Unencapsulated open cavity dressing for negative pressure therapy

Abstract

In some embodiments, a dressing can include a treatment device configured with a central hub and a plurality of legs extending outwardly from the central hub. In some embodiments, the central hub and the legs can collectively constitute a treatment manifold configured to minimize tissue ingrowth. For example, the treatment manifold can include closed cell foam. In some embodiments, the treatment manifold can be unencapsulated. For example, a single film layer can be attached to a first surface of the treatment manifold, while an opposite surface of the manifold can be exposed and / or uncovered. Other devices, dressings, systems, and methods are also disclosed.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 058,801, filed on July 30, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates generally to medical systems and, more particularly, but not by way of limitation, to absorbent dressings, systems, and methods for treating a tissue site by reducing pressure. Background Art

[0004] Clinical research and practice have shown that reducing the pressure near the tissue site can enhance and accelerate the growth of new tissue at the tissue site. The application of this phenomenon is numerous, but it has been proven to be particularly advantageous for treating wounds. Regardless of the cause of the wound, whether it is trauma, surgery or another reason, the correct care of the wound is important for the result. Treating a wound or other tissue by reducing pressure is generally referred to as "negative pressure therapy", but is also known by other names, including, for example, "negative pressure wound therapy", "reduced pressure therapy", "vacuum therapy" and "vacuum assisted closure". Negative pressure therapy can provide many benefits, including the migration of epithelial tissue and subcutaneous tissue, improved blood flow, the removal of fluids (such as exudate) from the wound site and micro-deformation of the tissue at the wound site. These benefits can together increase the development of granulation tissue and reduce healing time.

[0005] While the clinical benefits of negative pressure therapy are well known, the cost and complexity of negative pressure therapy can be limiting factors in its adoption, and the development and operation of negative pressure systems, components, and processes continue to present significant challenges to manufacturers, healthcare providers, and patients. Summary of the Invention

[0006] As shown and described in various illustrative, non-limiting exemplary embodiments herein, the shortcomings of certain aspects of tissue therapy dressings, systems, and methods are addressed.

[0007] In some example embodiments, a therapy device that can be configured to distribute negative pressure to extract liquid from an open cavity wound can include a closed cell foam therapy manifold having a central connector manifold member and a plurality of leg manifold members extending outwardly from the central connector manifold member, wherein each of the plurality of leg manifold members is in fluid communication with the central connector manifold member; and a single film layer disposed proximate to and attached to a first surface of the therapy manifold, wherein the film layer includes a plurality of fenestrations. In some embodiments, the film layer can extend between the leg manifold members. In some embodiments, a second surface of the therapy manifold can be uncovered and / or exposed, and the second surface can be opposite the first surface. In some embodiments, the therapy manifold can be configured to distribute negative pressure. For example, the therapy manifold can include a plurality of channels and a plurality of through-channels, wherein the plurality of channels are disposed on at least one of the first surface and the second surface, and wherein the plurality of through-channels are disposed through the first surface and the second surface. In some embodiments, the plurality of channels can be disposed on both the first surface and the second surface. In some embodiments, at least some of the through-channels can intersect and fluidly couple with at least some of the channels. For example, in some embodiments, each of the through-channels can intersect and fluidly couple with at least one of the channels. In some embodiments, the channels on the first surface can be offset from the channels on the second surface. In some embodiments, the channels on the first surface can be aligned with the channels on the second surface.

[0008] In some embodiments, the film layer can include a surface texture on one or both of a first film surface and an opposing second film surface, and the surface texture can include ridges and grooves. In some embodiments, the film layer can include at least one indentation configured as a complementary shape to at least the first surface of the therapy manifold. For example, the at least one indentation can be configured to allow a complementary portion of the first surface of the therapy manifold to seat in the at least one indentation in the film layer. In some embodiments, the central connector manifold member can include a plurality of constricting apertures configured such that the central connector manifold member constricts radially in a plane under negative pressure.

[0009] In some exemplary embodiments, a dressing or treatment device may include: a central fluid hub; and a plurality of elongated members, wherein the plurality of elongated members extend outwardly from the central fluid hub. In some embodiments, the central fluid hub may include a connecting manifold member, the elongated members may each include a leg manifold member, and each of the plurality of leg manifold members may be in fluid communication with the connecting manifold member. In some embodiments, the central fluid hub and the elongated members may be configured such that the connecting manifold member and the leg manifold members are unencapsulated. For example, only one substantially fluid-impermeable layer (such as a film layer) may be attached to a first surface of each of the leg manifold members and / or the connecting manifold member, wherein a second opposing surface of the leg manifold member and / or the connecting manifold member is not covered by the film and / or is exposed. In some embodiments, the substantially fluid-impermeable layer may include a plurality of fenestrations. In some embodiments, the connecting manifold member and / or the leg manifold member may not be covered by a film on both the first surface and the second surface and / or there may be no film directly attached to the connecting manifold member and / or the leg manifold member.

[0010] In some embodiments, the connection manifold member and the leg manifold member can each be configured to distribute negative pressure and / or withdraw fluid from a tissue site (e.g., when negative pressure is applied to the connection manifold member) while substantially minimizing tissue ingrowth during negative pressure therapy. In some embodiments, the connection manifold member and the leg manifold member can each include a closed-cell foam, and the closed-cell foam of the connection manifold member and the leg manifold member can be exposed on at least the second surface opposite the first surface. In some embodiments, the substantially fluid-impermeable layer can extend between the plurality of elongated members.

[0011] In some example embodiments, a method of manufacturing a therapeutic device or dressing that can be similar to those described herein can include providing a therapeutic manifold, which in some embodiments can be formed from a closed cell foam; providing a film layer having a plurality of windows; attaching the film layer to a first surface of the foam therapeutic manifold while leaving a second, opposite surface of the foam therapeutic manifold uncovered. In some embodiments, the therapeutic manifold can have a central connector manifold member and a plurality of leg manifold members extending outwardly from the central connector manifold member; and each of the plurality of leg manifold members can be in fluid communication with the central connector manifold member. In some embodiments, the closed cell foam therapeutic manifold can be configured to distribute negative pressure and / or to aspirate fluid from a tissue site in the presence of applied negative pressure. In some embodiments, attaching the film layer can include adhering the film layer to the therapeutic manifold, for example, using a polyurethane or acrylic adhesive. In some embodiments, providing the film layer can include providing a flat film and forming a textured surface of ridges and grooves on the film. In some embodiments, providing the film layer can include providing a flat or textured film and forming indentations on the film that are configured to allow the therapeutic manifold to be seated within the indentations. In some embodiments, providing the film layer can include thermoforming a film by heating the film and stretching the heated film over a mandrel tool to form a pattern, which can include a surface texture and / or the indentations configured to allow the therapeutic manifold to be seated within the film.

[0012] Other aspects, features, and advantages of illustrative example embodiments will become apparent from the detailed description and drawings. BRIEF DESCRIPTION OF DRAWINGS

[0013] Figure 1 is a block diagram of example embodiments of a therapeutic system and dressing that can provide negative pressure therapy and instillation therapy in accordance with the present specification;

[0014] Figure 2A is an example of a tissue interface that can be associated with some embodiments of the therapeutic system and dressing of Figure 1 ;

[0015] Figure 2B is an exploded isometric view of an example of a tissue interface that can be associated with some embodiments of the therapeutic system and dressing of Figure 1 ;

[0016] Figure 3A is a top view of a tissue interface of Figure 2A ;

[0017] Figure 3B is a detailed view of a tissue interface of Figure 3A , taken in reference to Figure 3B ; Figure 3A ;

[0018] Figure 4 is a top view of an example of a tissue interface under negative pressure;

[0019] Figure 5A It can be used with Figure 1 A top view of another example of a tissue interface associated with some embodiments of a therapeutic system and a dressing;

[0020] Figure 5B yes Figure 5A isometric view of a tissue interface illustrating additional features that may be associated with some embodiments;

[0021] Figure 6A It can be used with Figure 1 An isometric view of another example of a tissue interface associated with a therapeutic system and a dressing;

[0022] Figure 6B yes Figure 6A an isometric view of a second side of a tissue interface illustrating additional features that may be associated with some embodiments;

[0023] Figure 7 It can be used with Figure 1 An isometric view of another example of a tissue interface associated with a therapeutic system and a dressing;

[0024] Figure 8 is an isometric view of an exemplary tissue site, a portion of which is shown in cross-section;

[0025] Figure 9 is an isometric view of a portion of an exemplary embodiment of a therapeutic system and dressing deployed over an exemplary tissue site, a portion of which is shown in cross-section;

[0026] Figure 10 is a table showing improved collapse percentages of tissue interfaces according to the present disclosure;

[0027] Figure 11A Is with Figure 1 A schematic diagram of an illustrative exemplary embodiment of an open cavity reduced pressure treatment device within a similar treatment system, a portion of which is in cross-section;

[0028] Figure 11B yes Figure 11A a schematic cross-section of a portion of an exemplary therapeutic device;

[0029] Figure 11C yes Figure 11A a schematic cross-section of a portion of an exemplary therapeutic device taken along line 11C-11C;

[0030] Figure 11D yes Figure 11A a schematic cross-section of a portion of an exemplary system of;

[0031] Figure 12 yes 11A to 11D A schematic isometric view of an exemplary open cavity decompression treatment device;

[0032] Figure 13A is a schematic plan view of another illustrative exemplary embodiment of an open cavity reduced pressure treatment device;

[0033] Figure 13B yes Figure 13A A schematic plan view of a portion of an exemplary therapeutic device;

[0034] Figure 13C yes Figure 13B a schematic cross-section of a portion of an exemplary therapeutic device taken along line 13C-13C;

[0035] Figure 14A is a top plan view of yet another illustrative example of a therapeutic device that may be used with Figure 1 and / or Figure 11A Some embodiments of the therapeutic system are associated with:

[0036] Figure 14B yes Figure 14A a detailed isometric view of a portion of a therapeutic device showing additional details that may be associated with some embodiments;

[0037] Figure 14C yes Figure 14B an exploded cross-sectional view of a leg portion of FIG. 1 , showing additional details that may be associated with some embodiments;

[0038] Figure 14D It shows Figure 14C a schematic partial cross-sectional view of a portion of a leg manifold member of FIG. 1 , showing additional details that may be associated with some embodiments;

[0039] Figure 14E is a schematic partial cross-sectional illustration of another exemplary embodiment of a leg manifold member showing additional details that may be associated with some embodiments; and

[0040] Figure 14F yes Figure 14A A partial isometric view of a therapeutic device showing additional details that may be associated with some embodiments. DETAILED DESCRIPTION

[0041] The following description of example embodiments enables one skilled in the art to make and use the subject matter set forth in the claims. Certain details known by persons of ordinary skill in the art can be omitted. Thus, the following detailed description is exemplary and non-limiting.

[0042] Figure 1 is a block diagram of an example embodiment of a therapy system 100 according to the present specification that can provide negative pressure therapy through instillation of a topical treatment solution to a tissue site.

[0043] In this context, the term "tissue site" refers broadly to a wound, defect, or other treatment target located on or within tissue, including but not limited to a surface wound, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament. The term "tissue site" can also refer to a region of any tissue that is not necessarily injured or defective, but where additional tissue growth can be desired or facilitated. For example, negative pressure can be applied to a tissue site to cause additional tissue growth, which can then be harvested and transplanted. As used herein, a surface wound is a wound on the body that is exposed to the external environment, such as an injury or damage to the epidermis, dermis, and / or subcutaneous layer. For example, a surface wound can include an ulcer or a closed incision. As used herein, a surface wound does not include wounds that are contained within the abdominal cavity. Wounds can include, for example, chronic wounds, acute wounds, traumatic wounds, subacute wounds, and dehisced wounds, partial-thickness burns, ulcers such as diabetic ulcers, pressure ulcers, or venous insufficiency ulcers, flaps, and grafts.

[0044] The therapy system 100 can include a negative pressure source or negative pressure supply, such as negative pressure source 105, and one or more distribution components. The distribution components are preferably detachable and can be disposable, reusable, or recyclable. Dressings, such as dressing 110, and fluid containers, such as container 115, are examples of distribution components that can be associated with some examples of the therapy system 100. As Figure 1 As shown in the example of FIG. 1, in some embodiments, the dressing 110 can include a tissue interface 120, a cover 125, or both.

[0045] A fluid conductor is another illustrative example of a distribution component. In this context, a "fluid conductor" broadly includes a tube, pipe, hose, conduit, or other structure having one or more lumens or open paths suitable for conveying a fluid between two ends. Typically, a tube is an elongated cylindrical structure having a certain flexibility, but the geometry and stiffness can vary. In addition, some fluid conductors can be molded into other components or otherwise integrally combined with other components. The distribution component can also include or contain interfaces or fluid ports to facilitate coupling and disconnection of other components. In some embodiments, for example, a dressing interface can facilitate coupling the fluid conductor to the dressing 110. For example, such a dressing interface can be a SENSAT.RAC available from Kinetic Concepts, Inc., San Antonio, Texas. TM pad.

[0046] The treatment system 100 may also include a regulator or controller, such as controller 130. In addition, the treatment system 100 may include sensors to measure operating parameters and provide feedback signals indicative of the operating parameters to the controller 130. Figure 1 As shown, for example, treatment system 100 may include a first sensor 135 and a second sensor 140 coupled to controller 130 .

[0047] The treatment system 100 may also include an instillation solution source. For example, the solution source 145 may be fluidly coupled to the dressing 110, such as Figure 1 , as shown in an exemplary embodiment of . In some embodiments, the solution source 145 can 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 a drip regulator 155 can also be fluidly coupled to the solution source 145 and the dressing 110 to ensure appropriate dosage of the instillation solution (e.g., saline) to the tissue site. For example, the drip regulator 155 can include a piston that can be pneumatically actuated by the negative pressure source 105 to draw the instillation solution from the solution source during the negative pressure interval and drip the solution to the dressing during the discharge interval. In addition or alternatively, the controller 130 can be coupled to the negative pressure source 105, the positive pressure source 150, or both to control the dosage of the instillation solution to the tissue site. In some embodiments, the drip regulator 155 can also be fluidly coupled to the negative pressure source 105 via the dressing 110, such as Figure 1 .

[0048] Some components of the treatment system 100 may be housed within or used in conjunction with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate treatment. For example, in some embodiments, the negative pressure source 105 may be combined with the controller 130, the solution source 145, and other components into a treatment unit.

[0049] In general, the components of the treatment system 100 can be coupled directly or indirectly. For example, the negative pressure source 105 can be directly coupled to the container 115 and can be indirectly coupled to the dressing 110 through the container 115. The coupling can include fluid coupling, mechanical coupling, thermal coupling, electrical coupling, or chemical coupling (such as a chemical bond), or in some cases, some combination of couplings. For example, the negative pressure source 105 can be electrically coupled to the controller 130 and can be fluidically coupled to one or more distribution components to provide a fluid path to the tissue site. In some embodiments, the components can also be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material.

[0050] For example, a negative pressure supply device, such as the negative pressure source 105, can be a reservoir of air at negative pressure, or can be a manual or electric device, such as a vacuum pump, a suction pump, a wall suction port available in many healthcare facilities, or a micropump. "Negative pressure" or "reduced pressure" (which can be used interchangeably) generally refers to a pressure that is less than the local ambient pressure, such as the ambient pressure in the local environment outside the sealed treatment environment. In many cases, the local ambient pressure can also be the atmospheric pressure in which the tissue site is located. Alternatively, the pressure can be less than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise specified, the pressure values ​​described herein are gauge pressures. References to an increase in negative pressure generally refer 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 the negative pressure source 105 can vary depending on the treatment requirements, the pressure is typically a low vacuum (also commonly referred to as a rough vacuum) between -5 mm Hg (-667 Pa) and -500 mm Hg (-66.7 kPa). Common treatment ranges are between -50 mm Hg (-6.7 kPa) and -300 mm Hg (-39.9 kPa) or between -100 mm Hg and -200 mm Hg.

[0051] The reduced pressure delivered can be constant, varying, patterned, or random, and can be delivered continuously or intermittently. Although the terms "vacuum" and "negative pressure" may be used to describe the pressure applied to a tissue site, the actual pressure applied to a tissue site may be greater than the pressure typically associated with a complete vacuum. Consistent with the usage herein, an increase in reduced pressure corresponds to a decrease in pressure (more negative relative to ambient pressure), and a decrease in reduced pressure corresponds to an increase in pressure (less negative relative to ambient pressure).

[0052] Container 115 represents a container, canister, pouch, or other storage component that can be used to manage exudate and other fluids aspirated from a tissue site. In many environments, a rigid container may be preferred or necessary for collecting, storing, and disposing of fluids. In other environments, fluids can be appropriately disposed of without a rigid container storage device, and reusable containers can reduce waste and costs associated with negative pressure therapy.

