Wound treatment systems, devices, and methods

Abstract

A system and method for providing internal compression to an open abdominal wound using wound fillers and visceral protective layers for negative pressure treatment are described. While under negative pressure, the wound filler can pull the abdominal wall toward the midline. The wound filler can provide internal tension and reduce the risk of prolonged congestive rectal or abdominal separation. Visceral protective layers can also be modified to assist internal compression and promote fluidity.

Description

[Technical Field]

[0001] Reference to Related Application The present application claims priority from British Provisional Patent Application No. 2313507.2, filed on September 5, 2023 and entitled "MEDIAL COMPRESSION", and British Provisional Patent Application No. 2313509.8, filed on September 5, 2023 and entitled "ABDOMINAL WOUND TREATMENT". Each of the above applications is incorporated herein by reference in its entirety. The contents of the following applications and / or issued patents are incorporated herein by reference in their entireties as if fully set forth herein: U.S. Patent Application No. US8791315, entitled "SYSTEMS AND METHODS FOR using NEGATIVE PRESSURE WOUND THERAPY TO MANAGE Open ABDOMINAL WOUNDS", filed September 20, 2010; U.S. Patent No. 8791315, entitled "SYSTEMS AND METHODS FOR USEING NEGATIVE PRESSURE WOUND THERAPY TO MANAGE Open ABDOMINAL WOUNDS", issued July 29, 2014. Additional specifications referenced herein are also incorporated herein by reference in their entireties as if fully set forth herein.

[0002] Embodiments of the present invention relate to wound treatment systems, devices, and methods for wound irrigation and filling in wound treatment using negative pressure wound therapy, and more specifically, to improved apparatuses and methods for managing open abdominal wounds. [Background Art]

[0003] Description of Related Art The treatment of open or chronic wounds by applying negative pressure to wound sites that are too large to close naturally or otherwise will not heal is well known in the art. Negative pressure wound treatment systems currently known in the art generally involve placing a fluid-impermeable cover over the wound, using various mechanisms to seal the cover against the patient's surrounding tissue, and connecting a negative pressure source (such as a vacuum pump) to the cover by creating a negative pressure area directly beneath the cover in the area of ​​the wound. [Overview of the Initiative]

[0004] Embodiments of the present invention disclosed herein relate to decompression devices and therapeutic methods using decompression devices, which may be useful in the treatment of wounds using negative pressure.

[0005] Specific embodiments of the present invention relate to improved methods for treating abdominal wounds or incisions using negative pressure. For example, for illustrative purposes only, some embodiments utilize a porous wound filler having a removable section that allows for desired sizing of the wound filler to the wound site. Sizing of the foam wound filler may be carried out in a dimensionally independent manner, for example, so that the width and / or length can be changed independently of each other, in some embodiments. Further embodiments also provide a wound contact layer that is positioned in contact with the wound site, wherein the wound contact layer is minimally adhesive or non-adhesive to the wound site and preferably includes slits or other openings for removal of wound exudate or fluid and for application of negative pressure to the wound site.

[0006] A particular embodiment provides a negative pressure therapy system comprising: a wound contact layer placed over a wound; a porous wound filler configured to be sized and positioned on the wound contact layer; and a flexible drape positioned above the wound and configured to seal the skin surrounding the wound, further comprising a conduit configured to deliver negative pressure to the wound through an opening in the flexible drape and through the porous wound filler and the wound contact layer.

[0007] In a preferred embodiment, a porous wound filler is provided for the treatment of wounds using negative pressure, the porous wound filler comprising a porous material suitable for guiding wound exudate from the wound site to a negative pressure source. The porous wound filler preferably includes a substantially planar shape having a thickness less than its width and length, and preferably includes at least one slit extending through at least a portion of the thickness of the wound filler, thereby defining a wound filler section that is removable from the rest of the wound filler to allow for changes in the size (e.g., its length and / or width) of the wound filler. In a particular embodiment, the slit may consist of arcuate and / or elliptical slits and may further include additional inner and outer slits. In a further embodiment, additional intermediate slits may also be present.

[0008] In certain embodiments, a system for treating a wound site comprises a wound contact layer having openings for guiding wound exudate and distributing negative pressure; a generally planar, porous wound filler having at least one slit suitable for delivering negative pressure to the wound site and extending through a portion of the thickness of the wound filler to define a removable wound filler; a flexible drape; a conduit; and a negative pressure source configured to deliver negative pressure to the wound site through the conduit. In some embodiments, a method of treating a wound site using negative pressure may include: placing a wound contact layer over the wound site; placing a porous wound filler on the wound contact layer, wherein the porous wound filler is perforated to allow for sizing of the wound filler in a dimensionally independent manner and to allow for removal of portions of the wound filler to fit the wound site; sealing the wound site with a flexible drape positioned over the wound and configured to seal 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 properly.

[0009] A system for providing internal compression to a wound site may include a wound filler. The wound filler may include a closed layer configured to contact the patient's fascia. The wound filler may include a rim extending from the closed layer, which is configured to be positioned beneath the fascia. The wound filler may include a slit within the closed layer. The wound filler may be configured to apply internal tension to the fascia when negative pressure is applied to the wound filler.

