Wound treatment systems, devices, and methods

Abstract

Systems and methods for providing medial compression for abdominal open wounds for negative pressure procedures using wound filling materials and organ protection layers are described. The wound filler may pull the abdominal wall toward the midline when under negative pressure. The wound filler can provide medial tension and reduce the risk of long-term rectus abdominis separation or abdominal separation. The organ protection layer may also be modified to facilitate medial compression and promote fluid.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to UK Provisional Application No. 2313507.2 entitled “MEDIAL COMPRESSION”, filed on 5 September 2023, and UK Provisional Application No. 2313509.8 entitled “ABDOMINAL WOUNDTREATMENT”, filed on 5 September 2023. Each of the foregoing applications is incorporated herein by reference in its entirety. The contents of the following applications and / or granted patents are incorporated herein by reference in their entirety, as if fully set forth herein: U.S. Patent Application No. 8791315, filed September 20, 2010, entitled "Systems and methods for using negative pressure wound therapy to manage open abdominal wounds," and U.S. Patent No. 8791315, published July 29, 2014, entitled "Systems and methods for using negative pressure wound therapy to manage open abdominal wounds." Other applications mentioned in this application are also incorporated herein by reference in their entirety, as if fully set forth herein. background Technical Field

[0003] Embodiments of the present invention generally relate to wound treatment systems, apparatus, and methods using negative pressure wound therapy, such as for cleaning and filling wounds to treat wounds, and more specifically, to improved devices and methods for managing open abdominal wounds. Background Technology

[0004] Treating open or chronic wounds by applying negative pressure to the site of the wound (where the wound is too large to close spontaneously or otherwise fail to heal) is well known in the art. Negative pressure wound therapy systems currently known in the art typically involve placing a liquid-impermeable covering over the wound, sealing the covering to the patient tissue surrounding the wound using various mechanisms, and connecting a negative pressure source (e.g., a vacuum pump) to the covering, thereby creating a negative pressure zone beneath the covering in the wound area. Summary of the Invention

[0005] The embodiments of the present invention disclosed herein relate to decompression devices and treatment methods using decompression devices, and can be used to treat wounds using decompression.

[0006] Some embodiments of the present invention relate to improved methods of treating abdominal wounds or incisions with negative pressure. For example, and for illustrative purposes only, some embodiments employ porous wound packing materials with separable segments, thereby allowing for desired sizing of the wound packing material for the wound site. In some embodiments, the sizing of the foam wound packing material can be done in a size-independent manner, such that, for example, the width and / or length can be modified independently of each other. Further embodiments also provide a wound contact layer to be placed in contact with the wound site, wherein the wound contact layer is preferably minimally viscous or non-viscous to the wound site and is provided with slits or other openings for removing wound exudate or fluid and for applying negative pressure to the wound site.

[0007] Some embodiments provide a negative pressure therapy system comprising: a wound contact layer placed over a wound; a porous wound filler configured to be sized and positioned over the wound contact layer; a flexible cover drape configured to be placed over the wound and seal to the skin surrounding the wound; and further comprising a conduit configured to deliver negative pressure to the wound through openings in the flexible cover drape and through the porous wound filler and the wound contact layer.

[0008] In one embodiment, a porous wound packer for treating wounds with negative pressure is provided, wherein the porous wound packer is composed of a porous material suitable for guiding wound exudate from the wound site to a negative pressure source. The porous wound packer preferably comprises a generally planar shape having a thickness less than its width and length, and preferably includes at least one incision extending through at least a portion of the thickness of the wound packer material, whereby the incision defines a wound packer segment separable from the remainder of the wound packer to allow modification of the wound packer's dimensions (e.g., its length and / or width). In some embodiments, the incision may be an arcuate and / or elliptical incision, and may also include additional internal and external incisions. In other embodiments, an additional intermediate incision may also be present.

[0009] In some embodiments, a system for treating a wound site includes: a wound contact layer having openings for guiding wound exudate and distributing negative pressure; a generally planar porous wound filler adapted to deliver negative pressure to the wound site and including at least one incision extending through a portion of the thickness of the wound filler material to define a separable wound filler material; a flexible cover; a catheter; and a negative pressure source configured to deliver negative pressure to the wound site via the catheter. In some embodiments, a method of treating a wound site using negative pressure may include: placing the wound contact layer onto the wound site; placing the porous wound filler over the wound contact layer, wherein the porous wound filler is perforated to allow removal of portions of the wound filler to allow for size-independent sizing of the wound filler to fit the wound site; sealing the wound site with a flexible cover, the flexible cover configured to be positioned over the wound and sealed to the skin surrounding the wound; connecting the negative pressure source to the wound site; and maintaining the application of negative pressure until the wound site has adequately healed.

[0010] A system for providing medial compression to a wound site may include a wound filler. The wound filler may include a closure layer configured to contact the patient's fascia. The wound filler may include an edge extending from the closure layer, the edge being configured to be positioned beneath the fascia. The wound filler may include a slit in the closure layer. The wound filler may be configured to apply medial tension to the fascia when negative pressure is applied to the wound filler.

[0011] Any of the systems and / or devices, systems, or apparatuses disclosed herein that provide medial compression to a wound site, as described in any of the preceding paragraphs, may include one or more of the following features: The closure layer may include multiple slits. The closure layer may include three slits. The three slits may include one large slit and two small slits. The slits may be a pattern of holes. The slits may be oval holes. The edge may include multiple slits, with individual slits configured to attach to the fascia. The edge may be integral with the closure layer. The system may include a negative pressure source. The wound filler may also include a spacer material. The spacer material may be sandwiched between a top foam layer and a bottom foam layer. The wound filler may include foam. The system may include a wound contact layer configured to be positioned above the wound filler. The system may include an organ protection layer configured to be positioned below the wound filler. The organ protection layer may be cut by a user to adjust its size. The organ protection layer may include spacer material. The spacer material may be positioned such that fluid is guided from the edges of the organ protection layer to its central portion. The edge may be perforated to aid in its removal. The wound filler may include an open ellipse configured to allow a user to view the wound site.

[0012] In some instances, a method of treating a wound site using negative pressure may include: placing a wound contact layer onto the wound site; placing a porous pad over the wound contact layer, wherein the porous pad is perforated to allow removal of pad portions to allow the pad to be sized in a size-independent manner to fit the wound site; sealing the wound site with a flexible cover, the flexible cover being configured to be positioned over the wound and seal to the skin surrounding the wound; connecting a negative pressure source to the wound site; and maintaining the application of negative pressure until the wound site has healed adequately.

[0013] The wound treatment system may include an organ protection layer suitable for contact with a wound site. The organ protection layer may include multiple delivery tubes in fluid communication with the wound site. The organ protection layer may include a connector. The connector may include an inlet branch in fluid communication with a fluid source. The connector may include a delivery branch in fluid communication with the delivery tubes. The connector may include an outlet branch in fluid communication with a canister. The inlet, delivery, and outlet branches of the connector may be in fluid communication.

[0014] Any wound treatment system described in any of the preceding paragraphs and / or any of the devices, systems, or apparatuses disclosed herein may include one or more of the following features: The wound treatment system may include a manifold connected to a delivery tube and delivery branches, wherein the manifold is configured to dispense fluid to and receive fluid from the delivery tube. The delivery tube may be positioned between layers of spacer material. The inlet, delivery, and outlet branches of a connector may be connected at a joint. The connector may be a Y-connector. The connector and delivery tube may remove fluid from the wound site. The connector and delivery tube may deliver fluid to the wound site. The connector and delivery tube may simultaneously deliver and remove fluid from the wound site. The connector may include a switch that allows a user to control fluid flow within the connector. The switch may allow a user to restrict the inlet or outlet branch. The switch may be integral with the connector. The organ protection layer may be transparent. The connector may be transparent. The delivery tube may be transparent. The manifold may be transparent. The manifold may include an outlet configured to allow fluid to be released from the manifold. The manifold may include an inner wall separating the lumen of the manifold. The inner wall can divide the lumen into a delivery section and a removal section. The delivery tube can be circular. The delivery tube can be flat or elongated oval. The delivery tube may include teeth inside the delivery tube. The delivery tube may include top teeth and bottom teeth inside the delivery tube. The manifold can be made of any of polyurethane, silicone, foam, rubber, and polyisoprene. The spacer material can be made of any of foam, 3D fabric, silver, or a material with antimicrobial properties. The manifold can be octagonal, disc-shaped, flower-shaped, rectangular, curved, circular, or oval.

[0015] A method for cleaning a wound site may include placing an organ protectant on the wound site. The organ protectant may include a delivery tube in fluid communication with the wound site. The organ protectant may include an inlet branch of a connector connected to a fluid source. The method for cleaning the wound site may include connecting the delivery branch of the connector to the delivery tube. The method for cleaning the wound site may include connecting an outlet branch of the connector to a container. The method for cleaning the wound site may include allowing fluid to be delivered from the fluid source to the inlet branch of the connector, to the delivery branch of the connector, to the delivery tube, to the wound site, to the delivery branch of the connector, to the outlet branch of the connector, and to the container.

[0016] Any wound treatment method described in any of the preceding paragraphs and / or any of the devices, systems, or apparatuses disclosed herein may include one or more of the following features: A wound treatment method may include connecting a manifold to a delivery tube and delivery branches, wherein the manifold is configured to dispense fluid into and receive fluid from the delivery tube. The delivery tube may be positioned between layers of spacer material. The inlet, delivery, and outlet branches of a connector may be connected at a joint. The connector may be a Y-connector. The connector and delivery tube may remove fluid from the wound site. The connector and delivery tube may deliver fluid to the wound site. The connector and delivery tube may simultaneously deliver and remove fluid from the wound site. The connector may include a switch that allows a user to control fluid flow within the connector. The switch may allow a user to restrict the inlet or outlet branch. The switch may be integral with the connector. The organ protection layer may be transparent. The connector may be transparent. The delivery tube may be transparent. The manifold may be transparent. The manifold may include a discharge port configured to allow fluid to be released from the manifold. The manifold may include an inner wall separating the lumen of the manifold. The inner wall may divide the lumen into a delivery portion and a removal portion. The delivery tube can be circular. The delivery tube can be flat or elongated oval. The delivery tube may include teeth inside the delivery tube. The delivery tube may include top and bottom teeth inside the delivery tube. The manifold can be made of any of polyurethane, silicone, foam, rubber, and polyisoprene. The spacer material can be made of any of foam, 3D fabric, silver, or a material with antimicrobial properties. The manifold can be octagonal, disc-shaped, flower-shaped, rectangular, curved, circular, or oval.

[0017] In some instances, the wound treatment system described herein may include: an organ protection layer adapted to contact a wound site and configured to guide wound exudate and distribute negative pressure; an eye-shaped pad adapted to transmit negative pressure to the wound site, the pad including: a plurality of arcuate incisions extending through at least a portion of the thickness of the pad to define a pad segment separable from the pad to allow for setting the size of the pad; and a plurality of orifices configured to allow negative pressure to reach the wound site, wherein the plurality of orifices extend radially inward from the plurality of incisions; a negative pressure source; and a conduit configured to transmit negative pressure from the source to the pad.

[0018] In some instances, the system may include a flexible cover configured to be placed over the pad. In some instances, each of the plurality of orifices in the pad includes two linear orifices forming an acute angle. In some instances, the plurality of orifices are shaped to reduce tissue pull-up when negative pressure is applied.

[0019] In some instances, the organ protection layer described herein for contacting a wound site may include a plurality of curved spacer material portions radially positioned around the organ protection layer, the curved spacer material portions being configured to deliver fluid across the organ protection layer. In some instances, the organ protection layer may include a top membrane layer and a bottom membrane layer disposed around the plurality of curved spacer materials. In some instances, the plurality of curved spacer material portions are positioned in multiple rings on the organ protection layer.

[0020] In some instances, the organ protection layer described herein for contact with a wound site may include: a top membrane; a bottom membrane; and a spacer material positioned between the top and bottom membranes, the spacer material including: a central spacer material portion; a plurality of innermost curved spacer material portions radially positioned around the central spacer material portion; a plurality of intermediate curved spacer material portions radially positioned around the innermost curved spacer material portions; and a plurality of outermost curved spacer material portions radially positioned around the intermediate curved spacer material portions, wherein the top and bottom membranes are welded together along the periphery of the organ protection layer.

[0021] In some instances, the central septum material portion is circular or oval. In some instances, the top and bottom membranes are welded together between the central septum material portion and multiple innermost curved septum material portions. In some instances, the top and bottom membranes are welded together between multiple innermost curved septum material portions and multiple intermediate curved septum material portions. In some instances, the top and bottom membranes are welded together around the periphery of each portion of the septum material. In some instances, the organ protective layer is configured to be cut along the welded portion to reduce the size of the organ protective layer.

[0022] In some instances, the organ protection layer described herein for contacting a wound site may include: one or more membranes; and a plurality of slits in the one or more membranes, wherein each of the plurality of slits is positioned at an angle between 30 degrees and about 60 degrees to a horizontal axis, wherein each of the plurality of slits is positioned at an angle between about 30 degrees and about 60 degrees to a vertical axis, wherein each of the plurality of slits is oriented in opposite directions in a horizontally adjacent quadrant, and wherein each of the plurality of slits is oriented in opposite directions in a horizontally adjacent quadrant.

[0023] In some instances, the method described herein for positioning an organ protection layer at a wound site may include: providing an organ protection layer including a spacer material portion at the center of the organ protection layer; and positioning the organ protection layer at the wound site such that the spacer material portion is aligned with the center of the wound site.

[0024] In some instances, the suction adapter described herein for applying negative pressure therapy may include: a suction orifice configured to be in fluid communication with a wound site; a suction port in fluid communication with the suction orifice via a suction channel, the suction port being configured to receive a conduit for negative pressure; a leak orifice configured to be in fluid communication with a wound site; and a leak port in fluid communication with the leak orifice via a leak channel, wherein the suction channel and the leak channel are separated by an inner wall.

[0025] In some instances, the suction adapter is rigid. In some instances, the suction adapter is made of molded plastic. In some instances, the suction adapter may include a base flange, wherein the suction orifice and the leakage orifice are on the bottom surface of the base flange. In some instances, the suction adapter may include a cantilever portion above the base flange, wherein the suction port is on the cantilever portion. In some instances, the suction adapter may include a filter in the leakage channel. In some instances, the filter is vertically oriented. In some instances, the suction adapter may include a notch configured to receive a user's finger. In some instances, the suction adapter can withstand a force of approximately 250 mmHg.

[0026] In some instances, the method described herein for applying negative pressure wound therapy may include: positioning a foam pad on a wound site; positioning a suction adapter above the foam pad, the suction adapter including: a suction orifice; a suction port in fluid communication with the suction orifice via a suction channel; a leak orifice; and a leak port in fluid communication with the leak orifice via a leak channel, wherein the suction channel and the leak channel are separated by an inner wall; positioning a conduit for negative pressure in the suction port of the suction adapter; and detecting flow through the suction port to determine whether the suction adapter is in fluid communication with the foam pad.

[0027] In some instances, the method may include delivering negative pressure from a negative pressure source via a conduit.

[0028] In some instances, the organ protective layer described herein may include a first membrane layer, a second membrane layer, a central spacer material portion disposed between the first membrane layer and the second membrane layer, and a plurality of spacer material portions disposed between the first membrane layer and the second membrane layer. The plurality of spacer material portions may be radially outwardly positioned from the central spacer material portion.

[0029] In some examples, the central spacer material portion is circular or oval. In some examples, the central spacer material portion includes a central aperture, and the central aperture is circular or oval. In some examples, multiple spacer material portions are circular, oval, or stadium-shaped. In some examples, multiple spacer material portions are arranged in a ring circumferentially around the central spacer portion. In some examples, the first and second membrane layers are radially welded together between the rings. In some examples, multiple spacer material portions are circular, semi-circular, oval, or semi-oval. In some examples, multiple spacer material portions include apertures.

[0030] This document discloses any of the systems and methods for providing medial compression to a wound site as described in any of the preceding paragraphs, and / or any of the devices, apparatuses, or systems disclosed herein.

