Organ protection layer fluid management

Abstract

Systems and methods are described for organ protection layers for negative pressure treatment of a wound site. Organ protection layers can allow the delivery of fluids to the wound site and removal of fluids from the wound site to clean the wound site. Organ protection layers can include patterns and features to improve visibility and application.

Description

ORGAN PROTECTION LAYER FLUID MANAGEMENTCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to Great Britain Provisional Application No. 2313528.8, filed September 5, 2023, and titled ORGAN PROTECTION LAYER FLUID MANAGEMENT and Great Britain Provisional Application 2319583.7, filed December 20, 2023, and titled ORGAN PROTECTION LAYER FLUID MANAGEMENT. Each of the aforementioned applications is incorporated by reference herein in its entirety. The contents of the following applications and / or issued patents are hereby incorporated by reference in their entireties as if fully set forth herein: U.S. Patent Application No. US8791315, filed on September 20, 2010, entitled “SYSTEMS AND METHODS FOR USING NEGATIVE PRESSURE WOUND THERAPY TO MANAGE OPEN ABDOMINAL WOUNDS” and U.S. Pat. No. 8791315, “SYSTEMS AND METHODS FOR USING NEGATIVE PRESSURE WOUND THERAPY TO MANAGE OPEN ABDOMINAL WOUNDS,” issued July 29, 2014. Additional applications referenced herein this application are also hereby incorporated by reference in their entireties as if fully set forth herein.BACKGROUNDField of Use

[0002] Embodiments of the present invention relate generally to organ protection layers with fluid management systems, means of improved application and visibility, and instillation systems. Organ protection layers can be used for the treatment of wounds using negative pressure wound therapy, and more specifically to an improved apparatus and method thereof to manage open abdominal wounds.Description of Related Art

[0003] The treatment of open or chronic wounds by means of applying negative pressure to the site of the wound, where the wounds are too large to spontaneously close or otherwise fail to heal is well known in the art. Negative pressure wound treatment systems currently known in the art commonly involve placing a cover that is impermeable to liquids over the wound, using various mechanisms to seal the cover to the tissue of the patient surrounding the wound, and connecting a source of negative pressure (such as a vacuum pump)to the cover whereby an area of negative pressure is created under the cover in the area of the wound.SUMMARY

[0004] Embodiments of the invention disclosed herein are directed to a reduced pressure appliance and methods of treatment using a reduced pressure appliance, and may be useful in the treatment of wounds using reduced pressure.

[0005] Certain embodiments of the invention are directed to improved methods of treating abdominal wounds or incisions with negative pressure. For example and for illustrative purposes only, some embodiments employ a porous pad with detachable sections permitting desired sizing of the pad to the wound site. Sizing of the foam pad may in some embodiments be performed in a dimensionally-independent manner so that, for example, the width and / or length may be modified independently of each other. Further embodiments also provide for a wound contact layer to be placed in contact with the wound site, where the wound contact layer is preferably minimally or non-adherent to the wound site and provided with slits or other openings for the removal of wound exudate or fluids and the application of negative pressure to the wound site.

[0006] Certain embodiments provide for a negative pressure treatment system comprising a wound contact layer placed over the wound, a porous pad configured to be sized and positioned over the wound contact layer, a flexible drape configured to be placed above the wound and sealed to the skin surrounding the wound, and which further comprises a conduit configured to deliver negative pressure to the wound through an aperture in the flexible drape and through the porous pad and wound contact layer.

[0007] In a preferred embodiment, a porous pad is provided for the treatment of wounds with negative pressure, wherein the porous pad is comprised of a porous material suitable for channeling wound exudate from a wound site to a source of negative pressure. The porous pad preferably comprises a generally planar shape with a thickness less than its width and length, and preferably comprises at least one cut extending through a least a portion of the thickness of the pad, whereby the cut defines a pad section detachable from the remainder of the pad so as to permit modification of the size of the pad (for example its length and / or width). In certain embodiments, the cuts may be comprised of arcuate and / or elliptical cuts, and mayfurther comprise additional inner and outer cuts. In further embodiments, additional intermediate cuts may also be present.

[0008] In another preferred embodiment, a system for the treatment of a wound site comprises a wound contact layer provided with openings for channeling wound exudate and distributing negative pressure, a generally planar porous pad suitable for transmitting negative pressure to a wound site and comprising at least one cut extending through a portion of the pad’s thickness so as to define a detachable pad, a flexible drape, a conduit, and a source of negative pressure configured to deliver negative pressure through the conduit to the wound site.

[0009] In yet another preferred embodiment, a method of treating a wound site using negative pressure may comprise placing a wound contact layer onto the wound site; placing a porous pad over the wound contact layer, where the porous pad is perforated to allow removal of pad portions so as to permit sizing of the pad in a dimensionally-independent manner to fit the wound site; sealing the wound site with a flexible drape configured to be positioned over the wound and sealed to the skin surrounding the wound; connecting a source of negative pressure to the wound site; and maintaining the application of negative pressure until the wound site has healed appropriately.

[0010] A wound treatment device can include an organ protection layer configured to contact a wound site. The wound treatment device can include a tube positioned on or within the organ protection layer. The tube can be in fluid communication with the wound site. The wound treatment device can include a fabric positioned on or within the organ protection layer. The fabric can draw fluid to the tube.

[0011] The wound treatment device of any of the preceding paragraphs and / or any of the apparatuses, systems, or devices disclosed herein can include one or more of the following features. The organ protection layer can include a pattern configured to improve visibility. The organ protection layer can include a storage tab configured to improve visibility. The organ protection layer can include a pigmentation configured to improve visibility. The fabric can include 3D fabrics, spacer material, foam, gauze, or acquisition distribution layers. The fabric can be positioned in a center of the organ protection layer. The tube can extend to an edge of the organ protection layer. The tube can be a capillary comprising a valve. The valve can allow flow from the wound site and prevent flow to the wound site. In someembodiments, a system for treating a wound site can include an organ protection layer suitable for contacting a wound site. The system for treating a wound site can include a fabric positioned on or within the organ protection layer. The fabric can deliver fluids to the wound site and remove fluids from the wound site. The system for treating a wound site of any of the preceding paragraphs and / or any of the apparatuses, systems, or devices disclosed herein can include one or more of the following features. The fabric can include 3D fabrics, spacer material, foam, gauze, or acquisition distribution layers. The fabric can include a filler material. The organ protection layer can include a pattern configured to improve visibility. The organ protection layer can include a storage tab configured to improve visibility. The organ protection layer can include a pigmentation configured to improve visibility.

[0012] A system for cleaning a wound site can include an organ protection layer suitable for contacting a wound site. The system for cleaning a wound site can include an inlet tube positioned on or within in the organ protection layer. The inlet tube can deliver fluids to the wound site. The system for cleaning a wound site can include a fluid inlet connected to the inlet tube. The fluid inlet can receive fluid from a fluid source to the wound site. The system for cleaning a wound site can include an outlet tube positioned on or within in the organ protection layer. The outlet tube can remove fluids from the wound site. The system for cleaning a wound site can include a fluid outlet connected to the outlet tube. The fluid outlet can release fluid from the outlet tube. The system for cleaning a wound site of any of the preceding paragraphs and / or any of the apparatuses, systems, or devices disclosed herein can include one or more of the following features. The organ protection layer can include a pattern configured to improve visibility. The organ protection layer can include a storage tab configured to improve visibility. The organ protection layer can include a pigmentation configured to improve visibility. The inlet tube and the outlet tube can be separate. The inlet tube and the outlet tube can be in fluid communication.

[0013] In certain embodiments, a wound treatment device may comprise: an organ protection layer configured to contact a wound site, the organ protection layer comprising: a perforated boundary configured to allow the organ protection layer to be divided; and a spacer material leg positioned on or within the organ protection layer,the spacer material leg configured to be in fluid communication with the wound site, and the spacer material leg comprising a tab portion over the perforated boundary, the tab portion configured allow the spacer material leg to be divided.

[0014] The spacer material leg may be configured to be in fluid communication with a soft port. The organ protection layer may comprise a marking indicating which direction to pull the perforated boundaries to divide the organ protection layer. The organ protection layer may comprise a pinched film portion beneath the tab portion. In certain embodiments, a method of dividing an organ protection layer may comprises providing an organ protection layer comprising a perforated boundary, a spacer material leg comprising a tab portion aligned with the perforated boundary, tearing the organ protection layer at the perforated boundary, and peeling the tab portion from the spacer material leg. The method may additionally comprise removing a portion of the organ protection layer radially outward from the perforated boundary.

[0015] In some embodiments, a wound treatment device may comprise an organ protection layer configured to contact a wound site, a fluid pathway tube positioned on or within the organ protection layer, the fluid pathway tube configured to be in fluid communication with the wound site, an air-filled tube adjacent to the fluid pathway tube, the air-filled tube configured to maintain the fluid pathway tube in an open configuration; and a fabric positioned on or within the organ protection layer, the fabric configured to draw fluid to the fluid pathway tube.

