Systems, devices, and methods for negative pressure therapy that reduce tissue ingrown tissue and extend wear time.

Abstract

This invention describes a dressing, system, and method for treating tissue sites using negative pressure. The dressing includes: a manifold having a first surface and a second surface opposite the first surface; a first layer adjacent to the first surface; and a second layer adjacent to the second surface. The first layer and the second layer are each formed from a polymer film. A plurality of fluid-restricting portions are formed in the polymer film adjacent to at least the first surface. A first plurality of adhesive portions are formed between the first layer and the second layer. The first plurality of adhesive portions define a separable segment of the manifold. A second plurality of adhesive portions are formed between the first layer and the second layer. The second plurality of adhesive portions define a plurality of openings.

Description

[0001] Related patent applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 864164, filed June 20, 2019, which is incorporated herein by reference for all purposes. Technical Field

[0003] The invention set forth in the appended claims relates generally to tissue therapy systems, and more particularly, but not in a limiting way, to systems, dressings and fillers for negative pressure tissue therapy, and methods of using systems, dressings and fillers for negative pressure tissue 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 those sites. This phenomenon has numerous applications, but it has proven particularly beneficial for wound treatment. 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, liquid solutions can be used to clean wounds, or liquid solutions for therapeutic purposes can be used to clean cavities. 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 the retention of the fluid 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 infusion therapy are well-known, improvements to treatment systems, components, and processes can 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 therapeutic environment. Exemplary embodiments are also provided to enable those skilled in the art to make and use the claimed subject matter.

[0008] For example, a dressing for treating tissue sites using negative pressure can be described. The dressing may include a manifold having a first surface and a second surface opposite the first surface. The dressing may also include a first layer adjacent to the first surface and a second layer adjacent to the second surface. Each of the first and second layers may include a polymer membrane. A plurality of fluid-restricting portions may be disposed in the polymer membrane adjacent to at least the first surface. A first plurality of adhesive portions may be formed between the first and second layers. The first plurality of adhesive portions may define a separable segment of the manifold. A second plurality of adhesive portions may be formed between the first and second layers. The second plurality of adhesive portions may define a plurality of openings.

[0009] More generally, in some embodiments, a tissue interface for treating tissue sites using negative pressure can be described. The tissue interface may include a foam having a first surface and a second surface opposite the first surface. A first polymer film may be positioned adjacent to the first surface, and a second polymer film may be positioned adjacent to the second surface. A plurality of slits may be formed in the polymer film adjacent to at least the first surface. And components may be provided for bonding the first polymer film to the second polymer film to form the foam, including separable segments and a plurality of pores.

[0010] Other exemplary embodiments may relate to a device for providing negative pressure therapy to a tissue site. The device may include a manifold having a first side and a second side opposite the first side. A first layer may be positioned adjacent to the first side, and a second layer may be positioned adjacent to the second side. The first and second layers may each comprise a polymer membrane. A plurality of fluid-restricting portions may be formed in the polymer membrane adjacent to at least the first surface. A plurality of adhesive portions may be formed between the first and second layers, defining separable sections of the manifold and a plurality of openings. A negative pressure source may be fluidly coupled to the manifold.

[0011] 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

[0012] Figure 1 This is a functional block diagram of an exemplary embodiment of a treatment system that can provide negative pressure therapy according to this specification.

[0013] Figure 2 Is it possible to... Figure 1 An exploded view of the dressing associated with an exemplary embodiment of the treatment system.

[0014] Figure 3 yes Figure 2 A top view of the tissue interface of the dressing.

[0015] Figure 4 It is a section taken along line 4-4. Figure 3 A cross-sectional view of the organizational interface.

[0016] Figure 5 It is a section taken along line 5-5. Figure 3 A cross-sectional view of the organizational interface.

[0017] Figure 6 yes Figure 2 A top view of another tissue interface of the dressing.

[0018] Figure 7 yes Figure 2 A top view of another tissue interface of the dressing.

[0019] Figure 8 yes Figure 2 A top view of another tissue interface of the dressing.

[0020] Figure 9 It is a section taken along line 9-9. Figure 8 A cross-sectional view of the organizational interface.

[0021] Figure 10 yes Figure 2 A top view of another tissue interface of the dressing.

[0022] Figure 11 yes Figure 2 A top view of another tissue interface of the dressing.

[0023] Figure 12 yes Figure 2 A top view of another tissue interface of the dressing.

[0024] Figure 13 yes Figure 2 A top view of another tissue interface of the dressing.

[0025] Figure 14 It is a section taken along line 14-14. Figure 13 A cross-sectional view of the organizational interface.

[0026] Figure 15 yes Figure 2 A top view of another tissue interface of the dressing.

[0027] Figure 16 yes Figure 2 A top view of another tissue interface of the dressing. Detailed Implementation Plan

[0028] 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.

[0029] 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.

[0030] 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 surface wounds, bone tissue, adipose tissue, muscle tissue, nerve tissue, dermis, vascular tissue, connective tissue, cartilage, tendons, or ligaments. 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. As used herein, a surface wound is a wound on the body surface exposed to the external surface of the body, such as damage or injury to the epidermis, dermis, and / or subcutaneous layer. For example, a surface wound can include an ulcer or a closed incision. As used herein, a surface wound does not include wounds within the abdominal cavity. 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.

[0031] 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 therapeutic solution to a tissue site. For example, the treatment system 100 may include a negative pressure source or negative pressure supply source such as negative pressure source 102, a dressing 104, a fluid container such as container 106, and a regulator or controller such as controller 108. Additionally, the treatment system 100 may include sensors to measure operating parameters and provide feedback signals indicative of these operating parameters to controller 108. Figure 1 As shown, for example, the treatment system 100 may include a pressure sensor 110, an electrical sensor 112, or both, coupled to the controller 108. Figure 1 As shown in the examples, in some embodiments, dressing 104 may include tissue interface 114, cover 116 or both, or substantially consist of tissue interface, cover or both.

