Negative pressure wound therapy apparatus and system

Abstract

An apparatus and system for use in a negative pressure wound therapy environment. A dressing configured to be positioned at a tissue site includes a first film layer, a manifold, and a cover layer. The first film layer includes a treatment region having a plurality of first perforations, a sealing region surrounding the treatment region having a plurality of second perforations, and a sealing adhesive overlying the sealing region on a first side of the first film layer configured to face the tissue site. The manifold is disposed adjacent a second side of the first film layer, wherein the second side is opposite the first side. The cover layer is disposed over the manifold and coupled to the second side of the first film layer around the manifold. The cover layer includes a second film layer and a cover adhesive disposed adjacent the plurality of second perforations.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 349,375, filed on June 6, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention as set forth in the appended claims relates generally to tissue treatment systems and, more particularly but not by way of limitation, to dressings for tissue treatment with negative pressure and methods of using dressings for tissue treatment with negative pressure. Background Art

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

[0005] While the clinical benefits of negative pressure therapy are well known, improvements to therapy systems, components, and processes can benefit healthcare providers and patients. Summary of the invention

[0006] New and useful systems, devices, and methods for treating tissue in a negative pressure therapy environment are set forth in the appended claims. Exemplary embodiments are also provided to enable one skilled in the art to make and use the claimed subject matter.

[0007] For example, in some embodiments, a dressing for treating tissue may include a first film layer, a manifold, and a cover layer. The first film layer may include a treatment area and a sealing area surrounding the treatment area. The first film layer may also include a plurality of first perforations formed through the treatment area and a plurality of second perforations formed through the sealing area. The plurality of second perforations may be larger than the plurality of first perforations. The first film layer may also include a sealing adhesive that covers the sealing area on the first side of the first film layer that is configured to face the tissue site. The manifold may be disposed adjacent to the second side of the first film layer. The second side of the first film layer may be opposite to the first side of the first film layer. The cover layer may include a second film layer and a covering adhesive. The covering layer may be disposed on the manifold and may be coupled to the second side of the first film layer around the manifold. The covering adhesive may be disposed adjacent to the plurality of second perforations.

[0008] In some example embodiments, the first film layer may include a polyurethane film having a thickness of about 20 micrometers to about 35 micrometers.

[0009] In some example embodiments, the sealing adhesive may include a silicone adhesive having a coating weight of about 100 g / m2 to about 250 g / m2.

[0010] In some example embodiments, the manifold may include an open cell foam having a thickness of about 5 millimeters to about 10 millimeters.

[0011] In some example embodiments, the second film layer may include a polyurethane film having a thickness of about 20 micrometers to about 35 micrometers.

[0012] In some example embodiments, the cover adhesive may include an acrylic adhesive having a coating weight of about 25 grams per square meter to about 65 grams per square meter.

[0013] In some example embodiments, the cover adhesive may be configured to extend from the second side of the first film layer through the plurality of second perforations to the first side of the first film layer.

[0014] In some example embodiments, the treatment region may be configured to contact a tissue site and the sealing region may be configured to contact the epidermis surrounding the tissue site.

[0015] In some exemplary embodiments, the treatment area may be free of adhesive such that the first side of the first film layer in the treatment area is configured to be positioned in direct contact with the tissue site.

[0016] In some example embodiments, the plurality of first perforations may include slits arranged in a pattern.

[0017] In some example embodiments, the second plurality of perforations may include circular openings arranged in a pattern.

[0018] In some example embodiments, each first through-hole of the plurality of first through-holes may have a first opening area, and each second through-hole of the plurality of second through-holes may have a second opening area greater than the first opening area.

[0019] In some example embodiments, the first plurality of perforations may include a different shape than the second plurality of perforations.

[0020] In some example embodiments, the second plurality of perforations may be larger than the first plurality of perforations in at least one dimension.

[0021] In some example embodiments, the plurality of first perforations may be configured to increase in size when the tissue site is exposed to pressure. The plurality of second perforations do not change in size when exposed to pressure. The plurality of second perforations may be larger in size than the plurality of first perforations when the tissue site is exposed to pressure and when the tissue site is not exposed to pressure.

[0022] In some exemplary embodiments, the dressing may further comprise a carrier layer releasably coupled to the side of the cover layer opposite the cover adhesive.The carrier layer may comprise a coated paper or a polymer film.

[0023] Also described herein is an example system for treating a tissue site using negative pressure therapy. The system may include a dressing that may include a first film layer, a manifold, and a cover layer. The first film layer may include a treatment area and a sealing area surrounding the treatment area. The first film layer may also include a plurality of first perforations formed through the treatment area and a plurality of second perforations formed through the sealing area. The plurality of second perforations may be larger than the plurality of first perforations. The first film layer may also include a sealing adhesive that covers the sealing area on the first side of the first film layer that is configured to face the tissue site. The manifold may be disposed adjacent to the second side of the first film layer. The second side of the first film layer may be opposite to the first side of the first film layer. The cover layer may include a second film layer and a covering adhesive. The covering layer may be disposed on the manifold and may be coupled to the second side of the first film layer around the manifold. The covering adhesive may be disposed adjacent to the plurality of second perforations. The system may also include a negative pressure source that is configured to be fluidly coupled to the tissue site through the cover.

[0024] Another example system for treating a tissue site using negative pressure therapy is also described herein. The system may include a dressing configured to be positioned adjacent to the tissue site. The dressing may include a first film layer, a manifold, and a second film layer. The first film layer may include a treatment area and a sealing area surrounding the treatment area. A plurality of slits may be formed through the treatment area, and a plurality of holes may be formed through the sealing area. The plurality of holes may have an opening area larger than the plurality of slits. The first film layer may also include a sealing adhesive that covers the sealing area on the side of the first film layer configured to face the tissue site. The second film layer may include an orifice. The second film layer may be coated with a pressure-sensitive adhesive on the side of the second film layer configured to face the tissue site. The carrier layer, the first film layer, the manifold, and the second film layer may be assembled in a stacked relationship, wherein the first film layer and the second film layer encapsulate the manifold. The manifold may be aligned with the treatment area. The pressure-sensitive adhesive and the sealing area may be configured to face the tissue site, and at least some of the pressure-sensitive adhesive may be exposed through the plurality of holes. The carrier layer may be laminated to the second film layer on the side of the second film layer opposite to the pressure-sensitive adhesive. A negative pressure source may be configured to be fluidly coupled to the tissue site through the orifice, the manifold, and the plurality of slits.

[0025] In some exemplary embodiments, a sealing adhesive is not disposed over the treatment area.

[0026] In some example embodiments, the carrier layer may include a coated paper or a polymeric film.The carrier layer may be releasably coupled to the second film layer and may be configured to be removed from the second film layer after the dressing is positioned adjacent the tissue site.

[0027] In some example embodiments, the sealing adhesive may be applied to the first film layer in a pattern. The sealing adhesive may be applied to the first film layer in a pattern such that the treatment area is free of sealing adhesive. The sealing adhesive may be applied to the first film layer in a pattern such that the sealing area contains sealing adhesive, but the treatment area is free of sealing adhesive.

