Stripping and placement dressings for negative pressure therapy

Abstract

The invention relates to an exfoliation and placement dressing for negative pressure therapy. A dressing for treating a tissue site with negative pressure may include: a cap having an adhesive; a manifold; a perforated polymer film; and a perforated silicone gel having a therapeutic aperture. The cap, the manifold, the perforated polymer film, and the perforated silicone gel may be assembled in a stacked relationship such that the cap and the perforated silicone gel encapsulate the manifold. The perforated polymer film may be at least partially exposed through the treatment aperture, and at least a portion of the adhesive may be exposed through the perforated silicone gel around the treatment aperture.

Description

[0001] This application is a divisional application of the application filed on June 5, 2018, with application number 201880036541.6 and invention title "Removal and Placement Dressing for Negative Pressure Therapy". Related applications

[0002] This application claims the following benefits under 35 USC § 119(e): U.S. Provisional Patent Application Serial No. 62 / 650,572, filed March 30, 2018, entitled "Assembly Features and Methods for a Peel-and-Place Dressing for Use with Negative Pressure Therapy"; U.S. Provisional Patent Application Serial No. 62 / 633,438, filed February 21, 2018, entitled "Composite Dressing for Improved Granulation and Reduced Maceration with Negative Pressure Therapy"; and U.S. Provisional Patent Application Serial No. 62 / 633,438, filed January 29, 2018, entitled "Methods for Manufacturing and Assembling a Dual-Material Tissue Interface for Negative Pressure Therapy". U.S. Provisional Patent Application Serial No. 62 / 623,325, entitled "Manufacturing and Assembling Dual Material Tissue Interface for Negative-Pressure Therapy"; U.S. Provisional Patent Application Serial No. 62 / 625,704, filed February 2, 2018, entitled "Customizable Composite Dressings for Improved Granulation and Reduced Maceration with Negative-Pressure Treatment"; and U.S. Provisional Patent Application Serial No. 62 / 616, filed January 11, 2018, entitled "Composite Dressings for Improved Granulation and Reduced Maceration with Negative-Pressure Treatment".244. U.S. Provisional Patent Application Serial No. 62 / 615,821, filed January 10, 2018, entitled "METHODS FOR MANUFACTURING AND ASSEMBLING DUAL MATERIAL TISSUE INTERFACE FOR NEGATIVE-PRESSURE THERAPY"; U.S. Provisional Patent Application Serial No. 62 / 613,494, filed January 4, 2018, entitled "PEEL AND PLACE DRESSING FOR THICK EXUDATE AND INSTILLATION"; and U.S. Provisional Patent Application Serial No. 62 / 613,494, filed November 30, 2017, entitled "MULTI-LAYER WOUND FILLER FOR EXTENDEDWEAR". U.S. Provisional Patent Application Serial No. 62 / 592,950, filed October 24, 2017, entitled "Systems, Apparatuses, and Methods for Negative-Pressure Treatment with Reduced Tissue In-Growth"; U.S. Provisional Patent Application Serial No. 62 / 576,498, filed September 29, 2017, entitled "Composite Dressings for Improved Granulation and Reduced Maceration with Negative-Pressure Treatment"; and U.S. Provisional Patent Application Serial No. 62 / 565,754, filed June 7, 2017, entitled "Tissue Contact Interface" U.S. Provisional Patent Application Serial No. 62 / 516,540, filed June 7, 2017, entitled "Composite Dressings for Improved Granulation and Reduced Maceration with Negative-Pressure Treatment," contains patents related to the concept of "interface."U.S. Provisional Patent Application Serial No. 62 / 516,566, filed June 7, 2017, entitled "Composite Dressings for Improved Granulation and Reduced Maceration with Negative-Pressure Treatment," is incorporated herein by reference for all purposes. Technical Field

[0003] The invention set forth in the appended claims generally relates to tissue treatment systems, and more specifically, but not in a limiting way, to dressings for tissue treatment, and methods of using dressings for tissue treatment with negative pressure. Background Technology

[0004] Clinical research and practice have shown that reducing pressure near tissue sites can promote and accelerate the growth of new tissue at those sites. This phenomenon has many applications, but it has proven particularly beneficial in wound treatment. Regardless of whether the wound is caused by trauma, surgery, or other reasons, proper wound care is crucial to the outcome. Using decompression to treat wounds or other tissues is commonly referred to as "negative pressure therapy," but it also has other names, including "negative pressure wound therapy," "decompression therapy," "vacuum therapy," "vacuum-assisted closure," and "local negative pressure." Negative pressure therapy can provide many benefits, including the migration of epithelial and subcutaneous tissues, improved blood flow, and micro-deformation of tissues at the wound site. These benefits can collectively enhance granulation tissue development and reduce healing time.

[0005] It is also widely accepted that cleaning tissue sites is highly beneficial for new tissue growth. For example, liquid solutions can be used to cleanse wounds or cavities for therapeutic purposes. These practices are often referred to as “irrigation” and “cleaning,” respectively. “Infusion” is another practice that typically refers to the process of slowly introducing a fluid into a tissue site and retaining the fluid for a specified period of time before removing it. For example, infusing a local treatment solution into a wound bed can be combined with negative pressure therapy to further promote wound healing by diluting soluble contaminants in the wound bed and removing infectious material. As a result, the burden of soluble bacteria can be reduced, contaminants can be removed, and the wound can be cleaned.

[0006] While the clinical benefits of negative pressure therapy and / or infusion therapy are well known, improvements in therapy 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, apparatus, and methods for treating tissues in a negative pressure therapy environment. Several illustrative 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 may be a composite having multiple dressing layers, including a sealing layer, a fluid control layer, a manifold, and a cap. In some instances, the sealing layer may include a perforated gel layer, such as a silicone gel layer, or substantially thereof. A central region of the gel may be removed to define a treatment orifice. The fluid control layer may include a polyurethane membrane having fluid-restricting portions (such as windows in the membrane), or substantially thereof. In some embodiments, the membrane may be backed with an acrylic adhesive. In some instances, the manifold may be a mesh foam, and the polyurethane membrane may be laminated onto the manifold, or an acrylic adhesive on the polyurethane membrane may bond the two together. In some instances, the polyurethane membrane may be laminated onto the manifold and then cut to the desired size and shape, which can simplify the manufacturing process.

[0009] In some instances, the diameters of the manifold and the fluid control layer may be larger than the treatment port, such that the edges of the manifold are not exposed when assembled and applied to the tissue site. The fluid control layer may be disposed over the treatment port such that a significant amount of fluid confinement is aligned with the treatment port. For example, the manifold and the fluid control layer may be substantially aligned with the treatment port, but wide tolerances may be acceptable. The manifold and the fluid control layer may be superimposed on the area of ​​the sealing layer around the treatment port, and the sealing layer may have an adhesive in the superimposed area to secure the manifold, the fluid control layer, or both. The cap may be positioned on the assembled manifold and the fluid control layer and adhered to the sealing layer to encapsulate the manifold.

[0010] In some embodiments, the sealing layer may include a perforated gel layer, such as a silicone gel layer, or substantially composed thereof, having perforations continuously distributed across the sealing layer. Fluid constriction portions in the fluid control layer may be disposed within the perforations, which may provide functionality similar to the treatment port while increasing the surface area of ​​the sealing layer.

[0011] More generally, a dressing for treating tissue sites with negative pressure may include: a sealing layer having a treatment orifice and a plurality of perforations surrounding the treatment orifice; and a fluid control layer having a plurality of fluid restrictors aligned with the treatment orifice. A manifold may be arranged adjacent to the fluid restrictors, and a cap comprising a non-porous membrane may be disposed on and connected to the sealing layer around the manifold. The cap may also have a pressure-sensitive adhesive arranged adjacent to the plurality of perforations. In a more specific embodiment, the fluid control layer may comprise or be substantially composed of a polyurethane membrane. In some embodiments, the sealing layer may be formed of a gel, such as a silicone gel.

[0012] In some instances, the manifold may have a first edge defining a manifold face adjacent to the fluid control layer, and the fluid control layer may have a second edge defining a fluid control face adjacent to the manifold face. In some embodiments, the fluid control face and the manifold face may have similar shapes. The manifold face may be at least as large as the fluid control face, and the fluid control face may be larger than the treatment port. In more specific instances, at least one of the manifold and the fluid control layer may be coupled to an edge surrounding the treatment port.

[0013] Alternatively, another exemplary embodiment of a dressing for treating tissue sites with negative pressure may include a manifold and a fluid control layer including a plurality of fluid restrictors adjacent to the manifold. A sealing layer including a plurality of perforations may be arranged adjacent to the fluid control layer, and at least some of the perforations may be aligned with more than one of the fluid restrictors. A cap including a non-porous membrane may be disposed on the manifold and coupled to the sealing layer around the manifold. The cap may also have a pressure-sensitive adhesive arranged adjacent to the plurality of perforations. In a more specific embodiment, the fluid control layer may include or be substantially composed of a polyurethane membrane. In some embodiments, the sealing layer may be formed of a gel, such as a silicone gel.

[0014] In a more specific example, the fluid confinement may include a slit with a length of approximately 2 mm to approximately 5 mm. The perforations in the sealing layer may be circular with a diameter large enough to align with more than one of the fluid confinements. For example, diameters in the range of approximately 7 mm to approximately 9 mm may be suitable for some configurations.