[0016] Disclosed herein are systems and methods for providing medial compression to a wound site of any of the preceding paragraphs and / or any of the devices, apparatuses, or systems disclosed herein.

[0017] Any of the features, components, or details of any of the arrangements or embodiments disclosed in this application, including without limitation any of the apparatus embodiments and any of the wound site medial compression embodiments disclosed herein, are interchangeably combinable with any other features, components, or details of any of the arrangements or embodiments disclosed herein to form new arrangements and embodiments.BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1A is a schematic illustration of an example system for the treatment of abdominal wounds.

[0019] FIG. IB illustrates an example of a negative pressure treatment system.

[0020] FIG. 2 is a top view of an example of an organ protection layer with tubing for fluid assistance.

[0021] FIG. 3 is a side view of the organ protection layer with tubing for fluid assistance of FIG. 2.

[0022] FIG. 4 is an illustration of an example of an organ protection layer with fabric for fluid assistance.

[0023] FIG. 5 is an illustration of an example of another organ protection layer with fabric for fluid assistance.

[0024] FIG. 6 is an illustration of an example of another organ protection layer with fabric for fluid assistance.

[0025] FIG. 7 is an illustration of an example of another organ protection layer with fabric for fluid assistance.

[0026] FIG. 8 is an illustration of an example of another organ protection layer with fabric for fluid assistance.

[0027] FIG. 9 is an illustration of an example of another organ protection layer with fabric for fluid assistance.

[0028] FIG. 10 is a side view of an example of an organ protection layer with fabric for fluid assistance.

[0029] FIG. 11 is a side view of an example of an organ protection layer with filler on film for improved application.

[0030] FIG. 12 is an illustration of an example of an organ protection layer with capillaries for fluid assistance.

[0031] FIG. 13 is an illustration of an example of capillaries for fluid assistance.

[0032] FIG. 14 is an example of a tubular fabric.

[0033] FIG. 15 is an illustration of an example of organ protection layer with a pattern for visibility.

[0034] FIG. 16 is an illustration of an example of another organ protection layer with a pattern for visibility.

[0035] FIG. 17 is an illustration of an example of another organ protection layer with a pattern for visibility.

[0036] FIG. 18 is an illustration of an example of another organ protection layer with a pattern for visibility.

[0037] FIG. 19 is an illustration of an example of an organ protection layer with a storage tab for visibility.

[0038] FIG. 20 is an illustration of an example of an organ protection layer with pigmentation for visibility.

[0039] FIG. 21 is a top view of an example of organ protection layer with an instillation device.

[0040] FIG. 22 is a side view of the organ protection layer with an instillation device of FIG. 21.

[0041] FIG. 23 is a top view of an example of another organ protection layer with an instillation device.

[0042] FIG. 24 is a side view of the organ protection layer with an instillation device of FIG. 23.

[0043] FIG. 25 is a top view of an example of an organ protection layer with an instillation device.

[0044] FIG. 26 is a side view of the organ protection layer with an instillation device of FIG. 25.

[0045] FIG. 27 is a schematic illustration of an example of an instillation device.

[0046] FIG. 28 is a top view of another example of organ protection layer with an instillation device.

[0047] FIG. 29 is a side view of the organ protection layer with an instillation device of FIG. 28 with a saline bag disconnected.

[0048] FIG. 30 is a side view of the organ protection layer with an instillation device of FIG. 28 with a saline bag connected.

[0049] FIG. 31 is an illustration of an example of an organ protection layer with bladders integrated between layers of the organ protection layer.

[0050] FIG. 32 is an illustration of an example of an organ protection layer with spacer material legs.

[0051] FIG. 33 is an illustration of an example of an organ protection layer with spacer material legs and perforated boundaries.

[0052] FIG. 34 is an illustration of another example of an organ protection layer with spacer material legs and perforated boundaries.

[0053] FIG. 35 A is a side view of an example of an organ protection layer with spacer material legs and perforated boundaries.

[0054] FIG. 35B is the side view of the example of an organ protection layer with spacer material legs and perforated boundaries of FIG. 35 A with a portion of the organ protection layer removed.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0055] Preferred embodiments disclosed herein relate to wound therapy for a human or animal body. Therefore, any reference to a wound herein can refer to a wound on a human or animal body, and any reference to a body herein can refer to a human or animal body. The term “wound” as used herein, in addition to having its broad ordinary meaning, includes any body part of a patient that may be treated using reduced pressure. Wounds and / or wound sites include, but are not limited to, open wounds, pressure sores, ulcers and burns. Open wounds and / or wound sites may also include incisions (e.g., abdominal incisions) or other openings, tears, or fistulas, for example, in the abdominal or peritoneal cavity. Treatment of such wounds can be performed using negative pressure wound therapy, wherein a reduced or negative pressure can be applied to the wound to facilitate and promote healing of the wound. It will also be appreciated that the negative pressure systems and methods as disclosed herein may be applied to other parts of the body, and are not necessarily limited to treatment of wounds.

[0056] Turning to FIG. 1A, treatment of a wound with negative pressure in certain embodiments uses a negative pressure treatment system 101 as illustrated schematically here. In this embodiment, a wound site 111, illustrated here as an abdominal wound site, may benefit from treatment with negative pressure. Such abdominal wound sites may be a result of, for example, an accident or due to surgical intervention. In some cases, medical conditions such as abdominal compartment syndrome, abdominal hypertension, sepsis, or fluid edema may require decompression of the abdomen with a surgical incision through the abdominal wall toexpose the peritoneal space, after which the opening may need to be maintained in an open, accessible state until the condition resolves. Other conditions may also necessitate that an opening — particularly in the abdominal cavity — remain open, for example if multiple surgical procedures are required (possibly incidental to trauma), or there is evidence of clinical conditions such as peritonitis or necrotizing fasciitis. In cases where there is a wound, particularly in the abdomen, management of possible complications relating to the exposure of organs and the peritoneal space is desired, whether or not the wound is to remain open or if it will be closed. Therapy, preferably using the application of negative pressure, can be targeted to minimize the risk of infection, while promoting tissue viability and the removal of deleterious substances from the wound site. The application of reduced or negative pressure to a wound site has been found to generally promote faster healing, increased blood flow, decreased bacterial burden, increased rate of granulation tissue formation, to stimulate the proliferation of fibroblasts, stimulate the proliferation of endothelial cells, close chronic open wounds, inhibit burn penetration, and / or enhance flap and graft attachment, among other things. It has also been reported that wounds that have exhibited positive response to treatment by the application of negative pressure include infected open wounds, decubitus ulcers, dehisced incisions, partial thickness burns, and various lesions to which flaps or grafts have been attached. Consequently, the application of negative pressure to a wound site 111 can be beneficial to a patient. Accordingly, certain embodiments provide for a wound contact layer to be placed over the wound site 111. One of skill in the art will understand that the wound contact layer 105 may function as an organ protection layer. Preferably, the wound contact layer or organ protection layer 105 can be a thin, flexible material which will not adhere to the wound site or the exposed viscera in close proximity. For example, polymers such as polyurethane, polyethylene, polytetrafluoroethylene, or blends thereof may be used. In one embodiment, the wound contact layer is permeable. For example, the wound contact layer 105 can be provided with openings, such as holes, slits, or channels, to allow the removal of fluids from the wound site 111 or the transmittal of negative pressure to the wound site 111. Additional embodiments of the wound contact layer 105 are described in further detail below. Certain embodiments of the negative pressure treatment system 101 may also use a porous pad 103, which can be disposed over the wound contact layer 105. This pad 103 can be constructed from a porous material, for example foam, that is soft, resiliently flexible, and generally conformable to thewound site 111. Such a foam can include an open-celled and reticulated foam made, for example, of a polymer. Suitable foams include foams composed of, for example, polyurethane, silicone, and polyvinyl alcohol. Preferably, this pad 103 can channel wound exudate and other fluids through itself when negative pressure is applied to the wound. Some pads 103 may include preformed channels or openings for such purposes. In certain embodiments, the pad 103 may have a thickness between about one inch and about two inches. The pad may also have a length of between about 16 and 17 inches, and a width of between about 11 and 12 inches. In other embodiments, the thickness, width, and / or length can have other suitable values. Other aspects of the pad 103 are discussed in further detail below.