[0028] The objects, advantages and preferred modes of making and using the claimed subject matter may be best understood by referring to the accompanying drawings in conjunction with the following detailed description of illustrative embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 is a block diagram of an example embodiment of a treatment system that can provide tissue treatment according to the present specification;

[0030] Figure 2 yes Figure 1 An exploded view of an example of a dressing of a therapeutic system;

[0031] Figure 3 yes Figure 2 Assembly diagram of the dressing;

[0032] Figure 4A yes Figure 2 A top view of example layers of a dressing of , illustrating additional details that may be associated with some embodiments;

[0033] Figure 4B is a bottom view of the example layers of FIG. 4 illustrating additional details that may be relevant to some embodiments;

[0034] Figure 5 yes Figure 1 a cross-sectional view of an illustrative embodiment of a treatment system of depicting an illustrative example embodiment of a dressing interface and a dressing deployed at a tissue site;

[0035] Figure 5A yes Figure 5 The section at 5A depicted in FIG. Figure 5 Detail of the dressing;

[0036] Figure 5B yes Figure 5A Another detail of the dressing;

[0037] Fig. 6A yes Figure 1 an exploded view of another embodiment of a dressing of a therapeutic system; and

[0038] Figure 6B yes Fig. 6A Assembly diagram of the dressing. DETAILED DESCRIPTION

[0039] The following description of example embodiments provides information enabling those skilled in the art to make and use the subject matter set forth in the appended claims, and may omit certain details already known in the art. Therefore, the following detailed description is to be regarded as illustrative rather than limiting.

[0040] Figure 1 is a block diagram of an example embodiment of a therapy system 100 that can provide negative pressure therapy to a tissue site in accordance with the present specification.

[0041] In this article, the term "tissue site" refers broadly to a wound, defect or other treatment target located on or in a tissue, including but not limited to surface trauma, bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon or ligament. Wounds may include, for example, chronic wounds, acute wounds, traumatic wounds, subacute wounds and dehiscence wounds, partial thickness burns, ulcers (such as diabetic ulcers, pressure sores or venous insufficiency ulcers), flaps and grafts. The term "tissue site" may also refer to an area of ​​any tissue that is not necessarily injured or defective, but rather an area in which it may be desirable to add additional tissue or promote the growth of additional tissue. For example, negative pressure may be applied to a tissue site to allow additional tissue to grow, and then the additional tissue may be removed and transplanted.

[0042] The treatment system 100 may include a negative pressure source or negative pressure supply device (such as negative pressure source 105) and one or more dispensing components. The dispensing components are preferably detachable and can be disposable, reusable, or recyclable. Dressings (such as dressing 110) and fluid containers (such as container 115) are examples of dispensing components that may be associated with some examples of the treatment system 100. Figure 1 As illustrated in the example of , in some embodiments, the dressing 110 can include or consist essentially of a tissue interface 120, a cover 125, or both.

[0043] A fluid conductor is another illustrative example of a distribution component. In this article, a "fluid conductor" broadly includes a tube, a pipe or hose, a catheter, or other structure having one or more lumens or open passages suitable for conveying fluid between two ends. Typically, the tube is an elongated cylindrical structure with a certain flexibility, but the geometry and rigidity can vary. In addition, some fluid conductors can be molded into other components or otherwise integrally combined with other components. The distribution component may also include or include an interface or fluid port to facilitate the connection and separation of other components. In some embodiments, for example, a dressing interface can facilitate the connection of the fluid conductor to the dressing 110. For example, such a dressing interface can be a SENSAT.RAC available from 3M Company. TM pad.

[0044] The treatment system 100 may also include a regulator or controller, such as controller 130. In addition, the treatment system 100 may include sensors to measure operating parameters and provide feedback signals indicative of the operating parameters to the controller 130. Figure 1 As illustrated, for example, treatment system 100 may include a first sensor 135 and a second sensor 140 coupled to controller 130 .

[0045] Some components of treatment system 100 may be housed within or used in conjunction with other components (such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate treatment. For example, in some embodiments, negative pressure source 105 may be combined with controller 130 and other components into treatment unit 145.

[0046] In general, the components of the treatment system 100 may be coupled directly or indirectly. For example, the negative pressure source 105 may be directly coupled to the container 115 and may be indirectly coupled to the dressing 110 through the container 115. The coupling may include a fluid coupling, a mechanical coupling, a thermal coupling, an electrical coupling, or a chemical coupling (such as a chemical bond), or in some cases some combination of couplings. For example, the negative pressure source 105 may be electrically coupled to the controller 130 and may be fluidly coupled to one or more distribution components to provide a fluid path to the tissue site. In some embodiments, the components may also be coupled by means of physical proximity, integration into a single structure, or formation from the same piece of material.

[0047] Negative pressure supply device (such as negative pressure source 105) can be a reservoir of air at negative pressure, or can be a manual or electric device, such as, for example, a vacuum pump, a suction pump, a wall suction port available in many healthcare facilities, or a micro pump. "Negative pressure" generally refers to a pressure less than the local ambient pressure, such as the ambient pressure in the local environment outside the sealed treatment environment. In many cases, the local ambient pressure can also be the atmospheric pressure where the tissue site is located. Alternatively, the pressure can be less than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise specified, the value of the pressure stated herein is a gauge pressure. Mentioning the increase in negative pressure generally refers to the reduction in absolute pressure, and the reduction in negative pressure generally refers to the increase in absolute pressure. Although the amount and nature of the negative pressure provided by the negative pressure source 105 can vary according to treatment requirements, the pressure is generally a low vacuum between -5mmHg (-667Pa) and -500mmHg (-66.7kPa), which is also generally referred to as a rough vacuum. The common treatment range is between -50 mm Hg (-6.7 kPa) and -300 mm Hg (-39.9 kPa).

[0048] Container 115 represents a container, canister, pouch, or other storage component that can be used to manage exudate and other fluids drawn from a tissue site. In many environments, a rigid container may be preferred or required for collecting, storing, and disposing of fluids. In other environments, fluids may be properly disposed of without rigid container storage, and reusable containers may reduce waste and costs associated with negative pressure therapy.

[0049] A controller, such as controller 130, may be a microprocessor or computer programmed to operate one or more components of treatment system 100, such as negative pressure source 105. In some embodiments, for example, controller 130 may be a microcontroller, which typically includes an integrated circuit containing a processor core and a memory programmed to directly or indirectly control one or more operating parameters of treatment system 100. For example, the operating parameters may include the power applied to negative pressure source 105, the pressure generated by negative pressure source 105, or the 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.

[0050] The sensor (such as the first sensor 135 and the second sensor 140) may be any device operable to detect or measure a physical phenomenon or characteristic, and generally provides a signal indicating the detected or measured phenomenon or characteristic. For example, the first sensor 135 and the second sensor 140 may be configured to measure one or more operating parameters of the treatment system 100. In some embodiments, the first sensor 135 may be a transducer configured to measure the pressure in the pneumatic passage and convert the measurement result into a signal indicating the measured pressure. In some embodiments, for example, the first sensor 135 may be a piezoresistive strain gauge. In some embodiments, the second sensor 140 may optionally measure an operating parameter of the negative pressure source 105, such as voltage or current. Preferably, the signals from the first sensor 135 and the second sensor 140 are suitable as input signals to the controller 130, but in some embodiments, some signal conditioning may be appropriately performed. For example, before the signal can be processed by the controller 130, it may be necessary to filter or amplify the signal. Typically, the signal is an electrical signal, but can be represented in other forms, such as an optical signal.