[0015] In some embodiments, a dressing for treating tissue sites with negative pressure may include a cap having an adhesive, a manifold, a perforated polymer membrane, and a perforated silicone gel having a treatment port. The cap, the manifold, the perforated polymer membrane, and the perforated silicone gel may be assembled in a stacked relationship such that the cap and the perforated silicone gel encapsulate the manifold. The perforated polymer membrane may be at least partially exposed through the treatment port, and at least a portion of the adhesive may be exposed around the treatment port through the perforated silicone gel.

[0016] In some embodiments, a dressing for treating tissue sites with negative pressure may include a manifold, a gel layer, a fluid control layer, and a cap. The gel layer may include an open central window and a plurality of openings surrounding the open central window. The fluid control layer may extend beyond the open central window and include a plurality of fluid constrictions. The cap may include a non-porous membrane and a pressure-sensitive adhesive, wherein the non-porous membrane may be disposed on and around the manifold and coupled to the gel layer, and the pressure-sensitive adhesive may be disposed adjacent to the plurality of perforations.

[0017] In some embodiments, a dressing for treating tissue sites with negative pressure may include: a foam manifold through which negative pressure and wound fluid pass; a lower surface having an open area for delivering negative pressure via the manifold and for allowing wound fluid to pass, the open area being used to seal a cover area around the tissue, the cover area having an adhesive and not including an opening for negative pressure to pass through the manifold; and a polymer membrane wound contact layer extending beyond the open area in the lower surface and having an opening for negative pressure and wound fluid to enter the foam manifold. In some embodiments, the dressing may further include a cover comprising a cover cloth disposed on the manifold and coupled around the manifold to the cover area.

[0018] This application provides the following: 1) A dressing for treating tissue sites using negative pressure, said dressing comprising: A sealing layer, the sealing layer including a treatment port and a plurality of perforations surrounding the treatment port; A fluid control layer, the fluid control layer including a plurality of fluid restriction portions aligned with the treatment port; The manifold adjacent to the fluid confinement section; and A cover comprising a membrane and a pressure-sensitive adhesive, the membrane being disposed on the manifold and connected to the sealing layer around the manifold, and the pressure-sensitive adhesive being disposed adjacent to the plurality of perforations.

[0019] 2). The dressing according to 1), wherein the fluid control layer comprises a polyurethane film.

[0020] 3). The dressing according to 2), wherein the fluid constriction portion includes a slit in the membrane.

[0021] 4). The dressing according to 3), wherein the length of each of the slits is in the range of about 2 mm to about 5 mm.

[0022] 5). The dressing according to 3), wherein each of these slits is approximately 3 mm in length.

[0023] 6). The dressing according to any one of 1) to 5), wherein the sealing layer is formed of gel.

[0024] 7). The dressing according to any one of 1) to 6), wherein the sealing layer is formed of silicone gel.

[0025] 8). The dressing according to any one of 1) to 7), wherein: The manifold has a first edge that defines a manifold surface adjacent to the fluid control layer; The fluid control layer has a second edge that defines a fluid control surface adjacent to and similar in shape to the manifold surface; and The manifold surface is at least as large as the fluid control surface.

[0026] 9). The dressing according to 8), wherein the fluid control surface is larger than the treatment port.

[0027] 10). The dressing according to any one of 1) to 9), wherein at least one of the manifold and the fluid control layer is connected to the edge surrounding the treatment orifice.

[0028] 11). The dressing according to 10), wherein the width of the edge is in the range of about 2 mm to about 3 mm.

[0029] 12). The dressing according to any one of 1) to 11), wherein the treatment port is complementary to the manifold.

[0030] 13). The dressing according to any one of 1) to 12), wherein the treatment port forms a window around the manifold.

[0031] 14). The dressing according to any one of 1) to 13), wherein the width of the treatment hole is in the range of about 90 mm to about 110 mm and the length is in the range of about 150 mm to about 160 mm.

[0032] 15). A dressing for treating tissue sites using negative pressure, said dressing comprising: manifold; A fluid control layer, the fluid control layer including a plurality of fluid restriction sections adjacent to the manifold; A gel layer comprising a plurality of perforations, wherein at least some of the perforations are aligned with more than one of the fluid confinement portions; and A cover comprising a non-porous membrane and a pressure-sensitive adhesive, the non-porous membrane being disposed on the manifold and connected to the gel layer around the manifold, and the pressure-sensitive adhesive being disposed adjacent to the plurality of perforations.

[0033] 16). The dressing according to 15), wherein the perforation is circular and has a diameter in the range of about 7 mm to about 9 mm.

[0034] 17). The dressing according to 15) or 16), wherein the fluid control layer comprises a polyurethane membrane.

[0035] 18). The dressing according to any one of 15) to 17), wherein the fluid restricting portion comprises a slit in the membrane.

[0036] 19). The dressing according to 18), wherein the length of each of the slits is in the range of about 2 mm to about 5 mm.

[0037] 20). The dressing according to 19), wherein each of these slits has a length of about 3 mm.

[0038] 21). The dressing according to any one of 15) to 20), wherein the perforation is circular and has a diameter in the range of about 7 mm to about 9 mm.

[0039] 22). A dressing for treating tissue sites using negative pressure, said dressing comprising: Covers with adhesive; manifold; Perforated polymer membranes; and Perforated silicone gel with therapeutic pores; The cap, the manifold, the perforated polymer membrane, and the perforated silicone gel are assembled in a stacked relationship such that the cap and the perforated silicone gel encapsulate the manifold, the perforated polymer membrane is at least partially exposed through the treatment port, and at least a portion of the adhesive is exposed through the perforated silicone gel around the treatment port.

[0040] 23). The dressing according to 22), wherein the treatment port corresponds to the surface of the manifold.

[0041] 24). The dressing according to 22) or 23), wherein the treatment port forms a frame around the manifold.

[0042] 25). The dressing according to any one of 22) to 24), wherein the width of the treatment hole is in the range of about 90 mm to about 110 mm and the length is in the range of about 150 mm to about 160 mm.

[0043] 26). A dressing for treating tissue sites using negative pressure, said dressing comprising: manifold; A gel layer comprising an open central window and a plurality of perforations surrounding the open central window; A fluid control layer that extends beyond the open central window and includes multiple fluid restriction sections; A cover comprising a non-porous membrane and a pressure-sensitive adhesive, the non-porous membrane being disposed on the manifold and connected to the gel layer around the manifold, and the pressure-sensitive adhesive being disposed adjacent to the plurality of perforations.

[0044] 27). The dressing according to 26), wherein the open central window comprises an opening of about 20% to about 80% in the gel layer.

[0045] 28). The dressing according to 26) or 27), wherein the width of the open central window is in the range of about 90 mm to about 110 mm and the length is in the range of about 150 mm to about 160 mm.

[0046] 29). The dressing according to any one of 26) to 28), wherein the open central window includes an opening that allows fluid to pass through the fluid control layer.

[0047] 30). The dressing according to any one of 26) to 29), wherein the area of ​​the open central window is within 20% of the surface area of ​​the manifold adjacent to the open central window.

[0048] 31). A dressing for treating tissue sites using negative pressure, said dressing comprising: Foam manifolds for negative pressure and wound fluid passage; The lower surface has an open area for delivering negative pressure via the manifold and for allowing wound fluid to pass through, the open area being used to seal a drape area to the tissue, the drape area having an adhesive and not including an opening for allowing negative pressure to pass through the manifold; and A polymer membrane wound contact layer extends beyond the open area in the lower surface and has an opening for negative pressure and wound fluid to enter the foam manifold.

[0049] 32). The dressing according to 31), wherein the dressing further includes a cover, the cover including a cover cloth disposed on the manifold and connected around the manifold to the cover cloth area.

[0050] 33). Basically, the systems, devices and methods described herein.

[0051] The purpose, advantages, and preferred methods of making and using the claimed subject matter can be best understood by referring to the accompanying drawings and the following detailed description of illustrative embodiments. Attached Figure Description

[0052] Figure 1 This is a functional block diagram of an exemplary embodiment of a therapeutic system that can provide negative pressure therapy and infusion therapy according to this specification; Figure 2 This is an assembled view of an example of a dressing, showing how it can be combined with... Figure 1 Additional details associated with some exemplary embodiments of the therapeutic system; Figure 3 yes Figure 2 A top view of an exemplary dressing; Figure 4 yes Figure 2 A bottom view of an exemplary dressing; Figure 5 This is an assembled view of another example of dressing, showing how it can be used with... Figure 1 Additional details associated with a particular exemplary embodiment of the therapeutic system; Figure 6 It is possible to be with Figure 2 or Figure 5 A schematic diagram of an exemplary configuration of a fluid confinement portion in an associated layer of some embodiments of the dressing; Figure 7 It is possible to be with Figure 5 A schematic diagram of exemplary configurations of pores in the associated layers of some embodiments of the dressing; and Figure 8 yes Figure 6 Exemplary layers superimposed on Figure 7 A schematic diagram on an exemplary layer. Detailed Implementation

[0053] 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 already well known in the art may be omitted. Therefore, the following detailed description should be understood as illustrative rather than restrictive.

[0054] This document may also describe the exemplary embodiments with reference to the spatial relationships or spatial orientations of the different elements depicted in the accompanying drawings. Generally, such relationships or orientations assume a reference frame consistent with or relative to the patient in the position to be treated. However, those skilled in the art should recognize that this reference frame is merely a descriptive and appropriate measure, and not a strict specification.

