layer 215 includes a plurality of separable regions 270, such that one or more of the separable regions 270 can be removed to expose some or all of the adhesive 240. The plurality of separable regions 270 of the third layer 215 may have a shape similar to that of the first layer 205. Furthermore, the plurality of separable regions 270 may include a plurality of rings. The outer ring of the plurality of rings may not include channels 250 therein.

[0096] Figure 5 It is already assembled. Figure 4 The example shows a top view of dressing 110, which illustrates additional details that can be associated with some implementation schemes. Figure 5 As shown in the examples, the cover 125 and the fourth layer 400 may have substantially the same peripheral shape and size, such that in some examples, the cover 125 and the fourth layer 400 coexist. In some embodiments, the cover 125 may be substantially transparent, thereby allowing the visibility of the opening 415. The first layer 205 may be centrally positioned above the fourth layer 400, such as in the treatment opening 230. Figure 5 Above (not visible in the middle). Cover 125 may be disposed above the first layer 205 and connected around the first layer 205 to the fourth layer 400, such that at least some of the adhesive in the adhesive 285 may be disposed adjacent to the opening 415.

[0097] Figure 6 It is already assembled. Figure 4 The example shows a bottom view of dressing 110, with the third layer 215 removed, illustrating additional details that may be associated with some implementations. Figure 6As shown in the example, a plurality of perforations 220 may be aligned or otherwise exposed through treatment openings 410, and at least a portion of the first layer 205 may be disposed adjacent to the perforations 220 opposite to treatment openings 410. In some embodiments, the first layer 205 and the second layer 210 may be substantially aligned with treatment openings 410, or may extend over treatment openings 230.

[0098] Additionally, the first layer 205 may have a first edge 605, and the second layer 210 may have a second edge 610. In some examples, the first edge 605 and the second edge 610 may have substantially the same shape, such that adjacent faces of the first layer 205 and the second layer 210 are geometrically similar. In some examples, the first edge 605 and the second edge 610 may also be congruent, such that adjacent faces of the first layer 205 and the second layer 210 are substantially co-extended and have substantially the same surface area. Figure 6 In the example, the first edge 605 defines a face of the first layer 205, which is larger than the face of the second layer 210 defined by the second edge 610, and the larger face of the first layer 205 extends through the smaller face of the second edge 610.

[0099] In some embodiments, the surface defined by the first edge 605, the second edge 610, or both may also be geometrically similar to the treatment opening 410, such as... Figure 6 As shown in the example, and can be larger than the treatment opening 410. The fourth layer 400 may have an overlapping edge 615 surrounding the treatment opening 410, which may have additional adhesive disposed therein. Figure 6 As shown in the examples, in some embodiments, the treatment opening 410 may be elliptical or stadium-shaped. In some examples, the treatment opening 410 may have an area equal to about 20% to about 80% of the area of ​​the fourth layer 400. The treatment opening 410 may also have an area equal to about 20% to about 80% of the area of ​​the surface defined by the first edge 605 of the first layer 205. A width of about 90 mm to about 110 mm and a length of about 150 mm to about 160 mm may be suitable for some embodiments of the treatment opening 230. For example, the treatment opening 230 may have a width of about 100 mm and a length of about 155 mm. In some embodiments, a suitable width of the overlapping edge 615 may be about 2 mm to about 3 mm. For example, the overlapping edge 615 may coexist with the area defined between the treatment opening 410 and the first edge 605, and an adhesive may secure the first layer 205, the second layer 210, or both, to the third layer 215 and / or the fourth layer 400.

[0100] Figure 7 yes Figure 1Another example assembly diagram of dressing 110 shows additional details that can be associated with some implementation schemes. (See diagram for example.) Figure 7 As shown, some examples of the fourth layer 400 may not have the treatment opening 410, and the openings 415 may be distributed in a uniform pattern on the fourth layer 400. In some embodiments, one or more of the cover 125, the third layer 215, and the fourth layer 400 may also be congruent in some examples, such that the adjacent surfaces of one or more of the cover 125, the third layer 215, and the fourth layer 400 are substantially contiguous.

[0101] Figure 8 This is a schematic diagram of an exemplary configuration of opening 415, illustrating additional details that can be associated with some embodiments of the fourth layer 400. Figure 8 In the example, the opening 415 is generally circular and has a diameter D4, which in some embodiments may be about 6 mm to about 8 mm. A diameter D4 of about 7 mm may be particularly suitable for some embodiments. Figure 9 An example of a uniformly distributed pattern of openings 415 is also shown. Figure 9 In the fourth layer 400, openings 415 are distributed in a grid of parallel rows and columns. Within each row and column, openings 415 can be equidistant from each other, such as... Figure 8 As shown in the example. Figure 8 An exemplary configuration is shown that is particularly suitable for many applications, wherein the opening 415 is spaced apart by a distance D5 and offset by a distance D6 along each row and each column. In some examples, the distance D5 may be from about 9 mm to about 10 mm, and the offset D6 may be from about 8 mm to about 9 mm.

[0102] Figure 9 Is Figure 8 The overlap in the example Figure 3 A schematic diagram of the opening 415 on the first layer 205 illustrates additional details that can be associated with some exemplary embodiments of the organization interface 120. For example, as Figure 9 As shown, in some embodiments, more than one of the perforations 220 may be aligned, overlapped, aligned, or otherwise fluidly connected to the opening 415. In some embodiments, one or more of the perforations 220 may be only partially aligned with the opening 415. Figure 9 In the examples, the dimensions and construction of the opening 415 are typically configured such that at least four perforations in the perforations 220 are aligned with each opening in the opening 415. In other examples, one or more perforations in the perforations 220 may be aligned with more than one opening in the opening 415. For example, any one or more perforations in the perforations 220 may be perforations or window openings extending over two or more openings in the opening 415. Additionally or alternatively, one or more perforations in the perforations 220 may not be aligned with any of the openings in the opening 415.