[0051] The tissue interface 120 may generally be adapted to partially or completely contact a tissue site. The tissue interface 120 may take a variety of forms and may have a variety of sizes, shapes, or thicknesses, depending on various factors, such as the type of treatment being performed or the nature and size of the tissue site. For example, the size and shape of the tissue interface 120 may be adapted to the contours of a deep and irregularly shaped tissue site. Any or all surfaces of the tissue interface 120 may have an uneven, rough, or jagged profile.

[0052] In some embodiments, the tissue interface 120 may include or consist essentially of a manifold. The manifold herein may include or consist essentially of a device for collecting or distributing fluids passing through the tissue interface 120 under pressure. For example, the manifold may be adapted to receive negative pressure from a source and distribute the negative pressure through a plurality of orifices through the tissue interface 120, which may have the effect of collecting fluids from the tissue site and drawing the fluids toward the source. In some embodiments, the fluid path may be reversed or a secondary fluid path may be provided to facilitate delivery of fluids through the tissue site.

[0053] In some exemplary embodiments, the manifold may include a plurality of passages that may be interconnected to improve the distribution or collection of fluids. In some exemplary embodiments, the manifold may include or be substantially composed of a porous material having interconnected fluid passages. Examples of suitable porous materials that may be suitable for forming interconnected fluid passages (e.g., channels) may include: porous foams, including open-cell foams, such as reticulated foams; porous tissue collections; and other porous materials that typically include pores, edges, and / or walls, such as gauze or felt pads. Liquids, gels, and other foams may also include or be cured to include orifices and fluid passages. In some embodiments, the manifold may additionally or alternatively include projections that form interconnected fluid passages. For example, the manifold may be molded to provide surface projections that define interconnected fluid passages.

[0054] In some embodiments, the tissue interface 120 may include or consist essentially of a reticulated foam having a pore size and free volume that may vary according to the needs of the prescribed treatment. For example, a reticulated foam having at least 90% free volume may be suitable for many therapeutic applications, and a foam having an average pore size in the range of 400 microns to 600 microns (40 to 50 pores / inch) may be particularly suitable for some types of treatment. The tensile strength of the tissue interface 120 may also vary according to the needs of the prescribed treatment. The 25% compressive load deflection of the tissue interface 120 may be at least 0.35 pounds per square inch, and the 65% compressive load deflection may be at least 0.43 pounds per square inch. In some embodiments, the tensile strength of the tissue interface 120 may be at least 10 pounds per square inch. The tissue interface 120 may have a tear strength of at least 2.5 pounds per inch. In some embodiments, the tissue interface may be a foam composed of a polyol (such as a polyester or a polyether), an isocyanate (such as toluene diisocyanate), and a polymerization modifier (such as an amine and a tin compound). In some examples, tissue interface 120 may be a reticulated polyurethane foam, such as GRANUFOAM, both available from 3M Company. TM Dressing or VACVERAFLO TM dressing.

[0055] The thickness of the tissue interface 120 may also vary depending on the needs of the prescribed treatment. For example, the thickness of the tissue interface may be reduced to reduce tension on the surrounding tissue. The thickness of the tissue interface 120 may also affect the conformability of the tissue interface 120. In some embodiments, a thickness in the range of about 5 mm to 10 mm may be suitable.

[0056] The tissue interface 120 can be hydrophobic or hydrophilic. In examples where the tissue interface 120 can be hydrophilic, the tissue interface 120 can also wick fluid away from the tissue site while continuing to distribute negative pressure to the tissue site. The wicking properties of the tissue interface 120 can wick fluid away from the tissue site by capillary flow or other wicking mechanisms. Examples of materials that may be suitable hydrophilic materials are polyvinyl alcohol, open-cell foams such as WHITEFOAM available from 3M Company. TM Dressings. Other hydrophilic foams may include those made from polyethers. Other foams that may exhibit hydrophilic characteristics include hydrophobic foams that have been treated or coated to render them hydrophilic.

[0057] In some embodiments, the tissue interface 120 may be composed of a bioabsorbable material. Suitable bioabsorbable materials may include, but are not limited to, polymer blends of polylactic acid (PLA) and polyglycolic acid (PGA). Polymer blends may also include, but are not limited to, polycarbonate, polyfumarate, and caprolactone. The tissue interface 120 may also be used as a scaffold for new cell growth, or a scaffold material may be used in conjunction with the tissue interface 120 to promote cell growth. A scaffold is typically a material or structure for enhancing or promoting cell growth or tissue formation, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA / PGA, coral hydroxyapatite, carbonate, or treated allograft material.

[0058] In some embodiments, the cover 125 can provide a bacterial barrier and prevent physical trauma. The cover 125 can also be made of a material that can reduce evaporative losses and provide a fluid seal between two components or two environments (such as between a treatment environment and a local external environment). The cover 125 may include, for example, or be composed of an elastomeric film or diaphragm that can provide a seal sufficient to maintain negative pressure at the tissue site for a given negative pressure source. In some applications, the cover 125 may have a high moisture vapor transmission rate (MVTR). For example, in some embodiments, the MVTR may be at least 250 grams per cubic meter per twenty-four hours, which is measured using a cup technique at 38°C and 10% relative humidity (RH) according to ASTM E96 / E96M cup method. In some embodiments, an MVTR of up to 5,000 grams per square meter per twenty-four hours can provide effective breathability and mechanical properties.

[0059] In some example embodiments, the cover 125 may be a polymer drape that is permeable to water vapor but impermeable to liquids, such as a polyurethane film. Such a drape typically has a thickness in the range of 25 microns to 50 microns. For permeable materials, the permeability should generally be low enough so that the desired negative pressure can be maintained. The cover 125 may include, for example, one or more of the following materials: polyurethane (PU), such as hydrophilic polyurethane; cellulose; hydrophilic polyamide; polyvinyl alcohol; polyvinyl pyrrolidone; hydrophilic acrylic resin; silicone, such as hydrophilic silicone elastomer; natural rubber; polyisoprene; styrene-butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene-propylene rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene vinyl acetate (EVA); copolyester; and polyether block polyamide copolymer. Such materials are, for example, the following commercially available: polyurethane drapes commercially available from Avery Dennison Corporation, Pasadena, California; polyether block polyamide copolymers (PEBAX), commercially available, for example, from Arkema SA, Colombes, France; and polyols commercially available from Exopack Advanced Coatings, Wrexham, United Kingdom. 2301 and 2327. In some embodiments, the cover 125 may include a 2600 g / m 2 / 24 hours MVTR (stand-up cup technology) and a thickness of about 30 microns 2301.

[0060] Attachment means can be used to attach cover 125 to an attachment surface, such as an undamaged epidermis, a gasket, or another cover. Attachment means can take many forms. For example, attachment means can be a medically acceptable pressure-sensitive adhesive that is configured to bond cover 125 to the epidermis around the tissue site. In some embodiments, for example, some or all of cover 125 may be coated with an adhesive, such as an acrylic adhesive, that may have a coating amount of about 25 grams per square meter to 65 grams per square meter (gsm). In some embodiments, a thicker adhesive or a combination of adhesives may be applied to improve sealing and reduce leakage. Other example embodiments of attachment means may include double-sided tape, paste, aqueous colloid, hydrogel, silicone gel, or organic gel.

[0061] In operation, the tissue interface 120 can be placed in, above, above, or otherwise close to a tissue site. For example, if the tissue site is a wound, the tissue interface 120 can partially or completely fill the wound, or the tissue interface can be placed above the wound. The cover 125 can be placed above the tissue interface 120 and sealed to an attachment surface near the tissue site. For example, the cover 125 can be sealed to the undamaged epidermis around the tissue site. Therefore, the dressing 110 can provide a sealed treatment environment close to the tissue site, which is substantially isolated from the external environment, and the negative pressure source 105 can reduce the pressure in the sealed treatment environment.