[0010] A system providing internal compression to any wound site as described in the preceding paragraphs, and / or any apparatus, system, or device disclosed herein, may include one or more of the following configurations: A closure layer may include a plurality of slits. A 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-shaped holes. A rim may include a plurality of slits, each configured to adhere to the fascia. The rim may be integrated with the closure layer. The system may include a negative pressure source. The wound filler may further include a spacer material. The spacer material may be sandwiched between an upper 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 on top of the wound filler. The system may include a visceral protective layer configured to be positioned beneath the wound filler. The visceral protective layer may be cut by the user to accommodate the size of the visceral protective layer. The visceral protective layer may include spacer material. The spacer material may be positioned to guide fluid from the edge of the visceral protective layer to the central portion of the visceral protective layer. The rim may be perforated to facilitate removal of the rim. The wound filler may include an open ellipse configured to allow the user to view the wound site.

[0011] In certain examples, a method of treating a wound site using negative pressure may include: positioning a wound contact layer over the wound site; positioning a porous pad on the wound contact layer, wherein the porous pad is perforated to allow for dimensionally independent resizing of the pad and removal of pad portions to fit the wound site; sealing the wound site with a flexible drape positioned over the wound and configured to seal the surrounding skin; connecting a negative pressure source to the wound site; and maintaining the application of negative pressure until the wound site has healed properly.

[0012] The wound treatment system may include an internal protective layer suitable for contact with the wound site. The internal protective layer may include a plurality of delivery tubes that are in fluid communication with the wound site. The internal protective layer may include a connector. The connector may include an intake branch that is in fluid communication with a fluid source. The connector may include a delivery branch that is in fluid communication with a delivery tube. The connector may include an output branch that is in fluid communication with a canister. The intake branch, delivery branch, and output branch of the connector may be in fluid communication.

[0013] Any wound treatment system described in any of the preceding paragraphs, and / or any apparatus, system, or device disclosed herein, may include one or more of the following configurations: The wound treatment system may include a manifold connected to a delivery tube and a delivery branch, the manifold configured to distribute fluid to the delivery tube and receive fluid from the delivery tube. The delivery tube may be positioned between layers of spacer material. The intake branch, delivery branch, and output branch of the connector may be connected at a junction. 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 fluid to the wound site and remove fluid from the wound site. The connector may include a switch, which allows a user to control the flow of fluid within the connector. The switch may allow a user to restrict the intake branch or the output branch. The switch may be integrated with the connector. The internal protective layer may be transparent. The connector may be transparent. The delivery tube may be transparent. The manifold may be transparent. The manifold may include vents configured to allow fluid to be discharged from the manifold. The manifold may include an inner wall separating the inner cavity of the manifold. The inner wall can separate the inner cavity into a delivery section and a removal section. The delivery tube may be round. The delivery tube may be flat or oblong. The delivery tube may include teeth inside the delivery tube. The delivery tube may include upper teeth and bottom teeth inside the delivery tube. The manifold may be made from one of polyurethane, silicone, foam, rubber, and polyisoprene. The spacer material may be made from one of foam, 3D cloth, silver, or a material having antimicrobial properties. The manifold may be octagonal, disc-shaped, flower-shaped, rectangular, curved, circular, or oval-shaped.

[0014] A method for cleaning a wound site may include placing an internal protective layer on the wound site. The internal protective layer may include a delivery tube that communicates with the wound site. The internal protective layer may include an intake branch of a connector to a fluid source. A method for cleaning a wound site may include connecting the delivery branch of the connector to the delivery tube. A method for cleaning a wound site may include connecting the output branch of the connector to a canister. A method for cleaning a wound site may include enabling the fluid to pass from the fluid source to the intake 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 output branch of the connector, and to the canister.

[0015] Any wound treatment method described in any of the preceding paragraphs, and / or any apparatus, system, or device disclosed herein, may include one or more of the following features: The wound treatment method may include connecting a manifold to a delivery tube and a delivery branch, the manifold being configured to distribute fluid to the delivery tube and to receive fluid from the delivery tube. The delivery tube may be positioned between layers of spacer material. The intake branch, delivery branch, and output branch of the connector may be connected at a junction. The connector may be a Y-connector. The connector and delivery tube can remove fluid from a wound site. The connector and delivery tube can deliver fluid to a wound site. The connector and delivery tube can simultaneously deliver fluid to a wound site and remove fluid from a wound site. The connector may include a switch, which allows a user to control the flow of fluid within the connector. The switch may allow a user to restrict the intake branch or the output branch. The switch may be integrated with the connector. The internal protective layer may be transparent. The connector may be transparent. The delivery tube may be transparent. The manifold may be transparent. The manifold may include vents configured to allow fluid to be discharged from the manifold. The manifold may include an inner wall separating the inner cavity of the manifold. The inner wall can separate the inner cavity into a delivery section and a removal section. The delivery tube may be round. The delivery tube may be flat or oblong. The delivery tube may include teeth inside the delivery tube. The delivery tube may include upper teeth and bottom teeth inside the delivery tube. The manifold may be made from one of polyurethane, silicone, foam, rubber, and polyisoprene. The spacer material may be made from one of foam, 3D cloth, silver, or a material having antimicrobial properties. The manifold may be octagonal, disc-shaped, flower-shaped, rectangular, curved, circular, or oval-shaped.

[0016] In some examples, the wound treatment systems described herein include: an internal protective layer suitable for contact with a wound site, configured to guide wound exudate and distribute negative pressure; an eye-shaped pad suitable for transmitting negative pressure to the wound site, wherein the pad has a plurality of arc-shaped cuts extending through at least a portion of the thickness of the pad to define a removable pad section from the pad, thereby allowing the pad to be resized; and a plurality of openings configured to allow negative pressure to reach the wound site, wherein the plurality of openings are radially inward from the plurality of cuts and include a negative pressure source and a conduit configured to transmit negative pressure from the supply source to a wound filler.