[0053] A controller, such as controller 130, can 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, the controller 130 can be a microcontroller, typically comprising an integrated circuit containing a processor core and memory programmed to directly or indirectly control one or more operating parameters of the treatment system 100. The operating parameters can include, for example, the power applied to the negative pressure source 105, the pressure generated by the negative pressure source 105, or the pressure distributed to the tissue interface 120. The controller 130 is also preferably configured to receive one or more input signals, such as feedback signals, and is programmed to modify the one or more operating parameters based on the input signals.

[0054] Sensors, such as first sensor 135 and second sensor 140, are generally known in the art as any device operable to detect or measure a physical phenomenon or property, and generally provide a signal indicative of the detected or measured phenomenon or property. For example, first sensor 135 and second sensor 140 may be configured to measure one or more operating parameters of treatment system 100. In some embodiments, first sensor 135 may be a transducer configured to measure pressure in the pneumatic pathway and convert the measurement into a signal indicative of the measured pressure. In some embodiments, for example, first sensor 135 may be a piezoresistive strain gauge. In some embodiments, second sensor 140 may optionally measure an operating parameter of negative pressure source 105, such as voltage or current. Preferably, the signals from first sensor 135 and second sensor 140 are suitable as input signals to controller 130, but in some embodiments, some signal conditioning may be appropriate. For example, filtering or amplification may be required before the signals can be processed by controller 130. Typically, the signals are electrical signals, but may be represented in other forms, such as optical signals.

[0055] The tissue interface 120 can generally be adapted to partially or completely contact the tissue site. The tissue interface 120 can take a variety of forms and can have a variety of sizes, shapes, or thicknesses, depending on various factors, such as the type of treatment being administered 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 a deep and irregularly shaped tissue site. Any or all surfaces of the tissue interface 120 can have an uneven, rough, or jagged topography.

[0056] In some embodiments, the tissue interface 120 may include or may be a manifold. In this context, the manifold may include a device for collecting or distributing fluid under pressure across or through the tissue interface 120. For example, the manifold may be adapted to receive negative pressure from a source and distribute the negative pressure across the tissue interface 120 through a plurality of openings, which may have the effect of collecting fluid from the tissue site and drawing the fluid toward the source. In some embodiments, the fluid path may be reversed or an auxiliary fluid path may be provided to facilitate delivery of fluid, such as fluid from an instillation solution source, to the tissue site.

[0057] In some embodiments, the cover 125 can provide a bacterial barrier and protection from physical trauma. The cover 125 can also be constructed of a material that can reduce evaporative losses and provide a fluid seal between two components or two environments (such as between a treatment environment and a local external environment). The cover 125 can be, for example, an elastomeric film or thin film that can provide a seal sufficient to maintain a negative pressure at the tissue site for a given negative pressure source. In addition, the cover 125 can be vapor permeable and / or liquid impermeable, thereby allowing vapor and inhibiting liquid from leaving the sealed space between the cover 125 and the tissue site. In some applications, the cover 125 can have a high moisture vapor transmission rate (MVTR). For example, in some embodiments, the MVTR can be at least 250 grams per square meter per 24 hours, measured using an upright cup technique at 38°C and 10% relative humidity (RH) according to the ASTM E96 / E96M positive cup method. In some embodiments, the cover 125 can be a flexible, breathable film, film, or sheet having a high moisture vapor transmission rate (MVTR), for example, of at least about 300 g / m2 / 24 hours. In other embodiments, a low vapor transfer drape or a no vapor transfer drape can be used. The cover 125 can include a range of medically suitable films having a thickness of up to about 50 microns (μm). In some embodiments, an MVTR of up to 5,000 g / m2 / 24 hours can provide effective breathability and mechanical properties.

[0058] In some exemplary embodiments, the cover 125 may be a polymeric drape that is permeable to water vapor but impermeable to liquids, such as a polyurethane film. Such disinfection drapes typically have a thickness in the range of 25 microns to 50 microns. For permeable materials, the permeability should generally be low enough so that the desired negative pressure can be maintained. The cover 125 can be, for example, one or more of the following materials: polyurethane (PU), such as hydrophilic polyurethane; cellulose; hydrophilic polyamide; polyvinyl alcohol; polyvinyl pyrrolidone; hydrophilic acrylic resin; silicone, such as hydrophilic silicone elastomer; natural rubber; polyisoprene; styrene-butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene-vinyl acetate (EVA); copolyesters; and polyether block polyamide copolymers. Such materials are commercially available, for example, from 3M Company, Minneapolis Minnesota. Drapes; polyurethane (PU) drapes; polyether block polyamide copolymer (PEBAX) available from Arkema, France; and INSPIRE 2301 and INSPIRE 2327 polyurethane films commercially available from Expopack Advanced Coatings, Wrexham, United Kingdom. In some embodiments, the cover 125 can include INSPIRE 2301 having an MVTR (standing cup technology) of 2600 g / m2 / 24 hours and a thickness of about 30 microns, or an MVTR (standing cup technology) of 14400 g / m2 / 24 hours and a thickness of about 30 microns.

[0059] An attachment device can be used to attach the cover 125 to an attachment surface, such as an intact epidermis, a gasket, or another cover. The attachment device can take a variety of forms. For example, the attachment device can be a medically acceptable pressure-sensitive adhesive configured to bond the cover 125 to the epidermis around the tissue site. In some embodiments, for example, some or all of the cover 125 can be coated with an adhesive having a coating weight between 25 grams per square meter and 65 grams per square meter (gsm), such as an acrylic adhesive. In some embodiments, a thicker adhesive or a combination of adhesives can be applied to improve the seal and reduce leakage. Other exemplary embodiments of the attachment device can include double-sided tape, paste, aqueous colloid, hydrogel, silicone gel, or organogel.

[0060] Solution source 145 may also represent a container, canister, pouch, bag, or other storage component that can provide a solution for the infusion therapy. The composition of the solution may vary depending on the prescribed therapy, but examples of solutions that may be suitable for some prescriptions include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanide, cationic solutions, and isotonic solutions.

[0061] In operation, the tissue interface 120 can be placed within, above, on, or otherwise proximate to a tissue site. For example, if the tissue site is a wound, the tissue interface 120 can partially or completely fill the wound, or it can be placed over the wound. The cover 125 can be placed over the tissue interface 120 and sealed to an attachment surface near the tissue site. For example, the cover 125 can be sealed to the intact epidermis surrounding the tissue site. Thus, the dressing 110 can provide a sealed treatment environment proximate the tissue site that is substantially isolated from the external environment, and the negative pressure source 105 can reduce the pressure in the sealed treatment environment.

[0062] Generally speaking, exudates and other fluids flow along a fluid path toward lower pressure. Thus, the term "downstream" may refer to a location in a fluid path that is relatively closer to a negative pressure source or farther from a positive pressure source. Conversely, the term "upstream" may refer to a location farther from a negative pressure source or closer to a positive pressure source. Similarly, certain features may be conveniently described in terms of a fluid "inlet" or "outlet" in this reference frame. This orientation is generally assumed for the purposes of describing the various features and components herein. However, in some applications, the fluid path may be reversed, such as by replacing the negative pressure source with a positive pressure source.

[0063] The negative pressure applied to the tissue site by the tissue interface 120 in the sealed treatment environment can induce macrostrain and microstrain in the tissue site. The negative pressure can also remove exudate and other fluids from the tissue site, which can be collected in the container 115.

[0064] In some embodiments, the controller 130 may receive and process data from one or more sensors, such as the first sensor 135. The controller 130 may also control the operation of one or more components of the treatment system 100 to manage the pressure delivered to the tissue interface 120. In some embodiments, the controller 130 may include an input for receiving a desired target pressure and may be programmed to process data related to the setting and input of the target pressure to be applied to the tissue interface 120. In some exemplary embodiments, the target pressure may be a fixed pressure value that is set by the operator as the target negative pressure desired for treatment at the tissue site and then provided as an input to the controller 130. The target pressure may vary from one tissue site to another 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 preferences of the attending physician. After selecting the desired target pressure, the controller 130 may operate the negative pressure source 105 in one or more control modes based on the target pressure and may receive feedback from the one or more sensors to maintain the target pressure at the tissue interface 120.

[0065] In some embodiments, the controller 130 may have a continuous pressure mode, wherein the negative pressure source 105 is operated to provide a constant target negative pressure for the duration of the treatment or until manually deactivated. In addition or alternatively, the controller may have an intermittent pressure mode. For example, the controller 130 may operate the negative pressure source 105 to cycle between the target pressure and atmospheric pressure. For example, the target pressure may be set to a value of 135 mmHg for a specified period of time (e.g., 5 minutes) followed by a specified period of time (e.g., 2 minutes) of deactivation. The cycle may be repeated by activating the negative pressure source 105, which may form a square wave pattern between the target pressure and atmospheric pressure.

[0066] In some exemplary embodiments, the increase in negative pressure from ambient pressure to the target pressure may not be instantaneous. For example, the negative pressure source 105 and the dressing 110 may have an initial rise time. This initial rise time may vary depending on the type of dressing and treatment device used. For example, some treatment systems may increase negative pressure at a rate of approximately 20-30 mmHg / s, while other treatment systems may increase negative pressure at a rate of approximately 5-10 mmHg / s. If the treatment system 100 is operated in intermittent mode, the repetitive rise time may be substantially equal to the initial rise time.

[0067] 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, varying between negative pressures of 50 mmHg and 135 mmHg, with the negative pressure rise rate set at 25 mmHg / min and the fall rate set at 25 mmHg / min. In other embodiments of the treatment system 100, the triangular waveform may vary between negative pressures of 25 mmHg and 135 mmHg, with the rise rate being approximately 30 mmHg / min and the fall rate being approximately 30 mmHg / min.

[0068] In some embodiments, the controller 130 can control or determine a variable target pressure in a dynamic pressure mode, and the variable target pressure can vary between a maximum pressure value and a minimum pressure value, which can be set as input by the operator to specify a desired negative pressure range. The variable target pressure can also be processed and controlled by the controller 130, which can change the target pressure 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 desired for treatment.

[0069] In some embodiments, the controller 130 can receive and process data, such as data related to the instillation solution provided to the tissue interface 120. Such data can include the type of instillation solution specified by the clinician, the volume of fluid or solution to be instilled into the tissue site ("fill volume"), and the amount of time specified for the solution to remain at the tissue site before negative pressure is applied to the tissue site ("dwell time"). The fill volume can be, for example, between 10 mL and 500 mL, and the dwell time can be between 1 second and 30 minutes. The controller 130 can also control the operation of one or more components of the treatment system 100 to instill the solution. For example, the controller 130 can manage the fluid distributed from the solution source 145 to the tissue interface 120. In some embodiments, the fluid can be instilled into the tissue site by applying negative pressure from the negative pressure source 105 to reduce the pressure at the tissue site, thereby drawing the solution into the tissue interface 120. In some embodiments, the solution can be instilled into the tissue site by applying positive pressure from positive pressure source 150 to move the solution from solution source 145 to tissue interface 120. Additionally or alternatively, solution source 145 can be elevated to a height sufficient to allow gravity to move the solution into tissue interface 120.

[0070] The controller 130 can also control the fluid dynamics of the instillation by providing a continuous flow of solution or an intermittent flow of solution. Negative pressure can be applied to provide a continuous flow of solution or an intermittent flow. The application of negative pressure can be implemented to provide a continuous pressure operating mode, thereby achieving a continuous flow of the instillation solution flowing through the tissue interface 120, or it can be implemented to provide a dynamic pressure operating mode, thereby changing the flow of the instillation solution flowing through the tissue interface 120. Alternatively, the application of negative pressure can be implemented to provide an intermittent operating mode, thereby allowing the instillation solution to reside at the tissue interface 120. In the 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 being utilized. Negative pressure therapy can be applied after or during the solution instillation. The controller 130 can be used to select the operating mode and duration of the negative pressure therapy before starting another instillation cycle.

[0071] Some dressings can be worn to extend the time period exceeding seven days, which can be referred to as extending the wearing time. Dressings that continue to extend the wearing time can provide cost savings, time efficiency, and less trauma to the patient during dressing changes. Some highly felted foam materials can be worn to extend the time period and not experience tissue ingrowth. However, some felted foam materials may be quite hard. Harder foam materials may be difficult to conform, difficult to reset size, and cannot collapse under negative pressure to provide large strain to tissue site. In addition, hard foam materials may not effectively deliver fluid and pressure to tissue site because the manifold cannot radially contract.

[0072] These and other limitations can be addressed by the therapeutic system 100, which can provide both negative pressure therapy and infusion therapy. In some embodiments, the therapeutic system 100 can include a tissue interface or manifold layer that prevents tissue ingrowth while also being flexible, collapsible, and resizable. The tissue interface or manifold layer can include a pattern that enables the manifold to radially contract in all directions, thereby increasing the effectiveness of the therapeutic system 100.

[0073] Figure 2A yes Figure 1 100 , which illustrates additional details that may be associated with some embodiments. Various examples of tissue interfaces 120 that may be suitable for use with dressing 110 and therapeutic system 100 are described herein. Furthermore, features or elements of tissue interface 120 described herein may be referred to as part of therapeutic system 100 or dressing 110 without reference to tissue interface 120.

[0074] exist Figure 2AIn an example embodiment, the tissue interface 120 may include or may be a manifold, such as a manifold layer 205. The manifold layer 205 may also provide a means for collecting or distributing fluid under pressure across the tissue interface 120. For example, the manifold layer 205 may be adapted to receive negative pressure from a source and distribute the negative pressure across the tissue interface 120 through a plurality of openings, which may have the effect of collecting fluid from the tissue site and drawing the fluid toward the source. In some embodiments, the fluid path may be reversed or an auxiliary fluid path may be provided to facilitate the delivery of fluid, such as fluid from an instillation solution source, to the tissue interface 120.

[0075] In some exemplary embodiments, the passages of the manifold layer 205 may be interconnected to improve the distribution or collection of fluids. In some exemplary embodiments, the manifold layer 205 may be a porous material having interconnected fluid passages. Examples of suitable porous materials that include interconnected fluid passages (e.g., channels) or that may be suitable for forming interconnected fluid passages may include cellular foams, including open-cell foams such as reticulated foams; porous tissue collections; and other porous materials that typically include pores, edges, and / or walls, such as gauze or felt pads. Liquids, gels, and other foams may also include or be cured to include orifices and fluid passages. In some embodiments, the manifold layer 205 may additionally or alternatively include protrusions that form interconnected fluid passages. For example, the manifold layer 205 may be molded to provide surface protrusions that define interconnected fluid passages.

[0076] In some embodiments, the manifold layer 205 can be a foam having a pore size that can be varied as needed for the prescribed treatment. For example, a foam having an average pore size in the range of 50 microns to 120 microns may be particularly suitable for some types of treatments. The tensile strength of the manifold layer 205 can also be varied as needed for the prescribed treatment. For example, the tensile strength of the foam can be increased for use in instilling a topical treatment solution. In some embodiments, the manifold layer 205 can have a 25% compressive load deflection of about 1.8 to about 2.8 pounds per square inch, and a 65% compressive load deflection of about 2.2 to about 3.4 pounds per square inch. In some embodiments, the manifold layer 205 can be a foam composed of a polyol such as a polyester or polyether, an isocyanate such as toluene diisocyanate, and a polymerization modifier such as an amine and a tin compound. In some examples, the manifold layer 205 can be a reticulated polyurethane foam, such as that used in GRANUFOAM. TM Dressing or VACVERAFLO TM The reticulated polyurethane foam in the dressing is available from KCI, San Antonio, Texas.

[0077] In some embodiments, the manifold layer 205 can be formed by a felting process. Any porous foam suitable for felting can be used, including the exemplary foams mentioned herein, such as GRANUFOAM®. TMDressing. Felting involves a thermoforming process that permanently compresses the foam to increase its density while maintaining interconnected channels. Felting can be performed by any known method, which may include applying heat and pressure to a porous or foamed material. Some methods may include compressing the foam blank between one or more heated platens or dies (not shown) at a specified temperature for a specified period of time. The direction of compression may be along the thickness of the foam blank.

[0078] The compression period can range from 10 minutes to 24 hours, although this period can be more or less, depending on the specific type of porous material used. Furthermore, in some examples, the temperature can range from 120°C to 260°C. Generally speaking, the lower the temperature of the platen, the longer the porous material must remain compressed. After the specified period, the pressure and heat will form a felted structure or surface on, through, or on a portion of the porous material.