[0062] The process of reducing pressure may be described herein, for example, as "delivering," "dispensing," or "generating" negative pressure.

[0063] Typically, exudate and other fluids flow along the fluid path in the direction of lower pressure. Therefore, the term "downstream" generally means a position in the fluid path that is relatively closer to the negative pressure source or farther away from the positive pressure source. On the contrary, the term "upstream" means a position that is relatively farther away from the negative pressure source or closer to the positive pressure source. Similarly, it may be convenient to describe certain features in this type of reference frame according to the fluid "inlet" or "outlet". It is generally assumed that this orientation is to describe the various features and components of this article. However, in some applications, the fluid path may also be reversed, such as by replacing the negative pressure source with a positive pressure source, and this descriptive convention should not be understood as restrictive.

[0064] Negative pressure applied to a tissue site through tissue interface 120 in a sealed treatment environment can induce macro- and micro-strains in the tissue site. Negative pressure can also remove exudate and other fluids from the tissue site that may be collected in container 115.

[0065] In some embodiments, the controller 130 may receive and process data from one or more sensors (such as the first sensor 135). The controller 130 may also control the operation of one or more components of the treatment system 100 to manage the pressure delivered to the tissue interface 120. In some embodiments, the controller 130 may include an input for receiving a desired target pressure, and may be programmed to process data related to the setting and input of the target pressure to be applied to the tissue interface 120. In some example embodiments, the target pressure may be a fixed pressure value set by an operator as the target negative pressure desired for treatment at the tissue site and then provided as an input to the controller 130. The target pressure may vary from tissue site to tissue site based on the type of tissue forming the tissue site, the type of injury or wound (if any), the medical condition of the patient, and the preferences of the attending physician. After selecting the desired target pressure, the controller 130 may operate the 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 the tissue interface 120.

[0066] Figure 2 yes Figure 1 1 is an exploded view of an example embodiment of a dressing 110 illustrating additional details that may be associated with some embodiments in which the tissue interface 120 includes more than one layer. In some embodiments, the tissue interface 120 may include a manifold 202 and a first film layer 204. The manifold 202 may include a first surface 206 and a second surface 208 opposite the first surface 206. The first film layer 204 may include a first surface 210 and a second surface 212 opposite the first surface 210. The first surface 210 of the first film layer 204 may be coupled to the second surface 208 of the manifold 202 such that the manifold 202 is stacked on top of the first film layer 204 when the dressing 110 is assembled.

[0067] Manifold 202 may include the Figure 1 The manifold or manifold layer described or consisting essentially of it provides a means for collecting or distributing fluid under pressure across the tissue interface 120. In some embodiments, the manifold 202 can be an oval or stadium shaped manifold. In some embodiments, the manifold 202 can be a GRANUFOAM TM Or an open cell foam having a thickness between about 5 mm and about 10 mm. Manifold 202 can be adapted to receive negative pressure from a source such as negative pressure source 105 and distribute the negative pressure through multiple orifices through tissue interface 120, which can have the effect of collecting fluid from the tissue site and drawing the fluid toward the source. In some embodiments, the fluid path can be reversed or a secondary fluid path can be provided to facilitate delivery of fluid (such as fluid from an instillation solution source) through tissue interface 120.

[0068] The first film layer 204 may include or consist essentially of a device for controlling or managing fluid flow. The first film layer 204 may include a periphery 214 that may surround an inner portion 216. The inner portion 216 may be symmetrically and centrally disposed in the first film layer 204. In some embodiments, the periphery 214 may be a sealing area of ​​the first film layer 204, and the inner portion 216 may be a treatment area of ​​the first film layer 204. In some embodiments, the inner portion 216 may correspond to a surface area of ​​the manifold 202. In some embodiments, a boundary 218 may separate or separate the inner portion 216 from the periphery 214 of the first film layer 204. The first film layer 204 may also include a corner 220 and an edge 222, which may be a portion of the periphery 214.

[0069] The first film layer 204 may also include a plurality of first perforations 226 formed through the inner portion 216 and a plurality of second perforations 228 formed through the periphery 214. The plurality of first perforations 226 may be a fluid restriction, which may be bidirectional and pressure responsive. The plurality of first perforations 226 may generally include or consist essentially of an elastic channel that may expand in response to a pressure gradient. In some embodiments, the plurality of first perforations 226 may be formed by removing material from the first film layer 204. For example, in some embodiments, the plurality of first perforations 226 may be formed by cutting through the first film layer 204, which may also deform the edges of the plurality of first perforations 226. In the absence of a pressure gradient across the plurality of first perforations 226, the channel may be small enough to form a seal or flow restriction, which may significantly reduce or prevent liquid flow. Additionally or alternatively, one or more first perforations in the plurality of first perforations 226 may be an elastic valve that is generally closed to substantially prevent liquid flow when not strained or not subjected to negative pressure, and may open in response to a pressure gradient.

[0070] In some embodiments, a plurality of first perforations 226 may include or consist essentially of one or more slits or slots or a combination of slits or slots in the first film layer 204. In some examples, a plurality of first perforations 226 may include or consist essentially of a linear slot having a length less than 4 millimeters and a width less than 1 millimeter. In some embodiments, the length may be at least 2 millimeters, and the width may be at least 0.4 millimeters. A length of about 3 millimeters to a width of about 0.8 millimeters may be particularly suitable for many applications. A tolerance of about 0.1 millimeter is also acceptable. Such dimensions and tolerances may be realized, for example, with a laser cutter. The slot of such a structure may be used as an imperfect valve that significantly reduces liquid flow under a normally closed or static state. For example, such a slot may form a flow restriction without being completely closed or sealed. The slot may expand or open wider in response to a pressure gradient to allow increased liquid flow.

[0071] In some embodiments, the plurality of first perforations 226 may be slits or slots arranged in a pattern. For example, the slits or slots may be arranged in a V-shaped pattern, in a grid of parallel rows and columns, or in another pattern. Alternatively, the plurality of first perforations 226 may be randomly arranged throughout the interior portion 216 of the first film layer 204.

[0072] A plurality of second perforations 228 may be disposed through the perimeter 214 of the first film layer 204. The plurality of second perforations 228 may be, for example, orifices or holes that may be formed by cutting or by applying localized RF or ultrasonic energy or by other suitable techniques for forming openings. The plurality of second perforations 228 may have a uniform distribution pattern, or may be randomly distributed on the perimeter 214 of the first film layer 204. The plurality of second perforations 228 may have many shapes, including, for example, circles, squares, stars, ellipses, polygons, slits, complex curves, straight line shapes, triangles, or may have some combination of such shapes.

[0073] Each second perforation in the plurality of second perforations 228 may have uniform or similar geometrical properties. For example, in some embodiments, each second perforation in the plurality of second perforations 228 may be a circular orifice having substantially the same diameter. In some embodiments, the diameter of each second perforation in the plurality of second perforations 228 may be between about 1 mm and about 50 mm. In other embodiments, the diameter of each second perforation in the plurality of second perforations 228 may be between about 1 mm and about 20 mm.