[0031] Any feature, component, or detail of any arrangement or embodiment disclosed in this application (including, but not limited to, any device embodiment and any wound site inner compression embodiment disclosed herein) may be interchangeably combined with any other feature, component, or detail of any arrangement or embodiment disclosed herein to form new arrangements and embodiments. Attached Figure Description

[0032] Figure 1A This is a schematic diagram of a system used to treat abdominal wounds.

[0033] Figure 1B A negative pressure therapy system is shown.

[0034] Figure 2A This is a perspective view of an embodiment of a wound filler including an elongated layer, a lip, and a slit.

[0035] Figure 2B yes Figure 2A A top view of the wound filler.

[0036] Figure 3A It is positioned inside an open abdominal wound, covered with a drape, and attached to a negative pressure system. Figure 2A A top view of the wound filler.

[0037] Figure 3B yes Figure 3A A cross-sectional view of the wound filler.

[0038] Figure 4 This is a perspective view of another embodiment of a wound filling material including multiple slits.

[0039] Figure 5 This is a perspective view of another embodiment of a wound filling material including a central hole.

[0040] Figure 6AThis is a top view of another embodiment of a wound filling material including edges with multiple slits and a central hole.

[0041] Figure 6B yes Figure 6A A perspective view of the wound filler.

[0042] Figure 7 It is a top view of wound fillers that include various fluid-stabilizing structures.

[0043] Figure 8 This is a top view of another embodiment of a wound filler that includes various fluid-stabilized structures.

[0044] Figure 9 This is a top view of another embodiment of a wound filler having a spacer material sandwiched between two transversely cut foam layers.

[0045] Figure 10 This is a top view of another embodiment of a wound filler including a pattern for internal compression.

[0046] Figure 11 This is a top view of another embodiment of a wound filler including a small hole and a larger central hole.

[0047] Figure 12 This is a top view of another embodiment of a wound filler with X-shaped holes.

[0048] Figure 13 An organ protective layer is shown, comprising a spacer material and a filling material to promote internal tension and fluid management.

[0049] Figure 14 This is a top view of another embodiment of an organ protective layer with a cross-shaped design including filling material.

[0050] Figure 15 Another embodiment of an organ protective layer is shown, comprising a plurality of rectangular filling materials arranged horizontally, which are larger on the outside and can decrease in size toward the center.

[0051] Figure 16 Another embodiment of an organ protective layer is shown, comprising a plurality of rectangular filling materials arranged horizontally and vertically, which are larger on the outside and can decrease in size toward the center.

[0052] Figure 17 It is an example of a stretchable and compressible material.

[0053] Figure 18 This is a diagram of a connector used for cleaning abdominal wounds.

[0054] Figure 19 This is an example of an organ protective layer used to cover abdominal wounds.

[0055] Figure 20A This is a top view of the delivery tubes positioned between the layers of spacer material.

[0056] Figure 20B It is a perspective view of the delivery tubes positioned between the layers of spacer material.

[0057] Figure 21 This is an illustration of an organ protective layer used to cover an abdominal wound.

[0058] Figure 22 This is an illustration of an example of a manifold used for dispensing liquids.

[0059] Figure 23 This is an illustration of another example of a manifold used for distributing liquids.

[0060] Figure 24 This is an illustration of another example of a manifold used for distributing liquids.

[0061] Figure 25 This is an illustration of another example of a manifold used for distributing liquids.

[0062] Figure 26 This is an illustration of another example of a manifold used for distributing liquids.

[0063] Figure 27 This is an illustration of another example of a manifold used for distributing liquids.

[0064] Figure 28 This is an illustration of another example of a manifold used for distributing liquids.

[0065] Figure 29 It is connected to the delivery tube. Figure 22 A diagram of a manifold used for distributing liquids.

[0066] Figure 30 It is connected to the delivery tube. Figure 25 A diagram of a manifold used for distributing liquids.

[0067] Figure 31A This is a perspective view of a flat delivery tube.

[0068] Figure 31B This is a front cross-sectional view of the flat delivery tube.

[0069] Figure 32 This is a diagram of three flat delivery tubes on the bottom layer of spacer material.

[0070] Figure 33 This is a diagram of a flat delivery tube positioned between the cross-sections of the bottom and top layers of the spacer material.

[0071] Figure 34 This is a schematic diagram of a system used to clean abdominal wounds.

[0072] Figure 35 This is a diagram of a connector with an integrated switch used for cleaning abdominal wounds.

[0073] Figure 36 This is a front view of an example of an organ protective layer with slits.

[0074] Figure 37A This is a front view of an example of an organ protective layer with spacer material.

[0075] Figure 37B It has Figure 37A An exploded perspective view of an example of an organ protective layer made of spacer material.

[0076] Figure 37C yes Figure 37A A front view of an instance of the spacer material.

[0077] Figure 38 Another example of a pad is shown.

[0078] Figure 39A This is a side view of an instance of the suction adapter.

[0079] Figure 39B yes Figure 39A A top view of an example of a suction adapter.

[0080] Figure 39C yes Figure 39A The rear view of an instance of a suction adapter.

[0081] Figure 39D yes Figure 39A The front view of an instance of the suction adapter.

[0082] Figure 39E yes Figure 39A A bottom view of an example of a suction adapter.

[0083] Figure 39F It is parallel to Figure 39B The X-axis intercept shown Figure 39A A cross-sectional view of an example of a suction adapter.

[0084] Figures 40-48 An example of an organ protective layer with spacer material is shown. Detailed Implementation

[0085] The preferred embodiments disclosed herein relate to wound therapy for human or animal bodies. Therefore, any reference to wound herein may refer to a wound on the human or animal body, and any reference to the body herein may refer to the human or animal body. In addition to having its broad general meaning, the term "wound" as used herein includes any part of a patient's body to which decompression therapy may be used. 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 abdomen or peritoneal cavity. Such wounds can be treated using negative pressure wound therapy, where decompression or negative pressure is applied to the wound to facilitate and promote healing. It will also be appreciated that the negative pressure systems and methods disclosed herein can be applied to other parts of the body and are not necessarily limited to the treatment of wounds.

[0086] Go to Figure 1A In some embodiments, negative pressure wound therapy is performed using a negative pressure treatment system 101, as illustrated herein. In this embodiment, wound site 111, shown herein as an abdominal wound site, may benefit from treatment performed with negative pressure. Such an abdominal wound site may be the result of, for example, an accident or surgical intervention. In some cases, medical conditions such as abdominal compartment syndrome, abdominal hypertension, sepsis, or fluid edema may require abdominal decompression through a surgical incision in the abdominal wall to expose the peritoneal cavity, after which the opening may need to be kept open and accessible until the condition is resolved. Other conditions may also require the opening (particularly within the abdominal cavity) to remain open, for example, if multiple surgeries are required (which may be traumatic), or if there are signs of clinical conditions such as peritonitis or necrotizing fasciitis. In cases where the wound is located, particularly in the abdomen, it is necessary to manage potential complications related to the exposure of organs and the peritoneal space, whether the wound remains open or will close. Treatment using negative pressure is preferably targeted to minimize the risk of infection while promoting tissue viability and removal of harmful substances from the wound site. Applying decompression or negative pressure to the wound site has been found to promote faster healing, increased blood flow, reduced bacterial load, increased granulation tissue formation, stimulate fibroblast proliferation, stimulate endothelial cell proliferation, close chronic open wounds, inhibit burn penetration, and / or enhance flap and graft attachment. Wounds that have shown a positive response to treatment with negative pressure have also been reported, including infected open wounds, pressure ulcers, dehiscence, partial-thickness burns, and various lesions of attached flaps or grafts. Therefore, applying negative pressure to the wound site may be beneficial to the patient.

[0087] Therefore, some embodiments provide for placing a wound contact layer 105 over the wound site 111. Those skilled in the art will understand that the wound contact layer 105 can act as an organ protection layer. Preferably, the wound contact layer or organ protection layer 105 can be a thin, flexible material that does not adhere to the wound site or very close exposed internal organs. For example, polymers such as polyurethane, polyethylene, polytetrafluoroethylene, or blends thereof can be used. In one embodiment, the wound contact layer is permeable. For example, the wound contact layer 105 may be provided with openings, such as holes, slits, or channels, to allow the removal of fluid from the wound site 111 or the transfer of negative pressure to the wound site 111. Additional embodiments of the wound contact layer 105 are described in further detail below. Some embodiments of the negative pressure therapy system 101 may also use a porous pad 103, which may be disposed over the wound contact layer 105. The pad 103 may be made of a porous material (e.g., foam) that is soft, flexible, and generally conforms to the wound site 111. Such foam may include open-cell and mesh foams made of, for example, polymers. Suitable foams include those composed of, for example, polyurethane, silicone, and polyvinyl alcohol. Preferably, when negative pressure is applied to a wound, the pad 103 can guide wound exudate and other fluids through itself. Some pads 103 may include prefabricated channels or openings for such purposes. In some embodiments, the pad 103 may have a thickness between about one inch and about two inches. The pad may also have a length between about 16 and 17 inches and a width between about 11 and 12 inches. In other embodiments, the thickness, width, and / or length may have other suitable values. Other aspects of the pad 103 are discussed in more detail below.

[0088] Preferably, a cover 107 is used to seal the wound site 111. The cover 107 may be at least partially liquid-impermeable, thereby maintaining at least partial negative pressure at the wound site. Suitable materials for the cover 107 include, but are not limited to, synthetic polymeric materials that do not significantly absorb aqueous fluids, including polyolefins such as polyethylene and polypropylene, polyurethane, polysiloxanes, polyamides, polyesters, and other copolymers and mixtures thereof. The materials used in the cover may be hydrophobic or hydrophilic. Examples of suitable materials include Transeal® available from DeRoyal and OpSite® available from Smith & Nephew. To aid patient comfort and prevent skin maceration, the cover is at least partially breathable in some embodiments, allowing water vapor to pass through without being collected beneath the dressing. An adhesive layer may be provided on at least a portion of the underside of the cover 107 to secure the cover to the patient's skin; however, in some embodiments, a separate adhesive or adhesive tape may be used instead. Optionally, a release layer may be disposed on the adhesive layer to protect it before use and facilitate handling of the cover 107; in some embodiments, the release layer may consist of multiple segments. The negative pressure system 101 may be connected to a negative pressure source, such as a pump 114. An example of a suitable pump is the Renasys EZ pump available from Smith & Nephew. The cover 107 may be connected to the negative pressure source 114 via a conduit 112. The conduit 112 may be connected to a port 113 located above an orifice 109 in the cover 107, or the conduit 112 may be connected directly through the orifice 109 without using the port. In another alternative, the conduit may pass under the cover and extend from one side of the cover. Other similar aspects of negative pressure systems are disclosed in U.S. Patent No. 7,524,315 and are incorporated herein by reference in their entirety and should be considered part of this specification. In many applications, a container or other storage unit 115 may be positioned between the negative pressure source 114 and the conduit 112 to allow storage of wound exudate and other fluids removed from the wound site without allowing them to enter the negative pressure source. Certain types of negative pressure sources (e.g., peristaltic pumps) may also allow the container 115 to be placed after the pump 114. Some embodiments may also use filters to prevent fluids, aerosols, and other microbial contaminants from leaving the container 115 and / or entering the negative pressure source 114. Other embodiments may include shut-off valves or enclosed hydrophobic and / or oleophobic filters in the container to prevent overflow; other embodiments may include sensing devices, such as capacitive sensors or other level detectors, used to stop or shut off the negative pressure source if the level in the container approaches its capacity. An odor filter, such as an activated carbon canister, may also preferably be provided at the pump vent.

[0089] Of course, the foregoing description describes certain features, aspects, and advantages of the invention, and various changes and modifications can be made thereto without departing from the spirit and scope of the invention. Furthermore, the negative pressure therapy system disclosed herein does not necessarily need to have all the foregoing objectives, advantages, features, and aspects. Those skilled in the art will recognize that the invention can be embodied or practiced in a manner that achieves or optimizes one or more advantages taught herein, without necessarily achieving other objectives or advantages that may be taught or suggested herein. For example, in some embodiments, pad 103 may be used without wound contact layer 105 and / or cover 107. Additionally, while many variations of the invention have been shown and described in detail, other modifications and methods of use within the scope of the invention will be apparent to those skilled in the art. It is conceivable that various combinations or sub-combinations of these features and aspects of the embodiments are achievable and still fall within the scope of the invention. Therefore, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for each other to form variations of the discussed negative pressure therapy system.

[0090] Figure 1B Another negative pressure wound therapy system 100 is shown. The negative pressure wound therapy system 100 may have any components, features, or other details of any other negative pressure wound therapy system disclosed herein (including, but not limited to, the negative pressure wound therapy system shown in the figures) in combination with or in place of such other systems. Figure 1B Any component, feature, or other detail of the negative pressure wound therapy system 100 shown and / or described herein. The negative pressure wound therapy system 100 may have a wound covering 106 over the wound 104, which can seal the wound 104. A conduit 108, such as a single-lumen or multi-lumen tube, may be used to connect the wound covering 106 to a wound treatment device 110 (sometimes referred to integrally or partially as a “pump assembly”), which is configured to supply reduced pressure or negative pressure. The wound covering 106 may be in fluid communication with the wound 104. Reference Figure 1B The catheter 108 may have a bridging portion 130 and an applicator 132 at the distal end of the bridging portion 130, thereby forming a flexible suction adapter (or catheter) 108. The bridging portion may have a proximal portion and a distal portion (the distal portion being closer to the wound 104 than the proximal portion). A connector 134 may be disposed at the proximal end of the bridging portion 130 for connection to at least one channel in a passage that can extend along... Figure 1BThe bridging portion 130 of the conduit 108 shown extends in length. A cap 140 may be coupled to a portion of the conduit 108 and, in some cases, may be attached to a connector 134, as shown. The cap 140 serves to prevent fluid leakage from the proximal end of the bridging portion 130. The conduit 108 may be a flexible port manufactured by Smith & Nephew. As mentioned, the negative pressure wound therapy system 100 may include a negative pressure source, such as a wound therapy device 110, capable of supplying negative pressure to the wound 104 through the conduit 108. Although not required, the wound therapy device 110 may also include a tank or other container for storing wound exudate and other fluids that can be removed from the wound. The wound therapy device 110 may be connected to the connector 134 via a conduit or tube 142. In use, the applicator 132 may be placed over an opening formed in a wound covering 106, which is placed over a properly prepared wound or wound 104. Subsequently, with the wound treatment device 110 connected to the connector 134 via the tube 142, the wound treatment device 110 can be activated to supply negative pressure to the wound. The negative pressure can be applied until the desired healing level of the wound is achieved. The bridging portion 130 may include an upper channel material or layer positioned between the upper and intermediate layers, wherein a lower channel material or layer is positioned between the intermediate and bottom layers. The upper, intermediate, and bottom layers may have elongated portions extending between proximal and distal ends and may include fluid-impermeable materials, such as polymers like polyurethane. It should be appreciated that the upper, intermediate, and bottom layers may each freely comprise different material compositions including semi-permeable materials. In some cases, one or more of the upper, intermediate, and bottom layers may be at least partially transparent. In some cases, the upper and bottom layers may be curved, rounded, or convex outwards along their majority length.

[0091] The upper and lower channel layers may extend from the proximal end to the distal end of the bridging portion 130 and may each preferably comprise a porous material, including, for example, open-cell foam, such as polyethylene or polyurethane. In some cases, one or more of the upper and lower channel layers may be composed of fabric (e.g., knitted or woven spacer fabrics such as knitted polyester 3D fabric, Baltex 7970.RTM, or Gehring 879.RTM)) or nonwoven materials or terry-knitted or terry-pile materials. The fibers may not necessarily be woven and may include felted and flocked (including materials such as Flotex.RTM) fibrous materials. The selected materials are preferably adapted to guide wound exudate away from the wound through the channels and to deliver negative pressure or exhaust air to the wound site, and may also impart a degree of kinking or clogging resistance to the channel layers. Those skilled in the art will understand that such materials may also be referred to as spacer materials and may be present in layers called spacer layers. In one example, the upper channel layer may comprise an open-cell foam, such as polyurethane, and the lower channel layer may comprise a fabric. In another example, the upper channel layer is optional, and the system may instead be configured with an open upper channel. The upper channel layer may have a curved, rounded, or upwardly convex upper surface and a substantially flat lower surface, and the lower channel layer may have a curved, rounded, or downwardly convex lower surface and a substantially flat upper surface. The fabric or material of any component of the bridging portion 130 may have a three-dimensional (3D) structure, wherein one or more types of fibers form a structure in which fibers extend in all three dimensions. In some cases, such fabrics may aid in wicking, fluid delivery, or the transmission of negative pressure. In some cases, the material of the fabric or channel may comprise several layers of material stacked or laminated on top of each other, which may, in some cases, prevent the channel from collapsing under the application of negative pressure. The material used in some embodiments of the catheter 108 may be conformal and flexible, which in some cases may help avoid pressure ulcers and other complications that can be caused by the wound treatment system pressing against the patient's skin.