[0057] Preferably, a drape 107 is used to seal the wound site 111. The drape 107 can be at least partially liquid impermeable, such that at least a partial negative pressure may be maintained at the wound site. Suitable materials for the drape 107 include, without limitation, synthetic polymeric materials that do not significantly absorb aqueous fluids, including polyolefins such as polyethylene and polypropylene, polyurethanes, polysiloxanes, polyamides, polyesters, and other copolymers and mixtures thereof. The materials used in the drape may be hydrophobic or hydrophilic. Examples of suitable materials include Transeal® available from DeRoyal and OpSite® available from Smith & Nephew. In order to aid patient comfort and avoid skin maceration, the drapes in certain embodiments are at least partly breathable, such that water vapor is able to pass through without remaining trapped under the dressing. An adhesive layer may be provided on at least a portion the underside of the drape 107 to secure the drape to the skin of the patient, although certain embodiments may instead use a separate adhesive or adhesive strip. Optionally, a release layer may be disposed over the adhesive layer to protect it prior to use and to facilitate handling the drape 107; in some embodiments, the release layer may be composed of multiple sections. The negative pressure system 101 can be connected to a source of negative pressure, for example a pump 114. One example of a suitable pump is the Renasys EZ pump available from Smith & Nephew. The drape 107 may be connected to the source of negative pressure 114 via a conduit 112. The conduit 112 may be connected to a port 113 situated over an aperture 109 in the drape 107, or else the conduit 112 may be connected directly through the aperture 109 without the use of a port. In a further alternative, the conduit may pass underneath the drape and extend from a side of the drape. U.S. Patent No. 7,524,315 discloses other similar aspects of negativepressure systems and is hereby incorporated by reference in its entirety and should be considered a part of this specification. In many applications, a container or other storage unit 115 may be interposed between the source of negative pressure 114 and the conduit 112 so as to permit wound exudate and other fluids removed from the wound site to be stored without entering the source of negative pressure. Certain types of negative pressure sources — for example, peristaltic pumps — may also permit a container 115 to be placed after the pump 114. Some embodiments may also use a filter to prevent fluids, aerosols, and other microbial contaminants from leaving the container 115 and / or entering the source of negative pressure 114. Further embodiments may also include a shut-off valve or occluding hydrophobic and / or oleophobic filter in the container to prevent overflow; other embodiments may include sensing means, such as capacitative sensors or other fluid level detectors that act to stop or shut off the source of negative pressure should the level of fluid in the container be nearing capacity. At the pump exhaust, it may also be preferable to provide an odor filter, such as an activated charcoal canister.

[0058] Of course, the foregoing description is that of certain features, aspects and advantages of the present invention, to which various changes and modifications can be made without departing from the spirit and scope of the present invention. Moreover, the negative pressure treatment system disclosed herein need not feature all of the objects, advantages, features and aspects discussed above. Those of skill in the art will recognize that the invention can be embodied or carried out in a manner that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein. For example, in some embodiments the pad 103 can be used without the wound contact layer 105 and / or drape 107. In addition, while a number of variations of the invention have been shown and described in detail, other modifications and methods of use, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is contemplated that various combinations or subcombinations of these specific features and aspects of embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the discussed negative pressure treatment system.

[0059] Figure IB illustrates another negative pressure wound treatment system 100. The negative pressure wound treatment system 100 can have any of the components, features, or other details of any of the other negative pressure wound treatment system disclosed herein, including without limitation the negative pressure wound treatment system illustrated in Figure, in combination with or in place of any of the components, features, or other details of the negative pressure wound treatment system 100 shown in Figure IB and / or described herein. The negative pressure wound treatment system 100 can have a wound cover 106 over a wound 104 that can seal the wound 104. A conduit 108, such as a single or multi lumen tube can be used to connect the wound cover 106 with a wound therapy device 110 (sometimes as a whole or partially referred to as a “pump assembly”) configured to supply reduced or negative pressure. The wound cover 106 can be in fluidic communication with the wound 104. With reference to Figure IB, the conduit 108 can have a bridge portion 130 that can have a proximal end portion and a distal end portion (the distal end portion being closer to the wound 104 than the proximal end portion, and an applicator 132 at the distal end of the bridge portion 130 forming the flexible suction adapter (or conduit) 108. A connector 134 can be disposed at the proximal end of the bridge portion 130, so as to connect to at least one of the channels that can extend along a length of the bridge portion 130 of the conduit 108 shown in Figure IB. A cap 140 can be coupled with a portion of the conduit 108 and can, in some cases, as illustrated, be attached to the connector 134. The cap 140 can be useful in preventing fluids from leaking out of the proximal end of the bridge portion 130. The conduit 108 can be a Soft Port manufactured by Smith & Nephew. As mentioned, the negative pressure wound treatment system 100 can include a source of negative pressure, such as the wound therapy device 110, capable of supplying negative pressure to the wound 104 through the conduit 108. Though not required, the wound therapy device 110 can also include a canister or other container for the storage of wound exudates and other fluids that can be removed from the wound. The wound therapy device 110 can be connected to the connector 134 via a conduit or tube 142. In use, the applicator 132 can be placed over an aperture formed in a wound cover 106 that is placed over a suitably-prepared wound or wound 104. Subsequently, with the wound therapy device 110 connected via the tube 142 to the connector 134, the wound therapy device 110 can be activated to supply negative pressure to the wound. Application of negative pressure can be applied until a desired level of healing of the wound is achieved. The bridgeportion 130 can comprise an upper channel material or layer positioned between an upper layer and an intermediate layer, with a lower channel material or layer positioned between the intermediate layer and a bottom layer. The upper, intermediate, and lower layers can have elongate portions extending between proximal and distal ends and can include a material that is fluid-impermeable, for example polymers such as polyurethane. It will of course be appreciated that the upper, intermediate, and lower layers can each be constructed from different materials, including semi-permeable materials. In some cases, one or more of the upper, intermediate, and lower layers can be at least partially transparent. In some instances, the upper and lower layers can be curved, rounded or outwardly convex over a majority of their lengths.

[0060] The upper and lower channel layers can extend from the proximal end to the distal end of the bridge portion 130 and can each preferably comprise a porous material, including for example open-celled foams such as polyethylene or polyurethane. In some cases, one or more of the upper and lower channel layers can be comprised of a fabric, for example a knitted or woven spacer fabric (such as a knitted polyester 3D fabric, Baltex 7970.RTM., or Gehring 879.RTM.) or a nonwoven material, or terry-woven or loop-pile materials. The fibers may not necessarily be woven, and can include felted and flocked (including materials such as Flotex.RTM.) fibrous materials. The materials selected are preferably suited to channeling wound exudate away from the wound and for transmitting negative pressure or vented air to the wound site, and can also confer a degree of kinking or occlusion resistance to the channel layers. One of skill in the art will understand that such materials may also be referred to as spacer materials and may be present in a layer known as a spacer layer. In one example, the upper channel layer can include an open-celled foam such as polyurethane, and the lower channel layer can include a fabric. In another example, the upper channel layer is optional, and the system can instead be provided with an open upper channel. The upper channel layer can have a curved, rounded or upwardly convex upper surface and a substantially flat lower surface, and the lower channel layer can have a curved, rounded or downwardly convex lower surface and a substantially flat upper surface. The fabric or material of any components of the bridge portion 130 can have a three-dimensional (3D) structure, where one or more types of fibers form a structure where the fibers extend in all three dimensions. Such a fabric can in some cases aid in wicking, transporting fluid or transmitting negative pressure. In some cases,the fabric or materials of the channels can include several layers of material stacked or layered over each other, which can in some cases be useful in preventing the channel from collapsing under the application of negative pressure. The materials used in some implementations of the conduit 108 can be conformable and pliable, which can, in some cases, help to avoid pressure ulcers and other complications which can result from a wound treatment system being pressed against the skin of a patient.

[0061] The distal ends of the upper, intermediate, and lower layers and the channel layers can be enlarged at their distal ends (to be placed over a wound site), and can form a "teardrop" or other enlarged shape. The distal ends of at least the upper, intermediate, and lower layers and the channel layers can also be provided with at least one through aperture. This aperture can be useful not only for the drainage of wound exudate and for applying negative pressure to the wound, but also during manufacturing of the device, as these apertures can be used to align these respective layers appropriately. In some implementations, a controlled gas leak 146 (sometimes referred to as gas leak, air leak, or controlled air leak) can be disposed on the bridge portion 130, for example at the proximal end thereof. This air leak 146 can comprise an opening or channel extending through the upper layer of the bridge portion 130, such that the air leak 146 is in fluidic communication with the upper channel of the bridge portion 130. Upon the application of suction to the conduit 108, gas (such, as air) can enter through the gas leak 146 and move from the proximal end of the bridge portion 130 to the distal end of the bridge portion along the upper channel of the bridge portion 130. The gas can then be suctioned into the lower channel of the bridge portion 130 by passing through the apertures through the distal ends of the upper, intermediate, and lower layers. The air leak 146 can include a filter. Preferably, the air leak 146 is located at the proximal end of the bridge portion 130 so as to minimize the likelihood of wound exudate or other fluids coming into contact and possibly occluding or interfering with the air leak 146 or the filter. In some instances, the filter can be a microporous membrane capable of excluding microorganisms and bacteria, and which may be able to filter out particles larger than 45 pm. Preferably, the filter can exclude particles larger than 1.0 pm, and more preferably, particles larger than 0.2 pm. Advantageously, some implementations can provide for a filter that is at least partially chemically-resistant, for example to water, common household liquids such as shampoos, and other surfactants. In some cases, reapplication of vacuum to the suction adapter or wiping ofthe exposed outer portion of the filter may be sufficient to clear any foreign substance occluding the filter. The filter can be composed of a suitably-resistant polymer such as acrylic, polyethersulfone, or polytetrafluoroethylene, and can be oleophobic or hydrophobic. In some cases, the gas leak 146 can supply a relatively constant gas flow that does not appreciably increase as additional negative pressure is applied to the conduit 108. In instances of the negative pressure wound treatment system 100 where the gas flow through the gas leak 146 increases as additional negative pressure is applied, preferably this increased gas flow will be minimized and not increase in proportion to the negative pressure applied thereto. Further description of such bridges, conduits, air leaks, and other components, features, and details that can be used with any implementations of the negative pressure wound treatment systems disclosed herein are found in U.S. Patent No. 8,801,685, which is incorporated by reference in its entirety as if fully set forth herein.