[0032] The treatment system 100 may also include an infusion solution source. For example, the solution source 118 may be fluidly connected to the dressing 104, such as... Figure 1 The exemplary embodiments are shown below. In some embodiments, solution source 118 may be fluidly coupled to a positive pressure source such as positive pressure source 120, a negative pressure source such as negative pressure source 102, or both. A regulator such as drip regulator 122 may also be fluidly coupled to solution source 118 and dressing 104 to ensure that the dose of infusion solution (e.g., saline) is appropriate to the tissue site. For example, drip regulator 122 may include a piston that may be pneumatically actuated by negative pressure source 102 to draw infusion solution from solution source during negative pressure intervals and drip solution into dressing during discharge intervals. In addition or alternatively, controller 108 may be coupled to negative pressure source 102, positive pressure source 120, or both to control the dose of infusion solution to the tissue site. In some embodiments, drip regulator 122 may also be fluidly coupled to negative pressure source 102 via dressing 104, such as... Figure 1 As shown in the example.

[0033] 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 user interfaces that further facilitate treatment. For example, in some embodiments, the negative pressure source 102 may be combined with the solution source 118, the controller 108, and other components to form a treatment unit.

[0034] Generally, components of the treatment system 100 can be directly or indirectly coupled. For example, a negative pressure source 102 can be directly coupled to a container 106 and indirectly coupled to a dressing 104 via the container 106. Couplings can include fluid couplings, mechanical couplings, thermal couplings, electrical couplings, or chemical couplings (such as chemical bonds), or in some cases, combinations of couplings. For example, a negative pressure source 102 can be electrically coupled to a controller 108 and fluidly coupled to one or more dispensing components to provide a fluid path to the tissue site. In some embodiments, components can also be coupled by means of physical proximity, integral with a single structure, or formed from the same piece of material. For example, tissue interface 114 and covering 116 can be discrete layers disposed adjacent to each other and, in some embodiments, can be joined together.

[0035] The dispensing component is preferably detachable and may be disposable, reusable, or recyclable. Dressing 104 and container 106 illustrate the dispensing component. 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, tubes are slender cylindrical structures with a degree of flexibility, but their geometry and stiffness can vary. Furthermore, some fluid conductors may be molded into other components or otherwise integrally combined with other components. The dispensing component 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 dressing 104.

[0036] For example, a negative pressure supply device (such as negative pressure source 102) 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 which the tissue site is located. Alternatively, the pressure may be less than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise specified, the 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 applied to the tissue site may vary depending on the treatment requirements, the pressure is typically a low vacuum (often also referred to as a rough vacuum) between -5 mm Hg (-667 Pa) and -500 mm Hg (-66.7 kPa). Common treatment ranges are between -50 mmHg (-6.7 kPa) and -300 mmHg (-39.9 kPa).

[0037] Container 106 refers to a container, canister, pouch, or other storage component used to manage exudates and other fluids aspirated from tissue sites. In many environments, rigid containers may be preferred or necessary for the collection, storage, and disposal of fluids. In other environments, fluids may be properly disposed of without rigid container storage devices, and reusable containers can reduce waste and costs associated with negative pressure therapy.

[0038] A controller, such as controller 108, may be a microprocessor or computer programmed to operate one or more components of the treatment system 100, such as the negative pressure source 102. In some embodiments, for example, controller 108 may be a microcontroller that typically includes an integrated circuit including 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 102, pressure generated by the negative pressure source 102, or pressure distributed to the tissue interface 114. Controller 108 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.

[0039] Sensors such as pressure sensor 110 or electrical sensor 112 are generally known in the art as any device operable to detect or measure a physical phenomenon or characteristic, and typically provide a signal indicative of the detected or measured phenomenon or characteristic. For example, pressure sensor 110 and electrical sensor 112 may be configured to measure one or more operating parameters of therapeutic system 100. In some embodiments, pressure sensor 110 may be a transducer configured to measure pressure in a pneumatic passage and convert the measurement into a signal indicative of the measured pressure. In some embodiments, pressure sensor 110 may be a piezoresistive strain gauge. In some embodiments, electrical sensor 112 may optionally measure operating parameters of negative pressure source 102, such as voltage or current. Preferably, signals from pressure sensor 110 and electrical sensor 112 are suitable as input signals to controller 108, but some signal conditioning may be appropriate. For example, the signal may need to be filtered or amplified before it can be processed by controller 108. Typically, the signal is an electrical signal, but may be represented in other forms, such as an optical signal.

[0040] Tissue interface 114 is typically adapted to partially or completely contact the tissue site. Tissue interface 114 can take many forms and can have many sizes, shapes, or thicknesses, depending on various factors such as the type of treatment being performed or the nature and size of the tissue site. For example, the size and shape of tissue interface 114 can be adapted to the contours of deeper and irregularly shaped tissue sites.

[0041] In some embodiments, the cover 116 can provide a bacterial barrier and protection against physical trauma. The cover 116 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 116 may be, for example, an elastomeric membrane or film that provides a seal sufficient to maintain negative pressure at the tissue site against a given negative pressure source. In some applications, the cover 116 may have a high moisture vapor transmission rate (MVTR). For example, in some embodiments, the MVTR may be at least about 300 g / m³. 2 / 24 hours. In some exemplary embodiments, the cover 116 may be a water vapor-permeable but liquid-impermeable polymer sterilizing cover, such as a polyurethane membrane. Such sterilizing covers typically have a thickness ranging from about 25 micrometers to about 50 micrometers. For permeable materials, the permeability should generally be low enough to maintain the desired negative pressure.