[0092] The distal ends of the upper, middle, and lower layers, as well as the channel layer, may be enlarged at their distal ends (to be positioned above the wound site) and may form a "teardrop" or other enlarged shape. At least the distal ends of the upper, middle, and lower layers, as well as the channel layer, may also be provided with at least one through-hole. This orifice can be used not only to drain wound exudate and apply negative pressure to the wound, but also during the manufacture of the device, as these orifices can be used to properly align these respective layers. In some embodiments, a controlled gas leak 146 (sometimes referred to as a gas leak, air leak, or controlled air leak) may be provided on the bridging portion 130, for example, at its proximal end. This air leak 146 may include an opening or channel extending through the upper layer of the bridging portion 130, such that the air leak 146 is in fluid communication with the upper channel of the bridging portion 130. When suction is applied to the conduit 108, gas (such as air) may enter through the gas leak 146 and move along the upper channel of the bridging portion 130 from the proximal end to the distal end of the bridging portion 130. Gas can then be drawn into the lower channel of the bridging portion 130 through orifices extending through the distal ends of the upper, middle, and lower layers. An air leak 146 may include a filter. Preferably, the air leak 146 is located near the proximal end of the bridging portion 130 to minimize the possibility of wound exudate or other fluids coming into contact with and potentially clogging or interfering with the air leak 146 or the filter. In some cases, the filter may be a microporous membrane capable of excluding microorganisms and bacteria and potentially filtering out particles larger than 45 μm. Preferably, the filter excludes particles larger than 1.0 μm, and more preferably, particles larger than 0.2 μm. Advantageously, some embodiments provide a filter that is at least partially chemically resistant to, for example, water, common household liquids such as shampoo, and other surfactants. In some cases, applying a vacuum again to the suction adapter or wiping the exposed external portions of the filter may be sufficient to remove any foreign matter clogging the filter. The filter may be made of a suitably resistant polymer such as acrylic, polyethersulfone, or polytetrafluoroethylene, and may be oleophobic or hydrophobic. In some cases, the gas leak 146 can supply a relatively constant gas flow that does not increase significantly with the application of additional negative pressure to the conduit 108. In an example of the negative pressure wound therapy system 100, where the gas flow through the gas leak 146 increases with the application of additional negative pressure, preferably, this increase in gas flow is minimized and does not increase proportionally to the negative pressure applied thereto. Further description of such bridging elements, conduits, air leaks, and other components, features, and details that may be used with any embodiment of the negative pressure wound therapy system disclosed herein can be found in U.S. Patent No. 8,801,685, which is incorporated herein by reference in its entirety as if fully set forth herein.

[0093] Any wound treatment device disclosed herein (such as device 114 or 110) can provide continuous or intermittent negative pressure therapy. Continuous therapy can be delivered at pressures 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 negative pressure setpoints and high negative pressure setpoints (sometimes referred to as setpoints). The low setpoint can be set to 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. The high setpoint can be set to 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 treatment, negative pressure at a low setpoint can be delivered for a first duration, and after the first duration expires, negative pressure at a high setpoint can be delivered for a second duration. After the second duration expires, negative pressure at a low setpoint can be delivered. The first and second durations can be the same or different values. In operation, wound packing 102 can be inserted into the cavity of wound 104, and wound covering 106 can be placed to seal wound 104. Wound treatment device 110' can provide negative pressure to wound covering 106, which can be transmitted to wound 104 via wound packing 102. Fluids (such as wound exudate) can be drawn through conduit 108' and stored in a container. In some cases, the fluid is absorbed by wound packing 102 or one or more absorbent layers (not shown). Wound dressings that can be used with the pump assembly and system of this application include Renasy-F, Renasy-G, Renasy AB, and Pico Dressings, available from Smith & Nephew.Further descriptions of such wound dressings and other components of negative pressure wound therapy systems that can be used with the pump assembly and system of this application can be found in U.S. Patent Publications 2012 / 0116334, 2011 / 0213287, 2011 / 0282309, 2012 / 0136325 and U.S. Patent No. 9,084,845, and International Application No. WO2021 / 069642, each of which is incorporated herein by reference in its entirety as if fully set forth herein. In some cases, other suitable wound dressings may be used.

[0094] Figure 2A-2B An embodiment of wound packing 202 is shown, comprising a closure layer 210, an edge 212, and a slit 214. This wound packing is configured to be inserted into an abdominal incision, sealed with a diaphragm, and fluidly connected to a negative pressure source. Under negative pressure, wound packing 202 can collapse and pull the abdominal wall toward the midline. As those skilled in the art will understand, the wound packing can collapse anisotropically. Wound packing 202 can provide medial tension and reduce the risk of long-term diastasis recti or abdominal separation. In some embodiments, the closure layer can collapse under negative pressure, thereby pulling the walls of the fascia together. Wound packing 202 can be combined with… Figure 1A The pad 103 is interchangeable. Figure 2A An embodiment of the wound filler 202 is shown, which can be ring-shaped to fit abdominal wounds of different sizes. For example... Figure 2A As shown in -B, the wound filler 202 may have a closure layer 210, an edge 212, and a slit 214. In some embodiments, the edge 212 may be perforated to allow a user to remove the entire edge or a portion of the edge. In some embodiments, the closure layer may have an edge forming an L-shaped cross-section, such as... Figure 2A As shown in -B.

[0095] Slit 214 can improve fluid management and provide improved medial closure. The slit allows the wound filler to collapse laterally, thereby pulling tissue walls (such as fascia) toward each other. In some embodiments, wound filler 202 is placed within the fascia where a surgical incision has been made to pull the abdominal wall toward the midline and provide medial tension. Closure layers can protrude through openings in the fascia, thus positioning themselves between segments of the fascia. Wound filler 202 can be placed in the wound before or together with an organ protection layer, such as… Figure 1AAs shown in the diagram. When the wound filler 202 is annular in shape, the wound filler may have an outwardly extending edge 212. The edge 212 may be positioned beneath the patient's fascia to secure the wound filler 202 within the wound, such as a traumatic opening in the fascia. The edge may be attached to the underside of the fascia and serves to grip the fascia during collapse of the wound filler under negative pressure and thus apply tension to the fascia. In some embodiments, the wound filler 202 may be located beneath the abdominal wall to aid medial tension. In some embodiments, the surface of the closure layer 210 may be located between the fascia. In some embodiments, the abdominal wall / peritoneum may be located beneath the fascia.

[0096] In some instances, the wound filler described herein is designed to fit beneath and between openings in the fascia. As described above, the closure layer 210 may extend through the fascia, while the edge 212 extends beneath the fascia. As described elsewhere, the edge may be anchored to the underside of the fascia and facilitates fascial closure when the closure layer collapses under negative pressure.

[0097] In some embodiments, the edge 212 is flexible to conform to the contours of the abdominal and fascial regions and is embedded within the tissue at the wound boundary, securing the wound filler 202 within the wound opening. In some embodiments, the edge may extend beneath the deep fascia, subserosa fascia, serosa, peritoneum, or any other layer between the skin and viscera. For example, in one embodiment, for an abdominal wound, the edge may preferably be placed beneath the peritoneum. Thus, the use of an edge can help maintain and hold the wound filler in the correct vertical level within the wound while anchoring it to the fascia to help provide medial tension to the fascia under negative pressure, thereby promoting wound closure. The closure layer 210 may extend centrally from the edge and lie between the fascia. The slit 214 within the wound filler can contract and expand to allow the wound filler 202 to adjust the size of the abdominal wound and pull the abdominal wall toward the center to provide medial tension. The slit 214 may help reduce the risk of conditions such as chronic diastasis recti.

[0098] In some instances, the edge 212 can be positioned outward from the wound edge and placed beneath the fascia. The wound filler 202 can be located within the abdomen.

[0099] Figure 3A It is positioned inside an open abdominal wound, covered with a drape, and attached to a negative pressure system. Figure 2AA top view of the wound packing 202. Once negative pressure is applied via the catheter 112, the boundary of the abdominal wound tissue can be tightly sealed to the surface of the closure layer, and the wound packing 202 can pull the abdominal wall toward the midline. The wound packing can communicate with the abdominal wound and enable the application of negative pressure through the orifice 109 to provide a fluid connection from the wound to a negative pressure source (e.g., pump 114). The fluid connection between the orifice 109 and the pump 114 is created via the catheter 112. In some embodiments, the catheter 114 may include a RENASYS® Soft Port™ manufactured by Smith & Nephew. In some embodiments, the drape 107 may not necessarily include the orifice 109, and a fluid connection to the pump 114 can be formed by placing the catheter 114 under the drape. When under negative pressure, the wound packing 202 can pull the abdominal wall toward the midline and provide medial tension. The wound packing 202 can be biased toward the midline. The slit 214 can be shaped as a longitudinal strip configured to allow the wound packing to collapse. The slit 214 allows the stabilizing structure to flex more easily in a vertical plane. A single drape or multiple drapes can be placed over the wound packing 202 and can preferably adhere to or seal to the skin around the abdominal wound to create a fluid-impermeable seal.

[0100] Figure 3B This is a cross-sectional view of the wound filler 202 positioned between the fascia and overlying tissue. In some embodiments, the wound filler may be positioned below the fascia. After insertion of the wound filler, a drape 107 may cover the wound filler, and a conduit 112 may be connected to a port 113 located above an opening 109 in the drape 107. The edge 212 may deform when placed in the wound site. The edge 212 may be located below the skin. The edge 212 may be located below the adipose tissue. The edge 212 may be located below the muscle. The edge 212 may be located in the layer containing abdominal organs. As those skilled in the art will understand, the wound filler 202 can improve the primary closure rate and reduce pressure on the organ. Furthermore, the wound filler 202 can improve blood supply to the organ to produce improved results.

[0101] Figure 4An embodiment of a wound packing 700 (similar to the wound packing described herein) having multiple slits 714 is shown. In some embodiments, the wound packing may have one, two, three, four, five, six, seven, or more slits. As shown in the image, the wound packing 700 may have three slits 714. The wound packing 700 may preferentially collapse in one direction. Here, the wound packing 700 may comprise a porous wound packing material (e.g., foam) in which multiple slits 714 have been cut. These multiple slits 714 may preferably extend longitudinally through the thickness of the wound packing 700. Thus, when a force is applied in a direction perpendicular to the slits 714, the empty spaces may allow the wound packing 700 to preferentially collapse in one direction. Since the empty spaces are more easily compressed than the rest of the foam, the width and thickness of the foam will preferably not (or minimally) compress compared to the compression obtained perpendicular to the length of the wound packing 700. Multiple slits 714 may be advantageous by aiding in abdominal wound fluid management and medial closure of the abdomen.

[0102] Figure 5 An embodiment of a wound filler 800 (similar to other wound fillers described herein) including a central hole 814 is shown. The central hole 814 may be an oval hole 814. The central hole 814 allows the wound filler 800 to collapse under negative pressure, thereby pulling tissues (such as fascia) together. As a result, the empty space within the central hole 814 can pull the abdominal wall toward the midline and provide temporary closure of the abdominal wound. When the negative pressure is paused and the abdomen returns to normal pressure, the central hole 814 can act as a window for the user to view the abdomen.

[0103] Figures 6A-6B A top view, perspective view, and bottom view of another embodiment of a wound filler 900 are shown, the wound filler including a central hole 914 and an edge 912 having a plurality of slits 916, similar to other wound fillers described herein. Figure 6AThe wound filler in the image shows a pre-compression phase without negative pressure application. The edge 912 can be formed in an L-shape perpendicular to the closure layer 910, extending outward into the wound cavity. In some embodiments, the edge can extend beneath the deep fascia, subserosa fascia, serosa, peritoneum, or any other layer between the skin and viscera. For example, in one embodiment, the edge can preferably be positioned beneath the peritoneum. The edge 912 can include a plurality of slits 916 formed as longitudinal strips, preferably extending longitudinally along the longitudinal axis of the wound. As described elsewhere herein, in some embodiments, the edge 912 may have perforations, allowing removal of the entire edge or a portion of the edge 912 if desired. The width of the edge 912 can be longer than the height of the closure layer 910, thus extending outward into the wound cavity. The width of the edge 912 can be longer than the height of the closure layer 910, thus conforming to the shape of the organ. Therefore, the construction of the edge can protect the organ and facilitate fluid communication with the abdominal wound and the wound filler 900. In some embodiments, the edge may include one or each portion extending outward from the edge (e.g., as shown in the figure). Figures 6A-6B One or more slits on the two portions (described in the text). For example, each portion of the edge may include one, two, three, four, five or more slits to facilitate anchoring to the tissue layer.

[0104] Under negative pressure, the wound filler 900 can be compressed in the horizontal plane to bring the wound edges closer together. Therefore, when negative pressure is applied in a direction perpendicular to the slit 916, the empty space created by the slit 916 allows the wound filler to preferentially collapse in a certain direction. Thus, the wound filler 900 can be anchored to the underside of the fascia and helps to completely and temporarily close the open abdomen.

[0105] Figure 7An embodiment of a wound packer 1000, similar to those described elsewhere herein, is shown, comprising various patterned elements. As those skilled in the art will understand, the wound packer may be configured to anisotropically collapse under negative pressure, thereby collapsing across the width of the wound packer in the horizontal direction. In an embodiment, rhomboid elements 1010 form a rhomboid shape at the center of the wound packer 1000. A plurality of rhomboid elements 1010 may be arranged in a repeating pattern at the central location of the wound packer 1000, thereby forming a lattice. The plurality of rhomboid elements 1010 at the central location of the wound packer 1000 may collapse and compress along the length and width of the wound packing material, while facilitating fluid communication with the abdominal wound. Annular elements 1012 may be formed in an annular shape. A plurality of annular elements 1012 may be arranged in a repeating pattern in the proximal and distal portions of the plurality of rhomboid elements 1010. The elongated element 1014 can form longitudinal strips parallel to each other, extending toward the outer edge of the wound filler 1000 away from the rhomboid element 1010 and the annular element 1012. The elongated element 1014 can facilitate the anisotropic collapse of the rhomboid element 1010 and the annular element 1012 under negative pressure. As those skilled in the art will understand, this shape pattern can be used to enhance the collapse of the wound filler 1000.

[0106] The wound filler 1000 may have a concentrated shape in the middle and diffuse outwards to produce an inward compression effect. The wound filler 1000 may have a narrow slit pattern around the edge of the filler, which will allow inward compression to occur in different directions. These shapes can be cut using a laser cutter. The elongated element 1014 can collapse to help manage and close smaller elements.

[0107] Figure 8 Another embodiment of wound filler 1100 is shown, comprising a slit 1110, a plurality of longitudinal strips 1112 positioned around the slit, fan-shaped elements 1114 positioned laterally from the longitudinal strips, and one or more pairs of curved longitudinal strips 1116. The plurality of longitudinal strips 1112 and the fan-shaped elements 1114 facilitate fluid management. The fan-shaped elements 1114 are configured to be compressed under negative pressure and facilitate the collapse of the slit 1110 and pull the abdominal wall toward the midline, providing medial tension. The smaller slit and the larger slit 1110 in the center facilitate fluid management. The fan-shaped elements 1114 may be compressible to aid in medial compression of the foam.