[0055] Figure 1 This is a simplified functional block diagram of an exemplary embodiment of a therapy system 100 that can provide negative pressure therapy and local treatment solution infusion to tissue sites according to this specification.

[0056] In this context, the term "tissue site" broadly refers to a wound, defect, or other therapeutic target located on or within tissue, including but not limited to bone, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. Wounds can include, for example, chronic, acute, traumatic, subacute, and laceration wounds, 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 any area of ​​tissue that is not necessarily injured or defective, but rather an area in which the growth of additional tissue may be desired or facilitated. For example, negative pressure can be applied to a tissue site to encourage the growth of additional tissue that can be harvested and transplanted.

[0057] The therapy system 100 may include a negative pressure source or supply source, such as negative pressure source 105, and one or more distribution components. The distribution components are preferably detachable and may be disposable, reusable, or recyclable. Dressings, such as dressing 110, and fluid containers, such as container 115, are examples of distribution components that may be associated with some instances of the therapy 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 thereof.

[0058] A fluid conductor is another illustrative example of a distribution component. In this context, "fluid conductor" broadly includes tubes, pipes, hoses, conduits, or other structures having one or more lumens or open passages adapted to transmit fluid between two ends. Typically, a tube is an elongated cylindrical structure with some flexibility, but its geometry and rigidity can vary. Furthermore, some fluid conductors can be molded into other components or otherwise integrally combined with other components. Distribution components may also include or comprise interfaces or fluid ports to facilitate the attachment and disengagement of other components. In some embodiments, for example, a dressing interface can facilitate the attachment of a fluid conductor to a dressing 110. For example, such a dressing interface could be a SENSAT.RAC™ pad available from KineticConcepts, Inc., San Antonio, Texas.

[0059] The therapy system 100 may also include a regulator or controller, such as controller 130. Additionally, the therapy system 100 may include sensors for measuring operating parameters and providing feedback signals indicative of these parameters to controller 130. Figure 1 As shown, for example, the therapy system 100 may include a first sensor 135 and a second sensor 140 coupled to the controller 130.

[0060] The therapeutic 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 illustrated. In some embodiments, the solution source 145 may be fluidly coupled to a positive pressure source (e.g., positive pressure source 150), a negative pressure source (e.g., negative pressure source 105), or both. A regulator, such as an infusion regulator 155, may also be fluidly coupled to the solution source 145 and the dressing 110 to ensure proper administration of the infusion solution (e.g., saline) to the tissue site. For example, the infusion regulator 155 may include a piston that can be pneumatically actuated by the negative pressure source 105 to draw the infusion solution from the solution source during a negative pressure interval and to infuse the solution into the dressing during a ventilation interval. Alternatively or additionally, the controller 130 may be coupled to the negative pressure source 105, the positive pressure source 150, or both, to control the administration of the infusion solution to the tissue site. In some embodiments, the infusion regulator 155 may also be fluidly coupled to the negative pressure source 105 via the dressing 110, such as… Figure 1 The examples shown are as follows.

[0061] Some components of the therapy 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 therapy. 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 therapy unit.

[0062] In general, the components of the therapy system 100 can be directly or indirectly coupled. For example, the negative pressure source 105 can be directly coupled to the container 115 and indirectly coupled to the dressing 110 via the container 115. In some cases, the coupling may include fluid coupling, mechanical coupling, thermal coupling, electrical coupling, or chemical coupling (such as chemical bonds), or some combination of couplings. For example, the negative pressure source 105 may be electrically coupled to the controller 130 and fluidly coupled to one or more distribution components to provide a fluid path to the tissue site. In some embodiments, the components may also be coupled by physical proximity, integral with a single structure, or formed from the same material.

[0063] For example, the negative pressure supply source, such as negative pressure source 105, can be an air reservoir under negative pressure, or it can be a manual or electric device, such as a vacuum pump, a suction pump, a wall-mounted suction port available in many healthcare facilities, or a micropump. "Negative pressure" generally refers to a pressure less than the local ambient pressure, which is, for example, the ambient pressure in a local environment outside a sealed treatment environment. In many cases, the local ambient pressure can also be the atmospheric pressure at the location of the tissue site. Alternatively, the pressure can be less than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise stated, the pressure values ​​stated herein are gauge pressures. 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 can vary depending on treatment needs, the pressure is generally a low vacuum, also commonly 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 mm Hg (-6.7 kPa) and -300 mm Hg (-39.9 kPa).

[0064] Container 115 is representative of containers, canisters, pouches, or other storage components that can be 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 can be properly disposed of without the need for rigid container storage, and reusable containers can reduce waste and costs associated with negative pressure therapy.

[0065] A controller, such as controller 130, may be a microprocessor or computer programmed to operate one or more components of the therapy system 100 (e.g., negative pressure source 105). In some embodiments, controller 130 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 therapy system 100. For example, operating parameters may include power applied to negative pressure source 105, pressure generated by negative pressure source 105, or pressure distributed to 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.

[0066] Sensors, such as first sensor 135 and second sensor 140, are generally considered in the art to be any device operable to detect or measure a physical phenomenon or property, and typically provide a signal indicating the detected or measured phenomenon or property. For example, first sensor 135 and second sensor 140 may be configured to measure one or more operating parameters of the therapeutic system 100. In some embodiments, 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, first sensor 135 may be a piezoresistive strain gauge. In some embodiments, second sensor 140 may optionally measure operating parameters of the negative pressure source 105, such as voltage or current. Preferably, the signals from first sensor 135 and second sensor 140 are suitable as input signals to controller 130, but in some embodiments, some signal conditioning may be appropriate. For example, the signal may need to be filtered or amplified before being processed by controller 130. Typically, the signal is an electrical signal, but may be represented in other forms, such as an optical signal.

[0067] The tissue interface 120 can be generally 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 deep and irregularly shaped tissue sites. Any or all surfaces of the tissue interface 120 can have non-uniform, rough, or irregular contours.

[0068] In some embodiments, the tissue interface 120 may include or substantially consist of a manifold. In this context, the manifold may include, or substantially consist of, means for collecting fluid on the tissue interface 120 under pressure or for distributing fluid on the tissue interface. For example, the manifold may be adapted to receive negative pressure from a source and distribute the negative pressure on the tissue interface 120 through a plurality of orifices, which may have the effect of collecting fluid from the tissue site and drawing the 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.

[0069] In some embodiments, the cover 125 can provide a bacterial barrier and protection against physical trauma. The cover 125 may also be made of a material that reduces evaporation loss and provides a fluid seal between two components or two environments, such as 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 can provide 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 per 24 hours, measured using the upright cup technique according to the ASTM E96 / E96M upright cup method at 38°C and 10% relative humidity (RH). In some embodiments, an MVTR of up to 5,000 g / m² per 24 hours can provide effective breathability and mechanical properties.

[0070] In some exemplary embodiments, the cover 125 may be a non-porous polymer cover or membrane, such as a polyurethane membrane, that is permeable to water vapor but impermeable to liquids. Such 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 plastics; hydrophilic polyamides; polyvinyl alcohol; polyvinylpyrrolidone; hydrophilic acrylic compounds; silicones, such as hydrophilic silicone elastomers; natural rubber; polyisoprene; styrene-butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene vinyl acetate (EVA); copolyesters; and polyether block polyimide copolymers. Such materials are commercially available, such as Tegaderm® cover fabric from 3M Company in Minneapolis, Minnesota; polyurethane (PU) cover fabric from Avery Dennison Corporation in Pasadena, California; polyether block polyamide copolymer (PEBAX) from Arkema SA in Colombes, France; and Inspire 2301 and Inpsire 2327 polyurethane films from Expopack Advanced Coatings in Wrexham, United Kingdom. In some embodiments, cover 125 may include a 2600 g / m² polyurethane film. 2 / 24-hour MVTR (Upright Cup Technology) and INSPIRE 2301 with a thickness of approximately 30 microns.

[0071] An attachment device can be used to attach the cover 125 to an attachment surface, such as undamaged epidermis, a gasket, or another cover. The attachment device can take many forms. For example, the attachment device can be a medically acceptable pressure-sensitive adhesive configured to bond the cover 125 to the epidermis surrounding a tissue site. In some embodiments, for example, a portion or all of the cover 125 may be coated with an adhesive, such as an acrylic adhesive, having a coating weight of about 25 to 65 grams per square meter (gsm). In some embodiments, a thicker adhesive or adhesive combination may be applied to improve sealing and reduce leakage. Other exemplary embodiments of the attachment device may include double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, or organic gel.

[0072] Solution source 145 may also represent 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 solutions suitable for certain prescriptions include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanide, cation solutions, and isotonic solutions.

[0073] During operation, the tissue interface 120 can be placed within, above, on, or otherwise close to the tissue site. If the tissue site is, for example, a wound, the tissue interface 120 can partially or completely fill the wound, or it can be placed on the wound. A cap 125 can be placed on the tissue interface 120 and sealed to an attachment surface near the tissue site. For example, the cap 125 can be sealed to undamaged epidermis surrounding the tissue site. Thus, the dressing 110 can provide a sealed therapeutic environment that is substantially isolated from the external environment near the tissue site, and the negative pressure source 105 can reduce the pressure within the sealed therapeutic environment.