[0042] Cover 116 may include one or more of the following materials: hydrophilic polyurethane; cellulose; hydrophilic polyamide; polyvinyl alcohol; polyvinylpyrrolidone; hydrophilic acrylic resin; hydrophilic silicone elastomer; having, for example, about 14400 g / m². 2 24-hour MVTR (inverted cup technology) and approximately 30-micron thick INSPIRE 2301 material from Coveris Advanced Coatings, Wrexham, United Kingdom; thin, uncoated polymer sterilization covers; natural rubber; polyisoprene; styrene-butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; polyurethane (PU); EVA film; copolyester; siloxane; silicone sterilization covers; 3M Disinfecting covers; such as polyurethane (PU) disinfecting covers available from Avery Dennison Corporation, Glendale, California; polyether block polyamide copolymers (PEBAX) available from Arkema, France; INSPIRE 2327; or other suitable materials.

[0043] Attachment devices can be used to attach the cover 116 to an attachment surface, such as undamaged epidermis, a liner, 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 116 to the epidermis surrounding a tissue site. In some embodiments, for example, some or all of the cover 116 may be coated with an adhesive, such as an acrylic adhesive, with a coating weight between about 25 g / m² (gsm) and about 65 g.sm. 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.

[0044] Solution source 118 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 treatment, but examples of some prescribed solutions include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanide, cation solutions, and isotonic solutions.

[0045] 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.

[0046] Generally, exudates and other fluids flow towards lower pressure along the fluid path. Therefore, the term "downstream" typically means a location relatively closer to a negative pressure source or further away from a positive pressure source within the fluid path. Conversely, the term "upstream" means a location 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 may be reversed (e.g., by replacing the negative pressure source with a positive pressure source), and this descriptive convention should not be construed as restrictive.

[0047] Thick exudate may appear at some tissue sites. Thick exudate can inhibit negative pressure therapy by filling and blocking flow channels in the dressing. Some dressings provide a mesh-like felted foam with 1 cm diameter pores to allow free removal of thick exudate from the tissue site. Due to the reduced pore size of the felted foam, it can also reduce the rate of ingrown growth. Typically, other similarly felted foam layers can be applied over a porous contact layer to complete the wound dressing treatment sequence. While felted foam can reduce ingrown growth due to the reduced pore size, it can also have increased density, thus increasing its stiffness. Increased stiffness can reduce the flexibility and ability of the felted foam to cover complex structures. Increased stiffness means that the dimensions of the felted foam structure must be set to fill the wound; otherwise, the felted foam may come into contact with intact skin, leading to maceration. The use of felted foam can also increase the cost of the dressing due to the increased material density. Wound fillers that allow for the free removal of thick exudate, are variable in size, and have the potential for extended wear time due to their minimal inward growth are flexible and can be placed on wounds without the risk of maceration, which may provide additional benefits to the patient's healing process.

[0048] Figure 2 yes Figure 1 An assembly diagram of an example dressing 104 shows additional details that can be associated with some embodiments, wherein the tissue interface 114 includes separable segments. Figure 2 In one example, the tissue interface 114 includes one or more interface segments 205, which may be defined by a seam 210. Each interface segment 205 may include a manifold segment 215. In some examples, the seam 210 may be formed between or may define a manifold segment 215. In some embodiments, one or more openings 225 surrounded by a weld 230 may be formed through the tissue interface 114.

[0049] In some embodiments, manifold section 215 may include or be substantially 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 dressing's fluid retention capacity, 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 dressing's shape and increase flexibility, allowing it to conform to the wound bed and other tissue sites under negative pressure. In some embodiments, manifold section 215 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 section 215 may be formed from a colored material. Each manifold section in manifold section 215 may be the same color or different colors.

[0050] like Figure 2 As illustrated in the example, tissue interface 114 may have one or more fluid confinement portions 220, which may be uniformly or randomly distributed on tissue interface 114. The fluid confinement portions 220 may be bidirectional and pressure-responsive. For example, each fluid confinement portion 220 may typically include or be substantially composed of an elastic channel that is generally unstrained to significantly reduce fluid flow and may expand or open in response to a pressure gradient. The fluid confinement portions 220 may extend concurrently with manifold section 215.

[0051] For example, some embodiments of the fluid restrictor 220 may include one or more slits, slots, or combinations of slits and slots, or substantially consist thereof. In some examples, the fluid restrictor 220 may include or consist of linear slots having a length of less than 4 mm and a width of 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 220 may be formed by ultrasonic waves or other heating elements. 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.

[0052] like Figure 2As illustrated in the examples, in some embodiments, dressing 104 may include a release liner 245 to protect an optional adhesive on a portion of covering 116 prior to use. The release liner 245 may also provide stiffness to facilitate, for example, deployment of dressing 104. Release liner 245 may be, for example, cast paper, film, or polyethylene. Furthermore, in some embodiments, release liner 245 may be a polyester material, such as polyethylene terephthalate (PET) or a similar polar semi-crystalline polymer. Using a polar semi-crystalline polymer for release liner 245 can substantially eliminate wrinkles or other deformation of dressing 104. For example, the polar semi-crystalline polymer may be highly oriented and resistant to softening, swelling, or other deformation that may occur when in contact with components of dressing 104, or when subjected to temperature or environmental changes or sterilization. Additionally, a release agent may be provided on the side of release liner 245 configured to contact tissue interface 114. For example, the release agent may be a silicone coating and may have a release coefficient suitable for easy manual removal of the release liner 245 without damaging the dressing 104 or deforming the dressing. In some embodiments, the release agent may be, for example, a fluorocarbon compound or a fluorosiloxane. In other embodiments, the release liner 245 may be uncoated or otherwise used without a release agent.

[0053] Figure 2 An example of the fluid conductor 250 and the dressing interface 255 is also shown. Figure 2 As shown in the example, the fluid conductor 250 can be a flexible tube that is fluidly connected to the dressing interface 255 at one end. Figure 2 As shown in the example, the dressing interface 255 may be a bend connector that can be positioned above the opening 260 in the cover 116 to provide a fluid path between the fluid conductor 250 and the tissue interface 114.

