Removable and replaceable dressing interface for negative pressure therapy systems

Abstract

To provide a dressing for tissue treatment with negative pressure.SOLUTION: An interface 200 for connecting a negative-pressure source to a dressing comprises: a base 240; a conduit housing 245 attached to the base 240; a first layer having an adhesive with a first peel strength and an aperture through which the conduit housing 245 is configured to pass, the first layer coupled to the base 240; and a second layer having an adhesive with a second peel strength less than the first peel strength of the first layer, first multiple apertures, and second multiple apertures; where the first layer is configured to extend at least partially through the first and second multiple apertures in the second layer.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 798,275, filed January 29, 2019, which is incorporated herein by reference for all purposes.

[0002] The present invention as claimed herein relates generally to tissue treatment systems and more particularly, but not exclusively, to dressings for negative pressure tissue treatment and methods of using negative pressure tissue treatment dressings. [Background technology]

[0003] Clinical research and clinical practice have shown that reducing pressure proximal to a tissue site can enhance and accelerate the growth of new tissue at that tissue site. While the applications of this phenomenon are numerous, it has proven particularly advantageous for treating wounds. Regardless of the etiology of the wound, whether traumatic, surgical, or otherwise, proper wound care is important to the outcome. Treatment of wounds or other tissues with reduced pressure may generally be referred to as "negative pressure therapy," but is also known by other names, including, for example, "negative pressure wound therapy," "reduced pressure therapy," "vacuum therapy," "vacuum-assisted closure," and "topical negative pressure." Negative pressure therapy can provide several benefits, including epithelial and subcutaneous tissue migration, improved blood flow, and microdeformation of tissue at the wound site. Collectively, these benefits can promote the development of granulation tissue and shorten healing time.

[0004] It is also widely accepted that cleansing a tissue site can be highly beneficial to new tissue growth. For example, a wound or cavity can be flushed with a liquid solution for therapeutic purposes. These actions are commonly referred to as "irrigation" and "lavage," respectively. "Instillation" is another action that generally refers to the process of slowly introducing a fluid into a tissue site and leaving the fluid there for a predetermined period of time before removing it. For example, instillation of a topical treatment solution across a wound bed can be combined with negative pressure therapy to further promote wound healing by loosening soluble contaminants in the wound bed and removing infectious materials. As a result, the soluble bacterial load can be reduced, contaminants can be removed, and the wound can be cleansed.

[0005] While the clinical benefits of negative pressure and / or infusion therapy are widely known, improvements in treatment systems, components, and processes could benefit healthcare providers and patients. Summary of the Invention

[0006] Novel and useful systems, devices, and methods for treating tissue in a negative pressure therapy environment are set forth in the accompanying claims. Exemplary embodiments are also presented that will enable those skilled in the art to make and use the claimed subject matter.

[0007] For example, in some embodiments, a removable and replaceable dressing interface for connecting a negative pressure source to a dressing may include or consist essentially of a primary cover contact layer, a secondary cover contact layer, and a negative pressure adapter. The primary cover contact layer may be a low-tack gel adhesive, such as a silicone adhesive with a peel strength of approximately 0.8 N. However, in some embodiments, for example, the primary cover contact layer may be formed of a hydrocolloid adhesive or a low-tack polyurethane (PU) gel adhesive. In some implementations, the primary drape contact layer may be perforated to help adequately seal the negative pressure adapter to the cover during normal patient use. The perforations may have two sizes that allow the secondary drape contact layer to protrude through the primary cover contact layer into the dressing cover. The secondary cover contact layer may be a high-tack polyurethane film coated with an adhesive. The two perforation sizes in the primary cover contact layer may allow for variation in removal peel force when the dressing interface is adhered to the dressing cover. The portion of the dressing interface with larger perforations allows more of the high-tack secondary cover contact layer to adhere to the cover, and therefore may function as an anchor to the dressing interface. This portion may require the greatest peel force to remove the dressing interface from the cover. The portion of the dressing interface with smaller perforations allows fewer of the high-tack secondary cover contact layer to adhere to the cover. This portion may require less peel force to remove the dressing interface from the cover. Thus, this portion with smaller perforations may have a peel force that allows the user to remove and reapply the dressing interface to the cover while maintaining a seal sufficient to deliver negative pressure therapy to the tissue site. The peel force of the portion of the dressing interface with smaller perforations may be low enough to allow the dressing interface to be removed without damaging or destroying the cover.Additionally, the negative pressure port may have a flat or straight portion that may allow the negative pressure port to hinge when the dressing interface is removed or peeled away from the cover.

[0008] More generally, some embodiments can include a dressing interface for connecting a negative pressure source to the dressing, the dressing interface having a coupling member including an opening, a first adhesive region having a first region peel strength, and a second adhesive region having a second region peel strength less than the first region peel strength. The dressing interface can further include a negative pressure port for delivering negative pressure, where the negative pressure port is coupled to the coupling member.

[0009] In some embodiments, the negative pressure port includes a flange and a conduit housing coupled to the flange and extending through the opening in the interface layer.

[0010] In some embodiments, the coupling member can further include a shell layer and a contact layer including a plurality of openings, wherein the shell layer is configured to extend at least partially through the plurality of openings in the contact layer. In some embodiments, the plurality of openings further includes a first plurality of openings and a second plurality of openings.

[0011] In some embodiments, the second adhesive region is configured to be removable from the cover without destroying the cover, while the first adhesive region is configured to remain adhered to the cover.

[0012] Alternatively, another exemplary embodiment can include a dressing interface for connecting a negative pressure source to a dressing, the dressing interface having a base, a conduit housing attached to the base, a first layer coupled to the base, and a second layer. The first layer includes an adhesive having a first peel strength and an opening configured to allow the conduit housing to pass through. The second layer includes an adhesive having a second peel strength less than the first peel strength of the first layer, and a first plurality of openings and a second plurality of openings. The first layer is configured to extend at least partially through the first and second plurality of openings of the second layer.

[0013] In some embodiments, a first portion of the first layer extends through the first plurality of openings and is configured to cooperate with the second layer to form a first adhesive region having a first area peel strength, and a second portion of the first layer extends through the second plurality of openings and is configured to cooperate with the second layer to form a second adhesive region having a second area peel strength that is less than the first area peel strength.

[0014] In another exemplary embodiment, a dressing interface for connecting a negative pressure source to a dressing can include a negative pressure port coupled to at least one of a first layer and a second layer. The first layer can have a first side, a second side, and an adhesive on the first side having a first peel strength. The second layer can have a first side and a second side coupled to the first side of the first layer, the second layer including an adhesive having a second peel strength less than the first peel strength of the first layer and a plurality of openings. The first layer is configured to extend at least partially through the plurality of openings in the second layer.

[0015] In yet another exemplary embodiment, a dressing interface for connecting a negative pressure source to a dressing may include a base, a conduit housing attached to the base, a shell layer coupled to the base having a first side, a second side, and an opening configured for the conduit housing to pass through, and a contact layer having a first side, a second side coupled to the first side of the shell layer, and an opening configured for the base to reside within.

[0016] In yet another exemplary embodiment, a dressing interface for connecting a negative pressure source to a dressing may include a stretch releasing adhesive layer having an adhesive portion, a tab and an opening, a flange coupled to the stretch releasing adhesive layer, and a conduit housing coupled to the flange and extending through the opening in the stretch releasing adhesive layer.

[0017] In yet another exemplary embodiment, a dressing interface for connecting a negative pressure source to a dressing may include a coupling member including an opening, a first adhesive region having a first region peel strength, a second adhesive region having a second region peel strength less than the first region peel strength, and a hinge line between the first adhesive region and the second adhesive region.

[0018] In some embodiments, the dressing interface may further include a fluid conductor including an applicator and a bridge, where the applicator is coupled to the coupling member.

[0019] Systems for treating a tissue site are also described herein, where some exemplary embodiments include a manifold for placement adjacent to the tissue site, a cover configured to form a fluid seal on the manifold for placement on the patient's epidermis, a described dressing interface for coupling to the cover, and a negative pressure source for coupling to the manifold via the dressing interface.

[0020] Additionally, a method of treating a tissue site with negative pressure may include applying a manifold to the tissue site, applying a cover over the patient's epidermis to form a fluid seal on the manifold, applying a described dressing interface to a first position on the cover, fluidly coupling the manifold to a negative pressure source, and applying negative pressure from the negative pressure source to the manifold to promote healing and tissue granulation.

[0021] The objects, advantages and preferred modes of making and using the claimed subject matter will best be understood by referring to the accompanying drawings in conjunction with the following detailed description of illustrative embodiments. [Brief explanation of the drawings]

[0022] [Figure 1] FIG. 1 is a functional block diagram of an exemplary embodiment of a treatment system capable of providing negative pressure treatment and infusion treatment in accordance with the present disclosure.

[0023] [Figure 2] FIG. 2 is an isometric view of an example dressing interface showing further details that may be relevant to some exemplary embodiments of the treatment system of FIG. 1.

[0024] [Figure 3] FIG. 3 is an exploded view of the dressing interface of FIG. 2.

[0025] [Figure 4] 3 is a top view of the dressing interface of FIG. 2 assembled and coupled to an example cover that may be associated with some exemplary embodiments of the treatment system of FIG. 1.

[0026] [Figure 5] 5 is a cross-sectional view of the dressing interface and cover of FIG. 4 and also shows an example of a tissue interface that may be associated with some exemplary embodiments of the treatment system of FIG. 1.

[0027] [Figure 6] FIG. 6 is a detailed view of the dressing interface, cover, and tissue interface of FIG. 5. [Figure 7] FIG. 6 is a detailed view of the dressing interface, cover, and tissue interface of FIG. 5.

[0028] [Figure 8] FIG. 4 is a side view of the dressing interface and cover of FIG. 3.