[0103] like Figure 9 As shown in the example, the size of the opening 415 can be set to expose part of the first layer 205, the perforation 220, or both through the fourth layer 400. Figure 9 In the examples, the size of the opening 415 is typically set to expose more than one perforation in the perforation 220. The size of some or all of the openings in the opening 415 may be set to expose two or three perforations in the perforation 220. In some examples, the length of each perforation in the perforation 220 may be substantially smaller than the diameter of each opening in the opening 415. More generally, the average size of the perforations 220 is substantially smaller than the average size of the openings 415. In some examples, the opening 415 may be elliptical, and the length of each perforation in the perforation 220 may be significantly smaller than its major or minor axis. However, in some embodiments, the size of the perforation 220 may exceed the size of the opening 415, and the size of the opening 415 may limit the effective size of the perforation 220 exposed on the lower surface of the dressing 110.

[0104] exist Figures 4 to 9 In the example, the various components of dressing 110 may be bonded to each other or otherwise secured, for example, using solvent or non-solvent adhesives or by thermal welding, without adversely affecting fluid management.

[0105] Figure 10 yes Figure 1 An assembly diagram of another exemplary embodiment of the dressing 110 is shown, illustrating additional details that may be associated with some embodiments, wherein the tissue interface 120 includes separable segments. Figure 10 In one example, the tissue interface 120 includes one or more separable segments 1005, which may be defined by a seam 1010. Each separable segment 1005 may include a manifold segment 1015. In some examples, the seam 1010 may be formed between or may define a manifold segment 1015.

[0106] In some embodiments, manifold segment 1015 may include or be composed of foam. For example, the foam may be an open-cell foam, such as a mesh foam. The foam may also be relatively thin and hydrophobic to reduce the fluid retention capacity of the dressing, which can facilitate the rapid flow of exudate and other fluids into the external reservoir. The foam layer may also be thin to reduce the shape of the dressing and increase flexibility, which allows it to conform to the wound bed and other tissue sites under negative pressure. In some embodiments, manifold segment 1015 may be formed from three-dimensional textiles, nonwoven wicking materials, vacuum-formed textured surfaces, and composites thereof. Hydrophobic manifolds with a thickness of less than 7 mm and at least 90% free volume are suitable for a wide range of therapeutic applications. In some embodiments, manifold segment 1015 may be formed from a colored material. Each manifold segment in manifold segment 1015 may be the same color or different colors.

[0107] like Figure 10 As illustrated in the example, tissue interface 120 may have one or more channels 1020, such as fluid confinement sections, which may be uniformly or randomly distributed on tissue interface 120. Channels 1020 may be bidirectional and pressure-responsive. For example, each channel in channel 1020 may typically comprise or consist of a generally unstrained elastic channel to significantly reduce fluid flow, and may expand or open in response to a pressure gradient. Channels 1020 may coexist with manifold segment 1015.

[0108] For example, some embodiments of channel 1020 may include one or more slits, slots, or combinations of slits and slots, or substantially consist thereof. In some examples, channel 1020 may include or consist of linear slots with a length less than 4 mm and a width less than 1 mm. In some embodiments, the length may be at least 2 mm and the width may be at least 0.4 mm. A length of about 3 mm and a width of about 0.8 mm are particularly suitable for many applications, and a tolerance of about 0.1 mm is also acceptable. Such dimensions and tolerances can be achieved, for example, using a laser cutting machine. In some embodiments, the fluid restrictor 1120 may be formed by ultrasonic waves or other heating devices. Such a constructed slot can act as an imperfect valve, significantly reducing fluid flow in a normally closed or quiescent state. For example, such a slot can form a flow restriction without completely closing or sealing. The slot may expand or open wider in response to a pressure gradient to allow increased fluid flow.

[0109] In some embodiments, adhesive 1050 is applied to at least one surface of tissue interface 120. Adhesive 1050 may be, for example, a medically acceptable pressure-sensitive adhesive extending around, a portion of, or the entire tissue interface 120, as described herein.

[0110] like Figure 10As illustrated in the examples, in some embodiments, the dressing 110 may include a third layer 215 to protect the adhesive 1050 before and / or during use. The third layer 215 may include a plurality of separable regions 270 associated with each separable segment 1005, such that when the separable segment 1005 is separated, all or a portion of the third layer 215 of the separated separable segment 1005 may be removed to expose at least a portion of the adhesive 1050.

[0111] Figure 11 yes Figure 10 A top view of the organization interface 120, showing additional details that can be associated with some examples. The manifold segments 1015 in each separable segment 1005 can have the same shape or different shapes. For example... Figure 11 As shown in the example, the separable segment 1005 and the manifold segment 1015 can have similar shapes. In some embodiments, each interface segment and manifold segment in the separable segment 1005 and the manifold segment 1015 can have an interlocking shape, such as... Figure 11 The example is a roughly square shape, where the length of the side sides ranges from about 10 mm to about 30 mm (e.g., about 15 mm to about 25 mm or about 18 mm to about 22 mm). For example, the manifold section 1015 could be a square with dimensions of about 20 mm × about 20 mm.

[0112] Each joint in the joint 1010 may have a width W ranging from about 2 mm to about 5 mm, and may be wide enough to allow the separable section 1005 to separate along the joint 1010 without exposing any part of the manifold section 1015.