[0017] In some examples, the system may include a flexible drape configured to be placed on top of the pad. In some examples, each of the multiple openings in the pad includes two straight openings that form an acute angle. In some examples, the multiple openings are shaped to reduce tissue pull-up while negative pressure is applied.

[0018] In some examples, the visceral protective layer for contact with a wound site described herein may include a plurality of curved spacer material portions radially positioned around the visceral protective layer, the plurality of curved spacer material portions configured to transport fluid across the visceral protective layer. In some examples, the visceral protective layer may include an upper film layer and a lower film layer positioned around the plurality of curved spacer material portions. In some examples, the plurality of curved spacer material portions are positioned within a plurality of rings on the visceral protective layer.

[0019] In some examples, the visceral protective layer for contact with a wound site as described herein comprises an upper film layer, a bottom film layer, and a spacer material positioned between the upper film layer and the bottom film layer, wherein the spacer material comprises 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 plurality of innermost curved spacer material portions, and a plurality of outermost curved spacer material portions radially positioned around the plurality of intermediate curved spacer material portions, and the upper film layer and the bottom film layer are welded together along the perimeter of the visceral protective layer.

[0020] In some examples, the central spacer material portion is circular or oval-shaped. In some examples, the upper and bottom film layers are welded together between the central spacer material portion and multiple innermost curved spacer material portions. In some examples, the upper and bottom film layers are welded together between multiple innermost curved spacer material portions and multiple intermediate curved spacer material portions. In some examples, the upper and bottom film layers are welded together between multiple intermediate curved spacer material portions and multiple outermost curved spacer material portions. In some examples, the upper and bottom film layers are welded together around the perimeter of each portion of the spacer material. In some examples, the internal protective layer is configured to be cut along the welded portion to reduce the size of the internal protective layer.

[0021] In some examples, the visceral protective layer for contact with a wound site described herein comprises one or more film layers and a plurality of slits within one or more film layers, wherein each slit of the plurality of slits is positioned at an angle of 30 to about 60 degrees from the horizontal axis, each slit of the plurality of slits is positioned at an angle of about 30 to about 60 degrees from the vertical axis, each slit of the plurality of slits is oriented in the opposite direction to a slit in a horizontally adjacent quadrant, and each slit of the plurality of slits is oriented in the opposite direction to a slit in a horizontally adjacent quadrant.

[0022] In some examples, the method for positioning the visceral protective layer on a wound site as described herein may include providing a visceral protective layer that includes a spacer material portion on the center of the visceral protective layer, and positioning the visceral protective layer on the wound site such that the spacer material portion is aligned with the center of the wound site.

[0023] In some examples, a suction adapter for applying negative pressure therapy as described herein comprises a suction opening configured to be positioned in fluid communication with a wound site, and a suction port that is in fluid communication with the suction opening through a suction channel, wherein the suction port is configured to receive a conduit for negative pressure and comprises a leak opening configured to be positioned in fluid communication with a wound site, and a leak port that is in fluid communication with the leak opening through a leak channel, wherein the suction channel and the leak channel are separated by an inner wall.

[0024] In some examples, the suction adapter is rigid. In some examples, the suction adapter is made of molded plastic. In some examples, the suction adapter may include a base flange, with the suction opening and leak opening located on the bottom surface of the base flange. In some examples, the suction adapter may include a protruding portion above the base flange, with the suction port located on the protruding portion. In some examples, the suction adapter may include a filter within the leak channel. In some examples, the filter is oriented vertically. In some examples, the suction adapter may include a recess configured to accommodate the user's finger. In some examples, the suction adapter can withstand a force of approximately 250 mmHg.

[0025] In some examples, a method for applying negative pressure wound therapy described herein comprises positioning a foam pad over a wound site, positioning a suction adapter over the foam pad, the suction adapter comprising a suction opening, a suction port in fluid communication with the suction opening through a suction channel, a leak opening, and a leak port in fluid communication with the leak opening through a leak channel, wherein the suction channel and the leak channel are separated by an inner wall, positioning a conduit for negative pressure within 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.

[0026] In some examples, the method may comprise delivering negative pressure from a negative pressure source through the conduit.

[0027] In some examples, the visceral protective layer described herein may comprise a first film layer, a second film layer, a central spacer material portion disposed between the first film layer and the second film layer, and a plurality of spacer material portions disposed between the first film layer and the second film layer. The plurality of spacer material portions may be positioned radially outward from the central spacer material portion.

[0028] In some examples, the central spacer material portion is circular or oval. In some examples, the central spacer material portion comprises a central opening, and the central opening is circular or oval. In some examples, the plurality of spacer material portions are circular, oval, or stadium-shaped. In some examples, the plurality of spacer material portions are arranged circumferentially around the central spacer portion in a ring. In some examples, the first film layer and the second film layer are welded together radially between the rings. In some examples, the plurality of spacer material portions are circular, semicircular, oval, or semi-oval. In some examples, the plurality of spacer material portions comprise an opening.

[0029] The present disclosure discloses systems and methods for providing internal compression to a wound site according to any of the preceding paragraphs and / or within any device, apparatus or system disclosed in the present disclosure.