[0029] [Figure 9] 3A-3C are top views of exemplary configurations of hinge lines that may be associated with some embodiments of the dressing interface of FIG. 2. [Figure 10] 3A-3C are top views of exemplary configurations of hinge lines that may be associated with some embodiments of the dressing interface of FIG. 2.

[0030] [Figure 11] 1. FIG. 10 is an exploded view of another example of a dressing interface showing further details that may be relevant to some exemplary embodiments of the treatment system of FIG.

[0031] [Figure 12] 12 is a side view of the dressing interface of FIG. 11 and also shows an example of a cover that may be associated with some exemplary embodiments of the treatment system of FIG. 1.

[0032] [Figure 13] 1. FIG. 10 is an exploded view of another example of a dressing interface showing further details that may be relevant to some exemplary embodiments of the treatment system of FIG.

[0033] [Figure 14] 1. FIG. 2 is a side view of another example of a dressing interface and cover showing further details that may be relevant to some exemplary embodiments of the treatment system of FIG. 1. [Figure 15] 1. FIG. 2 is a side view of another example of a dressing interface and cover showing further details that may be relevant to some exemplary embodiments of the treatment system of FIG. 1.

[0034] [Figure 16] 1. FIG. 10 is an isometric view of another example of a dressing interface showing further details that may be relevant to some exemplary embodiments of the treatment system of FIG.

[0035] [Figure 17]1. FIG. 4 is a top view of another example of a dressing interface and cover showing further details that may be relevant to some exemplary embodiments of the treatment system of FIG. [Figure 18] 1. FIG. 4 is a top view of another example of a dressing interface and cover showing further details that may be relevant to some exemplary embodiments of the treatment system of FIG.

[0036] [Figure 19] FIG. 2 is a segmented isometric view of a lower portion of a dressing interface showing further details that may be relevant to some exemplary embodiments of the treatment system of FIG. 1.

[0037] [Figure 20] 20 is a segmented isometric view of the top of the dressing interface of FIG. 19, which may be associated with some exemplary embodiments of the treatment system 100 of FIG. 1. DETAILED DESCRIPTION OF THE INVENTION

[0038] The following description of exemplary embodiments provides information to enable one of ordinary skill in the art to make and use the claimed subject matter, but may omit certain details that are already known in the art. Therefore, the following detailed description is to be construed as illustrative and not limiting.

[0039] Example embodiments may also be described herein with reference to spatial relationships between or spatial orientations of various elements as shown in the accompanying drawings. Generally, such relationships or orientations assume a frame of reference that is consistent with or relative to a patient in a position to receive treatment. However, as should be recognized by those skilled in the art, this frame of reference is merely a convenience for purposes of explanation, rather than a strict prescription.

[0040] FIG. 1 is a simplified functional block diagram of an exemplary embodiment of a treatment system 100 according to the present disclosure that can provide negative pressure therapy involving instillation of a local treatment solution to a tissue site.

[0041] The term "tissue site," in this context, broadly refers to a wound, defect, or other treatment target located on or within tissue, including, but not limited to, bone tissue, adipose tissue, muscle tissue, nerve tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament. Wounds can include, for example, chronic, acute, traumatic, subacute, and dehiscence wounds, partial-thickness burns, ulcers (such as diabetic ulcers, pressure ulcers, or venous insufficiency ulcers), flap wounds, and transplanted tissue. The term "tissue site" can also refer to any area of tissue, not necessarily a wound or defect, but instead where it may be desirable to add or promote the growth of additional tissue. For example, negative pressure can be applied to a tissue site to grow additional tissue, which can then be harvested and transplanted.

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

[0043] A fluid conduit is another illustrative example of a distribution component. In this context, "fluid conduit" broadly includes a tube, pipe, hose, conduit, or other structure having one or more lumens or open passages adapted to transport fluid between two ends. Typically, a tube is an elongated, cylindrical structure with some flexibility, although the geometry and stiffness can vary. Furthermore, some fluid conduits may be molded into or otherwise integrally combined with other components. Distribution components may also include or comprise interfaces or fluid ports to facilitate coupling and decoupling of other components. In some embodiments, for example, a dressing interface may facilitate coupling of a fluid conduit to a dressing 110.

[0044] The treatment system 100 may also include a regulator or controller, such as a controller 130. Additionally, the treatment system 100 may include sensors for measuring operating parameters and providing feedback signals indicative of the operating parameters to the controller 130. For example, as shown in FIG. 1, the treatment system 100 may include a first sensor 135 and a second sensor 140 coupled to the controller 130.

[0045] Treatment system 100 may also include a source of infusion solution. For example, solution source 145 may be fluidly coupled to dressing 110, as shown in the exemplary embodiment of FIG. 1 . Solution source 145, in some embodiments, may be fluidly coupled to a positive pressure source, such as positive pressure source 150, a negative pressure source, such as negative pressure source 105, or both. A regulator, such as drip regulator 155, may also be fluidly coupled to solution source 145 and dressing 110 to ensure proper administration of infusion solution (e.g., saline) to the tissue site. For example, drip regulator 155 may include a piston that can be pneumatically actuated by negative pressure source 105 to aspirate infusion solution from the solution source during negative pressure intervals and inject solution into the dressing during vent intervals. Additionally or alternatively, controller 130 may be coupled to negative pressure source 105, positive pressure source 150, or both to control the administration of infusion solution to the tissue site. In some embodiments, as shown in the example of FIG. 1, the drip regulator 155 may also be fluidly coupled to the negative pressure source 105 via the dressing 110.

[0046] Some components of the treatment system 100 may be housed within or used in conjunction with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate treatment. For example, in some embodiments, the negative pressure source 105 may be combined with the controller 130, the solution source 145, and other components into a treatment unit.

[0047] In general, components of therapy system 100 may be coupled directly or indirectly. For example, negative pressure source 105 may be directly coupled to reservoir 115 or indirectly coupled to dressing 110 via reservoir 115. Coupling may include fluid coupling, mechanical coupling, thermal coupling, electrical coupling, or chemical coupling (e.g., chemical coupling), or some combination of couplings, depending on the context. For example, negative pressure source 105 may be electrically coupled to controller 130 and fluidly coupled to one or more distribution components to provide a fluid pathway to the tissue site. In some embodiments, components may also be coupled by physical proximity, integrated into a single structure, or formed from the same piece of material.

[0048] A negative pressure source, such as negative pressure source 105, can be a reservoir of air at negative pressure or can be a manual or powered device, such as a vacuum pump, a suction pump, a wall suction port available in many healthcare facilities, or a micropump. "Negative pressure" generally refers to a pressure that is lower 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 lower than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise indicated, pressure values described herein are gauge pressures. References to an increase in negative pressure typically refer to a decrease in absolute pressure, whereas a decrease in negative pressure typically refers to an increase in absolute pressure. The amount and nature of the negative pressure provided by the negative pressure source 105 can vary depending on the treatment requirements, but the pressure is typically a low vacuum, also commonly referred to as a rough vacuum, between -5 mmHg (-667 Pa) and -500 mmHg (-66.7 kPa). A typical treatment range is between -50 mmHg (-6.7 kPa) and -300 mmHg (-39.9 kPa).

[0049] 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 fluid collection, storage, and disposal. In other environments, fluids may be properly disposed of without being stored in a rigid container, and reusable containers may also reduce waste and costs associated with negative pressure therapy.

[0050] 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 generally includes an integrated circuit including a processor core and memory programmed to directly or indirectly control one or more operating parameters of treatment system 100. The operating parameters may include, for example, the power applied to negative pressure source 105, the pressure generated by negative pressure source 105, or the pressure delivered 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.

[0051] Sensors, such as first sensor 135 and second sensor 140, are generally known in the art as any device operable to detect or measure a physical phenomenon or characteristic and generally provide a signal indicative of the detected or measured phenomenon or characteristic. For example, first sensor 135 and second sensor 140 can be configured to measure one or more operating parameters of treatment system 100. In some embodiments, first sensor 135 may be a transducer configured to measure pressure in the pneumatic path and convert the measurement into a signal indicative of 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 an operating parameter of 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, although in some embodiments, some signal conditioning may be appropriate. For example, the signals may need to be filtered or amplified before they can be processed by controller 130. Typically, the signal is an electrical signal, but may be represented in other forms, such as an optical signal.

[0052] The tissue interface 120 can generally be adapted to partially or completely contact the tissue site. The tissue interface 120 can take many forms and can have many sizes, shapes, or thicknesses depending on various factors, such as the type of procedure being performed or the nature and size of the tissue site. For example, the size and shape of the tissue interface 120 can conform to the contours of a deep, irregularly shaped tissue site. Any or all of the surfaces of the tissue interface 120 can have an uneven, rough, or jagged profile.

[0053] In some embodiments, tissue interface 120 may include or consist essentially of a manifold. A manifold in this context may include or consist essentially of a means for collecting or distributing fluid across tissue interface 120 under pressure. For example, the manifold may be adapted to receive negative pressure from a source and distribute the negative pressure across tissue interface 120 through a plurality of openings, which may have the effect of collecting fluid across the tissue site and drawing the fluid toward the source. In some embodiments, the fluid path may be reversed or a secondary fluid path may be provided to facilitate delivery of fluid across a tissue site, such as fluid from a source of infusion solution.

[0054] In some exemplary embodiments, the manifold may include multiple passages that can be interconnected to improve fluid distribution or collection. In some exemplary embodiments, the manifold may include or consist essentially of a porous material having interconnected fluid passages. Examples of suitable porous materials that can be adapted to form interconnected fluid passages (e.g., channels) include cellular foams, including open-cell foams such as reticulated foams; porous tissue aggregates; and other porous materials, such as gauze or felt mats, that generally include pores, edges, and / or walls. Liquids, gels, and other foams may also include, or be hardened to include, openings and fluid passages. In some embodiments, the manifold may additionally or alternatively include protrusions that form the interconnected fluid passages. For example, the manifold may be molded to provide surface protrusions that define the interconnected fluid passages.