[0079] The felting process can change certain properties of the original material, including pore shape and / or pore size, elasticity, density, and density distribution. For example, the struts that define the pores in the foam can be deformed during the felting process, resulting in a flat pore shape. The deformed struts may additionally reduce the elasticity of the foam. The density of the foam is typically increased by felting. In some embodiments, contact with a hot press platen during the felting process can also produce a density gradient, where the density is greater at the surface and the pore size is smaller at the surface. In some embodiments, the felted structure can be relatively smoother than any unfinished or unfelt surface or portion of the porous material. In addition, the pores in the felted structure can be smaller than the pores throughout any unfinished or non-felt surface or portion of the porous material. In some examples, the felted structure can be applied to all surfaces or portions of the porous material. In addition, in some examples, the felted structure can extend into or through the entire thickness of the porous material so that all of the porous material is felted.

[0080] Felted foam can be characterized by a firmness factor that indicates the compression of the foam. The firmness factor of the felted foam can be specified as the ratio of the original thickness to the final thickness. Compressed or felted foam can have a firmness factor greater than 1. The degree of compressibility can affect the physical properties of the felted foam. For example, compared to foam of the same material that has not been felted, felted foam has an increased effective density. The felting process can also affect the interaction between fluids and foam. For example, as density increases, compressibility or collapsibility can decrease. Therefore, foams with different compressibility or collapsibility can have different firmness factors. In some exemplary embodiments, the firmness factor can range from about 2 to about 10. For example, in some embodiments, the firmness factor of the felted foam of the manifold layer 205 can be about 5 to 8. There is a generally linear relationship between firmness level, density, pore size (or number of pores per inch), and compressibility. For example, a foam felted to a firmness factor of 5 will show a five-fold increase in density and compress to about one-fifth of its original thickness.

[0081] In some embodiments, the manifold layer 205 can be a closed-cell foam, such as, for example, those manufactured by Zotefoams, Inc. of Walton, Kentucky, USA, including Azote, Plastazote, Evazote, Supazote, and Zotek grades. Such closed-cell foams can be made by extruding a polymer sheet or block and cross-linking it by high-energy radiation. Suitable polymers can include low-density and high-density polyolefins and copolymers with vinyl acetate, fluoropolymers, polyamides, and PEBAX. The polymer sheet can then be softened under heat and exposed to high-pressure nitrogen, which dissolves in the polymer. After cooling, the polymer sheet can be heated again and exposed to a pressure below atmospheric pressure, causing expansion and forming a closed-cell foam. In some embodiments, the closed-cell foam can be thermoformed. Thermoforming the foam involves embossing patterns and structures (such as channels) into the surface of the foam in order to convert what would otherwise be a non-manifolded material into a structure that manifolds pressure and fluid along the channels.

[0082] In some embodiments, one or more suitable foam blanks can be used to form the manifold layer 205. The foam blank can be an open-cell foam, a felted foam, a closed-cell foam, or another foam described herein. However, the properties of any of these foam blanks can have an average of about 200 to about 400 cells per inch, a density of about 6.5 to about 12.8 lb / ft3, a free volume of about 90% or more, an average pore size in the range of about 50 to about 120 microns, and / or a 25% compressive load deflection of at least 1.5 pounds per square inch. In some embodiments, the foam blank can have a thickness greater than 8 mm (e.g., 8 mm to 16 mm).

[0083] like Figure 2A, the manifold layer 205 can include one or more holes or shrinkage openings 210 extending through a first side 230, a second side 235 opposite the first side 230, and a thickness of the manifold layer 205. The thickness of the manifold layer 205 can be between about 8 mm and 16 mm. The plurality of shrinkage openings 210 can be distributed uniformly or randomly across the manifold layer 205. In some embodiments, the plurality of shrinkage openings 210 can be positioned in at least a first row 204 and a second row 206 offset or staggered from the first row 204. The plurality of shrinkage openings 210 extending through the manifold layer 205 can form a plurality of walls 215 extending through the manifold layer 205. The shrinkage openings 210 can be configured to shrink radially in all directions in response to application of negative pressure to the tissue interface 120 such that radial mechanical deformation occurs at the tissue site.

[0084] In some embodiments, the shrinkage openings 210 can be formed during molding of the manifold layer 205. In other embodiments, the shrinkage openings 210 can be formed by cutting, melting, or vaporizing the manifold layer 205. For example, the shrinkage openings 210 can be formed in the manifold layer 205 by laser cutting a felted foam of the manifold layer 205.

[0085] Figure 2B yes Figure 1 FIG2 is an exploded view of another example of a tissue interface 120 of FIG2 , showing additional details that may be associated with some embodiments. In some embodiments, the tissue interface 120 may include a manifold layer 205 and an optional contact layer, which in some embodiments may be a non-adhesive drape or a substantially fluid-impermeable layer, such as a film layer 220. In some embodiments, the film layer 220 may optionally be positioned adjacent to the manifold layer 205. For example, the film layer 220 and the manifold layer 205 may be stacked such that the film layer 220 is in contact with the manifold layer 205. In some embodiments, the film layer 220 may also be thermally bonded or adhered to the manifold layer 205 (e.g., using a hot melt adhesive). In some embodiments, the film layer 220 may optionally include a low-tack adhesive that may be configured to hold the tissue interface 120 in place when the cover 125 is applied. The low-tack adhesive may be applied continuously on the film layer 220 or in a pattern. In some embodiments, the film layer 220 may be configured to be positioned between the manifold layer 205 and the tissue site. In some embodiments, the membrane layer 220 can be configured to be positioned in direct contact with a tissue site. The membrane layer 220 can provide additional protection to the epidermis from irritation that can be caused by expansion, contraction, or other movement of the manifold layer 205. The membrane layer 220 can also reduce tissue ingrowth into the manifold layer 205.

[0086] The membrane layer 220 may include a device for controlling or managing the flow of fluid. In some embodiments, the membrane layer 220 may be a fluid control layer comprising an elastomeric material that is impermeable to liquids. For example, the membrane layer 220 may be a polymer film, such as a polyurethane film. In some embodiments, the membrane layer 220 may be the same material as the cover 125. In some embodiments, the membrane layer 220 may also have a smooth or matte surface texture. According to the SPI (Plastics Industry Association) standard, a glossy or shiny surface that is better than or equal to B3 grade may be particularly advantageous for some applications. In some embodiments, the variation in surface height may be limited to an acceptable tolerance. For example, the surface of the membrane layer 220 may have a substantially flat surface, wherein the height variation is limited to 0.2 mm over one centimeter.

[0087] In some embodiments, the film layer 220 may be hydrophobic. The hydrophobicity of the film layer 220 may vary, but in some embodiments, may have a contact angle with water of at least ninety degrees. In some embodiments, the film layer 220 may have a contact angle with water of no more than 150 degrees. For example, in some embodiments, the contact angle of the film layer 220 may be in the range of at least 90 degrees to about 120 degrees, or in the range of at least 120 degrees to 150 degrees. The water contact angle may be measured using any standard device. Although a manual goniometer may be used to visually approximate the contact angle, a contact angle measuring instrument may typically include an integrated system involving a water platform, a liquid dropper such as a syringe, a camera, and software designed to more accurately and precisely calculate the contact angle. Non-limiting examples of such integrated systems may include all commercially available from First Ten Angstroms, Inc., Portsmouth, VA and The contact angles of water herein are measured using deionized and distilled water at 20° C. to 25° C. and 20% to 50% relative humidity in air on a horizontal sample surface for a sessile drop added from a height of no more than 5 cm, unless otherwise specified. The contact angles herein represent the average of 5 to 9 measurements, with the highest and lowest values ​​discarded. The hydrophobicity of the membrane layer 220 can be further enhanced with hydrophobic coatings of other materials such as silicones and fluorocarbons, such as those applied by liquid or plasma.

[0088] The membrane layer 220 may also be suitable for welding to other layers, including the manifold layer 205. For example, the membrane layer 220 may be suitable for welding to polyurethane foam using heat, radio frequency (RF) welding, or other heat-generating methods such as ultrasonic welding. RF welding may be particularly suitable for more polar materials such as polyurethanes, polyamides, polyesters, and acrylates. A sacrificial polar interface may be used to facilitate RF welding of less polar membrane materials such as polyethylene. In some embodiments, the membrane layer 220 may be flame laminated to the manifold layer 205.

[0089] The areal density of the film layer 220 can vary depending on the intended treatment or application. In some embodiments, an areal density of less than 40 g / m² can be suitable, and an areal density of about 20 g / m² to 30 g / m² can be particularly advantageous for some applications.

[0090] In some embodiments, for example, rete 220 can be a hydrophobic polymer such as polyethylene film. The simple and inert structure of polyethylene can provide a surface that interacts with biological tissue and fluid seldom (if any), thereby providing a surface that can promote free flow of liquid and low adhesion, which may be particularly advantageous for many applications. Other suitable polymer films include polyurethane, acrylic resin, polyolefin (such as cycloolefin copolymer), polyacetate, polyamide, polyester, copolyester, PEBAX block copolymer, thermoplastic elastomer, thermoplastic vulcanizate, polyether, polyvinyl alcohol, polypropylene, polymethylpentene, polycarbonate, styrene resin, organosilicon, fluoropolymer and acetate. The thickness between 20 microns and 100 microns can be applicable to many applications. Film can be light-transmitting, painted or printed. The larger film that is suitable for being laminated to the polarity on the polyethylene film includes polyamide, copolyester, ionomer and acrylic resin. In order to contribute to the bonding between polyethylene and the polar film, a bonding layer can be used, such as ethylene-vinyl acetate or modified polyurethane. For some constructions, methyl acrylate (EMA) films may also have suitable hydrophobicity and welding properties.

[0091] The membrane layer 220 may have one or more channels that may be uniformly or randomly distributed on the membrane layer 220. In some embodiments, the channels may be bidirectional and pressure responsive. For example, each of the channels may be an elastic channel that is generally strain-free to significantly reduce liquid flow and may expand or open in response to a pressure gradient and / or in response to contraction of the manifold layer 205. Figure 2BAs shown in the example of , the channel can be a plurality of perforations 225 provided through opposing surfaces of the membrane layer 220. The plurality of perforations 225 can be formed by removing material from the membrane layer 220. For example, the plurality of perforations 225 can be formed by cutting through the membrane layer 220. In the absence of a pressure gradient across the plurality of perforations 225, the plurality of perforations 225 can be small enough to form a seal or fluid restriction, which can significantly reduce or prevent liquid flow. In addition or alternatively, one or more of the channels can be or can function as an elastomeric valve that is normally closed when unstrained to substantially prevent liquid flow and can open in response to a pressure gradient and / or in response to contraction of the manifold layer 205. In some examples, the channel can be a fenestration in the membrane layer 220. Typically, a fenestration is a type of perforation and can also be formed by removing material from the membrane layer 220. The amount of material removed and the resulting size of the fenestration can be up to an order of magnitude smaller than the perforation.

[0092] In some embodiments, the plurality of perforations 225 may be formed as slots (or fenestrations formed as slits) in the membrane layer 220. In some examples, the plurality of perforations 225 may be linear slots having a length of less than about 4 mm and a width of less than about 1 mm. In some embodiments, the length may be at least 2 mm and the width may be at least 0.4 mm. A length of about 3 mm and a width of about 0.8 mm may be particularly suitable for many applications, and a tolerance of about 0.1 mm is also acceptable. Such dimensions and tolerances may be achieved, for example, with a laser cutter. Slots of this type of construction may act as imperfect elastomeric valves that significantly reduce liquid flow in a normally closed or static state. For example, such slots may form flow restrictions without being completely closed or sealed. The slots may expand or open wider to allow increased liquid flow in response to a pressure gradient and / or in response to contraction of the manifold layer 205.

[0093] Figure 3A yes Figure 2A A top view of the tissue interface of FIG. 1 , showing additional details that may be associated with some embodiments. Figure 3A As shown, in some embodiments, the tissue interface 120 can have a first orientation line 305 and a second orientation line 310 that is perpendicular to the first orientation line 305. In some embodiments, the first orientation line 305 can be parallel to the tissue interface 120 and the length LM of the manifold layer 205, and the second orientation line 310 can be parallel to the tissue interface 120 and the width WM of the manifold layer 205. Generally speaking, the first orientation line 305 and the second orientation line 310 help describe the tissue interface 120.

[0094] In some embodiments, the manifold layer 205 can be configured to contract radially in all directions in a plane when negative pressure is applied. For example, the length LM of the manifold layer 205 and the width WM of the manifold layer 205 can lie in a contraction plane, wherein the manifold layer 205 is configured to contract radially in all directions in the contraction plane, or a planar region defined by the first side 230 and / or the second side 235 of the manifold layer 205. For example, if the tissue interface 120 is not subjected to negative pressure, the length LM can be the nominal or relaxed length and the width WM can be the nominal or relaxed width. In some embodiments, the length LM can be greater than the width WM, such that the width WM can be less than the length LM. For example, the tissue interface 120 can have an elongated shape. In some embodiments, for example, the tissue interface 120 can have a ratio of length LM to width WM of at least 4:1. In some embodiments, the length LM can be equal to the width WM. In some embodiments, the length LM can be less than the width WM.

[0095] While the manifold layer 205 is shown as having an elongated rectangular shape, the manifold layer 205 can have other shapes. For example, the manifold layer 205 can have a stadium-shaped, diamond-shaped, square-shaped, oval-shaped, or circular-shaped shape. In some embodiments, the shape of the manifold layer 205 can be selected to accommodate the type of tissue site being treated. For example, the manifold layer 205 can have an oval or circular shape to accommodate an oval or circular tissue site. In other exemplary embodiments, the manifold layer 205 can be resized and formed into any desired shape by a clinician prior to placement at the tissue site.

[0096] like Figure 3A As further shown in FIG. 2 , the shrinkage apertures 210 may include a first plurality of shrinkage apertures 315 in the first row 204 and a second plurality of shrinkage apertures 320 in the second row 206. Figure 3A Each of the first and second pluralities of contraction apertures 315 , 320 can be configured to have an elongated shape extending through the first side 230 , the second side 235 , and the thickness of the manifold layer 205 .

[0097] In some embodiments, each of the first plurality of shrinkage openings 315 and the second plurality of shrinkage openings 320 may have a length that is longer than and perpendicular to the hole width. In some embodiments, each of the first plurality of shrinkage openings 315 and the second plurality of shrinkage openings 320 may have a shape configured as a parallelogram. In some embodiments where the shrinkage opening 210 is a parallelogram shape, each of the first plurality of shrinkage openings 315 may have a length L1 and a width W1 that is perpendicular to the length L1, and each of the second plurality of shrinkage openings 320 may have a length L2 and a width W2 that is perpendicular to the length L2. Figure 3AIn some embodiments, L1 and L2 can be about 10 millimeters to 17 millimeters, and W1 and W2 can be about 3 millimeters to 8 millimeters. In some embodiments, length L1 can be equal to length L2. In some embodiments, width W1 can be equal to width W2. In other embodiments, L1 and L2 can be substantially equal, and W1 and W2 can be substantially equal, within acceptable manufacturing tolerances.

[0098] The first plurality of shrink apertures 315 and the second plurality of shrink apertures 320 can be distributed across the manifold layer 205 in one direction or in different directions in one or more rows. In some embodiments, the rows of the first plurality of shrink apertures 315 and the second plurality of shrink apertures 320 can be offset or staggered. In some embodiments, a length LI of one or more of the first plurality of shrink apertures 315 in the first row 204 can be directed toward a length L2 of one or more of the second plurality of shrink apertures 320 in the second row 206. In some embodiments, a length L2 of one or more of the second plurality of shrink apertures 320 in the second row 206 can be directed toward a length LI of one or more of the first plurality of shrink apertures 315 in the first row 204.

[0099] In some embodiments, the first plurality of shrink apertures 315 in the first row 204 can overlap the second plurality of shrink apertures 320 in the second row 206. For example, at least a portion of the first plurality of shrink apertures 315 in the first row 204 will also be positioned or extend into the second row 204, and at least a portion of the second plurality of shrink apertures 320 in the second row 206 will also be positioned or extend into the first row 206. In other embodiments, the first plurality of shrink apertures 315 in the first row 204 can not overlap the second plurality of shrink apertures 320 in the second row 206. For example, the first plurality of shrink apertures 315 can be positioned entirely in the first row 204, separate from the second plurality of shrink apertures 320 positioned entirely in the second row 206.

[0100] In some embodiments, the length L1 of one or more of the first plurality of shrinkage openings 315 in the first row 204 can be positioned at an angle relative to the length L2 of one or more of the second plurality of shrinkage openings 320 in the second row 206. In some embodiments, the length L1 of one or more of the first plurality of shrinkage openings 315 in the first row 204 can be angled toward the length L2 of one or more of the second plurality of shrinkage openings 320 in the second row 206. In some embodiments, the length L1 of one or more of the first plurality of shrinkage openings 315 in the first row 204 can form an angle of approximately 90 degrees relative to the length L2 of one or more of the second plurality of shrinkage openings 320 in the second row 206. In some embodiments, the length L1 of one or more of the first plurality of shrinkage openings 315 in the first row 204 can form an angle of approximately 45 degrees relative to the width W2 of one or more of the second plurality of shrinkage openings 320 in the second row 206.