[0030] Any configuration, component or feature of any configuration or embodiment disclosed herein (including but not limited to all apparatus embodiments and all wound site internal compression embodiments disclosed in the present disclosure) may be interchangeably combined with any configuration, component or feature of any other configuration or embodiment disclosed in the present disclosure to form new configurations and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] [Figure 1A] FIG. 1A is a schematic diagram of a system for treating an abdominal wound. [Figure 1B] FIG. 1B shows a negative pressure wound therapy system. [Figure 2A] FIG. 2A is a perspective view of one embodiment of a wound filler comprising an elongate layer, a lip and a slit. [Figure 2B] FIG. 2B is a top view of the wound filler of FIG. 2A. [Figure 3A] FIG. 3A is a top view of the wound filler of FIG. 2A positioned within an open abdominal wound, covered by a drape and attached to a negative pressure system. [Figure 3B] FIG. 3B is a cross-sectional view of the wound filler of FIG. 3A. [Figure 4] FIG. 4 is a perspective view of a further embodiment of a wound filler comprising a plurality of slits. [Figure 5] FIG. 5 is a perspective view of a further embodiment of a wound filler provided with a central bore. [Figure 6A] FIG. 6A is a top view of a further embodiment of a wound filler comprising a rim having a plurality of slits and a central bore. [Figure 6B] FIG. 6B is a perspective view of the wound filler of FIG. 6A. [Figure 7]Figure 7 is a top view of wound fillings, including various fluid stabilization structures. [Figure 8] Figure 8 is a top view of a further embodiment of a wound filling material, including various fluid stabilization structures. [Figure 9] Figure 9 is a top view of a further embodiment of a wound filling having a spacer material sandwiched between two cut foam layers. [Figure 10] Figure 10 is a top view of a further embodiment of a wound filling material including a pattern for internal compression. [Figure 11] Figure 11 is a top view of a further embodiment of a wound filling material including small holes and a larger central hole. [Figure 12] Figure 12 is a top view of a further embodiment of a wound filling material having an X-shaped hole. [Figure 13] Figure 13 illustrates the internal protective layer, including spacer material to facilitate internal tension and fluid management, along with the filler material. [Figure 14] Figure 14 is a top view of a further embodiment of the internal protective layer, including a cross-cross design of the filler material. [Figure 15] Figure 15 illustrates a further embodiment of an internal protective layer that includes a plurality of horizontally arranged rectangles of filler material, which may be larger on the outside and smaller towards the center. [Figure 16] Figure 16 illustrates a further embodiment of an internal protective layer that includes multiple rectangles of filler arranged horizontally and vertically, which may be larger on the outside and smaller towards the center. [Figure 17] Figure 17 shows an example of a stretchable, compressible material. [Figure 18] Figure 18 shows a connector for cleaning an abdominal wound. [Figure 19] Figure 19 shows an example of a visceral protective layer for covering an abdominal wound. [Figure 20A] Figure 20A is a top view of the delivery tube positioned between layers of spacer material. [Figure 20B] Figure 20B is a perspective view of the delivery tube positioned between layers of spacer material. [Figure 21] Figure 21 is a diagram of a visceral protective layer for covering an abdominal wound. [Figure 22] Figure 22 shows an example of a manifold for distributing liquids. [Figure 23] Figure 23 shows another example of a manifold for distributing liquids. [Figure 24] Figure 24 shows another example of a manifold for distributing liquids. [Figure 25] Figure 25 shows another example of a manifold for distributing liquids. [Figure 26] Figure 26 shows another example of a manifold for distributing liquids. [Figure 27] Figure 27 shows another example of a manifold for distributing liquids. [Figure 28] Figure 28 shows another example of a manifold for distributing liquids. [Figure 29] Figure 29 is a diagram of a manifold for distributing the liquid from Figure 22, which is connected to a delivery tube. [Figure 30] Figure 30 is a diagram of a manifold for distributing the liquid from Figure 25, which is connected to a delivery tube. [Figure 31A] Figure 31A is a perspective view of a flat delivery tube. [Figure 31B] Figure 31B is a front cross-sectional view of a flat delivery tube. [Figure 32] Figure 32 shows three flat delivery tubes on the lower layer of spacer material. [Figure 33] Figure 33 shows a flat delivery tube positioned between the cross-sections of the lower and upper layers of the spacer material. [Figure 34] Figure 34 is a schematic diagram of a system for cleaning abdominal wounds. [Figure 35] Figure 35 shows a connector for cleaning abdominal wounds with an integrated switch. [Figure 36] Figure 36 is a front view of an example of an internal organ protection layer having slits. [Figure 37A]Figure 37A is a front view of an example of an internal protective layer having a spacer material. [Figure 37B] Figure 37B is an exploded perspective view of an example of an internal protective layer having the spacer material shown in Figure 37A. [Figure 37C] Figure 37C is a front view of an example having the spacer material shown in Figure 37A. [Figure 38] Figure 38 shows another example of a pad. [Figure 39A] Figure 39A is a side view of an example of a suction adapter. [Figure 39B] Figure 39B is a top view of an example of the suction adapter shown in Figure 39A. [Figure 39C] Figure 39C is a rear view of an example of the suction adapter shown in Figure 39A. [Figure 39D] Figure 39D is a front view of an example of the suction adapter shown in Figure 39A. [Figure 39E] Figure 39E is a bottom view of an example of the suction adapter shown in Figure 39A. [Figure 39F] Figure 39F is a cross-sectional view of an example of the suction adapter shown in Figure 39A along a line parallel to the X-axis shown in Figure 39B. [Figure 40] [Figure 41] [Figure 42] [Figure 43] [Figure 44] [Figure 45] [Figure 46] [Figure 47] [Figure 48] Figures 40, 41, 42, 43, 44, 45, 46, 47, and 48 show examples of internal protective layers with spacer material. [Modes for carrying out the invention]

[0032] Preferred embodiments disclosed herein relate to wound therapy for the human or animal body. Therefore, any reference to wounds herein may refer to wounds on the human or animal body, and any reference to the body herein may refer to the human or animal body. The term “wound” as used herein includes, in addition to its broad, ordinary meaning, any part of a patient’s body that can be treated using decompression. Wounds and / or wound sites include, but are not limited to, open wounds, pressure ulcers, ulcers, and burns. Open wounds and / or wound sites may also include, for example, incisions in the abdomen or peritoneal cavity (e.g., abdominal incisions) or other openings, lacerations, or fistulas. Treatment of such wounds may be carried out using negative pressure wound therapy, in which decompression or negative pressure may be applied to the wound to facilitate and promote wound healing. It will also be understood that negative pressure systems and methods as disclosed herein may be applied to other parts of the body and are not necessarily limited to the treatment of wounds.