[0074] 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 illustratively described herein as, for example, “delivering,” “distributing,” or “generating” negative pressure.

[0075] Generally, exudates and other fluids flow along the fluid path toward lower pressure. Therefore, the term "downstream" typically refers to 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" refers to a location relatively further away from a negative pressure source or closer to a positive pressure source. Similarly, it may be appropriate to describe certain features in this frame of reference according to the fluid's "inlet" or "outlet." This orientation is generally assumed to be for describing the different features and components described herein. However, in some applications, the fluid path can 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.

[0076] Negative pressure applied to the tissue site through tissue interface 120 in a 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.

[0077] 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 the therapy 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 relating to 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 an operator to achieve the desired target negative pressure at the tissue site and then provided as input to controller 130. The target pressure may vary between tissue sites 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.

[0078] In some embodiments, the controller 130 may have a continuous pressure mode in which the negative pressure source 105 is operated to provide a constant target negative pressure for the duration of treatment or until manual decommissioning. Alternatively, the controller may have an intermittent pressure mode. For example, the controller 130 may operate the negative pressure source 105 to cycle between a target pressure and atmospheric pressure. For example, the target pressure value may be set to 135 mmHg for a specified duration (e.g., 5 minutes), followed by a specified decommissioning period (e.g., 2 minutes). This cycle can be repeated by activating the negative pressure source 105, which can create a square wave pattern between the target pressure and atmospheric pressure.

[0079] In some exemplary embodiments, the increase in negative pressure from ambient pressure to the target pressure may not be instantaneous. For example, the negative pressure source 105 and the dressing 110 may have an initial rise time. The initial rise time may vary depending on the type of dressing and therapeutic equipment used. For example, for one therapeutic system, the initial rise time may be in the range of about 20 to 30 mmHg / s, while for another therapeutic system it may be in the range of about 5 to 10 mmHg / s. If the therapeutic system 100 operates in intermittent mode, the repetition rise time may be a value substantially equal to the initial rise time.

[0080] In some exemplary dynamic pressure control modes, the target pressure can vary over time. For example, the target pressure can vary in the form of a triangular waveform between a negative pressure of 50 and 135 mmHg, with the rise time set at a rate of +25 mmHg / min and the fall time set at -25 mmHg / min. In other embodiments of the therapy system 100, the triangular waveform can vary between a negative pressure of 25 and 135 mmHg, with the rise time set at a rate of +30 mmHg / min and the fall time set at -30 mmHg / min.

[0081] In some embodiments, the controller 130 can control or determine a variable target pressure in a dynamic pressure mode, and the variable target pressure can vary between a maximum pressure value and a minimum pressure value, which can be set as operator-specified inputs representing a desired negative pressure range. The variable target pressure can also be processed and controlled by the controller 130, which can change the target pressure based on a predetermined waveform (e.g., a triangular waveform, a sine waveform, or a sawtooth waveform). In some embodiments, the waveform can be set by the operator to a predetermined negative pressure desired for the therapy or a negative pressure that varies over time.

[0082] In some embodiments, controller 130 may receive and process data, such as data relating to the infusion solution provided to tissue interface 120. Such data may include the clinician-specified type of infusion solution, the volume of fluid or solution to be infused into the tissue site (“fill volume”), and a specified amount of time (“retention time”) for which the solution remains at the tissue site before negative pressure is applied. The fill volume may be, for example, between 10 and 500 mL, and the residence time may be between 1 second and 30 minutes. Controller 130 may also control the operation of one or more components of the therapy system 100 to infuse the solution. For example, controller 130 may manage the distribution of fluid from solution source 145 to tissue interface 120. In some embodiments, the solution may be infused into the tissue interface 120 by applying negative pressure from negative pressure source 105 to reduce pressure at the tissue site. In some embodiments, the solution may be infused into the tissue site by applying positive pressure from positive pressure source 160 to move the solution from solution source 145 into tissue interface 120. Alternatively, the solution source 145 may be raised to a height sufficient to allow gravity to move the solution into the tissue interface 120.

[0083] The controller 130 can also control the hydrodynamics of the infusion by providing a continuous or intermittent flow of solution. Negative pressure can be applied to provide a continuous or intermittent flow of solution. The application of negative pressure can be implemented to provide a continuous pressure operating mode to allow a continuous flow of infusion solution through the tissue interface 120, or it can be implemented to provide a dynamic pressure operating mode to vary the flow rate of the infusion solution through the tissue interface 120. Alternatively, negative pressure can be implemented to provide an intermittent operating mode to allow the infusion solution to remain at the tissue interface 120. In intermittent mode, a specific fill volume and residence time can be provided, depending on, for example, the type of tissue site being treated and the type of dressing used. Negative pressure treatment can be applied after or during the solution infusion. The controller 130 can be used to select the operating mode and the duration of negative pressure treatment before the start of another infusion cycle.

[0084] Figure 2 yes Figure 1 An assembled view of an instance of dressing 110 shows additional details that can be associated with some embodiments where the tissue interface 120 therein includes more than one layer. Figure 2In an example, the organization 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 arranged adjacent to the second layer 210, and the third layer 215 may be arranged adjacent to the second layer 210 and opposite 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 be co-extended with the surface of the first layer 205. In some embodiments, at least some portions of the third layer 215 may be bonded to the second layer 210.

[0085] The first layer 205 generally comprises or is substantially composed of a manifold or manifold layer that provides means for collecting fluid on the tissue interface 120 under pressure or for distributing fluid on the tissue interface. For example, the first layer 205 may be adapted to receive negative pressure from a source and distribute the negative pressure on the tissue interface 120 through a plurality of orifices, which may have the effect of collecting fluid from the tissue site and drawing the 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, for example, from an infusion solution source, to the tissue interface 120.

[0086] In some illustrative embodiments, the pathways of the first layer 205 may be interconnected to improve fluid distribution or collection. In some illustrative embodiments, the first layer 205 may comprise or be substantially composed of a porous material having interconnected fluid pathways. Examples of suitable porous materials that include or can be adapted to form interconnected fluid pathways (e.g., channels) may include honeycomb foams (including open-cell foams, such as mesh foams); porous tissue aggregates; 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 first layer 205 may additionally or alternatively include protrusions forming interconnected fluid pathways. For example, the first layer 205 may be molded to provide surface protrusions defining interconnected fluid pathways.

[0087] In some embodiments, the first layer 205 may comprise or be substantially composed of a mesh foam, the pore size and free volume of which may be varied as required by the prescribed therapy. For example, a mesh foam having at least 90% free volume may be suitable for many therapeutic applications, and foams with an average pore size in the range of 400 to 600 micrometers may be particularly suitable for certain types of therapy. The tensile strength of the first layer 205 may also be varied as required by the prescribed therapy. For example, the tensile strength of the foam may be increased for instilling a topical treatment solution. The 25% compressive load deflection of the first layer 205 may be at least 0.35 psi, and the 65% compressive load deflection 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 first layer 205 may have a tear strength of at least 2.5 psi. In some embodiments, the first layer 205 may be a foam composed of a polyol (such as a polyester or polyether), an isocyanate (such as toluene diisocyanate), and a polymerization modifier (such as an amine or a tin compound). In some instances, the first layer 205 may be, for example, a mesh polyurethane foam used in GRANUFOAM™ dressings or VAC VERAFLO™ dressings, both of which are available from KCI in San Antonio, Texas.

[0088] Other suitable materials for the first layer 205 may include, for example, nonwoven fabrics (Libeltex, Freudenberg), three-dimensional (3D) polymer structures (molded polymers, embossed and molded films, and fused-bonded films [Supracore]), and mesh.

[0089] In some instances, the first layer 205 may comprise a 3D textile, such as various textiles commercially available from Baltex, Muller, and Heathcoates. 3D textiles of polyester fibers may be particularly advantageous in some embodiments. For example, the first layer 205 may comprise or be substantially composed of a three-dimensional woven polyester fiber. In some embodiments, the fibers may be elastic in at least two dimensions. For some embodiments, puncture-resistant fabrics of polyester and cotton fibers having a weight of about 650 g / m² and a thickness of about 1 to 2 mm may be particularly advantageous. In some embodiments, such puncture-resistant fabrics may have a warp tensile strength of about 330 to 340 kg and a weft tensile strength of about 270 to 280 kg. Another particularly suitable material may be a polyester spacer fabric having a weight of about 470 g / m², and in some embodiments, a thickness of about 4 to 5 mm. Such spacer fabrics may have a compressive strength of about 20 to 25 kPa (at 40% compression). Alternatively or concurrently, the first layer 205 may comprise or be composed of a material having substantially linear stretch characteristics (e.g., a polyester spacer fabric having biaxial stretch and a weight of about 380 g / m²). In some embodiments, the thickness of a suitable spacer fabric may be about 3 to 4 mm, and the warp and weft tensile strengths may be about 30 to 40 kg. In some instances, the fabric may have a tightly woven layer of polyester on one or more opposing surfaces. In some embodiments, the woven layers may be advantageously arranged on the first layer 205 facing the tissue site.

