Removable and replaceable dressing interface for negative pressure therapy systems

Abstract

The present invention provides a dressing interface for connecting a negative pressure source to a dressing. The dressing interface may have a connecting 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 may also have a flange connected to the connecting member, and a conduit housing connected to the flange and extending through the opening in the contact layer.

Description

[0001] Related patent applications

[0002] This invention claims priority to U.S. Provisional Patent Application No. 62 / 798,275, filed January 29, 2019, which is incorporated herein by reference for all purposes. Technical Field

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

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

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

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

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

[0008] For example, in some embodiments, the removable and replaceable dressing interface for connecting a negative pressure source to the dressing may comprise or substantially consist 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 having a peel strength of about 0.8 N. However, in some embodiments, for example, the primary cover contact layer may be formed of an aqueous colloidal adhesive or a low-tack polyurethane (PU) gel adhesive. In some embodiments, the primary sterile cover contact layer may be perforated to help adequately seal the negative pressure adapter to the cover during normal patient use. The perforation may have two sizes, allowing the secondary sterile cover contact layer to protrude through the primary cover contact layer into the dressing cover. The secondary cover contact layer may be a high-tack, adhesive-coated polyurethane film. The two perforation sizes in the primary cover contact layer allow for variations in removal peel force when the dressing interface adheres to the dressing cover. The portion of the dressing interface with larger perforations allows more of the highly adhesive auxiliary cover layer to adhere to the cover and thus acts as an anchor for the dressing interface. This portion may require maximum peel force to remove the dressing interface from the cover. The portion of the dressing interface with smaller perforations allows less of the highly adhesive auxiliary cover layer to adhere to the cover. This portion may require less peel force to remove the dressing interface from the cover. Therefore, this portion with smaller perforations can have a peel force that allows the user to remove the dressing interface and reapply it to the cover while still maintaining sufficient seal to deliver negative pressure therapy to the tissue site. The peel force of the portion of the dressing interface with smaller perforations can be low enough to allow the dressing interface to be removed without damaging or destroying the cover. Additionally, the negative pressure port can have a flat or straight portion that allows the negative pressure port to hinge when the dressing interface is removed or peeled from the cover.

[0009] More generally, some embodiments may include a dressing interface for connecting a negative pressure source to a dressing, the dressing interface having a connecting 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 may also include a negative pressure port for delivering negative pressure, wherein the negative pressure port is coupled to the connecting member.

[0010] In some implementations, the negative pressure port includes a flange and a conduit housing that is coupled to the flange and extends through an opening in the contact layer.

[0011] In some embodiments, the connecting member may further include a housing layer and a contact layer including a plurality of openings, wherein the housing 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.

[0012] In some implementations, the second adhesive region is configured to be removable from the cover without damaging the cover, while the first adhesive region is configured to remain adhered to the cover.

[0013] Alternatively, other exemplary embodiments may 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 and a second layer coupled to the base. The first layer includes an adhesive having a first peel strength and an opening through which the conduit housing is configured. The second layer has an adhesive, a first plurality of openings and a second plurality of openings, the adhesive having a second peel strength less than the first peel strength of the first layer. The first layer is configured to extend at least partially through the first plurality of openings and the second plurality of openings in the second layer.

[0014] In some embodiments, a first portion of the first layer is configured to extend through a first plurality of openings and cooperate with the second layer to form a first adhesive region having a first region peel strength, and a second portion of the first layer is configured to extend through a second plurality of openings and cooperate with the second layer to form a second adhesive region having a second region peel strength less than the first region peel strength.

[0015] In other exemplary embodiments, the dressing interface for connecting a negative pressure source to a dressing may include a negative pressure port coupled to at least one of a first layer and a second layer. The first layer may have a first side, a second side, and an adhesive having a first peel strength on the first side. The second layer may have a first side, a second side coupled to the first side of the first layer, and the second layer includes an adhesive and a plurality of openings, the adhesive having a second peel strength less than the first peel strength of the first layer. The first layer is configured to at least partially extend through the plurality of openings in the second layer.

[0016] In other exemplary embodiments, a dressing interface for connecting a negative pressure source to a dressing may include: a base; a conduit housing attached to the base; an outer shell layer having a first side, a second side, and an opening, the conduit housing being configured to pass through the opening and the outer shell layer being coupled to the base; and a contact layer having a first side, a second side coupled to the first side of the outer shell layer, and an opening, the base being configured to reside in the opening.

[0017] In other exemplary embodiments, the dressing interface for connecting a negative pressure source to a dressing may include a stretch release adhesive layer having an adhesive portion, tabs and openings, a flange coupled to the stretch release adhesive layer, and a conduit housing coupled to the flange and extending through the openings in the stretch release adhesive layer.

[0018] In other exemplary embodiments, the dressing interface for connecting a negative pressure source to a dressing may include a connecting member comprising 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.

[0019] In some embodiments, the dressing interface may additionally include a fluid conductor comprising an applicator and a bridging member, wherein the applicator is coupled to the bridging member.

[0020] This document also describes a system for treating tissue sites, some exemplary embodiments of which include a manifold for placement adjacent to the tissue site, a cover for placement on the patient's epidermis and configured to form a fluid seal on the manifold, a dressing interface as described for attachment to the cover, and a negative pressure source for connection to the manifold via the dressing interface.

[0021] Additionally, methods of treating tissue sites with negative pressure may include applying a manifold to the tissue site, applying a cover to the patient's epidermis to form a fluid seal on the manifold, applying the dressing interface to a first location on the cover, connecting the manifold fluid to a negative pressure source, and applying negative pressure from the negative pressure source to the manifold, thereby promoting healing and granulation tissue development.

[0022] The objectives, advantages, and preferred modes of making and using the subject matter protected by the claims can be best understood by referring to the accompanying drawings in conjunction with the following detailed description of exemplary embodiments. Attached Figure Description

[0023] Figure 1 This is a functional block diagram of an exemplary embodiment of a treatment system that can provide negative pressure therapy and infusion therapy according to this specification;

[0024] Figure 2 This is an isometric view of an example dressing interface, showing how it can be used with... Figure 1 Additional details associated with some exemplary implementations of the treatment system;

[0025] Figure 3 yes Figure 2 An exploded view of the dressing interface;

[0026] Figure 4 This is an example of assembling and attaching to the cover. Figure 2 A top view of the dressing interface, the cover can be used with Figure 1 This is associated with some exemplary implementations of the treatment system;

[0027] Figure 5 yes Figure 4 A cross-sectional view of the dressing interface and the covering, and can be used with Figure 1 Examples of organizational interfaces associated with some exemplary implementations of the treatment system;

[0028] Figure 6 and Figure 7 yes Figure 5 Detailed diagrams of the dressing interface, covering, and tissue interface;

[0029] Figure 8 yes Figure 3 Side view of the dressing interface and the covering;

[0030] Figure 9 and Figure 10 Is it possible to be with Figure 2 A top view of an exemplary construction of the hinge associated with some implementations of the dressing interface;

[0031] Figure 11 This is an exploded view of another example of a dressing interface, showing its compatibility with... Figure 1 Additional details associated with some exemplary implementations of the treatment system;

[0032] Figure 12 yes Figure 11 A side view of the dressing interface, and what it can be used with Figure 1 Examples of coverage components associated with some exemplary implementations of the treatment system;

[0033] Figure 13 This is an exploded view of another example of a dressing interface, showing its compatibility with... Figure 1 Additional details associated with some exemplary implementations of the treatment system;

[0034] Figure 14 and Figure 15 This is another example of a dressing interface and cover, shown as a side view, illustrating how it can be used with... Figure 1 Additional details associated with some exemplary implementations of the treatment system;

[0035] Figure 16 This is another example of an isometric view of a dressing interface, showing how it can be used with... Figure 1 Additional details associated with some exemplary implementations of the treatment system;

[0036] Figure 17 and Figure 18 This is a top view of another example of a dressing interface and cover, showing how it can be used with... Figure 1 Additional details associated with some exemplary implementations of the treatment system;

[0037] Figure 19 This is a segmented isometric view of the bottom part of the dressing interface, showing its compatibility with... Figure 1Additional details associated with some exemplary embodiments of the treatment system; and

[0038] Figure 20 It is possible to be with Figure 1 Some exemplary embodiments of the treatment system 100 are associated with Figure 19 The segmented isometric view at the top of the dressing interface. Detailed Implementation Plan

[0039] The following description of exemplary embodiments provides information that enables those skilled in the art to make and use the subject matter set forth in the appended claims, but certain details well known in the art may be omitted. Therefore, the following detailed description should be considered exemplary and not restrictive.

[0040] This document may also describe exemplary embodiments with reference to the spatial relationships between various elements or the spatial orientations of various elements depicted in the accompanying drawings. Generally, such relationships or orientations are assumed to be consistent with or relative to the patient in the location to be treated. However, as those skilled in the art will recognize, this frame of reference is merely descriptive convenience and not a strict specification.

[0041] Figure 1 This is a simplified functional block diagram of an exemplary embodiment of a treatment system 100 according to this specification, which can provide negative pressure therapy in conjunction with the infusion of a local treatment solution to a tissue site.

[0042] In this context, the term "tissue site" broadly refers to a wound, defect, or other therapeutic target located on or within a tissue, including but not limited to bone, adipose tissue, muscle tissue, nerve tissue, dermis, vascular tissue, connective tissue, cartilage, tendons, or ligaments. Wounds can include, for example, chronic wounds, acute wounds, traumatic wounds, subacute wounds, and dehiscences, partial skin burns, ulcers (such as diabetic ulcers, pressure ulcers, or venous insufficiency ulcers), flaps, and grafts. The term "tissue site" can also refer to an area of ​​any tissue that is not necessarily injured or defective, but rather an area where it may be desirable to add or promote the growth of additional tissue. For example, negative pressure can be applied to a tissue site to encourage the growth of additional tissue, which can then be harvested and transplanted.