[0054] Figure 3 yes Figure 2 A top view of the organizational interface 114, showing additional details that can be associated with some exemplary embodiments. The manifold segments 215 in each interface segment 205 may have the same shape or different shapes. For example... Figure 3 As shown in the example, interface segment 205 and manifold segment 215 can have similar shapes. In some embodiments, each interface segment and manifold segment in interface segment 205 and manifold segment 215 can have an tessellated shape, such as Figure 3 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 215 can be a square with dimensions of about 20 mm × about 20 mm.

[0055] Each joint in joint 210 may have a width W ranging from about 2 mm to about 5 mm, and may be wide enough to allow interface segments 205 to separate along joint 210 without exposing any portion of manifold segments 215. In some embodiments, joint 210 may be perforated. The perforations may be spaced apart to allow interface segments 205 to separate from each other along the perforation lines.

[0056] In some embodiments, opening 225 may include or be substantially composed of holes, apertures, flow channels, or perforations. In some embodiments, each opening 225 may have an average effective diameter between about 5 mm and about 10 mm. The effective diameter of a non-circular region may be the diameter of a circular region having the same surface area as the non-circular region. In some embodiments, opening 225 may have uniform dimensions. In other embodiments, opening 225 may have different diameters. Opening 225 may be circular, polygonal, elliptical, or amorphous. In some embodiments, opening 225 may have a uniform shape. In some embodiments, opening 225 may be formed with sharp corners to create stress points in the underlying tissue during use. In other embodiments, opening 225 may have different shapes. For example, a portion of opening 225 may have a first shape, and a portion of opening 225 may have a second shape different from the first shape. Openings 225 with different shapes may be distributed to change the deformation pattern in the underlying tissue upon repeated placement of tissue interface 114. In other embodiments, each opening 225 may include an array of openings having a diameter smaller than that of opening 225.

[0057] Opening 225 may be located at center 235. Center 235 may be a symmetrical position of opening 225 in at least one plane perpendicular to the surface of center 235. In other embodiments, center 235 may be a position where opening 225 is bisected by at least one plane perpendicular to the surface of center 235, so that opening 225 has an equal area on either side of the plane. In some embodiments, center 235 of opening 225 may be located at the intersection of seams 210. For example, seams 210 parallel to the width of tissue interface 114 may be perpendicular to seams 210 extending parallel to the length of tissue interface 114. Seams 210 orthogonal to each other will intersect at right angles on tissue interface 114, thereby forming a grid having manifold segments 215 disposed in the cells formed by the grid of seams 210. Center 235 of opening 225 may be located at the intersection of seams 210 and allow fluid to flow through tissue interface 114. In some embodiments, opening 225 may allow thick exudate to flow through tissue interface 114. The opening 225 may have a pitch parallel to the length and width of the tissue interface 114. For example, the opening 225 may have a pitch parallel to the length of the tissue interface 114 between about 20 mm and about 40 mm, and a pitch parallel to the width of the tissue interface 114 between about 20 mm and about 40 mm. The pitch parallel to the length and width of the tissue interface 114 may be at least about twice the average effective diameter of the opening 225 in the tissue interface 114.

[0058] In some embodiments, the opening 225 may be defined by a weld 230. In some embodiments, the weld 230 may have a width 240 between about 2 mm and about 5 mm. For example, the width 240 of the weld 230 can be measured from a position on the weld 230 adjacent to the opening 225 to the closest position on the weld 230 surrounding the opening 225. In some embodiments, the width 240 may be the difference between the radius of the opening 225 and the radius of the weld 230. In some embodiments, a portion of the manifold section 215 adjacent to the weld 230 may be removed to accommodate the weld 230. For example, a manifold section 215 having a square shape may have a corner adjacent to the weld 230. The corner of the manifold section 215 may be chamfered to accommodate the weld 230. In other embodiments, the corner of the manifold section 215 may be rounded or otherwise shaped to receive part of the weld 230. The weld 230 may be flexible and conformable without exposing unfused foam.

[0059] Figure 4 It is a section taken along line 4-4. Figure 3 A cross-sectional view of the organizational interface 114 shows additional details that can be associated with some implementation schemes. Figure 4In the example, the organization interface 114 includes a first layer 405, a second layer 410, and a manifold section 215 disposed between the first layer 405 and the second layer 410. In some embodiments, the first layer 405 and the second layer 410 may be disposed adjacent to the manifold section 215, such as... Figure 4 As shown in the example. Similarly, as... Figure 4 As shown in the example, seam 210 may be formed by one or more adhesive portions between the first layer 405 and the second layer 410. The adhesive portions may be continuous or discrete.

[0060] The first layer 405 and the second layer 410 may include or be substantially composed of components for controlling or managing fluid flow. In some embodiments, the first layer 405 and the second layer 410 may include or be substantially composed of an elastic material that is impermeable to liquids. For example, the first layer 405 and the second layer 410 may include or be substantially composed of a polymer film. In some embodiments, the first layer 405 and the second layer 410 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 second layer 410 may have a substantially flat surface, where variations in height are limited to 0.2 mm per centimeter.

[0061] In some embodiments, the first layer 405 and the second layer 410 may comprise or be substantially composed of a hydrophobic material. 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, 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. 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 are 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 on a horizontal sample surface. The contact angles reported herein represent the average of 5 to 9 measurements, with the highest and lowest measurements discarded. The hydrophobicity of the first layer 405, the second layer 410, or both can be further enhanced with hydrophobic coatings of other materials such as silicone and fluorocarbons, such as hydrophobic coatings applied by liquid coating or plasma coating.

[0062] The first layer 405 and the second layer 410 may also be adapted for bonding with other layers, including bonding with each other. For example, the first layer 405, the second layer 410, 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 membrane materials such as polyethylene. The first layer 405 and the second layer 410 may include a hot melt film.

[0063] The areal density of the first layer 405 and the second layer 410 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.