[0074] In other embodiments, the geometric characteristics of the plurality of second through-holes 228 may vary. For example, the diameter of the plurality of second through-holes 228 may vary depending on the location of the plurality of second through-holes 228. In some embodiments, the plurality of second through-holes 228 disposed in the corner 220 may have a diameter between about 7.75 mm and about 8.75 mm, and the remainder of the plurality of second through-holes 228 may have a diameter between about 9.8 mm and about 10.2 mm.

[0075] At least one of the plurality of second perforations 228 may be positioned at an edge 222 of the perimeter 214 and may have an inner cutout that is open or exposed at the edge 222 and is in fluid communication with the edge 222 in a lateral direction. The lateral direction may refer to a direction toward the edge 222 and in the same plane as the first film layer 204. The plurality of second perforations 228 positioned near or at the edge 222 may be substantially equally spaced around the perimeter 214. Alternatively, the spacing of the plurality of second perforations 228 near or at the edge 222 may be irregular.

[0076] In some embodiments, each first perforation in the plurality of first perforations 226 may have a first opening area, and each second perforation in the plurality of second perforations 228 may have a second opening area. Each second opening area may be larger than each first opening area. Similarly, each second perforation in the plurality of second perforations 228 may be larger than each first perforation in the plurality of first perforations 226 in at least one dimension. As described above, each first perforation in the plurality of first perforations 226 may be pressure responsive, and thus each first perforation in the plurality of first perforations 226 may be configured to increase in size when the tissue site is exposed to pressure (such as negative pressure from the negative pressure source 105). In contrast, when exposed to pressure, the plurality of second perforations 228 may not change in size. In addition, when the tissue site is exposed to pressure and when the tissue site is not exposed to pressure, the plurality of second perforations 228 may be larger in size than the plurality of first perforations 226.

[0077] In some embodiments, the first film layer 204 may also include a sealing adhesive 230. The sealing adhesive 230 may be disposed on the second surface 212 of the first film layer 204 so that when the dressing 110 is placed at the tissue site, the sealing adhesive 230 will face the tissue site and contact the periwound area of ​​the tissue site. The sealing adhesive 230 may be disposed on the periphery 214 and may not be disposed on the inner portion 216 of the first film layer 204. The sealing adhesive 230 may be pattern-applied to the first film layer 204 so that the inner portion 216 does not have the sealing adhesive 230. In some embodiments, the sealing adhesive 230 may be or may include a coating of a silicone material. Suitable silicone adhesives are described in, for example, U.S. Patent Publication 2011 / 0212325 and are incorporated herein by reference. In some embodiments, silicone oils such as OHX4070 from Dow and AK1,000,000 from Wacker Chemicals may be included in the sealing adhesive 230. In some embodiments, the sealing adhesive 230 can have a coating weight of about 100 grams per square meter to about 250 grams per square meter.

[0078] The first film layer 204 may include or consist essentially of a film that can provide a fluid seal with a tissue site and can have a substantially flat surface. In some embodiments, the first film layer 204 may be a polyurethane film such as 5863-86A (Lubrizol). In some embodiments, the thickness of the first film layer 204 can be between about 20 microns and about 35 microns. In some embodiments, the first film layer 204 can also include an adhesive on the first surface 210 of the first film layer 204. The adhesive on the first surface 210 can adhere the first film layer 204 to the cover 125 and / or the manifold 202. The adhesive on the first surface 210 of the first film layer 204 can include the adhesive described above with reference to Figure 1 Any material described for use with the attachment device.

[0079] The dressing 110 may also include a second film layer such as a cover 125. The cover 125 may include a first surface 232 and a second surface 234 opposite the first surface 232. The second surface 234 of the cover 125 may be configured to couple to the first surface 206 of the manifold 202 of the tissue interface 120. The cover 125 may include or be substantially composed of a polyurethane film such as 5863-86A (Lubrizol). In some embodiments, the cover 125 may have a thickness of about 20 microns to about 35 microns. The dressing 110 may also include an attachment device such as the one described above. Figure 1 The attachment means or covering adhesive or adhesive 236 described. Adhesive 236 can be, for example, a medically acceptable pressure-sensitive adhesive extending around the perimeter, a portion or all of the second surface 234 of the cover 125. In some embodiments, for example, adhesive 236 can be an acrylic adhesive having a coating weight of about 25 g.sm to about 65 g.sm. In some embodiments, a thicker adhesive or combination of adhesives can be applied to improve the seal and reduce leakage. Adhesive 236 can be a layer having substantially the same shape as the perimeter 214 of the first film layer 204. In some embodiments, adhesive 236 can be continuous or discontinuous. The discontinuity in adhesive 236 can be provided by an orifice or hole (not shown) in adhesive 236. The orifice or hole in adhesive 236 can be formed after applying adhesive 236, or by applying adhesive 236 in a pattern on the second surface 234 of cover 125. In some example embodiments, the size of the orifice or hole in adhesive 236 can be set to enhance the MVTR of dressing 110.

[0080] like Figure 2As shown in the example of , in some embodiments, the release liner 240 may be attached to the first film layer 204 or positioned adjacent to the first film layer to protect the adhesive 236 prior to use. The release liner 240 may also provide rigidity to assist in, for example, the deployment of the dressing 110. The release liner 240 may be, for example, a casting paper, a film, or polyethylene. In addition, in some embodiments, the release liner 240 may be a polyester material, such as polyethylene terephthalate (PET) or a similar polar semi-crystalline polymer. The use of a polar semi-crystalline polymer for the release liner 240 may substantially prevent the dressing 110 from wrinkling or otherwise deforming. For example, the polar semi-crystalline polymer may be highly oriented and resistant to softening, swelling, or other deformation that may occur when in contact with components of the dressing 110 or when subjected to temperature or environmental changes or sterilization. In some embodiments, the release liner 240 may have a surface texture that may be embossed on an adjacent layer (such as the first film layer 204). In some embodiments, the release liner 240 may be a Scotchpak TM Fluoropolymer coated release liner (3M). In addition, a release agent may be disposed on one side of the release liner 240 that is configured to contact the first film layer 204. For example, the release agent may be a silicone coating and may have a release coefficient that is suitable for facilitating manual removal of the release liner 240 without damaging or deforming the dressing 110. In some embodiments, the release agent may be, for example, a fluorocarbon or a fluorosilicone. In other embodiments, the release liner 240 may be uncoated or may otherwise be used without a release agent.

[0081] In some embodiments, the dressing 110 may further include a carrier 242. The carrier 242 may have a first surface 244 and a second surface 246 opposite the first surface 244. The second surface 246 of the carrier 242 may be configured to be coupled to the first surface 232 of the cover 125. In some embodiments, the carrier 242 may be releasably coupled to the first surface 232 of the cover 125. In some embodiments, the carrier 242 may be laminated to the first surface 232 of the cover 125. The carrier 242 may enable stable handling after the release liner 240 is removed from the dressing 110. In some embodiments, the carrier 242 may have a first elongated portion 248 and a second elongated portion 250 connected by a connecting portion 252. In some embodiments, the carrier 242 may have another shape or size, but may still provide a structure for the dressing 110 after the release liner 240 is removed. In some embodiments, the carrier 242 may be composed of a coated paper or film. Examples of carrier materials may include polyethylene / vinyl acetate copolymer coated kraft paper available from Loparex.