[0055] In some embodiments, the tissue interface 120 may include or consist essentially of a reticulated foam with pore size and free volume that can vary depending on the prescribed treatment needs. For example, a reticulated foam with at least 90% free volume may be suitable for many treatment applications, and a foam with an average pore size in the 400-600 micron range (40-50 pores per inch) may be particularly suitable for some types of treatment. The tensile strength of the tissue interface 120 may also vary depending on the prescribed treatment needs. For example, the tensile strength of the foam may be increased for instillation of a topical treatment solution. 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 square inch. In some embodiments, the tissue interface 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 tin compound. In some examples, the tissue interface 120 may be a reticulated polyurethane foam, such as found in GRANUFOAM™ dressings or VACVERAFLO™ dressings, both available from Kinetic Concepts, Inc. (San Antonio, Texas).

[0056] 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 peripheral 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 approximately 5 millimeters to 10 millimeters may be appropriate.

[0057] The tissue interface 120 can be either hydrophobic or hydrophilic. In embodiments in which 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 draw fluid away from the tissue site by capillary flow or other wicking mechanisms. One example of a suitable hydrophilic material is a polyvinyl alcohol open-cell foam, such as VACWHITEFOAM™ dressing available from Kinetic Concepts, Inc. (San Antonio, Texas). Other hydrophilic foams can include those made from polyethers. Other foams that can exhibit hydrophilic properties include hydrophobic foams that have been treated or coated to impart hydrophilic properties.

[0058] In some embodiments, the tissue interface 120 may be comprised of a bioresorbable material. Suitable bioresorbable materials 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 further function 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 generally a substance or structure used to enhance or promote cell growth or tissue formation, such as a three-dimensional porous structure that provides a template for cell growth. Examples of scaffold materials include calcium phosphate, collagen, PLA / PGA, coral hydroxyapatite, carbonate, or engineered allograft materials.

[0059] In some embodiments, the cover 125 may provide a barrier against bacteria and protection from physical trauma. The cover 125 may also be constructed from a material capable of reducing evaporative loss and providing 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 or consist of, for example, an elastomeric film or membrane capable of providing an adequate seal to maintain negative pressure at the tissue site for a given negative pressure source. The cover 125 may, in some applications, have a high moisture vapor transmission rate (MVTR). For example, the MVTR, in some embodiments, is at least 250 grams per square meter per 24 hours (g / m) when measured using the standing cup technique according to ASTM E96 / E96M standing cup method at 38°C and 10% relative humidity (RH). 2 / 24 hours). In some embodiments, up to 5,000 g / m 2 / 24 hour MVTR can provide effective breathability and mechanical properties.

[0060] In some exemplary embodiments, the cover 125 can be a polymer drape, such as a polyurethane film, that is permeable to water vapor but impermeable to liquids. Such drapes typically have a thickness in the range of 25 to 50 microns. For permeable materials, the permeability should generally be low enough to maintain the desired negative pressure. The cover 125 can include, for example, one or more of the following materials: polyurethanes (PU), such as hydrophilic polyurethanes; cellulose derivatives; hydrophilic polyamides; polyvinyl alcohols; polyvinylpyrrolidones; hydrophilic acrylics; 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, for example, as Tegaderm® drapes available from 3M Company (Minneapolis, Minnesota); polyurethane (PU) drapes available from Avery Dennison Corporation (Pasadena, California); polyether block polyamide copolymer (PEBAX) available from Arkema SA (Colombes, France); and Inspire 2301 and Inspire 2327 polyurethane films available from Expopack Advanced Coatings (Wrexham, United Kingdom). In some embodiments, the cover 125 is 2600 g / m 2 / INSPIRE2301, which has a 24-hour MVTR (Upright Cup Technology) and a thickness of approximately 30 microns.

[0061] An attachment device can be used to attach the cover 125 to an attachment surface, such as an intact 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 the tissue site. In some embodiments, for example, part or all of the cover 125 can be coated with an adhesive, such as an acrylic adhesive, which can have a coating weight of approximately 25 to 65 grams per square meter (gsm). In some embodiments, a thicker adhesive or combination of adhesives can be applied to improve the seal and reduce leakage. Other exemplary embodiments of attachment devices can include double-sided tape, glue, hydrocolloid, hydrogel, silicone gel, or organogel.

[0062] Solution source 145 may also represent a container, canister, pouch, bag, or other storage component capable of providing a solution for infusion therapy. While the composition of the solution may vary according to a given treatment, examples of solutions that may be suitable for some formulations include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanides, cationic solutions, and isotonic solutions.

[0063] In operation, tissue interface 120 can be positioned within, on, over, or otherwise proximal to the tissue site. For example, if the tissue site is a wound, tissue interface 120 can partially or completely occlude or be positioned over the wound. Cover 125 can be positioned over tissue interface 120 and sealed to an attachment surface near the tissue site. For example, cover 125 can be sealed to intact epidermis surrounding the tissue site. Thus, dressing 110 can provide a sealed treatment environment proximal to the tissue site that is substantially isolated from the external environment, and negative pressure source 105 can reduce pressure in the sealed treatment environment.

[0064] The fluid dynamics of using a negative pressure source to reduce pressure in another component or location, such as within an enclosed therapy environment, can be mathematically complex, but 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 may illustratively be described herein as, for example, "delivering," "distributing," or "generating" negative pressure.

[0065] Generally, exudate and other fluids flow along a fluid pathway toward lower pressure. Thus, the term "downstream" typically refers to something within a fluid pathway that is relatively closer to a negative pressure source or farther away from a positive pressure source. Conversely, the term "upstream" refers to something that is relatively farther away from a negative pressure source or closer to a positive pressure source. Similarly, it may be convenient to describe certain features in terms of a fluid "inlet" or "outlet" in such a frame of reference. This orientation is generally assumed for purposes of describing various features and components herein. However, fluid pathways may also be reversed in some applications, such as by replacing a negative pressure source with a positive pressure source, and this descriptive definition should not be construed as limiting.

[0066] In a sealed treatment environment, negative pressure applied across the tissue site via tissue interface 120 can induce macro- and micro-strains in the tissue site. The negative pressure can also remove exudates and other fluids from the tissue site, which can be collected in container 115.

[0067] In some embodiments, the controller 130 can receive and process data from one or more sensors, such as the first sensor 135. The controller 130 can 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 can include an input for receiving a desired target pressure and can be programmed to process data regarding the setting and input of the target pressure to be applied to the tissue interface 120. In some exemplary embodiments, the target pressure can be a fixed pressure value set by an operator as the desired target negative pressure for treatment at the tissue site and then provided as an input to the controller 130. The target pressure can 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 patient's medical condition, and the attending physician's preferences. After selecting the desired target pressure, the controller 130 can operate the negative pressure source 105 in one or more control modes based on the target pressure and can receive feedback from one or more sensors to maintain the target pressure at the tissue interface 120.

[0068] In some embodiments, the controller 130 can 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 the treatment or until manually stopped. Additionally or alternatively, the controller can have an intermittent pressure mode. For example, the controller 130 can operate the negative pressure source 105 to cycle between the target pressure and atmospheric pressure. For example, the target pressure may be set to a value of -135 mmHg for a specified period of time (e.g., 5 minutes) and then stopped for a specified period of time (e.g., 2 minutes). This cycle can be repeated by operating the negative pressure source 105, which can form a square wave pattern between the target pressure and atmospheric pressure.

[0069] 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 treatment device being used. For example, the initial rise time for one treatment system may be in the range of approximately 20-30 mmHg / sec, while for another treatment system, it may be in the range of approximately 5-10 mmHg / sec. If the treatment system 100 is operating in an intermittent mode, the recurring rise time may be substantially equal to the initial rise time.

[0070] 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 varying between 50 and 135 mmHg of negative pressure with a rise time set at a rate of +25 mmHg / min and a fall time set at -25 mmHg / min. In other embodiments of the treatment system 100, the triangular waveform can vary between 25 and 135 mmHg of negative pressure with a rise time set at a rate of +30 mmHg / min and a fall time set at -30 mmHg / min.

[0071] In some embodiments, the controller 130 can control or determine a variable target pressure in a dynamic pressure mode, which can vary between a maximum and minimum pressure value that can be set as an operator-defined input as a range of desired negative pressure. The variable target pressure can also be processed and controlled by the controller 130, which can vary the target pressure according to a predetermined waveform, such as a triangular waveform, a sinusoidal waveform, or a sawtooth waveform. In some embodiments, the waveform can be set by the operator as a predetermined negative pressure or a time-varying negative pressure desired for treatment.

[0072] In some embodiments, the controller 130 can receive and process data, such as data related to the infusion solution being delivered to the tissue interface 120. Such data may include the type of infusion solution prescribed by the clinician, the volume of fluid or solution to be infused at the tissue site (the "fill volume"), and the prescribed amount of time the solution is allowed to remain at the tissue site before applying negative pressure to the tissue site (the "dwell time"). The fill volume may be, for example, 10 to 500 mL, and the dwell time may be 1 second to 30 minutes. The controller 130 can also control the operation of one or more components of the treatment system 100 to infuse the solution. For example, the controller 130 can manage the fluid dispensed from the solution source 145 to the tissue interface 120. In some embodiments, the fluid can be infused at the tissue site by applying negative pressure from the negative pressure source 105 to reduce pressure at the tissue site and draw the solution into the tissue interface 120. In some embodiments, the solution can be infused at the tissue site by applying positive pressure from the positive pressure source 150 to move the solution from the solution source 145 to the tissue interface 120. Additionally or alternatively, the solution source 145 can be elevated to a height sufficient to allow gravity to move the solution to the tissue interface 120 .