[0108] Figure 9Another embodiment of a wound filler 1200 is shown, comprising a spacer material sandwiched between two foam layers 1240. The wound filler 1200 can pull on skin / fat tissue as well as more or all of the abdominal layer. Multiple pores allow fluid to pass through the padding of the top foam layer 1240. A circle 1242 can be cut in the center to expel fluid below. When compressed, the top foam layer 1240 can collapse, allowing fluid to travel through the foam. Cutouts may also be present in the wound filler to allow for shaping the wound filler for a specific wound.

[0109] Figure 10 Another embodiment of a wound filler 1300 including a pattern for medial compression is shown. The wound filler 1300 may have a concave lenticular slit 1352 surrounded by a triangle 1350 at its center, as a different way to promote medial compression. A narrow slit 1354 may surround the concave lenticular slit 1352 and the triangle 1350. The arrangement of these shapes may be advantageous for medial compression.

[0110] Figure 11 Another embodiment of a wound filler 1400 is shown, comprising small holes 1460 and a larger central hole 1462. The small holes 1460 may be distributed throughout the wound filler material. The small holes 1460 may form an array. The large central hole 1462 may aid in medial pressure. In some embodiments, the wound filler 1400 may have multiple overlapping perforation lines and / or shapes to allow the user to select the desired shape or size for the incision type.

[0111] Figure 12 Another embodiment of a wound filler 1500 including X-shaped holes 1564 is shown. The X-shaped holes 1564 may be evenly distributed on the surface of the wound filler 1500. The X-shaped holes 1564 may facilitate internal compression. In some embodiments, as disclosed elsewhere herein, the wound filler 1400 may have multiple overlapping perforation lines and / or shapes to allow a user to select the desired shape or size for the incision type.

[0112] Figure 13An organ protection layer 1600 is shown, comprising a spacer material 1670 (e.g., a spacer material described elsewhere herein) for promoting medial tension and fluid management, and a filler material 1672. The spacer material may be H-shaped to facilitate fluid management from the four sides of the abdomen and to allow fluid to move toward the center for fluid removal. Fluid can be removed using negative pressure wound therapy. The spacer material may be positioned between the membrane layers of the organ protection layer 1600. The spacer material may be sandwiched between the membrane layers. The spacer material 1670 may have polyurethane directly behind the fabric. The organ protection layer 1600 may have a membrane layer, a protective layer, and a spacer layer. The membrane may be in direct contact with the spacer material 1670. The filler material 1672 may be sandwiched between the membrane layers. The filler material 1672 may dispense fluid to and from the spacer material 1670. The spacer material 1670 may be connected to a flexible port.

[0113] Figure 14 Another embodiment of the organ protection layer 1700 constructed with a cross-shaped design 1780 of filling material is shown. The cross-shaped design 1780 of filling material can be a manner that guides fluid from all sides of the abdomen toward the midline for fluid management. The cross-shaped design 1780 can mechanically promote medial compression.

[0114] Figure 15 Another embodiment of the organ protection layer 1800 is shown, comprising a plurality of horizontally arranged rectangles 1882, larger on the outside and decreasing in size towards the center, of a filling material. In some embodiments, this design facilitates fluid delivery towards the center and inward compression. The center may have a large rectangle 1884. The large rectangle 1884 may be connected to a flexible port. The rectangles 1882 and the large rectangle 1884 may be spacer material sandwiched between layers of the membrane.

[0115] Figure 16 Another embodiment of the organ protection layer 1900 is shown, comprising a plurality of rectangles 1982 arranged horizontally and vertically, larger externally and decreasing in size towards the center, of filling material. In some embodiments, this design facilitates fluid delivery towards the center and internal compression. The center may have a large rectangle 1984. The large rectangle 1984 may be connected to a flexible port. This design allows the organ protection layer 1900 to be adaptable to various sizes. The rectangles 1982 and the large rectangle 1984 may be spacer material sandwiched between the layers of the membrane. A user can cut the organ protection layer 1900 between the rectangles 1982. For example, a user can cut the membrane between the uppermost rectangles 1982. The organ protection layer 1900 can be cut to a size suitable for the wound site. The organ protection layer 1900 may be thin. In some embodiments, the shape of the organ protection layer may aid in navigation and / or shaping of the organ protection layer 1900 for a centrally fitted fit within the abdomen.

[0116] Figure 17 This is an example of a stretchable and compressible material 2000. The stretchable and compressible material 2000 can serve as a spacer material. The spacer material can be sandwiched within an organ protection layer and can aid in fluid management and internal compression. The stretchable and compressible material 2000 can be a double-mesh spacer with monofilaments. The double-mesh spacer can have monofilaments between the two mesh layers. The monofilaments can be manufactured at 90° and 45° angles or any suitable angle. Monofilaments manufactured at a 45° angle can leave channels in the design. This can guide the user to cut the organ protection layer without causing the fabric to detach. The spacer can also be made from spun-dyed yarns. The spacer can also be made from stretched spacers. Spacer fabrics can also be used to aid in fluid management by helping fluid move across and / or within a 3D fabric.

[0117] In some embodiments, the 3D spacer fabric may be a moisture-wicking polyester. Once stretched within the organ protection layer, the stretchable spacer material can re-adjust to its original shape. This can aid in internal compression and bring the abdominal layers closer together. The stretchable spacer material can be any stretchable material. The 3D spacer fabric may include silver. If negative pressure is no longer applied, fluid can remain within the material. In some embodiments, silver may be added to prevent and limit bacterial growth.

[0118] Figure 18 This is an illustration of an example of a connector 3200 for cleaning an abdominal wound. The connector 3200 can flush and remove fluid from the wound site. The connector 3200 may be a Y-connector. Fluid can enter the connector 3200 at an inlet port 3212, which may be a Luer connector with a one-way valve. Fluid can enter the connector 3200 through the inlet port 3212 into an inlet branch 3202. The inlet branch 3202 of the connector 3200 may connect to a delivery branch 3204 and an outlet branch 3206 at a mating point 3208. The inlet branch 3202 may allow unidirectional flow. The inlet branch 3202 may allow inward flow. In some embodiments, the connector 3200 may consist of a rotary valve that allows fluid to enter or exit the abdomen. The valve may be configured to prevent fluid from entering the abdomen while allowing fluid to exit the abdomen.

[0119] In some embodiments, fluid can flow from the inlet branch 3202 through the junction 3208 to the delivery branch 3204. The delivery branch 3204 can be connected to an organ protector covering the wound site at the delivery port 3214. Fluid can flow from the delivery branch 3204 through the delivery port 3214 into a delivery tube on the organ protector to flush the wound site. The delivery port 3214 can be a quick-lock connector. Fluid can flow from the wound site or the delivery tube through the delivery port 3214 to the delivery branch 3204. The delivery branch 3204 can allow multidirectional flow. The delivery branch 3204 can allow both inward and outward flow.

[0120] In a particular embodiment, fluid can flow from delivery branch 3204 through junction 3208 to output branch 3206. Output branch 3206 can be connected to a tank via output port 3216. An example of a suitable tank is the RENASYS Device Canister, available from Smith & Nephew. Fluid can flow from output branch 3206 to the tank via output port 3216. Output port 3216 can be a quick-clamp connector. Output branch 3206 can allow unidirectional flow. Output branch 3206 can allow outward flow.

[0121] Connector 3200 facilitates the removal of fluid from the wound site. Connector 3200 can deliver fluid to the wound site. Connector 3200 can simultaneously deliver and remove fluid from the wound site. Fluid can be delivered to and removed from the wound site to clean the wound site. The system described herein can be used to clean the wound site during negative pressure therapy. (See below for details.) Figure 35 As further described herein, in some embodiments, the switch can be used to switch between an incoming branch and an output branch.

[0122] Figure 19 This is an example of an organ protection layer 3300 used to cover an abdominal wound as described elsewhere herein. The organ protection layer 3300 may be placed on the wound site. In some embodiments, the organ protection layer 3300 may be sealed to the wound site, or may simply cover the underlying tissue. The organ protection layer can be used to protect the underlying tissue from damage caused by other components of the abdominal treatment system. A delivery port 3214 can connect the connector 3200 to the delivery tube 3310. The delivery port 3214 may be a flexible port. The delivery tube 3310 can deliver fluid to the wound site. The delivery tube 3310 can deliver fluid to the paracolic gutter of the abdomen. The delivery tube 3310 may be made of a spacer material, such as any suitable spacer material described herein. The organ protection layer 3300 may be transparent. The delivery tube 3310 may be transparent.

[0123] In some embodiments, the organ protection layer 3300 may be interchangeable with the pad 103. The organ protection layer 3300 may be interchangeable with the wound contact layer 105. The organ protection layer 3300 may be interchangeable with both the pad 103 and the wound contact layer 105. The organ protection layer 3300 may be rectangular. The organ protection layer 3300 may have rounded corners. The organ protection layer 3300 may have delivery tubes 3310 extending to the corners of the organ protection layer 3300. The organ protection layer 3300 may have delivery tubes 3310 extending to the sides of the organ protection layer 3300. In some instances, the organ protection layer may include one, two, three, four, five, six, seven, eight, nine, ten, fifteen, twenty, or more delivery tubes. In some embodiments, the organ protection layer 3300 may have six delivery tubes 3310. The delivery tubes 3310 facilitate the removal of fluid from the wound site. The delivery tubes 3310 deliver fluid to the wound site. The delivery tube 3310 can simultaneously deliver fluid to and remove fluid from the wound site.

[0124] Figure 20A This is a top view of an embodiment of a delivery tube 1710 positioned between layers of spacer material. Figure 20B This is a perspective view of a delivery tube 1710 positioned between layers of spacer material. The delivery tube 1710 is in fluid communication with the interior of the spacer manifold 3400. The delivery tube 1710 may be positioned below the top layer 4524 of the spacer material. The delivery tube 1710 may be positioned above the bottom layer (not depicted) of the spacer material. The delivery tube 1710 delivers fluid from the spacer material to the wound site.

[0125] Figure 21 This is an illustration of an embodiment of an organ protective layer 3300' for covering an abdominal wound. The organ protective layer 3300' may be circular. The organ protective layer 3300' may have delivery tubes 3310' extending along the radius of the organ protective layer 3300' to its edge. The organ protective layer 3300' may have eight delivery tubes 3310' as shown in the figure. However, those skilled in the art will understand that the organ protective layer may include any suitable number of delivery tubes.

[0126] Figure 22This is an illustration of an example of a manifold 3500 for dispensing fluid to and / or removing fluid or exudate from the abdomen. The manifold 3500 may have a port 3550 that can be connected to a delivery tube. The port 3550 may extend from the outside of the manifold 3500. The port 3550 may have a lumen in fluid communication with the inner lumen of the manifold 3500. The manifold 3500 may have a drain port 3560 that may facilitate internal compression. The drain port 3560 may allow fluid that may have seeped into the packing to be released from the manifold 3500. The manifold 3500 may be octagonal. The manifold 3500 may have any suitable number of ports 3550. For example, Figure 5 The manifold and any of the manifolds described herein may include one, two, three, four, five, six, seven, eight, nine, ten, fifteen, twenty or more ports.

[0127] Figure 23 This is an illustration of an example of a manifold 3600 for dispensing fluid into and / or removing fluid or exudate from the abdomen. The manifold 3600 may have a port 3650 that can be connected to a delivery tube. The port 3650 may extend from the outside of the manifold 3600. The port 3650 may have a lumen in fluid communication with the interior of the manifold 3600. The port 3650 may be connected to a circular tube. The manifold 3600 may be octagonal and may have any suitable number of ports, such as eight ports 3650.

[0128] Figure 24 This illustration shows another example of a manifold 3700 for dispensing fluid to and / or removing fluid or exudate from the abdomen. The manifold 3700 may have a port 3750 that can be connected to a delivery tube. The port 3750 may extend from the outside of the manifold 3700. The port 3750 may have a lumen in fluid communication with the interior of the manifold 3700. The port 3750 may be connected to a flat or elongated oval tube. The manifold 3700 may be octagonal and may have any suitable number of ports, such as eight ports 3750.

[0129] Figure 25This is an illustration of another example of a manifold 3800 for dispensing fluid to and / or removing fluid or exudate from the abdomen. The manifold 3800 may have a port 3850 that can be connected to a delivery tube. The port 3850 may be flush with the outside of the manifold 3800. The port 3850 may have a cavity in fluid communication with the inner lumen of the manifold 3800. The manifold 3800 may be kite-shaped. The manifold 3800 may have rounded corners. The manifold 3800 may have six ports 3850. The manifold 3800 may have an inner lumen separated by an inner wall 3870. The manifold 3800 may be a partitioned manifold. The inner wall 3870 of the manifold 3800 may separate the fluid removal portion from the fluid delivery portion. The manifold 3800 may have one side of the inner lumen for flushing techniques. The manifold 3800 may have one side of the inner lumen for fluid removal. In some embodiments, the inner wall 3870 may be removed if not needed during use.

[0130] Figure 26 This is an illustration of another example of a manifold 3900 for dispensing liquids. The manifold 3900 may have a port 3950 that can be connected to a delivery tube. The port 3950 may be flush with the outside of the manifold 3900. The port 3950 may have a cavity in fluid communication with the inner lumen of the manifold 3900. The manifold 3900 may be disc-shaped. The manifold 3900 may be flower-shaped. The manifold 3900 may be flower-disc shaped. The shape of the manifold 3900 may allow for flexibility. The manifold 3900 may be inserted under the fascia. The manifold 3900 may have eight ports 3950. The manifold 3900 may have a central gap 980. The gap 980 may connect to a delivery port 214.

[0131] Figure 27 This is an illustration of another example of a manifold 4000 for dispensing fluid into and / or removing fluid or exudate from the abdomen. The manifold 4000 may have ports 4050 that can be connected to a delivery tube. Ports 4050 may be flush with the outside of the manifold 4000. Ports 4050 may have a lumen in fluid communication with the interior of the manifold 4000. The manifold 4000 may be oval-shaped. The manifold 4000 may have six ports 4050. The manifold 4000 may be a filler manifold. Such a manifold 4000 can eliminate the need for filler by engaging with openings through tissue layers (e.g., fascia).

[0132] Figure 28This is an illustration of another example of a manifold 4100 for dispensing fluid to and / or removing fluid or exudate from the abdomen. The manifold 4100 may have a port 4150 that can be connected to a delivery tube. The port 4150 may be flush with the outside of the manifold 4100. The port 4150 may have a lumen in fluid communication with the interior of the manifold 4100. The manifold 4100 may be rectangular. The manifold 4100 may be curved. The manifold 4100 may have rounded corners. The manifold 4100 may have six ports 4150. The manifold 4100 may be a flatbed manifold. The manifold 4100 may allow for variability in the position of the delivery port 214.

[0133] Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 can be connected to delivery port 214. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 can dispense fluid from connector 200 to the wound site. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 can remove fluid from the wound site back to connector 200. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 can have one, two, three, four, five, six, seven, eight, nine, ten, or more than ten ports. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 can be made of any of polyurethane, silicone, foam, rubber, and polyisoprene. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 can be colored or transparent. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 can have different depths, which can be located within the filler and directly connected to the cover or delivery port. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 can be located below the filler material. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 can be available in various colors to improve visibility. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100, along with delivery tubing, can be used to dispense and aspirate fluid from different areas of the wound site.

[0134] Figure 29 It is connected to delivery tube 4210. Figure 5 An illustration of an example of a manifold 3500 for dispensing liquid. Delivery tube 4210 can be sealed to port 3550.

[0135] Figure 30It is connected to delivery tubes 4310 and 4320. Figure 8 An illustration of an example of a manifold 3800 for dispensing fluid. Delivery tubes 4310 and 4320 can be sealed to port 3550. Delivery tube 4310 can deliver fluid to a wound site. Delivery tube 4320 can remove fluid from a wound site. Delivery tube 4310 can be connected to a lumen on one side of the inner wall 3870. Delivery tube 4320 can be connected to a lumen on the other side of the inner wall 3870. Manifold 3800 can be connected to two, four, or more delivery tubes 4310. Manifold 3800 can be connected to two, four, or more delivery tubes 4320.