[0113] Figure 12 It is a section taken along line 12-12. Figure 11 A cross-sectional view of the organizational interface 120 shows additional details that can be associated with some implementation schemes. Figure 12 In the example, the tissue interface 120 includes a first membrane layer 1205, a second membrane layer 1210, and a manifold section 1015 disposed between the first membrane layer 1205 and the second membrane layer 1210. In some embodiments, the first membrane layer 1205 and the second membrane layer 1210 may be disposed adjacent to the manifold section 1015, such as... Figure 12 As shown in the example. Similarly, as... Figure 12 As shown in the example, the seam 1010 may be formed by one or more adhesive portions between the first film layer 1205 and the second film layer 1210. The adhesive portions may be continuous or discrete.

[0114] The first membrane layer 1205 and the second membrane layer 1210 may include or be substantially composed of means for controlling or managing fluid flow. In some embodiments, the first membrane layer 1205 and the second membrane layer 1210 may include or be substantially composed of an elastic material that is impermeable to liquids. For example, the first membrane layer 1205 and the second membrane layer 1210 may include or be substantially composed of a polymer membrane. In some embodiments, the first membrane layer 1205 and the second membrane layer 1210 may also have a smooth or matte surface texture. A glossy or bright surface, preferably or equal to B3 grade according to SPI (Plastics Industry Association) standards, may be particularly advantageous for some applications. In some embodiments, the variation in surface height may be limited to acceptable tolerances. For example, the surface of the second layer may have a substantially flat surface, wherein the variation in height is limited to 0.2 mm per centimeter.

[0115] In some embodiments, the first membrane layer 1205 and the second membrane layer 1210 may comprise or be substantially composed of a hydrophobic material. In some embodiments, the hydrophobicity may vary, but may have a contact angle with water of at least ninety degrees. In some embodiments, the hydrophobic material may have a contact angle with water of no more than 150 degrees. For example, in some embodiments, the contact angle may be in the range of at least 90 degrees to about 120 degrees, or in the range of at least 120 degrees to 150 degrees. The water contact angle can be measured using any standard apparatus. While a manual goniometer can be used to visually approximate the contact angle, contact angle measuring instruments may generally include an integrated system involving a water platform, liquid droplets such as syringes, a camera, and software designed to calculate the contact angle more accurately and precisely. Non-limiting examples of such integrated systems may include all of which are commercially available from First Ten Angstroms, Inc., Portsmouth, VA. 125. 200 2000 and The 4000 system, as well as all commercially available DTA25, DTA30, and DTA100 systems from Kruss GmbH, Hamburg, Germany, were used. Unless otherwise specified, the water contact angles described herein were measured in air using deionized and distilled water at 20°C to 25°C and 20% to 50% relative humidity for fixative droplets added from a height not exceeding 5 cm onto a horizontal sample surface. The contact angles reported herein represent the average of 5 to 9 measurements, discarding the highest and lowest values. The hydrophobicity of the first film layer 1205, the second film layer 1210, or both can be further enhanced with hydrophobic coatings of other materials such as silicone and fluorocarbons, such as liquid-coated or plasma-coated hydrophobic coatings.

[0116] The first film layer 1205 and the second film layer 1210 may also be adapted to be bonded to other layers, including to each other. For example, the first film layer 1205, the second film layer 1210, or both may be adapted to be welded to polyurethane foam using thermal welding, radio frequency (RF) welding, or other heat-generating methods such as ultrasonic welding. RF welding may be particularly suitable for materials with higher polarity, such as polyurethane, polyamide, polyester, and acrylate. Sacrificial polarity interfaces may be used to facilitate RF welding of less polar film materials such as polyethylene. The first film layer 1205 and the second film layer 1210 may include a hot melt film.

[0117] The areal density of the first membrane layer 1205 and the second membrane layer 1210 may vary depending on the prescribed treatment or application. In some embodiments, an areal density of less than 40 g / m² may be suitable, and an areal density of about 20 g / m² to 30 g / m² may be particularly advantageous for some applications.

[0118] In some embodiments, for example, the first membrane layer 1205, the second membrane layer 1210, or both may comprise or be substantially composed of a hydrophobic polymer such as a polyethylene membrane. The simple and inert structure of polyethylene provides a surface with minimal (if any) interaction with biological tissues and fluids, thus providing a surface that promotes free flow of liquids and low adhesion, which can be particularly advantageous for many applications. Other suitable polymer membranes include polyurethanes, acrylic resins, polyolefins (such as cyclic olefin copolymers), polyacetates, polyamides, polyesters, copolyesters, PEBAX block copolymers, thermoplastic elastomers, thermoplastic vulcanizates, polyethers, polyvinyl alcohol, polypropylene, polymethylpentene, polycarbonate, styrene resins, silicones, fluoropolymers, and acetates. Thicknesses between 20 micrometers and 100 micrometers are suitable for many applications. The membrane can be translucent, colored, or printed. More polar membranes suitable for lamination onto polyethylene membranes include polyamides, copolyesters, ionomers, and acrylic resins. To facilitate adhesion between the polyethylene and the polar membrane, bonding layers, such as ethylene-vinyl acetate or modified polyurethane, can be used. For some constructions, methyl acrylate (EMA) films can also possess suitable hydrophobicity and weldability.

[0119] In some embodiments, channel 1020 may include or substantially consist of a perforation in at least one of the first membrane layer 1205 and the second membrane layer 1210. The perforation may be formed by removing material from the first membrane layer 1205, the second membrane layer 1210, or both. For example, the perforation may be formed by cutting through the material, which in some embodiments may also deform the edges of the perforation. Where there is no pressure gradient over the perforation, the channel may be small enough to form a seal or fluid restriction that can significantly reduce or prevent fluid flow. Additionally or alternatively, one or more channels in channel 1020 may be elastomeric valves that are normally closed when unstrained to substantially prevent fluid flow and may open in response to a pressure gradient. A window in the material may be a valve suitable for some applications. A window may also be formed by removing material, but the amount of material removed and the size of the resulting window may be an order of magnitude smaller than that of a perforation, and may not deform the edges. In some embodiments, channel 1020 extends through both the first membrane layer 1205 and the second membrane layer 1210, and channel 1020 co-extends with at least one of the first membrane layer 1205 and the second membrane layer 1210.