[0043] Treatment system 100 may include a negative pressure source or negative pressure supply device such as negative pressure source 105, and one or more dispensing components. The dispensing components are preferably removable and may be disposable, reusable, or recyclable. Dressings such as dressing 110 and fluid containers such as container 115 are examples of dispensing components that may be associated with some examples of treatment system 100. Figure 1As shown in the examples, in some embodiments, dressing 110 may include tissue interface 120, cover 125 or both, or substantially consist of tissue interface, cover or both.

[0044] A fluid conductor is another exemplary example of a dispensing component. In this context, "fluid conductor" broadly includes tubes, pipes, hoses, conduits, or other structures having one or more lumens or open paths suitable for conveying fluid between two ends. Typically, a tube is an elongated cylindrical structure with a degree of flexibility, but its geometry and stiffness can vary. Furthermore, some fluid conductors may be molded into other components or otherwise integrally combined with other components. Dispensing components may also include or contain interfaces or fluid ports to facilitate attachment and disengagement from other components. In some embodiments, for example, a dressing interface may facilitate attachment of the fluid conductor to dressing 110.

[0045] The treatment system 100 may also include a regulator or controller, such as controller 130. Additionally, the treatment system 100 may include sensors to measure operating parameters and provide feedback signals indicative of these operating parameters to controller 130. Figure 1 As shown, for example, the treatment system 100 may include a first sensor 135 and a second sensor 140 connected to the controller 130.

[0046] The treatment system 100 may also include an infusion solution source. For example, the solution source 145 may be fluidly coupled to the dressing 110, such as... Figure 1 The exemplary embodiments are shown. In some embodiments, the solution source 145 may be fluidly coupled to a positive pressure source such as positive pressure source 150, a negative pressure source such as negative pressure source 105, or both. A regulator such as an infusion regulator 155 may also be fluidly coupled to the solution source 145 and the dressing 110 to ensure that the dose of the infusion solution (such as saline) is appropriate to the tissue site. For example, the infusion regulator 155 may include a piston that may be pneumatically actuated by the negative pressure source 105 to draw the infusion solution from the solution source during a negative pressure interval and to drip the solution into the dressing during a discharge interval. In addition or alternatively, a controller 130 may be coupled to the negative pressure source 105, the positive pressure source 150, or both to control the dose of the infusion solution to the tissue site. In some embodiments, the infusion regulator 155 may also be fluidly coupled to the negative pressure source 105 via the dressing 110, such as... Figure 1 As shown in the example.

[0047] Some components of the treatment system 100 may be housed within or combined with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate treatment. For example, in some embodiments, the negative pressure source 105 may be combined with the controller 130, the solution source 145, and other components to form a treatment unit.

[0048] Generally, components of the treatment system 100 can be directly or indirectly coupled. For example, a negative pressure source 105 can be directly coupled to a container 115 and indirectly coupled to a dressing 110 via the container 115. Couplings can include fluid couplings, mechanical couplings, thermal couplings, electrical couplings, or chemical couplings (such as chemical bonds), or in some cases, combinations of couplings. For example, the negative pressure source 105 can be electrically coupled to a controller 130 and fluidly coupled to one or more dispensing components to provide a fluid pathway to the tissue site. In some embodiments, components may also be coupled by means of physical proximity, integral integration with a single structure, or formation from the same piece of material.

[0049] For example, a negative pressure supply device such as negative pressure source 105 may be a reservoir of air under negative pressure, or it may be a manual or electric device such as a vacuum pump, a suction pump, a wall suction port, or a micropump available in many healthcare facilities. “Negative pressure” generally refers to a pressure less than the local ambient pressure, such as the ambient pressure in a local environment outside a sealed treatment environment. In many cases, the local ambient pressure may also be the atmospheric pressure at which the tissue site is located. Alternatively, the pressure may be less than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise specified, the pressure values ​​described herein are gauge pressures. A reference to an increase in negative pressure generally refers to a decrease in absolute pressure, while a decrease in negative pressure generally refers to an increase in absolute pressure. Although the amount and nature of the negative pressure provided by negative pressure source 105 may vary depending on the treatment requirements, the pressure is typically a low vacuum (often also referred to as a rough vacuum) between -5 mm Hg (-667 Pa) and -500 mm Hg (-66.7 kPa). Common treatment ranges are between -50 mm Hg (-6.7 kPa) and -300 mm Hg (-39.9 kPa).

[0050] Container 115 refers to a container, canister, pouch, or other storage component used to manage exudates and other fluids aspirated from tissue sites. In many settings, rigid containers may be preferred or necessary for the collection, storage, and disposal of fluids. In other settings, fluids may be properly disposed of without rigid container storage devices, and reusable containers can reduce waste and costs associated with negative pressure therapy.

[0051] A controller, such as controller 130, may be a microprocessor or computer programmed to operate one or more components of the treatment system 100, such as the negative pressure source 105. In some embodiments, for example, controller 130 may be a microcontroller that typically includes an integrated circuit including a processor core and memory programmed to directly or indirectly control one or more operating parameters of the treatment system 100. Operating parameters may include, for example, power applied to the negative pressure source 105, pressure generated by the negative pressure source 105, or pressure distributed to the tissue interface 120. Controller 130 is also preferably configured to receive one or more input signals, such as feedback signals, and is programmed to modify one or more operating parameters based on the input signals.

[0052] Sensors such as the first sensor 135 and the second sensor 140 are generally known in the art as any device capable of operating to detect or measure a physical phenomenon or characteristic, and typically provide a signal indicating the detected or measured phenomenon or characteristic. For example, the first sensor 135 and the second sensor 140 may be configured to measure one or more operating parameters of the treatment system 100. In some embodiments, the first sensor 135 may be a transducer configured to measure pressure in a pneumatic passage and convert the measurement into a signal indicating the measured pressure. In some embodiments, for example, the first sensor 135 may be a piezoresistive strain gauge. In some embodiments, the second sensor 140 may optionally measure operating parameters of the negative pressure source 105, such as voltage or current. Preferably, the signals from the first sensor 135 and the second sensor 140 are suitable as input signals to the controller 130, but in some embodiments, some signal conditioning may be appropriate. For example, the signals may need to be filtered or amplified before they can be processed by the controller 130. Typically, the signals are electrical signals, but may be represented in other forms, such as optical signals.

[0053] The tissue interface 120 is typically adapted to partially or completely contact the tissue site. The tissue interface 120 can take many forms and can have various sizes, shapes, or thicknesses, depending on factors such as the type of treatment being performed or the nature and size of the tissue site. For example, the size and shape of the tissue interface 120 can be adapted to the contours of deeper and irregularly shaped tissue sites. Any or all surfaces of the tissue interface 120 can have an uneven, rough, or serrated profile.

[0054] In some embodiments, the tissue interface 120 may include or be substantially composed of a manifold. In this context, the manifold may include or be substantially composed of means for collecting or distributing fluid at the tissue interface 120 under pressure. For example, the manifold may be adapted to receive negative pressure from a source and distribute negative pressure at the tissue interface 120 through a plurality of openings, which may have the effect of collecting fluid at the tissue site and drawing fluid toward the source. In some embodiments, the fluid path may be reversed or an auxiliary fluid path may be provided to facilitate the delivery of fluid, such as fluid from an infusion solution source, at the tissue site.

[0055] In some exemplary embodiments, the manifold may include multiple passages that can be interconnected to improve fluid distribution or collection. In some exemplary embodiments, the manifold may include or be substantially composed of a porous material with interconnected fluid passages. Examples of suitable porous materials suitable for forming interconnected fluid passages (e.g., channels) may include cellular foams, including open-cell foams such as mesh foams; porous tissue collections; and other porous materials that typically include pores, edges, and / or walls, such as gauze or felt pads. Liquids, gels, and other foams may also include or be cured to include openings and fluid passages. In some embodiments, the manifold may additionally or alternatively include protrusions forming interconnected fluid passages. For example, the manifold may be molded to provide surface protrusions defining interconnected fluid passages.

[0056] In some embodiments, tissue interface 120 may comprise or be substantially composed of a mesh foam having a pore size and free volume that can be varied according to the requirements of the prescribed treatment. For example, a mesh foam with a free volume of at least 90% is suitable for many therapeutic applications, and a foam with an average pore size in the range of 400 to 600 micrometers (40 to 50 pores / inch) is particularly suitable for some types of treatment. The tensile strength of tissue interface 120 may also be varied according to the requirements of the prescribed treatment. For example, the tensile strength of the foam may be increased for use with infusion of topical treatment solutions. The 25% compressive load flexure of tissue interface 120 may be at least 0.35 psi, and the 65% compressive load flexure may be at least 0.43 psi. In some embodiments, the tensile strength of tissue interface 120 may be at least 10 psi. Tear strength of tissue interface 120 may be at least 2.5 psi. In some embodiments, the interface may be a foam composed of polyols (such as polyesters or polyethers), isocyanates (such as toluene diisocyanate), and polymerization modifiers (such as amines and tin compounds). In some examples, the interface 120 may be a network polyurethane foam, such as that present in Granufoam. ™ Dressing or VACVERAFLO ™Both the mesh polyurethane foam in the dressing and the other material were available from Kinetic Concepts in San Antonio, Texas.

[0057] The thickness of the tissue interface 120 can also be varied according to the needs of the prescribed treatment. For example, the thickness of the tissue interface can be reduced to decrease tension on the surrounding tissues. The thickness of the tissue interface 120 can also affect its conformability. In some embodiments, a thickness in the range of about 5 mm to about 10 mm may be appropriate.

[0058] The tissue interface 120 can be hydrophobic or hydrophilic. In an example where the tissue interface 120 is hydrophilic, the tissue interface 120 can also wick fluid away from the tissue site while continuing to distribute negative pressure to the tissue site. The wicking properties of the tissue interface 120 can draw fluid away from the tissue site through capillary flow or other wicking mechanisms. An example of a potentially suitable hydrophilic material is open-cell polyvinyl alcohol foam, such as WHITEFOAM, available from Kinetic Concepts, San Antonio, Texas. ™ Dressings. Other hydrophilic foams may include those made of polyether. Other foams that may exhibit hydrophilic properties include hydrophobic foams that have been treated or coated to provide hydrophilicity.