[0062] Any of the wound therapy devices (such as, the device 114 or 110) disclosed herein can provide continuous or intermittent negative pressure therapy. Continuous therapy can be delivered at above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, - 180 mmHg, -200 mmHg, or below -200 mmHg. Intermittent therapy can be delivered between low and high negative pressure set points (sometimes referred to as setpoint). Low set point can be set at above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, or below -180 mmHg. High set point can be set at above -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -200 mmHg. During intermittent therapy, negative pressure at low set point can be delivered for a first time duration, and upon expiration of the first time duration, negative pressure at high set point can be delivered for a second time duration. Upon expiration of the second time duration, negative pressure at low set point can be delivered. The first and second time durations can be same or different values. In operation, the wound filler 102 can be inserted into the cavity of the wound 104, and wound cover 106 can be placed so as to seal the wound 104. The wound therapy device 110’ can provide negative pressure to the wound cover 106, which can be transmitted to the wound 104 via the wound filler 102. Fluid (such as, wound exudate) can be drawnthrough the conduit 108’ and stored in a canister. In some cases, fluid is absorbed by the wound filler 102 or one or more absorbent layers (not shown). Wound dressings that can be utilized with the pump assembly and systems of the present application include Renasys-F, Renasys-G, Renasys AB, and Pico Dressings available from Smith & Nephew. Further description of such wound dressings and other components of a negative pressure wound therapy system that can be used with the pump assembly and systems of the present application are found in U.S. Patent Publication Nos. 2012 / 0116334, 2011 / 0213287, 2011 / 0282309, 2012 / 0136325, U.S. Patent No. 9,084,845, and International Patent Publication No. WO2021 / 069642, each of which is incorporated by reference in its entirety as if fully set forth herein. In some cases, other suitable wound dressings can be utilized.

[0063] FIG. 2 is a top view of an example of an organ protection layer 200 with tubing for fluid assistance. The organ protection layer 200 can be interchanged with the wound contact layer 105 of FIG. 1A. The tubes 204 may be suitably constructed to improve handleability of the organ protection layer 200. The tubes 204 can sit between two layers of film 206. The film 206 can be polyurethane film. The film 206 can be perforated. The tubes 204 can lead to the edge of the organ protection layer 200. The organ protection layer 200 can be ovular, circular, square, triangular, or a different shape depending on the wound site. The tubes 204 can allow fluid to be pulled from the gutters of the abdomen to the soft port. The tubes 204 can allow fluid to be pulled from the wound site to the soft port. The soft port can connect to the area of the organ protection layer 200 with the foam 202. The foam 202 can draw fluid to the area. The fluid can be used for cleaning the wound site or gutters of the abdomen.

[0064] FIG. 3 is a side view of an example of the organ protection layer 200 with tubing for fluid assistance of FIG. 2. The top layer of the organ protection layer 200 can be film 206. The second layer of the organ protection layer 200 can be foam 202. The foam 202 can draw in fluid. The foam 202 can allow fluid to pass to the soft port through the upper layer. The third layer can include foam 202 and tubing 204. Fluid can pass between the foam 202 of the first layer and the foam 202 of the second layer. Fluid can pass between the foam 202 of the second layer and the tubes 204. The tubes 204 can distribute fluid between the wound site and the foam 202. The bottom layer of the organ protection layer 200 can be film 206.

[0065] FIG. 4 is an illustration of an example of an organ protection layer 400 with fabric 410 for fluid assistance. The organ protection layer 400 can include fabric 410 that sits between layers of film 406. The fabric 410 can be 3D fabrics, spacer material, foam, gauze, or acquisition distribution layers. A soft port can connect to the organ protection layer 400 in an area with the fabric. Fluid can pass between the fabric 410 and the soft port through the film 406. The fabric 410 can distribute the fluid to and from the gutters of the abdomen. The fabric 410 can distribute the fluid to and from the wound site. The fabric 410 can draw fluid in. The film 406 layers can be bonded using glues, hotmelt glues, infra-red bonding, high frequency bonding, and ultrasonic welding. The organ protection layer 400 can be cuttable.

[0066] The fabric 410 can include a circular or ovular central portion. The fabric 410 can include two triangular portions extending from the central portion to the edge of the organ protection layer. The fabric 410 can include two portions that widen as they extend radially outward extending from the central portion to the edge of the organ protection layer.

[0067] FIG. 5 is an illustration of an example of an organ protection layer 500 with fabric 510 for fluid assistance. The organ protection layer 500 can include fabric 510 that sits between layers of film 506. The fabric 510 can be 3D fabrics, spacer material, foam, gauze, or acquisition distribution layers. A soft port can connect to the organ protection layer 500 in an area with the fabric. Fluid can pass between the fabric 510 and the soft port through the film 506. The fabric 510 can distribute the fluid to and from the gutters of the abdomen. The fabric 510 can distribute the fluid to and from the wound site. The fabric 510 can draw fluid in. The film 506 layers can be bonded using glues, hotmelt glues, infra-red bonding, high frequency bonding, and ultrasonic welding. The organ protection layer 500 can be cuttable.

[0068] The fabric 510 can include a central star-shaped portion. The fabric 510 can include a central portion of eight triangles extending radially outward. The fabric 510 can include teardrop shaped portions extending radially outward. The fabric 510 can include eight teardrop shaped portions extending radially outward toward the edge of the organ protection layer 500.

[0069] FIG. 6 is an illustration of an example of an organ protection layer 600 with fabric 610 for fluid assistance. The organ protection layer 600 can include fabric 610 that sits between layers of film 606. The fabric 610 can be 3D fabrics, spacer material, foam, gauze, or acquisition distribution layers. A soft port can connect to the organ protection layer 600 in anarea with the fabric. Fluid can pass between the fabric 610 and the soft port through the film 606. The fabric 610 can distribute the fluid to and from the gutters of the abdomen. The fabric 610 can distribute the fluid to and from the wound site. The fabric 610 can draw fluid in. The film 606 layers can be bonded using glues, hotmelt glues, infra-red bonding, high frequency bonding, and ultrasonic welding. The organ protection layer 600 can be cuttable.

[0070] In certain embodiments, the fabric 610 can be a snowflake shape. The fabric 610 can include line portions that extend from the center. The fabric 610 can include six line portions that extend from the center. Each line portion of the fabric 610 can include further line portions that extend from them. Each line portion of the fabric 610 can break into three prongs toward the edge of the organ protection layer 600.

[0071] FIG. 7 is an illustration of an example of an organ protection layer with fabric for fluid assistance. The organ protection layer 700 can include fabric 710 that sits between layers of film 706. The fabric 710 can be 3D fabrics, spacer material, foam, gauze, or acquisition distribution layers. A soft port can connect to the organ protection layer 700 in an area with the fabric. Fluid can pass between the fabric 710 and the soft port through the film 706. The fabric 710 can distribute the fluid to and from the gutters of the abdomen. The fabric 710 can distribute the fluid to and from the wound site. The fabric 710 can draw fluid in. The film 706 layers can be bonded using glues, hotmelt glues, infra-red bonding, high frequency bonding, and ultrasonic welding. The organ protection layer 700 can be cuttable.

[0072] The fabric 710 can include a central circular portion. The fabric 710 can include lines that extend from the central circular portion. The fabric 710 can include four lines that extend from the central circular portion. The lines that extend from the central circular portion can extend to curved trapezoidal portions. The lines that extend from the central circular portion can extend to portions that expand as they extend radially outward. The curved trapezoidal portions can extend to an area near the edge of the organ protection layer 700.