[0101] In some embodiments, the first plurality of shrinkage openings 315 in the first row 204 and the second plurality of shrinkage openings 320 in the second row 206 can extend along the length LM of the manifold layer 205. In some embodiments, the length L1 of the first plurality of shrinkage openings 315 and the length L2 of the second plurality of shrinkage openings 320 can be positioned at an angle relative to the length LM of the manifold layer 205. For example, each of the first plurality of shrinkage openings 315 can have a first major axis, such as a first reference line 325, which can be parallel to the length L1 of the first plurality of shrinkage openings 315. Each of the second plurality of shrinkage openings 320 can have a second major axis, such as a second reference line 330, which can be parallel to the length L2 of the second plurality of shrinkage openings 320. In some embodiments, one or both of the first reference line 325 and the second reference line 330 can be defined relative to the length LM. For example, the first reference line 325 can form a first angle 335 relative to the length LM, and the second reference line 330 can form a second angle 340 relative to the length LM. In some embodiments, the first angle 335 may be about 45° relative to the length LM and the second angle 340 may be about 135° relative to the length LM. In some embodiments, the first angle may be about 135° relative to the length LM and the second angle may be about 45° relative to the length LM.

[0102] The pattern of shrinkage openings 210 can be characterized by a pitch that indicates the spacing between corresponding points on the shrinkage openings 210 within the pattern. In an exemplary embodiment, the pitch can indicate the spacing between the centroids of the shrinkage openings 210 within the pattern. Some patterns can be characterized by a single pitch value, while other patterns can be characterized by at least two pitch values. For example, if the spacing between the centroids of the shrinkage openings 210 is the same in all orientations, the pitch can be characterized by a single value that indicates the spacing between the centroids in adjacent rows. In some embodiments, a pattern including a first plurality of shrinkage openings 315 and a second plurality of shrinkage openings 320 can be characterized by two pitch values, P1 and P2. P1 can be the spacing between the centroids of one or more of the first plurality of shrinkage openings 315 and another of the first plurality of shrinkage openings 315 in the first row 204 along the first orientation line 305. P2 can be the spacing between the centroids of one or more of the first plurality of shrinkage apertures 315 in the first row 204 and one or more of the second plurality of shrinkage apertures 320 in the second row 206, perpendicular to the first orientation line 305. In some embodiments, P1 can be approximately 18 mm to 22 mm and P2 can be approximately 10 mm to 15 mm.

[0103] Figure 3B is Figure 3A Reference Figure 3B Detailed view of a cutaway view of the manifold layer 205. In some embodiments, the rows can be offset or staggered. The staggering can be characterized by the orientation of corresponding points in consecutive rows relative to an edge or other reference line associated with the manifold layer 205. In some embodiments, the rows of the first plurality of shrinkage openings 315 can be staggered with the rows of the second plurality of shrinkage openings 320. In some embodiments, the staggering can be characterized by a distance or stagger value S1, where S1 can be the spacing between the centroids of one or more of the first plurality of shrinkage openings 315 in the first row 204 and one or more of the second plurality of shrinkage openings 320 in the second row 206 in a direction perpendicular to the first orientation line 305.

[0104] In some embodiments, the plurality of walls 215 can form a web comprising a plurality of alternating first wall portions 345 and second wall portions 350. The first wall portions 345 can be oriented at an angle Φ relative to the first orientation line 305. Figure 3B In the example of , the first wall portion 345 can be oriented at approximately 45° relative to the first orientation line 305. The second wall portion 350 can be oriented at an angle ψ relative to the first orientation line 305. Figure 3BIn the example of FIG, the second wall portion 350 can be approximately 135° relative to the first orientation line 305. In some embodiments, the first wall portion 345 can be parallel to the length L1 of the first plurality of contraction openings 315, and the second wall portion 350 can be parallel to the length L2 of the second plurality of contraction openings 320. The first wall portion 345 and the second wall portion 350 can have an angle β of approximately 90° between each wall portion.

[0105] Figure 4 is in a retracted position Figure 2A A top view of an example of a manifold layer 205 showing additional details that may be associated with some embodiments. Figure 4 As shown, if negative pressure is applied to the tissue interface 120, the plurality of contraction openings 210 of the manifold layer 205 can collapse or contract from a relaxed position to a contracted position. In some embodiments, the manifold layer 205 can be configured to contract to a contracted position when exposed to a reduced pressure of approximately 125 mm Hg. Contraction can occur in all directions because the contraction openings 210 become smaller under the compressive force of the negative pressure and can generate a juxtaposition force. Even when the contraction openings 210 are collapsed, the contraction openings 210 help deliver negative pressure and remove fluid. When using an instillation therapy, the contraction openings 210 can help deliver fluid even when contracted. Additionally, if negative pressure is applied to the tissue interface 120, the manifold layer 205 can collapse or contract to a contracted length and contracted width, wherein the contracted length and contracted width are less than the relaxed length and relaxed width in the absence of negative pressure. Under applied negative pressure, tissue interface 120 may collapse or contract to a contracted length LC and contracted width WC that are less than a nominal or relaxed length LM and a nominal or relaxed width WM of tissue interface 120. As tissue interface 120 contracts, contraction may be applied to the tissue site.

[0106] In some embodiments, the manifold layer 205 may include a first surface area when in a relaxed position and a second surface area when in a contracted position. Figure 4 As shown, the second surface area can be about 20% to 35% smaller than the first surface area. In some embodiments, the second surface area can be at least 20% smaller than the first surface area.

[0107] Figure 5A It can be used with Figure 2A and Figure 2BFIG20 is a top view of another example of a manifold layer 205 associated with some embodiments of the tissue interface 120 of FIG20. In some embodiments, the manifold layer 205 can include at least one surface channel 500 having a channel length that extends along at least one manifold surface or side of the manifold layer 205. For example, the channel length of the at least one surface channel 500 can extend along one or both of the first side 230 or the second side 235 of the manifold layer 205. In some embodiments, the at least one surface channel 500 can be a plurality of surface channels 500. In some embodiments, the plurality of surface channels 500 can also intersect with the plurality of constriction openings 210. The plurality of surface channels 500 can also intersect with each other at intersection angles 515 to form one or more grid patterns as described herein.

[0108] For example, the plurality of surface channels 500 may intersect to form a first grid 505 and a second grid 510. A first plurality of surface channels 500 and a second plurality of surface channels 530 in the plurality of surface channels 525 may intersect to form the first grid 505. In some embodiments, the first plurality of surface channels 525 and the second plurality of surface channels 530 in the first grid 505 may intersect to form an intersection angle 515. The intersection angle 515 may be approximately 90 degrees and form a square grid pattern. In some embodiments, the plurality of surface channels 500 may further include a third plurality of surface channels 535. The third plurality of surface channels 535 may intersect with the first plurality of surface channels 525 and the second plurality of surface channels 530 to form the second grid 510. In some embodiments, the third plurality of surface channels 535 may intersect with the first plurality of surface channels 525 and the second plurality of surface channels 530 at the same point where the first plurality of surface channels 525 and the second plurality of surface channels 530 intersect. In some embodiments, the third plurality of surface channels 535 may intersect with the first grid 505 to form the second grid 510. The third plurality of surface channels 535 can intersect the first grid 505 at a grid angle 550. In some embodiments, the grid angle 550 can be approximately 45 degrees.

[0109] In some embodiments, the plurality of surface channels 500 can be spaced apart by a separation distance. For example, each of the first plurality of surface channels 525 can extend from a first end 540 of the manifold layer 205 to a second end 545 opposite the first end 540. In some embodiments, each of the first plurality of surface channels 525 can be spaced apart by a distance D1 along the width WM of the manifold layer 205. The second plurality of surface channels 530 can be perpendicular to the first plurality of surface channels 525. In some embodiments, each of the second plurality of surface channels 530 can be spaced apart by a distance D2 along the length LM of the manifold layer 205. Figure 5A In the example of FIG, D1 and D2 may be between about 8 mm and about 12 mm.

[0110] Figure 5B yes Figure 5A 555 or a second manifold surface 560 opposite the first manifold surface 555. While in Figure 5B Not shown, but in addition to or in lieu of the plurality of surface channels 500 shown on the first manifold surface 555, a plurality of surface channels 500 may be positioned on the second manifold surface 560. In some embodiments, the channel depth CD may be between about 1 mm and about 8 mm, and the channel width CW may be between about 0.5 mm and about 2 mm.

[0111] In some embodiments, the first plurality of surface channels 525 and the second plurality of surface channels 530 in the plurality of surface channels 500 may each have a first channel depth CD1 and a second channel depth CD2, respectively. In some embodiments, the second channel depth CD2 is greater than the first channel depth CD1 (CD2>CD1). In some embodiments, the third plurality of surface channels 535 forming the second grid 510 may have a third channel depth CD3 (not shown). In some embodiments, the first channel depth CD1 and the second channel depth CD2 may be equal so that the first plurality of surface channels 525 and the second plurality of surface channels 530 forming the first grid 505 have the same depth (CD2=CD1). In some embodiments, the third channel depth CD3 is greater than both the first channel depth CD1 and the second channel depth CD2 so that the depth of the second grid 510 is greater than the depth of the first grid 505 (CD3>[CD2=CD1]).

[0112] Figure 6A It can be used with Figure 2A and Figure 2B 1 is a perspective view of another example of a manifold layer 205 associated with some embodiments of the tissue interface 120. In some embodiments, the plurality of surface channels 500 can extend along a first manifold surface 555 of the manifold layer 205. In some embodiments, the plurality of surface channels 500 can extend along both the first manifold surface 555 and the second manifold surface 560. For example, the second plurality of surface channels 530 can extend along the first manifold surface 555, and the first plurality of surface channels 525 can extend along the second manifold surface 560.

[0113] Figure 6B yes Figure 6A120, which illustrates additional features that may be associated with some embodiments. In some embodiments, the first plurality of surface channels 525 may extend along the second manifold surface 560 at a 90 degree angle relative to the second plurality of surface channels 530 extending along the first manifold surface 555. Figure 6A and Figure 6B , the second channel depth CD2 of the second plurality of surface channels 530 can extend from the first manifold surface 555 toward the second manifold surface 560, and the first channel depth CD1 of the first plurality of surface channels 525 can extend from the second manifold surface 560 toward the first manifold surface 555. In some embodiments, the first channel depth CD1 can intersect the second channel depth CD2 to form a channel opening 600 that extends through the first manifold surface 555, the second manifold surface 560, and the thickness of the manifold layer 205.

[0114] Figure 7 It can be used with Figure 1 10 is a perspective side view of another example of a manifold layer 205 associated with some embodiments of the tissue interface 120. In some embodiments, the manifold layer 205 can be formed from two or more layers. For example, the manifold layer 205 can include a first manifold layer 705 and a second manifold layer 710. Similar to the embodiment of the manifold layer 205, the first manifold layer 705 can include a first manifold surface 555 and a second manifold surface 560. The second manifold layer 710 can include a third manifold surface 715 and a fourth manifold surface 720. In some embodiments, the first manifold surface 555, the second manifold surface 560, the third manifold surface 715, and the fourth manifold surface 720 can each include a plurality of surface channels 500. In some embodiments, the first manifold surface 555, the second manifold surface 560, the third manifold surface 715, and the fourth manifold surface 720 can each include a first plurality of surface channels 525 and a second plurality of surface channels 530.

[0115] In some embodiments, the first manifold layer 705 and the second manifold layer 710 can be bonded together to form the manifold layer 205. In some embodiments, the second manifold surface 560 of the first manifold layer 705 can be bonded to the third manifold surface 715 of the second manifold layer 710. In some embodiments, the first plurality of surface channels 525 on the second manifold surface 560 can be aligned with the first plurality of surface channels 525 on the third manifold surface 715, and the second plurality of surface channels 530 on the second manifold surface 560 can be aligned with the second plurality of surface channels 530 on the third manifold surface 715 to form at least one cross-sectional channel 725 extending into the thickness of the manifold layer 205 substantially parallel to the first manifold surface 555, the second manifold surface 560, the third manifold surface 715, and the fourth manifold surface 720. In some embodiments, the at least one cross-sectional channel can be a plurality of cross-sectional channels 725. In other embodiments, the manifold layer 205 can be formed using a single layer, such as the manifold layer 205, and perforating the manifold layer 205 along the length and width of the manifold layer 205 to form the plurality of cross-sectional channels 725.

[0116] In other embodiments, the manifold layer 205 can be a laminate of different densities of closed cell foam. In such embodiments, the manifold layer 205 can feel more flexible. In other embodiments, the laminate forming the manifold layer 205 can include three layers, such as two outer layers and one inner layer. The inner layer can be sandwiched between the outer layers. The outer layers can be stiffer than the inner layer, and the inner layer can be softer and more likely to conform. In yet other embodiments, the manifold layer 205 can be perforated along its length and width by closed cell foam to provide lateral manifold channels, such as the plurality of cross-sectional channels 725. The plurality of cross-sectional channels 725 can be formed by bonding at least two laminate layers, with the channels thermoformed onto the surface of the laminate layers. The bonding process does not seal the channels closed. Thus, each thinner layer of closed cell foam will be embossed on each side and then bonded to form a multi-oriented manifold structure. Suitable adhesives for bonding include hot melt. The hot melt can be pattern coated onto the surface so as not to block the channels. In some embodiments, the adhesive can be sprayed onto the surface of the manifold layer 205. If the depth of the channels is about 2 to 3 millimeters, a fine mist of adhesive is unlikely to block the channels. Additionally or alternatively, solvent borne adhesives such as acrylic or reactive polyurethane can be used. A form of thermal lamination can also be used, where localized heat is applied to the foam layers to soften or tack the bonding surface before the foam layers are pressed together. A two-part reactive adhesive can also be used, where one surface is coated with a first adhesive and the other surface is coated with a second adhesive. The surfaces including the first and second adhesives are then brought together to form the bond.

[0117] In other embodiments, one or both of the outer surfaces of the manifold layer 205 can include a texture. For example, one or both of the first manifold surface 555 and the fourth manifold surface 720 can include a texture. The texture can allow areas of the manifold layer 205 that do not contain channels to form manifold regions. In some embodiments, the texture can include a random peak pattern, such as a tough Standex finish; a leather-effect pattern; a pyramidal pattern; a triangular pattern; or other shaped patterns. Additionally or alternatively, one or both of the outer surfaces of the manifold layer 205 can be coated with a hydrophilic or hydrophobic material (e.g., by plasma coating) to modify the fluid distribution characteristics of the manifold layer 205. In some embodiments, the channels of the manifold layer 205 can be specifically coated with a hydrophilic or hydrophobic material.

[0118] In yet other embodiments, all or some of the layers forming the manifold layer 205 can be different colors. Different colors can improve visualization of fluids, such as bleeding. A full range of colors can be used to form the manifold layer 205.

[0119] Main references Figure 8 and Figure 9 , an exemplary embodiment of a portion of a therapeutic system 100 is presented. Figure 8 and Figure 9 The therapeutic system 100 is depicted assembled in stages at a tissue site 805, which can be a wound. In some embodiments, the tissue site 805 can be a deep wound. In some embodiments, the tissue site 805 can include a portion through the epidermis 810, the dermis 815, and the subcutaneous tissue 820. Figure 9 , the dressing 110 can be positioned within the tissue site 805. The geometry and dimensions of the tissue interface 120, the cover 125, or both can be varied to suit a particular application or anatomical structure. For example, the dressing 110 can be cut to the dimensions of a particular area or anatomical region. The dressing 110 can be cut without losing fragments of the tissue interface 120 and without separating the tissue interface 120. In other embodiments, the dressing 110 can be placed proximate to the tissue site 805.

[0120] The tissue interface 120 can be placed in, over, on, or otherwise proximate to the tissue site 805. The manifold layer 205 can be cut to size, folded, and rolled into the tissue site 805. In some embodiments, a cover 125 can be placed over the manifold layer 205. The cover 125 can be configured to create a sealed space at the tissue site that contains the manifold layer 205. The negative pressure source 105 can be configured to be positioned in fluid communication with the sealed space and the manifold layer 205 through the cover 125.

[0121] In some examples, the dressing 110 may include one or more attachment means. In some embodiments, one or more of the attachment means may include an adhesive 905. In some examples, the adhesive 905 may be, for example, a medically acceptable pressure-sensitive adhesive that extends around the perimeter, a portion, or the entire surface of each of the cover members 125. In some embodiments, for example, the adhesive 905 may be an acrylic adhesive having a coating weight between 25 grams per square meter (gsm) and 65 grams per square meter. In some embodiments, a thicker adhesive or a combination of adhesives may be applied to improve the seal and reduce leakage. In some embodiments, such an adhesive 905 layer may be continuous or discontinuous. The interruptions in the adhesive 905 may be provided by openings or holes (not shown) in the adhesive 905. The openings or holes in the adhesive 905 may be formed after the adhesive 905 is applied or by pattern-coating the adhesive 905 on a carrier layer, such as, for example, on one side of the cover member 125. In some exemplary embodiments, the size of the openings or holes in the adhesive 905 may also be set to enhance the MVTR of the adhesive 905.