[0059] In some embodiments, the tissue interface 120 may be constructed of a bioresorbable material. Suitable bioresorbable materials may include, but are not limited to, polymer blends of polylactic acid (PLA) and polyglycolic acid (PGA). The polymer blend may also include, but is not limited to, polycarbonate, polyfumarate, and caprolactone. The tissue interface 120 may also serve as a scaffold for new cell growth, or a scaffold material may be used in conjunction with the tissue interface 120 to promote cell growth. Scaffolds are typically substances or structures used to enhance or promote cell growth or tissue formation, such as three-dimensional porous structures that provide a template for cell growth. Exemplary examples of scaffold materials include calcium phosphate, collagen, PLA / PGA, coral hydroxyapatite, carbonates, or processed allogeneic graft materials.

[0060] In some embodiments, the cover 125 may provide a bacterial barrier and protection against physical trauma. The cover 125 may also be constructed of a material that reduces evaporation loss and provides a fluid seal between two components or two environments, such as between a treatment environment and a local external environment. The cover 125 may include or be composed of an elastomeric membrane or film that provides a seal sufficient to maintain negative pressure at the tissue site against a given negative pressure source. In some applications, the cover 125 may have a high moisture vapor transmission rate (MVTR). For example, in some embodiments, the MVTR may be at least 250 g / m² / 24h (g / m²). 2( / 24 hours), this value is measured using the upright cup technique at 38°C and 10% relative humidity (RH) according to the ASTM E96 / E96M upright cup method. In some embodiments, up to 5000 g / m 2 / 24-hour MVTR provides effective breathability and mechanical properties.

[0061] In some exemplary embodiments, the cover 125 may be a water vapor-permeable but liquid-impermeable polymer sterilization cover, such as a polyurethane membrane. Such sterilization covers typically have a thickness in the range of 25 to 50 micrometers. For permeable materials, permeability should generally be low enough to maintain the desired negative pressure. The cover 125 may include one or more of the following materials: polyurethane (PU), such as hydrophilic polyurethane; cellulose; hydrophilic polyamide; polyvinyl alcohol; polyvinylpyrrolidone; hydrophilic acrylic resins; silicone, such as hydrophilic silicone elastomers; natural rubber; polyisoprene; styrene-butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene-vinyl acetate (EVA); copolyester; and polyether block polyamide copolymers. Such materials are commercially available, for example, Tegaderm, which is available from 3M Company, Minneapolis, Minnesota. ® Disinfecting cover; a polyurethane (PU) disinfecting cover commercially available from Avery Dennison Corporation, Pasadena, California; a polyether block polyamide copolymer (PEBAX) commercially available, for example from Arkema SA, Colombes, France; and Inspire 2301 and Inpsire 2327 polyurethane films commercially available from Expopack Advanced Coatings, Wrexham, United Kingdom. In some embodiments, the cover 125 may include a 2600 g / m² polyurethane film. 2 INSPIRE 2301 features 24-hour MVTR (positive cup technology) and a thickness of approximately 30 microns.

[0062] Attachment devices can be used to attach cover 125 to an attachment surface, such as undamaged epidermis, a liner, or another cover. Attachment devices can take many forms. For example, an attachment device can be a medically acceptable pressure-sensitive adhesive configured to bond cover 125 to the epidermis surrounding a tissue site. In some embodiments, for example, some or all of cover 125 may be coated with an adhesive, such as an acrylic adhesive, with a coating weight between 25 g / m² and 65 g / m². In some embodiments, a thicker adhesive or combination of adhesives may be applied to improve sealing and reduce leakage. Other exemplary embodiments of attachment devices may include double-sided tape, paste, aqueous colloid, hydrogel, silicone gel, or organic gel.

[0063] Solution source 145 may also refer to a container, canister, pouch, bag, or other storage component that can provide a solution for infusion therapy. The composition of the solution may vary depending on the prescribed treatment, but examples of some prescribed solutions include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanide, cation solutions, and isotonic solutions.

[0064] During operation, the tissue interface 120 can be placed within, above, on, or otherwise close to the tissue site. For example, if the tissue site is a wound, the tissue interface 120 can partially or completely fill the wound, or it can be placed above the wound. The covering 125 can be placed above the tissue interface 120 and sealed to the attachment surface near the tissue site. For example, the covering 125 can be sealed to the undamaged epidermis surrounding the tissue site. Thus, the dressing 110 provides a sealed therapeutic environment close to the tissue site and substantially isolated from the external environment, and the negative pressure source 105 reduces the pressure within the sealed therapeutic environment.

[0065] The fluid dynamics of using a negative pressure source to reduce pressure in another component or location (such as within a sealed treatment environment) can be mathematically complex. However, the basic principles of fluid dynamics applicable to negative pressure therapy and infusion are generally well known to those skilled in the art, and the process of reducing pressure can be exemplarily described herein as, for example, “delivering,” “distributing,” or “generating” negative pressure.

[0066] Generally, exudates and other fluids flow towards lower pressure along the fluid path. Therefore, the term "downstream" typically means something relatively closer to a negative pressure source or further away from a positive pressure source within the fluid path. Conversely, the term "upstream" means something relatively further away from a negative pressure source or closer to a positive pressure source. Similarly, certain features can conveniently be described according to the fluid's "inlet" or "outlet" in this frame of reference. This orientation is generally assumed for the purpose of describing the various features and components described herein. However, in some applications, the fluid path may be reversed, such as by replacing the negative pressure source with a positive pressure source, and this descriptive convention should not be construed as restrictive.

[0067] The negative pressure applied to the tissue site by the tissue interface 120 within the sealed treatment environment can induce macro- and micro-strains within the tissue site. The negative pressure can also remove exudates and other fluids from the tissue site, which can be collected in container 115.

[0068] In some embodiments, controller 130 may receive and process data from one or more sensors, such as first sensor 135. Controller 130 may also control the operation of one or more components of treatment system 100 to manage pressure delivered to tissue interface 120. In some embodiments, controller 130 may include input for receiving a desired target pressure and may be programmed to process data associated with the setting and input of the target pressure to be applied to tissue interface 120. In some exemplary embodiments, the target pressure may be a fixed pressure value set by the operator as the desired negative pressure for treatment at the tissue site and then provided as input to controller 130. The target pressure may vary depending on the tissue site, based on the type of tissue forming the tissue site, the type of injury or wound (if any), the patient's medical condition, and the attending physician's preferences. After selecting the desired target pressure, controller 130 may operate negative pressure source 105 in one or more control modes based on the target pressure and may receive feedback from one or more sensors to maintain the target pressure at tissue interface 120.

[0069] In some implementations, controller 130 may have a continuous pressure mode, wherein negative pressure source 105 is operated to provide a constant target negative pressure for the duration of treatment or until manual deactivation. Alternatively, controller 130 may have an intermittent pressure mode. For example, controller 130 may operate negative pressure source 105 to cycle between a target pressure and atmospheric pressure. For example, the target pressure may be set to a value of -135 mmHg for a specified duration (e.g., 5 minutes), followed by a specified deactivation duration (e.g., 2 minutes). This cycle can be repeated by activating negative pressure source 105, which may form a square wave pattern between the target pressure and atmospheric pressure.

[0070] 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 dressing 110 may have an initial rise time. The initial rise time may vary depending on the type of dressing and treatment device used. For example, the initial rise time of one treatment system may be in the range of about 20 mmHg / s to 30 mmHg / s, and the initial rise time of another treatment system may be in the range of about 5 mmHg / s to 10 mmHg / s. If the treatment system 100 operates in intermittent mode, the repeated rise time may be a value substantially equal to the initial rise time.

[0071] In some exemplary dynamic pressure control modes, the target pressure may vary over time. For example, the target pressure may vary in the form of a triangular waveform, alternating between a negative pressure of 50 mmHg and 135 mmHg, with the rise time set at a rate of +25 mmHg / min and the fall time set at -25 mmHg / min. In other embodiments of the treatment system 100, the triangular waveform may vary between a negative pressure of 25 mmHg and 135 mmHg, with the rise time set at a rate of +30 mmHg / min and the fall time set at -30 mmHg / min.

[0072] In some embodiments, the controller 130 can dynamically control or determine a variable target pressure, which can vary between a maximum pressure value and a minimum pressure value, which can be set as inputs specified by the operator for the desired negative pressure range. The variable target pressure can also be processed and controlled by the controller 130, which can change the target pressure according to a predetermined waveform such as a triangular waveform, a sine waveform, or a sawtooth waveform. In some embodiments, the waveform can be set by the operator to a predetermined or time-varying negative pressure required for treatment.

[0073] In some embodiments, controller 130 may receive and process data, such as data relating to the infusion solution supplied to tissue interface 120. Such data may include the type of infusion solution prescribed by a clinician, the volume of fluid or solution to be infused into the tissue site (“fill volume”), and the prescribed amount of time the solution remains at the tissue site before negative pressure is applied (“residence time”). The fill volume may be, for example, between 10 mL and 500 mL, and the residence time may be between 1 second and 30 minutes. Controller 130 may also control the operation of one or more components of treatment system 100 to infuse the solution. For example, controller 130 may manage the fluid dispensed from solution source 145 to tissue interface 120. In some embodiments, fluid may be infused into the tissue site by applying negative pressure from negative pressure source 105 to reduce the pressure at the tissue site, thereby aspirating the solution into tissue interface 120. In some embodiments, the solution can be dripped into the tissue site by applying positive pressure from a positive pressure source 150 to move the solution from a solution source 145 to the tissue interface 120. Alternatively or otherwise, the solution source 145 may be raised to a height sufficient to allow gravity to move the solution into the tissue interface 120.