[0090] The first layer 205 generally has a first planar surface and a second planar surface opposite to the first planar surface. The thickness of the first layer 205 between the first and second planar surfaces can also be varied according to the needs of the prescribed therapy. For example, the thickness of the first layer 205 can be reduced to alleviate stress on other layers and reduce tension on peripheral tissues. The thickness of the first layer 205 may also affect its compliance. In some embodiments, suitable foams may have a thickness in the range of about 5 mm to 10 mm. The thickness of the fabric (including suitable 3D textiles and spacer fabrics) may range from about 2 mm to about 8 mm.

[0091] The second layer 210 may include or be substantially composed of means for controlling or managing fluid flow. In some embodiments, the second layer 210 may be a fluid control layer comprising or substantially composed of a liquid-impermeable elastomeric material. For example, the second layer 210 may include or be substantially composed of a polymer film, such as a polyurethane film. In some embodiments, the second layer 210 may include or be substantially composed of the same material as the cover 125. In some embodiments, the second layer 210 may also have a smooth or matte surface texture. A gloss or bright finish better than or equal to B3 grade according to SPI (Plastics Industry Association) may be particularly advantageous for certain applications. In some embodiments, variations in surface height may be limited to acceptable tolerances. For example, the surface of the second layer 210 may have a substantially flat surface with height variations limited to 0.2 mm over one centimeter.

[0092] In some embodiments, the second layer 210 may be hydrophobic. In some embodiments, the hydrophobicity of the second layer 210 may vary, but the contact angle with water may be at least 90 degrees. In some embodiments, the contact angle of the second layer 210 with water may not exceed 150 degrees. For example, in some embodiments, the contact angle of the second layer 210 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. Any standard device can be used to measure the water contact angle. While a manual goniometer can be used to visually estimate the contact angle, contact angle measuring instruments typically include an integrated system, which in particular includes a leveling platform, a liquid dropper (e.g., a syringe), a camera, and software designed to calculate the contact angle more accurately and precisely. Non-limiting examples of such integrated systems may include the FTÅ125, FTÅ200, FTÅ2000, and FTÅ4000 systems, all commercially available from First Ten Angstroms, Inc., Portsmouth, VA; and the DTA25, DTA30, and DTA100 systems, all commercially available from Kruss GmbH, Hamburg, Germany. Unless otherwise stated, the water contact angles described herein were measured using deionized and distilled water on a level sample surface with seated drops added from a height of no more than 5 cm in air at 20°C–25°C and 20%–50% relative humidity. The contact angles presented herein represent the average of 5 to 9 measurements, discarding both the maximum and minimum measured values. The hydrophobicity of the second layer 210 can be further enhanced by a hydrophobic coating of other materials (such as silicone and fluorocarbons), either by liquid coating or plasma coating.

[0093] The second layer 210 can also be adapted to be welded to other layers (including the first layer 205). For example, the second layer 210 can be adapted to be welded to polyurethane foam using heat, radio frequency (RF) welding, or other heat-generating methods (such as ultrasonic welding). RF welding is particularly suitable for highly polar materials such as polyurethane, polyamide, polyester, and acrylate. Sacrificial polarity interfaces can be used to facilitate RF welding of less polar membrane materials (such as polyethylene).

[0094] The area density of the second layer 210 can vary depending on the prescribed therapy or application. In some embodiments, an area density of less than 40 grams per square meter may be suitable, and an area density of about 20 to 30 grams per square meter may be particularly advantageous for certain applications.

[0095] In some embodiments, for example, the second layer 210 may comprise, or be substantially composed of, a hydrophobic polymer, such as a polyethylene film. The simple and inert structure of polyethylene can provide a surface that interacts little (if any) with biological tissues and fluids, thus providing a surface that can facilitate free flow of liquids and low adhesion, which can be particularly advantageous for many applications. Other suitable polymer films include polyurethanes, acrylic compounds, polyolefins (e.g., cycloolefin copolymers), polyacetates, polyamides, polyesters, copolyesters, PEBAX block copolymers, thermoplastic elastomers, thermoplastic vulcanizates, polyethers, polyvinyl alcohol, polypropylene, polymethylpentene, polycarbonate, styrene, silicone, fluoropolymers, and acetates. Thicknesses between 20 micrometers and 100 micrometers are suitable for many applications. The film can be transparent, colored, or printed. Suitable highly polar films laminated onto polyethylene films include polyamides, copolyesters, ionomers, and acrylic compounds. To aid adhesion between the polyethylene and the polar film, a bonding layer, such as ethylene vinyl acetate or modified polyurethane, can be used. Methyl acrylate (EMA) films can also have hydrophobic and weldable properties suitable for certain configurations.

[0096] As in Figure 2As shown in the examples, the second layer 210 may have one or more fluid confinement portions 220, which may be uniformly or randomly distributed on the second layer 210. The fluid confinement portions 220 may be bidirectional and pressure-responsive. For example, each fluid confinement portion 220 may generally include or be substantially composed of an elastic channel, which is typically unstrained to significantly reduce fluid flow and may expand or open in response to a pressure gradient. In some embodiments, the fluid confinement portions 220 may include or be substantially composed of perforations in the second layer 210. Perforations may be formed by removing material from the second layer 210. For example, in some embodiments, perforations may be formed by cutting through the second layer 210, which may also deform the edges of the perforations. Where there is no pressure gradient across the perforation, the channel may be small enough to form a seal or fluid confinement, which may significantly reduce or prevent fluid flow. Alternatively or additionally, one or more fluid confinement portions 220 may be elastomeric valves that are normally closed when unstrained to significantly prevent fluid flow and may open in response to a pressure gradient. The opening in the second layer 210 can be a valve suitable for some applications. The opening can also be formed by removing material from the second layer 210, but the amount of material removed and the size of the resulting opening can be at most on the order of a perforation and can avoid deforming the edges.

[0097] For example, some embodiments of the fluid restrictor 220 may include one or more slits, slots, or combinations of slits and slots in the second layer 210, or substantially consist thereof. In some instances, the fluid restrictor 220 may include, or consist of, a linear slot 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 may be particularly suitable for many applications, and a tolerance of about 0.1 mm may also be acceptable. For example, such dimensions and tolerances can be achieved using a laser cutter. Such a slot configuration can be used as an imperfect valve, which significantly reduces fluid flow in a normally closed or idle state. For example, such a slot can form a flow restrictor rather than a completely closed or sealed one. The slot can expand or open wider in response to a pressure gradient to allow increased fluid flow.

[0098] The third layer 215 may include or substantially consist of a sealing layer and may have a substantially flat surface. This sealing layer is formed of a soft, flexible material (e.g., a suitable gel material) suitable for providing a fluid seal with the tissue site. For example, the third layer 215 may include, but is not limited to: silicone gel, soft silicone, hydrocolloid, hydrogel, polyurethane gel, polyolefin gel, hydrogenated styrene copolymer gel, foam gel, soft closed-cell foam (e.g., polyurethane and polyolefin coated with an adhesive), polyurethane, polyolefin, or hydrogenated styrene copolymer. In some embodiments, the third layer 215 may have a thickness between about 200 micrometers (μm) and about 1000 micrometers (μm). In some embodiments, the third layer 215 may have a hardness between about 5 Shore 00 and about 80 Shore 00. Additionally, the third layer 215 may be composed of a hydrophobic or hydrophilic material.

[0099] In some embodiments, the third layer 215 may be a hydrophobic coating material. For example, the third layer 215 may be formed by coating a spacer material (such as a woven, nonwoven, molded, or extruded mesh) with a hydrophobic material. For example, the hydrophobic material used for coating may be soft silicone.

[0100] The third layer 215 may have a periphery 225 surrounding or surrounding the treatment hole 230, and holes 235 arranged in the periphery 225 surrounding the treatment hole 230. In some instances, the treatment hole 230 may be complementary to or correspond to the surface area of ​​the first layer 205. For example, the treatment hole 230 may form a frame, window, or other opening around the surface of the first layer 205. The third layer 215 may also have corners 240 and edges 245. These corners 240 and edges 245 may be part of the periphery 225. The third layer 215 may have an inner boundary 250 surrounding the treatment hole 230, which may be substantially without holes 235, such as... Figure 2 As shown in the examples. In some instances, such as Figure 2 As shown, the treatment port 230 can be symmetrically and centrally arranged in the third layer 215, thus forming an open central window.

[0101] The aperture 235 can be formed by cutting, perforating, or by applying localized RF or ultrasonic energy, or by other suitable techniques for forming openings or perforations in the third layer 215. The aperture 235 can have a uniform distribution pattern or can be randomly distributed on the third layer 215. The aperture 235 in the third layer 215 can have a variety of shapes, including, for example, circular, square, star-shaped, oval, polygonal, slit, complex curve, straight line, triangular, or some combination of such shapes.

[0102] Each hole 235 may have uniform or similar geometric characteristics. For example, in some embodiments, each hole 235 may be a circular hole having substantially the same diameter. In some embodiments, the diameter of each hole 235 may be from about 1 mm to about 50 mm. In other embodiments, the diameter of each hole 235 may be from about 1 mm to about 20 mm.

[0103] In other embodiments, the geometry of the hole 235 can be varied. For example, the diameter of the hole 235 can vary depending on its location in the third layer 215. For example, in some embodiments, the diameter of the hole 235 disposed in the periphery 225 can be between about 5 mm and about 10 mm. A range of about 7 mm to about 9 mm may be suitable for some instances. In some embodiments, the diameter of the hole 235 disposed in the corner 240 can be between about 7 mm and about 8 mm.