[0120] Each manifold segment in manifold segment 1015 has a length L1, which can range from about 10 mm to about 30 mm (e.g., about 15 mm to about 25 mm or about 18 mm to about 22 mm). For example, each manifold segment in manifold segment 1015 can have a length of about 20 mm. In some embodiments, manifold segments 1015 can be spaced apart by a distance X1 of about 5 mm to about 15 mm. For example, a distance X1 of about 10 mm may be particularly advantageous for some embodiments.

[0121] In some embodiments, each manifold segment 1015 in the organization interface 120 may be the same size. In other embodiments, one or more manifold segments 1015 in the organization interface 120 may have different sizes.

[0122] In some embodiments, the tissue interface 120 has a thickness T1 ranging from about 5 mm to about 20 mm (e.g., about 8 mm to about 18 mm, or about 10 mm to about 15 mm). For example, the tissue interface 120 may have a thickness T1 of about 8 mm. The thickness T1 of the tissue interface 120 may vary depending on the thickness of the manifold segments 1015 used to form the tissue interface 120. For example, each manifold segment in the manifold segments 1015 may have a thickness ranging from about 5 mm to about 15 mm (e.g., about 8 mm to about 12 mm).

[0123] In some implementations, the first layer 1205 and the second layer 1210 may be formed of a transparent polymer to help cut the separable section 1005 along the seam 1010.

[0124] In some embodiments, the interface 120 can be formed by spacing the manifold segments 1015, placing a first layer 1205 of the polymer film above the manifold segments 1015, placing a second layer 1210 below the manifold segments 1015, and bonding the first layer 1205 to the second layer 1210, thereby forming a seam 1010 between the manifold segments 1015. Suitable means for bonding the first layer 1205 to the second layer 1210 may include, for example, adhesives (such as acrylics) and welding (such as thermal welding, radio frequency (RF) welding, or ultrasonic welding). In some embodiments, a sacrificial material may be disposed between the first layer 1205 and the second layer 1210 to facilitate welding. Suitable sacrificial materials may include, for example, hot melt films supplied by Bayer (such as H2, HU2, and H5 membranes), Cornelius (Collano membranes), or Prochimir (such as TC203 or TC206 membranes).

[0125] In some embodiments, the manifold section may be formed of a monolithic manifold material such as foam. In some embodiments, for example, the adhesive portion between the first layer 1205 and the second layer 1210 may extend through the manifold material layer to define the manifold section 1015. For example, some embodiments of the manifold layer may have a thickness ranging from about 5 mm to about 8 mm, and at least one of the first layer 1205 and the second layer 1210 may melt through the manifold layer during welding to form the joint 1010.

[0126] Additionally or alternatively, the monolithic manifold material can be perforated and cut to define manifold segments 1015 in a variety of suitable shapes and patterns. In some embodiments, seams 1010 can be aligned with perforations between manifold segments 1015. In some examples, sacrificial joints can be left between manifold segments 1015 to hold the manifold segments 1015 together as a single unit. Holding the manifold segments 1015 as a single unit makes it easier to assemble the tissue interface 120. In some embodiments, either or both of the first layer 1205 and the second layer 1210 can also be bonded to the manifold segments 1015 to increase stability.

[0127] Figure 13 yes Figure 1 An assembly diagram of another example of dressing 110 shows additional details that can be associated with some embodiments in which tissue interface 120 includes more than one layer. Figure 13 In the example, tissue interface 120 includes a first layer 205, a second layer 210, and a third layer 215. In some embodiments, the first layer 205 may be disposed adjacent to the second layer 210. For example, the first layer 205 and the second layer 210 may be stacked such that the first layer 205 contacts the second layer 210. In some embodiments, the first layer 205 may also be thermally bonded or adhered to the second layer 210. In some embodiments, the first layer 205 optionally includes an adhesive 240, such as a low-tack adhesive or an acrylic adhesive. The adhesive 240 may be applied continuously to the first layer 205 or applied in a pattern.

[0128] The first layer 205 may include or be substantially composed of means for controlling or managing fluid flow. In some embodiments, the first layer 205 may be a fluid control layer comprising or substantially composed of a liquid-impermeable elastomeric material. For example, the first layer 205 may include or be substantially composed of a polymer film (such as a polyurethane film), as described herein. In some embodiments, the first layer 205 may include or be substantially composed of the same material as the cover 125. In some embodiments, the first layer 205 may also have a smooth or matte surface texture. A glossy or bright surface, preferably or equal to B3 grade according to SPI (Plastics Industry Association) standards, may be particularly advantageous for some applications. In some embodiments, variations in surface height may be limited to acceptable tolerances. For example, the surface of the first layer 205 may have a substantially flat surface, wherein variations in height are limited to 0.2 mm per centimeter.

[0129] In some implementation schemes, such as Figure 13 As shown, the shape of the tissue interface 120, including the third layer 215, can be substantially rectangular. Furthermore, each of the plurality of separable regions 270 in the third layer 215 can be rectangular in shape.

[0130] Figure 14 This is a schematic diagram of another example of layer 205, showing additional details that can be associated with some implementation schemes. For example... Figure 14 As shown in the example, the first layer 205 may have a rectangular shape.