[0033] Referring to Figure 1A, in a particular embodiment, the treatment of a wound using negative pressure utilizes a negative pressure treatment system 101, as schematically shown in the figure. In this embodiment, the wound site 111 shown in the figure as an abdominal wound site may benefit from negative pressure treatment. Such an abdominal wound site may be, for example, the result of an accident or surgical intervention. In some cases, conditions such as abdominal compartment syndrome, abdominal hypertension, sepsis, or edema may require decompression of the abdomen by surgical incision through the abdominal wall to expose the peritoneal cavity, after which the opening may need to be kept open and accessible until the condition recovers. Other conditions may also require openings, specifically such as the abdominal cavity, to remain open, for example, if multiple surgical procedures are required (sometimes occurring in conjunction with trauma), or if there is evidence of a pathological condition such as peritonitis or necrotizing fasciitis. Especially when there is a wound in the abdomen, it is desirable to manage potential complications related to the exposure of organs and the peritoneal cavity, whether the wound remains open or if the wound is to be closed. Therapies that preferably use the application of negative pressure may aim to minimize the risk of infection while promoting tissue survival and removing harmful substances from the wound site. Applying decompression or negative pressure to the wound site has been shown to generally promote rapid healing, increased blood flow, reduced bacterial load, increased rate of granulation tissue formation, stimulate fibroblast proliferation, stimulate endothelial cell proliferation, close chronic open wounds, prevent burn penetration, and / or, among other things, enhance flap and graft adhesion. Wounds that have shown a favorable response to treatment with the application of negative pressure have also been reported to include infected open wounds, pressure ulcers, dehiscences, midlayer burns, and various lesions to which flaps or grafts have been attached. As a result, the application of negative pressure to the wound site 111 may be beneficial for the patient.

[0034] Accordingly, in certain embodiments, a wound contact layer 105 is provided to be placed on the wound site 111. Those skilled in the art will understand that the wound contact layer 105 may function as an internal organ protection layer. Preferably, the wound contact layer or internal organ protection layer 105 may be a thin, flexible material that does not adhere very well to the wound site or nearby exposed internal organs. Polymers such as polyurethane, polyethylene, polytetrafluoroethylene, or mixtures thereof may be used. In one embodiment, the wound contact layer is permeable. For example, the wound contact layer 105 may have openings such as holes, slits, or channels to allow for 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. Certain embodiments of the negative pressure therapy system 101 may also use a porous pad 103 which may be placed on top of the wound contact layer 105. The pad 103 may be constructed from a porous material, such as a foam, that is soft, elastic, flexible, and generally conforms to the wound site 111. Such foams may include, for example, open-cell network foams made from polymers. Suitable foams include, for example, foams made of polyurethane, silicone, and polyvinyl alcohol. The pad 103 is preferably capable of guiding wound exudate and other fluids through the pad when negative pressure is applied to the wound. Some pads 103 may include channels or openings pre-formed for such purposes. In certain embodiments, the pad 103 may have a thickness of about 1 inch to about 2 inches. The pad may also have a length of about 16 to 17 inches and a width of about 11 to 12 inches. In other embodiments, the thickness, width, and / or length may have other suitable values. Other embodiments of the pad 103 are described in further detail below.

[0035] The drape 107 is preferably used to seal the wound site 111. The drape 107 may be at least partially impermeable to fluid so as to be able to maintain at least some negative pressure at the wound site. Suitable materials for the drape 107 include, but are not limited to, synthetic polymer materials that do not absorb much fluid, including polyolefins such as polyethylene and polypropylene, polyurethane, polysiloxane, polyamide, polyester, and other copolymers, and mixtures thereof. The material used for the drape may be hydrophobic or hydrophilic. Examples of suitable materials include Transeal®, commercially available from DeRoyal, and OpSite®, commercially available from Smith & Nephew. To aid in patient comfort and avoid skin maceration, the drape in certain embodiments may be at least partially breathable so as to allow water vapor to pass through rather than remain trapped under the dressing. In certain embodiments, a separate adhesive or adhesive strip may be used instead, but the adhesive layer may, at least in part, provide the bottom surface of the drape 107 to secure the drape to the patient's skin. Optionally, a release layer may be placed on top of the adhesive layer to protect the adhesive layer before use and to facilitate handling of the drape 107, and in some embodiments, the release layer may consist of multiple sections. The negative pressure system 101 may be connected to a negative pressure source, such as a pump 114. A suitable example of a pump is the Renasys EZ pump, commercially available from Smith & Nephew. The drape 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 the opening 109 of the drape 107, or the conduit 112 may be connected directly through the opening 109 without using a port. In further alternatives, the conduit may pass below the drape and extend from the side of the drape. U.S. Patent No. 7,524,315 discloses other similar embodiments of negative pressure systems, and by reference thereto, it is incorporated in whole and should be considered part of this Specified.In many applications, the container or other storage unit 115 may be placed 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. Alternatively, the container 115 may be placed after the pump 114 by a certain type of negative pressure supply source, such as a peristaltic pump. 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. Further embodiments may also include a shut-off valve or a blocking hydrophobic and / or oleophobic filter in the container to prevent overflow, and other embodiments may include sensing means such as a volume sensor or other fluid level detector that works to stop or shut off the negative pressure supply source when the fluid level in the container approaches its capacity. It is also preferable that an odor filter, such as an activated carbon canister, be provided at the pump discharge.