[0064] In some implementations, for example, the first layer 405, the second layer 410, or both 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, bonding layers, such as ethylene-vinyl acetate or modified polyurethanes, can be used. For some constructions, methyl acrylate (EMA) films may also possess suitable hydrophobicity and weldability. In some embodiments, the first layer 405 and the second layer 410 may be formed of a transparent polymer to help cut the interface segment 205 along the seam 210.

[0065] In some embodiments, the first layer 405 and the second layer 410 may be printed with various information, such as product identification, instructions for placement, cutting, or sizing, or numbers. For example, each dressing or individual pillow block may be numbered. In other embodiments, the manifold section 215 may be printed.

[0066] In some embodiments, the fluid restriction portion 220 may include or substantially consist of a perforation in at least one of the first layer 405 and the second layer 410. The perforation may be formed by removing material from the first layer 405, the second layer 410, 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 significantly reduces or prevents fluid flow. Alternatively or concurrently, one or more fluid restrictions in the fluid restriction portion 220 may be an elastomeric valve that is normally closed when unstrained to substantially prevent fluid flow and may open in response to a pressure gradient. The aperture in the material may be a valve suitable for some applications. The aperture may also be formed by removing material, but the amount of material removed and the size of the resulting aperture may be an order of magnitude smaller than that of a perforation, and may not deform the edges. In some embodiments, the fluid restriction portion 220 extends through both the first layer 405 and the second layer 410, and the fluid restriction portion 220 extends together with at least one of the first layer 405 and the second layer 410.

[0067] Each manifold segment 215 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 215 can have a length of about 20 mm. In some embodiments, the manifold segments 215 can be spaced apart by a distance D1 of about 5 mm to about 15 mm. For example, a distance D1 of about 10 mm may be particularly advantageous for some embodiments. In some embodiments, each manifold segment 215 in the tissue interface 114 can be the same size. In other embodiments, each manifold segment 215 in the tissue interface 114 can have different sizes.

[0068] In some embodiments, the tissue interface 114 may have 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 114 may have a thickness T1 of about 8 mm. The thickness T1 of the tissue interface 114 may vary depending on the thickness of the manifold segments 215 used to form the tissue interface 114. For example, each manifold segment 215 may have a thickness ranging from about 5 mm to about 15 mm (e.g., about 8 mm to about 12 mm).

[0069] In some embodiments, the interface 114 can be formed by spacing the manifold segments 215, placing a first layer 405 of the polymer film above the manifold segments 215, placing a second layer 410 below the manifold segments 215, and bonding the first layer 405 to the second layer 410, thereby forming a seam 210 between the manifold segments 215. Suitable means for bonding the first layer 405 to the second layer 410 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 405 and the second layer 410 to facilitate welding. Suitable sacrificial materials may include, for example, hot melt films supplied by Bayer (such as H2, HU2, and H5 membranes), Comelius (Collano membranes), or Prochimir (such as TC203 or TC206 membranes).

[0070] In some embodiments, manifold section 215 may be formed of a monolithic manifold material such as foam. In some embodiments, for example, the adhesive between the first layer 405 and the second layer 410 may extend through the manifold material layer to define manifold section 215. 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 405 and the second layer 410 may melt through the manifold layer during welding to form joint 210.

[0071] Additionally or alternatively, the monolithic manifold material can be perforated and cut to define manifold segments 215 in a variety of suitable shapes and patterns. In some embodiments, seams 210 can be aligned with perforations between manifold segments 215. In some examples, sacrificial joints can be left between manifold segments 215 to hold the manifold segments 215 together as a single unit. Holding the manifold segments 215 as a single unit makes it easier to assemble the tissue interface 114. In some embodiments, either or both of the first layer 405 and the second layer 410 can also be bonded to the manifold segments 215 to increase stability.

[0072] Figure 5 It is a section taken along line 5-5. Figure 3 A cross-sectional view of the interface 114 shows additional details that may be associated with some embodiments. In some embodiments, a first layer 405 of the polymer film may be placed above the manifold segment 215, a second layer 410 may be placed below the manifold segment 215, and the first layer 405 and the second layer 410 may be bonded to each other to form a seam 210 between the manifold segments 215. Suitable means for bonding the first layer 405 to the second layer 410 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 405 and the second layer 410 to facilitate welding. Suitable sacrificial materials may include, for example, hot melt films supplied by Bayer (such as H2, HU2, and H5 membranes), Comelius (Collano membranes), or Prochimir (such as TC203 or TC206 membranes). The center 235 of the opening 225 may be positioned, and additional welding processes may form a weld 230. In some embodiments, opening 225 may be cut through weld 230, thereby removing portions of the first layer 405 and the second layer 410 at opening 225. In other embodiments, weld 230 may be formed by bonding the first layer 405 to the second layer 410 in the same process as forming joint 210.

[0073] Figure 6 This is a top view of another example of the organizational interface 114, showing additional details that can be associated with some implementation schemes. Figure 6 In the example, the organization interface 114 has a generally hexagonal shape, and each interface segment 205 in the organization interface 114 has a generally circular shape. Figure 6 The organizational interface 114 comprises 13 interface segments 205 arranged in three rows. A seam 210 can be formed, and it can typically be tangent to the circular interface segments 205. The seam 210 can form a hexagon surrounding each interface segment 205, such that the intersection of the seam 210 and adjacent interface segments 205 can have three adjacent interface segments 205. The center 235 of the opening 225 can be located at the intersection of three adjacent interface segments 205. Figure 6 The organizational interface 114 can be similar to Figures 2-5 The organizational interface 114 is formed in this way.

[0074] Figure 7 This is a top view of another example of the organizational interface 114, showing additional details that can be associated with some implementation schemes. Figure 7 In the example, the tissue interface 114 has a generally circular shape, and the interface segment 205 has a generally annular or circular shape. Each manifold segment in the manifold segment 215 also has a generally annular or circular shape and can be attached to an adjacent manifold segment 215 via a seam 210. Figure 7 The interface 114 comprises two concentric rings surrounding the circular interface segment 205. In one embodiment, an opening 225 defined by weld 230 is circumferentially positioned on the joint 210. In some embodiments, the opening 225 may have a circumferential pitch of about 10 mm to about 40 mm. In other embodiments, the opening 225 may be preferably placed in a portion of the interface 114 such that the openings 225 are unevenly spaced from each other. Figure 7 The organizational interface 114 can be similar to Figures 2-5 The organizational interface 114 is formed in this way.