[0073] The controller 130 can also control the fluid dynamics of the infusion by providing a continuous flow of solution or an intermittent flow of solution. Negative pressure can be applied to provide either a continuous or intermittent flow of solution. The application of negative pressure can be implemented to provide a continuous pressure operating mode to achieve a continuous flow rate of the infusion solution through the tissue interface 120, or a dynamic pressure operating mode to vary the flow rate of the infusion solution through the tissue interface 120. Alternatively, the application of negative pressure can be implemented to provide an intermittent operating mode to allow the infusion solution to dwell at the tissue interface 120. The intermittent mode can provide a specific fill volume and dwell time depending, for example, on the type of tissue site being treated and the type of dressing being utilized. Negative pressure therapy can be applied after or during the infusion of solution. The controller 130 can be utilized to select the operating mode and duration of negative pressure therapy before initiating another infusion cycle by infusing more solution.

[0074] FIG. 2 is an isometric view illustrating a dressing interface 200 configured to connect a negative pressure source 105 to a dressing 110. The dressing interface 200 can be easily removed, replaced, and / or repositioned on the cover 125 without damaging or destroying the cover 125. In the example of FIG. 2, the dressing interface 200 includes a coupling member 205 coupled to a negative pressure port 210. The coupling member 205 includes an opening 215, a first adhesive region 220, and a second adhesive region 225. A hinge line 230 may be formed between the first adhesive region 220 and the second adhesive region 225. The first adhesive region 220 has a first peel strength, and the second adhesive region 225 has a second peel strength, where the second peel strength is less than the first peel strength. The dressing interface 200 may further include a tab 235 coupled to the second adhesive region 225.

[0075] The negative pressure port 210 includes a base, such as a flange 240, and a conduit housing 245 extending from the flange 240. The conduit housing 245 may be an elbow connector. The conduit housing may extend through an opening 215 in the coupling member 205. A fluid conductor 250, which may be, for example, a flexible tube, may be fluidly coupled to the conduit housing 245 at one end.

[0076] FIG. 3 is an exploded view of the dressing interface 200 of FIG. 2 , showing additional details that may be relevant to certain embodiments. The flange 240 of the negative pressure port 210 may have at least one straight edge and one rounded edge. For example, the flange 240 may have a rounded edge 300 corresponding to a major arc of a circle and a straight edge 305 corresponding to a chord of the circle. The rounded edge 300 and the straight edge 305 define a shape that corresponds to a major segment of the circle. That is, the flange 240 may have straight portions or flat spots. In some embodiments, the straight edge 305 may be parallel to the hinge line 230. In some cases, the straight edge 305 may be offset from the hinge line 230 by a distance into or toward the second adhesive region 225. In other embodiments, the straight edge 305 may be collinear with the hinge line 230. The straight edge 305 may lie along the hinge line 230 without being offset from the hinge line 230. The straight edge 305 of the flange 240 may allow the negative pressure port 210 to hinge about the hinge line 230 when the second adhesive region 225 is removed from the cover 125 as described herein. In some embodiments, the flange 240 of the negative pressure port 210 may be sufficiently flexible to allow folding and bending of the flange 240 such that a portion of the flange 240 extends across the hinge line 230 and does not interfere with or inhibit the hinging of the second adhesive region 225.

[0077] Although flange 240 is described as having a truncated circular shape, in some embodiments flange 240 may have any suitable shape, such as, for example, a circle, a triangle, a square, a rectangle, a pentagon, a hexagon, an octagon, a star, an oval, a polygon, or a rectilinear shape. In some embodiments in which flange 240 has a shape having at least one straight edge (e.g., a triangle, a square, a rectangle, a pentagon, a hexagon, an octagon), the straight edge may be parallel to or collinear with hinge line 230, as described above with respect to straight edge 305.

[0078] 3, coupling member 205 may include a shell layer 310 and a contact layer 315. Shell layer 310 may be formed from any material that allows for a fluid seal. A fluid seal is one that is adequate to maintain negative pressure at a desired location given the particular negative pressure source or system involved. Shell layer 310 may include, for example, one or more of the following materials: hydrophilic polyurethane, cellulose derivatives, hydrophilic polyamide, polyvinyl alcohol, polyvinylpyrrolidone, hydrophilic acrylic, hydrophilic silicone elastomer, e.g., 14400 g / m 2 / INSPIRE 2301 or 2317 material from Expopack Advanced Coatings (Wrexham, United Kingdom) with a 24 hour MVTR (inverted cup technology) and a thickness of about 30 microns, uncoated thin polymer drapes, natural rubber, polyisoprene, styrene butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, butyl rubber, ethylene propylene rubber, ethylene propylene diene monomer, chlorosulfonated polyethylene, polysulfide rubber, polyurethane (PU), EVA film, copolyester, silicone, silicone drapes, 3M Tegaderm® drapes, polyurethane (PU) drapes such as those available from Avery Dennison Corporation (Pasadena, California), e.g., polyether block polyamide copolymer (PEBAX) from Arkema (France), Expopack 2327, or other suitable materials.

[0079] The shell layer 310 may be vapor permeable and liquid impermeable. In some embodiments, the shell layer 310 may be, for example, at least about 300 g / m per 24 hours. 2 The shell layer 310 may be a flexible, breathable film, membrane, or sheet having a high MVTR. In other embodiments, low vapor permeable films or vapor impermeable films may be used. The shell layer 310 may include a range of medically suitable films having a thickness between about 15 microns (μm) and about 50 microns (μm). In some embodiments, the shell layer 310 may be formed of the same material as the cover 125. In some embodiments, the shell layer 310 may be clear, transparent, translucent, opaque, and / or colored.

[0080] The shell layer 310 may have a first side and a second side. The first side of the shell layer 310 may include an adhesive. The adhesive may be bonded to the first side of the shell layer 310. In some embodiments, the adhesive may be coated or deposited on the first side of the shell layer 310. The adhesive may be a medically acceptable adhesive. The adhesive may also be flowable. For example, the adhesive may include an acrylic adhesive, a rubber adhesive, a high tack or tacky silicone adhesive, polyurethane, or other adhesive substance. In some embodiments, the adhesive of the shell layer 310 has a viscosity of 15 grams / m 2 (gsm) ~70 grams / m 2 The adhesive may be a pressure-sensitive adhesive, such as an acrylic adhesive with a coating weight of 1000 gsm. In some embodiments, the adhesive may have a peel strength, or resistance to peeling from a stainless steel material, ranging from about 6.4 N to about 8.8 N. In some embodiments, the adhesive may have a peel strength, or resistance to peeling from a stainless steel material, of about 7.8 N. Peel strength can be measured by using a roller to apply a 1-inch (2.54 cm) wide adhesive test strip to a stainless steel plate. The test strip is then peeled back onto itself (at a 180-degree angle) and the force required to peel the strip is measured. This test is performed on a stainless steel substrate at 23°C and 50% relative humidity in accordance with ASTM D3330. In some embodiments, the adhesive of the shell layer 310 can be reduced or deactivated using ultraviolet light. Ultraviolet light can be irradiated onto the shell layer 310, and the ultraviolet light can reduce the peel strength of the adhesive by an amount sufficient to allow removal of the dressing interface 200 from the cover 125 without damaging or destroying the cover 125.

[0081] The shell layer 310 further includes an opening 320. In some embodiments, the opening 320 may be centrally located in the shell layer 310. The opening 320 may be sized or dimensioned to receive the conduit housing 245 of the negative pressure port 210. In some embodiments, the shape of the opening 320 may be coextensive with or match the shape of the conduit housing 245 where the conduit housing 245 meets the flange 240. In other embodiments, the size of the opening 320 in the shell layer 310 may be larger than the size of the conduit housing 245 where the conduit housing 245 meets the flange 240. In some embodiments, the shape of the opening 320 may differ from the shape of the conduit housing 245 where the conduit housing 245 meets the flange 240. An upper side of the flange 240 of the negative pressure port 210 may be bonded to the first surface of the shell layer 310 by an adhesive on the first surface of the shell layer 310 to form a fluid seal around the flange 240. In some embodiments, the shell layer 310 may also include a tab 325 located around the periphery of the shell layer 310 on the second adhesive region 225 side of the hinge line 230 .

[0082] In some embodiments, the interface layer 315 can have a first side and a second side. The second side of the interface layer 315 can be bonded to the first side of the shell layer 310. The interface layer 315 can include an adhesive. For example, the interface layer 315 can be a soft, pliable material suitable for providing a fluid seal with the cover 125, as described herein. For example, the interface layer 315 can include silicone gel, soft silicone, hydrocolloid, hydrogel, polyurethane gel, polyolefin gel, hydrogenated styrenic copolymer gel, foam gel, soft closed-cell foam such as adhesive-coated polyurethane and polyolefin, polyurethane, polyolefin, hydrogenated styrenic copolymer, or an adhesive-coated film, membrane, or sheet. The interface layer 315 can include a hydrophobic or hydrophilic material. In some embodiments, the interface layer 315 can be clear, transparent, translucent, opaque, and / or colored. The interface layer 315 can have a thickness of between about 500 microns (μm) and about 1000 microns (μm). In some embodiments, the contact layer 315 has a stiffness of about 5 Shore 00 to about 80 Shore 00. In some embodiments, the contact layer 315 has a peel strength in the range of about 0.37 N to about 0.44 N. In some embodiments, for example, the contact layer 315 has a peel strength in the range of about 0.5 N to about 1.0 N. In some embodiments, for example, the contact layer 315 has a peel strength of about 0.4 N. In some embodiments, for example, the contact layer 315 has a peel strength of about 0.8 N. In some embodiments, for example, the contact layer 315 has a peel strength of about 0.9 N. In some embodiments, for example, the contact layer 315 has a peel strength of about 2.8 N. The peel strength of the contact layer 315 may be less than the peel strength of the adhesive of the shell layer 310.