[0122] Adhesive 905 can be provided on the underside of the cover 125 and can be pressed onto the cover 125 and the epidermis 810 (or other attachment surface) to secure the dressing 110 in place and seal the tissue interface 120 above the patient. In some embodiments, adhesive 905 can be provided only around the edges of the cover 125.

[0123] Figure 9 Also shown is an example of a fluid conductor 910 and a dressing interface 915. Figure 9 As shown in the example of , the fluid conductor 910 can be a flexible tube that can be fluidly coupled to a dressing interface 915 at one end. The dressing interface 915 can be an elbow connector. In some examples, the tissue interface 120 can be applied to the tissue site before the cover 125 is applied over the tissue interface 120. The cover 125 can include an opening 920, or the opening 920 can be cut into the cover 125 before or after the cover 125 is positioned over the tissue interface 120. The opening 920 can be located off-center or adjacent to an end or edge of the cover 125. In other examples, the opening 920 can be located in the center. The dressing interface 915 can be placed over the opening 920 to provide a fluid path between the fluid conductor 910 and the tissue interface 120. In other examples, the fluid conductor 910 can be inserted directly into the tissue interface 120 through the cover 125.

[0124] If not already configured, the dressing interface 915 can be positioned over the aperture 920 and attached to the cover 125. The fluid conductor 910 can be fluidly coupled to the dressing interface 915 and the source of negative pressure 105.

[0125] Negative pressure from the negative pressure source 105 can be distributed to the tissue interface 120 via the fluid conductor 910 and the dressing interface 915. The dressing 110 can be a backing pad used to assist in closing the tissue site 805. The tissue interface 120 can contract in response to the application of negative pressure. In some embodiments, the manifold layer 205 of the tissue interface 120 is configured to contract. For example, under applied negative pressure, the manifold layer 205 can contract radially in all directions.

[0126] Figure 10 is a table showing the improved collapse percentage of the tissue interface 120 according to the present disclosure. Testing was performed on manifolds including multiple holes (shaped like an oval, a star, a parallelogram, and a parallelogram with overlapping perforations). The testing measured the collapse percentage of each manifold under negative pressure (approximately -125 mm Hg). The collapse percentage typically ranged from about 20% to 30% of the initial area of ​​the manifold. However, the collapse percentage of the manifolds having holes shaped like a parallelogram and the manifolds having holes shaped like a parallelogram with overlapping perforations according to the present disclosure resulted in 32.05% and 35.51% collapse, respectively, which was higher than any other shape or pattern tested.

[0127] 11A to 11D Another exemplary embodiment of a treatment system 100 is directed to a device configured for use on an open cavity, such as the abdominal cavity. In some embodiments, 11A to 11D The treatment system 100 may include a dressing 110 having a treatment device 1102. For example, in some embodiments, the tissue interface of the dressing 110 may include the treatment device 1102. The open cavity reduced pressure treatment system 100 and the treatment device 1102 are used to treat a tissue site 805 of a patient. The tissue site 805 can be any body tissue of a human, animal, or other organism, including bone tissue, adipose tissue, muscle tissue, dermal tissue, tissue, connective tissue, cartilage, tendon, ligament, or any other tissue. In this exemplary embodiment, the tissue site 805 includes tissue in a body cavity, particularly the abdominal cavity, and includes abdominal contents or tissue proximal to the abdominal cavity. Treatment of the tissue site 805 may include removing fluids such as exudate or ascites, protecting the abdominal cavity, or reducing pressure.

[0128] As shown, treatment device 1102 is positioned within the abdominal cavity of a patient to treat tissue site 805. Treatment device 1102 includes a plurality of encapsulated leg members 1106 supported by abdominal contents, which form a surface upon which leg members 1106 are positioned. One or more of leg members 1106 may be positioned in or near a first paracolic gutter 1108, and one or more of leg members 1106 may be positioned in or near a second paracolic gutter 1110. Leg members 1106 are coupled to a central connecting member 1112, and fluid communication exists between leg members 1106 and central connecting member 1112. Leg members 1106 and / or central connecting member 1112 may be formed with fenestrations 1114, 1116, 1118, 1120 (or other such passages or perforations) that allow fluid in the abdominal cavity to pass therethrough. The windows 1114, 1116, 1118, 1120 can take any shape, such as a circular opening, a rectangular opening, a polygon, etc., but in this exemplary embodiment are presented as slits or linear cuts. In alternative embodiments, one or more windows 1114, 1116, 1118, 1120 can be omitted.

[0129] Manifold pad 1122 (which may be similar to Figure 1 11. The manifold 1122 may be configured to distribute reduced pressure to the treatment device 1102. For example, the tissue interface 120 may include a manifold pad 1122 coupled to the treatment device 1102. A sealing member, such as a cover 125, may provide a pneumatic seal over the body cavity opening 1126. One or more skin closure devices may be placed over the patient's epidermis 1134. Reduced pressure is delivered to the manifold pad 1122 through the dressing interface 915, which is coupled to the fluid conductor 910. The negative pressure source 105 delivers reduced pressure to the fluid conductor 910.

[0130] Decompression can be applied to tissue site 805 to help promote the removal of ascites, exudate or other fluids from tissue site 805. In some cases, decompression can be applied to stimulate the growth of other tissues. In some cases, only fluid removal may be required. In the case of a wound at tissue site 805, the growth of granulation tissue, the removal of exudate or the removal of bacteria can help promote wound healing. In the case of non-injured or non-defective tissue, decompression can be used in some cases to promote tissue growth, and the tissue can be collected and transplanted to another tissue site.

[0131] The reduced pressure may initially generate fluid flow in the manifold pad 1122, the fluid conductor 910, and the nearby tissue site 805. When the static pressure of the fluid surrounding the tissue site 805 approaches the desired reduced pressure, the flow may subside and the reduced pressure may be maintained.

[0132] Figure 11A11. The manifold pad 1122 is positioned adjacent the central connecting member 1112. The manifold pad 1122 can take a variety of forms. Similar to the description above, as used herein, the term "manifold" generally refers to a substance or structure provided to assist in applying reduced pressure to, delivering fluid to, or removing fluid from, the tissue site 805. The manifold pad 1122 typically includes a plurality of flow channels or pathways that distribute fluid provided to and removed from the tissue site 805 around the manifold pad 1122 and through the central connecting member 1112. In an exemplary embodiment, the flow channels or pathways are interconnected to improve the distribution of fluid provided to or removed from the tissue site 805. The manifold pad 1122 can be a biocompatible material that can be placed in contact with the tissue site 805 and distribute reduced pressure to the tissue site 805.

[0133] Examples of suitable materials for the manifold pad 1122 may include, but are not limited to, devices having structural elements arranged to form flow channels, porous foams such as open-cell foams, porous tissue collectors, liquids that include or solidify to include flow channels, gels, and foams. The manifold pad 1122 may be porous and may be made of foam, gauze, felt, silicone, polyvinyl alcohol, or any other material suitable for a particular biological application. In one embodiment, the manifold pad 1122 is a porous foam and includes a plurality of interconnected pores or holes that act as passageways or flow channels. The porous foam may be an open-cell reticulated foam made of polyurethane or polyether, such as GRANUFOAM available from Kinetic Concepts, Incorporated of San Antonio, Texas, USA. TM Materials. Other embodiments may include "closed cells." These closed-cell portions of the manifold may contain a plurality of pores, most of which are not fluidically connected to adjacent pores. Closed cells may optionally be provided in the manifold pad 1122 to prevent fluid from being transferred through the peripheral surface of the manifold pad 1122. In some cases, the manifold pad 1122 may also be used to distribute fluids such as drugs, antimicrobials, growth factors, and various solutions to the tissue site 805. Other layers may be included in or on the manifold pad 1122, such as absorbent materials, wicking materials, hydrophobic materials, and hydrophilic materials.

[0134] Depending on the application, the density is higher than GRANUFOAM TM Materials higher or lower may be desired. Among the many possible materials, the following can be used: GRANUFOAM TM Materials, FOAMEX TMTechnical foam, a molded bed of staple structures, a patterned mesh material (such as those manufactured by Sercol Industrial Fabrics), a 3D textile (such as those manufactured by Baltex of Derby, UK), gauze, a member containing a flexible channel, a graft, or the like. In some cases, ionic silver can be added to the manifold pad 1122 by, for example, a microbonding process. Other substances, such as antimicrobial agents, can also be added to the manifold pad 1122.

[0135] Figure 11A The cover 125 in is configured to be placed over the body cavity opening 1126 and can be formed of any material capable of providing a pneumatic or fluid seal suitable for enabling the open cavity reduced pressure system 100 to maintain reduced pressure at the tissue site 805. The cover 125 can be used to secure the manifold pad 1122 to the central connecting member 1112. The cover 125 can be impermeable or semi-permeable. After the cover 125 is installed over the body cavity opening 1126, the cover 125 can maintain reduced pressure at the tissue site 805. The cover 125 can be a flexible drape or membrane formed from a silicone-based compound, acrylic, a hydrogel, or a material that forms a hydrogel, or any other biocompatible material that includes impermeable or permeable properties as desired for applying reduced pressure to the tissue site 805.

[0136] The cover 125 may also include an attachment means 1131 for securing the cover 125 to the patient's epidermis 1134. The attachment means 1131 may take a variety of forms; for example, an adhesive layer 1136 (e.g., having a Figure 9 An adhesive layer 1136 (e.g., adhesives such as adhesives of the type described herein) may be positioned along the perimeter of the cover 125 or any portion of the cover 125 to directly or indirectly provide a pneumatic seal to the patient's epidermis 1134. An adhesive layer 1136 may also be pre-applied to the cover 125 and covered with a removable backing or member (not shown) that is removed upon application. In some embodiments, the adhesive layer 1136 may include adhesive 905 or a similar adhesive material.

[0137] As one example, the dressing interface 915 can be a port or connector that allows fluid to pass from the manifold pad 1122 to the fluid conductor 910, and vice versa. For example, fluid collected from the tissue site 805 using the manifold pad 1122 and the therapy device 1102 can pass into the fluid conductor 910 via the connector. In another embodiment, the open cavity reduced pressure system 100 can omit the connector, and the fluid conductor 910 can be inserted directly into the cover 125 and into the manifold pad 1122. The fluid conductor 910 can be a medical catheter or tubing or any other device for transporting reduced pressure and fluid. The fluid conductor 910 can be a multi-lumen member for easy delivery of reduced pressure and removal of fluid. In one embodiment, the fluid conductor 910 is a dual lumen catheter, with one lumen for reduced pressure and liquid transport and one lumen for pressure communication to a pressure sensor.

[0138] Reduced pressure is generated by the reduced pressure source 105 and supplied to the fluid conductor 910. A wide range of reduced pressures can be generated or supplied by the reduced pressure source 105. In one embodiment, the range can include -50 mm Hg to -300 mm Hg, and in another embodiment, the range can include -100 mm Hg to -200 mm Hg. In one illustrative embodiment, the reduced pressure source 105 includes preset selectors for -100 mm Hg, -125 mm Hg, and -150 mm Hg. The reduced pressure source 105 can also include a plurality of alarms, such as an occlusion alarm, a leak alarm, or a low battery alarm.

[0139] A number of different devices can be added to the intermediate portion of the fluid conductor 910. For example, the devices can be a fluid reservoir, or canister collection member, a pressure feedback device, a volume detection system, a blood detection system, an infection detection system, a filter, a port with a filter, a flow monitoring system, a temperature monitoring system, etc. Multiple devices can be included. Some of these devices (e.g., the fluid collection member) can be integrally formed with the reduced pressure source 105. For example, the reduced pressure port on the reduced pressure source 105 can include a filter member (not shown) that includes one or more filters, and can include a hydrophobic filter that prevents liquid from entering the interior space of the reduced pressure source 105.

[0140] Referring now to Figure 11A , Figure 11C and Figure 12 , the therapy device 1102 can include a non-adherent drape 1148. The non-adherent drape 1148 can be formed from a non-adherent material that prevents tissue from adhering to the non-adherent drape 1148. In some embodiments, the non-adherent drape 1148 can be similar to the non-adherent drape 1148 described above with respect to the therapy device 1102. Figure 2B2. The non-adhesive drape 1148 may comprise a substantially fluid-impermeable layer, which may be the membrane layer 220. In some embodiments, the non-adhesive drape 1148 is formed from a breathable polyurethane film. The non-adhesive drape 1148 may comprise a plurality of openings, apertures, channels, perforations, or fenestrations 1150. The fenestrations 1150 may take a variety of shapes, such as circular openings, rectangular openings, polygonal openings, etc., but are shown in FIG2 as slits or linear cuts. The fenestrations may have different sizes depending on the specific application of the therapeutic device 1102, the desired fluid flow and / or pressure delivery, or other system parameters.

[0141] refer to Figure 11A 、 Figure 11D and Figure 12 , the treatment device 1102 includes a central connecting member 1112 to which a plurality of encapsulated leg members 1106 are coupled. The central connecting member 1112 includes a connecting manifold member 1154 that is encapsulated by a first connecting encapsulating member 1186 (which may be referred to as a first non-adhesive drape 1186) and a second connecting encapsulating member 1192 (which may be referred to as a second non-adhesive drape 1192). A portion of the central connecting member 1112 may be fluidly coupled at the leg coupling region 1152 to allow fluid communication between the central connecting member 1112 and the plurality of encapsulated leg members 1106. The first connecting encapsulating member or non-adhesive drape 1186 and the second connecting encapsulating member or non-adhesive drape 1192 may be defined by a single piece of material or, as shown, by more than one piece of material. For example, the non-adhesive drape 1148 may be used as a single piece or may include the first non-adhesive drape 1186 and the second non-adhesive drape 1192.

[0142] As discussed above, the central connecting member 1112 can be in fluid communication with the manifold pad 1122. In one aspect, fenestrations 1118, similar to those described above, can allow for fluid communication. Additionally or alternatively, one or more portions of the first connecting enclosure member or non-adhesive drape 1186 can be exposed to the manifold pad 1122.

[0143] Reference again 11A to 11D Each of the plurality of enclosed leg members 1106 can include a leg manifold member 1160, which can be a single manifold member extending between the leg modules 1156 and / or the central connecting member 1112, or a separate manifold component. The leg manifold member 1160 is disposed within an interior portion 1162 of each enclosed leg member 1106. Each leg manifold member 1160 has a first side 1164 and an inwardly facing (patient-facing) second side 1166.

[0144] In some embodiments, the junction manifold member 1154 and one or more leg manifold members 1160 extending from the junction manifold member 1154 can form a treatment manifold 1167. The treatment manifold 1167 including the leg manifold members 1160 and the junction manifold member 1154 can include or be formed of a manifold material that is a foam or similar or analogous to the manifold materials described herein with respect to the manifold pad 1122 or the manifold layer 205.

[0145] In some embodiments, a non-adhering drape 1148 can surround the treatment manifold 1167. For example, the non-adhering drape 1148 can be coupled around the leg manifold members 1160 and the junction manifold member 1154 to provide a plurality of enclosed leg members 1106 in fluid communication with the central connection member 1112. In some embodiments, the non-adhering drape 1148 can include a first non-adhering drape 1186 and a second non-adhering drape 1192, and the treatment manifold 1167 can be positioned as a layer between the first non-adhering drape 1186 and the second non-adhering drape 1192. The first non-adhering drape 1186 can be coupled to the second non-adhering drape 1192 to provide a plurality of enclosed leg members 1106 in fluid communication with the central connection member 1112.

[0146] In one embodiment, one or more of the plurality of leg manifold members 1160 can have different material properties or structures. For example, different flow rates can be required in different enclosed leg members 1106. In one aspect, different manifold materials or manifold properties, different manifold sizes, manifold compression, use of flow restriction material structures, and / or valves can provide different fluid flow rates through the enclosed leg members and / or the central connection member.

[0147] In one aspect, a first leg encapsulating member 1168, which may be formed with fenestrations 1114, is disposed on a first side 1164 of the leg manifold member 1160. A second leg encapsulating member 1170, which may include fenestrations 1116, is disposed on an inwardly facing second side 1166 of the leg manifold member 1160. The first leg encapsulating member 1168 and the second leg encapsulating member 1170 may be part of a non-adhesive drape 1148. In some embodiments, the first leg encapsulating member 1168 may be part of a first non-adhesive drape 1186, and the second leg encapsulating member 1170 may be part of a second non-adhesive drape 1192. In some embodiments, the encapsulated leg members 1106 may be coupled to one another, for example, via the drapes 1148. In some embodiments, the encapsulated leg members 1106 may be independently movable relative to one another, except for their proximal ends adjacent the central connecting member 1112. For example, the encapsulated leg members 1106 need not be connected to one another. In another embodiment, a portion of the material connecting the encapsulated leg members 1106 (e.g., the non-adhesive cover cloth 1148 between adjacent encapsulated leg members 1106) is expandable (e.g., a stretchable, flexible, deformable and / or elastic material) and allows the individual encapsulated leg members 1106 to move relative to each other.