[0075] Figure 8 This is a top view of another example of the organizational interface 114, showing additional details that can be associated with some implementation schemes. Figure 8In the example, tissue interface 114 may have a rectangular shape, and interface segment 205 may have a square shape. Similarly, each manifold segment 215 also has a generally square shape and can be attached to adjacent manifold segments 215 via seam 210. In some embodiments, an opening 225 defined by weld 230 is located in the interface segment 205. For example, a center 235 may surround the center of each manifold segment 215. In some embodiments, the openings 225 are distributed throughout the tissue interface 114 such that each interface segment 205 with an opening 225 is adjacent to an interface segment 205 without an opening 225. When multiple layers of tissue interface 114 are stacked within a deep wound, the arrangement of the openings 225 can collect fluid on tissue interface 114 while limiting or preventing the propagation of a continuous fibrin membrane on tissue interface 114. If the two layers of tissue interface 114 are aligned, discontinuities in the surface of tissue interface 114 can prevent fibrin membrane formation. Figure 8 The organizational interface 114 can be similar to Figures 2-5 The organizational interface 114 is formed in this way.

[0076] Figure 9 It is a section taken along line 9-9. Figure 8 A cross-sectional view of the organizational interface 114 shows additional details that can be associated with some implementation schemes. Figure 9 In the example, the organization interface 114 includes a first layer 405, a second layer 410, and a manifold section 215 disposed between the first layer 405 and the second layer 410. In some embodiments, the first layer 405 and the second layer 410 may be disposed adjacent to the manifold section 215, such as... Figure 9 As shown in the example. Similarly, as... Figure 9As shown in the example, joint 210 may be formed by one or more adhesive portions between the first layer 405 and the second layer 410. The adhesive portions may be continuous or discrete. Opening 225 may be formed in interface segment 205. In some embodiments, hole 905 may be formed in manifold segment 215 prior to the location of the first layer 405 and the second layer 410. Hole 905 may have an average effective diameter between about 1 mm and about 2 mm. The average effective diameter of opening 225 and the width 240 of weld 230 may be reduced to fit within hole 905. First layer 405 may be bonded to second layer 410 at hole 905 in manifold segment 215 to form weld 230. Opening 225 may be formed in weld 230. In some embodiments, manifold segment 215 may surround weld 230 and opening 225. In some embodiments, the bond between the first layer 405 and the second layer 410 forming the weld 230 may extend through the manifold material layer of the manifold section 215. 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 405 and the second layer 410 may melt through the manifold layer during welding to form the weld 230 and the hole 905.

[0077] Figure 10 This is a top view of another example of the organizational interface 114, showing additional details that can be associated with some implementation schemes. Figure 10 In the example, tissue interface 114 has a generally rectangular shape, and interface segment 205 has a generally square shape. Each manifold segment in manifold segment 215 also has a generally square shape and can be attached to adjacent manifold segment 215 via seam 210. In some embodiments, openings 225 are provided in interface segments 205. For example, openings 225 are distributed throughout tissue interface 114 such that each interface segment 205 with an opening 225 is adjacent to an interface segment 205 without an opening 225. In some embodiments, the center 235 of the opening 225 may also be located at the junction of seams 210. In some embodiments, the openings 225 provided in interface segments 205 may have a different average effective diameter than the openings 225 provided at the junction of seams 210. For example, the openings 225 provided in interface segments 205 may have a smaller average effective diameter than the openings 225 provided at the junction of seams 210. In other embodiments, the opening 225 in the interface section 205 may have a larger average effective diameter than the opening 225 at the junction of the joint 210. In some embodiments, the opening 225 in the interface section 205 may be about 5 mm to about 15 mm smaller than the opening 225 at the junction of the joint 210. Figure 10 The organizational interface 114 can be similar to Figures 2-5The organizational interface 114 is formed in this way.

[0078] Figure 11 This is a top view of another example of the organizational interface 114, showing additional details that can be associated with some implementation schemes. Figure 11 In the example, interface 114 has a generally rectangular shape, and interface segment 205 has a generally square shape. Each manifold segment in manifold segment 215 also has a generally square shape and can be attached to adjacent manifold segment 215 via seam 210. In some embodiments, center 235 is located at the intersection of seams 210 that are orthogonal to each other. Weld 230 can be formed by welding, bonding, adhering, or otherwise joining the first layer 405 to the second layer 410. In some embodiments, the first layer 405 and the second layer 410 remain intact after weld 230 is formed. Each weld 230 may include a tear line 1105. Tear line 1105 may be a circle of perforations in weld 230 having an average effective diameter approximately equal to the average effective diameter of opening 225. In some embodiments, tear line 1105 may be a separation line. For example, the tear line 1105 can allow the removal of the first layer 405 and the second layer 410 of the weld 230 inside the tear line 1105, thereby forming an opening 225. In this way, a clinician can determine appropriate areas to allow fluid flow across the tissue interface 114. For example, a clinician can determine that a portion of the tissue site may have necrotic tissue or slough, and another portion of the tissue site may not have necrotic tissue or slough. The clinician can create an opening 225 along the tear line 1105 in the necrotic tissue or slough area, thereby keeping the weld 230 intact in the remaining area of ​​the tissue interface 114 along the tear line 1105. In some embodiments, the first layer 405 and the second layer 410 may include a fluid confinement portion 220 inside the tear line 1105 at each center 235. In other embodiments, the first layer 405 and the second layer 410 may not include a fluid confinement portion 220 inside the tear line 1105. Figure 11 The organizational interface 114 can be similar to Figures 2-5 The organizational interface 114 is formed in this way.