[0131] Figure 15 yes Figure 13 A side view of an example of dressing 110, which can be used with... Figure 1 This is related to some implementation schemes of the treatment system. For example... Figure 15 As shown, the organization interface 120 has an exposed perimeter 1500. More specifically, in Figure 15 In the example, cover 125, first layer 205, second layer 210 and third layer 215 each have an exposed periphery, and there are no seams, welds or seals along the exposed periphery 1600.

[0132] Figure 16 yes Figure 1 Another example assembly diagram of dressing 110 shows additional details that may be associated with some implementations, wherein tissue interface 120 may include additional layers. Figure 16 In the example, the organization interface 120 includes a fifth layer 1605 in addition to the first layer 205, the second layer 210, and the third layer 215, but does not include... Figure 4The fourth layer 400 of the implementation scheme. In some implementation schemes, the fifth layer 1605 may be adjacent to the first layer 205 opposite to the second layer 210. In some implementation schemes, the fifth layer 1605 may also be bonded to the first layer 205.

[0133] The fifth layer 1605 may comprise or be substantially composed of a sealing layer formed of a soft, flexible material (such as an adhesive gel) suitable for providing a fluid seal with the tissue site, and may have a substantially flat surface. For example, the fifth layer 1605 may include, but is not limited to, silicone gels, soft silicones, aqueous colloids, hydrogels, polyurethane gels, polyolefin gels, hydrogenated styrene copolymer gels, foamed gels, soft closed-cell foams such as polyurethane and polyolefins coated with adhesives, polyurethanes, polyolefins, or hydrogenated styrene copolymers. The fifth layer 1605 may comprise an adhesive surface on the underside and a patterned coating of an acrylic resin on the top side. The patterned coating of the acrylic resin may be applied around the peripheral area to provide stronger adhesion to areas that may come into contact with the skin rather than wound areas. In other embodiments, the fifth layer 1605 may comprise a low-tack adhesive layer instead of silicone. In some embodiments, the fifth layer 1605 may have a thickness between about 200 micrometers (μm) and about 1000 micrometers (μm). In some embodiments, the fifth layer 1605 may have a hardness between about 5 Shore A00 and about 80 Shore A00. Furthermore, the fifth layer 1605 may be composed of a hydrophobic or hydrophilic material.

[0134] In some embodiments, the fifth layer 1605 may be a hydrophobically coated material. For example, the fifth layer 1605 may be formed by coating a porous material (such as, for example, a woven, nonwoven, molded, or extruded mesh) with a hydrophobic material. The hydrophobic material used for coating may be, for example, a soft silicone.

[0135] The fifth layer 1605 may also have corners 1610 and edges 1615. The fifth layer 1605 may also include openings 1620. Openings 1620 may be formed by cutting or by applying, for example, localized RF or ultrasonic energy or by other suitable techniques for forming openings. Openings 1620 may have a uniform distribution pattern or may be randomly distributed on the fifth layer 1605. Openings 1620 in the fifth layer 1605 may have many shapes, including, for example, circles, squares, stars, ellipses, polygons, slits, complex curves, straight lines, triangles, or combinations of such shapes.

[0136] Each opening in the aperture 1620 may have uniform or similar geometric characteristics. For example, in some embodiments, each opening in the aperture 1620 may be a circular aperture having substantially the same diameter. In some embodiments, the diameter of each opening in the aperture 1620 may be between about 1 mm and about 50 mm. In other embodiments, the diameter of each opening in the aperture 1620 may be between about 1 mm and about 20 mm.

[0137] In other embodiments, the geometry of the opening 1620 can vary. For example, the diameter of the opening 1620 can vary depending on its position in the fifth layer 1605. The openings 1620 can be substantially equidistant above the fifth layer 1605. Alternatively, the spacing of the openings 1620 can be irregular.

[0138] like Figure 16 As shown in the examples, some embodiments of dressing 110 may include a third layer 215 that can protect the fifth layer 1705 and cover the adhesive 1630 applied to the surface of the fifth layer 1605 before use. As in other embodiments, at least one of the plurality of separable regions 270 of the third layer 215 may be removed to expose at least a portion of the adhesive 1630 on the fifth layer 1605.

[0139] Figure 17 This is a schematic diagram of an exemplary configuration of opening 1620, illustrating additional details that can be associated with some embodiments of the fifth layer 1605. In some embodiments, Figure 17 The opening 1620 shown may be associated only with the internal portion of the fifth layer 1605. Figure 17 In the example, the opening 1620 is approximately circular and has a width W, which in some examples may be approximately 2 millimeters. Figure 17 An example of a uniformly distributed pattern for aperture 1620 is also shown. Figure 17 In the middle, the openings 1620 are distributed in a grid of parallel rows and columns on the fifth layer 1605. Within each row and column, the openings 1620 can be equidistant from each other, such as... Figure 17 As shown in the example. These rows can be spaced apart by a distance D7, and the openings 1620 within each row can be spaced apart by a distance D8. For example, a distance D7 approximately 3 mm above the center and a distance D8 approximately 3 mm above the center may be suitable for some embodiments. The openings 1620 in adjacent rows can be aligned or offset. For example, adjacent rows can be offset, such as... Figure 17 As shown, the openings are aligned in alternating rows with a spacing of D9. A spacing of approximately 6 mm D9 is suitable for some examples. In some embodiments, the spacing of the openings 1620 can be varied to increase the density of the openings 1620 according to treatment requirements.