[0074] The controller 130 can also control the hydrodynamic characteristics of the infusion by providing a continuous or 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, thereby achieving a continuous flow rate of the infused solution across the tissue interface 120, or it can be implemented to provide a dynamic pressure operating mode, thereby varying the flow rate of the infused solution across the tissue interface 120. Alternatively, negative pressure can be applied to provide an intermittent operating mode, thereby allowing the infused solution to reside at the tissue interface 120. In intermittent mode, a specific fill volume and residence time can be provided based on, for example, the type of tissue site being treated and the type of dressing used. Negative pressure therapy can be applied after or during the solution infusion. The controller 130 can be used to select the operating mode and duration of negative pressure therapy by infusing more solution before starting another infusion cycle.

[0075] Figure 2 This is an isometric view showing 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 it. Figure 2In the example, the dressing interface 200 includes a connecting member 205 coupled to a negative pressure port 210. The connecting 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, wherein the second peel strength is less than the first peel strength. The dressing interface 200 may also include a tab 235 coupled to the second adhesive region 225.

[0076] 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 a flexible tube, may be fluidly coupled to the conduit housing 245 at one end.

[0077] Figure 3 yes Figure 2 An exploded view of the dressing interface 200 shows additional details that may be associated with a particular embodiment. 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 a circle. The rounded edge 300 and the straight edge 305 define the shape corresponding to the main segment of the circle. That is, the flange 240 may have a straight portion or a flat point. In some embodiments, the straight edge 305 may be parallel to the hinge line 230. In some examples, 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 be positioned along the hinge line 230 without being offset from it. If the second adhesive region 225 is removed from the cover 125 as described herein, the straight edge 305 in the flange 240 allows the negative pressure port 210 to hinge around the hinge line 230. In some embodiments, the flange 240 of the negative pressure port 210 may be sufficiently flexible to allow the flange 240 to fold and bend, such that a portion of the flange 240 can extend across the hinge line 230 without impeding or preventing the hinge of the second adhesive region 225.

[0078] Although flange 240 is described as having a truncated circular shape, in some embodiments, flange 240 may have any suitable shape, such as a circle, triangle, square, rectangle, pentagon, hexagon, octagon, star, oval, polygon, or straight shape. In some embodiments where flange 240 has a shape with at least one straight edge (e.g., triangle, square, rectangle, pentagon, hexagon, octagon), the straight edge may be parallel to or collinear with hinge line 230, as described above with respect to straight edge 305.

[0079] Continue to refer to Figure 3 The connecting member 205 may include a housing layer 310 and a contact layer 315. The housing layer 310 may be formed of any material that allows for a fluid seal. A fluid seal is a seal sufficient to maintain negative pressure at a desired location given a specific negative pressure source or system involved. The housing layer 310 may comprise one or more of the following materials, such as: hydrophilic polyurethane; cellulose; hydrophilic polyamide; polyvinyl alcohol; polyvinylpyrrolidone; hydrophilic acrylic resins; hydrophilic silicone elastomers; or INSPIRE 2301 or 2317 material from Expopack Advanced Coatings, Wrexham, United Kingdom, having a density of 14400 g / m³. 2 24-hour MVTR (inverted cup technology) and approximately 30 microns thick; thin, uncoated polymer sterilization covers; natural rubber; polyisoprene; styrene-butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; polyurethane (PU); EVA film; copolyester; siloxane; silicone sterilization covers; 3M Tegaderm ® Disinfecting drapes; polyurethane (PU) disinfecting drapes available from Avery Dennison Corporation, Pasadena, California; polyether block polyamide copolymers (PEBAX) available from Arkema, France; Expopack 2327; or other suitable materials.

[0080] The outer shell layer 310 can be vapor-permeable and liquid-impermeable. In some embodiments, the outer shell layer 310 can have, for example, a density of at least about 300 g / m³. 2A flexible, breathable membrane, film, or sheet with a high MVTR (volatile matter ratio) of 24 hours. In other embodiments, a low vapor transfer membrane or a vapor transfer-free membrane may be used. The outer shell layer 310 may comprise a range of medically suitable membranes having a thickness between about 15 micrometers (µm) and about 50 micrometers (µm). In some embodiments, the outer shell layer 310 may be formed of the same material as the cover 125. In some embodiments, the outer shell layer 310 may be light-transmitting, transparent, translucent, opaque, and / or colored.

[0081] The outer shell layer 310 may have a first side and a second side. The first side of the outer shell layer 310 may contain an adhesive. The adhesive may be bonded to the first side of the outer shell layer 310. In some embodiments, the adhesive may be applied or deposited onto the first side of the outer shell layer 310. The adhesive may be a medically acceptable adhesive. The adhesive may also be flowable. For example, the adhesive may include acrylic adhesives, rubber adhesives, high-tack or adhesive silicone adhesives, polyurethanes, or other adhesive substances. In some embodiments, the adhesive of the outer shell layer 310 may be a pressure-sensitive adhesive, such as one with a strength of 15 g / m³. 2 (gsm) up to 70 g / m 2 The adhesive is an acrylic adhesive with a coating weight of (gsm). In some embodiments, the adhesive may have a peel strength or resistance to peeling from stainless steel in the range of about 6.4 N to about 8.8 N. In some embodiments, the adhesive may have a peel strength or resistance to peeling from stainless steel in the range of about 7.8 N. Peel strength can be measured by applying a 1-inch (2.54 cm) wide adhesive test strip to a stainless steel plate using a roller. The test strip is then peeled back on itself (at an angle of 180 degrees), and the force required to peel the test strip is measured. The test is performed on a stainless steel substrate at 23°C and 50% relative humidity, based on ASTM D3330. In some embodiments, the adhesive of the outer shell layer 310 may be reduced or deactivated using ultraviolet light. Ultraviolet light may be applied to the outer shell layer 310, and the ultraviolet light may reduce the peel strength of the adhesive by a sufficient amount to allow removal of the dressing interface 200 from the cover 125 without damaging or destroying the cover 125.

[0082] The outer shell layer 310 also includes an opening 320. In some embodiments, the opening 320 may be centrally located within the outer shell layer 310. The size or dimensions of the opening 320 may be designed to receive the conduit housing 245 of the negative pressure port 210. In some embodiments, the shape of the opening 320 may be co-located with or consistent with the shape of the conduit housing 245 at the junction of the conduit housing 245 and the flange 240. In other embodiments, the size of the opening 320 in the outer shell layer 310 may be larger than the size of the conduit housing 245 at the junction of the conduit housing 245 and the flange 240. In some embodiments, the shape of the opening 320 may differ from the shape of the conduit housing 245 at the junction of the conduit housing 245 and the flange 240. The top side of the flange 240 of the negative pressure port 210 may be bonded to the first side of the outer shell layer 310 by an adhesive on the first side of the outer shell layer 310 to form a fluid seal around the flange 240. In some embodiments, the housing layer 310 may also include a tab 325 located on the periphery of the housing layer 310 on the side of the second adhesive region 225 of the hinge line 230.

[0083] In some embodiments, contact layer 315 may have a first side and a second side. The second side of contact layer 315 may be coupled to the first side of housing layer 310. Contact layer 315 may contain an adhesive. For example, contact layer 315 may be a soft, flexible material suitable for providing a fluid seal with cover 125, as described herein. For example, contact layer 315 may contain silicone gel, soft silicone, aqueous colloid, hydrogel, polyurethane gel, polyolefin gel, hydrogenated styrene copolymer gel, foamed gel, soft closed-cell foam such as polyurethane and polyolefin coated with adhesive, polyurethane, polyolefin, hydrogenated styrene copolymer, or adhesive-coated film, membrane, or sheet. Contact layer 315 may be composed of a hydrophobic or hydrophilic material. In some embodiments, contact layer 315 may be translucent, transparent, translucent, opaque, and / or colored. Contact layer 315 may have a thickness between about 500 micrometers (µm) and about 1000 micrometers (µm). In some embodiments, contact layer 315 has a hardness between about 5 Shore 00 and about 80 Shore 00. In some embodiments, 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, 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, contact layer 315 has a peel strength of about 0.4 N. In some embodiments, for example, contact layer 315 has a peel strength of about 0.8 N. In some embodiments, for example, contact layer 315 has a peel strength of about 0.9 N. In some embodiments, for example, contact layer 315 has a peel strength of about 2.8 N. The peel strength of contact layer 315 may be less than the peel strength of the adhesive of housing layer 310.

[0084] In some embodiments, the ratio of the peel strength of the contact layer 315 to the peel strength of the adhesive of the outer shell layer 310 may be about 1:2. In some embodiments, the ratio of the peel strength of the contact layer 315 to the peel strength of the adhesive of the outer 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 peel strength of the adhesive of the outer 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 peel strength of the adhesive of the outer 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 peel strength of the adhesive of the outer shell layer 310 may be about 1:8. In some embodiments, the ratio of the peel strength of the contact layer 315 to the peel strength of the adhesive of the outer 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 peel strength of the adhesive of the outer shell layer 310 may be about 1:11. In some embodiments, the ratio of the peel strength of the contact layer 315 to the peel strength of the adhesive of the outer shell layer 310 may be about 1:14.5. In some embodiments, the ratio may be about 1:17.3. In some embodiments, the ratio may be about 1:19.5. In some embodiments, the ratio may be about 1:20. In some embodiments, the ratio may be about 1:23.8. In some embodiments, the ratio 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 outer shell layer 310 may be in the range of about 1:2 to about 1:25.

[0085] The contact layer 315 may also include an opening 330 located in the second adhesive region 225. The size or dimension of the opening 330 may be designed to receive the flange 240 of the negative pressure port 210 therein. In some embodiments, the shape of the opening 330 may be co-linear with or consistent with the shape of the flange 240 of the negative pressure port 210. In embodiments where 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 may be parallel to the hinge line 230 in the connecting member 205. For example, the straight edge 305 may be parallel to the hinge line 230, but may be offset a distance from the hinge line 230 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 be positioned 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 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. Therefore, the flange 240 may be thicker than the contact layer 315.