[0079] Figure 12 This is a top view of another example of the organizational interface 114, showing additional details that can be associated with some implementation schemes. Figure 12In the example, the tissue interface 114 has a generally rectangular shape, and the interface segment 205 has a generally square shape. Each manifold segment in the manifold segment 215 also has a generally square shape and can be attached to an adjacent manifold segment 215 via a seam 210. In some embodiments, the center 235 is located at the intersection of the seams 210 that are orthogonal to each other. The weld 230 can be formed by welding, bonding, adhering, or otherwise joining the first layer 405 to the second layer 410. In some embodiments, the first layer 405 and the second layer 410 remain intact after the weld 230 is formed. For example, the first layer 405 and the second layer 410 can remain joined to form the weld 230 and remain intact after the joining process. The first layer 405 and the second layer 410 may not contain the fluid restriction portion 220 at the weld 230. In some embodiments, the first layer 405 and the second layer 410 can be cut at the weld 230 by a clinician. For example, a clinician can use scissors or another cutting device to create an opening 225 in the weld 230 and then apply the tissue interface 114 to the tissue site. In this way, the clinician can determine the appropriate area to allow fluid to flow through the tissue interface 114. Figure 12 The organizational interface 114 can be similar to Figures 2-5 The organizational interface 114 is formed in this way.

[0080] Figure 13 This is a top view of another example of the interface 114, showing additional details that can be associated with some embodiments. In some embodiments, an orifice 905 may be formed in the manifold segment 215, and the manifold segment 215 may be enclosed in the first layer 405 and the second layer 410. For example, the orifice 905 may be formed near the center of the manifold segment 215. A seam 210 may be formed to divide the manifold segment 215 into an interface segment 205. A restraint 220 may be formed in the first layer 405 and the second layer 410. In some embodiments, an additional restraint 220 may be positioned above the orifice 905, thereby increasing fluid flow through the orifice 905 while reducing localized granulation that may occur below the orifice 905. Figure 13 The organizational interface 114 can be similar to Figures 2-5 The organizational interface 114 is formed in this way.

[0081] Figure 14 It is a section taken along line 14-14. Figure 13 A cross-sectional view of the organizational interface 114 shows additional details that can be associated with some implementation schemes. Figure 14 In the example, the organization interface 114 includes a first layer 405, a second layer 410, and a manifold section 215 disposed between the first layer 405 and the second layer 410. In some embodiments, the first layer 405 and the second layer 410 may be disposed adjacent to the manifold section 215, such as... Figure 14 As shown in the example. Similarly, as... Figure 14 As shown in the example, the seam 210 may be formed by one or more adhesive portions between the first layer 405 and the second layer 410. The adhesive portions may be continuous or discrete. In some embodiments, a hole 905 may be formed in the manifold section 215 before positioning the first layer 405 and the second layer 410. The first layer 405 and the second layer 410 may not be joined at the hole 905. In some embodiments, a fluid constriction portion 220 may be formed in the first layer 405 and the second layer 410 above the hole 905 in the manifold section 215.

[0082] Figure 15 This is a top view of another example of the tissue interface 114, showing additional details that can be associated with some embodiments. In some embodiments, the opening 225 and the weld 230 may be elongated and have a mortise shape. For example, each opening 225 may have a certain length 1505 and two semicircular portions 1510. The portions 1510 may be located at each end of the length 1505. The portions 1510 of the opening 225 may have an average effective diameter between about 5 mm and about 10 mm, and the length 1505 may be between about 10 mm and about 30 mm. In some embodiments, the center 235 of the opening 225 may be located at the intersection of orthogonal seams 210. For example, the opening 225 may be positioned on a seam 210 parallel to the length of the tissue interface 114, at the intersection of seams 210 parallel to the width of the tissue interface 114. In other embodiments, the center 235 may be offset from the intersection of orthogonal seams 210. For example, center 235 can be located on seam 210, which is parallel to the width of tissue interface 114, and offset from seam 210, which is parallel to the length of tissue interface 114. Figure 15 The organizational interface 114 can be similar to Figures 2-5 The organizational interface 114 is formed in this way.

[0083] Figure 16This is a top view of another example of the tissue interface 114, showing additional details that can be associated with some embodiments. In some embodiments, the openings 225 and welds 230 can be elongated. For example, each opening 225 can have a length 1505 and two semi-circular portions 1510. Portions 1510 can be located at each end of the length 1505. The portions 1510 of the opening 225 can have an average effective diameter between about 5 mm and about 10 mm, and the length 1505 can be between about 20 mm and about 40 mm. In some embodiments, the center 235 of each opening 225 can surround the center of an adjacent manifold segment 215. The length 1505 of the openings 225 can make the ends of the welds 230 adjacent to each other. In some embodiments, the ends of the elongated welds 230 can contact each other to form a mesh. For example, the openings 225 can have an average effective diameter of about 50 mm. Fluid can flow freely through the openings 225 through the tissue interface 114. In some embodiments, the manifold segments 215 may be separated from each other before being encapsulated in the first layer 405 and the second layer 410, thereby providing a more uniform structure and reducing uneven granulation formation. In other embodiments, the manifold segments 215 may be separated from each other during encapsulation by the first layer 405 and the second layer 410. Figure 16 The organizational interface 114 can be similar to Figures 2-5 The organizational interface 114 is formed in this way.

[0084] In other embodiments, the organization interface 114 may include more or fewer interface segments 205. Each interface segment 205 may have different or the same dimensions. Each interface segment 205 may have the same or different shapes. For example, the interface segment 205 may be in the form of an equilateral polygon, having sides not exceeding about 20 millimeters and an area of ​​less than about 400 square millimeters.