[0083] In some embodiments, the ratio of the peel strength of the contact layer 315 to the adhesive of the shell layer 310 may be about 1:2. In some embodiments, the ratio of the peel strength of the contact layer 315 to the adhesive of the shell layer 310 may be about 1:2.3. In some embodiments, the ratio of the peel strength of the contact layer 315 to the adhesive of the shell layer 310 may be about 1:3.1. In some embodiments, the ratio of the peel strength of the contact layer 315 to the adhesive of the shell layer 310 may be about 1:7.1. In some embodiments, the ratio of the peel strength of the contact layer 315 to the adhesive of the shell layer 310 may be about 1:8. In some embodiments, the ratio of the peel strength of the contact layer 315 to the adhesive of the shell layer 310 may be about 1:9.8. In some embodiments, the ratio of the peel strength of the contact layer 315 to the adhesive of the shell layer 310 may be about 1:11. In some embodiments, the ratio of the peel strength of the contact layer 315 to the adhesive of the shell layer 310 may be about 1:14.5. In some embodiments, the ratio of the peel strength of the contact layer 315 to the adhesive of the shell layer 310 may be about 1:17.3. In some embodiments, the ratio of the peel strength of the contact layer 315 to the adhesive of the shell layer 310 may be about 1:19.5. In some embodiments, the ratio of the peel strength of the contact layer 315 to the adhesive of the shell layer 310 may be about 1:20. In some embodiments, the ratio of the peel strength of the contact layer 315 to the adhesive of the shell layer 310 may be about 1:23.8. In some embodiments, the ratio of the peel strength of the contact layer 315 to the adhesive of the shell layer 310 may range from about 1:2 to about 1:23.8. In some embodiments, the ratio of the peel strength of the contact layer 315 to the peel strength of the adhesive of the shell layer 310 may range from about 1:2 to about 1:25.

[0084] The contact layer 315 may further include an opening 330 located in the second adhesive region 225. The opening 330 may be sized or dimensioned to receive the flange 240 of the negative pressure port 210 therein. In some embodiments, the shape of the opening 330 may be coextensive with or match the shape of the flange 240 of the negative pressure port 210. In embodiments in which the flange 240 is a truncated circle with a straight edge 305, the opening 330 may also have a truncated circular shape corresponding to the shape of the flange 240. In some embodiments, the opening 330 may be positioned such that the straight edge 305 of the flange 240 is parallel to the hinge line 230 of the coupling member 205. For example, the straight edge 305 may be parallel to the hinge line 230 but offset from the hinge line 230 by a distance into or toward the second adhesive region 225. In other embodiments, the straight edge 305 may be collinear with the hinge line 230. The straight edge 305 may lie along the hinge line 230 without being offset from the hinge line 230. In some embodiments, the flange 240 of the negative pressure port 210 has a thickness, and the contact layer 315 has a thickness that is at least as thick as the flange 240. In other embodiments, the thickness of the contact layer 315 is less than the thickness of the flange 240. Thus, the flange 240 may be thicker than the contact layer 315.

[0085] The interface layer 315 may further include a plurality of openings 335. The plurality of openings 335 may be formed by cutting, drilling, punching, or other suitable techniques for forming openings, apertures, perforations, or holes in the interface layer 315, including, but not limited to, using single or multiple blade cutters, lasers, water jets, hot knives, computer numerically controlled (CNC) cutters, hot wires, localized RF or ultrasonic energy, and / or single or multiple punch tools. The plurality of openings 335 in the interface layer 315 may have many shapes, including, but not limited to, circular, triangular, rectangular, square, pentagonal, hexagonal, octagonal, elliptical, oval, star, polygonal, slit, complex curve, and linear shapes, or may have some combination of shapes.

[0086] The contact layer 315 may further include a tab 340 disposed around the periphery of the contact layer 315 on the second adhesive region 225 side of the hinge line 230. The tab 340 of the contact layer 315 and the tab 325 of the shell layer 310 may collectively form the tab 235 of the coupling member 205.

[0087] FIG. 4 shows a top view of the dressing interface 200 assembled and coupled to the cover 125. As shown in FIG. 4, the plurality of openings 335 may include a first plurality of openings 400 and a second plurality of openings 405. At least one of the first plurality of openings 400 is disposed on a first side of the hinge line 230 (e.g., in the first adhesive region 220), and at least one of the second plurality of openings 405 is disposed on a second side opposite the first side of the hinge line 230 (e.g., in the second adhesive region 225). In some embodiments, the first plurality of openings 400 and the second plurality of openings 405 in the contact layer 315 may be substantially circular in shape. The widths of each of the first plurality of openings 400 and the second plurality of openings 405 may define the areas of the first plurality of openings 400 and the second plurality of openings 405, respectively. As shown in the example of FIG. 4 , where the plurality of openings 405 are circular, the diameter D1 and opening area of each of the first plurality of openings 400 is greater than the diameter D2 and opening area of each of the second plurality of openings 405. For example, in some embodiments, the diameter D1 of the first plurality of openings 400 can be in the range of about 4 millimeters to about 15 millimeters. In some embodiments, the diameter D1 of the first plurality of openings 400 can be in the range of about 5 millimeters to about 10 millimeters. In some embodiments, the diameter D1 of the first plurality of openings 400 can be about 10 millimeters. For example, in some embodiments, the diameter D2 of the second plurality of openings 405 can be in the range of about 1 millimeter to about 10 millimeters. In some embodiments, the diameter D2 of the second plurality of openings 405 can be in the range of about 2 millimeters to about 7 millimeters. In some embodiments, the diameter D2 of the second plurality of openings 405 can be about 5 millimeters.

[0088] While each opening of the first plurality of openings 400 is shown as having the same diameter D1 and each opening of the second plurality of openings 405 is shown as having the same diameter D2, it will be understood that in other embodiments, the openings of the first plurality of openings 400 may have different dimensions (i.e., open areas), and the openings of the second plurality of openings 405 may have different dimensions (i.e., open areas). For example, the first plurality of openings 400 may have openings of two or more opening areas that collectively form the overall open area of the first adhesive region 220. Similarly, the second plurality of openings 405 may have openings of two or more opening areas that collectively form the overall open area of the second adhesive region 225. Thus, similar to the different diameters of dimples on a golf ball, in some embodiments, the openings of the first plurality of openings 400 may have different dimensions, and the openings of the second plurality of openings 405 may have different dimensions.

[0089] The first plurality of openings 400 are shown as having a circular shape. However, in other embodiments, the first plurality of openings 400 may have many shapes, including, but not limited to, a triangle, a rectangle, a square, a pentagon, a hexagon, an octagon, an ellipse, an oval, a star, a polygon, a slit, a complex curve, a linear shape, or some combination of shapes. Also, the second plurality of openings 405 are shown as having a circular shape. However, in other embodiments, the second plurality of openings 405 may have many shapes, including, but not limited to, a triangle, a rectangle, a square, a pentagon, a hexagon, an octagon, an ellipse, an oval, a star, a polygon, a slit, a complex curve, a linear shape, or some combination of shapes.

[0090] Figure 5 is a cross-sectional view of the dressing interface 200 of Figure 4 taken along section line 5-5, showing additional details that may be relevant to some embodiments. For example, when the dressing interface 200 is assembled, the flange 240 of the negative pressure port 210 can be positioned below the shell layer 310, and the conduit housing 245 can extend upward through the opening 320 in the shell layer 310. The second surface of the interface layer 315 can be bonded to the first surface of the shell layer 310 by an adhesive on the first surface of the shell layer 310. Furthermore, the flange 240 of the negative pressure port 210 can be positioned within the opening 330 in the interface layer 315. The opening 320 in the shell layer 310 and the opening 330 in the interface layer 315 can collectively form the opening 215 in the coupling member 205. 5, the dressing interface 200 can then be placed on top of the cover 125 such that the conduit housing 240 of the negative pressure port 210 is positioned over the opening 500 in the cover 125 and the fluid conductor 250 is fluidly coupled with the tissue interface 120 through the opening 500. In other embodiments, for example, the flange 240 of the negative pressure port 210 may be positioned over the shell layer 310. For example, the underside of the flange 240 may be adhered to the second side or upper side of the shell layer 310 to form a fluid seal.

[0091] 6 and 7 are detailed views of features in the example of FIG. 5. In FIGS. 6 and 7, the shell layer 310 may extend or be pressed through the plurality of openings 335 to contact the cover 125 to secure the dressing interface 200 to, for example, the cover 125. The plurality of openings 335 may provide sufficient contact of the shell layer 310 to the cover 125 to secure the dressing interface 200 to the cover 125. The plurality of openings 335 may be sized to control the amount of the shell layer 275 that extends through the plurality of openings 335 in the contact layer 315 and reaches the cover 125. Thus, the configuration of the plurality of openings 335, the shell layer 310, and the contact layer 315 may allow for release and repositioning of the dressing interface 200 on the cover 125. At least a portion of the shell layer 310 may be configured to extend at least partially through one or more of the plurality of openings 335 in the contact layer 315. For example, at least a first portion of the shell layer 310 can extend at least partially through the first plurality of openings 400 in the contact layer 315 (see FIG. 6 ), and at least a second portion of the shell layer 310 can extend at least partially through the second plurality of openings 405 in the contact layer 315 (see FIG. 7 ). In some examples, the diameter D1 of the first plurality of openings 400 is larger than the diameter D2 of the second plurality of openings 405, allowing more of the shell layer 310 to contact the cover 125 at each opening of the first plurality of openings 400 than can contact the cover 125 at each opening of the second plurality of openings 405. This results in two distinct adhesive regions, i.e., the first adhesive region 220 and the second adhesive region 225, where the two adhesive regions are on either side of the hinge line 230. The first adhesive region 220 may be formed by a first portion of the contact layer 315 proximate the first plurality of openings 400 and a first portion of the shell layer 310 extending through the first plurality of openings 400. The second adhesive region 225 may be formed by a second portion of the contact layer 315 proximate the second plurality of openings 405 and a second portion of the shell layer 310 extending through the second plurality of openings 405.A first region peel strength is achieved by the combination of the peel strength of the shell layer 310, the amount of the shell layer 310 that extends through the first plurality of openings 400 to contact the cover 125, and the peel strength of the contact layer 315 that contacts the cover 125. Similarly, a second region peel strength is achieved by the combination of the peel strength of the shell layer 310, the amount of the shell layer 310 that extends through the second plurality of openings 405 to contact the cover 125, and the peel strength of the contact layer 315 that contacts the cover 125. The first region peel strength is greater than the second region peel strength. Thus, the bonding member 205 can have a first region peel strength in the first adhesive region 220 and a second region peel strength in the second adhesive region 225.