[0086] The contact layer 315 may also include a plurality of openings 335. The plurality of openings 335 may be formed by cutting, perforating, punching, or by other suitable techniques for forming openings, openings, perforations, or holes in the contact layer 315, including but not limited to using single-blade or multi-blade cutters, lasers, waterjet, hot cutters, computer numerical control (CNC) cutters, hot wire, local RF or ultrasonic energy, and / or single-punch or multi-punch tools. The plurality of openings 335 in the contact layer 315 may have a variety of shapes, including but not limited to circular, triangular, rectangular, square, pentagonal, hexagonal, octagonal, oval, elliptical, star-shaped, polygonal, slit, complex curved, and straight shapes, or combinations thereof.

[0087] The contact layer 315 may also include a tab 340 located on the periphery of the contact layer 315 on the side of the second adhesive region 225 of the hinge line 230. The tab 340 of the contact layer 315 and the tab 325 of the outer shell layer 310 may cooperate to form the tab 235 of the connecting member 205.

[0088] Figure 4 A top view of the dressing interface 200 assembled and attached to the cover 125 is shown. Figure 4As shown, 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 located 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 located on a second side of the hinge line 230 opposite to the first side (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 width of each of the first plurality of openings 400 and the second plurality of openings 405 may define the area of ​​each of the first plurality of openings 400 and the second plurality of openings 405. For example, where the plurality of openings 405 are circular... Figure 4 As shown in the example, the diameter D1 of each of the first plurality of openings 400, and therefore the opening area, 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 may range from about 4 mm to about 15 mm. In some embodiments, the diameter D1 of the first plurality of openings 400 may range from about 5 mm to about 10 mm. In some embodiments, the diameter D1 of the first plurality of openings 400 may be about 10 mm. For example, in some embodiments, the diameter D2 of the second plurality of openings 405 may range from about 1 mm to about 10 mm. In some embodiments, the diameter D2 of the second plurality of openings 405 may range from about 2 mm to about 7 mm. In some embodiments, the diameter D2 of the second plurality of openings 405 may be about 5 mm.

[0089] Although each of the first plurality of openings 400 is shown to have the same diameter D1, and each of the second plurality of openings 405 has the same diameter D2, it should be understood that in other embodiments, the openings of the first plurality of openings 400 may have different sizes (and therefore opening areas), and the openings of the second plurality of openings 405 may have different sizes (and therefore opening areas). For example, the first plurality of openings 400 may have openings with two or more opening areas that cooperate to form the total opening area of ​​the first adhesive region 220. Similarly, the second plurality of openings 405 may have openings with two or more opening areas that cooperate to form the total opening area of ​​the second adhesive region 225. Thus, much like the different diameters of the dimples on a golf ball, in some embodiments, the sizes of the openings in the first plurality of openings 400 may vary, and the sizes of the openings in the second plurality of openings 405 may vary.

[0090] The first plurality of openings 400 are shown to have a circular shape; however, in other embodiments, the first plurality of openings 400 may have a variety of shapes, including but not limited to triangles, rectangles, squares, pentagons, hexagons, octagons, ovals, ellipses, stars, polygons, slits, complex curves, straight lines, or combinations of some shapes. Additionally, the second plurality of openings 405 are shown to have a circular shape; however, in other embodiments, the second plurality of openings 405 may have a variety of shapes, including but not limited to triangles, rectangles, squares, pentagons, hexagons, octagons, ovals, ellipses, stars, polygons, slits, complex curves, straight lines, or combinations of some shapes.

[0091] Figure 5 It was cut along section line 5-5. Figure 4 The cross-section of the dressing interface 200 shows additional details that may be associated with some embodiments. For example, when assembling the dressing interface 200, the flange 240 of the negative pressure port 210 may be located below the outer shell layer 310, and the conduit housing 245 may extend upward through the opening 320 in the outer shell layer 310. The second side of the contact layer 315 may be bonded to the first side of the outer shell layer 310 by an adhesive on the first side of the outer shell layer 310. Additionally, the flange 240 of the negative pressure port 210 may be located in the opening 330 of the contact layer 315. The opening 320 in the outer shell layer 310 and the opening 330 in the contact layer 315 may mate to form the opening 215 in the connecting member 205. Figure 5 As further shown, the dressing interface 200 can then be placed on top of the cover 125 such that the conduit housing 245 of the negative pressure port 210 is positioned above the opening 500 in the cover 125, and the fluid conductor 250 is fluidly connected to 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 above the outer shell layer 310. For example, the bottom side of the flange 240 may be adhered to a second side or top side of the outer shell layer 310 to form a fluid seal.

[0092] Figure 6 and Figure 7 yes Figure 5 A detailed view of the feature portion in the example. Figure 6 and Figure 7In this configuration, the outer shell layer 310 may extend or be compressed through a plurality of openings 335 to contact the cover 125 for securing the dressing interface 200 to, for example, the cover 125. The plurality of openings 335 provide sufficient contact between the outer shell layer 310 and the cover 125 to secure the dressing interface 200 to the cover 125. The dimensions of the plurality of openings 335 may be designed to control the amount by which the outer shell layer 275 extends through the plurality of openings 335 in the contact layer 315 to reach the cover 125. Therefore, the configuration of the plurality of openings 335, the outer shell layer 310, and the contact layer 315 allows for the release and repositioning of the dressing interface 200 on the cover 125. At least a portion of the outer 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 outer shell layer 310 may extend at least partially through a first plurality of openings 400 in the contact layer 315 (see...). Figure 6 ), and at least a second portion of the outer casing layer 310 may extend at least partially through the second plurality of openings 405 in the contact layer 315 (see Figure 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, thereby allowing more housing layers to contact the cover 125 at each of the first plurality of openings 400 compared to the housing layer 310 which can contact the cover 125 at each of the second plurality of openings 405. This creates two distinct bonding regions: a first bonding region 220 and a second bonding region 225, wherein the two bonding regions are located on opposite sides of the hinge line 230. The first bonding region 220 may be formed by a first portion of the contact layer 315 adjacent to the first plurality of openings 400 and an extension of the housing layer 310 through the first plurality of openings 400. The second bonding region 225 may be formed by a second portion of the contact layer 315 adjacent to the second plurality of openings 405 and an extension of the housing layer 310 through the second plurality of openings 405. The peel strength of the outer shell layer 310, the amount of the outer shell layer 310 extending through the first plurality of openings 400 and contacting the cover 125, and the peel strength of the contact layer 315 contacting the cover 125 combine to produce a first region peel strength. Similarly, the peel strength of the outer shell layer 310, the amount of the outer shell layer 310 extending through the second plurality of openings 405 and contacting the cover 125, and the peel strength of the contact layer 315 contacting the cover 125 combine to produce a second region peel strength. The first region peel strength is higher than the second region peel strength. Therefore, the connecting member 205 may have a first region peel strength in the first adhesive region 220 and a second region peel strength in the second adhesive region 225.

[0093] The peel strength of the second region of the second adhesive region 225 is low enough to allow removal of the second adhesive region 225 from the cover 125 without damaging or destroying the cover 125. Additionally, in some examples, 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 serve as an anchor to hold the dressing interface 200 to the cover 125.

[0094] Figure 8 yes Figure 2 A front view of the dressing interface 200. A pull tab 235 is provided to remove the second adhesive area 225 from the cover 125. In some embodiments, the pull tab 235 is pullable to completely remove the dressing interface 200 from the cover 125. In some embodiments, the pull tab 235 is non-adhesive, allowing it to be easily lifted and pulled to remove part or all of the dressing interface 200 from the cover 125. In other embodiments, the pull tab 235 may comprise a low-peel-stretch adhesive configured to retain the pull tab 235 attached to the cover 125, preventing it from being unintentionally pulled by snagging on clothing, medical devices, other people, or other objects. The pull tab 235 removes the second adhesive region 225 of the connecting member 205 from the cover 125, such that the second adhesive region 225 is hinged or rotated about the hinge line 230 relative to the first adhesive region 220 of the connecting member 205 (as shown by curve A), wherein the first adhesive region 220 remains adhered to the cover 125. The negative pressure port 210 may also be located in the second adhesive region 225 and may also be hinged or rotated about the hinge line 230. The second plurality of openings 405 may also be hinged or rotated about the hinge line 230. By positioning the negative pressure port 210 in the second adhesive region 225, the underside of the negative pressure port 210 and the interior of the catheter housing 245 can be inspected and / or accessed to remove exudates, blockages, and / or other materials from the interior of the negative pressure port 210 and / or the catheter housing 245, or otherwise clean the interior of the negative pressure port and / or the catheter housing. This cleaning can be performed without damaging or destroying the cover 125, the tissue interface 120, or the tissue site. Once the negative pressure port 210 is cleaned, the second adhesive area 225 can be reattached to the cover 125 and negative pressure therapy can be resumed.

[0095] Several factors can be used to control the first and second area peel strength of the dressing interface 200, including but not limited to the area and number of the first plurality of openings 400 and the second plurality of openings 405 in the contact layer 315, the thickness of the contact layer 315, the thickness and amount of adhesive on the outer shell layer 310, the peel strength of the adhesive on the outer shell layer 310, and the peel strength of the contact layer 315. An increase in the amount of adhesive extending through the plurality of openings 335 of the outer shell layer 310 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 extending through the plurality of openings 335 of the outer shell layer 310. Therefore, for example, the diameter and configuration of the first plurality of openings 400 and the second plurality of openings 405, the amount and peel strength of the adhesive on the outer shell layer 310, the thickness of the contact layer 315, and the peel strength of the contact layer 315 utilized can be varied to provide the dressing interface 200 with the desired first and second area peel strength.