[0085] In some embodiments, the method for treating a tissue site may include removing a separable segment of a dressing based on at least one of the size and shape of the tissue site being treated. The method may also include applying the dressing to fill and / or cover the tissue site and sealing the dressing to the epidermis adjacent to the tissue site. The method may further include fluidly coupling the dressing to a negative pressure source and applying negative pressure from the negative pressure source to the dressing.

[0086] In some implementations, cutting the separable section may include cutting the seam or seal between the separable sections. In some configurations, the separable section may be cut without exposing the manifold section inside the dressing.

[0087] In some implementations, applying negative pressure from a negative pressure source to a dressing may include aspirating tissue into an opening at the tissue interface. This method may rupture or otherwise disrupt the tissue aspirated into the opening, thereby aiding in the removal of necrotic tissue or necrotic tissue.

[0088] The systems, apparatus, and methods described herein offer significant advantages. For example, in some embodiments, the seam 210 may be wide enough to allow the interface segment 205 to be cut or otherwise separated to obtain a tissue interface 114 with a desired size and shape. For example, the size and shape of the tissue interface 114 can be set to fill deep and / or irregular wounds by separating the interface segment 205. Furthermore, some embodiments of the dressing 104 can be worn for approximately 3 to approximately 10 days (e.g., approximately 7 days). The tissue interface 114 can provide improved flexibility and less uneven granulation effect. The tissue interface 114 can be used both as a wound interface and as a peri-wound interface. While the tissue interface 114 is variable in size, it can also be reduced in size and placed around a full wound with little or no negative impact on the peri-wound area. In some embodiments, the tissue interface 114 can allow the user to customize the opening 225, choosing to release the opening 225 in desired areas and close the opening 225 in undesirable areas.

[0089] 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, and that such changes and modifications fall within the scope of the appended claims. Furthermore, descriptions using various alternative terms such as “or” need not be mutually exclusive unless the context explicitly requires it, and the indefinite articles “a” or “an” do not limit the subject matter to a single instance unless the context explicitly requires it. Components may also be combined or eliminated in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, dressing 102, container 112, or both may be eliminated or manufactured or sold separately from other components. In other exemplary constructions, controller 108 may also be manufactured, configured, assembled, or sold independently of other components.

[0090] 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 tissue sites using negative pressure, the dressing comprising: Organization interface, the organization interface includes: A manifold having a first surface and a second surface opposite to the first surface; A first layer adjacent to the first surface and a second layer adjacent to the second surface, each of the first layer and the second layer comprising a polymer film; A plurality of fluid confinement portions adjacent to at least the first surface in the polymer film; A first plurality of adhesive portions between the first layer and the second layer, the first plurality of adhesive portions defining a separable section of the manifold; and A second plurality of adhesive portions are provided between the first layer and the second layer, the second plurality of adhesive portions defining a plurality of openings through the tissue interface; A cover, which is configured to be disposed above the tissue interface.

2. The dressing of claim 1, wherein the first plurality of adhesive portions form a seam between the separable sections of the manifold.

3. The dressing of claim 1, wherein the first plurality of adhesive portions form a seam with a width of at least 2 mm between the separable sections of the manifold.

4. The dressing of claim 1, wherein the first plurality of adhesive portions form a seam with a width of at least 2 mm and less than 5 mm between the separable sections of the manifold.

5. The dressing according to claim 1, wherein: The first plurality of adhesive portions include intersecting linear adhesive portions; and The second plurality of adhesive portions are located at the intersection of the first plurality of adhesive portions.

6. The dressing according to claim 1, wherein: The first plurality of adhesive portions include intersecting linear adhesive portions; The second plurality of adhesive portions are located at the intersection of the first plurality of adhesive portions; and The opening is circular.

7. The dressing of claim 6, wherein the opening has a diameter between about 5 mm and about 10 mm.

8. The dressing according to claim 1, wherein: The first plurality of adhesive portions include intersecting linear adhesive portions; and The second plurality of adhesive portions are displaced from the first plurality of adhesive portions.

9. The dressing according to claim 1, wherein: The first plurality of adhesive portions include intersecting linear adhesive portions; The first portion of the second plurality of adhesive portions is located at the intersection of the first plurality of adhesive portions; and The second portion of the second plurality of adhesive portions is displaced from the first plurality of adhesive portions.

10. The dressing of claim 1, wherein the plurality of openings are circular.

11. The dressing of claim 1, wherein the plurality of openings are elliptical.

12. The dressing of claim 1, wherein the plurality of openings are polygonal.

13. The dressing of claim 1, wherein the plurality of openings are amorphous.

14. The dressing according to claim 1, wherein: The first portion of the plurality of openings has a first average effective diameter; and The second portion of the plurality of openings has a second average effective diameter, which is different from the first average effective diameter.

15. The dressing of claim 1, wherein the opening has an average effective diameter between about 5 mm and about 10 mm.

16. The dressing of claim 1, wherein the manifold includes a perforation aligned with the first plurality of adhesive portions.

17. The dressing of claim 1, wherein the manifold includes perforations between the separable sections.

18. The dressing of claim 1, wherein the manifold comprises: Perforations aligned with the first plurality of adhesive portions; as well as Sacrificial joints between the separable sections.

19. The dressing of claim 1, wherein the first plurality of adhesive portions form a seal between the separable sections of the manifold.

20. The dressing of claim 19, wherein the plurality of openings are disposed near the center of each separable segment of the manifold, and the second plurality of adhesive portions seal and separate the manifold segments from the openings.

21. The dressing of claim 1, wherein the first plurality of adhesive portions form a seal between the separable sections of the manifold, the seal being configured to be cut without exposing the manifold.

22. The dressing of claim 1, wherein the plurality of openings extend through the manifold.

23. The dressing of claim 1, wherein the plurality of openings extend through the manifold, the first layer, and the second layer.

24. The dressing of claim 1, wherein each of the plurality of openings is elongated.

25. The dressing of claim 24, wherein the plurality of openings form a mesh.

26. The dressing of claim 1, wherein the plurality of second adhesive portions are perforated.

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