[0082] In some embodiments, the dressing 110 may also include an optional gripping strip (not shown). The optional gripping strip may provide a location for a healthcare provider or user to hold the dressing 110 when applying the dressing 110 to a tissue site. In some embodiments, the optional gripping strip may be coupled to the adhesive 236 of the cover 125. In other embodiments, the optional gripping strip may be located at a different location on the dressing 110.

[0083] Figure 2 Also shown is an example embodiment of a fluid conductor 256 and a dressing interface 258. The fluid conductor 256 can be a flexible tube that can be fluidly coupled to the dressing interface 258 on one end. The dressing interface 258 can be an elbow connector that can be placed through an aperture 260 in the carrier 242 that can be placed around an aperture 262 in the cover 125. The aperture 262 can provide a fluid path between the fluid conductor 256 and the tissue interface 120 of the dressing 110.

[0084] In use, the release liner 240 (if included) can be removed to expose the first film layer 204, which can be placed in, above, on, or otherwise adjacent to a tissue site (particularly a surface tissue site and adjacent epidermis). The first film layer 204 can be inserted between the manifold 202 and the tissue site, which can significantly reduce or eliminate adverse interactions with the manifold 202. For example, the first film layer 204 can be placed above a surface wound (including the edge of the wound) and an undamaged epidermis to prevent direct contact with the manifold 202. Treatment of surface wounds or placing a dressing 110 on a surface wound includes placing the dressing 110 in close proximity to the body surface or extending on at least a portion of the body surface. Treatment of surface wounds does not include placing the dressing 110 completely in the body or completely below the body surface, such as placing the dressing in the abdominal cavity. In some applications, the inner portion 216 of the first film layer 204 can be positioned adjacent to, close to, or covering the tissue site. The perimeter 214 of the first film layer 204 can be positioned adjacent or proximate to tissue surrounding or encircling the tissue site. The first film layer 204 can be sufficiently adhesive to hold the dressing 110 in place while also allowing the dressing 110 to be removed or repositioned without trauma to the tissue site.

[0085] Removing the release liner 240 may also expose the adhesive 236 of the cover 125 to the tissue site. For example, the cover 125 may be attached to the epidermis at the periphery of the tissue site around the manifold 202. In some embodiments, the adhesive 236 may be in fluid communication with the attachment surface through the plurality of second perforations 228 in at least the periphery 214 of the first film layer 204. The adhesive 236 may also be in fluid communication with the edge 222 through the plurality of second perforations 228 exposed at the edge 222.

[0086] Once the dressing 110 is in the desired position, the adhesive 236 can be pressed through the plurality of second perforations 228 to bond the dressing 110 to the attachment surface. The plurality of second perforations 228 at the edge 222 can allow the adhesive 236 to flow around the edge 222 to enhance the adhesion of the edge 222 to the attachment surface.

[0087] In some embodiments, the size of the plurality of second perforations 228 in the first film layer 204 can be set to control the amount of adhesive 236 that is in fluid communication with the attachment surface through the plurality of second perforations 228. For a given geometry of the corner 220, the relative size of the plurality of second perforations 228 can be configured to maximize the surface area of ​​adhesive 236 exposed and in fluid communication with the plurality of second perforations 228 at the corner 220. For example, the edge 222 can intersect at substantially right angles or about 90 degrees to define the corner 220. In some embodiments, the corner 220 can have a radius of about 10 millimeters. In addition, in some embodiments, three second perforations in the plurality of second perforations 228 having a diameter between about 7.75 millimeters and about 8.75 millimeters can be positioned in a triangular configuration at the corner 220 to maximize the exposed surface area of ​​adhesive 236. In other embodiments, depending on the selected geometry of the corner 220, the size and number of the plurality of second perforations 228 in the corner 220 can be adjusted as needed to maximize the exposed surface area of ​​the adhesive 236. In addition, the plurality of second perforations 228 at the corner 220 can be completely contained within the first film layer 204, thereby substantially preventing fluid communication in the lateral direction outside the corner 220. The plurality of second perforations 228 at the corner 220 being completely contained within the first film layer 204 can substantially prevent fluid communication of the adhesive 236 outside the corner 220 and can provide improved handling of the dressing 110 during deployment at a tissue site. In addition, the substantial absence of adhesive 236 outside the corner 220 can increase the flexibility of the corner 220, thereby improving comfort.

[0088] In some embodiments, the bond strength of the adhesive 236 can vary at different locations of the dressing 110. For example, the adhesive 236 can have a lower bond strength at locations where the plurality of second perforations 228 of the first film layer 204 is relatively large, and can have a higher bond strength at locations where the plurality of second perforations 228 is smaller. The adhesive 236 having a lower bond strength in combination with the larger plurality of second perforations 228 can provide a bond comparable to the adhesive 236 having a higher bond strength in locations with the smaller plurality of second perforations 228, thereby providing a substantially constant overall bond along the perimeter 214 of the second surface 212 of the first film layer 204.

[0089] The geometry and dimensions of the tissue interface 120, the cover 125, or both can be varied to accommodate a particular application or anatomical structure. For example, the geometry or dimensions of the tissue interface 120 and the cover 125 can be adapted to provide an effective and reliable seal against challenging anatomical surfaces at and around a tissue site, such as an elbow or a heel. Additionally or alternatively, the dimensions can be modified to increase the surface area of ​​the first film layer 204, thereby enhancing the migration and proliferation of epithelial cells at the tissue site and reducing the likelihood of ingrowth of granulation tissue.

[0090] In addition, the dressing 110 can allow for reapplication or repositioning to reduce or eliminate leaks that can be caused by wrinkles and other discontinuities in the dressing 110 and tissue site. In some embodiments, the ability to correct leaks can increase the reliability of treatment and reduce power consumption.

[0091] therefore, Figure 2 The dressing 110 in the example of can provide a sealed treatment environment close to the tissue site, substantially isolated from the external environment, and the negative pressure source 105 can reduce the pressure in the sealed treatment environment. The first film layer 204 can provide an effective and reliable seal against challenging anatomical surfaces at and around the tissue site, such as elbows or heels. In addition, the dressing 110 can allow for reapplication or repositioning to correct air leaks caused, for example, by wrinkles and other discontinuities in the dressing 110. In some embodiments, the ability to correct leaks can increase the efficiency of treatment and reduce power consumption.

[0092] If not already configured, the dressing interface 258 can be disposed over the aperture 262 and attached to the cover 125. The fluid conductor 256 can be fluidly coupled to the dressing interface 258 and to the source of negative pressure 105.

[0093] The negative pressure applied by the tissue interface 120 can generate a negative pressure difference across the first plurality of perforations 226 in the first film layer 204, which can open or expand the first plurality of perforations 226 from its static state. For example, in some embodiments where the first plurality of perforations 226 may include substantially closed fenestrations through the first film layer 204, the pressure gradient across the fenestrations can strain the adjacent materials of the first film layer 204 and increase the size of the fenestrations to allow liquid to move through the fenestrations, similar to the operation of a duckbill valve. Opening the first plurality of perforations 226 can allow exudates and other liquids to move into the manifold 202 and the container 115 through the first plurality of perforations 226. Changes in pressure can also cause the manifold to expand and contract, and the boundary 218 can protect the epidermis from irritation. The first film layer 204 can also significantly reduce or prevent tissue exposure to the manifold 202, which can inhibit tissue growth into the manifold 202.