[0140] Figure 18 It is overlapping Figure 3 On the first floor, 205 Figure 16 A schematic diagram of the fifth layer 1605 illustrates additional details that can be associated with some exemplary embodiments of the organization interface 120. For example, as Figure 18 As shown, in some embodiments, the perforation 220 may be aligned, overlapped, aligned, or otherwise fluidly connected to the opening 1620. In some embodiments, one or more perforations in the perforation 220 may be aligned with the opening 1620 only in their internal portions, or only partially aligned with the opening 1620. Figure 18 In the examples, the perforations 220 are typically configured such that each perforation in the perforations 220 is aligned with only one opening in the openings 1620. In other examples, one or more perforations in the perforations 220 may be aligned with more than one opening in the openings 1620. For example, any one or more perforations in the perforations 220 may extend through two or more openings in the openings 1620. Additionally or alternatively, one or more perforations in the perforations 220 may not be aligned with any of the openings in the openings 1620.

[0141] like Figure 18 As illustrated in the examples, the size of the opening 1620 may be configured to expose a portion of the first layer 205, the perforation 220, or both through the fifth layer 1605. In some embodiments, the size of one or more openings in the opening 1620 may be configured to expose more than one perforation in the perforation 220. For example, the size of some or all of the openings in the opening 1620 may be configured to expose two or three perforations in the perforation 220. In some examples, the length of each perforation in the perforation 220 may be substantially equal to the diameter of each opening in the opening 1620. More generally, the average size of the perforations is substantially similar to the average size of the opening 1620. For example, in some embodiments, the opening 1620 may be elliptical, and the length L of each perforation in the perforation 220 may be substantially equal to the major or minor axis of the ellipse. In some embodiments, the size of the perforation 220 may exceed the size of the opening 1620, and the size of the opening 1620 may limit the effective size of the perforation 220 exposed through the fifth layer 1605.

[0142] Figure 19 This is another example assembly diagram of dressing 110, showing its compatibility with... Figure 1 Additional details associated with some exemplary implementations of the treatment system. Figure 19In the example, in addition to the first layer 205 and the second layer 210, the tissue interface 120 also includes a bonding layer 1905. In some embodiments, the bonding layer 1905 may have perforations 1910 and its thickness may be between 10 micrometers and 100 micrometers. The bonding layer 1905 may be translucent, colored, or printed. Figure 19 As shown, bonding layer 1905 may be disposed between first layer 205 and second layer 210. In some embodiments, bonding layer 1905 may also be bonded to at least one of first layer 205 and second layer 210.

[0143] Bonding layer 1905 may include, for example, a polyurethane film that can be bonded to the first layer 205 and the second layer 210. For example, if the first layer 205 is formed of a polyethylene film and the second layer 210 is a polyurethane foam, the first layer 205 may be bonded to the bonding layer 2005 more easily than if it were directly bonded to the second layer 210.

[0144] exist Figure 19 In one embodiment, the first layer 205 may have an adhesive 240 thereon. The third layer 215 may be in contact with the adhesive 240. As in other embodiments, the third layer 215 includes a plurality of separable regions 270 that can be separated by perforations 280. One or more of the plurality of separable regions 270 may be removed to expose at least a portion of the adhesive 240, such that the dressing 110 may adhere to the area around the wound during infusion treatment.

[0145] Figure 20 This is a side sectional view of another example of the organization interface 120, showing its compatibility with... Figure 1 Additional details associated with some exemplary embodiments of the treatment system. In some embodiments, such as Figure 20 As shown, dressing 110 may include a second layer 210, which is a manifold layer. The second layer 210 may have an adhesive 240 applied to one side thereon. A first layer 205 may be located on a second side of the second layer 210 opposite to the adhesive 240. The first layer 205 may be a polymer film including a plurality of perforations 220. A perforated silicone, polyurethane gel, or acrylic layer (such as a fifth layer 1605) may be located on the second side of the first layer 205. A third layer 215 may cover the adhesive 240. The adhesive 240 may be an acrylic adhesive or a silicone adhesive.

[0146] Figure 21 This is an exploded side sectional view of another example of the organization interface 120, showing its compatibility with... Figure 1 Additional details associated with some exemplary implementations of the treatment system. For example... Figure 21As shown, embodiments of the tissue interface 120 may include a second layer 210, a first layer 205, and a third layer 215. The first layer 205 may include an adhesive 240 opposite to the second layer 210. In some embodiments, the adhesive 240 may be an acrylic adhesive. In some embodiments, the adhesive 240 may be a silicone adhesive. In some embodiments, the adhesive 240 may be a polyurethane gel adhesive.

[0147] Figure 22 This is an exploded side sectional view of another example of the organization interface 120, showing its compatibility with... Figure 1 Additional details associated with some exemplary implementations of the treatment system. For example... Figure 22 As shown, an embodiment of tissue interface 120 may include a second layer 210 between two first layers 205 (shown as 205a and 205b), wherein the first of the first layers 205, 205a, is located on a first side of the second layer 210, while the second of the first layers 205, 205b, is located on a second side of the second layer 210 opposite to the first side. The first of the first layers 205, 205a, may not include any adhesive opposite the second layer 210. The second of the first layers 205, 205b, may include an adhesive 240 opposite the second layer 210. In some embodiments, adhesive 240 may be an acrylic adhesive. In some embodiments, adhesive 240 may be a silicone adhesive. In some embodiments, adhesive 240 may be a polyurethane gel adhesive. Additionally, tissue interface 120 may include a third layer 215 adjacent to adhesive 240. By including a first layer 205 on either side of the second layer 210, wherein the first 205a of the first layer 205 has no outward-facing adhesive, while the second 205b of the first layer 205 has adhesive 240, the tissue interface 120 can be flipped as needed so that the adhesive 240 faces or does not face the tissue site. Alternatively, the third layer 215 can be left intact, some of the third layer 215 can be removed, or all of the third layer 215 can be removed to selectively expose the adhesive 240 to the tissue site.