[0036] The foregoing description concerns specific configurations, aspects, and advantages of the present invention, which can be modified in various ways without departing from the spirit and scope of the invention. Furthermore, the negative pressure therapy systems disclosed herein do not necessarily have to feature all of the above-mentioned objects, advantages, features, and aspects. Those skilled in the art will recognize that it is not necessary to achieve other objects or advantages as may be taught or suggested herein, and that the present invention can be embodied or performed in a manner that achieves or optimizes one or more advantages as taught herein. For example, in some embodiments, the pad 103 can be used without the wound contact layer 105 and / or the drape 107. In addition, while numerous variations of the present invention have been shown and described in detail, other modifications and uses that fall within the scope of the invention will be readily apparent to those skilled in the art based on this disclosure. Various combinations or subcombinations of these particular features and aspects of embodiments are expected to be made and further within the scope of the invention. Therefore, it should be understood that various features and aspects of the disclosed embodiments can be combined or substituted for each other to form various modes of the negative pressure therapy systems considered.

[0037] Figure 1B shows another negative pressure wound treatment system 100. The negative pressure wound treatment system 100 may have, in combination with or as a substitute for, any of the components, configurations, or other details of any of the other negative pressure wound treatment systems disclosed in this disclosure, including but not limited to the negative pressure wound treatment system illustrated in the drawings, of any of the components, configurations, or other details of the negative pressure wound treatment system 100 illustrated in Figure 1B and / or described in this disclosure. The negative pressure wound treatment system 100 may have a wound cover 106 over the wound 104 that can seal the wound 104. The wound cover 106 may be connected to a wound treatment device 110 (which may be referred to as a “pump assembly” as a whole or in part) configured to supply depressurization or negative pressure using a conduit 108 such as a single-lumen or multi-lumen conduit. The wound cover 106 may be in fluid communication with the wound 104. Referring to Figure 1B, the conduit 108 may have a bridge portion 130 which may have a proximal end portion and a distal end portion (the distal end portion being closer to the wound 104 than the proximal end portion), and an applicator 132 at the distal end of the bridge portion 130 which forms a flexible suction adapter (or conduit) 108. A connector 134 may be positioned at the proximal end of the bridge portion 130 so as to extend along the length of the bridge portion 130 of the conduit 108 shown in Figure 1B and connect to at least one of the channels. A cap 140 may be connected to a portion of the conduit 108 and, in some cases, can be attached to the connector 134 as shown. The cap 140 may be useful in preventing fluid from leaking out from the proximal end of the bridge portion 130. The conduit 108 may be a Soft Port manufactured by Smith & Nephew. As described above, the negative pressure wound healing system 100 may include a negative pressure source, such as a wound healing device 110, which can supply negative pressure to the wound 104 through a conduit 108. Although not required, the wound healing device 110 may also include a canister or other container for storing wound exudate and other fluids that may be removed from the wound. The wound healing device 110 may be connected to the connector 134 via a conduit or tube 142.During use, the applicator 132 may be placed over an opening formed in a wound cover 106 placed over a suitably prepared wound or wound 104. The wound treatment device 110 can then be operated to supply negative pressure to the wound, with the wound treatment device 110 connected to the connector 134 via the tube 142. The application of negative pressure may be continued until a desired level of healing of the wound is achieved. The bridge portion 130 may include an upper channel material or layer positioned between the upper layer and the intermediate layer, with the lower channel material or layer positioned between the intermediate layer and the lower layer. The upper layer, intermediate layer, and lower layer may have elongated portions extending between their proximal and distal ends and may include fluid-impermeable materials, such as polymers such as polyurethane. Naturally, it will be understood that the upper layer, intermediate layer, and lower layer may each be constructed from different materials, including semi-permeable materials. In some cases, one or more of the upper layer, intermediate layer, and lower layer may be at least partially transparent. In some examples, the upper and lower layers may be curved, rounded, or convex outward for most of their length.

[0038] The upper and lower channel layers may extend from the proximal to the distal end of the bridge portion 130, and each may preferably contain a porous material including, for example, an open-cell foam such as polyethylene or polyurethane. In some cases, one or more of the upper and lower channel layers may contain, for example, a knitted or woven spacer cloth (such as a knitted polyester 3D fabric, Baltex 7970.RTM., or Gehring 879.RTM.), or a nonwoven material, or a terry weave or loop pile material. The fibers are not necessarily woven and may include felt and flock fiber materials (including materials such as Flotex.RTM.). The selected material is preferably positioned to guide wound exudate away from the wound, to transmit negative pressure or expelled air to the wound site, and to provide some torsional or occlusive resistance to the channel layer. Those skilled in the art will understand that such materials may also be called spacer materials and may be present in layers known as spacer layers. In one example, the upper channel layer may include an open-cell foam such as polyurethane, and the lower channel layer may include a fabric. In another example, the upper channel layer is optional, and the system may instead include an open upper channel. The upper channel layer may have an upper surface that is curved, rounded, or convex upward and a substantially flat lower surface, and the lower channel layer may have a lower surface that is curved, rounded, or convex downward and a substantially flat upper surface. The fabric or material of any component of the bridge portion 130 may have a three-dimensional (3D) structure, and one or more types of fibers may form a structure in which the fibers extend in all three-dimensional directions. Such fabrics may, in some cases, assist in wicking, fluid transport, or negative pressure transmission. In some cases, the channel fabric or material may consist of several layers of material stacked on top of each other or layered, which in some cases may be useful in preventing the channel from collapsing under the application of negative pressure.The material used in the implementation of part of conduit 108 may be conformable and flexible, which in some cases may help avoid pressure ulcers and other complications that may arise from the wound healing system pressed against the patient's skin.