[0094] In some embodiments, the manifold 202 can be hydrophobic to minimize retention or storage of liquid in the dressing 110. In other embodiments, the manifold 202 can be hydrophilic. In examples where the manifold 202 can be hydrophilic, the manifold 202 can also wick fluid away from the tissue site while continuing to distribute negative pressure to the tissue site. The wicking properties of the manifold 202 can, for example, wick fluid away from the tissue site by capillary flow or other wicking mechanisms. Examples of hydrophilic manifolds 202 are polyvinyl alcohol, open cell foams such as VACWHITEFOAM available from KCI, San Antonio, Texas. TM Dressings. Other hydrophilic foams may include those made from polyethers. Other foams that may exhibit hydrophilic characteristics include hydrophobic foams that have been treated or coated to render them hydrophilic.

[0095] If the negative pressure source 105 is removed or turned off, the pressure differential across the plurality of first perforations 226 can dissipate, allowing the plurality of first perforations 226 to move to their resting state and preventing or reducing the rate at which exudate or other liquid returns to the tissue site through the first membrane layer 204.

[0096] Additionally or alternatively, an instillation solution or other fluid can be dispensed 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 across the plurality of first perforations 226 in the first membrane layer 204, which can cause the plurality of first perforations 226 to open or expand from their resting state to allow the instillation solution or other fluid to be dispensed into the tissue site.

[0097] Figure 3 yes Figure 2 125 of the dressing 110. When assembling the dressing 110, the second surface 234 of the cover 125 can be coupled to the first surface 206 of the manifold 202, the second surface 208 of the manifold 202 can be coupled to the first surface 210 of the first film layer 204, and the second surface 212 of the first film layer 204 can be coupled to the release liner 240. Prior to placing the dressing 110 at a tissue site, the release liner 240 can be removed from the second surface 212 of the first film layer 204. In some embodiments, the carrier 242 can be removed from the dressing 110 after the dressing is placed on the tissue site and before the dressing interface 258 is attached to the first surface 232 of the cover 125 of the dressing 110.

[0098] The individual components of the dressing 110 can be bonded or otherwise secured to each other, for example, with a solvent or non-solvent adhesive or with heat welding, without adversely affecting fluid management. In addition, the manifold 202 can be coupled to the border 218 of the first film layer 204 in any suitable manner, such as, for example, by welding or an adhesive.

[0099] The cover 125, the manifold 202, the first film layer 204, or various combinations can be assembled prior to application or in situ. For example, in some embodiments, the cover 125 can be laminated to the manifold 202. In some embodiments, the first film layer 204 can also be coupled to the manifold 202 opposite the cover 125. In some embodiments, the dressing 110 can be provided as a single composite dressing. For example, the first film layer 204 can be coupled to the cover 125 to enclose the manifold 202, wherein the first film layer 204 is configured to face the tissue site.

[0100] refer to Figure 4A and Figure 4B , the first membrane layer 204 of the tissue interface 120 is shown. Figure 4A is a top view of the first film layer 204, and Figure 4B 2 is a bottom view of the first film layer 204. The first film layer 204 may include a perimeter 214, an interior portion 216, and a border 218 that may surround the interior portion 216 and may separate or separate the interior portion 216 from the perimeter 214. A sealing adhesive 230 may be disposed on the second surface 212 of the first film layer 204. The sealing adhesive 230 may be disposed on the perimeter 214 and may not be disposed on the interior portion 216 of the first film layer 204. The sealing adhesive 230 may be applied to the first film layer 204 such that the interior portion 216 is free of the sealing adhesive 230 and the sealing adhesive 230 surrounds each of the plurality of second perforations 228. In some embodiments, the sealing adhesive 230 may be applied to the first film layer 204 in a pattern. Further, in some embodiments, the sealing adhesive 230 may be applied to the perimeter 214 of the second surface 212 of the first film layer 204 before forming the plurality of first perforations 226 and / or the plurality of second perforations 228 through the first film layer 204. In some example embodiments, the sealing adhesive 230 may be a layer that may have a partial cutout corresponding to the inner portion 216 of the first film layer 204. The sealing adhesive 230 may then be laminated to the second surface 212 of the first film layer 204, and a plurality of first perforations 226 may be formed through the inner portion 216 of the first film layer 204, and a plurality of second perforations 228 may be formed through the sealing adhesive 230 and the perimeter 214 of the first film layer 204. The plurality of first perforations 226 and the plurality of second perforations 228 may be formed by die cutting or another method of forming perforations. In some embodiments, the border 218 may also be free of the sealing adhesive 230.

[0101] refer to Figure 5 , treatment system 100 is shown at tissue site 502. Tissue site 502 may extend through or otherwise involve epidermis 504, dermis 506, and subcutaneous tissue 508. Tissue site 502 may be, for example, Figure 5 A subsurface tissue site is depicted that extends below the surface of the epidermis 504. Additionally, tissue site 502 may be a surface tissue site (not shown) that is primarily present on the surface of the epidermis 504, such as, for example, an incision. Therapeutic system 100 may provide treatment to, for example, the epidermis 504, dermis 506, and subcutaneous tissue 508, regardless of the positioning of the therapeutic system 100 or the type of tissue site. Therapeutic system 100 may also be used at other tissue sites without limitation.

[0102] The treatment system 100 may include a dressing 110, a container 115, and a treatment unit 145 that may include a negative pressure source 105. In addition, the treatment system 100 may include a filler material 510 as an optional component of the treatment system 100, which may be omitted for different types of tissue sites or different types of treatments using negative pressure, such as, for example, epithelialization. The filler material 510, if provided, may be adapted to be positioned close to or adjacent to the tissue site 502, such as, for example, by cutting the filler material 510 in any suitable manner or otherwise shaping it to fit the tissue site 502 and fill the space between the tissue site 502 and the dressing 110. Similar to the manifold 202 of the tissue interface 120, the filler material 510 may be composed of the manifold material described herein and may be adapted to be positioned in fluid communication with the tissue site 502 to distribute negative pressure to the tissue site 502. In some embodiments, the filler material 510 may be positioned in direct contact with the tissue site 502 and positioned between the tissue site 502 and the dressing 110. If filler material 510 is omitted, tissue interface 120 of dressing 110 may be positioned in direct contact with tissue site 502. Dressing 110 may be adapted to provide or distribute negative pressure to tissue site 502 from negative pressure source 105 of treatment unit 145 directly or through filler material 510, if provided.

[0103] refer to Figure 5A and Figure 5B , showing Figure 5 Detailed view of the portion of the treatment system 100 indicated at reference numeral 5A. Figure 5A The dressing 110 is shown before a force is applied to the dressing 110 to push the adhesive 236 through the second plurality of perforations 228 of the first film layer 204 . Figure 5B520 has been applied to the dressing 110. As described above, in some embodiments, the adhesive 236 can be in fluid communication with the attachment surface through the plurality of second perforations 228 in at least the periphery 214 of the first film layer 204 or otherwise exposed to the attachment surface. In some embodiments, the attachment surface can be the epidermis 504 of the tissue site 502. The adhesive 236 can also be in fluid communication with the edge 222 through the plurality of second perforations 228 exposed at the edge 222. Once the dressing 110 is in a position such as Figure 5A As shown in the desired location, adhesive 236 can be pressed through plurality of second perforations 228 to bond dressing 110 to epidermis 504. Second plurality of perforations 228 at edge 222 can allow adhesive 236 to flow around edge 222 to enhance adhesion of edge 222 to an attachment surface.