[0148] like Figure 11B As shown by arrows 1172 in the longitudinal cross-section of FIG, fluid can flow from the leg module 1156 to the central connecting member 1112. As shown by arrows 1174, the fluid can enter the fenestrations 1114 and 116 and flow into the leg manifold member 1160 and then flow to the central connecting member 1112, as shown by arrows 1172.

[0149] In plan view, the enclosed leg member 1106 can take a variety of different shapes, such as an elongated shape, a rectangular shape, an oval shape, etc. In one aspect, the enclosed leg member 1106 can include leg modules 1156. Adjacent leg modules 1156 are fluidly coupled to each other and have a manipulation area 1158 therebetween. In one aspect, the manipulation area includes a weakened or perforated area to facilitate sizing the device. For example, a clinician can cut through a leg module to determine the size of the device. By pulling on the partially cut leg module, the manifold can be torn off at the next manipulation area. In one aspect, the recessed shape of the manipulation area 1158 can prevent additional leg modules from being accidentally removed. Additionally or alternatively, an outer portion of the leg module can be secured to the device to prevent undesirable manifold removal.

[0150] The encapsulated leg member 1106 may also have various dimensions. If the longer dimension (e.g., lengthwise or longitudinal dimension) of the encapsulated leg 106 is L1 and the width is w1, then the aspect ratio is given by L1 / W1. The aspect ratio may be 8.0, 7.0, 6.0, 5.0, 4.0, 3.0, 2.0, or any value therebetween. In addition, other aspect ratios are also possible. Typically, the width w1 of the encapsulated leg member will be greater than the width w2 of the central connecting member 1112, i.e., w2>w1. For example, in one exemplary embodiment, the encapsulated leg member 1106 is approximately 270 mm long, 60 mm wide (w1), and 10 mm thick, and the central connecting member has a width (w2) of approximately 130 mm parallel to the first width (w1). Therefore, in this exemplary example, the aspect ratio of the encapsulated leg 106 is approximately (270 / 60) or 4.5. In this same exemplary embodiment, the manipulation region 158 has a width of approximately 10 mm.

[0151] refer to Figure 11C , shows a lateral cross-section of a portion of the encapsulated leg member 1106. As previously described, it can be seen that the first side 1164 of the leg manifold member 1160 is covered with the first leg encapsulation member 1168, and the inwardly facing second side 1166 of the leg manifold member 1160 is covered with the second leg encapsulation member 1170, which in this case is a portion of the non-adhesive drape 1148. Thus, in this exemplary embodiment, the fenestrations 1116 can be some of the plurality of fenestrations 1150 in the non-adhesive drape 1148. In this exemplary embodiment, the peripheral edge 1176 of the leg manifold member 1160 is also covered by a portion of the first leg encapsulation member 1168. The peripheral edge 1176 includes a first lateral edge 1177 and a second lateral edge 1179. The first leg encapsulation member 1168 covers the first side 1164 and the peripheral edge 1176, extends onto the first surface 1178 of the non-adhesive drape 1148 and forms an extension 1180. The extension 1180 has been coupled to the second leg encapsulation member 1170 by a weld 1182. However, the first leg encapsulation member 1168 may be coupled to the second leg encapsulation member 1170 using any known technique, including welding (e.g., ultrasonic welding or RF welding), bonding, adhesives, glues, etc.

[0152] In some embodiments, at least a portion of the longitudinal length of at least one of the encapsulated leg members 1106 is configured to contact the tissue site 805. Additionally, in some embodiments, fenestrations 1116 can be positioned along the longitudinal length of at least one of the encapsulated leg members 1160.

[0153] Reference again Figure 11D and Figure 12, the central connecting member 1112 includes a connecting manifold member 1154 enclosed within a first connecting encapsulating member 1186 having a window 1118. The first connecting encapsulating member 1186 is disposed on a first side 1188 of the connecting manifold member 1154. A second connecting encapsulating member 1192 is disposed on an inwardly facing second side 1190 of the connecting manifold member 1154. The second connecting encapsulating member 1192 is formed with a window 1120. As shown in FIG. 2 , the first connecting encapsulating member 1186 has a peripheral region or edge 1194. In a similar manner, the second connecting encapsulating member 1192 has a peripheral region or edge (not explicitly shown) that is aligned with the peripheral edge 1194. The peripheral edge 1194 of the first connecting encapsulating member 1186 is coupled to the peripheral edge of the second connecting encapsulating member 1192, except at the leg coupling area 1152, so as to allow fluid within the plurality of encapsulated leg members 1106 to flow into the connecting manifold member 1154, as shown. Figure 11D 1196. Fluid can also enter the connection manifold member 1154 directly by flowing through the fenestrations 1120, as indicated by arrows 1198. Manifold pad 1122 is positioned adjacent to first connection enclosure member 1186, and when reduced pressure is applied to manifold pad 1122, the reduced pressure causes fluid to flow from the connection manifold member 1154, through the fenestrations 1118, and into manifold pad 1122, as indicated by arrows 1200. The fluid continues to flow in the direction of the dressing interface 915, through which it is removed to the fluid conductor 910.

[0154] refer to 11A to 11D and Figure 12 In operation, the exemplary open cavity decompression system 100 may be used by first sizing the treatment device 1102, as will be described below in conjunction with Figure 13A As further explained, a non-adherent drape 1148 having a plurality of containment leg members 1106 is positioned within the abdominal cavity through the body cavity opening 1126 and dispensed against the abdominal contents; this may include placing at least one containment leg member 1106 in or near the first paracolic gutter 1108, the second paracolic gutter 1110, or behind the liver, etc. Once the treatment device 1102 has been dispensed, the manifold pad 1122 is placed adjacent to the first side 1184 of the first connected containment member 1186. The cover 125 can then be applied over the body cavity opening 1126 to provide a pneumatic seal thereover.

[0155] In addition to the cover 125, the body cavity opening 1126 can be closed or reinforced using mechanical closure devices such as staples or using a reduced pressure closure system. The cover 125 can be applied in a variety of ways, but according to one illustrative embodiment, a peelable backing member on an adhesive layer 1136 of the cover 125 is removed and the cover 125 is then placed around the body cavity opening 1126 against the epidermis 1134 of the patient. The dressing interface 915 is then coupled or attached to the cover 125 so that reduced pressure can be delivered by the dressing interface 915, through the cover 125, and to the manifold pad 1122 and the central connecting manifold member 1154. The fluid conductor 910 is fluidly coupled to the dressing interface 915 and to the reduced pressure port on the reduced pressure source 105.

[0156] The reduced pressure source 105 is activated and thereby provides reduced pressure into the fluid conductor 910, which delivers the reduced pressure to the dressing interface 915 and into the manifold pad 1122 and the central connecting manifold member 1154. The manifold pad 1122 distributes the reduced pressure and draws fluid through the windows 1118 from the connecting manifold member 1154. As shown by arrows 196, the connecting manifold member 1154 draws fluid from the abdominal cavity through the windows 1120 and from the plurality of enclosed leg members 1106. Fluid from the abdominal cavity flows into the plurality of enclosed leg members 1106 through the windows 1114 on the first leg enclosed member 1168 and through the windows 1116 on the second leg enclosed member 1170 and then flows through the legs as shown by arrows 1172 toward the connecting manifold member 1154. The fluid then flows through the manifold pad 1122, the dressing interface 915, and into the fluid conductor 910.

[0157] Referring now to 13A to 13C , another illustrative embodiment of an open cavity reduced pressure therapy device 1302 is presented. The open cavity reduced pressure therapy device 1302 is similar in most respects to the therapy device 1102 of Figures 11A-11D . This open cavity reduced pressure therapy device 1302 has a non-adhering drape 1304 (which can be similar to the non-adhering drape 1148 in Figure 11A ), a plurality of enclosed leg members 1306, and a central connecting member 1308. In this particular illustrative embodiment, the non-adhering drape 1304 is generally formed into an oval or arcuate shape. The non-adhering drape 1304 is formed with a plurality of windows 1305, which can be similar to, for example, the windows 1114, 1116, 1118, 1120, and 1150. The non-adhering drape 1304 forms a second leg enclosed member (see the analogous second leg enclosed member 1170 in Figure 11B ) and a second connecting enclosed member (see the analogous second connecting enclosed member 1168 in Figure 11D1192). Thus, the plurality of fenestrations 1305 serve as flow passages for the plurality of encapsulated leg members 1306 and the central connecting member 1308 on the second, inwardly facing side. The non-adhesive drape 1304 may also be used on the first side of the plurality of encapsulated leg members 1306 and the central connecting member 1308.

[0158] Each enclosed leg member 1306 may be formed with a plurality of leg modules 1310 with a maneuvering area 1312 therebetween. Figure 11A -D, the manipulation area 1312 facilitates movement of the plurality of containment leg members 1306 within the body cavity and provides an easier location for cutting the plurality of containment leg members 1306 when the open cavity reduced pressure treatment device 1302 is sized for a particular application. In this regard, visual markings 1314 may be added to the non-adhesive drape 1304 to assist the healthcare provider in knowing where to cut the non-adhesive drape 1304 for different sized applications within the cavity. The visual markings 1314 may include a cut line, a shaped perforation line, or a scale that preferably passes through the manipulation area 1312. The manipulation area 1312 provides a convenient and easy location for cutting the open cavity reduced pressure treatment device 1302.

[0159] refer to Figure 13C , shows a lateral cross-section of a portion of the encapsulated leg member 1306. The plurality of encapsulated leg members 1306 are formed with a leg manifold member 1318 having a first side 1320 and a second, inwardly facing (patient-facing) side 1322. A first leg encapsulating member 1324 covers the first side 1320 of the leg manifold member 1318 and covers a lateral region or edge 1326 of the leg manifold member 1318. The second inwardly facing side 1322 of the leg manifold member 1318 is covered by a second leg encapsulating member 1328, which in this embodiment is a portion of the non-adhesive drape 1304. The first leg encapsulating member 1324 is coupled to the second leg encapsulating member 1328 by any means known in the art, such as by welding (e.g., ultrasonic or RF), bonding, adhesive, glue, etc. In this exemplary embodiment, first leg encapsulation member 1324 and second leg encapsulation member 1328 are coupled by weld 1330. Figure 13B , welds 1330 are shown along the perimeter of the plurality of leg modules 1310 .

[0160] Reference again Figure 13A , the central connecting member 1308 is similar to Figure 1213. The first and second connected enclosure members 1334 and 1336 of the central connection member 1308 are connected along a peripheral edge 1332 using welds 1333 or another connection technique, such as those previously mentioned. However, the peripheral edge 1332 is not sealed near each of the enclosure leg members 1306 to provide a passage for fluid to flow from the plurality of enclosure leg members 1306 into the central connection member 1308.

[0161] According to an exemplary method for constructing an open cavity decompression treatment device 1302, a non-adhesive drape 1304 having a plurality of fenestrations 1305 formed therein and having visual indicia 1314 is provided. A leg manifold member 1318 is disposed adjacent to the non-adhesive drape 1304. A central connection manifold 1308 is disposed adjacent to or may be integrally formed with the leg manifold member 1318. A first connection encapsulation member 1334 is placed on the central connection member 1308, and a first leg encapsulation member 1324 is placed above the leg manifold member 1318. The first connection encapsulation member 1334 and the first leg encapsulation member 1324 may be formed from a unitary sheet of material. Next, welds 1330 and 1333 are applied.

[0162] In an alternative embodiment for manufacturing an open cavity decompression treatment device, a first non-adhesive drape 1304 including a plurality of fenestrations can be provided, and the leg manifold members 1318 and the central connecting manifold 1308 are disposed on the first non-adhesive drape 1304. A second non-adhesive drape having fenestrations is placed over the first non-adhesive drape 1304, the leg manifold members 1318, and the central connecting manifold 1308. Next, multiple welds are performed (e.g., using thermal bonding or RF bonding or another bonding technique), such as using welds 1330. The first non-adhesive drape 1304 and the second non-adhesive drape can be cut to size before or after assembly. By using two drapes, the first non-adhesive drape 1304 and the second non-adhesive drape can provide better decompression distribution and can simplify the manufacturing process.

[0163] The fenestration can be formed before or after assembly. The perimeters of the first non-adhesive drape 1304 and the second non-adhesive drape can be welded. Other points can be welded between the drapes to form a single unit. In another alternative embodiment, the drapes can initially be placed and welded without the fenestration, and then the fenestration can be added to the drapes so that the fenestration is aligned. The fenestration can also be formed using an electrical component that simultaneously cuts and seals to form an aligned "button hole" fenestration through the two drapes.

[0164] Another exemplary embodiment of using an open cavity decompression treatment device or system according to the present disclosure will now be presented. This system may be particularly suitable for temporary bridging of abdominal wall openings where primary closure may not be readily possible and / or repeated abdominal entry is necessary. The exemplary system described herein may be used for open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. Hemostasis should generally be achieved prior to application of the system.

[0165] When deploying the open cavity decompression treatment system, the decompression treatment device preferably covers all exposed internal organs and preferably completely separates these internal organs from contact with the abdominal wall. For example, the size and shape of the lower surface of the decompression treatment device (such as a drape 1148) can be set to allow coverage. The decompression treatment device can be placed over the omentum or exposed internal organs and carefully tucked between the abdominal wall and the internal organs. In doing so, the healthcare provider can use the decompression treatment device to completely separate the abdominal wall from the internal organs.

[0166] To prepare for deployment of the system, any sharp edges or bone fragments are removed or covered from the wound area. The abdominal wound is irrigated and the periwound area is cleaned. The periwound tissue at the epidermis is typically dried before further application.

[0167] The reduced pressure therapy device is then sized by determining the appropriate size and cutting. The reduced pressure therapy device is initially deployed in a sterile field. Either side of the reduced pressure therapy device can be placed over the omentum or viscera. The reduced pressure therapy device is gently placed over the open abdominal cavity. The orientation of the reduced pressure therapy device is determined for the specific application. If the reduced pressure therapy device will be placed around a tube, drain, or falciform ligament, the reduced pressure therapy device is cut only between the multiple encapsulating leg members. The reduced pressure therapy device is placed in the appropriate orientation before cutting.

[0168] The reduced pressure therapy device is then folded to the appropriate size and used in this manner or it can be cut. The healthcare provider holds the reduced pressure therapy device by the edges and lifts the reduced pressure therapy device slightly. With one hand, slowly lower the reduced pressure therapy device into the paracolic gutter and with the other hand, slowly and evenly lower the reduced pressure therapy device. The healthcare provider folds any excess portion of the reduced pressure therapy device upward onto itself. The healthcare provider continues to place the reduced pressure therapy device between the abdominal wall and the internal organs throughout the abdominal compartment. The healthcare provider preferably provides complete coverage of all internal organs. The reduced pressure therapy device can then be cut as needed to determine the size of the outside of the wound.

[0169] To size the device, the reduced pressure therapy device may be cut through the center of one of the large manifold blocks or leg modules using sterile scissors. In this exemplary embodiment, the cut may not be through the manipulation area, but rather through the leg module. The healthcare provider may then, with one hand, pinch the remaining half of the foam block or leg module, and the adjacent inner manipulation area, through the encapsulating member and pull the manifold material. The manifold material in the leg module and manipulation area will separate at the next block or leg module. This will ensure that the edge of the reduced pressure therapy device covers the edge of the manifold that would otherwise be exposed. The manifold material (e.g., foam) preferably does not contact the organ.

[0170] Next, prepare the manifold pad to be placed on top of the central connecting member. In this embodiment, the manifold can be a perforated foam manifold with perforations to assist in tearing the manifold to the desired size. The manifold pad is preferably assembled directly over the treatment device while still in contact with the wound edges. The manifold pad should not contact intact skin. In some cases, two or more manifolds may be used. The sized manifold pad is then gently placed in the wound cavity over the treatment device. The healthcare provider preferably takes care to avoid placing the manifold pad below the level of the abdominal incision or wound.

[0171] The drape, cover, or overdrape is then applied. To apply the drape, the backing can be removed from the adhesive layer on one side of the drape and the drape can be applied. The drape covers the manifold and a portion of the intact epidermis. Preferably, the drape covers at least an 8 cm - 10 cm edge of the intact periwound tissue. Additional drape material can be added to seal any difficult areas.