[0096] Figure 9 and Figure 10 This is a top view of the dressing interface 200, showing additional details that may be associated with certain embodiments. While the hinge line 230 of various embodiments of the dressing interface 200 is described and shown as straight, in some embodiments, the hinge line 230 may be non-linear (e.g., curved, arcuate, wavy, serrated). 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 tangential to the flange 240. Figure 9 In the exemplary embodiment shown, the hinged wire 230 bends toward the negative pressure port 210. The connecting member 205 includes a periphery 900, and the hinged wire 230 has a first endpoint 905 on the periphery 900 and a second endpoint 910 on the periphery 900. An imaginary line 915 can be drawn from the first endpoint 905 to the second endpoint 910, and no portion of the imaginary line 915 intersects with the flange 240 of the negative pressure port 210. Therefore, in Figure 10 In the exemplary embodiment shown, where the hinge line 230 bends away from the negative pressure port 210, the second adhesive area 225 can rotate around the hinge line 230 as long as the imaginary line 915 extending from the first end point 905 to the second end point 910 does not intersect the flange 240, and the user can easily access the interior of the conduit housing 245 of the negative pressure port 210.

[0097] Figure 11 This is an exploded view of an exemplary configuration of multiple openings 335, illustrating additional details that can be associated with some embodiments of the dressing interface 200. Figure 11In the example, the dressing interface 200 includes a coupling member 205 configured to connect to a negative pressure port 210. The coupling member 205 may include a housing layer 310, a contact layer 315, and tabs 235. The housing layer 310 may also include an opening 320 through which the conduit housing 245 of the negative pressure port 210 is configured to extend. The contact layer 315 has an opening 330 for receiving a flange 240 of the negative pressure port 210, and a plurality of openings 335. Figure 11 As shown, flange 240 may be circular and may not include... Figures 2 to 5 The straight edge 305 is shown. In some embodiments, the flange 240 may include the straight edge 305. Additionally, Figure 11 The example of contact layer 315 shown includes only a single set of multiple openings 335. In some embodiments, for example, the single set of multiple openings 335 may be a second set of multiple openings 405. Thus, in some embodiments, the dressing interface 200 may have only a single adhesive area with a single area peel strength. By including only a second set of multiple openings 405, the entire dressing interface 200 can be removed from the cover 125 without damaging or destroying the cover 125.

[0098] Figure 12 yes Figure 11 The front view of the dressing interface 200 shown illustrates complete removal of the dressing interface 200 from the cover 125 along line B without damaging or destroying the cover 125 or tissue interface 120. However, it should be understood that less than the entire dressing interface 200 can also be removed from the cover 125 without damaging or destroying the cover 125. The dressing interface 200 can be reattached by pressing down along line B.

[0099] Figure 13 This is an exploded view of another exemplary construction of the dressing interface 200, illustrating additional details that may be associated with some embodiments of the dressing interface 200. Figure 13 In the example, the dressing interface 200 includes a coupling member 205 configured to connect to a negative pressure port 210. The coupling member 205 may include a housing layer 310, a contact layer 315, and a tab 235. The housing layer 310 may also include an opening 320 through which the conduit housing 245 of the negative pressure port 210 is configured to extend. The contact layer 315 includes an opening 330 for receiving a flange 240 of the negative pressure port 210. Figure 13 As shown, flange 240 may be circular and may not include... Figures 2 to 5 The straight edge 305 is shown. Furthermore, with... Figures 2 to 8 and Figure 11 The example shown has a contact layer 315 with multiple openings 335, which is different. Figure 13The example of contact layer 315 shown lacks multiple openings 335. In some embodiments, the dressing interface 200 may have only a single adhesive region with a single area peel strength, wherein the single area peel strength is defined by the peel strength of contact layer 315. In the case of low peel strength of contact layer 315, the entire dressing interface 200 can be removed from cover 125 without damaging or destroying cover 125. In some embodiments, for example, contact layer 315 has a peel strength in the range of about 0.44 N to about 3.1 N. In some embodiments, for example, contact layer 315 may comprise or consist essentially of a silicone adhesive having a peel strength of about 2.8 N.

[0100] Figure 14 and Figure 15 This is a front view of the dressing interface 200 and the cover 125, showing additional details that can be associated with some embodiments of the dressing interface 200. Figure 14 and Figure 15 In some examples, the connecting member 205 of the dressing interface 200 may comprise a stretch-release adhesive. In some examples, the stretch-release adhesive may be COMMAND brand adhesive, commercially available from 3M Company of Minneapolis, Minnesota. The tab 235 of the connecting member 205 may be pulled along line C in a direction substantially parallel to the connecting member 205 to remove the dressing interface 200 from the cover 125. When the tab 235 is pulled along line C, the stretch-release adhesive of the connecting member 205 is stretched and thinned, which reduces the peel force of the stretch-release adhesive until the connecting member 205 is lifted away from the cover 125, as shown by line D. In some embodiments, the connecting member 205 may be perforated or cut along the hinge line 230 such that the perforation can be broken when the tab 235 is pulled, and the portion of the connecting member 205 on one side of the tab 235 of the hinge line 230 can be removed, leaving the portion of the connecting member 205 on the opposite side of the hinge line 230 intact and attached to the cover 125. In such embodiments, a new stretch-release adhesive portion can be provided, and the dressing interface 200 can be reapplied to the cover 125. In some embodiments, the connecting member 205 may be perforated or cut along the hinge line 230 and may include tabs 235 on each side of the hinge line 230 such that each side of the connecting member 205 can be independently removable. In other embodiments, the contact layer 315 may contain a stretch-release adhesive that can be independently removed from the housing layer 310. After stretching the contact layer 315 to remove it from the cover 125 and the outer shell 310, a new contact layer 315 can be applied to the outer shell 310, and the dressing interface 200 can be reapplied.

[0101] Figure 16 This is an isometric view of another exemplary construction of the dressing interface 200, showing additional details that may be associated with some embodiments of the dressing interface 200. Figure 15 In the example, the dressing interface 200 includes a plurality of perforations 1600 in the outer shell layer 310 aligned with at least a portion of the first plurality of openings 400. Over time, the adhesion between the dressing interface 200 and the cover 125 can increase in the first adhesive region 220, and thus the first adhesive region provides greater resistance to removal. Additionally, applying heat can increase the adhesive strength of the adhesive on the outer shell layer 310. Therefore, the perforations 1600 can be configured to allow liquid to be drawn through the plurality of perforations 1600, such that the liquid comes into contact with the adhesive on the outer shell layer 310. The liquid then interacts with the adhesive on the outer shell layer 310 to reduce the peel strength of the adhesive on the outer 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 a prolonged period. In some embodiments, the liquid may be alcohol, such as isopropyl alcohol. For example, a user can apply a small amount of isopropyl alcohol to the outer shell layer 310 via an readily available alcohol wipe. Isopropyl alcohol is then aspirated through the perforations 1600 and will soften the adhesive of the outer shell layer 310 for a period of approximately 2 to 3 minutes, thereby reducing the peel strength of the adhesive of the outer shell layer 310. The dressing interface 200 can then be removed from the cover 125. After removal, the isopropyl alcohol will evaporate, and the peel strength of the adhesive of the outer shell layer 310 will return to only slightly less than its initial level (approximately 80%), thereby allowing the dressing interface 200 to re-adhere to the cover 125. In some embodiments, the perforations 1600 may include slits, slots, fenestrations, or other openings that allow liquid to flow from above the outer shell layer 310 to the adhesive of the outer shell layer 310. The perforations 1600 do not adversely affect the seal or integrity of the tissue site because the perforations 1600 are located sufficiently far from the pneumatic or fluid connection to the tissue site in the first adhesive area.

[0102] Figure 17 and Figure 18 This is a top view of the dressing interface 200 and the cover 125, which shows in more detail the ability of the dressing interface 200 to move. Figure 17 As shown in the example, the dressing interface 200 is in its initial position on the cover 125. If it is necessary to move the dressing interface 200 for a specific reason, the dressing interface 200 can be removed and placed as shown in the example. Figure 18The second location is shown. This can be achieved without removing the cover 125 and the underlying tissue interface 120 from the patient's tissue site. A new opening can be cut through the cover 125, and the dressing interface 200 can be sealed over the new opening to fluidly connect the fluid conductor 250 to that opening. Figure 18 As shown, the opening 500 in the cover 125 can be sealed by the patch 1800. The patch 1800 can be made of the same material as the cover 125. Negative pressure therapy can be restored when the dressing interface 200 is located at a second position on the cover 125 and the opening 500 is sealed.

[0103] Figure 19 This is a segmented isometric view of the bottom section of another exemplary construction of the dressing interface 200, showing additional details that can be associated with some embodiments. For example... Figure 19 As shown, in some embodiments, the dressing interface 200 may include a bridging element 1900, which may typically have a thin profile. The bridging element 1900 may be configured to fluidly connect the negative pressure source 105 to the therapeutic environment of the dressing 110. Figure 19 The bridging element 1900 is substantially flat and flexible, and may also be compressible without obstructing or blocking the fluid pathway between the fluid conductor 250 and the tissue interface 120. In some embodiments, the dressing interface 200 may include an applicator 1905 adapted to be positioned in fluid communication with the tissue interface 120. The bridging element 1900 may be fluidly coupled to the applicator 1905 and extend to the negative pressure port 210. The bridging element 1900 may have a substantially flat profile, and the negative pressure port 210 may be configured to fluidly couple the bridging element 1900 to a tube or other circular fluid conductor, such as the fluid conductor 250. In some embodiments, Figure 19 The dressing interface 200 may have a length ranging from about 15 cm to about 30 cm. In some embodiments, the bridging element 1900 and the applicator 1905 may be formed as a single device as shown. In other embodiments, the bridging element 1900 and the applicator 1905 may be separate components joined together to form a single device. In yet another embodiment, the bridging element 1900 and the applicator 1905 may be separate components that can be used independently of each other as individual components in the treatment system 100.