[0148] In some embodiments, one or more components of dressing 110 may be additionally treated with an antimicrobial agent. For example, the second layer 210 may be a foam, mesh, or nonwoven fabric coated with an antimicrobial agent. In some embodiments, the second layer 210 may include antimicrobial elements, such as fibers coated with an antimicrobial agent. Additionally or alternatively, some embodiments of the first layer 205 may be a polymer coated with an antimicrobial agent or a mixture thereof. In other examples, the fluid conductor 290 may be additionally or alternatively treated with one or more antimicrobial agents. Suitable antimicrobial agents may include, for example, metallic silver, PHMB, iodine, or complexes and mixtures thereof, such as povidone-iodine, copper compounds, chlorhexidine, or combinations thereof.

[0149] Alternatively, one or more of the components may be coated with a mixture that may contain citric acid and collagen, which can reduce biofilm and infection. For example, the second layer 210 may be a foam coated with such a mixture.

[0150] In use, the third layer 215 can be at least partially removed to expose adhesive 240, adhesive 285, or both. This provides a lower surface for the dressing 110 to be placed within, above, on, or otherwise close to tissue sites, particularly surface tissue sites and adjacent epidermis. The third layer 215 can be at least partially removed to expose at least a portion of the adhesive 240 to adhere the dressing 110 to the wound periphery and protect the wound periphery from the risk of maceration during infusion treatment.

[0151] The geometry and dimensions of the tissue interface 120, the cover 125, or both can be varied to suit a particular application or anatomical structure. For example, the geometry or dimensions of the tissue interface 120 and the cover 125 can be adapted to provide an effective and reliable seal at and around the tissue site on challenging anatomical surfaces such as the elbow or heel.

[0152] Alternatively, an infusion solution or other fluid may be dispensed into the dressing 110, which may increase the pressure in the tissue interface 120. This increased pressure in the tissue interface 120 may generate a positive pressure differential across the perforations 220 in the second layer 210, which may open the perforations 220 to allow the infusion solution or other fluid to be distributed to the tissue site. If in contact with an attachment surface such as the epidermis, the adhesive 240 may seal the perforations 220, preventing the infusion solution from being exposed to the attachment surface. Otherwise, the adhesive 240 allows the infusion solution to move through the perforations 220.

[0153] In some embodiments, when adhesive is not needed or desired, the dressing 110 can be flipped so that a non-adhesive film or liner remains in place on the film, preventing the dressing 110 from adhering to the wound and surrounding area. Thus, the user can choose to have no adhesive on the area in contact with the wound under the manifold, or to expose the adhesive for adhesion to the surrounding area. In some embodiments, the dressing 110 may provide different adhesives in different areas of the dressing 110. For example, a portion of the third layer 215 may remain in contact with a portion of the first layer 205 such that the portion of the third layer 215 covers the adhesive 240 on the portion of the first layer 205. Additionally, an acrylic adhesive may be used radially around this portion of the first layer 205, where immersion may be involved. This can be achieved, for example, by removing a portion of the third layer 215, thereby exposing the adhesive 240. Alternatively, an area of ​​silicone adhesive may extend radially around the adhesive 240 to achieve a fluid and / or air seal with the tissue site. Therefore, in some embodiments, concentric areas without adhesive and / or adhesive variation may be used.

[0154] The systems, devices, and methods described herein offer significant advantages. For example, some embodiments of dressing 110 allow for selective application and regionalization of adhesive between the perforated membrane layer 205 and the wound periphery, which can reduce or prevent maceration around the wound if dressing 110 is used in conjunction with infusion therapy. Additionally, the perforated release liner 215 can be held in place on dressing 110 or removed depending on the application, thus allowing dressing 110 to be used with or without infusion therapy.

[0155] Although illustrated in several exemplary embodiments, those skilled in the art will recognize that the systems, apparatuses, and methods described herein are readily adaptable to various changes and modifications that fall within the scope of the appended claims. Furthermore, unless the context explicitly requires it, the descriptions using various alternative terms such as “or” need not be mutually exclusive, and unless the context explicitly requires it, the indefinite articles “a” or “an” do not limit the subject matter to a single instance.

[0156] Without departing from the scope of the invention as defined by the appended claims, the features, elements, and aspects described herein in the context of some embodiments may also be omitted, combined, or substituted by alternative features for the same, equivalent, or similar purposes. For example, one or more features of some layers may be combined with features of other layers to provide equivalent functionality. For example, in some configurations, dressing 110, container 115, or both may be manufactured or sold separately from other components. In other exemplary configurations, components of dressing 110 may also be manufactured, constructed, assembled, or sold independently or as a kit.

[0157] The appended claims set forth the novel and inventive aspects of the subject matter described above, but the claims may also cover additional subject matter not specifically referenced. For example, if it is not necessary to distinguish between novel and inventive features and features known to a person skilled in the art, certain features, elements, or aspects may be omitted from the claims. Without departing from the scope of the invention as defined by the appended claims, features, elements, and aspects described herein in the context of some embodiments may also be omitted, combined, or replaced by alternative features for the same, equivalent, or similar purposes.

Claims

1. A dressing for treating a tissue site with an instillation therapy, the dressing comprising: a first layer comprising a polymeric film having a plurality of channels therethrough; a second layer adjacent to the first layer, the second layer having a plurality of apertures; a layer of adhesive on at least a portion of the first layer; and a third layer on the layer of adhesive, the third layer being at least partially removable from the layer of adhesive, the third layer comprising: a plurality of channels therethrough; and a plurality of perforations forming a plurality of regions, the regions being separable from one another.