[0136] In some embodiments, the delivery tube may have different diameters based on its ability to handle various fluid viscosities. The tube shape may be elongated elliptical, circular, or triangular. The delivery tube may have a color that enhances the visibility of the organ protection layer. The delivery tube may be glued or welded to the manifold. The delivery tube may be pinned to the organ protection layer membrane. The delivery tube may be positioned between two layers of the organ protection layer membrane. The manifold may be adhered to the center of the organ protection layer membrane. The delivery tube may be loose, allowing the user to place the tube where it is most needed.

[0137] In some embodiments, transparent delivery tubes can allow surgeons better visibility of the wound site. Transparent organ protection layers can also allow surgeons better visibility of the wound site. Transparent manifolds can further enhance surgical visibility of the wound site. The use of tubing, spacers, and manifolds can reduce flow restrictions and provide faster and more efficient fluid drainage.

[0138] Figure 31A This is a perspective view of an embodiment of the flat delivery tube 4410. Figure 31B This is a front cross-sectional view of the flat delivery tube 4410. The flat delivery tube 4410 may be elongated elliptical. The flat delivery tube 4410 allows for pressure distribution on the organ during use. The flat delivery tube 4410 may have teeth 4402 and 4404. Teeth 4402 and 4404 can be extruded through the center. Teeth 4402 and 4404 can restrict the flat delivery tube 4410 from complete closure. Teeth 4402 and 4404 can allow for improved fluid management from the parasitic sulcus to the center of the organ's protective layer. When the flat delivery tube 4410 is compressed, the bottom tooth 4402 can impact the top inner wall of the flat delivery tube 4410. Once the bottom tooth 4402 impacts the top inner wall, the bottom tooth is restricted to horizontal movement by the top tooth 4404.

[0139] Figure 32 This is an illustration of an embodiment of three flat delivery tubes 4410 on the bottom layer 4522 of the spacer material. Figure 33This is an illustration of an embodiment of a flat delivery tube 4410 positioned between the cross-sections of the bottom layer 4522 and the top layer 4524 of the spacer material. In some embodiments, the delivery tube positioned between the layers of spacer material can be in fluid communication without manifolds 3500, 3600, 3700, 3800, 3900, 4000, 4100. The top layer 4524 and bottom layer 4522 of the spacer material can form a spacer manifold 3400. The flat delivery tube 4410 can, for example, be compressed between the two layers of spacer material or between the spacers to facilitate fluid drainage. The top layer 4524 and bottom layer 4522 of the spacer material can be 3D printed.

[0140] In some embodiments, the spacer manifold 3400 or flexible manifold may be made of foam, 3D fabric, silver, or other materials with antimicrobial properties. The spacer manifold 3400 may have varying depths. The spacer manifold 3400 may be located within the filler and directly connected to a cover or delivery port. The spacer manifold 3400 may be located below the filler material. Using the spacer manifold 3400 eliminates the need for additional filler material located between the fascia.

[0141] Figure 34 This is a schematic diagram of an embodiment of a system for cleaning an abdominal wound. Fluid can flow from a fluid source 4804 through an inlet tube 4802. The fluid source 4804 may be a saline container. Fluid can flow from the inlet tube 4802 to a connector 200. Fluid can flow from the connector 200 to a spacer manifold 3400 through a delivery port 214 or a flexible port. Fluid can flow from the spacer manifold 3400 to a delivery tube 4810. The delivery tube 4810 may be positioned across an organ protection layer 4800. Fluid can flow from the delivery tube 4810 to the wound site. The fluid may, for example, enter the abdomen and diffuse evenly within the abdominal cavity. Fluid can flow back from the wound site into the delivery tube 4810 and into the spacer manifold 3400. Fluid can flow from the spacer manifold 3400 into the connector 200 through the delivery port 214. Fluid can flow from the connector 200 into a container 4814 through an outlet tube 4812. The container 4814 may store the fluid.

[0142] Figure 35 This is an illustration of an embodiment of a connector 4900 for cleaning abdominal wounds, featuring an integrated switch 4912. Similar to... Figure 18Connector 4900 may include an inlet branch 4902, a delivery branch 4904, and an outlet branch 4906 connected at a junction 4908. Junction 4908 may have an integrated switch 4912 or a valve that allows the user to select the direction of flow. The integrated switch 4912 may be replaced with a removable switch. The integrated switch 4912 or the valve may restrict flow in a certain direction. For example, flow into the delivery branch 4904, from the delivery branch 4904 to the outlet branch 4906, and outward from the outlet branch 4906 may be allowed, while flow into the inlet branch 4902, from the inlet branch 4902 to the delivery branch 4904, and outward from the delivery branch 4904 may be restricted. Conversely, flow into delivery branch 4904, from delivery branch 4904 to output branch 4906, and outward from output branch 4906 can be restricted, while flow into entry branch 4902, from entry branch 4902 to delivery branch 4904, and outward from delivery branch 4904 is permitted. In some embodiments, the user can control whether the fluid is removed from the wound site or delivered to the wound site.

[0143] Figure 36 This is a front view of an example of an organ protective layer 5000 with slits 5060.

[0144] In some instances, the organ protection layer 5000 may resemble the wound contact layer and organ protection layer described above. The organ protection layer 5000 may be positioned to contact the wound site. In some embodiments, the organ protection layer 5000 may adhere minimally or not at all to the wound site and is provided with slits 5060 or other openings for removing wound exudate or fluid and applying negative pressure to the wound site. The slits 5060 may all be oriented towards the center of the organ protection layer 5000 for visual guidance. A user may be able to identify the center of the organ protection layer 5000 based on the orientation of the slits 5060. Those skilled in the art will understand that the slits described herein may be constructed as holes, openings, perforations, incisions, or other suitable structures.

[0145] In some instances, slit 5060 can be formed at a depth along the axis Z of the organ protection layer 5000. Slit 5060 can be a linear slit. The organ protection layer 5000 can have four quadrants or four quarter-quadrants. Slit 5060 can be aligned with the orientation of other slits in the same quadrant of the organ protection layer 5000. Slit 5060 can be opposite to the orientation of other slits in vertically and / or horizontally adjacent quadrants. Each slit 5060 can be positioned at an angle relative to the horizontal axis X and vertical axis Y of the organ protection layer 5000. For example, each slit 5060 can be positioned at an angle of approximately 45 degrees relative to the horizontal axis X of the organ protection layer 5000. In some embodiments, each slit 5060 can be positioned at an angle between approximately 30 degrees and approximately 60 degrees relative to the horizontal axis X of the organ protection layer 5000. In some embodiments, each slit 5060 can be positioned at an angle between approximately 10 degrees and approximately 80 degrees relative to the horizontal axis X of the organ protection layer 5000. In some embodiments, each slit 5060 may be positioned at an angle of approximately 45 degrees relative to the vertical axis Y of the organ protection layer 5000. In some embodiments, each slit 5060 may be positioned at an angle between approximately 30 degrees and approximately 60 degrees relative to the vertical axis Y of the organ protection layer 5000. In some embodiments, each slit 5060 may be positioned at an angle between approximately 10 degrees and approximately 80 degrees relative to the vertical axis Y of the organ protection layer 5000. For example, approximately 20 degrees, approximately 40 degrees, or approximately 70 degrees.

[0146] In some instances, the slits 5060 in adjacent horizontal or vertical quadrants of the organ protection layer 5000 may be angularly away from each other. For example, the slits 5060 in adjacent horizontal or vertical quadrants of the organ protection layer 5000 may face away from each other at an angle B of approximately 90 degrees. In some embodiments, angle B may be between approximately 80 degrees and approximately 100 degrees. In some embodiments, angle B may be between approximately 50 degrees and approximately 130 degrees.

[0147] In some instances, the organ protective layer 5000 may have a width of 660 mm along the horizontal axis X. In some embodiments, the organ protective layer 5000 may have a width between approximately 655 mm and approximately 665 mm along the horizontal axis X. In some embodiments, the organ protective layer 5000 may have a width between approximately 600 mm and approximately 700 mm along the horizontal axis X. In some embodiments, the organ protective layer 5000 may have a width between approximately 400 mm and approximately 900 mm along the horizontal axis X. In some embodiments, the organ protective layer 5000 may have a width between approximately 100 mm and approximately 1200 mm along the horizontal axis X.

[0148] In some embodiments, the organ protective layer 5000 may have a length of approximately 800 mm along the vertical axis Y. In some embodiments, the organ protective layer 5000 may have a length between approximately 795 mm and approximately 805 mm along the vertical axis Y. In some embodiments, the organ protective layer 5000 may have a length between approximately 700 mm and approximately 900 mm along the vertical axis Y. In some embodiments, the organ protective layer 5000 may have a length between approximately 500 mm and approximately 1100 mm along the vertical axis Y. In some embodiments, the organ protective layer 5000 may have a length between approximately 100 mm and approximately 1500 mm along the vertical axis Y.

[0149] In some instances, the organ protective layer 5000 may have a depth along axis Z (not shown). In some embodiments, the depth along axis Z may be 0.1 mm. In some embodiments, the depth along axis Z may be between about 0.05 mm and about 0.5 mm. In some embodiments, the depth along axis Z may be between about 0.01 mm and about 1 mm. In some embodiments, the depth along axis Z may be between about 0.001 mm and about 10 mm.

[0150] In some instances, each slit 5060 may have a certain length. In some embodiments, each slit 5060 may have a length of 4 mm. In some embodiments, each slit 5060 may have a length between about 3 mm and about 5 mm. In some embodiments, each slit 5060 may have a length between about 1 mm and about 7 mm. In some embodiments, each slit 5060 may have a length between about 0.1 mm and about 10 mm.

[0151] In some embodiments, slits 5060 in the same quadrant may be separated by a first space from the end of slit 5060 to the end of an adjacent slit. Slits 5060 in the same quadrant may be separated by a second space from the edge of slit 5060 to the edge of an adjacent slit. In some embodiments, slits 5060 in the same quadrant may have a first space of 16 mm therebetween. In some embodiments, slits 5060 in the same quadrant may have a first space between about 11 mm and about 21 mm therebetween. In some embodiments, slits 5060 in the same quadrant may have a first space between about 1 mm and about 30 mm therebetween. In some embodiments, slits 5060 in the same quadrant may have a second space between 10 mm therebetween. In some embodiments, slits 5060 in the same quadrant may have a second space between about 5 mm and about 25 mm therebetween. In some embodiments, slits 5060 in the same quadrant may have a second space between about 1 mm and about 30 mm therebetween.

[0152] Figure 37A This is a front view of an example of an organ protective layer 5100 having spacer material 5170. Figure 37B It has Figure 37A An exploded perspective view of an example of an organ protective layer 5100 of spacer material 5170. Figure 37C It shows Figure 37A Front view of an example of spacer material 5170.

[0153] In some instances, the organ protection layer 5100 may resemble the wound contact layer and organ protection layer described above. The organ protection layer 5100 may include a top membrane layer 5172 and a bottom membrane layer 5174. Membranes 5172 and 5174 may be bonded at a weld area 5176. In some embodiments, membranes 5172 and 5174 may be bonded at the weld area 5176 using welding, adhesives, and / or another bonding method. A spacer material 5170 may be sealed between the top membrane layer 5172 and the bottom membrane layer 5174. In some embodiments, the spacer material 5170 may be sealed within the weld area 5176 to prevent movement of the spacer material 5170 within the organ protection layer 5100. The spacer material 5170 may assist in fluid drainage by transferring fluid across the organ protection layer 5100.

[0154] In some instances, the top membrane 5172 and the bottom membrane 5174 may seal the entire periphery of the organ protection layer 5100. The organ protection layer 5100 may include slits in the membranes 5172 and 5174, for example, regarding Figure 36The slits described. In some embodiments, the organ protective layer 5100 may include a welded area radially outward from the outermost spacer material 5170d. In some embodiments, the organ protective layer 5100 may include a welded area surrounding the periphery of the organ protective layer 5100.

[0155] In some instances, the spacer material 5170 may include a central spacer material 5170a positioned at the center of the organ protection layer 5100. The central spacer material 5170a may be circular or oval. Surrounding the central spacer material 5170a, the organ protection layer 5100 may include three rings of spacer materials 5170b, c, and d, which may be curved or straight. These rings of spacer material may include an innermost spacer material 5170b, a middle spacer material 5170c, and an outermost spacer material 5170d. In some embodiments, the organ protection layer 5100 may include one to five rings surrounding the central spacer material. In some embodiments, the organ protection layer 5100 may include one to ten rings surrounding the central spacer material. Advantageously, the central spacer material 5170a may indicate the position where the organ protection layer 5100 should be placed on the wound site. For example, the organ protection layer 5100 may be positioned such that the central spacer material 5170a is substantially aligned with the center of the wound site.

[0156] In some instances, spacer material 5170 may include innermost spacer material 5170b. The innermost spacer material 5170b may be radially positioned around the central spacer material 5170a. The innermost spacer material 5170b may be shaped as a curved line or a semicircle. In some embodiments, organ protection layer 5100 may include eight innermost spacer materials 5170b. In some embodiments, organ protection layer 5100 may include four to twelve innermost spacer materials 5170b. In some embodiments, organ protection layer 5100 may include one to fifteen innermost spacer materials 5170b. In some embodiments, organ protection layer 5100 may include one to twenty innermost spacer materials 5170b. The shapes of the innermost spacer material 5170b, intermediate spacer material 5170c, and / or outermost spacer material 5170d may be curved or arc-shaped.

[0157] In some instances, spacer material 5170 may include intermediate spacer material 5170c. Intermediate spacer material 5170c may be radially positioned around the innermost spacer material 5170b. Intermediate spacer material 5170c may be shaped as a curved line or a semicircle. In some embodiments, organ protection layer 5100 may include eight intermediate spacer materials 5170c. In some embodiments, organ protection layer 5100 may include four to twelve intermediate spacer materials 5170c. In some embodiments, organ protection layer 5100 may include one to fifteen intermediate spacer materials 5170c.

[0158] In some instances, spacer material 5170 may include outermost spacer material 5170d. The outermost spacer material 5170d may be radially positioned around the intermediate spacer material 5170c. The outermost spacer material 5170d may be shaped as a curved line or a semicircle. In some embodiments, organ protection layer 5100 may include eight outermost spacer materials 5170d. In some embodiments, organ protection layer 5100 may include four to twelve outermost spacer materials 5170d. In some embodiments, organ protection layer 5100 may include one to fifteen outermost spacer materials 5170d.

[0159] In some instances, the organ protective layer 5100 may include a welded region 5176 between the central spacer material 5170a and the innermost spacer material 5170b. The organ protective layer 5100 may include a welded region 5176 between the innermost spacer material 5170b and the intermediate spacer material 5170c. The organ protective layer 5100 may include a welded region 5176 between the intermediate spacer material 5170c and the outermost spacer material 5170d. In some embodiments, the organ protective layer 5100 may include a welded region 5177 extending radially outward from the outermost spacer material 5170d. The welded region 5177 may be along the periphery of the organ protective layer 5100.

[0160] like Figure 37C As shown, in some instances, the spacer material at each level may be arranged along a ring or ellipse. In some instances, the spacer material at each level may be arranged along a triangle, square, or rectangle. Each ring of the spacer material may have a favorable large diameter and a small diameter for fluid transfer. The large diameter of each ring of the spacer material may be the maximum diameter, while the small diameter of each ring of the spacer material may be the minimum diameter. The large and small diameters can be measured from the center of the rings of the spacer material.

[0161] In some embodiments, the small diameter DB1 of the innermost spacer material 5170b is 228 mm. In some embodiments, the small diameter DB1 of the innermost spacer material 5170b is between 200 mm and 250 mm. In some embodiments, the small diameter DB1 of the innermost spacer material 5170b is between 100 mm and 400 mm. In some embodiments, the large diameter DB2 of the innermost spacer material 5170b is 271 mm. In some embodiments, the large diameter DB2 of the innermost spacer material 5170b is between 250 mm and 300 mm. In some embodiments, the large diameter DB2 of the innermost spacer material 5170b is between 150 mm and 450 mm.