[0104] At least one hole 235 in the periphery 225 of the third layer 215 can be positioned at the edge 245 of the periphery 225 and can have an internal cutout that opens or exposes at the edge 245, the internal cutout being in fluid communication with these edges 245 in a lateral direction. This lateral direction can refer to a direction toward the edge 245 and coplanar with the third layer 215. Figure 2 As shown in the example, the holes 235 in the periphery 225 can be positioned near or at the edges 245 and are in fluid communication with these edges 245 in the lateral direction. The holes 235 positioned near or at the edges 245 can be spaced substantially equidistantly around the periphery 225, such as... Figure 2 As shown in the example. Alternatively, the spacing of the holes 235 near or at edge 245 can be irregular.

[0105] As in Figure 2As shown in the examples, dressing 110 may further include an application device, such as adhesive 255. Adhesive 255 may be, for example, a medically acceptable pressure-sensitive adhesive that extends around the periphery, a portion, or the entire surface of cover 125. In some embodiments, for example, adhesive 255 may be an acrylic adhesive having a coating weight between 25 and 65 grams per square meter (gsm). In some embodiments, a thicker adhesive or adhesive combination may be applied to improve sealing and reduce leakage. In some embodiments, such an adhesive 255 layer may be continuous or discontinuous. Discontinuity of adhesive 255 may be provided by holes or pores (not shown) in adhesive 255. Holes or pores in adhesive 255 may be formed after the application of adhesive 255 or by patterning adhesive 255 onto a carrier layer, such as the side of cover 125. In some exemplary embodiments, the size of the holes or pores in adhesive 255 may also be determined to enhance the MVTR of dressing 110.

[0106] like Figure 2 As shown in the examples, in some embodiments, dressing 110 may include a release liner 260 to protect adhesive 255 prior to use. Release liner 260 may also provide stiffness to aid, for example, in the deployment of dressing 110. Release liner 260 may be, for example, cast paper, film, or polyethylene. Furthermore, in some embodiments, release liner 260 may be a polyester material, such as polyethylene terephthalate (PET) or a similar polar semicrystalline polymer. The use of a polar semicrystalline polymer in release liner 260 can substantially prevent wrinkling or other deformation of dressing 110. For example, the polar semicrystalline polymer may be highly oriented and resistant to softening, swelling, or other deformation that may occur upon contact with components of dressing 110 or upon exposure to temperature or environmental changes or sterilization. Additionally, a release agent may be applied to the sides of release liner 260 configured to contact the second layer 210. For example, the release agent may be a silicone coating and may have a release factor suitable for facilitating manual removal of the release liner 260 without damaging or deforming the dressing 110. In some embodiments, the release agent may be a fluorocarbon or a fluorosilicone. In other embodiments, the release liner 260 may be uncoated or otherwise without a release agent.

[0107] Figure 2 An example of the fluid conduction element 265 and the dressing interface 270 is also shown. For example... Figure 2 As shown in the example, the fluid conductor 265 can be a flexible tube, one end of which can be fluidly connected to the dressing interface 270. The dressing interface 270 can be an elbow connector, such as... Figure 2As shown in the example, the elbow connector can be placed on the hole 275 in the cover 125 to provide a fluid path between the fluid conductor 265 and the tissue interface 120.

[0108] In some embodiments, one or more components of dressing 110 may be additionally treated with an antimicrobial agent. For example, the first layer 205 may be a foam, mesh, or nonwoven fabric coated with an antimicrobial agent. In some embodiments, the first layer may include an antimicrobial element, such as fibers coated with an antimicrobial agent. Additionally or alternatively, some embodiments of the second layer 210 may be a polymer coated or infused with an antimicrobial agent. In other instances, the fluid conduction element 265 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 some combination of these materials.

[0109] Alternatively or concurrently, 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 first layer 205 may be a foam coated with such a mixture.

[0110] Figure 3 yes Figure 2 The top view of the dressing 110 in the example, when assembled, shows additional details that can be associated with some embodiments. (As in...) Figure 2 As shown in the examples, in some instances, the cover 125 and the third layer 215 may have substantially the same perimeter shape and size, such that the cover 125 and the third layer 215 are co-linear. In some embodiments, the cover 125 may be substantially transparent, thereby allowing the hole 235 to be seen. The first layer 205 may be centrally arranged on the third layer 215, for example, at the treatment hole 230 ( Figure 3 (Invisible) On. The cover 125 can be arranged on the first layer 205 and connected around the first layer 205 to the third layer 215, such that at least a portion of the adhesive 255 can be arranged adjacent to the hole 235.

[0111] Figure 4 yes Figure 2 The bottom view of the dressing 110 in the example, when assembled, shows additional details that can be associated with some embodiments. (As in...) Figure 4 As illustrated in the examples, a plurality of fluid confinement portions 220 may be aligned with or otherwise exposed through the treatment port 230, and at least a portion of the first layer 205 may be arranged adjacent to the fluid confinement portions 220 and opposite the treatment port 230. In some embodiments, the first layer 205 and the second layer 210 may be substantially aligned with the treatment port 230 or may extend beyond the treatment port 230.

[0112] Additionally, the first layer 205 may have a first edge 405, and the second layer 210 may have a second edge 410. In some instances, the first edge 405 and the second edge 410 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 instances, the first edge 405 and the second edge 410 may also be congruent, such that adjacent faces of the first layer 205 and the second layer 210 are substantially coaxial and have substantially the same surface area. Figure 4 In one example, the surface of the first layer 205 defined by the first edge 405 is larger than the surface of the second layer 210 defined by the second edge 410, and the larger surface of the first layer 205 extends beyond the smaller surface of the second edge 410.

[0113] In some embodiments, the surface defined by the first edge 405, the surface defined by the second edge 410, or both may also be geometrically similar to the treatment port 230 (e.g., Figure 4 (As shown in the example), and can be larger than treatment hole 230. A third layer 215 may surround treatment hole 230 with an overlapping edge 415, which may have additional adhesive disposed therein. (As shown in...) Figure 4 As shown in the examples, in some embodiments, the treatment hole 230 may be elliptical or field-shaped. In some embodiments, the area of ​​the treatment hole 230 may be approximately 20% to approximately 80% of the area of ​​the third layer 215. The area of ​​the treatment hole 230 may also be approximately 20% to approximately 80% of the area of ​​the surface of the first layer 205 defined by the first edge 405. A width of approximately 90 mm to approximately 110 mm and a length of approximately 150 mm to approximately 160 mm may be suitable for some embodiments of the treatment hole 230. For example, the width of the treatment hole 230 may be approximately 100 mm and the length may be approximately 155 mm. In some embodiments, the suitable width of the overlapping edge 415 may be approximately 2 mm to approximately 3 mm. For example, the overlapping edge 415 may be co-extended with the area defined between the treatment hole 230 and the first edge 405, and an adhesive may secure the first layer 205, the second layer 210, or both, to the third layer 215.

[0114] Figure 5 yes Figure 1 An assembled view of another example of dressing 110, showing additional details that can be associated with some embodiments. (See attached image.) Figure 5 As shown, some instances of the third layer 215 may not have treatment holes 230, and the holes 235 may be distributed in a uniform pattern on the third layer 215.

[0115] Figure 6This is a schematic diagram of an instance of the second layer 210, illustrating additional details that can be associated with some embodiments. (As shown in...) Figure 6 As shown in the examples, the fluid restriction section 220 can each essentially consist of one or more slits having a length L. A length of approximately 3 mm may be particularly suitable for some embodiments. Figure 6 An example of a uniformly distributed pattern in the fluid confinement section 220 is also shown. Figure 6 In this configuration, the fluid restrictors 220 extend substantially along the second layer 210 and are distributed on the second layer 210 in a grid of parallel rows and columns, wherein these slits are also parallel to each other. In some embodiments, these rows may be spaced apart by a distance D1. A center-to-center distance of approximately 3 mm may be suitable for some embodiments. In some instances, the centers of the fluid restrictors 220 within each row may be spaced apart by a distance D2 (approximately 3 mm). In some embodiments, the fluid restrictors 220 in adjacent rows may be aligned or offset. For example, in some embodiments, such as Figure 6 As shown, adjacent rows may be offset such that the fluid restrictors 220 are aligned in the alternating rows and spaced apart by a distance D3 (which may be about 6 mm). In some embodiments, the spacing of the fluid restrictors 220 may be varied to increase the density of the fluid restrictors 220 according to treatment needs.

[0116] Figure 7 This is a schematic diagram of an exemplary configuration of aperture 235, illustrating additional details that can be associated with some embodiments of the third layer 215. Figure 7 In some embodiments, the hole 420 is generally circular and has a diameter D4, which can be about 6 mm to about 8 mm. A diameter D4 of about 7 mm may be particularly suitable for some embodiments. Figure 7 An example of a uniformly distributed pattern of aperture 235 is also shown. Figure 7 In the middle, holes 235 are distributed in a grid of parallel rows and columns on the third layer 215. Within each row and column, holes 235 can be equidistant from each other, such as... Figure 7 As shown in the examples. Figure 7 An exemplary configuration is shown that can be particularly well-suited for many applications, wherein the aperture 235 can be spaced apart by a distance D5 and an offset of D6 along each row and each column. In some instances, the distance D5 can be from about 9 mm to about 10 mm, and the offset D6 can be from about 8 mm to about 9 mm.