[0073] FIG. 8 is an illustration of an example of an organ protection layer with fabric for fluid assistance. The organ protection layer 800 can include fabric 810 that sits between layers of film 806. The fabric 810 can be 3D fabrics, spacer material, foam, gauze, or acquisition distribution layers. In certain embodiments, the fabric sections 810 can be air. In some embodiments, similar to bubble wrap, the fluid can track along the sealed areas, between the air pockets. A soft port can connect to the organ protection layer 800 in an area with thefabric. Fluid can pass between the fabric 810 and the soft port through the film 806. The fabric 810 can distribute the fluid to and from the gutters of the abdomen. The fabric 810 can distribute the fluid to and from the wound site. The fabric 810 can draw fluid in. The film 806 layers can be bonded using glues, hotmelt glues, infra-red bonding, high frequency bonding, and ultrasonic welding. The organ protection layer 800 can be cuttable.

[0074] The fabric 810 can be a honeycomb pattern. The fabric 810 can be hexagons. The hexagons can be separate from each other. The hexagons can extend to near the edge of the organ protection layer 800. As described above, if the fabric sections are merely air, then fluid may track along the sealed areas between the honeycomb air pockets.

[0075] FIG. 9 is an illustration of an example of an organ protection layer with fabric for fluid assistance. The organ protection layer 900 can include fabric 910 that sits between layers of film 906. The fabric 910 can be 3D fabrics, spacer material, foam, gauze, or acquisition distribution layers. As will be understood by one of skill in the art, any of the fabric elements or layers described herein may be constructed of the materials referenced as relating to fabric 910. A soft port can connect to the organ protection layer 900 in an area with the fabric. Fluid can pass between the fabric 910 and the soft port through the film 906. The fabric 910 can distribute the fluid to and from the gutters of the abdomen. The fabric 910 can distribute the fluid to and from the wound site. The fabric 910 can draw fluid in. The film 906 layers can be bonded using glues, hotmelt glues, infra-red bonding, high frequency bonding, and ultrasonic welding. The organ protection layer 900 can be cuttable.

[0076] In some embodiments, the fabric 910 can be a spiral pattern. The spiral pattern can extend from a central ovular portion of fabric 910. The spiral pattern can loop around the central ovular portion while extending toward the edge of the organ protection layer 900. The film 906 can be perforated between the spiral pattern foam. Perforations can allow a user to reduce the size of the organ protection layer 900. The user can cut the organ protection layer 900 along the perforations. In certain embodiments, the perforations allow a user to tear sections of the organ protection layer away to form a desired shape.

[0077] FIG. 10 is a side view of an example of an organ protection layer 1000 with fabric 1010 for fluid assistance. The fabric 1010 can be positioned between layers of film 1006. The organ protection layer 1000 can correspond to the organ protection layers of FIG. 4, FIG. 5, FIG. 6, FIG. 7, FIG. 8, or FIG. 9.

[0078] FIG. 11 is a side view of an example of an organ protection layer 1100 with filler 1102 on film 1106 for improved application. The filler 1102 can sit on a bottom layer of the 1106. The organ protection layer 1100 can lack a top layer of film 1106. Filler 1102 materials on one side of the organ protection layer 1100 can reduce time of application. Filler 1102 materials on one side of the organ protection layer 1100 can assist with handleability. Filler 1102 materials on one side of the organ protection layer 1100 can assist with locating the organ protection layer 1100 within the abdomen.

[0079] FIG. 12 is an illustration of an example of an organ protection layer 1200 with capillaries 1250 for fluid assistance. FIG. 13 is an illustration of an example of capillaries 1250 for fluid assistance. The capillaries 1250 can be positioned between layers of film 1206. The capillaries 1250 can allow fluid to be drawn up in the soft port and not back into the wound site. The capillaries 1250 can allow fluid to be drawn up in the soft port and not back into the gutters of the abdomen. The capillaries 1250 can extend from a central portion. The central portion 1202 can be 3D fabrics, spacer material, foam, gauze, or acquisition distribution layers. A soft port can connect to the central portion 1202. The capillaries 1250 can extend to the edge of the organ protection layer 1200. The capillaries 1250 can include valves 1260. The valves 1260 can allow fluid to pass from the wound site to the soft port. The valves 1260 can prevent fluid from passing from the soft port to the wound site. The valves 1260 can allow flow when negative pressure is applied, as fluid will be taken in from the wound site. The valves 1260 can prevent flow when negative pressure is not applied, as fluid will not be taken in from the wound site.

[0080] FIG. 14 is an example of a tubular fabric 1400. The tubular fabric 1400 is a type of fabric that can be used in FIG. 2, FIG. 3, FIG. 4, FIG. 5, FIG. 6, FIG. 7, FIG. 8, FIG. 9, FIG. 10, FIG. 11, and FIG. 12. The tubular fabric 1400 can have cavities for fluid distribution. Other fabrics can include spacer fabrics, mesh, acquisition distribution layers, and reinforced fiber composites.

[0081] In some embodiments, the tubular fabric 1400 can form tracks or corrugations of the organ protection layer. Some tracks of the tubular fabric 1400 can be airfilled tubes and some tracks of the tubular fabric 1400 can be fluid pathway tubes. The fluid pathway tubes can meet in the middle of the organ protection layer, allowing interaction with a soft port, similar to as described with respect to FIG. 12. The air-filled tubes can keep thestructure of the organ protection layer rigid. In certain embodiments, this approach can keep the fluid pathway tubes open to allow the passage of exudate to the central point. The air-filled tubes can provide tension or force that pulls the fluid pathway tubes open. In some embodiments, the tubular fabric 1400 can be made of film, for example plastic film. The tubular fabric 1400 can be inflated such that the air-filled tubes expand to a point of rigidity and the fluid pathway tubes remain open. The air-filled tubes can be adjacent to the fluid pathway tubes, such that they can maintain the fluid pathway tubes in an open configuration. The air-filled tubes can be filled with a fluid, for example a liquid or gas.

[0082] Other filler materials can include silicone foam, white foam, and gauze. Tubes can be polyethylene, linear low-density polyethylene, silicone, polyethylene bio tube, RENASYS drains, BlOSilicone, or Flat Hose. Tubes can be colored. Foam can vary in pores per square inch, density, and color. The film can be silicone rubber, biopolymer, EVA, EU94, or EU30 / EU33.

[0083] FIG. 15 is an illustration of an example of an organ protection layer 1500 with a pattern 1570 for visibility. The pattern 1570 can be integrated with the film 1506. The pattern 1570 can be printed on the film 1506. The pattern 1570 can be drawn on the film 1506. The pattern 1570 can allow the organ protection layer 1500 to be clearly visible within the packaging. The pattern 1570 can allow the organ protection layer 1500 to be clearly visible in use, such as when covering a wound site. The pattern 1570 can allow a user to determine where the center of the organ protection layer 1500 is. The pattern 1570 can be printed in various colors. The pattern 1570 can be made of biocompatible inks, iodine, silver, or charcoal. The pattern 1570 can be made of or incorporate a logo. The pattern 1570 can provide odor control based on the properties of the material making up the pattern 1570. The pattern 1570 can provide reduction in infection based on the properties of the material making up the pattern 1570.

[0084] The pattern 1570 can be a wave-like pattern. The pattern 1570 can be made up of curved lines. The curved lines can be duplicated across the organ protection layer 1500.

[0085] FIG. 16 is an illustration of an example of another organ protection layer with a pattern for visibility. The pattern 1670 can be integrated with the film 1606. The pattern 1670 can be printed on the film 1606. The pattern 1670 can be drawn on the film 1606. The pattern 1670 can allow the organ protection layer 1600 to be clearly visible within thepackaging. The pattern 1670 can allow the organ protection layer 1600 to be clearly visible in use, such as when covering a wound site. The pattern 1670 can allow a user to determine where the center of the organ protection layer 1600 is. The pattern 1670 can be printed in various colors. The pattern 1670 can be made of biocompatible inks, iodine, silver, or charcoal. The pattern 1670 can be made of or incorporate a logo. The pattern 1670 can provide odor control based on the properties of the material making up the pattern 1670. The pattern 1670 can provide reduction in infection based on the properties of the material making up the pattern 1670.

[0086] The pattern 1670 can be a target pattern. The pattern 1670 can include a central solid circular portion. The pattern 1670 can include straight lines that extend horizontally and vertically from the center. The pattern 1670 can include circle outlines around the central solid circular portion. The pattern 1670 can include three circle outlines of varying sizes around the central solid circular portion.

[0087] FIG. 17 is an illustration of an example of another organ protection layer with a pattern for visibility. The pattern 1770 can be integrated with the film 1706. The pattern 1770 can be printed on the film 1706. The pattern 1770 can be drawn on the film 1706. The pattern 1770 can allow the organ protection layer 1700 to be clearly visible within the packaging. The pattern 1770 can allow the organ protection layer 1700 to be clearly visible in use, such as when covering a wound site. The pattern 1770 can allow a user to determine where the center of the organ protection layer 1700 is. The pattern 1770 can be printed in various colors. The pattern 1770 can be made of biocompatible inks, iodine, silver, or charcoal. The pattern 1770 can be made of or incorporate a logo. The pattern 1770 can provide odor control based on the properties of the material making up the pattern 1770. The pattern 1770 can provide reduction in infection based on the properties of the material making up the pattern 1770.