[0162] In some embodiments, the small diameter DC1 of the intermediate spacer material 5170c is 390 mm. In some embodiments, the small diameter DC1 of the intermediate spacer material 5170c is between 350 mm and 400 mm. In some embodiments, the small diameter DC1 of the intermediate spacer material 5170c is between 200 mm and 550 mm. In some embodiments, the large diameter DC2 of the intermediate spacer material 5170c is 463 mm. In some embodiments, the large diameter DC2 of the intermediate spacer material 5170c is between 450 mm and 500 mm. In some embodiments, the large diameter DC2 of the intermediate spacer material 5170c is between 300 mm and 650 mm.

[0163] In some embodiments, the minor diameter DD1 of the outermost spacer material 5170d is 567 mm. In some embodiments, the minor diameter DD1 of the outermost spacer material 5170d is between 550 mm and 600 mm. In some embodiments, the minor diameter DD1 of the outermost spacer material 5170d is between 400 mm and 750 mm. In some embodiments, the major diameter DD2 of the outermost spacer material 5170d is 683 mm. In some embodiments, the major diameter DD2 of the outermost spacer material 5170d is between 650 mm and 700 mm. In some embodiments, the major diameter DD2 of the outermost spacer material 5170d is between 500 mm and 850 mm.

[0164] The spacer material 5170 may have a depth along dimension Z (not shown). In some embodiments, the spacer material 5170 may have a depth of 3 mm along dimension Z. In some embodiments, the spacer material 5170 may have a depth between about 1 mm and about 5 mm along dimension Z. In some embodiments, the spacer material 5170 may have a depth between about 0.1 mm and about 10 mm along dimension Z.

[0165] In some instances, the innermost spacer material 5170b may have a degree of curvature. The innermost spacer material 5170b may have a radius at each circular end. In some embodiments, the degree of curvature is approximately 20 degrees. In some embodiments, the degree of curvature is between approximately 10 degrees and approximately 30 degrees. In some embodiments, the degree of curvature is between approximately 0 degrees and approximately 45 degrees. In some embodiments, the radius at the circular end is approximately 15 mm. In some embodiments, the radius at the circular end is between approximately 5 mm and approximately 25 mm. In some embodiments, the radius at the circular end is between approximately 1 mm and approximately 30 mm.

[0166] In some instances, the intermediate spacer material 5170c may have a degree of curvature. The intermediate spacer material 5170c may have a radius at each circular end. In some embodiments, the degree of curvature is approximately 32 degrees. In some embodiments, the degree of curvature is between approximately 20 degrees and approximately 40 degrees. In some embodiments, the degree of curvature is between 0 degrees and approximately 60 degrees. In some embodiments, the radius at the circular end is approximately 18 mm. In some embodiments, the radius at the circular end is between approximately 5 mm and approximately 25 mm. In some embodiments, the radius at the circular end is between approximately 1 mm and approximately 30 mm.

[0167] In some instances, the outermost spacer material 5170d may have a degree of curvature. The outermost spacer material 5170d may have a radius at each circular end. In some embodiments, the degree of curvature is about 11 degrees. In some embodiments, the degree of curvature is between about 5 degrees and about 20 degrees. In some embodiments, the degree of curvature is between about 0 degrees and about 30 degrees. In some embodiments, the radius at the circular end is about 18 mm. In some embodiments, the radius at the circular end is between about 5 mm and about 25 mm. In some embodiments, the radius at the circular end is between about 1 mm and about 30 mm.

[0168] Figure 38 This is a top view of an example of pad 2203.

[0169] In some instances, pad 5203 can be used in this article (e.g., regarding...). Figure 1A and 1B In the negative pressure wound therapy system described above, in some embodiments of the negative pressure therapy system, a pad 5203 may be disposed above the wound contact layer. The pad 5203 may be made of a porous material (e.g., foam) that is soft, flexible, and generally conforms to the wound site. Such foam may include open-cell and mesh foams made of, for example, polymers. Suitable foams include foams composed of, for example, polyurethane, silicone, and polyvinyl alcohol. Preferably, when negative pressure is applied to the wound, the pad 5203 may guide wound exudate and other fluids through itself. The pad 5203 may include prefabricated channels or openings 2384 for such purposes.

[0170] In some embodiments, pad 5203 may have a thickness of about 25 mm. In some embodiments, pad 5203 may have a thickness between about 10 mm and about 40 mm. In some embodiments, pad 5203 may have a thickness between about 5 mm and about 60 mm. In some embodiments, pad 5203 may have a thickness between about 1 mm and about 80 mm.

[0171] In some instances, pad 5203 may have a length between about 400 mm and about 450 mm. In some embodiments, pad 5203 may have a length between about 350 mm and about 500 mm. In some embodiments, pad 5203 may have a length between about 300 mm and about 600 mm. In some embodiments, pad 5203 may have a length between about 100 mm and about 1,000 mm.

[0172] In some instances, pad 5203 may have a width between about 525 mm and about 275 mm. In some embodiments, pad 5203 may have a length between about 200 mm and about 300 mm. In some embodiments, pad 5203 may have a length between about 100 mm and about 400 mm. In some embodiments, pad 5203 may have a length between about 50 mm and about 800 mm. In other embodiments, the thickness, width, and / or length may have other suitable values.

[0173] In some instances, pad 5203 may be eye-shaped. In some embodiments, pad 5203 may be circular or oval. Pad 5203 may have corners 5280 on both sides of pad 5203. Corner 5280 may be rounded corners.

[0174] In some instances, the pad 5203 may include a slit or cut 5282. The cut 5282 may provide a flexible area for the pad 5203 and / or make portions of the pad 5203 easily separable. The cut 5282 may be an arcuate perforation formed in an elliptical pattern. The cut 5282 may extend through at least a portion of the pad's thickness to define a pad segment separable from the pad to allow for setting the pad's size. In some embodiments, the cut 5282 may allow for size-independent removal of portions of the porous pad 5203, wherein the length and width of the pad 5203 can be modified independently of each other. A user can remove portions of the pad 5203 along the cut 5282, causing the pad 5203 to fit over a wound site. The pad 5203 preferably comprises a generally planar shape with a thickness less than its width and length, and preferably includes at least one cut 5282 extending through at least a portion of the thickness of the pad 5203, whereby the cut 5282 defines a pad segment separable from the remainder of the pad 5203 to allow modification of the dimensions of the pad 5203 (e.g., its length and / or width). In some embodiments, the cut 5282 may be formed by an arcuate and / or elliptical cut, and may also include additional inner and outer cuts. In other embodiments, additional intermediate cuts may also be present.

[0175] In some instances, the pad 5203 may include an outer cutout 5282a surrounding the pad 5203. The outer cutout 5282a may allow removal of the outermost portion 5286 of the pad 5203. The outer cutout 5282a may be parallel to the corresponding edge of the pad 5203. The outer cutout 5282a may be a curved line. The outer cutout 5282a may be arranged in an eye-like shape. The pad 5203 may include four outer cutouts 5282a. In some embodiments, the pad 5203 may include 2-6 outer cutouts 5282a. In some embodiments, the pad 5203 may include 1-10 outer cutouts 5282a.

[0176] In some instances, the pad 5203 may include an inner cutout 5282b surrounding the pad 5203. The inner cutout 5282b may be radial between the outer cutout 5282a and the opening 5284. The inner cutout 5282b may allow removal of the outermost portion 5286 and the middle portion 5288 of the pad 5203. The inner cutout 5282b may be parallel to the corresponding edge of the pad 5203. The inner cutout 5282b may be a curved line. The inner cutout 5282b may be arranged in an eye-like shape. The pad 5203 may include four inner cutouts 5282b. In some embodiments, the pad 5203 may include 2-6 inner cutouts 5282b. In some embodiments, the pad 5203 may include 1-10 inner cutouts 5282b.

[0177] In some instances, pad 5203 may include openings 5284. Openings 5284 can be used to guide wound exudate and distribute negative pressure through pad 5203. Openings 5284 may extend completely through the thickness of pad 5203. Each opening 5284 may have a length between about 13 mm and 14 mm along its outer edge. In some embodiments, each opening 5284 may have a length between about 10 mm and 20 mm along its outer edge. In some embodiments, each opening 5284 may have a length between about 5 mm and 30 mm along its outer edge. Each opening 5284 may have a length between about 5 mm and 6 mm along its inner edge. In some embodiments, each opening 5284 may have a length between about 2 mm and 9 mm along its inner edge. In some embodiments, each opening 5284 may have a length between about 0.5 mm and 20 mm along its inner edge.

[0178] In some instances, each opening 5284 may be shaped as two linear apertures forming an acute angle. In some embodiments, each opening 5284 may be triangular or arrowhead shaped. The opening 5284 may be shaped to reduce tissue pull when negative pressure is applied. Each opening 5284 may have a wider end along the X-axis closer to the center of the pad 5203. Each opening 5284 may have a point along the X-axis further away from the center of the pad 5203. The pad 5203 may have 88 openings 5284. In some embodiments, the pad 5203 may have 50 to 100 openings 5284. In some embodiments, the pad 5203 may have 25 to 125 openings 5284. In some embodiments, the pad 5203 may have 10 to 150 openings 5284. Each opening 5284 may point towards the center of the pad 5203.

[0179] In some instances, the openings 5284 may be arranged in a diamond shape. The openings 5284 may be located at the center of the pad 5203. The openings 5284 may be arranged in columns. Columns of openings 5284 along the X-axis toward the center may contain more openings 5284 than columns of openings 5284 further away from the center at the ends. The number of openings 5284 in each column may gradually decrease in each column further away from the center along the X-axis.

[0180] Figure 39A This is a side view of an example of the suction adapter 5313. Figure 39B yes Figure 39A A top view of an example of the suction adapter 5313. Figure 39C yes Figure 39A Rear view of an instance of the suction adapter 5313. Figure 39D yes Figure 39A Front view of an instance of the suction adapter 5313. Figure 39E yes Figure 39A A bottom view of an example of the suction adapter 5313. Figure 39F It is parallel to Figure 39B The X-axis intercept shown Figure 39A A cross-sectional view of an example of the suction adapter 5313.

[0181] In some instances, the suction adapter 5313 can be used as, for example, regarding Figure 1A and 1B The port described. The suction adapter 5313 can be a rigid or hard port. The suction adapter 5313 can be an applicator or fluid connector for delivering negative pressure to the wound site.

[0182] In some instances, the suction adapter 5313 may include a base flange 5390, a suction port 5392, and an air leak port 5396. The base flange 5390 may be positioned at the wound site to achieve negative pressure therapy. In some instances, the base flange 5390 may be positioned over a hole in a drape. Negative pressure can be applied to the dressing, pad, and / or wound site through the suction channel 5393, which allows air to flow through the air leak channel 5397 to reach the dressing, pad, and / or wound site.

[0183] In some instances, the suction adapter 5313 may include a droop portion 5399 or a shield. The droop portion 5399 may include a suction port 5392. The droop portion 5399 may be positioned above the base flange 5390. The droop portion 5399 prevents a user's fingers from obstructing the flow through the suction adapter 5313. The suction adapter 5313 may be angled upwards from the droop portion 5399 to the air leak port 5396.

[0184] In some instances, the length of the pendant portion 5399 may be approximately 5 mm. In some embodiments, the length of the pendant portion 5399 may be between approximately 2 mm and approximately 8 mm. In some embodiments, the length of the pendant portion 5399 may be between approximately 1 mm and approximately 10 mm. In some embodiments, the length of the pendant portion 5399 may be between approximately 0.1 mm and approximately 20 mm. The pendant portion 5399 may have an increased length to increase the depth of the suction channel 5393. Advantageously, a deeper suction channel 5393 may be associated with a longer conduit.

[0185] like Figure 39E As shown, the suction adapter 5313 may include at least one suction port 5394, which is designed to be positioned above the wound site and can be used to fluidly connect the wound site to a negative pressure source. The suction adapter 5313 may include at least one air leak port 5398, which is designed to be positioned above the wound site and can be used as an air leak outlet and a conduit for drawing air into the wound site.

[0186] In some instances, the suction channel 5393 can fluidly connect the suction orifice 5394 to the suction port 5392. The suction adapter 5313 can be connected to a negative pressure source via a conduit. The conduit can be connected to the suction port 5392 of the suction adapter 5313. The suction adapter 5313 can be positioned such that the suction orifice 5394 is positioned above an opening in the cover drape. The suction orifice 5394 can be D-shaped or at least partially semi-circular. In some instances, the suction orifice 5394 can be rectangular with two rounded corners.

[0187] In some instances, an air leak passage 5397 or an air exhaust passage can fluidly connect an air leak orifice 5398 to an air leak port 5396. A suction adapter 5313 can be positioned such that the air leak orifice 5398 is positioned above an opening in the cover. Air can flow through the air leak port 5396, through the air leak passage 5397, and to the air leak orifice 5398. Air from the air leak orifice 5398 can ventilate the wound site and then flow through the suction orifice 5394.

[0188] In some instances, the air leak port 5396 may have a larger diameter than the suction port 5392. For example, the air leak port 5396 may be approximately twice the size of the suction port 5392. In some embodiments, the air leak port 5396 may be approximately 1.5 to approximately 3 times the size of the suction port 5392. In some embodiments, the air leak port 5396 may be approximately 1.25 to approximately 5 times the size of the suction port 5392.

[0189] In some instances, the air leak port 5396 may have an inner diameter of approximately 52 mm. In some embodiments, the air leak port 5396 may have an inner diameter between approximately 40 mm and approximately 60 mm. In some embodiments, the air leak port 5396 may have an inner diameter between approximately 20 mm and approximately 80 mm. In some embodiments, the air leak port 5396 may have an inner diameter between approximately 10 mm and approximately 100 mm.

[0190] In some instances, the suction port 5392 may have an inner diameter of approximately 25 mm. In some embodiments, the suction port 5392 may have an inner diameter between approximately 15 mm and approximately 35 mm. In some embodiments, the suction port 5392 may have an inner diameter between approximately 5 mm and approximately 50 mm. In some embodiments, the suction port 5392 may have an inner diameter between approximately 1 mm and approximately 75 mm.

[0191] In some instances, the air leak channel 5397 may include a filter. For example, the air leak channel 5397 may include a vertically oriented filter. The filter may be positioned adjacent to the air leak port 5396. In some instances, the filter may be thermally welded to the suction adapter 5313. The filter can filter particles from the air as it enters the suction adapter 5313. This filtering device can improve the safety and effectiveness of negative pressure wound therapy by preventing certain particles from entering the wound site.

[0192] In some instances, the negative pressure source can be a vacuum source. Vacuuming from the suction port 5394 to the wound site allows wound exudate to flow through the suction adapter 5313.

[0193] like Figure 39F As shown, the suction adapter 5313 may have an inner wall 5391 separating the suction channel 5393 from the air leakage channel 5397. The inner wall 5391 prevents wound exudate from entering the air leakage channel 5397 from the suction channel 5393. The user can determine whether the suction adapter 5313 is in fluid communication with the wound site by the flow through the suction channel 5393 or the suction port 5392. When the air leakage channel 5397 is separated from the suction channel 5393 by the inner wall 5391, the presence of flow in the suction channel 5393 or the suction port 5392 can indicate proper fluid communication with the wound site, so if the suction orifice 5394 is blocked, for example, by a diaphragm, the flow through the suction channel 5393 will be blocked. Conversely, when the suction orifice 5394 is blocked due to the lack of an inner wall 5391, other suction adapters still have flow through the suction channel 5393 because air will still flow from the air leakage channel 5397 to the suction channel 5393. Fluid communication with the wound site may include fluid communication with the foam pad that is in contact with the wound site.

[0194] In some instances, the suction adapter 5313 can be used to detect whether the negative pressure system is connected to the foam pad. If there is a blockage in the suction adapter 5313 or the negative pressure system, or if the suction adapter 5313 is not positioned above the hole in the cover drape, the suction orifice 5394 will not drain wound exudate. In this instance, the user can determine the lack of wound exudate by indicating a blockage or improper positioning of the suction adapter 5313.

[0195] In some instances, the suction adapter 5313 may be made of molded plastic. The suction adapter 5313 may be rigid enough to prevent it from collapsing. For example, the suction adapter 5313 may withstand approximately 250 mmHg. In some embodiments, the suction adapter 5313 may withstand approximately 200 mmHg to approximately 300 mmHg. In some embodiments, the suction adapter 5313 may withstand approximately 100 mmHg to approximately 500 mmHg.