[0117] Figure 8 yes Figure 7 In the example, hole 235 is superimposed on Figure 6 The schematic diagram on the second layer 210 illustrates additional details that can be associated with some exemplary embodiments of the organization interface 120. For example, as Figure 8As shown, in some embodiments, more than one fluid confinement portion 220 may be aligned, overlapped, aligned, or otherwise fluidly connected to the orifice 235. In some embodiments, one or more fluid confinement portions 220 may be partially aligned with the orifice 235. Figure 8 In the examples, the size and configuration of the orifices 235 are generally determined such that at least four fluid restrictors 220 are aligned with each orifice 235. In other examples, one or more fluid restrictors 220 may be aligned with more than one orifice 235. For example, any one or more fluid restrictors 220 may be a perforation or window extending across two or more orifices 235. Alternatively or concurrently, one or more fluid restrictors 220 may not be aligned with any orifice 235.

[0118] As in Figure 8 As shown in the example, the size of the orifice 235 can be determined to expose a portion of the second layer 210, the fluid confinement portion 220, or both, through the third layer 215. Figure 8 In some examples, the size of the orifice 235 is generally determined to expose more than one fluid confinement portion 220. Some or all of the orifices 235 may be determined to expose two or three fluid confinement portions 220. In some examples, the length of each fluid confinement portion 220 may be significantly smaller than the diameter of each orifice 235. More generally, the average size of the fluid confinement portions 220 may be significantly smaller than the average size of the orifices 235. In some examples, the orifices 235 may be elliptical, and the length of each fluid confinement portion 220 may be significantly smaller than its major or minor axis. Although, in some embodiments, the size of the fluid confinement portion 220 may be larger than the size of the orifice 235, the size of the orifice 235 may limit the effective size of the fluid confinement portion 220 exposed to the lower surface of the dressing 110.

[0119] Figures 2 to 8 In the example, the various components of dressing 110 can be bonded to each other by solvent-based or non-solvent-based adhesives, or by means of, for example, thermal welding, or otherwise, without adversely affecting fluid management. Additionally, the second layer 210 or the first layer 205 can be joined to the inner boundary 250 or overlapping edge 415 of the third layer 215 in any suitable manner, such as by, for example, welding or adhesive.

[0120] The cover 125, first layer 205, second layer 210, third layer 215, or a variety of different combinations thereof can be assembled prior to application or assembled on-site. For example, in some embodiments, the second layer 210 may be laminated onto the first layer 205. In some embodiments, the cover 125 may be disposed on the first layer 205 and attached around the first layer 205 to the third layer 215. In some embodiments, one or more layers of the tissue interface 120 may be co-extended. For example, the second layer 210 may be cut flush with the edge of the first layer 205. In some embodiments, the dressing 110 may be provided as a single composite dressing. For example, the third layer 215 may be attached to the cover 125 to enclose the first layer 205 and the second layer 210, wherein the third layer 215 may be configured to face the tissue site.

[0121] In use, the release liner 260 (if included) can be removed to expose a third layer 215, which can provide the lower surface of the dressing 110 to be placed within, above, over, or otherwise adjacent to the tissue site, particularly the surface tissue site and adjacent epidermis. The second layer 210, the third layer 215, or both can be positioned between the first layer 205 and the tissue site, which can significantly reduce or eliminate adverse interactions between the first layer 205 and the tissue site. For example, the third layer 215 can be placed over the surface wound (including the wound edges) and undamaged epidermis to prevent direct contact with the first layer 205. In some applications, the treatment port 230 of the third layer 215 can be positioned adjacent to, near, or covering the tissue site. In some applications, the second layer 210, the fluid restriction portion 220, or at least a portion thereof can be exposed to the tissue site through the treatment port 230, the orifice 235, or both. The periphery 225 of the third layer 215 can be positioned adjacent to or near tissue surrounding or encircling the tissue site. The third layer 215 is tacky enough to hold the dressing 110 in place while allowing it to be removed or repositioned without causing trauma to the tissue site.

[0122] Removing the release liner 260 exposes the adhesive 255, and the cap 125 can be attached to the attachment surface, such as the periphery 225 or other areas, around the treatment hole 230 and the first layer 205. The adhesive 255 can also be attached to the epidermis surrounding the tissue site around the first layer 205 and the second layer 210. For example, the adhesive 255 can be in fluid communication with the attachment surface through holes 235 in at least the periphery 225 of the third layer 215. The adhesive 255 can also be in fluid communication with the edge 245 through holes 235 exposed at the edge 245.

[0123] Once the dressing 110 is in the desired position, the adhesive 255 can be pressed through the hole 235 to bond the dressing 110 to the attachment surface. The hole 235 at the edge 245 allows the adhesive 255 to flow around the edge 245 to enhance the adhesion between the edge 245 and the attachment surface.

[0124] In some embodiments, the size of the orifice 235 can be determined to control the amount of adhesive 255 exposed through the orifice 235. For a given geometry of the corner 240, the relative sizes of the orifices 235 can be configured to maximize the surface area of ​​the adhesive 255 exposed at the corner 240 and in fluid communication through the orifices 235 at the corner. For example, the edges 245 may intersect substantially right-angled or at approximately 90 degrees to define the corner 240. In some embodiments, the corner 240 may have a radius of approximately 10 mm. Additionally, in some embodiments, the three orifices 235 may be positioned in a triangular configuration at the corner 240 to maximize the exposed surface area of ​​the adhesive 255. In other embodiments, the size and number of orifices 235 in the corner 240 may be adjusted, if necessary, depending on the selected geometry of the corner 240 to maximize the exposed surface area of ​​the adhesive 255. Furthermore, the orifices 235 at the corner 240 may be completely contained within the third layer 215, thereby significantly preventing fluid communication in the lateral direction outside the corner 240. The fact that the hole 235 at the corner 240 is completely contained within the third layer 215 significantly prevents fluid communication of the adhesive 255 outside the corner 240 and provides improved maneuverability of the dressing during the deployment of the dressing 110 to the tissue site. Furthermore, the substantially adhesive-free exterior of the corner 240 increases the flexibility of the corner 240 for improved comfort.

[0125] In some embodiments, the adhesive strength of the adhesive 255 may vary based on the configuration of the third layer 215. For example, the adhesive strength may vary based on the size of the orifice 235. In some instances, the adhesive strength may be inversely proportional to the size of the orifice 235. Alternatively or alternatively, for example, if the size of the orifice 235 varies, the adhesive strength may vary at different locations. For example, a lower adhesive strength combined with a larger orifice 235 may provide an adhesion comparable to the higher adhesive strength at a location with a smaller orifice 235.

[0126] The geometry and dimensions of the tissue interface 120, the cap 125, or both can be modified to suit a specific application or anatomical structure. For example, the geometry or dimensions of the tissue interface 120 and the cap 125 can be adapted to provide an effective and reliable seal relative to challenging anatomical surfaces at or around the tissue site (e.g., the elbow or heel). Alternatively or additionally, dimensions can be modified to increase the surface area of ​​the third layer 215, thereby enhancing the movement and proliferation of epithelial cells at the tissue site and reducing the likelihood of inward granulation tissue growth.

[0127] Therefore, dressing 110 can provide a sealed therapeutic environment that is substantially isolated from the external environment close to the tissue site, and negative pressure source 105 can reduce pressure within the sealed therapeutic environment. Treatment port 230 can provide an open area for delivering negative pressure through the second layer 210 and the first layer 205 and for allowing wound fluid to pass through. Third layer 215 can provide an effective and reliable seal relative to challenging anatomical surfaces at or around the tissue site, such as the elbow or heel. Additionally, dressing 110 can allow for reapplication or repositioning to, for example, repair air leaks caused by wrinkles and other discontinuities in dressing 110. In some embodiments, the ability to correct leaks can increase the efficacy of the therapy and reduce power consumption.

[0128] If not already configured, the dressing interface 270 can be positioned above the hole 275 and attached to the cover 125. The fluid conductor 265 can be fluidly connected to the dressing interface 270 and the negative pressure source 105.

[0129] The negative pressure applied through tissue interface 120 can create a negative pressure differential on the fluid confinement portion 220 in the second layer 210, which can cause the fluid confinement portion 220 to open or expand. For example, in some embodiments where the fluid confinement portion 220 may include a substantially closed window through the second layer 210, the pressure gradient over the window can cause strain in the adjacent material of the second layer 210 and increase the size of the window to allow fluid to move through it, similar to the operation of a duckbill valve. Opening the fluid confinement portion 220 allows exudates and other fluids to move through the fluid confinement portion 220 into the first layer 205. The first layer 205 can be used for negative pressure and wound fluid, which can be collected in container 115. Pressure changes can also cause the first layer 205 to expand and contract, and the second layer 210, the third layer 215, or both can protect the epidermis from irritation that may result from the expansion, contraction, or other movement of the first layer 205. For example, in some embodiments, an overlapping edge 415 may be disposed between the first layer 205 and the epidermis surrounding the tissue site. The second layer 210 and the third layer 215 can also significantly reduce or prevent tissue sites from being exposed to the first layer 205, which can inhibit tissue growth into the first layer 205. For example, the second layer 210 can cover the treatment hole 230 to prevent direct contact between the first layer 205 and the tissue site.

[0130] If the negative pressure source 105 is removed or turned off, the pressure difference on the fluid restriction section 220 can dissipate, thereby allowing the fluid restriction section 220 to close and preventing exudate or other fluids from passing through the second layer 210 back to the tissue site.