[0088] The pattern 1770 can include a grid pattern. The grid pattern can be overlapping vertical and horizontal straight lines. The overlapping vertical and horizontal straight lines can be equidistant from each other.

[0089] FIG. 18 is an illustration of an example of another organ protection layer with a pattern for visibility. The pattern 1870 can be integrated with the film 1806. The pattern 1870 can be printed on the film 1806. The pattern 1870 can be drawn on the film 1806. Thepattern 1870 can allow the organ protection layer 1800 to be clearly visible within the packaging. The pattern 1870 can allow the organ protection layer 1800 to be clearly visible in use, such as when covering a wound site. The pattern 1870 can allow a user to determine where the center of the organ protection layer 1800 is. The pattern 1870 can be printed in various colors. The pattern 1870 can be made of biocompatible inks, iodine, silver, or charcoal. The pattern 1870 can be made of or incorporate a logo. The pattern 1870 can provide odor control based on the properties of the material making up the pattern 1870. The pattern 1870 can provide reduction in infection based on the properties of the material making up the pattern 1870.

[0090] The pattern 1870 can be a gradient pattern. The gradient pattern can be a series of ovals of different sizes. The ovals of different sizes can be vertically and horizontally aligned with the center. The ovals can be different colors. The ovals can be the same color. The ovals can be different shades of a color.

[0091] FIG. 19 is an illustration of an example of an organ protection layer 1900 with a storage tab 1980 for visibility. The storage tab 1980 can wrap around the film 1906. The storage tab 1980 can improve visibility of the organ protection layer 1900 when stored. The storage tab 1980 can improve visibility of the organ protection layer 1900 when stored in packaging.

[0092] FIG. 20 is an illustration of an example of an organ protection layer 2000 with pigmentation 2070 for visibility. The pigmentation 2070 can be integrated with the film 1806. The pigmentation 2070 can be printed on the film 2006. The pigmentation 2070 can be drawn on the film 2006. The pigmentation 2070 can allow the organ protection layer 2000 to be clearly visible within the packaging. The pigmentation 2070 can allow the organ protection layer 2000 to be clearly visible in use, such as when covering a wound site. The pigmentation 2070 can be printed in various colors. The pigmentation 2070 can be made of biocompatible inks, iodine, silver, or charcoal. The pigmentation 2070 can provide odor control based on the properties of the material making up the pigmentation 2070. The pigmentation 2070 can provide reduction in infection based on the properties of the material making up the pigmentation 2070.

[0093] FIG. 21 is a top view of an example of an organ protection layer 2100 with an instillation device. FIG. 22 is a side view of the example organ protection layer with aninstillation device of FIG. 21. The instillation device can allow the system to cleanse the wound site. The organ protection layer 2100 with the instillation device can be placed in the open abdomen of a patient. The instillation device can include a fluid outlet 2142 to remove fluid from the abdomen. The fluid outlet 2142 can consist of tubing, 3D material, or foam. The fluid outlet 2142 can be tucked into the gutters of the abdomen or the wound site. The fluid outlet 2142 can allow for quick removal of fluid from the abdomen. The fluid inlet 2140 can consist of tubing, 3D material or foam. The fluid inlet 2140 can be tucked into the base of the gutters of the abdomen or wound site. The fluid inlet 2140 can inject fluid into the gutters of the abdomen or wound site. The fluid inlet 2140 can inject saline, plasma, crystalloid fluids, or other fluids. The fluid inlet 2140 can house a one-way valve 2146, or similar device, to ensure fluid only travels to the wound site. The fluid inlet 2140 can house a one-way valve 2146, or similar device, to ensure exudate does not leave the wound site via that route. The fluid inlet 2140 and fluid outlet 2142 can be separate to reduce cross contamination. Instillation devices can be used for irrigation of the wound site. Instillation devices can be wound cleansing agents used in conjunction with negative pressure devices. The fluid inlet 2140 can receive fluid from a fluid source.

[0094] The fluid inlet 2140 can be made of filler material. The fluid inlet 2140 can be positioned above the film 2106 of the organ protection layer 2100. The fluid inlet 2140 can be positioned above distribution material 2248. Distribution material 2248 can be positioned above tubing 2144. Tubing 2144 can deliver fluid to the fluid inlet 2140 from the wound site. Tubing 2144 from the fluid inlet 2140 can include valves 2146 to ensure one way flow. Tubing 2144 can extend to the edge of the organ protection layer 2100. In some embodiments, the fluid inlet 2140 and fluid outlet 2142 can be in fluid communication.

[0095] The fluid outlet 2142 can be made of filler material. The fluid outlet 2142 can be positioned above the film 2106 of the organ protection layer 2100. The fluid outlet 2142 can be positioned above distribution material 2248. Distribution material 2248 can be positioned above tubing 2144. Tubing 2144 can deliver fluid from the fluid outlet 2142 to the wound site. Tubing 2144 can extend to the edge of the organ protection layer 2100.

[0096] FIG. 23 is a top view of an example of an organ protection layer 2300 with an instillation device. FIG. 24 is a side view of the organ protection layer with an instillation device of FIG. 23. The fluid inlet 2340 can lack a port in some embodiments. The organprotection layer 2300 can have a shape corresponding to the wound site. The organ protection layer 2300 can have a shape corresponding to the gutters of the wound site. The organ protection layer 2300 can have a central rectangular portion. The organ protection layer 2300 can have rectangular portions extending from the central rectangular portion. The organ protection layer 2300 can have rounded triangular portions extending from the central rectangular portion. The organ protection layer 2300 can have a semi-ovular portion extending from the central rectangular portion. The fluid inlet 2340 can be positioned above the film 2306. The fluid inlet 2340 can be positioned above 3D material or tubes 2344. The tubes 2344 can have valves 2346 similar to FIG. 21. The fluid outlet 2342 can be positioned over 3D material or fabric 2352. The 3D material or fabric 2352 can be positioned inside layers of film 2306. The 3D material or fabric 2352 can distribute fluid to the wound site or gutters of the abdomen. The fluid inlet 2340 can be removed by a user. The fluid inlet 2340 can have perforations around it so that a user can cut and / or tear the organ protection layer 2300 to remove the fluid inlet 2340. Further, in embodiments, the perforations allow a user to remove / tear sections that may contain fluid, thereby allowing for the remove of the fluid in the torn and / or cut section.

[0097] The fluid outlet 2342 can be made of filler material. The fluid outlet 2342 can be positioned above the film 2306 of the organ protection layer 2300. The fluid outlet 2342 can be positioned above fabric 2352.

[0098] FIG. 25 is a top view of an example of an organ protection layer 2500 with an instillation device. FIG. 26 is a side view of the organ protection layer with an instillation device of FIG. 25. The fluid inlet 2540 can lack a port in some embodiments. The organ protection layer 2500 can have an ovular shape. The organ protection layer 2500 can have an irregular round shape. The fluid inlet 2540 can be positioned above the film 2506. The fluid inlet 2540 can be positioned above 3D material or tubes 2544. The tubes 2544 can have valves 2546 similar to FIG. 21. The fluid outlet 2542 can be positioned over 3D material or fabric 2552. The 3D material or fabric 2552 can be positioned inside layers of film 2506. The 3D material or fabric 2552 can distribute fluid to the wound site or gutters of the abdomen.

[0099] The fluid outlet 2542 can be made of filler material. The fluid outlet 2542 can be positioned above the film 2506 of the organ protection layer 2500. The fluid outlet 2542 can be positioned above fabric 2352.

[0100] FIG. 27 is a schematic illustration of an example of an instillation device 2700. The instillation device 2700 can be similar to the instillation devices of FIG. 24 and FIG. 25. The instillation device can include a fluid inlet 2740, a fluid outlet 2742, and fabric 2752 for distribution of fluid. The fabric 2752 can be 3D material or foam.

[0101] FIG. 28 is a top view of an example of an organ protection layer 2800 with an instillation device. FIG. 29 is a side view of the example organ protection layer 2800 with an instillation device of FIG. 28 with a saline bag 2954 disconnected. FIG. 30 is a side view of the example organ protection layer 2800 with an instillation device of FIG. 28 with a saline bag 2954 connected. The organ protection layer 2800 can have an inlet port 2840. The inlet port 2840 can have a luer connector for connecting to the soft port. The inlet port 2840 can connect to inlet pipes 2852 for irrigation or instillation of the wound site or the gutters of the abdomen. The organ protection layer 2800 can have an outlet port 2842. The outlet port 2842 can connect to outlet pipes 2844 for removal of fluids from the wound site or the gutters of the abdomen. The inlet pipes 2852 and outlet pipes 2844 can be positioned between layers of film 2806.

[0102] A saline bag 2954 can be connected to the inlet port 2840. The saline bag 2954 can be disconnected from the inlet port 2840 to stop irrigation or instillation of the wound site or the gutters of the abdomen. The saline bag 2954 can be connected to the luer connector of the inlet port 2840.