[0092] The second region peel strength of the second adhesive region 225 may be low enough to allow the second adhesive region 225 to be removed from the cover 125 without damaging or destroying the cover 125. Furthermore, in some cases, the first adhesive region 220 may remain attached to the cover 125 when the second adhesive region 225 is removed. The first adhesive region 220 may function as an anchor to hold the dressing interface 200 to the cover 125.

[0093] 8 is a front view of the dressing interface 200 of FIG. 2. The tab 235 can be pulled to remove the second adhesive region 225 from the cover 125. In some embodiments, the tab 235 can be pulled to completely remove the dressing interface 200 from the cover 125. In some embodiments, the tab 235 is non-adhesive, so that the tab 235 can be easily lifted and pulled to remove part or all of the dressing interface 200 from the cover 125. In other embodiments, the tab 235 can include a low-peel adhesive configured to keep the tab 235 attached to the cover 125 so that the tab 235 cannot be inadvertently pulled up by catching on clothing, a medical device, another person, or other object. Pulling tab 235 removes second adhesive region 225 of coupling member 205 from cover 125, causing second adhesive region 225 to hinge or rotate about hinge line 230 relative to first adhesive region 220 of coupling member 205 (as shown by curve A), while first adhesive region 220 remains adhered to cover 125. Negative pressure port 210 may also be disposed within second adhesive region 225 and may also hinge or rotate about hinge line 230. Second plurality of openings 405 may also hinge or rotate about hinge line 230. By placing the negative pressure port 210 within the second adhesive region 225, the underside of the negative pressure port 210 and the interior of the conduit housing 245 can be inspected and / or accessed to remove or otherwise clean exudate, clogs, and / or other material from the negative pressure port 210 and / or the interior of the conduit housing 245. This cleaning can be done without damaging or destroying the cover 125, the tissue interface 120, or the tissue site. Once the negative pressure port 210 has been cleaned, the second adhesive region 225 can be reattached to the cover 125 and negative pressure therapy can be resumed.

[0094] Several factors can be utilized to control the first and second region peel strengths of the dressing interface 200, including, but not limited to, the area and number of the first and second plurality of openings 400 and 405 in the contact layer 315, the thickness of the contact layer 315, the thickness and amount of adhesive on the shell layer 310, the peel strength of the adhesive on the shell layer 310, and the peel strength of the contact layer 315. An increase in the amount of adhesive on the shell layer 310 extending through the plurality of openings 335 generally corresponds to an increase in the peel strength of the dressing interface 200. A decrease in the thickness of the contact layer 315 generally corresponds to an increase in the amount of adhesive on the shell layer 310 extending through the plurality of openings 335. Thus, for example, the diameter and configuration of the first and second plurality of openings 400 and 405 utilized, the amount and peel strength of adhesive on the shell layer 310, the thickness of the contact layer 315, and the peel strength of the contact layer 315 can be varied to provide the desired first and second region peel strengths for the dressing interface 200.

[0095] 9 and 10 are top views of the dressing interface 200 showing further details that may be relevant to particular embodiments. While the hinge line 230 of various embodiments of the dressing interface 200 has been described and illustrated as being straight, in some embodiments, the hinge line 230 may be non-straight (e.g., curved, arcuate, wavy, sawtooth). In other embodiments, no portion of the hinge line 230 intersects with the flange 240 of the negative pressure port 210. In other embodiments, the hinge line 230 may be tangent to the flange 240. In the exemplary embodiment shown in FIG. 9, the hinge line 230 curves toward the negative pressure port 210. The coupling member 205 includes a perimeter 900, and the hinge line 230 has a first endpoint 905 on the perimeter 900 and a second endpoint 910 on the perimeter 900. An imaginary line 915 may be drawn from the first endpoint 905 to the second endpoint 910, with no portion of the imaginary line 915 intersecting the flange 240 of the negative pressure port 210. Thus, in the exemplary embodiment shown in Figure 10, if the hinge line 230 curves away from the negative pressure port 210, as long as the imaginary line 915 extending from the first endpoint 905 to the second endpoint 910 does not intersect the flange 240, the second adhesive region 225 can rotate about the hinge line 230, allowing a user to easily access the interior of the conduit housing 245 of the negative pressure port 210.

[0096] FIG. 11 is an exploded view of an exemplary configuration of the plurality of openings 335, showing further details that may be relevant to some embodiments of the dressing interface 200. In the example of FIG. 11, the dressing interface 200 includes a coupling member 205 configured to couple to the negative pressure port 210. The coupling member 205 may include a shell layer 310, a contact layer 315, and a tab 235. The shell layer 310 may further include an opening 320 configured for the conduit housing 245 of the negative pressure port 210 to extend therethrough. The contact layer 315 has an opening 330 for receiving the flange 240 of the negative pressure port 210 and a plurality of openings 335. As shown in FIG. 11, the flange 240 may be circular and may not include the cord 305 shown in FIGS. 2-5. In some embodiments, the flange 240 may include the cord 305. Furthermore, the example of the contact layer 315 shown in FIG. 11 includes only a single plurality of openings 335. In some embodiments, for example, the single plurality of openings 335 may be a second plurality of openings 405. As a result, in some embodiments, the dressing interface 200 may have only a single adhesive area with a single area peel strength. By including only the second plurality of openings 405, the entire dressing interface 200 may be removed from the cover 125 without damaging or destroying the cover 125.

[0097] 12 is a front view of the dressing interface 200 shown in FIG. 11 illustrating complete removal of the dressing interface 200 from the cover 125 along line B without damaging or destroying the cover 125 or the tissue interface 120. However, it will be understood that less than the entire dressing interface 200 can be removed from the cover 125 without damaging or destroying the cover 125. The dressing interface 200 can be reattached by pushing down along line B.

[0098] FIG. 13 is an exploded view of another exemplary configuration of the dressing interface 200, illustrating further details that may be relevant to some embodiments of the dressing interface 200. In the example of FIG. 13, the dressing interface 200 includes a coupling member 205 configured to be coupled to the negative pressure port 210. The coupling member 205 may include a shell layer 310, a contact layer 315, and a tab 235. The shell layer 310 may further include an opening 320 configured to receive the conduit housing 245 of the negative pressure port 210. The contact layer 315 includes an opening 330 for receiving the flange 240 of the negative pressure port 210. As shown in FIG. 13, the flange 240 may be circular and may not include the cord 305 shown in FIGS. 2-5. Furthermore, unlike the example of the contact layer 315 shown in FIGS. 2-8 and 11, which includes multiple openings 335, the example of the contact layer 315 shown in FIG. 13 lacks multiple openings 335. In some embodiments, the dressing interface 200 may have only a single adhesive region having a single-region peel strength, where the single-region peel strength is defined by the peel strength of the contact layer 315. If the peel strength of the contact layer 315 is low, the entire dressing interface 200 may be removed from the cover 125 without damaging or destroying the cover 125. In some embodiments, for example, the contact layer 315 has a peel strength in the range of about 0.44 N to about 3.1 N. In some embodiments, the contact layer 315 may comprise or consist essentially of a silicone adhesive having a peel strength of about 2.8 N.

[0099] 14 and 15 are front views of the dressing interface 200 and cover 125 showing further details that may be relevant to some embodiments of the dressing interface 200. In the example of FIGS. 14 and 15, the bonding layer 205 of the dressing interface 200 may include a stretch-releasing adhesive. In some examples, the stretch-releasing adhesive may be a COMMAND brand adhesive commercially available from 3M Company (Minneapolis, Minnesota). The dressing interface 200 can be removed from the cover 125 by pulling the tab 235 of the bonding layer 205 along line C in a direction substantially parallel to the bonding layer 205. As the tab 235 is pulled along line C, the stretch-releasing adhesive of the bonding layer 205 is stretched and thinned, thereby reducing the release force of the stretch-releasing adhesive until the bonding layer 305 is lifted away from the cover 125, as shown by line D. In some embodiments, the bonding layer 305 may be perforated or cut along the hinge line 230 so that when the tab 235 is pulled, the perforation breaks and the portion of the bonding layer 305 on the tab 235 side of the hinge line 230 is removed, while the portion of the bonding layer 305 on the opposite side of the hinge line 230 remains intact and attached to the cover 125. In such embodiments, a new stretch releasing adhesive portion can be provided and the dressing interface 200 can be reapplied to the cover 125. In some embodiments, the bonding layer 305 may be perforated or cut along the hinge line 230 and may include a tab 235 on each side of the hinge line 230 so that each side of the bonding layer 305 may be independently removable. In other embodiments, the contact layer 315 may include a stretch releasing adhesive that can be removed independently from the shell layer 310. After the contact layer 315 has been stretched and removed from the cover 125 and shell layer 310, a new contact layer 315 can be applied to the shell layer 310 and the dressing interface 200 can be reapplied.