[0131] In some applications, a filler may also be disposed between the tissue site and the third layer 215. For example, if the tissue site is a surface wound, a wound filler may be applied inside the wound periphery, and the third layer 215 may be disposed around the wound and above the wound filler. In some embodiments, the filler may be a manifold, such as open-cell foam. In some embodiments, the filler may comprise or consist of the same material as the first layer 205 or substantially of it.

[0132] Alternatively, an infusion solution or other fluid can be distributed into the dressing 110, which can increase the pressure in the tissue interface 120. The increased pressure in the tissue interface 120 can create a positive pressure differential on the fluid confinement section 220 in the second layer 210, which can open the fluid confinement section 220 to allow the infusion solution or other fluid to be distributed to the tissue site.

[0133] The systems, devices, and methods described herein can offer significant advantages. For example, some dressings used in negative pressure therapy may require time and skill to properly determine their size and apply for good fit and seal. In contrast, some embodiments of dressing 110 provide an easy-to-apply negative pressure dressing, thereby reducing application and removal time. In some embodiments, such as dressing 110, dressing 110 can be a fully integrated negative pressure therapy dressing that can be applied in one step to a tissue site (including around a wound) without being cut to a fixed size, while still providing or improving many of the benefits of other negative pressure therapy dressings that require size adjustment. Such benefits can include good manifolding, beneficial granulation, protection of surrounding tissue from blistering, protection of the tissue site from material detachment, and low-trauma and highly sealing adhesion. These features can be particularly advantageous for surface wounds with moderate depth and moderate to high levels of exudate. Some embodiments of dressing 110 can remain on the tissue site for at least 5 days, and some embodiments can remain for at least 7 days. The antimicrobial agent in dressing 110 can extend the usable life of dressing 110 by reducing or eliminating the risk of infection that may be associated with prolonged use, especially when used on infected or highly exudative wounds.

[0134] While illustrated in some 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 falling within the scope of the appended claims. Furthermore, unless the context clearly requires, the use of terms such as “or” to describe different alternatives need not be mutually exclusive, and unless the context clearly requires, the indefinite articles “a” or “an” do not limit the subject matter to a single instance. Components can also be combined or excluded in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, dressing 110, container 115, or both may be eliminated or separated from other components for manufacture or sale. In other exemplary configurations, controller 130 may also be manufactured, configured, assembled, or sold independently of other components.

[0135] The appended claims set forth the novelty and inventive step aspects of the subject matter described above; however, the claims may also cover other subject matter not explicitly enumerated. For example, certain features, elements, or aspects may be omitted from the claims if it is not necessary to distinguish novel and inventive features from those known to a person skilled in the art. Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced with alternative features for the same, equivalent, or similar purpose without departing from the scope of the invention as defined by the appended claims.

Claims

1. A dressing for treating tissue sites using negative pressure, said dressing comprising: A sealing layer comprising a single opening defining a treatment port, an inner boundary surrounding the treatment port, and a plurality of perforations surrounding the treatment port and the inner boundary, wherein the inner boundary has no perforations, and wherein the size of each of the plurality of perforations is smaller than the size of the treatment port; A fluid control layer comprising a liquid-impermeable material extending beyond the treatment orifice and a plurality of fluid confinement portions aligned with the treatment orifice, wherein the plurality of fluid confinement portions are configured to move from a normally confined position to an open position in response to a pressure gradient, and wherein the face of the fluid control layer overlaps with the inner boundary at the edge to which the fluid control layer is joined. The manifold adjacent to the fluid confinement section; as well as A cover comprising a membrane and a pressure-sensitive adhesive, the membrane being disposed on the manifold and connected to the sealing layer around the manifold, and the pressure-sensitive adhesive being disposed adjacent to the plurality of perforations.

2. The dressing according to claim 1, wherein, The fluid control layer comprises a polyurethane membrane.

3. The dressing according to claim 2, wherein, The fluid confinement portion includes a slit in the membrane.

4. The dressing according to claim 3, wherein, The length of each slit is in the range of approximately 2 mm to approximately 5 mm.

5. The dressing according to claim 3, wherein, Each of these slits is approximately 3 millimeters long.

6. The dressing according to claim 1, wherein, The sealing layer is formed from gel.

7. The dressing according to claim 1, wherein, The sealing layer is formed of silicone gel.

8. The dressing according to claim 1, wherein: The manifold has a first edge that defines a manifold surface adjacent to the fluid control layer; The surface of the fluid control layer is a fluid control surface defined by the second edge of the fluid control layer; and The manifold surface is larger than the fluid control surface, such that the manifold surface extends beyond the second edge of the fluid control layer.

9. The dressing according to claim 8, wherein, The manifold surface is connected to the edge around the second edge of the fluid control layer.

10. The dressing according to claim 1, wherein, The width of the edge is in the range of about 2 mm to about 3 mm.

11. The dressing according to claim 1, wherein, The treatment port is complementary to the manifold.

12. The dressing according to claim 1, wherein, The treatment port forms a window around the manifold.

13. The dressing according to claim 1, wherein, The width of the treatment port is in the range of about 90 mm to about 110 mm and the length is in the range of about 150 mm to about 160 mm.

14. A dressing for treating tissue sites using negative pressure, said dressing comprising: Covers with adhesive; manifold; Perforated polymer membranes, including liquid-impermeable materials; as well as A perforated silicone gel having a treatment hole, an inner boundary surrounding the treatment hole, and a plurality of perforations surrounding the treatment hole and the inner boundary, wherein the inner boundary is not perforated, and wherein the size of each of the plurality of perforations is smaller than the size of the treatment hole; The cap, the manifold, the perforated polymer membrane, and the perforated silicone gel are assembled in a stacked relationship such that the cap and the perforated silicone gel encapsulate the manifold, the perforated polymer membrane extends across the treatment port and a plurality of perforations in the perforated polymer membrane are at least partially exposed through the treatment port, and at least some of the adhesives are exposed around the treatment port through the perforated silicone gel.

15. The dressing according to claim 14, wherein, The treatment port corresponds to the surface of the manifold.

16. The dressing according to claim 14, wherein, The treatment port is defined by a single opening forming a frame around the manifold.

17. A dressing for treating tissue sites using negative pressure, said dressing comprising: manifold; A gel layer comprising an open central window and a plurality of openings surrounding the open central window, wherein the size of each of the plurality of openings is smaller than the size of the open central window; A fluid control layer extends beyond the open central window and includes a liquid-impermeable material and a plurality of fluid confinement portions, wherein at least a portion of the plurality of fluid confinement portions is aligned with the open central window and configured to move from a normal confinement position to an open position in response to a pressure gradient. as well as A cover comprising a membrane and a pressure-sensitive adhesive, the membrane being disposed on the manifold and connected to the gel layer around the manifold, and the pressure-sensitive adhesive being disposed adjacent to the plurality of openings.

18. The dressing according to claim 17, wherein, The open central window includes an opening in the gel layer that covers approximately 20% to approximately 80% of the surface area of ​​the gel layer.

19. The dressing according to claim 17, wherein, The width of the open central window is in the range of about 90 mm to about 110 mm and the length is in the range of about 150 mm to about 160 mm.

20. The dressing according to claim 17, wherein, The open central window includes an opening that allows fluid to pass through the fluid control layer.

21. The dressing according to claim 17, wherein, The area of ​​the open central window is within 20% of the surface area of ​​the manifold adjacent to the open central window.

22. A dressing for treating tissue sites using negative pressure, said dressing comprising: The first layer includes a manifold; The second layer includes a membrane and a plurality of fluid confinement portions adjacent to the manifold; The third layer includes a coating adjacent to the second layer, wherein treatment holes and a plurality of perforations surrounding the treatment holes are arranged through the coating, and at least a portion of each of the plurality of fluid confinements and a portion of the second layer surrounding the plurality of fluid confinements are exposed through the treatment holes and configured to directly contact the tissue site; as well as A cover comprising a non-porous membrane and an adhesive, the non-porous membrane being coupled to the manifold and the adhesive being arranged adjacent to the plurality of perforations such that at least some of the adhesive is exposed through the perforations to contact tissue sites around the treatment port.

23. The dressing according to claim 22, wherein, The plurality of perforations are smaller than the treatment holes.

24. The dressing according to claim 22, wherein, The coating comprises a hydrophobic material.

25. The dressing according to claim 22, wherein, The coating comprises a gel.

26. The dressing according to claim 22, wherein, The coating includes silicone.

27. The dressing according to claim 22, wherein, The perforation is circular and has a diameter ranging from about 7 mm to about 9 mm.

28. The dressing according to claim 22, wherein, The second layer includes a polyurethane film.

29. The dressing according to claim 22, wherein, The fluid confinement portion includes a slit in the membrane.

30. The dressing according to claim 29, wherein, The length of each slit is in the range of approximately 2 mm to approximately 5 mm.

31. The dressing according to claim 22, wherein, The width of the treatment port is in the range of about 90 mm to about 110 mm and the length is in the range of about 150 mm to about 160 mm.

32. The dressing according to claim 22, wherein, The cover, the manifold, the membrane, and the coating are assembled in a stacked relationship such that the portion of the coating and the plurality of fluid confinement portions exposed through the treatment orifice is configured to face the tissue site.

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