[0172] The dressing interface or interface pad is then added. The healthcare provider selects the application site. The site is selected to optimize fluid flow and to facilitate easy positioning of the tubing. The healthcare provider pinches the drape and cuts a 2.5 cm hole (preferably not a slit) through the drape. A dressing interface pad is applied, which may have a center disc and a surrounding outer adhesive skirt. The dressing interface pad is applied by removing the backing layer on the inward-facing surface of the interface pad to expose the adhesive. The dressing interface pad opening in the center disc is placed directly over the hole in the drape. Pressure is gently applied to the center disc and outer skirt to ensure complete adhesion of the dressing interface pad. One or more stabilization layers may then be removed from the first side of the skirt. The system is now ready for application of reduced pressure.

[0173] Figure 14A -F shows yet another embodiment of a treatment device 1102 showing additional details that may be associated with some embodiments. Figure 14A -F can be similar in many respects to the exemplary embodiment shown in FIG. 11A to 13CThe embodiment shown differs in that the treatment manifold 1167 (eg, the central connecting manifold member 1154 and / or the leg manifold members 1160) may not be encapsulated. Figure 14A Instead of having a non-adhesive drape (e.g., a membrane) that completely surrounds and / or encloses the treatment manifold 1167, the treatment device 1102 of FIG-F may have only a single film layer 220 or non-adhesive drape in contact with the first surface 1405 of the treatment manifold 1167, and a second surface 1410 of the treatment manifold 1167 (e.g., opposite the first surface 1405) may be exposed and / or not covered by a film or other contact layer or non-adhesive drape. In some embodiments, to address tissue ingrowth that may result from having an exposed manifold surface, the treatment manifold 1167 may be configured to minimize tissue ingrowth. For example, the treatment manifold 1167 may include or consist essentially of closed-cell foam, such as, for example, those manufactured by Zotefoams, Inc. of Walton, Kentucky, USA, including Azote, Plastazote, Evazote, Supazote, and Zotek grades.

[0174] For example, Figure 14A As shown in FIG-F, the treatment device 1102 may include: a central fluid hub 1412, which may include or may be a connection manifold member 1154; a plurality of elongated members 1413, each of which may include or may be a leg manifold member 1160; and only one substantially fluid-impermeable layer (such as the membrane layer 220) attached to the first surface 1405 of each of the leg manifold members 1160. In some embodiments, the fluid-impermeable layer may also be attached to the first surface of the connection manifold member 1154. In some embodiments, the plurality of elongated members 1413 (e.g., the leg manifold members 1160) may extend outward from the central fluid hub 1412 (e.g., the centrally located connection manifold member 1154), and each of the plurality of leg manifold members 1160 may be in fluid communication with the connection manifold member 1154. In some embodiments, the substantially fluid-impermeable layer (eg, membrane layer 220 ) can include a plurality of fenestrations 1305 (eg, configured to allow fluid communication between the manifold and the tissue site through the liquid-impermeable membrane layer 220 ).

[0175] In some embodiments, the treatment manifold 1167 (e.g., the connecting manifold member 1154 and / or the leg manifold members 1160) can be configured to distribute negative pressure (e.g., along one or more exterior surfaces) while substantially minimizing tissue ingrowth during negative pressure therapy. The configuration of the treatment manifold 1167 can allow for effective distribution of negative pressure and / or aspiration of fluid from a tissue site under negative pressure, even when the treatment manifold 1167 is formed from a material that may not be inherently effective for manifolding, distributing negative pressure, and / or aspiration of fluids, such as closed-cell foam. For example, the connecting manifold member 1154 and the leg manifold member 1160 can each include or consist essentially of closed-cell foam (such as, for example, those manufactured by Zotefoams, Inc. of Walton, Kentucky, USA, including Azote, Plastazote, Evazote, Supazote, and Zotek grades), which can be configured with fluid pathways to allow for negative pressure distribution. In some embodiments, the treatment manifold 1167 may be formed of some different manifold material other than closed-cell foam, wherein the different manifold material is configured to minimize tissue ingrowth during negative pressure therapy. For example, the different manifold material may be felted foam. Some alternative embodiments of the treatment device 1102 may include a second film layer (not shown, but which may be similar to the first film layer 220) attached to the second surface 1410 of the treatment manifold 1167. Some other alternative embodiments of the treatment device 1102 (not shown) may not include any film layer, but may include or consist essentially of only a treatment manifold 1167 configured to minimize tissue ingrowth. For example, in such embodiments, no film may be attached to the treatment manifold 1167.

[0176] like Figure 14A As shown in FIG-F, the treatment manifold 1167 may not be encapsulated. For example, the treatment manifold 1167 may be covered by a film on only one surface (e.g., a single film layer 220 may be attached only to the first surface 1405), and the second surface 1410 of the treatment manifold 1167 may be uncovered (e.g., may not contact the film layer and / or may be configured to directly contact tissue). The second surface 1410 of the treatment manifold 1167 may be opposite the first surface 1405, e.g., where the first and second surfaces 1405, 1410 are separated by the thickness of the treatment manifold 1167 (e.g., disposed substantially parallel to and separated by the thickness of the treatment manifold 1167). In some embodiments, the leg manifold members 1160 and the central connecting manifold member 1154 may all be positioned in the same plane. For example, each of the leg manifold members 1160 may extend outwardly from the central connecting manifold member 1154 in substantially the same plane as the central connecting manifold member 1154. In some embodiments, the thickness of the treatment manifold 1167 can be approximately 4 mm to 6 mm.

[0177] In some embodiments, each leg manifold member 1160 can include a proximal end 1415 and a distal end 1420, and the proximal end 1415 of each leg manifold member 1160 can be attached to and in fluid communication with the central connecting manifold member 1154, such that, for example, fluid communication therebetween is through the proximal end 1415 of the leg manifold member 1160. In some embodiments, the leg manifold members 1160 may not contact each other (e.g., there may not be contact between adjacent leg manifold members 1160). Instead, there may be space between adjacent leg manifold members 1160. In some embodiments, a plurality of leg manifold members 1160 can extend outwardly from the central connecting manifold member 1154 to be spaced apart, wherein the space between adjacent leg manifold members 1160 increases as the leg manifold members 1160 extend outwardly. In some embodiments, the plurality of leg manifold members 1160 can include six or eight leg manifold members 1160. In some embodiments, the leg manifold members 1160 can be spaced approximately equally around the central connecting manifold member 1154. For example, adjacent leg manifold members 1160 can be spaced so as to extend at an angle of approximately 45 degrees. In some embodiments, each of the leg manifold members 1160 can be shaped to extend substantially straight away from the central connecting manifold member 1154.

[0178] In some embodiments, the treatment manifold 1167 can be configured to distribute negative pressure (e.g., from the central connecting manifold member 1154 outward through the leg manifold members 1160) and thereby draw fluid from the tissue site through the leg manifold members 1160 to the central connecting manifold member 1154 and out of the central connecting manifold member 1154 toward the source of the negative pressure. And as described above, the treatment manifold 1167 can also be configured to minimize ingrowth of tissue during extended wear or use (e.g., for at least 7 days, at least 10 days, or at least 14 days), for example, by being formed of closed-cell foam. For example, the treatment manifold 1167 can include a plurality of channels 500 (which can be similar to Figures 5A to 71405 or other surfaces of the treatment manifold 1167. In some embodiments, the plurality of channels 500 may be disposed on at least one of the first surface 1405 and the second surface 1410 of the treatment manifold 1167. In some embodiments, the channels 500 may be disposed on both the first surface 1405 and the second surface 1410 of the treatment manifold 1167. In some embodiments, at least some of the through-channels may intersect at least some of the channels 500. For example, in some embodiments, each through-channel in the leg manifold member 1160 may intersect at least one of the plurality of channels 500. In some embodiments, each of the leg manifold members 1160 may intersect with two channels 500, such as a channel 500 on a first surface 1405 and a channel 500 on a second surface 1410 of the treatment manifold 1167, wherein the through-channel extends through the thickness of the treatment manifold 1167 between the first surface 1405 and the second surface 1410.

[0179] In some embodiments, the channels 500 on the first surface 1405 may be offset from the channels 500 on the second surface 1410, such as Figure 14D As shown. For example, the channels 500 on the first surface 1405 may not be aligned with the channels 500 on the second surface 1410 (e.g., may be misaligned across the thickness of the treatment manifold 1167). In some embodiments, the channels 500 on the first surface 1405 may not be directly across from the channels 500 in the second surface 1410 through the thickness of the treatment manifold 1167. In some embodiments, the channels 500 on the first surface 1405 (e.g., the center or deepest portion of the channels 500) may not overlap with the channels 500 on the second surface 1410 (e.g., the center or deepest portion of the channels 500), but may be offset or disposed at an angle through the thickness of the treatment manifold 1167. In some embodiments, the maximum depth of the channels 500 on the first surface 1405 may correspond to the minimum depth of the channels 500 on the second surface 1410 (e.g., the portion of the second surface 1410 that has no channel depth), and vice versa. In some embodiments, this offset can allow the thickness of the treatment manifold 1167 to be substantially consistent across the treatment manifold 1167 despite the presence of the channel 500 .

[0180] Alternatively, if Figure 14EIn some embodiments, as shown, the channels 500 on the first surface 1405 can be aligned with the channels 500 on the second surface 1410. In some embodiments, a center or deepest portion of each channel 500 in the first surface 1405 can be aligned with and / or directly across from a center or deepest portion of a corresponding channel 500 in the second surface 1410, such that the channels 500 in the first surface 1405 and the corresponding channels 500 in the second surface 1410 can be stacked and separated across the thickness of the treatment manifold 1167. This alignment can cause the thickness of the treatment manifold 1167 to vary along its length and / or width, for example, being thinner at points between the aligned channels 500 (e.g., between corresponding channels 500 on the first and second surfaces) and being wider at points between adjacent sets of corresponding channels 500 (e.g., spaced apart along the treatment manifold 1167). In some embodiments, a line extending perpendicularly through the deepest portion of a channel 500 on the first surface 1405 and through the thickness of the treatment manifold 1167 can also extend perpendicularly through the deepest portion of a corresponding channel 500 on the second surface 1410 of the treatment manifold 1167, bisecting the corresponding channels 500 on the opposing surfaces of the treatment manifold 1167.

[0181] In some embodiments, each of the plurality of channels 500 can be about 2 mm wide and / or about 2 mm deep. In some embodiments, each of the plurality of channels 500 can have a depth that is about 1 / 3 to 1 / 2 of the thickness of the manifold (e.g., in portions of the treatment manifold 1167 that do not have channels 500). In some embodiments, the plurality of channels 500 can cover about 50% of the surface area of the first surface 1405 and / or about 50% of the surface area of the second surface 1410 of the treatment manifold 1167. In some embodiments, the plurality of channels 500 can span only the first and / or second surfaces 1410 of the plurality of leg manifold members 1160. In some embodiments, the plurality of channels 500 can span the central connecting manifold member 1154 in addition to the leg manifold members 1160, for example, across the entire first and / or second surfaces 1410 of the treatment manifold 1167.

[0182] In some embodiments, the plurality of channels 500 can include a plurality of longitudinal channels 1430, which can each extend longitudinally along a corresponding leg manifold member 1160, and a plurality of lateral channels 1435, which can extend across the width of a corresponding leg manifold member 1160. In some embodiments, the longitudinal channels 1430 and the lateral channels 1435 can collectively form a grid of channels 500, which can be similar to that described with respect to FIGS. 14A-14B. Figure 5AThe grid of channels 500 can be configured to effectively distribute negative pressure across the treatment manifold 1167 and / or to effectively draw fluid across the treatment manifold 1167. In some embodiments, each leg manifold member 1160 can include two to three longitudinal channels 1430 on the first surface 1405. In some embodiments, each leg manifold member 1160 can include two to three longitudinal channels 1430 on the second surface 1410. In some embodiments, some of the plurality of longitudinal channels 1430 can be located on the first surface 1405 of the treatment manifold 1167, and some of the plurality of lateral channels 1435 can be located on the first surface 1405 of the treatment manifold 1167, some of the plurality of longitudinal channels 1430 can be located on the second surface 1410 of the treatment manifold 1167, and / or some of the plurality of lateral channels 1435 can be located on the second surface 1410 of the treatment manifold 1167. In some embodiments, both the first surface 1405 and the second surface 1410 of the treatment manifold 1167 can have a grid of channels 500 .

[0183] In some embodiments, the plurality of through-channels in the treatment manifold 1167 can include a plurality of constriction openings 210 and / or a plurality of through-holes 1425. In some embodiments, the through-holes 1425 can each have a diameter of approximately 1 mm to 2 mm. In some embodiments, the through-holes 1425 can be distributed or positioned only on the leg manifold members 1160, e.g., wherein each through-hole 1425 passes through the thickness of the corresponding leg manifold member 1160. In some embodiments, each through-hole 1425 can intersect at least one channel 500. In some embodiments, each through-hole 1425 can intersect at least one longitudinal channel 1430 and at least one lateral channel 1435 (e.g., the through-hole 1425 can be positioned at the intersection of the lateral channel 1435 and the longitudinal channel 1430 relative to the grid of channels 500). In some embodiments, each through-hole 1425 can intersect at least one channel 500 on the first surface 1405 and at least one channel 500 on the second surface 1410 of the treatment manifold 1167. In some embodiments, each through-hole 1425 can intersect one longitudinal channel 1430 and one lateral channel 1435 on the first surface 1405, and one longitudinal channel 1430 and one lateral channel 1435 on the second surface 1410. In some embodiments, at least some of the plurality of through-holes 1425 can be located in the central connecting manifold member 1154 (e.g., the plurality of through-holes 1425 can be distributed across the entire treatment manifold 1167).

[0184] In some embodiments, the central connecting manifold member 1154 may include a plurality of constriction openings 210 that may be similar to Figures 2A to 4For example, in some embodiments, the only through-going passages in the central connecting manifold member 1154 may be the contraction openings 210 (although in other embodiments, the central connecting manifold member 1154 may have both through-going passages and contraction openings 210). In some embodiments, a plurality of contraction openings 210 may be positioned or disposed solely on or through the central connecting manifold member 1154. For example, each contraction opening 210 may pass through the thickness of the central connecting manifold member 1154 from the first surface 1405 to the second surface 1410.

[0185] In some embodiments, the plurality of constriction openings 210 in the central connecting manifold member 1154 can be configured to provide constriction radially in all directions upon application of negative pressure. In some embodiments, the leg manifold members 1160 can also have constriction openings 210 that can be configured to provide only longitudinal constriction of the leg manifold members 1160. In some embodiments, all through-channels in the treatment manifold 1167 can be constriction openings 210. In other embodiments, the through-channels in the central connecting manifold member 1154 can be constriction openings 210, and the through-channels in the leg manifold members 1160 can be through-holes 1425 (e.g., not configured to facilitate constriction of the treatment manifold 1167).

[0186] In some embodiments, each of the plurality of constriction openings 210 can intersect at least one of the plurality of channels 500. In some embodiments, each constriction opening 210 can intersect at least one longitudinal channel 1430 and at least one lateral channel 1435 (e.g., the constriction opening 210 can be positioned relative to the grid of channels 500 at the intersection of the lateral channels 1435 and the longitudinal channels 1430). In some embodiments, each constriction opening 210 can intersect at least one channel 500 on the first surface 1405 and at least one channel 500 on the second surface 1410 of the treatment manifold 1167. In some embodiments, each constriction opening 210 can intersect one longitudinal channel 1430 and one lateral channel 1435 on the first surface 1405, and one longitudinal channel 1430 and one lateral channel 1435 on the second surface 1410.

[0187] In some embodiments, the membrane layer 220 can be adhered to the first surface 1405 of the treatment manifold 1167, such as Figure 14B -C. Although the film layer 220 is Figure 14C1405 of the treatment manifold 1167, but in other embodiments, the first surface 1405 and the second surface 1410 can be reversed so that the membrane layer 220 can be attached to the second surface 1410. In some embodiments, the membrane layer 220 can be bonded to the treatment manifold 1167 by an adhesive 905, such as a polyurethane or acrylic adhesive. In some embodiments, the membrane layer 220 can be similar to the membrane layer 220 with respect to the treatment manifold 1167. Figure 11A and Figure 13A In some embodiments, the film layer 220 may comprise or consist essentially of a polyurethane film. In some embodiments, the film layer 220 may be about 75 microns to 120 microns thick. In some embodiments, the film layer 220 may include a plurality of fenestrations 1305, perforations, or channels, which may be similar to those described with respect to Figure 2B 、 Figure 11A and Figure 13A Those described.

[0188] In some embodiments, the membrane layer 220 can span across the first surface 1405 of at least a plurality of the leg manifold members 1160. In some embodiments, the membrane layer 220 can span across the first surface 1405 of the central connecting manifold member 1154. In some embodiments, the membrane layer 220 can extend between the leg manifold members 1160. Figure 14A , the membrane layer 220 is shown spanning the entire first surface 1405 of the treatment manifold 1167 and spanning the space between the leg manifold members 1160.