[0100] FIG. 16 is an isometric view of another exemplary configuration of the dressing interface 200, showing further details that may be relevant to some embodiments of the dressing interface 200. In the example of FIG. 15, the dressing interface 200 includes a plurality of perforations 1600 in the shell layer 310 that align with at least a portion of the first plurality of openings 400. Over time, the first adhesive region 220 may increase the bond between the dressing interface 200 and the cover 125, and thus the first adhesive region may provide greater resistance to removal. Furthermore, the application of heat can increase the bond strength of the adhesive in the shell layer 310. Thus, the perforations 1600 may be configured to allow liquid to be drawn through the plurality of perforations 1600 so that the liquid contacts the adhesive in the shell layer 310. The liquid then interacts with the adhesive in the shell layer 310, reducing the peel strength of the adhesive in the shell layer 310. This allows the first adhesive region 220 to be removed from the cover 125 without damaging or destroying the cover 125, even if the dressing interface 200 has been adhered to the cover 125 for an extended period of time. In some embodiments, the liquid can be an alcohol, such as isopropyl alcohol. For example, a user can apply a small amount of isopropyl alcohol to the shell layer 310 via a readily available alcohol wipe. The isopropyl alcohol is then sucked through the multiple perforations 1600, softening the adhesive of the shell layer 310 for approximately 2 to 3 minutes, thereby reducing the peel strength of the adhesive of the shell layer 310. The dressing interface 200 can then be removed from the cover 125. After removal, the isopropyl alcohol evaporates, and the peel strength of the adhesive of the shell layer 310 returns to only a slightly lower level (approximately 80%) than its original level, allowing the dressing interface 200 to be re-adhered to the cover 125. In some embodiments, the plurality of perforations 1600 may include slits, slots, fenestrations, or other openings that allow the flow of liquid from above the shell layer 310 to the adhesive of the shell layer 310 .The plurality of perforations 1600 does not adversely affect the seal or integrity of the tissue site because the location of the plurality of perforations 1600 in the first adhesive region is sufficiently removed from any pneumatic or fluid connection with the tissue site.

[0101] FIGS. 17 and 18 are top views of the dressing interface 200 and cover 125, illustrating the ability to move the dressing interface 200 in more detail. As shown in the example of FIG. 17, the dressing interface 200 is in an initial position on the cover 125. If the dressing interface 200 needs to be moved for a specific reason, it can be removed and placed in a second position as shown in FIG. 18. This can be accomplished without removing the cover 125 and the underlying tissue interface 120 from the patient's tissue site. A new opening can be cut in the cover 125, and the dressing interface 200 can be sealed over the new opening to fluidly couple the fluid conductor 250 to the opening. As shown in FIG. 18, the opening 500 in the cover 125 can be sealed with a patch 1800. The patch 1800 can be made of the same material as the cover 125. With the dressing interface 200 placed in the second position on the cover 125 and the opening 500 sealed, negative pressure therapy can be resumed.

[0102] FIG. 19 is a bottom segmented isometric view of another exemplary configuration of the dressing interface 200, showing further details that may be relevant to some embodiments. As shown in FIG. 19 , in some embodiments, the dressing interface 200 may include a bridge 1900, which may have a generally low-profile structure. The bridge 1900 may be configured to fluidly couple the negative pressure source 105 to the treatment environment of the dressing 110. The bridge 1900 of FIG. 19 is substantially flat and flexible and may be compressible without occluding or blocking the fluid path between the fluid conductor 250 and the tissue interface 120. In some embodiments, the dressing interface 200 may include an applicator 1905 that may be adapted to be placed in fluid communication with the tissue interface 120. The bridge 1900 is fluidly coupled to the applicator 1905 and may extend to the negative pressure port 210. The bridge 1900 may have a substantially flat profile, and the negative pressure port 210 may be configured to fluidly couple the bridge 1900 to tubing or other circular fluid conductors, such as fluid conductor 250. In some embodiments, the dressing interface 200 of FIG. 19 may have a length ranging from about 15 cm to about 30 cm. In some embodiments, the bridge 1900 and the applicator 1905 may be formed as a single device, as shown. In other embodiments, the bridge 1900 and the applicator 1905 may be separate components that are coupled together to form a single device. In still other embodiments, the bridge 1900 and the applicator 1905 may be separate components that can be used independently of each other as a single component in the treatment system 100.

[0103] As further shown in FIG. 19 , the applicator 1905 can be bulbous, round, or any shape suitable for applying treatment to the tissue interface 120, depending on the size and nature of the tissue site. The bridge 1900 in the example of FIG. 19 is generally long and narrow. In some exemplary embodiments, the bridge 1900 and applicator 1905 can include a top layer, such as a first layer 1915, and a base layer, such as a second layer 1920. The second layer 1920 can be bonded to the first layer 1915 around the periphery of the first layer 1915 to form a sealed space within the dressing interface 200. A sealed space may be formed between the first layer 1915 and the second layer 1920 of both the bridge 1900 and the applicator 1905. In some embodiments, a sealed space may be sealed along the periphery of the bridge 1900, the applicator 1905, or both. The first layer 1915 and the second layer 1920 may both be formed from or include a polymer film. The first layer 1915 and the second layer 1920 can be joined around the periphery of the dressing interface 200 to form a sealed space by welding (RF or ultrasonic), heat sealing, or adhesive bonding, such as with an acrylic or curable adhesive. For example, the first layer 1915 and the second layer 1920 can be welded to one another around the periphery of the dressing interface 200, and the welding can form a flange 1925 around the periphery of the dressing interface 200. One skilled in the art will appreciate that there are various methods for joining the first layer 1915 and the second layer 1920 to form a sealed space within the dressing interface 200.

[0104] 19 may further include at least one barrier or wall, such as a first wall 1930, between the first layer 1915 and the second layer 1920. In some embodiments, the first wall 1930 may extend from an end of the bridge 1900 adjacent the negative pressure port 210 into the applicator 1905, forming at least two enclosed spaces or fluid pathways between the first layer 1915 and the second layer 1920 within the dressing interface 200. In some examples, the dressing interface 200 may further include a second barrier, such as a second wall 1935, between the first layer 1915 and the second layer 1920. In some embodiments, the second wall 1935 may also extend from an end of the bridge 1900 adjacent the negative pressure port 210 into the applicator 1905. In some exemplary embodiments, the first wall 1930 and the second wall 1935 may comprise a polymer film bonded between the first layer 1915 and the second layer 1920. In some other exemplary embodiments, the first wall 1930 and the second wall 1935 may comprise a weld (RF or ultrasonic), a heat seal, an adhesive bond, or any combination of the foregoing. In those embodiments including two walls, e.g., the first wall 1930 and the second wall 1935, such embodiments may form three sealed spaces or fluid paths within the sealed space between the first layer 1915 and the second layer 1920. In some embodiments, two of the fluid paths may be dedicated to pressure measurement. For example, the first pressure sensing path 1940 and the second pressure sensing path 1945 (as indicated by the dashed arrows) in the example of FIG. 19 may be configured as feedback paths. A third fluid path, such as the negative pressure path 1950 (as indicated by the dashed arrow), may be utilized to provide negative pressure.

[0105] In some exemplary embodiments, the first pressure sensing path 1940, the negative pressure path 1950, and the second pressure sensing path 1945 may be fluidly coupled to the fluid conductor 250 by the negative pressure port 210. For example, the negative pressure path 1950 may be fluidly coupled to the fluid conductor 250 such that the negative pressure path 1950 functions to deliver negative pressure to the tissue interface 120. The first pressure sensing path 1940 and the second pressure sensing path 1945 may be fluidly coupled to the fluid conductor 250. In other embodiments, the first pressure sensing path 1940 and the second pressure sensing path 1945 may both be fluidly coupled to a single space within the negative pressure port 210, which is also fluidly coupled to the fluid conductor 250. In some exemplary embodiments, the other ends of the first pressure sensing path 1940, the negative pressure path 1950, and the second pressure sensing path 1945 may terminate within the applicator 1905 and may be fluidly coupled to each other within the applicator 1905 to deliver and sense negative pressure associated with the tissue interface 120.

[0106] The applicator 1905 may include an opening or aperture 1955 in the second layer 1920 adapted to fluidly couple the enclosed space of the dressing interface 200 to the tissue interface 120. The aperture 1955, together with portions of the first layer 1915 and second layer 1920 of the applicator 1905, may define a recessed space 1960 within the enclosed space of the applicator 1905, where the recessed space 1960 is adapted to be in fluid communication with the tissue interface 120 during use. The portion of the recessed space 1960 covered by the second layer 1920 of the applicator 1905 may be referred to as a covered space. In some embodiments, the first wall 1930 and the second wall 1935 can extend only partially into the recessed space 1960 such that ends of the first wall 1930 and the second wall 1935 are exposed by the aperture 1955. The first pressure sensing path 1940 and the second pressure sensing path 1945 can be in fluid communication with the recessed space 1960. The negative pressure path 1950 can also be in fluid communication with the recessed space 1960 and can be adapted to deliver negative pressure to the tissue interface 120 via the recessed space 1960. In some exemplary embodiments (not shown), the first wall 1930 and the second wall 1935 can extend beyond the opening 1955 such that less of the first pressure sensing path 1940 and the second pressure sensing path 1945 is exposed to the negative pressure being delivered to the tissue interface 120 by the negative pressure path 1950 to avoid closure and / or blockage from the tissue site.

[0107] The dressing interface 200 may further include a means for supporting the fluid pathway under pressure. In some embodiments, the support means may include multiple support features, such as flexible protrusions, standoffs, nodes, cellular porous fibers, porous foam, or some combination of features disposed in the fluid pathway. For example, the dressing interface 200 of FIG. 19 includes multiple supports 1965. The supports 1965 of FIG. 19 may be generally characterized as bubbles having a lower portion extending from the first layer 1915 and an upper portion extending within the enclosed space toward the second layer 1920 outside the recessed space 1960. Within the recessed space 1960, the upper portion of the supports 1965 extending from the first layer 1915 can extend toward the tissue interface 120 and may be adapted to be in direct contact with the tissue interface 120 during use, or may be disposed above the tissue interface 120. Features such as the support 1965 can provide a cushion that helps prevent the sealed space of the dressing interface 200 from collapsing as a result of an external force. In some exemplary embodiments, the top of the support 1965 may contact the second layer 1920, and in some other exemplary embodiments, the top of the support 1965 may be coupled to the second layer 1920.