[0103] FIG. 31 is an illustration of an example of an organ protection layer 3100 with bladders 3152 integrated between layers of the organ protection layer 3100. The bladders 3152 can be positioned between layers of film 3106. The bladders 3152 can store and distribute fluid. The organ protection layer can include tubes 3144. The tubes 3144 can be positioned between layers of film 3106. The tubes 3144 can be positioned between the bladders 3152. The tubes 3144 can extend from the fluid inlet / outlet 3162. The fluid inlet / outlet 3162 can be one port for allowing fluid to flow to and from the fluid source and the wound site or gutters of the abdomen. Eight tubes 3144 can extend from the fluid inlet / outlet 3162 toward the edge of the organ protection layer 3100. Eight bladders 3152 can be positioned between the eight tubes 3144.

[0104] FIG. 32 is an illustration of an example of an organ protection layer 3200 with spacer material legs 3272. The spacer material legs 3272 can be positioned between layersof film 3206. The spacer material legs 3272 can lead to the edge of the organ protection layer 3200. The organ protection layer 3200 can be ovular, circular, square, triangular, or a different shape depending on the wound site. The spacer material legs 3272 can allow fluid to be pulled from the gutters of the abdomen to a soft port such as the soft ports disclosed herein this section and elsewhere in the specification. The spacer material legs 3272 can allow fluid to be pulled from the wound site to the soft port. The soft port can connect to the area of the organ protection layer 3200 with foam in the center 3202. The foam center 3202 can draw fluid to the area. The fluid can be used for cleaning the wound site or gutters of the abdomen. The organ protection layer 3200 can have at least about 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 or more spacer material legs 3272.

[0105] The organ protection layer 3200 can be cut to a smaller size and / or shaped to fit a wound site. The spacer material legs 3272 can be divided when the organ protection layer 3200 is cut, for example at the narrow portions 3273 of the legs. In some embodiments, each spacer material leg 3272 can have two narrow portions 3273 at which they can be easily divided when the organ protection layer 3200 is cut. In some embodiments, each spacer material leg 3272 can have 1-10 narrow portions 3273 at which they can be easily divided when the organ protection layer 3200 is cut. In other embodiments, the spacer material leg 3272 can be configured to be cut through the wider portion of the spacer material leg 3272,

[0106] The film 3206 can be printed to indicate where and / or which direction to pull, cut, or tear to separate the organ protection layer 3200. This approach can reduce the risk of a user incorrectly cutting or handling the organ protection layer 3200 and can reduce the application time. This approach can also improve user interaction with the organ protection layer 3200. The spacer material legs 3272 can be made of foam or another suitable absorbent material.

[0107] FIG. 33 is an illustration of an example of an organ protection layer 3300 with spacer material legs 3372 and perforated boundaries 3374. The spacer material legs 3372 can be positioned between layers of film 3306. The spacer material legs 3372 can lead to the edge of the organ protection layer 3300. The organ protection layer 3300 can be ovular, circular, square, triangular, or a different shape depending on the wound site. The spacer material legs 3372 can allow fluid to be pulled from the gutters of the abdomen to a soft port. The spacer material legs 3372 can allow fluid to be pulled from the wound site to the soft port.The soft port can connect to the area of the organ protection layer 3300 with foam in the center 3302. The foam center 3302 can draw fluid to the area. The fluid can be used for cleaning the wound site or gutters of the abdomen. The organ protection layer 3300 can have 4 spacer material legs 3372. In some embodiments, the organ protection layer 3300 can have 1-20 spacer material legs 3372.

[0108] The film 3306 can be printed with a marking to indicate where and / or which direction to pull to separate the organ protection layer 3300 at the perforated boundaries 3374. This approach can reduce the risk of a user incorrectly cutting or handling the organ protection layer 3300 and can reduce the application time. This can also improve user interaction with the organ protection layer 3300. The spacer material legs 3372 can be made of foam or another absorbent material. Portions of the film 3306 can be welded together around the perforated boundaries 3374.

[0109] The organ protection layer 3300 can be oversized to accommodate larger or bariatric patients. Reduction of the organ protection layer 3300 can accommodate smaller patients. The spacer material legs 3372 can be made up of overlapping portions. The overlapping portions of the spacer material legs 3372 can align with the perforated boundaries 3374. The perforated boundaries 3374 can be ovular, circular, square, triangular, or a different shape depending on the wound site. The organ protection layer 3300 can have two perforated boundaries 3374 so that the organ protection layer 3300 can be reduced to two different sizes. In some embodiments, the organ protection layer 3300 can have 1-10 perforated boundaries 3374 so that the organ protection layer 3300 can be reduced to 1-10 different sizes.

[0110] The organ protection layer 3300 can be reduced in size by tearing along the perforated boundaries 3374 and pulling the outer portion of the spacer material leg 3372 away from the organ protection layer 3300. The more outer portions of the spacer material legs 3372 can be stacked above the more inner portions of the spacer material legs 3372. This can be advantageous to allow the outer portions of the organ protection layer 3300 to be easily removed to reduce the size of the organ protection layer 3300. The more outer portions of the spacer material legs 3372 can have tab portions 3376 that extend over the perforated boundaries 3374 and onto the more inner portions of the spacer material legs 3372. The tab portions 3376 can be removable such that they can be peeled off the inner portions of the spacer material legs3372. The portion of the organ protection layer 3300 radially outward from the perforated boundary 3374 can be removed.

[0111] FIG. 34 is an illustration of another example of an organ protection layer 3400 with spacer material legs 3472 and perforated boundaries 3474. The spacer material legs 3472 can be positioned between layers of film 3406. The spacer material legs 3472 can lead to the edge of the organ protection layer 3400. The organ protection layer 3400 can be ovular, circular, square, triangular, or a different shape depending on the wound site. The spacer material legs 3472 can allow fluid to be pulled from the gutters of the abdomen to a soft port. The spacer material legs 3472 can allow fluid to be pulled from the wound site to the soft port. The soft port can connect to the area of the organ protection layer 3400 with foam in the center 3402. The foam center 3402 can draw fluid to the area. The fluid can be used for cleaning the wound site or gutters of the abdomen. The organ protection layer 3400 can have 4 spacer material legs 3472. In some embodiments, the organ protection layer 3400 can have 1-20 spacer material legs 3472.

[0112] The organ protection layer 3400 can be oversized to accommodate larger or bariatric patients. Reduction of the organ protection layer 3400 can accommodate smaller patients. The spacer material legs 3472 can be made up of overlapping portions. The overlapping portions of the spacer material legs 3472 can align with the perforated boundaries 3474. The perforated boundaries 3474 can be ovular, circular, square, triangular, or a different shape depending on the wound site. The organ protection layer 3400 can have two perforated boundaries 3474 so that the organ protection layer 3400 can be reduced to two different sizes. In some embodiments, the organ protection layer 3400 can have 1-10 perforated boundaries 3474 so that the organ protection layer 3400 can be reduced to 1-10 different sizes.

[0113] The film 3406 can be printed with a marking to indicate where and / or which direction to pull to separate the organ protection layer 3400 at the perforated boundaries 3474. Advantageously, can reduce the risk of a user incorrectly cutting or handling the organ protection layer 3400 and can reduce the application time. This can also improve user interaction with the organ protection layer 3400. The spacer material legs 3472 can be made of foam or another absorbent material. Portions of the film 3406 can be welded together around the perforated boundaries 3474.

[0114] The organ protection layer 3400 can be reduced in size by tearing along the perforated boundaries 3474 and pulling the outer portion of the spacer material leg 3472 away from the organ protection layer 3400. The more outer portions of the spacer material legs 3472 can be stacked above the more inner portions of the spacer material legs 3472. This can be advantageous to allow the outer portions of the organ protection layer 3400 to be easily removed to reduce the size of the organ protection layer 3400. The more outer portions of the spacer material legs 3472 can have tab portions 3476 that extend over the perforated boundaries 3474 and onto the more inner portions of the spacer material legs 3472. The tab portions 3476 can be removable such that they can be peeled off the inner portions of the spacer material legs 3472. The portion of the organ protection layer 3300 radially outward from the perforated boundary 3374 can be removed.

[0115] The spacer material legs 3472 can have square or rectangular portions between the perforated boundaries 3474, and / or between the outer borders of the organ protection layer 3400 and the perforated boundaries 3474. The tab portions 3476 can extend from the inner side of the square or rectangular portions of the spacer material legs 3472. The tab portions 3476 can extend over a narrow portion of the spacer material legs 3472.

[0116] FIG. 35 A is a side view of an example of an organ protection layer 3500 with spacer material legs 3572 and perforated boundaries 3574. The organ protection layer 3500 can be similar to the organ protection layers 3300, 3400 of FIG. 33 and 34. The spacer material legs 3572 can be positioned between layers of film 3506. The organ protection layer 3500 can have perforated boundaries 3574 that allow the film to be easily torn apart without tearing the spacer material legs 3572.