[0189] In some embodiments, the film layer 220 can include a surface texture (e.g., a microtexture). In some embodiments, the surface texture can be provided on one or both of the first film surface 1440 and the opposing second film surface 1442. For example, Figure 14CAs shown, the surface texture may include a plurality of ridges 1445 and grooves 1447, and in some embodiments, at least one of the ridges 1445 on the first film surface 1440 may correspond to a groove 1447 on the second film surface 1442. In some embodiments, each ridge 1445 on the first film surface 1440 may correspond to a groove 1447 on the second film surface 1442, and vice versa. In some embodiments, the surface texture may include a repetitive pattern that forms a textured surface. For example, the surface texture may include a pattern of ridges 1445 and grooves 1447 that may form peaks and valleys in the film surface, sharp corners, diamonds, triangles, squares, and / or other tessellated shapes. In some embodiments, the peak-to-peak height (e.g., the total film thickness, e.g., between a peak or ridge 1445 on the first film surface 1440 and an adjacent peak or ridge 1445 on the second film surface 1442) may be approximately 1 mm to 1.5 mm. In some embodiments, the spacing between adjacent peaks or ridges 1445 on the first film surface may be approximately 1 mm to 1.5 mm. In some embodiments, the surface texture can be embossed on the film layer 220. In some embodiments, the surface texture can be imparted to the film layer 220 by heating the film and stretching the heated film over a mandrel tool so as to thermoform the surface texture on the film as it cools. In other embodiments, the surface texture can be imparted to the film layer 220 by corrugating the film through a texturing roller.

[0190] In some embodiments, surface texture can be provided on at least a portion of the membrane layer 220 between the leg manifold members 1160, which can form additional fluid pathways (e.g., in addition to the channels 500 and / or through-channels in the treatment manifold 1167) for fluid flow when negative pressure is applied to the treatment device 1102. These additional fluid pathways (e.g., formed by the surface texture of the membrane layer 220) can be configured to allow fluid flow in the area between the leg manifold members 1160 (e.g., providing additional manifolding capabilities beyond those provided solely by the treatment manifold 1167). For example, under negative pressure, fluid can flow along the membrane layer 220 within the grooves 1447 toward the central connecting manifold member 1154, and / or fluid can flow along the membrane layer 220 within the grooves 1447 toward adjacent leg manifold members 1160. In some embodiments, the surface texture may also span portions of the membrane layer 220 that span and / or are attached to the leg manifold members 1160 and / or the central connecting manifold member 1154 (eg, forming a fluid pathway between the membrane and the treatment manifold 1167).

[0191] In some embodiments, for example Figure 14F As shown, the membrane layer 220 may also have one or more indentations 1450 or depressions in the first membrane surface 1440 (e.g., facing the treatment manifold 1167), which may be configured to allow the treatment manifold 1167 to be seated in the membrane layer 220. Although not shown for clarity in FIG. Figure 14F Not shown, but Figure 14C The surface texture shown, including a plurality of ridges 1445 and grooves 1447, can be deployed with indentations 1450. In some embodiments, indentations 1450 can be shaped similarly to the first surface 1405 of the treatment manifold 1167, such that indentations 1450 can form an impression of the treatment manifold 1167. In some embodiments, indentations 1450 can be configured to be complementary in shape to at least the first surface 1405 of the treatment manifold 1167, and indentations 1450 can be configured to allow a complementary portion of the first surface 1405 of the treatment manifold 1167 to be positioned within indentations 1450 in the film layer 220. In some embodiments, when the treatment manifold 1167 is positioned within indentations 1450, the film layer 220 can extend between the leg manifold members 1160 at a level or plane between the first surface 1405 and the second surface 1410 of the treatment manifold 1167 (e.g., the depth of indentations 1450 can be less than the thickness of the treatment manifold 1167).

[0192] Some embodiments of the therapeutic device 1102 may also include one or more lines 1455 of sizing perforations 1457 that generally surround the central connecting manifold member 1154. In some embodiments, the line 1455 of sizing perforations 1457 may form a visual marker for sizing the device. In some embodiments, the line 1455 of sizing perforations 1457 may perforate the membrane layer 220 and the foam of the leg manifold members, or may perforate the membrane layer 220 and extend through the manipulation area of ​​the leg manifold member 1160. In some embodiments, the line 1455 of sizing perforations 1457 may be configured to allow the therapeutic device 1102 to be torn or cut to appropriately size the therapeutic device 1102 for a particular patient. In some embodiments, the line 1455 of sizing perforations 1457 may be spaced (e.g., concentrically) approximately 50 mm to 60 mm apart. Figure 14A -F sizing of the treatment device 1102 (e.g., by tearing or cutting) can be performed without substantially increasing the risk of tissue ingrowth because the closed-cell treatment manifold 1167 can resist such tissue ingrowth (e.g., despite the treatment manifold 1167 being exposed to the tissue site after tearing or cutting to sizing the treatment device 1102).

[0193] In some embodiments, the closed-cell foam manifold may be coated with starch to form a starch coating (not shown). In some embodiments, the starch coating may be configured to initially limit shrinkage of the treatment manifold 1167 and / or stiffen the treatment manifold 1167, but to break down over time. For example, the starch coating may have a thickness of approximately 0.5 mm to 1 mm. In some embodiments of the treatment device 1102, the treatment manifold 1167 may include an antimicrobial coating (not shown). In some embodiments, the antimicrobial coating may include silver and / or an oxygen-containing salt. In some embodiments, the antimicrobial coating may be disposed within the channel 500 of the treatment manifold 1167, for example, between the treatment manifold 1167 and a membrane layer covering the channel 500 of the first surface 1405 of the treatment manifold 1167.

[0194] With respect to manufacturing, it can be similar to the above with respect to Figure 14A -F, the method may include: providing a closed-cell foam treatment manifold (e.g., having a central connecting manifold member and a plurality of leg manifold members extending outwardly from the central connecting manifold member, wherein each of the plurality of leg manifold members is in fluid communication with the central connecting manifold member, and the closed-cell foam manifold is configured to distribute negative pressure); providing a film layer having a plurality of fenestrations; and attaching the film layer to a first surface of the closed-cell foam treatment manifold while leaving a second, opposing surface of the closed-cell foam treatment manifold uncovered (e.g., such that the closed-cell foam manifold can be unencapsulated). In some embodiments, attaching the film layer to the closed-cell foam treatment manifold may include adhering the film layer to the closed-cell foam treatment manifold. For example, adhering the film layer to the closed-cell foam treatment manifold may include applying (e.g., by roller application, spraying, or pattern coating) a polyurethane or acrylic adhesive to the first surface of the closed-cell foam treatment manifold; and applying the film layer so that it is in contact with the adhesive. The adhesive may be applied so that it is not mobile and may not flow over the film or foam during formation so that the adhesive may not block the fenestrations in the film layer or the through-channels in the treatment manifold.

[0195] In some embodiments, providing the closed-cell foam treatment manifold may include forming the closed-cell foam treatment manifold having a plurality of channels and a plurality of through-channels, for example, wherein each of the through-channels intersects at least one of the channels. In some embodiments, the plurality of channels may be formed on at least the first surface of the closed-cell foam treatment manifold. In some embodiments, the plurality of channels may be formed on the first surface and the second surface of the closed-cell foam treatment manifold. In some embodiments, the channels on the first surface may be offset from the channels on the second surface, and providing the closed-cell foam treatment manifold may include providing a 4 mm thick foam blank. In some embodiments, the channels on the first surface may be aligned with the channels in the second surface, and providing the closed-cell foam treatment manifold may include providing a 5 mm to 6 mm thick foam blank. In some embodiments, at least some of the plurality of channels may be formed to extend along the length of the plurality of leg manifold members. In some embodiments, forming the closed-cell foam treatment manifold may include providing a blank of closed-cell foam; and thermoforming the plurality of channels. In some embodiments, forming the closed-cell foam treatment manifold can include perforating the foam blank to form the plurality of through-channels. Some method embodiments can also include maintaining an exposed second surface of the closed-cell foam treatment manifold (e.g., leaving the second surface of the treatment manifold exposed so that the finished treatment device may not be encapsulated, but may have at most one membrane layer attached to the treatment manifold).

[0196] In some embodiments, providing the film layer may include providing a flat film and forming a surface texture (e.g., a microtexture) on the film. In some embodiments, forming the surface texture may include thermoforming the film to form the film layer having a repetitive texture pattern. In some embodiments, forming the surface texture may include wrinkling (e.g., embossing) the film by a texturing roller. In some embodiments, providing the film layer may include providing a flat film and forming an indentation on the film (e.g., the first film surface of the film layer), the indentation being configured to allow the closed-cell foam treatment manifold to be positioned within the indentation. In some embodiments, forming the indentation may include thermoforming the flat film by a die of the first surface of the treatment manifold. In some embodiments, thermoforming (e.g., to form the surface texture and / or the indentation) may include heating the film and stretching the heated film over a mandrel tool. When thermoformed, the thickness of the film may be in the range of 75 microns to 120 microns.

[0197] Some method embodiments can also include forming a constricting aperture in at least the central connecting manifold member. In some method embodiments, the constricting aperture in the central connecting manifold member can be formed to create a radial constriction under negative pressure. Some method embodiments can also include coating the closed cell foam treatment manifold with starch, for example to form a starch coating having a thickness of about 0.5 mm to 1 mm. In some embodiments, the method can also include selecting and providing the starch to substantially prevent constriction, but to decompose and / or be removed from the tissue site by fluid flow so as to allow significant constriction of at least the leg.

[0198] The systems, devices, and methods described herein can provide significant advantages. For example, some embodiments can be configured to allow for resizing without significant risk of tissue ingrowth. Minimizing tissue ingrowth can allow for easier removal of the dressing and / or treatment device without causing significant damage to the tissue site during removal. Some embodiments can also be configured to allow the dressing to be left in place for an extended period of time during use without requiring frequent dressing changes, thereby preventing tissue ingrowth that can occur over an extended wear period. Some embodiments can also be configured to minimize fluid retention in the treatment device, which can prove beneficial in reducing the risk of infection. Some embodiments can be configured to provide radial constriction of the treatment device when negative pressure is applied, which can improve the manifolding of fluids and pressure and / or pull the edges of the wound together to reduce the overall wound size. Some embodiments can be configured to provide additional manifolding and fluid flow (e.g., between the legs of the treatment manifold), thereby improving the overall ability of the dressing to remove fluid from the wound. Some embodiments of the treatment device can provide easier construction and can be more economical, for example by minimizing the number of layers and / or by positioning and / or attaching layers to minimize movement during manufacturing, which can result in improved pricing for the end user. Some embodiments can provide ease of use and can require less personnel training to effectively size the dressing and place the dressing in a wound, for example by allowing for sizing of the dressing to a particular wound without significant concern for tissue ingrowth. These and other advantages can result from the present disclosure.

[0199] If something is described as "exemplary" or "examples," it should be understood that this refers to non-exclusive examples. When used with a number, the terms "about" or "approximately," etc., can refer to that specific number, or alternatively, a range close to that specific number (e.g., + / - 10%) as understood by those skilled in the art. The use of broad terms such as "comprising," "including," and "having" should be understood to provide support for narrower terms such as "consisting of," "consisting essentially of." The use of the terms "optionally," "may," "might," "can," "could," "would," "will," "should," "preferably," "typically," "often," etc., with respect to any element, component, feature, characteristic, etc. of an embodiment means that the element, component, feature, characteristic, etc. is not required, or alternatively, the element, component, feature, characteristic, etc. is required, both alternatives being within the scope of the embodiment. Such elements, components, features, characteristics, and the like may optionally be included in some embodiments, or may be excluded (e.g., to form alternative embodiments, all of which are included within the scope of this disclosure). The section headings used herein are provided for consistency and convenience and shall not limit or characterize any invention that may be set forth in any claims that may issue from this disclosure. If a reference numeral is used to refer to a specific example of a more general term, that reference numeral may also be used to refer to the general term (and vice versa).

[0200] Although shown in several exemplary embodiments, those skilled in the art will recognize that the systems, apparatus, and methods described herein are susceptible to various changes and modifications that fall within the scope of the appended claims. Furthermore, descriptions using various alternatives to terms such as "or" need not be mutually exclusive unless the context clearly requires otherwise, and the indefinite articles "a" or "an" do not limit the subject matter to a single instance unless the context clearly requires otherwise. It is also possible to combine or eliminate components in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, the dressing, container, or both may be eliminated or separated from the other components for manufacture or sale. In other exemplary configurations, the controller may also be manufactured, constructed, assembled, or sold independently of the other components.

[0201] The appended claims set forth novel and inventive aspects of the subject matter described above, but the claims may also cover additional subject matter not specifically cited. For example, certain features, elements, or aspects may be omitted from the claims if it is not necessary to distinguish novel and inventive features from features known to those of ordinary skill in the art. Features, elements, and aspects described herein in the context of some embodiments may also be omitted, combined, or replaced by alternative features serving the same, equivalent, or similar purposes without departing from the scope of the invention as defined by the appended claims. Moreover, features, elements, and aspects described with respect to a particular embodiment may be combined with features, elements, and aspects described with respect to one or more other embodiments.

Claims

1. A therapeutic device, comprising: a closed-cell foam treatment manifold having a central connecting manifold member and a plurality of leg manifold members extending outwardly from the central connecting manifold member, wherein each of the plurality of leg manifold members is in fluid communication with the central connecting manifold member; and a single membrane layer positioned proximate to and attached to the first surface of the treatment manifold, wherein the membrane layer includes a plurality of fenestrations; Wherein a second surface of the treatment manifold is uncovered and is opposite to the first surface.

2. The therapeutic device of claim 1 , wherein the membrane layer extends between the leg manifold members.

3. The treatment device of claim 1 , wherein the treatment manifold comprises a plurality of channels and a plurality of through-channels, wherein the plurality of channels are disposed on at least one of the first surface and the second surface opposite to the first surface, and wherein the plurality of through-channels are disposed through the first surface and the second surface.

4. The therapeutic device of claim 3, wherein the plurality of channels are provided on both the first surface and the second surface.

5. The therapeutic device of claim 3, wherein at least some of the through-channels intersect at least some of the channels.

6. The therapeutic device of claim 4, wherein the channels on the first surface are offset from the channels on the second surface.

7. The therapeutic device of claim 4, wherein the channels on the first surface are aligned with the channels on the second surface.

8. The therapeutic device of claim 1 , wherein the membrane layer comprises a surface texture on one or both of a first membrane surface and an opposing second membrane surface of the membrane layer, wherein the surface texture comprises ridges and grooves.

9. The therapeutic device of claim 1 , wherein the film layer comprises at least one indentation configured to have a shape complementary to at least the first surface of the treatment manifold, wherein the at least one indentation is configured to allow a complementary portion of the first surface of the treatment manifold to be positioned within the at least one indentation in the film layer.

10. The treatment device of claim 1, wherein the central connecting manifold member comprises a plurality of contraction openings configured to cause the central connecting manifold member to contract radially in a plane under negative pressure.

11. The therapeutic device of claim 1 , wherein the membrane layer is adhered to the first surface of the treatment manifold.

12. The therapeutic device of claim 1, wherein the membrane layer spans the first surface of the plurality of leg manifold members.

13. The therapeutic device of claim 12, wherein the membrane layer further spans the surface of the central connecting manifold member.

14. The therapeutic device of claim 1, wherein the treatment manifold is not encapsulated.

15. The treatment device of claim 1, wherein a membrane is attached to the treatment manifold only at the first surface, and the second surface is exposed.

16. The treatment device of claim 4, wherein the channels on the first surface are not aligned with the channels in the second surface across the thickness of the treatment manifold.

17. The treatment device of claim 4, wherein each channel in the first surface is alignable with a corresponding channel in the second surface such that a line bisecting the channel in the first surface and extending through the thickness of the treatment manifold also bisects the corresponding channel in the second surface.

18. A dressing comprising: a central fluid hub including a connecting manifold member; a plurality of elongated members, each of the plurality of elongated members comprising a leg manifold member, wherein the plurality of elongated members extend outwardly from the central fluid hub and each of the plurality of leg manifold members is in fluid communication with the connecting manifold member; and a substantially fluid-impermeable layer attached to the first surface of each of the leg manifold members, wherein the substantially fluid-impermeable layer includes a plurality of fenestrations; wherein the connecting manifold member and the leg manifold member are each configured to distribute negative pressure while substantially minimizing tissue ingrowth during negative pressure therapy; The connecting manifold member and the leg manifold member each include a closed-cell foam, wherein the closed-cell foam of the connecting manifold member and the leg manifold member is exposed on a second surface opposite the first surface.

19. The dressing of claim 18, wherein the substantially fluid impermeable layer extends between the plurality of elongate members.

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