[0196] In some instances, the suction adapter 5313 may include a notch 5387 for user manipulation. For example, the notch 5387 may be sized to receive a user's finger. The user can grasp the notch 5387 with their finger to move and / or position the suction adapter 5313.

[0197] Figures 40-48 An example of an organ protective layer with spacer material positioned between membrane layers is shown. Figures 40-48 Any of its features can be combined with other embodiments / examples described herein.

[0198] Figure 40An example of an organ protective layer 5400 having spacer material 5470 is shown.

[0199] Organ protective layer 5400 may include Figure 37A -C Any features of the organ protective layer 5100. The organ protective layer 5400 may have welding regions 5476 separating the various regions of the organ protective layer 5400. The organ protective layer 5400 may include a membrane layer 5472 having spacer material 5470 disposed between the layers. The spacer material 5470 may be elliptical, such as circular or oval. The organ protective layer 5400 may include an outermost ring, an intermediate ring, and a central portion of the spacer material. In some instances, the central portion of the spacer material may be formed as a ring, such as a circle or ellipse having a space at the center.

[0200] In some instances, the organ protective layer 5400 may include eight portions of spacer material in the outermost ring. The organ protective layer 5400 may include four to twelve portions of spacer material in the outermost ring. The organ protective layer 5400 may include two to fifteen portions of spacer material in the outermost ring.

[0201] In some instances, the organ protective layer 5400 may include eight portions of spacer material in the intermediate ring. The organ protective layer 5400 may include four to twelve portions of spacer material in the intermediate ring. The organ protective layer 5400 may include two to fifteen portions of spacer material in the intermediate ring.

[0202] Figure 41 An example of an organ protective layer 5500 having spacer material 5570 is shown.

[0203] Organ protection layer 5500 may include Figure 37A -C Any feature of the organ protective layer 5100. The organ protective layer 5500 may include a membrane layer 5572 having spacer material 5570 disposed between the layers. The spacer material 5570 may be elliptical, such as circular or oval. The spacer material 5570 may be arranged in a cross or asterisk shape. The spacer material 5570 may include a central portion, a plurality of portions vertically aligned above and below the central portion, a plurality of portions horizontally aligned on either side of the central portion, and / or a plurality of portions diagonally arranged from the central portion.

[0204] In some instances, spacer material 5570 may include three portions vertically aligned above the central portion and three portions vertically aligned below the central portion. Spacer material 5570 may include 1-5 portions vertically aligned above the central portion and 1-5 portions vertically aligned below the central portion. In some instances, spacer material 5570 may include three portions horizontally aligned on one side of the central portion and three portions horizontally aligned on the other side of the central portion. Spacer material 5570 may include 1-5 portions horizontally aligned on one side of the central portion and 1-5 portions horizontally aligned on the other side of the central portion. In some instances, spacer material 5570 may include two portions diagonally aligned in each of the four directions originating from the central portion. Spacer material 5570 may include 1-5 portions diagonally aligned in each of the four directions originating from the central portion.

[0205] Figure 42 An example of an organ protective layer 5600 having spacer material 5670 is shown.

[0206] Organ protective layer 5600 may include Figure 37A -C Any feature of the organ protective layer 5100. The organ protective layer 5600 may include spacer material 5670 disposed between membrane layers 5672. In some instances, the organ protective layer 5600 may include 21 portions of spacer material 5670. The organ protective layer 5600 may include 10-30 portions of spacer material 5670. The organ protective layer 5600 may include 5-40 portions of spacer material 5670.

[0207] Figure 43 An example of an organ protective layer 5700 having spacer material 5770 is shown.

[0208] In some instances, the organ protection layer 5700 may include Figure 37A -C Any feature of the organ protective layer 5100. The organ protective layer 5700 may include spacer material 5770 disposed between membrane layers 5772. In some instances, the organ protective layer 5700 may include 25 portions of spacer material 5770. The organ protective layer 5700 may include 10-30 portions of spacer material 5770. The organ protective layer 5700 may include 5-40 portions of spacer material 5770.

[0209] In some instances, the organ protection layer 5700 may include three rings of spacer material 5770 and a central portion of spacer material 5770. The organ protection layer 5700 may include 1-5 rings of spacer material 5770 and a central portion of spacer material 5770. A membrane layer 5772 surrounding each ring of spacer material 5770 may include a welding region 5776. In some instances, each ring of spacer material 5770 may include 8 portions of spacer material 5770. Each ring of spacer material 5770 may include 5-10 portions of spacer material 5770. Each ring of spacer material 5770 may include 2-15 portions of spacer material 5770. The spacer material 5770 in the rings may be oval. The central spacer material 5770 may be oval. The spacer material 5770 in the rings may be narrower than the central spacer material 5770.

[0210] Figure 44 An example of an organ protective layer 5800 having spacer material 5870 is shown.

[0211] In some instances, the organ protection layer 5800 may include Figure 37A -C Any feature of the organ protective layer 5100. The organ protective layer 5800 may include spacer material 5870 disposed between membrane layers 5872. In some instances, the organ protective layer 5800 may include 25 portions of spacer material 5870. The organ protective layer 5800 may include 10-30 portions of spacer material 5870. The organ protective layer 5800 may include 5-40 portions of spacer material 5870.

[0212] In some instances, the organ protective layer 5800 may include three rings of spacer material 5870 and a central portion of spacer material 5870. The organ protective layer 5800 may include 1-5 rings of spacer material 5870 and a central portion of spacer material 5870. A membrane layer 5872 surrounding each ring of spacer material 5870 may include a welding region 5876. In some instances, each ring of spacer material 5870 may include eight portions of spacer material 5870. Each ring of spacer material 5870 may include 5-10 portions of spacer material 5870. Each ring of spacer material 5870 may include 2-15 portions of spacer material 5870. The spacer material 5870 in the rings may be curved, spherical, and / or stadium-shaped. The central spacer material 5870 may be oval.

[0213] Figure 45 An example of an organ protective layer 5900 having spacer material 5970 is shown.

[0214] In some instances, the organ protection layer 5900 may include Figure 37A-C Any feature of the organ protective layer 5100. The organ protective layer 5900 may include spacer material 5970 disposed between membrane layers 5972. In some instances, the organ protective layer 5900 may include 32 portions of spacer material 5970. The organ protective layer 5900 may include 25-50 portions of spacer material 5970. The organ protective layer 5900 may include 10-80 portions of spacer material 5970.

[0215] In some instances, the organ protection layer 5900 may include four rings of spacer material 5970 and a central portion of spacer material 5970. The organ protection layer 5900 may include 1-10 rings of spacer material 5970 and a central portion of spacer material 5970. In some instances, the membrane layer 5972 between the second and third outermost rings of spacer material 5970 may be separated by a welding region 5976. In some instances, the membrane layer 5972 between the central spacer material 5970 and the innermost ring of spacer material 5970 may be separated by a welding region 5976. In some instances, each ring of spacer material 5970 may include eight portions of spacer material 5970. Each ring of spacer material 5970 may include 5-10 portions of spacer material 5970. Each ring of spacer material 5970 may include 2-15 portions of spacer material 5970. The spacer material 5970 in the ring may be circular. The central spacer material 5970 can be annular, such as circular or oval, with a space in the center.

[0216] Figure 46 An example of an organ protective layer 6000 having spacer material 6070 is shown.

[0217] In some instances, the organ protection layer 6000 may include Figure 37A -C Any feature of the organ protective layer 5100. The organ protective layer 6000 may include spacer material 6070 disposed between membrane layers 6072. In some instances, the organ protective layer 6000 may include 6 portions of spacer material 6070. The organ protective layer 6000 may include 3-10 portions of spacer material 6070. The organ protective layer 6000 may include 1-15 portions of spacer material 6070.

[0218] In some instances, the organ protection layer 6000 may include two rings of spacer material 6070 and a central portion of spacer material 6070. The organ protection layer 6000 may include 1-10 rings of spacer material 6070 and a central portion of spacer material 6070. In some instances, the outermost ring of spacer material 6070 may include four portions of spacer material 6070. The outermost ring of spacer material 6070 may include 1-8 portions of spacer material 6070. The outermost ring of spacer material 6070 may be shaped as a curved rectangle, semicircle, or semi-oval, having oval spaces within it. In some instances, each curved rectangle of spacer material 6070 may include two oval spaces. Each curved rectangle of spacer material 6070 may include 1-5 oval spaces. In some instances, the second outermost ring of spacer material 6070 may include one portion of spacer material 6070. The second outermost ring of spacer material 6070 may include 1-5 portions of spacer material 6070. The second outermost ring of the spacer material 6070 can be formed as a circle or an ellipse, having an oval space within the ring. In some examples, the second outermost ring of the spacer material 6070 may include eight oval spaces. The second outermost ring of the spacer material 6070 may include five to ten oval spaces. The central spacer material 6070 can be annular, such as circular or oval, with a space in the center.

[0219] Figure 47 An example of an organ protective layer 6100 having spacer material 6170 is shown.

[0220] In some instances, the organ protection layer 6100 may include Figure 37A -C Any feature of the organ protective layer 5100. The organ protective layer 6100 may include spacer material 6170 disposed between membrane layers 6172. In some instances, the organ protective layer 6100 may include 17 portions of spacer material 6170. The organ protective layer 6100 may include 10-20 portions of spacer material 6170. The organ protective layer 6100 may include 5-30 portions of spacer material 6170.

[0221] In some instances, the organ protection layer 6100 may include two rings of spacer material 6170 and a central portion of spacer material 6170. The organ protection layer 6100 may include 1-10 rings of spacer material 6170 and a central portion of spacer material 6170. In some instances, the outermost ring of spacer material 6170 may include 4 portions of spacer material 6170. The outermost ring of spacer material 6170 may include 1-8 portions of spacer material 6170. The outermost ring of spacer material 6170 may be shaped as a curved rectangle, semicircle, or semi-ellipse, having circular spaces within it. In some instances, each curved rectangle of spacer material 6170 may include 3 circular spaces. Each curved rectangle of spacer material 6170 may include 1-5 circular spaces. In some instances, the second outermost ring of spacer material 6170 may include 12 portions of spacer material 6170. The second outermost ring of spacer material 6170 may include 5-15 portions of spacer material 6170. The second outermost ring of the spacer material 6170 may include a circular portion of the spacer material 6170. The central spacer material 6170 may be annular, such as circular or oval, with a space in the center.

[0222] Figure 48 An example of an organ protective layer 6200 having spacer material 6270 is shown.

[0223] In some instances, the organ protection layer 6200 may include Figure 37A -C Any feature of the organ protective layer 5100. The organ protective layer 6200 may include spacer material 6270 disposed between membrane layers 6272. In some instances, the organ protective layer 6200 may include 24 portions of spacer material 6270. The organ protective layer 6200 may include 20-30 portions of spacer material 6270. The organ protective layer 6200 may include 15-40 portions of spacer material 6270.

[0224] In some instances, the organ protective layer 6200 may include an outer ring of spacer material 6270 and a central portion of spacer material 6270. The organ protective layer 6200 may include 1-10 rings of spacer material 6270. In some instances, the spacer material rings 6270 may include 16 portions of spacer material 6270. The outermost ring of spacer material 6270 may include 10-20 portions of spacer material 6270. The rings of spacer material 6270 may be shaped as curved rectangles or trapezoids. In some instances, the central spacer material 6270 may include 8 portions of spacer material 6270. The central spacer material 6270 may include 5-15 portions of spacer material 6270. The central spacer material 6270 may include triangular portions of spacer material 6270. The central spacer material 6270 may be arranged in a rectangle aligned with the center of membrane layer 6200.

[0225] Example

[0226] The following provides some additional, non-limiting embodiments covered by this application.

[0227] Example 1. A method for positioning an organ protective layer on a wound site, the method comprising: providing an organ protective layer including a spacer material portion at the center of the organ protective layer; and positioning the organ protective layer on a wound site such that the spacer material portion is aligned with the center of the wound site.

[0228] Example 2. A method for applying negative pressure wound therapy, the method comprising: positioning a foam pad on a wound site; positioning a suction adapter above the foam pad, the suction adapter comprising: a suction orifice; a suction port, the suction port being in fluid communication with the suction orifice via a suction channel; a leak orifice; and a leak port, the leak port being in fluid communication with the leak orifice via a leak channel, wherein the suction channel and the leak channel are separated by an inner wall; positioning a conduit for negative pressure in the suction port of the suction adapter; and detecting flow through the suction port to determine whether the suction adapter is in fluid communication with the foam pad.

[0229] Example 3. The method according to Example 2 further includes delivering negative pressure from a negative pressure source through the conduit.

[0230] Example 4. A method for cleaning a wound site, the method comprising: placing an organ protectant on the wound site, the organ protectant including a delivery tube in fluid communication with the wound site; connecting an inlet branch of a connector to a fluid source; connecting a delivery branch of the connector to the delivery tube; connecting an outlet branch of the connector to a container; and allowing fluid to be delivered from the fluid source to the inlet branch of the connector, to the delivery branch of the connector, to the delivery tube, to the wound site, to the delivery branch of the connector, to the outlet branch of the connector, and to the container.

[0231] Example 5. The method according to Example 4 further includes connecting a manifold to the delivery tube and the delivery branch, wherein the manifold is configured to dispense fluid into and from the delivery tube.

[0232] Example 6. The method according to any one of Examples 4 or 5, wherein the delivery tube is positioned between the layers of spacer material.

[0233] Example 7. The method according to any one of Examples 4-6, wherein the inlet branch, delivery branch and outlet branch of the connector are connected at the joint.

[0234] Example 8. The method according to any one of Examples 4-7, wherein the connector is a Y-shaped connector.

[0235] Example 9. The method according to any one of Examples 4-8, wherein the connector and the delivery tube are configured to remove fluid from the wound site.

[0236] Example 10. The method according to any one of Examples 4-9, wherein the connector and the delivery tube are configured to deliver fluid to the wound site.

[0237] Example 11. The method according to any one of Examples 4-10, wherein the connector and the delivery tube are configured to simultaneously deliver fluid to and remove fluid from the wound site.

[0238] Example 12. The method according to any one of Examples 4-11, wherein the connector further includes a switch that allows a user to control fluid flow in the connector.

[0239] Example 13. According to the method of Example 12, wherein the switch allows the user to restrict the inbound branch or the outbound branch.

[0240] Example 14. The method according to Example 12, wherein the switch is integral with the connector.

[0241] Example 15. The method according to any one of Examples 4-14, wherein the organ protective layer is transparent.

[0242] Example 16. The method according to any one of Examples 4-15, wherein the connector is transparent.

[0243] Example 17. The method according to any one of Examples 4-16, wherein the delivery tube is transparent.

[0244] Example 18. The method according to Example 5, wherein the manifold is transparent.

[0245] Example 19. The method of Example 5, wherein the manifold includes an outlet configured to allow fluid to be released from the manifold.

[0246] Example 20. According to the method of Example 5, wherein the manifold includes an inner wall that separates the inner lumen of the manifold.

[0247] Example 21. According to the method of Example 20, wherein the inner wall divides the cavity into a delivery portion and a removal portion.

[0248] Example 22. The method according to any one of Examples 4-21, wherein the delivery tube is circular.

[0249] Example 23. The method according to any one of Examples 4-22, wherein the delivery tube is flat or elongated elliptical.

[0250] Example 24. The method according to any one of Examples 4-23, wherein the delivery tube includes teeth inside the delivery tube.

[0251] Example 25. According to the method of Example 24, the delivery tube includes top teeth and bottom teeth inside the delivery tube.

[0252] Example 26. According to the method of Example 5, wherein the manifold is made of any one of polyurethane, silicone, foam, rubber and polyisoprene.

[0253] Example 27. According to the method of Example 6, the spacer material is made of any one of foam, 3D fabric, silver, or a material with antimicrobial properties.

[0254] Example 28. According to the method of Example 5, the manifold is any one of octagonal, disc-shaped, flower-shaped, rectangular, curved, circular, or oval.