[0108] 19 , in some embodiments, the dressing interface 200 may further include a coupling member 205 for releasably coupling the applicator 1905 to the dressing 110. The shell layer 310 of the coupling member 205 may be coupled to the dressing interface 200 such that the shell layer 310 is disposed between the contact layer 315 and the second layer 1920 of the dressing interface 200. The coupling member 205 may be disposed on the applicator 1905 with the opening 330 of the coupling member 205 configured to be in fluid communication with the opening 1955. In some embodiments, the opening 330 may be aligned with the opening 1955. In some embodiments, in addition to the first surface of the shell layer 310 including an adhesive as described above, the second surface of the shell layer 310 may also include an adhesive such that the shell layer 310 can be coupled to the second layer 1920 of the dressing interface 200. In some embodiments, an adhesive may be applied to the second layer 1920 of the dressing interface 200 to bond the shell layer 310 to the dressing interface 200 .

[0109] In some embodiments, the shell layer 310 can be omitted from the coupling member 205, and the adhesive can be coated or deposited on the second layer 1920 of the dressing interface 200. In such embodiments, the second layer 1920 of the dressing interface 200 can function as the shell layer 310. The adhesive can be a medically acceptable adhesive. The adhesive can also be flowable. For example, the adhesive can include an acrylic adhesive, a rubber adhesive, a high tack or tacky silicone adhesive, polyurethane, or other adhesive substance. In some embodiments, the adhesive of the second layer 1920 can have a viscosity of 15 grams / m 2 (gsm) ~70 grams / m 2The adhesive may be a pressure-sensitive adhesive, such as an acrylic adhesive having a coating weight of 1000 gsm. In some embodiments, the adhesive may have a peel strength or resistance to peeling from a stainless steel material ranging from about 6.4 N to about 8.8 N. In some embodiments, the adhesive may have a peel strength or resistance to peeling from a stainless steel material of about 7.8 N. In some embodiments, the adhesive of the second layer 1920 may be reduced or deactivated using ultraviolet light. Ultraviolet light may be applied to the dressing interface 200, and the ultraviolet light may reduce the peel strength of the adhesive by an amount sufficient to allow removal of the dressing interface 200 from the cover 125 without damaging or destroying the cover 125.

[0110] FIG. 20 is a segmented isometric view of the top of the dressing interface 200 of FIG. 19 , which may be relevant to some exemplary embodiments of the treatment system 100 of FIG. 1 . As shown in FIG. 20 , in some embodiments, the coupling member 205 may be configured to releasably couple the negative pressure port 210 to the bridge 1900. The coupling member 205 may be used to couple the negative pressure port 210 to the first layer 1915. In some embodiments, the dressing interface 200 includes a first coupling member 205 on the applicator 1905 and a second coupling member 205 on the bridge 1900. In some embodiments, the dressing interface 200 includes the coupling member 205 on the applicator 1905 but not on the bridge 1900. In some embodiments, the dressing interface 200 includes the coupling member 205 on the bridge 1900 but not on the applicator 1905.

[0111] Although the plurality of openings 335 are shown as circular, in other embodiments, the plurality of openings 335 may comprise elongated openings, such as slots, disposed partially within the first adhesive region 220 and extending across the hinge line 230 into the second adhesive region 225. The portion of the elongated opening within the first adhesive region 220 may have a larger opening area than the portion of the elongated opening within the second adhesive region 225. In some embodiments, for example, the elongated opening may have a wider opening portion within the first adhesive region 220 and a narrower opening portion within the second adhesive region 225.

[0112] Accordingly, a method for treating a tissue site with negative pressure can be performed utilizing the dressing interface 200. The method may include applying the tissue interface 120 to the tissue site, applying the cover 125 over the patient's epidermis to form a fluid seal over the tissue interface 120, coupling the dressing interface 200 to a first position on the cover 125, fluidly coupling the tissue interface 120 to a negative pressure source 105, and applying negative pressure from the negative pressure source 105 to the tissue interface 120 to promote healing and tissue granulation. In some embodiments, the method may further include removing at least a portion of the dressing interface 200 from the cover 125 and then reapplying the dressing interface 200 to the cover 125. In some embodiments, the method may further include cleaning or removing any occlusions from the dressing interface 200 after removing at least a portion of the dressing interface 200 from the cover 125 and before reapplying the dressing interface 200 to the cover 125. In some embodiments, the method may further include removing the entire dressing interface 200 from the cover 125 and reapplying the dressing interface 200 to the cover 125. In some embodiments, the method may further include reapplying the dressing interface 200 to a second position on the cover 125, wherein the second position is different from the first position. In some embodiments, the method may further include cleaning or removing occlusions from the dressing interface 200 after removing the entire dressing interface 200 from the cover 125 and before reapplying the dressing interface 200 to the cover 125.

[0113] The systems, devices, and methods described herein can provide significant advantages. For example, the dressing interface 200 can be removed, replaced, or repositioned to quickly and efficiently resolve connection issues without damaging or destroying the cover 125. The ability to reposition the negative pressure port 210 on the cover 125 using the dressing interface 200 can reduce troubleshooting time and avoid the need for a complete replacement of the dressing 110. The dressing interface 200 can also avoid the need for a complete replacement of the negative pressure port 210, tissue interface 120, and / or cover 125, reducing the cost of an entirely new dressing 110. As a result, treatment interruptions due to removal of the entire dressing 110 can be reduced.

[0114] The systems, devices, and methods described herein may provide even further important advantages. For example, if the negative pressure port 210 becomes clogged, the dressing interface 200 can be easily peeled off or lifted, allowing the negative pressure port 210 to be cleaned. Furthermore, it may be easier to apply topical medications while the negative pressure port 210 is peeled off. Following cleaning and / or medication application, the second adhesive region 225 of the dressing interface 200 can be pushed back onto the cover 125, resealing the negative pressure port 210 to the cover, and treatment can be resumed without damaging or destroying the cover 125 in any way. Furthermore, in some embodiments, the entire dressing interface 200 can be removed and repositioned without damaging or destroying the cover 125. Following initial placement, it may be necessary to reposition the negative pressure port 210 on the cover 125 in certain circumstances where a more suitable location on the dressing 110 is available that can accommodate more fluid using gravity. Additionally, the dressing interface 200 and negative pressure port 210 can withstand some tugging or pulling forces without damaging or destroying the cover 125. The dressing interface 200 also avoids the need to completely replace the negative pressure port 210 in the event of a leak. That is, if a leak occurs, the dressing interface 200 can be peeled or lifted back onto the cover 125, and the negative pressure port 210 can be resealed to the cover 125.

[0115] While illustrated in several exemplary embodiments, those skilled in the art will recognize that the systems, devices, and methods described herein are susceptible to various changes and modifications that fall within the scope of the appended claims. Moreover, the description of various alternatives using terms such as "or" does not require mutual exclusivity unless clearly required by context, and the definite article "a" or "an" does not limit subject matter to a single example unless clearly required by context. Components may also be combined or removed in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, the dressing 110, the container 115, or both may be removed or separated from other components for manufacture or sale. In other exemplary configurations, the controller 130 may also be manufactured, configured, assembled, or sold independently of other components.

[0116] The appended claims set forth novel and inventive aspects of the subject matter described above, but the claims may also encompass additional subject matter not specifically recited in detail. For example, certain features, elements, or aspects may be omitted from the claims if they are not necessary to distinguish the novel and inventive features from those known to those skilled in the art. Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced by alternative features serving the same, equivalent, or similar purpose without departing from the scope of the invention as defined by the appended claims.

Claims

1. 1. An interface for connecting a negative pressure source to a dressing, the interface comprising: With the base, a conduit housing attached to the base; a first layer coupled to the base, the first layer having a first adhesive having a first peel strength and an opening configured to receive the conduit housing; a second layer having a second adhesive having a second peel strength less than the first peel strength, a first plurality of openings, a second plurality of openings, and a hinge line between the first plurality of openings and the second plurality of openings; a first portion of the first layer configured to extend through the first plurality of openings and cooperate with the second layer to form a first adhesive region having a first region peel strength; a second portion of the first layer configured to extend through the second plurality of openings and cooperate with the second layer to form a second adhesive region having a second region peel strength that is less than the peel strength of the first region; the first adhesive region and the second adhesive region are on opposite sides of the hinge line; The base and the conduit housing are positioned in the second adhesive region. An interface characterized by:

2. 2. The interface of claim 1, wherein each opening of the first plurality of openings has a first opening area and each opening of the second plurality of openings has a second opening area, the second opening area being smaller than the first opening area.

3. 2. The interface of claim 1, wherein the base, the conduit housing, and the second plurality of openings are configured to rotate about the hinge line.

4. 10. The interface of claim 1, wherein the second adhesive region is configured to be removable from the cover without destroying the cover, while the first adhesive region remains adhered to the cover.

5. 10. The interface of claim 1, wherein the second layer further includes an opening configured to receive the base.

6. 2. The interface of claim 1, wherein the base has a first thickness and the second layer has a second thickness, the second thickness being at least as thick as the first thickness.

7. 10. The interface of claim 1, wherein the second adhesive of the second layer comprises an adhesive selected from one of a silicone adhesive, a hydrocolloid adhesive, and a polyurethane gel adhesive.

8. 2. The interface of claim 1, wherein the second peel strength is about 0.8 Newtons.

9. 10. The interface of claim 1, wherein the first adhesive of the first layer comprises an adhesive selected from one of an acrylic adhesive, a tacky silicone adhesive, a pressure-sensitive adhesive, and an adhesive configured to be deactivated by ultraviolet light.

Images