[0104] refer to Fig. 6A and Figure 6B , showing another embodiment of the dressing 110. The cover 125, tissue interface 120, dressing interface 258, and fluid conductor 256 can be substantially as described above with reference to Figure 2 In some embodiments, the carrier 242 can be Figure 2 602. The carrier 242 may be shaped differently than shown. For example, the carrier 242 may be substantially rectangular and may include a central aperture 602. The carrier 242 may have a first portion 604, a second portion 606 opposite the first portion 604, a third portion 608 coupling the first portion 604 and the second portion 606, and a fourth portion 610 opposite the third portion 608. The dressing interface 258 may be coupled to the aperture 262 of the cover 125 through the central aperture 602 of the carrier 242. In other embodiments, the carrier 242 may be another shape or size that may provide structure to the dressing 110 before and after the release liner 240 is removed from the dressing 110.

[0105] The systems, devices, and methods described herein can provide significant advantages over existing dressings. The dressing 110 can be thin and can be highly conformable because the tissue interface 120 can include the manifold 202 and the first film layer 204, wherein the sealing adhesive 230 is pattern-coated to the second surface 212 of the first film layer 204. Due to the thin construction, the dressing 110 can also be breathable. Due to the thin edge thickness of the dressing 110, the dressing 110 can also be easier to lift from the tissue site 502.

[0106] Although shown in several exemplary embodiments, it will be appreciated by those skilled in the art that the systems, apparatuses, and methods described herein are susceptible to various changes and modifications, and that these changes and modifications fall within the scope of the appended claims. In addition, unless the context clearly requires otherwise, descriptions of various alternatives using terms such as "or" do not need to be mutually exclusive, and unless the context clearly requires otherwise, the indefinite article "a" or "an" does not limit the subject matter to a single instance. For the purpose of sale, manufacture, assembly, or use, components may also be combined or removed in various configurations. For example, in some configurations, the dressing 110, the container 115, or both may be removed or separated from the other components for manufacture or sale.

[0107] The appended claims set forth novel and inventive aspects of the subject matter described above, but the claims may also include additional subject matter not specifically described in detail. For example, certain features, elements, or aspects may be omitted from the claims if it is not necessary to distinguish novel and inventive features from features known to those of ordinary skill in the art. Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced by alternative features that serve the same, equivalent, or similar purposes without departing from the scope of the invention as defined by the appended claims.

Claims

1. A dressing configured to be positioned adjacent a tissue site, the dressing comprising: a first film layer comprising a treatment area and a sealing area surrounding the treatment area, a plurality of first perforations formed through the treatment area, a plurality of second perforations formed through the sealing area that are larger than the plurality of first perforations, and a sealing adhesive covering the sealing area on a first side of the first film layer configured to face the tissue site; a manifold disposed adjacent a second side of the first membrane layer, the second side being opposite the first side; as well as A cover layer including a second film layer and a cover adhesive is disposed over the manifold and coupled to the second side of the first film layer around the manifold, the cover adhesive being disposed adjacent the second plurality of perforations.

2. The dressing of claim 1, wherein the first film layer comprises a polyurethane film having a thickness of about 20 microns to about 35 microns.

3. The dressing of claim 1, wherein the sealing adhesive comprises a silicone adhesive having a coating weight of about 100 grams per square meter to about 250 grams per square meter.

4. The dressing of claim 1, wherein the manifold comprises an open-cell foam having a thickness of about 5 mm to about 10 mm.

5. The dressing of claim 1, wherein the second film layer comprises a polyurethane film having a thickness of about 20 microns to about 35 microns.

6. The dressing of claim 1, wherein the cover adhesive comprises an acrylic adhesive having a coating weight of about 25 grams per square meter to about 65 grams per square meter.

7. The dressing of claim 1, wherein the cover adhesive is configured to extend from the second side of the first film layer through the plurality of second perforations to the first side of the first film layer.

8. The dressing of claim 1, wherein the treatment area is configured to contact the tissue site and the sealing area is configured to contact the epidermis surrounding the tissue site.

9. The dressing of claim 1, wherein the treatment area is free of adhesive such that the first side of the first film layer in the treatment area is configured to be positioned in direct contact with the tissue site.

10. The dressing of claim 1, wherein the first plurality of perforations comprises slits arranged in a pattern.

11. The dressing of claim 1 , wherein the second plurality of perforations comprises circular openings arranged in a pattern.

12. The dressing of claim 1, wherein each first perforation of the first plurality of perforations has a first open area, and each second perforation of the second plurality of perforations has a second open area greater than the first open area.

13. The dressing of claim 1, wherein the first plurality of perforations comprises a different shape than the second plurality of perforations.

14. The dressing of claim 1, wherein the second plurality of perforations are larger than the first plurality of perforations in at least one dimension.

15. A dressing according to claim 1, wherein the plurality of first perforations are configured to increase in size when the tissue site is exposed to pressure, wherein the plurality of second perforations do not change in size when exposed to the pressure, and wherein the plurality of second perforations are larger in size than the plurality of first perforations when the tissue site is exposed to the pressure and when the tissue site is not exposed to the pressure.

16. The dressing of claim 1 further comprising a carrier layer releasably coupled to a side of the cover layer opposite the cover adhesive.

17. A dressing according to claim 16, wherein the carrier layer comprises a coated paper or a polymer film.

18. A system for treating a tissue site using negative pressure therapy, the system comprising: The dressing according to claim 1; as well as A negative pressure source is configured to be fluidly coupled to the tissue site through the cover layer.

19. A system for treating a tissue site using negative pressure therapy, the system comprising: A dressing configured to be positioned adjacent to the tissue site, the dressing comprising: Carrier layer; a first film layer, the first film layer comprising a treatment area and a sealing area surrounding the treatment area, a plurality of slits formed through the treatment area, a plurality of holes formed through the sealing area and having an opening area larger than the plurality of slits, and a sealing adhesive covering the sealing area on a side of the first film layer configured to face the tissue site, Manifold, and a second film layer, the second film layer comprising an orifice, the second film layer being coated with a pressure sensitive adhesive on a side of the second film layer configured to face the tissue site; wherein the carrier layer, the first film layer, the manifold, and the second film layer are assembled in a stacked relationship, wherein the first film layer and the second film layer encapsulate the manifold, the manifold is aligned with the treatment area, the pressure sensitive adhesive and the sealing adhesive are configured to face the tissue site, at least some of the pressure sensitive adhesive is exposed through the plurality of apertures, and the carrier layer is laminated to the second film layer on a side of the second film layer opposite the pressure sensitive adhesive; and Wherein a negative pressure source is configured to be fluidly coupled to the tissue site through the orifice, the manifold, and the plurality of slits.

20. The system of claim 19, wherein the sealing adhesive is not disposed over the treatment area.

21. The system of claim 19, wherein the carrier layer comprises a coated paper or a polymer film.

22. The system of claim 21, wherein the carrier layer is releasably coupled to the second membrane layer.

23. The system of claim 22, wherein the carrier layer is configured to be removed from the second film layer after the dressing is positioned adjacent the tissue site.

24. The system of claim 19, wherein the sealing adhesive is applied to the first film layer in a pattern.

25. The system of claim 24, wherein the sealing adhesive is applied to the first film layer in a pattern such that the treatment area is free of the sealing adhesive.

26. The system of claim 25, wherein the sealing adhesive is applied to the first film layer in a pattern such that the sealing area contains the sealing adhesive but the treatment area is free of the sealing adhesive.

27. Systems, apparatus and methods substantially as described herein.

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