[0255] The foregoing description describes certain features, aspects, and advantages of the invention, and various changes and modifications can be made thereto without departing from the spirit and scope of the invention. Furthermore, the negative pressure therapy system disclosed herein does not necessarily need to have all the foregoing objectives, advantages, features, and aspects. Those skilled in the art will recognize that the invention can be embodied or practiced in a manner that achieves or optimizes one or more advantages taught herein, without necessarily achieving other objectives or advantages that may be taught or suggested herein. For example, in some embodiments, pad 103 can be used without organ protection layer 105 and / or drape 107. Advantageously, the systems and methods described herein can operate without drape 107. There is no need to interfere with the wound by having to cut into drape 107 to insert additional connectors, as the system described herein can deliver fluid to the wound site. Additionally, while many variations of the invention have been shown and described in detail, other modifications and methods of use will be apparent to those skilled in the art within the scope of the invention. It is contemplated that various combinations or sub-combinations of these features and aspects of the embodiments are achievable and still fall within the scope of the invention. Therefore, it should be understood that various features and aspects of the disclosed embodiments may be combined with or substituted for each other to form variations of the negative pressure therapy system discussed.

[0256] Although certain embodiments / examples are described in this disclosure, those skilled in the art will understand that many aspects of the methods and apparatus shown and described in this disclosure can be combined and / or modified differently to form other embodiments or acceptable examples. All such modifications and variations are intended to be included within the scope of this disclosure. In fact, various designs and methods are possible and within the scope of this disclosure. The features, structures, or steps disclosed herein are not essential or indispensable. Furthermore, while exemplary embodiments have been described herein, the scope of any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., aspects across various embodiments), substitutions, adaptations, and / or changes will be understood by those skilled in the art based on this disclosure. Although certain embodiments have been described, these embodiments are presented by way of example only and are not intended to limit the scope of protection.

[0257] Features, materials, characteristics, or groups described in connection with a particular aspect, embodiment, or example should be understood to be applicable to any other aspect, embodiment, or example described elsewhere in this section or in this specification, unless incompatible therewith. All features disclosed in this specification (including any appended claims, abstract, and drawings), and / or all steps of any method or process so disclosed, may be combined in any combination, except for at least some mutually exclusive combinations of such features and / or steps. Protection is not limited to the details of any of the foregoing embodiments. Protection extends to any novel feature or any novel combination of features disclosed in this specification (including any appended claims, abstract, and drawings), or any novel feature or any novel combination of steps of any method or process so disclosed.

[0258] Furthermore, some features described in this disclosure in the context of individual implementations may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented individually or in any suitable sub-combination in multiple implementations. Moreover, although the features above may be described as operating in certain combinations, in some cases, one or more features from the claimed combination may be removed from the combination, and the combination may be claimed as a sub-combination or a variation of a sub-combination.

[0259] Furthermore, while operations may be depicted in the accompanying drawings or described in the specification in a specific order, it is not necessary to perform these operations in the specific order shown or sequentially, or to perform all operations to achieve the desired result. Other operations not depicted or described may be incorporated into the exemplary methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any described operations. Additionally, in other embodiments, operations may be rearranged or reordered. Those skilled in the art will recognize that in some embodiments, the actual steps taken in the illustrated and / or disclosed processes may differ from the steps shown in the figures. According to embodiments, some of the above-described steps may be removed, and other steps may be added. Moreover, the features and properties of the specific embodiments disclosed above may be combined in different ways to form other embodiments, all of which fall within the scope of this disclosure. Furthermore, the separation of various system components in the above embodiments should not be construed as requiring such separation in all embodiments, 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.

[0260] For the purposes of this disclosure, certain aspects, advantages, and novel features have been described herein. Not all such advantages may be realized according to any particular embodiment. Thus, for example, those skilled in the art will recognize that this disclosure may be embodied or implemented in a manner that achieves one or a set of advantages taught herein, without necessarily achieving other advantages that may be taught or suggested herein.

[0261] Unless otherwise expressly stated, or otherwise understood in the context in which they are used, conditional language such as “can,” “may,” “possibly,” or “may” is generally intended to express that certain embodiments include certain features, elements, and / or steps that are not included in other embodiments. Therefore, such conditional language is not generally intended to imply that one or more embodiments require features, elements, or steps in any way, or that one or more embodiments must include logic for determining whether such features, elements, and / or steps are included in or performed in any particular embodiment, with or without user input or prompting.

[0262] Unless otherwise explicitly stated, connective language such as the phrase "at least one of X, Y, and Z" is understood in the context to generally express that items, terms, etc., may be X, Y, or Z. Therefore, such connective 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.

[0263] The degree language used herein, such as the terms “approximately,” “about,” “substantially,” and “basically,” as used herein, indicates a value, quantity, or characteristic that is close to a specified value, quantity, or characteristic that still performs the desired function or achieves the desired result. For example, the terms “approximately,” “about,” “substantially,” and “basically” can refer to a quantity that is less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of a specified quantity. As another example, in some embodiments, the terms “substantially parallel” and “basically parallel” refer to a value, quantity, or characteristic that deviates from exact parallelism by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degrees, or other values, quantities, or characteristics.

[0264] The scope of this disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this part or elsewhere in this specification, but may be defined by the claims in this part or elsewhere in this specification or future. The language of the claims will be interpreted broadly based on the language used in the claims and is not limited to the examples described in this specification or during the examination of the application, which should be interpreted as non-exclusive.

Claims

1. An organ protective layer for contact with a wound site, comprising: First membrane layer; Second film layer; A central spacer material portion is disposed between the first film layer and the second film layer; as well as Multiple spacer material portions are disposed between the first film layer and the second film layer, and the multiple spacer material portions are positioned radially outward from the central spacer material portion.

2. The organ protective layer according to claim 1, wherein the central spacer material portion is circular or oval.

3. The organ protective layer according to any one of claims 1 or 2, wherein the central spacer material portion includes a central aperture, and wherein the central aperture is circular or oval.

4. The organ protective layer according to any one of claims 1-3, wherein the plurality of spacer material portions are circular, oval, or stadium-shaped.

5. The organ protective layer according to any one of claims 1-4, wherein the plurality of spacer material portions are arranged in a ring around the central spacer portion in a circumferential direction.

6. The organ protective layer according to claim 5, wherein the first membrane layer and the second membrane layer are radially welded together between the rings.

7. The organ protective layer according to any one of claims 1-6, wherein the plurality of spacer material portions are circular, semi-circular, oval, or semi-oval.

8. The organ protection layer of claim 7, wherein the plurality of spacer material portions include orifices.

9. An organ protective layer for contact with a wound site, comprising: Multiple curved spacer material portions are radially positioned around the organ protective layer and are configured to deliver fluid across the organ protective layer.

10. The organ protection layer of claim 9, further comprising a top membrane layer and a bottom membrane layer disposed around a plurality of curved spacer materials.

11. The organ protective layer according to any one of claims 9 or 10, wherein the plurality of curved spacer material portions are positioned in a plurality of rings on the organ protective layer.

12. An organ protective layer for contact with a wound site, comprising: Top membrane layer; Bottom film layer; as well as Spacer material, positioned between the top film layer and the bottom film layer, the spacer material comprising: The central spacer material section; Multiple innermost curved spacer material portions, the multiple innermost curved spacer material portions being radially positioned around the central spacer material portion; A plurality of intermediate curved spacer material portions, the plurality of intermediate curved spacer material portions being radially positioned around the plurality of innermost curved spacer material portions; and Multiple outermost curved spacer material portions, the multiple outermost curved spacer material portions being radially positioned around the multiple intermediate curved spacer material portions. The top membrane and the bottom membrane are welded together along the periphery of the organ protective layer.

13. The organ protective layer of claim 12, wherein the central spacer material portion is circular or oval.

14. The organ protective layer according to any one of claims 12 or 13, wherein the top membrane and the bottom membrane are welded together between the central spacer material portion and the plurality of innermost curved spacer material portions.

15. The organ protective layer according to any one of claims 12-14, wherein the top membrane and the bottom membrane are welded together between the plurality of innermost curved spacer material portions and the plurality of intermediate curved spacer material portions.

16. The organ protective layer according to any one of claims 12-15, wherein the top membrane and the bottom membrane are welded together between the plurality of intermediate curved spacer material portions and the plurality of outermost curved spacer material portions.

17. The organ protective layer according to any one of claims 12-16, wherein the organ protective layer is configured to be cut along the weld portion to reduce the size of the organ protective layer.

18. A suction adapter for negative pressure wound therapy, comprising: A suction port, wherein the suction port is configured to be in fluid communication with the wound site; A suction port, which is in fluid communication with the suction orifice via a suction channel, is configured to receive a conduit for negative pressure. A leakage orifice, the leakage orifice being configured to be in fluid communication with the wound site; and A leakage port, which is in fluid communication with the leakage orifice via a leakage channel. The suction channel and the leakage channel are separated by an inner wall.

19. The suction adapter of claim 18, wherein the suction adapter is rigid.

20. The suction adapter of claim 19, wherein the suction adapter is made of molded plastic.

21. The suction adapter according to any one of claims 18-20, further comprising a base flange, wherein the suction orifice and the leakage orifice are on the bottom surface of the base flange.

22. The suction adapter of claim 21, further comprising a hanging portion above the base flange, wherein the suction port is located on the hanging portion.

23. The suction adapter according to any one of claims 18-22, further comprising a filter in the leakage channel, wherein the filter is vertically oriented.

24. The suction adapter according to any one of claims 18-23, further comprising a notch configured to receive a user's finger.

25. The suction adapter according to any one of claims 18-24, wherein the suction adapter is capable of withstanding a force of about 250 mmHg.

26. A wound treatment system, comprising: An organ protective layer, which is adapted to contact the wound site and is configured to guide wound exudate and distribute negative pressure; A pad, the pad being adapted to deliver negative pressure to the wound site, the pad comprising: Multiple arcuate cuts extending through at least a portion of the thickness of the pad to define pad segments separable from the pad to allow for setting the size of the pad; and Multiple orifices configured to allow negative pressure to reach the wound site, wherein the multiple orifices extend radially inward from the multiple incisions; Negative pressure source; and A conduit configured to transmit negative pressure from the source to the pad.

27. The system of claim 26, wherein each of the plurality of orifices in the pad comprises two linear orifices forming an acute angle.

28. The system according to any one of claims 26 or 27, wherein the plurality of orifices are shaped to reduce tissue pull-up when negative pressure is applied.

29. An organ protective layer for contact with a wound site, comprising: One or more membrane layers; as well as Multiple slits in one or more of the membrane layers, Each of the plurality of slits is positioned at an angle between approximately 30 degrees and approximately 60 degrees to the horizontal axis. Each of the plurality of slits is positioned at an angle between approximately 30 degrees and approximately 60 degrees to the vertical axis. Each of the plurality of slits is oriented in opposite directions in horizontally adjacent quadrants, and Each of the plurality of slits is oriented in the opposite direction of the slit in a horizontally adjacent quadrant.

30. A wound treatment system, comprising: An organ protection layer suitable for contact with a wound site, the organ protection layer comprising a plurality of delivery tubes in fluid communication with the wound site; as well as Connector, the connector comprising: Entering a branch, the entering branch being in fluid communication with a fluid source; A delivery branch in fluid communication with the delivery tube; and The output branch is in fluid communication with the tank. The connector’s inlet branch, delivery branch, and outlet branch are in fluid communication.

31. The system of claim 30, further comprising a manifold connected to the delivery tube and the delivery branch, wherein the manifold is configured to dispense fluid to and receive fluid from the delivery tube.

32. The system according to any one of claims 30 or 31, wherein the delivery tube is positioned between the layers of spacer material.

33. The system according to any one of claims 30-32, wherein the inlet branch, delivery branch and outlet branch of the connector are connected at the engagement point.

34. The system according to any one of claims 30-33, wherein the connector is a Y-type connector.

35. The system according to any one of claims 30-34, wherein the connector and the delivery tube are configured to remove fluid from the wound site.

36. The system according to any one of claims 30-35, wherein the connector and the delivery tube are configured to deliver fluid to the wound site.

37. The system according to any one of claims 30-36, wherein the connector and the delivery tube are configured to simultaneously deliver fluid to and remove fluid from the wound site.

38. The system according to any one of claims 30-37, wherein the connector further comprises a switch that allows a user to control fluid flow in the connector.

39. The system of claim 38, wherein the switch allows the user to restrict the incoming branch or the outgoing branch.

40. The system according to any one of claims 38 or 39, wherein the switch is integral with the connector.

41. The system according to any one of claims 30-40, wherein the organ protective layer is transparent.

42. The system according to any one of claims 30-41, wherein the connector is transparent.

43. The system according to any one of claims 30-42, wherein the delivery tube is transparent.

44. The system of claim 31, wherein the manifold is transparent.

45. The system of claim 31, wherein the manifold includes an outlet configured to allow fluid to be released from the manifold.

46. ​​The system of claim 31, wherein the manifold includes an inner wall separating the inner lumen of the manifold.

47. The system of claim 46, wherein the inner wall divides the cavity into a delivery portion and a removal portion.

48. The system according to any one of claims 30-47, wherein the delivery tube is circular.

49. The system according to any one of claims 30-48, wherein the delivery tube is flat or elongated elliptical.

50. The system according to any one of claims 30-49, wherein the delivery tube includes teeth inside the delivery tube.

51. The system of claim 50, wherein the delivery tube includes top teeth and bottom teeth inside the delivery tube.

52. The system of claim 31, wherein the manifold is made of any one of polyurethane, silicone, foam, rubber and polyisoprene.

53. The system of claim 32, wherein the spacer material is made of any one of foam, 3D fabric, silver, or a material having antimicrobial properties.

54. The system of claim 31, wherein the manifold is any one of octagonal, disc-shaped, flower-shaped, rectangular, curved, circular, or oval.

55. A system for providing medial compression to a wound site, the system comprising: Wound filler, the wound filler comprising: A closure layer, which is configured to contact the patient's fascia; An edge extending from the closed layer, the edge being configured to be positioned beneath the fascia; and The slit in the closed layer; and The wound filler is configured to apply medial tension to the fascia when a negative pressure is applied to the wound filler.

56. The system of claim 55, wherein the closure layer comprises a plurality of slits.

57. The system of claim 56, wherein the closure layer comprises three slits.

58. The system of claim 57, wherein the three slits comprise a large slit and two small slits.

59. The system according to any one of claims 55-58, wherein the slit is a pattern of holes.

60. The system according to any one of claims 55-59, wherein the slit is an oval aperture.

61. The system according to any one of claims 55-60, wherein the edge includes a plurality of slits, each slit being configured to attach to the fascia.

62. The system according to any one of claims 55-61, wherein the edge is integral with the closure layer.

63. The system according to any one of claims 55-62 further includes a negative pressure source.

64. The system according to any one of claims 55-63, wherein the wound filler further comprises a spacer material.

65. The system of claim 64, wherein the spacer material is sandwiched between the top foam layer and the bottom foam layer.

66. The system according to any one of claims 55-65, wherein the wound filler comprises foam.

67. The system according to any one of claims 55-66 further includes a wound contact layer configured to be positioned above the wound filler.

68. The system according to any one of claims 55-67, further comprising an organ protection layer configured to be positioned below the wound filler.

69. The system of claim 68, wherein the organ protection layer is configured to be cut by a user to adjust the size of the organ protection layer.

70. The system according to any one of claims 68-69, wherein the organ protective layer comprises a spacer material.

71. The system of claim 70, wherein the spacer material is positioned such that fluid is guided from the edge of the organ protection layer to the central portion of the organ protection layer.

72. The system according to any one of claims 55-71, wherein the edge is perforated such that the entire edge or a portion of the edge is configured to be removed.

73. The system according to any one of claims 55-72, wherein the wound filler further comprises an open ellipse configured to allow a user to view the wound site.

74. A pad for transmitting negative pressure to a wound site, the pad comprising: Multiple arc-shaped cuts extending through at least a portion of the thickness of the pad to define a pad segment separable from the pad to allow for setting the size of the pad; as well as Multiple orifices are configured to allow negative pressure to reach the wound site, wherein the orifices extend radially inward from the multiple incisions, and each of the orifices is shaped as two lines forming an acute angle, the orifices being shaped to reduce tissue pull-up when negative pressure is applied. The pad described therein is eye-shaped.

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

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

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

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