[0104] like Figure 19 As further shown, depending on the size and nature of the tissue site, the applicator 1905 can be spherical, circular, or any shape suitable for applying treatment to the tissue interface 120. Figure 19In the example, the bridging element 1900 is generally long and narrow. In some exemplary embodiments, the bridging element 1900 and the applicator 1905 may include a top layer such as a first layer 1915 and a base layer such as a second layer 1920. The second layer 1920 may be coupled to the first layer 1915 around the periphery of the first layer 1915 to form a closed space within the dressing interface 200. The closed space may be formed between the first layer 1915 and the second layer 1920 of both the bridging element 1900 and the applicator 1905. In some embodiments, the closed space may be sealed along the periphery of the bridging element 1900, the applicator 1905, or both. Both the first layer 1915 and the second layer 1920 may be formed of or comprise a polymer film. The first layer 1915 and the second layer 1920 may be coupled around the periphery of the dressing interface 200 by welding (RF welding or ultrasonic welding), heat sealing, or adhesive bonding, such as acrylic adhesives or curing adhesives, to form the closed space. For example, the first layer 1915 and the second layer 1920 may be welded together around the periphery of the dressing interface 200, and a flange 1925 may be formed around the periphery of the dressing interface 200 due to the welding. Those skilled in the art will understand that there are various methods for joining the first layer 1915 and the second layer 1920 to form a closed space within the dressing interface 200.

[0105] Figure 19 The bridging element 1900 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 bridging element 1900 adjacent to the negative pressure port 210 into the applicator 1905 to form at least two closed spaces or fluid passages 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 bridging element 1900 adjacent to 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 interposed 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 include welded components (RF welded components or ultrasonic welded components), heat-sealed components, adhesive bonding components, or any combination thereof. In those embodiments that include two walls (e.g., the first wall 1930 and the second wall 1935), such embodiments may form three enclosed spaces or fluid passages within the enclosed space between the first layer 1915 and the second layer 1920. In some embodiments, two of the fluid passages may be dedicated to measuring pressure. For example, in Figure 19In the example, the first pressure sensing path 1940 and the second pressure sensing path 1945 (as indicated by the dashed arrow) can be configured as feedback paths. A third fluid path, such as the negative pressure path 1950 (as indicated by the dashed arrow), can be used to provide negative pressure.

[0106] In some exemplary embodiments, the first pressure sensing passage 1940, the negative pressure passage 1950, and the second pressure sensing passage 1945 may be fluidly coupled to the fluid conductor 250 via the negative pressure port 210. For example, the negative pressure passage 1950 may be fluidly coupled to the fluid conductor 250 such that the negative pressure passage 1950 is used to deliver negative pressure to the tissue interface 120. The first pressure sensing passage 1940 and the second pressure sensing passage 1945 may be fluidly coupled to the fluid conductor 250. In other embodiments, both the first pressure sensing passage 1940 and the second pressure sensing passage 1945 may 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 passage 1940, the negative pressure passage 1950, and the second pressure sensing passage 1945 may terminate within an applicator 1905 and may be fluidly coupled to each other within the applicator 1905 for delivering and sensing negative pressure associated with the tissue interface 120.

[0107] The applicator 1905 may include an opening or aperture 1955 in a second layer 1920 adapted to fluidly connect the enclosed space of the dressing interface 200 to the tissue interface 120. The aperture 1955 of the applicator 1905, together with portions of the first layer 1915 and the second layer 1920, may define a recessed space 1960 within the enclosed space of the applicator 1905, wherein the recessed space 1960 is adapted to fluidly communicate with the tissue interface 120 in use. The portion of the recessed space 1960 covered by the second layer 1920 of the applicator 1905 may be referred to as the covered space. In some embodiments, the first wall 1930 and the second wall 1935 may extend only partially into the recessed space 1960, such that the ends of the first wall 1930 and the second wall 1935 are exposed through the aperture 1955. A first pressure sensing passage 1940 and a second pressure sensing passage 1945 may be in fluid communication with the recessed space 1960. The negative pressure passage 1950 may also be in fluid communication with the recessed space 1960 and may be adapted to deliver negative pressure to the tissue interface 120 through the recessed space 1960. In some exemplary embodiments (not shown), the first wall 1930 and the second wall 1935 may extend beyond the opening 1955, such that a smaller portion of the first pressure sensing passage 1940 and the second pressure sensing passage 1945 is exposed to the negative pressure delivered to the tissue interface 120 by the negative pressure passage 1950, in order to avoid blockage and / or clogging from the tissue site.

[0108] The dressing interface 200 may also include means for supporting the fluid path under pressure. In some embodiments, the support means may include multiple support features disposed in the fluid path, such as flexible protrusions, legs, nodes, cells porous textile, porous foam, or combinations of features. For example, Figure 19 The dressing interface 200 includes multiple support members 1965. Figure 19 The support member 1965 can be generally characterized as a bubble having a bottom portion extending from the first layer 1915 and a top portion extending within the enclosed space toward the second layer 1920 beyond the recessed space 1960. Within the recessed space 1960, the top portion of the support member 1965 extending from the first layer 1915 may extend toward the tissue interface 120 and may be adapted to directly contact the tissue interface 120 in use, or may be positioned above the tissue interface 120. Features such as the support member 1965 may provide cushioning to help prevent the enclosed space of the dressing interface 200 from collapsing due to external forces. In some exemplary embodiments, the top portion of the support member 1965 may contact the second layer 1920, and in some other exemplary embodiments, the top portion of the support member 1965 may be coupled to the second layer 1920.

[0109] like Figure 19 As further shown, in some embodiments, the dressing interface 200 may also include a connecting member 205 for releasably connecting the applicator 1905 to the dressing 110. A housing layer 310 of the connecting member 205 may be coupled to the dressing interface 200 such that the housing layer 310 is located between the contact layer 315 and the second layer 1920 of the dressing interface 200. The connecting member 205 may be located on the applicator 1905, wherein an opening 330 of the connecting member 205 is configured to be in fluid communication with an opening 1955. In some embodiments, the opening 330 may coincide with the opening 1955. In some embodiments, in addition to the first side of the housing layer 310 containing the adhesive as described above, the second side of the housing layer 310 may also contain adhesive such that the housing layer 310 is connectable to the second layer 1920 of the dressing interface 200. In some embodiments, the adhesive may be applied to the second layer 1920 of the dressing interface 200 to connect the housing layer 310 to the dressing interface 200.

[0110] In some embodiments, the outer shell layer 310 may be omitted from the connecting member 205, and the adhesive may be applied or deposited onto the second layer 1920 of the dressing interface 200. In such embodiments, the second layer 1920 of the dressing interface 200 may serve as the outer shell layer 310. The adhesive may be a medically acceptable adhesive. The adhesive may also be flowable. For example, the adhesive may include acrylic adhesives, rubber adhesives, high-viscosity or adhesive silicone adhesives, polyurethanes, or other adhesive substances. In some embodiments, the adhesive of the second layer 1920 may be a pressure-sensitive adhesive, such as one having a strength of 15 g / m³. 2 (gsm) up to 70 g / m 2 An acrylic adhesive with a coating weight of (gsm). In some embodiments, the adhesive may have a peel strength or resistance to peeling from stainless steel materials in the range of about 6.4 N to about 8.8 N. In some embodiments, the adhesive may have a peel strength of about 7.8 N or resistance to peeling from stainless steel materials. In some embodiments, the adhesive of the second layer 1920 may be reduced or deactivated by 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 a sufficient amount to allow removal of the dressing interface 200 from the cover 125 without damaging or destroying the cover 125.

[0111] Figure 20 It is possible to be with Figure 1 Some exemplary embodiments of the treatment system 100 are associated with Figure 19 The segmented isometric view of the top of the dressing interface 200. (See also:) Figure 20 As shown, in some embodiments, the connecting member 205 may be configured to releasably connect the negative pressure port 210 to the bridging member 1900. The connecting member 205 may be used to connect the negative pressure port 210 to the first layer 1915. In some embodiments, the dressing interface 200 includes a first connecting member 205 on the applicator 1905 and a second connecting member 205 on the bridging member 1900. In some embodiments, the dressing interface 200 includes the connecting member 205 on the applicator 1905 but not the connecting member on the bridging member 1900. In some embodiments, the dressing interface 200 includes the connecting member 205 on the bridging member 1900 but not the connecting member on the applicator 1905.

[0112] Although the plurality of openings 335 are shown as circular, in other embodiments, the plurality of openings 335 may include elongated openings such as slots, which are partially located in the first adhesive region 220 and extend across the hinge line 230 into the second adhesive region 225. The portion of the elongated opening in the first adhesive region 220 may have a larger opening area than the portion of the elongated opening in the second adhesive region 225. In some embodiments, for example, the elongated opening may have a wider opening portion in the first adhesive region 220 and a narrower opening portion in the second adhesive region 225.

[0113] Therefore, the dressing interface 200 can be used to perform a method of treating a tissue site with negative pressure. This method may include applying the tissue interface 120 to the tissue site, applying a cover 125 to the patient's epidermis to form a fluid seal over the tissue interface 120, attaching the dressing interface 200 to a first location on the cover 125, fluidly attaching 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 granulation tissue development. 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 obstructions 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 location on the cover 125, wherein the second location is different from the first location. In some embodiments, the method may further include cleaning or removing any obstructions 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.

[0114] The systems, apparatus, and methods described herein offer significant advantages. For example, dressing interface 200 can be removed, replaced, or repositioned to quickly and effectively resolve connectivity issues without damaging or destroying cover 125. The ability to reposition negative pressure port 210 onto cover 125 using dressing interface 200 reduces troubleshooting time and avoids the need for a complete replacement of dressing 110. Dressing interface 200 also avoids the need for a complete replacement of negative pressure port 210, tissue interface 120, and / or cover 125, thereby reducing the cost of a brand new dressing 110. Therefore, treatment interruptions caused by removing the entire dressing 110 can be reduced.