2. The dressing of claim 1, wherein the third layer is not an adhesive.

3. The dressing of claim 1, wherein the third layer comprises a polyurethane.

4. The dressing of claim 1, wherein the channels of the first layer comprise a plurality of fenestrations.

5. The dressing of claim 4, wherein the channels of the third layer comprise a plurality of fenestrations.

6. The dressing of claim 1, wherein the plurality of regions are configured in a tessellation pattern.

7. The dressing of claim 1, wherein the plurality of regions are configured in concentric rings.

8. The dressing of claim 1, wherein the plurality of channels through the third layer are aligned with the plurality of channels through the first layer.

9. The dressing of claim 1, wherein the third layer comprises at least one tab.

10. The dressing of claim 1, wherein the layer of adhesive comprises a polyurethane adhesive or an acrylic adhesive.

11. The dressing of claim 1, wherein the layer of adhesive comprises a silicone adhesive.

12. The dressing of claim 1, wherein: the second layer is a manifold comprising a first surface and a second surface opposite the first surface; and the first layer is adjacent to the first surface.

13. The dressing of claim 12, further comprising: a fourth layer adjacent to the second surface of the second layer, the fourth layer comprising a polymeric film having a plurality of fluid restrictions therethrough.

14. The dressing of claim 13, further comprising: a fifth layer adjacent to the fourth layer, the fifth layer comprising a polymeric drape.

15. The dressing of claim 14, wherein the fourth layer is enclosed between the second layer and the fifth layer.

16. The dressing of claim 12, further comprising: a fourth layer adjacent to the second surface of the second layer, the fourth layer being a gel having a coat weight of about 250 grams per square meter.

17. The dressing of claim 16, wherein the gel is a silicone gel.

18. The dressing of claim 17, wherein the silicone gel has a coat weight of about 250 grams per square meter.

19. The dressing of claim 1, wherein the second layer comprises a hydrophobic polymer.

20. The dressing of claim 19, wherein the hydrophobic polymer comprises a silicone, a polyurethane, a hydrocolloid, or an acrylic. ​ ​ 21. The dressing of claim 1, wherein the polymeric film of the first layer is hydrophobic.

22. The dressing of claim 1, wherein the polymeric film of the first layer is polyethylene.

23. The dressing of claim 1, wherein the polymeric film is a polyethylene film having an areal density of less than 30 grams per square meter.

24. The dressing of claim 1, wherein at least some of the apertures are aligned with at least some of the channels of the first layer.

25. The dressing of claim 1, wherein the channels of the first layer have an average length that does not substantially exceed an average size of the apertures.

26. The dressing of claim 1, wherein the apertures restrict an effective size of the channels of the first layer.

27. The dressing of claim 1, wherein each of the apertures is sized to expose no more than two of the channels of the first layer.

28. The dressing of claim 14, wherein the polymeric drape includes a margin extending beyond the first and second layers, and an adhesive layer disposed in the margin.

29. The dressing of claim 1, wherein the channels of one or more of the first and third layers include a plurality of slots, each of the slots having a length of less than 5 millimeters.

30. The dressing of claim 1, wherein the channels of one or more of the first and third layers include a plurality of slots, each of the slots having a width of less than 2 millimeters.

31. The dressing of claim 1, wherein the channels of one or more of the first and third layers include a plurality of slots, each of the slots having a length of less than 4 millimeters and a width of less than 2 millimeters.

32. The dressing of claim 1, wherein the channels of one or more of the first and third layers comprise or consist essentially of elastomeric valves in the polymeric film, and the elastomeric valves are normally closed.

33. The dressing of claim 1, wherein the channels of one or more of the first and third layers comprise windows in the polymeric film.

34. The dressing of claim 1, wherein the channels of the first layer comprise slits in the polymeric film.

35. The dressing of claim 1, wherein the channels of the first layer comprise intersecting slits in the polymeric film.

36. The dressing of claim 14, further comprising a fluid port coupled to the fifth layer, the fluid port configured to be coupled to a fluid conductor.

37. A system for treating a tissue site, the system comprising: a dressing comprising: a first layer comprising a polymeric film having a plurality of fluid restrictions therethrough; a second layer adjacent to the first layer, the second layer comprising a polymer having a plurality of apertures; an adhesive layer on at least a portion of the first layer; and a third layer comprising a polymeric film having a plurality of channels therethrough. a third layer on the adhesive layer, the third layer being at least partially removable from the adhesive layer, the third layer comprising: a plurality of fluid restrictions through the third layer; and a plurality of perforations forming a plurality of regions, the regions being separable from one another; and a source of instillation solution.

38. The system of claim 37, wherein the third layer is a non-adhesive third layer.

39. The system of claim 37, wherein the third layer comprises polyurethane.

40. The system of claim 37, wherein the plurality of regions are tessellated.

41. The system of claim 37, wherein the plurality of regions are concentric rings.

42. The system of claim 37, wherein the plurality of fluid restrictions in the third layer are aligned with the plurality of fluid restrictions in the first layer.

43. The system of claim 37, wherein the third layer comprises at least one tab.

44. The system of claim 37, wherein the adhesive layer comprises a polyurethane adhesive.

45. The system of claim 37, wherein the adhesive layer comprises a silicone adhesive.

46. The system of claim 37, wherein the second layer is a manifold comprising a first surface and a second surface opposite the first surface, the first layer being adjacent the first surface.

47. The system of claim 37, further comprising: a fourth layer adjacent a second side of the second layer, the fourth layer comprising a polymeric film having a plurality of fluid restrictions through the polymeric film.

48. The system of claim 47, further comprising: a fifth layer adjacent the fourth layer, the fourth layer comprising a polymeric drape.

49. The system of claim 37, further comprising: a fourth layer adjacent a second side of the second layer, the fourth layer comprising a gel.

50. The system of claim 49, wherein the gel is a silicone gel.

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