[0039] The distal ends of the upper, middle, and lower layers, as well as the channel layer, may be expanded at their distal ends (placed over the wound site) to form a “teardrop” or other expanded shape. At least the distal ends of the upper, middle, and lower layers, as well as the channel layer, may also include at least one through-opening. This opening may be useful not only for draining wound exudate and applying negative pressure to the wound, but also during the manufacturing of the device, as these openings may be used to properly align each of these layers. In some implementations, a controlled gas leak section 146 (which may also be referred to as a gas leak section, air leak section, or controlled air leak section) may be located on the bridge section 130, for example, at its proximal end. This air leak section 146 may include an opening or channel extending through the upper layer of the bridge section 130 so that the air leak section 146 is in fluid communication with the upper channel of the bridge section 130. When suction is applied to the conduit 108, gas (such as air) may enter through the gas leak section 146 and travel along the upper channel of the bridge section 130 from the proximal end to the distal end of the bridge section 130. The gas can then be drawn into the lower channel of the bridge section 130 by passing it through the opening through the distal ends of the upper, intermediate, and lower layers. The air leak section 146 may include a filter. Preferably, the air leak section 146 is located at the proximal end of the bridge section 130 to minimize the possibility of wound exudate or other fluids coming into contact with the air leak section 146 or filter and blocking or obstructing the air leak section 146 or filter. In some examples, the filter may be a microporous membrane that can remove microorganisms and bacteria and can filter out particles larger than 45 μm. Preferably, the filter can remove particles larger than 1.0 μm, more preferably larger than 0.2 μm. Advantageously, some implementations can provide filters that are at least partially chemically resistant to, for example, water, common household liquids such as shampoo, and other surfactants.In some cases, reapplying vacuum to the suction adapter or wiping the exposed outer portion of the filter may be sufficient to clear any foreign matter blocking the filter. The filter may be composed of a suitably resistant polymer such as acrylic, polyethersulfone, or polytetrafluoroethylene, and may be oily or hydrophobic. In some cases, the gas leak section 146 may supply a relatively constant gas flow that does not increase noticeably when additional negative pressure is applied to the conduit 108. In an example of the negative pressure wound treatment system 100 in which the gas flow through the gas leak section 146 increases when additional negative pressure is applied, preferably this increased gas flow is minimized and does not increase in proportion to the negative pressure applied thereto. Further descriptions of such bridges, conduits, air leak sections, and other components, features, and details that may be used in any implementation example of the negative pressure wound treatment system disclosed herein are found in U.S. Patent No. 8,801,685, which is incorporated herein by reference in its entirety as fully described herein.

[0040] Any of the wound treatment devices disclosed herein (such as device 114 or 110) may provide continuous or intermittent negative pressure therapy. Continuous therapy may be delivered 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 may be delivered between a low negative pressure setpoint and a high negative pressure setpoint (sometimes referred to as a setpoint). Lower settings may be set 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. Higher setting points can be set 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 lower setting point can be delivered for a first duration, and at the end of the first duration, negative pressure at a higher setting point can be delivered for a second duration. At the end of the second duration, negative pressure at a lower setting point can be delivered. The first and second durations may be the same or different. During operation, the wound filler 102 may be inserted into the cavity of the wound 104, and the wound cover 106 may be positioned to seal the wound 104. The wound treatment device 110' can provide negative pressure to the wound cover 106, which can be transmitted to the wound 104 via the wound filler 102. Fluids (such as wound exudate) may be drawn out through the conduit 108' and stored in a canister. In some cases, the fluid is absorbed by the wound filler 102 or one or more absorbent layers (not shown).Wound dressings that may be used in the pump assembly and system of this application include Renasys-F, Renasys-G, Renasys AB, and Pico dressings available from Smith & Nephew. Further descriptions of such wound dressings and other components of negative pressure wound therapy systems that may be used in the pump assembly and system of this application can be found in U.S. Patent Publications 2012 / 0116334, 2011 / 0213287, 2011 / 0282309, 2012 / 0136325, U.S. Patent No. 9,084,845, and International Patent Publication WO2021 / 069642, each of which is incorporated by reference in whole as fully described herein. In some cases, other suitable wound dressings may be used.

[0041] Figures 2A and 2B illustrate embodiments of a wound filler 202 comprising a closure layer 210, a rim 212, and a slit 214. Such wound fillers are inserted into an abdominal incision, sealed with a drape, and connected to a negative pressure source via a fluid connection. While under negative pressure, the wound filler 202 can fold, pulling the abdominal wall toward the midline. As will be understood by those skilled in the art, the wound filler may fold anisotropically. The wound filler 202 can provide internal tension, reducing the risk of prolonged congestion or abdominal separation. In certain embodiments, the closure layer may fold under negative pressure, thereby pulling the fascial walls together. The wound filler 202 is interchangeable with the pad 103 in Figure 1A. Figure 2A shows that embodiments of the wound filler 202 may be annular in shape to accommodate abdominal wounds of different sizes. As illustrated in Figures 2A and 2B, the wound filler 202 may have a closure layer 210, a rim 212, and a slit 214. In certain embodiments, the rim 212 may be perforated so that the user can remove the entire rim or a portion of the rim. In some embodiments, the closure layer may have a rim that forms an L-shaped cross-section as illustrated in Figures 2A and 2B.