[0115] The systems, apparatus, and methods described herein also offer additional significant advantages. For example, if the negative pressure port 210 becomes blocked, the dressing interface 200 can be easily peeled off or lifted, and the negative pressure port 210 can be cleaned. Additionally, topical medication can be applied more easily when the negative pressure port 210 is peeled off. After cleaning and / or application of medication, the second adhesive area 225 of the dressing interface 200 can then be pressed back onto the cover 125 to reseal the negative pressure port 210 to the cover, and treatment can be resumed, all without damaging or destroying the cover 125. Furthermore, in some embodiments, the entire dressing interface 200 can be removed and repositioned without damaging or destroying the cover 125. In some cases, it may be necessary to change the position of the negative pressure port 210 on the cover 125 when a more suitable location exists on the dressing 110 after initial placement, where gravity can accommodate more fluid. Additionally, the dressing interface 200 and the negative pressure port 210 can withstand some dragging or pulling forces without damaging or destroying the cover 125. In the event of a leak, the dressing interface 200 also avoids the need to completely replace the negative pressure port 210. That is, if a leak occurs, the dressing interface 200 can be peeled off or lifted and placed back onto the cover 125 to reseal the negative pressure port 210 onto the cover 125.

[0116] Although illustrated in several exemplary embodiments, those skilled in the art will recognize that the systems, apparatuses, and methods described herein are readily adaptable to various changes and modifications, and that such changes and modifications fall within the scope of the appended claims. Furthermore, descriptions using various alternative terms such as “or” need not be mutually exclusive unless the context explicitly requires it, and the indefinite articles “a” or “an” do not limit the subject matter to a single instance unless the context explicitly requires it. Components may also be combined or eliminated in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, dressing 110, container 115, or both may be eliminated or manufactured or sold separately from other components. In other exemplary configurations, controller 130 may also be manufactured, configured, assembled, or sold independently of other components.

[0117] The appended claims set forth the novel and inventive aspects of the subject matter described above, but the claims may also cover additional subject matter not specifically referenced. For example, if it is not necessary to distinguish between novel and inventive features and features known to a person skilled in the art, certain features, elements, or aspects may be omitted from the claims. Without departing from the scope of the invention as defined by the appended claims, features, elements, and aspects described herein in the context of some embodiments may also be omitted, combined, or replaced by alternative features for the same, equivalent, or similar purposes.

Claims

1. A dressing interface for connecting a negative pressure source to a dressing, the dressing interface comprising: A connecting member configured to connect to a cover of the dressing, the connecting member comprising: Including the contact layer of the first opening; A housing layer, the housing layer being connected to the contact layer and configured to be opposite the cover, the housing layer having a second opening; A first adhesive region having a first region peel strength; A second adhesive region having a second region peel strength that is less than that of the first region; A hinge line between the first adhesive area and the second adhesive area, wherein the first adhesive area is located on a first side of the hinge line and the second adhesive area is located on a second side of the hinge line, the second side being opposite to the first side; and A third opening formed by the first opening and the second opening, the third opening being located in the second adhesive region on the second side of the hinge line; and A negative pressure port, used to deliver negative pressure, includes: A flange, the flange being coupled to the outer shell layer and located in the first opening of the contact layer; and A conduit housing, which is coupled to the flange and extends through the third opening in the outer shell layer.

2. The dressing interface of claim 1, wherein the contact layer includes a plurality of fourth openings; and the outer shell layer is configured to extend at least partially through the plurality of fourth openings in the contact layer.

3. The dressing interface of claim 2, wherein at least one of the plurality of fourth openings is located in the first adhesive region and extends across the hinge line into the second adhesive region.

4. The dressing interface according to claim 2, wherein the plurality of fourth openings further includes: Multiple fifth openings; and Multiple sixth openings.

5. The dressing interface of claim 4, wherein the outer shell layer is configured to extend at least partially through the plurality of fifth openings to form the first adhesive region, and the outer shell layer is configured to extend at least partially through the plurality of sixth openings to form the second adhesive region.

6. The dressing interface according to claim 4, wherein: The first adhesive region is configured to be formed by a first portion of the contact layer adjacent to the plurality of fifth openings and an extension of the outer shell layer through the first portion of the plurality of fifth openings; as well as The second adhesive region is configured to be formed by a second portion of the contact layer adjacent to the plurality of sixth openings and an extension of the outer shell layer through the second portion of the plurality of sixth openings.

7. The dressing interface according to any one of claims 4 to 6, wherein each of the plurality of fifth openings has a first opening area, and each of the plurality of sixth openings has a second opening area, and the second opening area is smaller than the first opening area.

8. The dressing interface according to any one of claims 1 to 6, wherein the hinge line is straight.

9. The dressing interface according to any one of claims 1 to 6, wherein the hinge line is curved.

10. The dressing interface according to any one of claims 1 to 6, wherein no portion of the hinge line intersects with the third opening.

11. The dressing interface according to any one of claims 1 to 6, wherein the connecting member further comprises a periphery, and the hinge line has a first endpoint on the periphery and a second endpoint on the periphery, and wherein a line extending from the first endpoint to the second endpoint does not intersect the third opening.

12. The dressing interface according to any one of claims 1 to 6, wherein the hinge line is tangent to the third opening.

13. The dressing interface according to any one of claims 4 to 6, wherein the negative pressure port and the plurality of sixth openings are configured to rotate about the hinge line.

14. The dressing interface of claim 1, wherein the flange has a truncated circular shape to form a truncated circle, the chord being configured parallel to the hinge line.

15. The dressing interface of claim 14, wherein the chord is configured to be collinear with the hinge line.

16. The dressing interface according to any one of claims 14 to 15, wherein the string allows the flange to rotate about the hinge line.

17. The dressing interface according to any one of claims 1-6 and 14-15, wherein the second adhesive region is configured to be removable from the cover without damaging the cover, and the first adhesive region is configured to remain adhered to the cover.

18. The dressing interface of claim 17, wherein the covering has a thickness in the range of 25 micrometers to 50 micrometers.

19. The dressing interface of claim 17, wherein the covering comprises a polymer sterile drape.

20. The dressing interface according to any one of claims 1-6, 14-15 and 18-19, wherein the contact layer comprises a silicone adhesive.

21. The dressing interface according to any one of claims 1-6, 14-15 and 18-19, wherein the contact layer comprises an aqueous colloidal adhesive.

22. The dressing interface according to any one of claims 1-6, 14-15 and 18-19, wherein the contact layer comprises a polyurethane gel adhesive.

23. The dressing interface according to any one of claims 1-6, 14-15 and 18-19, wherein the contact layer has a peel strength of 0.8 N.

24. The dressing interface according to any one of claims 1-6, 14-15 and 18-19, wherein the outer shell layer comprises an acrylic adhesive.

25. The dressing interface according to any one of claims 1-6, 14-15 and 18-19, wherein the outer shell layer comprises an adhesive silicone adhesive.

26. The dressing interface according to any one of claims 1-6, 14-15 and 18-19, wherein the outer shell layer comprises a pressure-sensitive adhesive.

27. The dressing interface according to any one of claims 1-6, 14-15 and 18-19, wherein the outer shell layer is configured to be deactivated by ultraviolet light.

28. The dressing interface according to any one of claims 1-6, 14-15 and 18-19, wherein the first adhesive region further includes a plurality of perforations.

29. The dressing interface of claim 28, wherein the plurality of perforations are configured to allow liquid to be drawn through the connecting member to reduce the peel strength of the first region.

30. The dressing interface of claim 29, wherein the liquid is alcohol.

31. The dressing interface according to any one of claims 1-6, 14-15, 18-19 and 29-30, wherein the connecting member includes a pull tab adjacent to the second adhesive region and opposite to the first adhesive region.

32. The dressing interface of claim 31, wherein the pull tab is non-adhesive.

33. The dressing interface according to any one of claims 2-6, wherein the plurality of fourth openings are circular.

34. The dressing interface according to any one of claims 2-6, wherein the plurality of fourth openings are oval.

35. The dressing interface according to any one of claims 2-6, wherein the plurality of fourth openings are octagonal.

36. The dressing interface according to any one of claims 2-6, wherein the plurality of fourth openings are hexagonal.

37. The dressing interface according to any one of claims 2-6, wherein the plurality of fourth openings are pentagonal.

38. The dressing interface according to any one of claims 2-6, wherein the plurality of fourth openings are rectangular.

39. The dressing interface according to any one of claims 4-6, wherein the plurality of fifth openings are circular.

40. The dressing interface according to any one of claims 4-6, wherein the plurality of fifth openings are oval.

41. The dressing interface according to any one of claims 4-6, wherein the plurality of fifth openings are octagonal.

42. The dressing interface according to any one of claims 4-6, wherein the plurality of fifth openings are hexagonal.

43. The dressing interface according to any one of claims 4-6, wherein the plurality of fifth openings are pentagonal.

44. The dressing interface according to any one of claims 4-6, wherein the plurality of fifth openings are rectangular.

45. The dressing interface according to any one of claims 4-6, wherein the plurality of sixth openings are circular.

46. ​​The dressing interface according to any one of claims 4-6, wherein the plurality of sixth openings are oval.

47. The dressing interface according to any one of claims 4-6, wherein the plurality of sixth openings are octagonal.

48. The dressing interface according to any one of claims 4-6, wherein the plurality of sixth openings are hexagonal.

49. The dressing interface according to any one of claims 4-6, wherein the plurality of sixth openings are pentagonal.

50. The dressing interface according to any one of claims 4-6, wherein the plurality of sixth openings are rectangular.

51. A system for treating a tissue site, the system comprising: Manifold, the manifold being disposed adjacent to the tissue site; A cover, the cover being configured to be placed on the patient’s epidermis and to form a fluid seal over the manifold; The dressing interface according to any one of claims 1 to 50, wherein the dressing interface is used for attachment to the cover; and A negative pressure source, the negative pressure source being fluidly connected to the manifold via the dressing interface.

52. The system of claim 51, wherein the cover has a thickness in the range of 25 micrometers to 50 micrometers.

53. The system according to any one of claims 51 to 52, wherein the cover comprises a polymer disinfecting tarpaulin.

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