[0117] The organ protection layer 3500 can be oversized to accommodate larger or bariatric patients. Reduction of the organ protection layer 3500 can accommodate smaller patients. The spacer material legs 3572 can be made up of overlapping portions. The overlapping portions of the spacer material legs 3572 can align with the perforated boundaries 3574.

[0118] The organ protection layer 3500 can be reduced in size by tearing along the perforated boundaries 3574 and pulling a portion of the spacer material leg 3572 away from the organ protection layer 3500. Portions of the spacer material legs 3572 can be stacked above the other portions of the spacer material legs 3572. This can be advantageous to allow portionsof the organ protection layer 3500 to be easily removed to reduce the size of the organ protection layer 3500. Portions of the spacer material legs 3572 can have tab portions 3576 that extend over the perforated boundaries 3574 and onto the more inner portions of the spacer material legs 3572. The tab portions 3576 can be removable such that they can be peeled off the inner portions of the spacer material legs 3572.

[0119] FIG. 35B is the side view of the example of an organ protection layer 3500 with spacer material legs 3572 and perforated boundaries 3574 of FIG. 35A with a portion of the organ protection layer 3500 removed. When a portion of the organ protection layer 3500 is removed, the outer film 3506 can collapse into a pinched portion 3582, covering the end of the spacer material leg 3572. For example, the outer film 3506 can have adhesive on the inside of the top layer and / or bottom layer near the perforated boundaries 3574 such that the ends of the material stick together when the tab portions 3576 are peeled away. In some embodiments, portions of the film 3506 can be welded together around the perforated boundaries 3574 to form the pinched portion 3582. The pinched portion 3582 can be beneath the tab portion 3576, such that there is film 3506 at least partially between the tab portion 3576 and the lower portion of the spacer material leg 3572. Advantageously, this can reduce risk of interaction of the spacer material legs 3572 with organs within the abdomen.

[0120] The systems and methods herein can reduce risk of infection within the open abdomen. The systems and methods herein can reduce the risk of sepsis within the open abdomen. The systems and methods herein can allow for a longer wear time. The systems and methods herein can allow fluid to be quickly removed from the gutters. The systems and methods herein can allow fluid to be put into the base of the gutters. The devices herein can be made of easy to cut, minimal shedding materials. The use of perforated materials can allow for a reduced fitting time.

[0121] The foregoing description is that of certain features, aspects and advantages of the present invention, to which various changes and modifications can be made without departing from the spirit and scope of the present invention. Moreover, the negative pressure treatment system disclosed herein need not feature all of the objects, advantages, features and aspects discussed above. Those of skill in the art will recognize that the invention can be embodied or carried out in a manner that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other objects or advantages as maybe taught or suggested herein. For example, in some embodiments the organ protection layer 103 can be used without the organ protection layer 105 and / or drape 107. Advantageously, the systems and methods described herein can operate without the drape 107. There is no need to disturb the wound by having to cut into the drape 107 to input additional connectors, as the system herein can deliver fluid to the wound site. In addition, while a number of variations of the invention have been shown and described in detail, other modifications and methods of use, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is contemplated that various combinations or subcombinations of these specific features and aspects of embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the discussed negative pressure treatment system.

[0122] Although this disclosure describes certain embodiments, it will be understood by those skilled in the art that many aspects of the methods and devices shown and described in the present disclosure may be differently combined and / or modified to form still further embodiments or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. Indeed, a wide variety of designs and approaches are possible and are within the scope of this disclosure. No feature, structure, or step disclosed herein is essential or indispensable. Moreover, while illustrative embodiments have been described herein, the scope of any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), substitutions, adaptations and / or alterations as would be appreciated by those in the art based on the present disclosure. While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of protection.

[0123] Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at leastsome of such features and / or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0124] Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as a subcombination or variation of a subcombination.

[0125] Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, or that all operations be performed, to achieve desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, the operations may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and / or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products.

[0126] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages may be achieved inaccordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0127] Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and / or steps. Thus, such conditional language is not generally intended to imply that features, elements, and / or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and / or steps are included or are to be performed in any particular embodiment.

[0128] Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0129] Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degree, or otherwise.

[0130] The scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments in this section or elsewhere in this specification, and may be defined by claims as presented in this section or elsewhere in this specification or as presented in the future. The language of the claims is to be interpreted broadly based on thelanguage employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive.

Claims

WHAT IS CLAIMED IS:

1. A wound treatment device, the device comprising: an organ protection layer configured to contact a wound site; a tube positioned on or within the organ protection layer, the tube configured to be in fluid communication with the wound site; and a fabric positioned on or within the organ protection layer, the fabric configured to draw fluid to the tube.

2. The device of claim 1, wherein the organ protection layer comprises a pattern configured to improve visibility.

3. The device of any one of claims 1 or 2, wherein the organ protection layer comprises a storage tab configured to improve visibility.

4. The device of any one of claims 1-3, wherein the organ protection layer comprises a pigmentation configured to improve visibility.

5. The device of any one of claims 1-4, wherein the fabric comprises 3D fabrics, spacer material, foam, gauze, or acquisition distribution layers.

6. The device of any one of claims 1-5, wherein the fabric is positioned in a center of the organ protection layer.

7. The device of any one of claims 1 -6, wherein the tube extends to an edge of the organ protection layer.

8. The device of any one of claims 1-7, wherein the tube is a capillary comprising a valve, the valve configured to allow flow from the wound site and prevent flow to the wound site.

9. A system for treating a wound site, the system comprising: an organ protection layer suitable for contacting a wound site; and a fabric positioned on or within the organ protection layer, the fabric configured to deliver fluids to the wound site and remove fluids from the wound site.

10. The system of claim 9, wherein the fabric comprises 3D fabrics, spacer material, foam, gauze, or acquisition distribution layers.

11. The system of any one of claims 9 or 10, wherein the fabric comprises a filler material.

12. The system of any one of claims 9-11, wherein the organ protection layer comprises a pattern configured to improve visibility.

13. The system of any one of claims 9-12, wherein the organ protection layer comprises a storage tab configured to improve visibility.

14. The system of any one of claims 9-13, wherein the organ protection layer comprises a pigmentation configured to improve visibility.

15. A system for cleaning a wound site, the system comprising: an organ protection layer suitable for contacting a wound site; an inlet tube positioned on or within in the organ protection layer, the inlet tube configured to deliver fluids to the wound site; a fluid inlet connected to the inlet tube, the fluid inlet configured to receive fluid from a fluid source to the wound site; an outlet tube positioned on or within in the organ protection layer, the outlet tube configured to remove fluids from the wound site; and a fluid outlet connected to the outlet tube, the fluid outlet configured to release fluid from the outlet tube.

16. The system of claim 15, wherein the organ protection layer comprises a pattern configured to improve visibility.

17. The system of any one of claims 15 or 16, wherein the organ protection layer comprises a storage tab configured to improve visibility.

18. The system of any one of claims 15-17, wherein the organ protection layer comprises a pigmentation configured to improve visibility.

19. The system of any one of claims 15-18, wherein the inlet tube and the outlet tube are separate.

20. The system of any one of claims 15-19, wherein the inlet tube and the outlet tube are in fluid communication.

21. A wound treatment device, the device comprising: an organ protection layer configured to contact a wound site, the organ protection layer comprising: a perforated boundary configured to allow the organ protection layer to be divided; and a spacer material leg positioned on or within the organ protection layer,the spacer material leg configured to be in fluid communication with the wound site, and the spacer material leg comprising a tab portion over the perforated boundary, the tab portion configured allow the spacer material leg to be divided.

22. The device of claim 21, wherein the spacer material leg is configured to be in fluid communication with a soft port.

23. The device of any one of claims 21 or 22, wherein the organ protection layer comprises a marking indicating which direction to pull the perforated boundaries to divide the organ protection layer.

24. The device of any one of claims 21-23, wherein the organ protection layer comprises a pinched film portion beneath the tab portion.

25. A method of dividing an organ protection layer, the method comprising: providing an organ protection layer comprising: a perforated boundary; and a spacer material leg comprising a tab portion aligned with the perforated boundary; tearing the organ protection layer at the perforated boundary; and peeling the tab portion from the spacer material leg.

26. The method of claim 25, further comprising removing a portion of the organ protection layer radially outward from the perforated boundary.

27. A wound treatment device, the device comprising: an organ protection layer configured to contact a wound site; a fluid pathway tube positioned on or within the organ protection layer, the fluid pathway tube configured to be in fluid communication with the wound site; an air-filled tube adjacent to the fluid pathway tube, the air-filled tube configured to maintain the fluid pathway tube in an open configuration; and a fabric positioned on or within the organ protection layer, the fabric configured to draw fluid to the fluid pathway tube.

28. An apparatus substantially as shown and / or described.

29. A method substantially as shown and / or described.

30. A system substantially as shown and / or described.

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