[0042] The slit 214 may improve fluid management and provide improved internal closure. The slit allows for lateral folding of the wound filler, thereby drawing tissue walls, such as fascia, toward each other. In some embodiments, the wound filler 202 is placed within the fascia where the surgical incision was made, pulling the abdominal wall toward the midline and providing internal tension. The closure layer may protrude through the opening in the fascia, thereby being positioned between sections of fascia. The wound filler 202 may be placed in the wound anterior to or together with the visceral protective layer, as shown in Figure 1A. The wound filler 202 may have a rim 212 extending outward when the wound filler is annular in shape. The rim 212 may be placed beneath the patient's fascia to secure the wound filler 202 within the wound, such as in the wound opening in the fascia. The rim may be attached to the underside of the fascia to grasp it and thereby function to apply tension to the fascia during the folding of the wound filler while under negative pressure. In some embodiments, the wound filler 202 may be seated beneath the abdominal wall to support the internal 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 seated beneath the fascia.

[0043] In some examples, the wound fillers described herein are designed to fit under and between fascial openings. As described above, the closure layer 210 may extend through the fascia, and the rim 212 may extend beneath the fascia. As described elsewhere, the rim may adhere to the underside of the fascia and assist in pulling the fascia when the closure layer is folded under negative pressure.

[0044] In certain embodiments, the rim 212 is flexible to accommodate the contours of the abdominal and fascial regions, embedded in the tissue at the wound margin, and secures the wound filler 202 within the wound opening. In some embodiments, the rim may extend beneath the deep fascia, subserosal fascia, septal membrane, peritoneum, or any other layer between the skin layer and the viscera. For example, in one embodiment, for an abdominal wound, the rim may preferably be located beneath the peritoneum. Thus, the use of the rim facilitates the maintenance and retention of the wound filler at the correct vertical level within the wound, while also being able to secure it to the fascia, which helps the wound filler provide internal tension to the fascia while under negative pressure, thereby promoting wound closure. The closure layer 210 may extend centrally from the rim and be placed between the fascia. Slits 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 centrally to provide internal tension. Slit 214 may be advantageous in reducing the risk of conditions such as chronic congestion.

[0045] In some examples, the rim 212 may be positioned outward from the wound margin and located beneath the fascia. The wound filler 202 may be seated within the abdominal cavity.

[0046] Figure 3A is a top view of the wound filler 202 of Figure 2A, positioned within an open abdominal wound, covered by a drape, and attached to a negative pressure system. When negative pressure is applied through the conduit 112, the edges of the abdominal wound tissue can be tightly sealed with the surface of the closure layer, and the wound filler 202 can pull the abdominal wall toward the midline. The wound filler can communicate with the abdominal wound and allow the application of negative pressure through the opening 109 to provide a fluid connection from the wound to a negative pressure source such as a pump 114. The fluid connection between the opening 109 and the pump 114 can be made through the conduit 112. In some embodiments, the conduit 114 may comprise a RENASYS® Soft Port® manufactured by Smith & Nephew. In some embodiments, the drape 107 does not necessarily include the opening 109, and the fluid connection to the pump 114 may be made by positioning the conduit 114 beneath the drape. Under negative pressure, the wound filler 202 can pull the abdominal wall toward the midline and provide internal tension. The wound filler 202 can be biased toward the midline. The slit 214 may be in the form of a longitudinal strip configured to allow the wound filler to fold. The slit 214 may allow the stabilizing structure to bend more easily in the vertical plane. A single drape or multiple drapes may be placed on the wound filler 202 and preferably adhere to or seal to the skin around the periphery of the abdominal wound so as to form a fluid seal.

[0047] Figure 3B is a cross-sectional view of a wound filler 202 positioned between the fascia and the overlying tissue. In some embodiments, the wound filler may be positioned beneath the fascia. After insertion of the wound filler, a drape 107 covers the wound filler, and a conduit 112 may be connected to a port 113 located above the opening 109 of the drape 107. The rim 212 may deform when placed at the wound site. The rim 212 can sit beneath the skin. The rim 212 may be positioned beneath adipose tissue. The rim 212 may be positioned beneath muscle. The rim 212 may be positioned in the layer containing the abdominal organs. As will be understood by those skilled in the art, the wound filler 202 may improve the primary closure rate and reduce pressure on organs. Furthermore, the wound filler 202 may improve blood supply to organs, resulting in improved outcomes.

[0048] Figure 4 illustrates an embodiment of a wound filler 700 (similar to the wound filler described herein) having a plurality of slits 714. In a particular embodiment, the wound filler may have one, two, three, four, five, six, seven or more slits. As shown in the image, the wound filler 700 may have three slits 714. The wound filler 700 may fold preferentially along one direction. Here, the wound filler 700 may include a porous wound filler (e.g., a foam) with a plurality of slits 714 cut into it. The plurality of slits 714 may preferably penetrate the thickness direction of the wound filler 700 and extend longitudinally. Thus, the space may allow the wound filler 700 to fold preferentially in a certain direction when a force is applied perpendicular to the slits 714. Since the space is more easily compressed than the rest of the foam, it is preferable that the width and thickness of the foam are not compressed (or are compressed minimally) compared to the compression perpendicular to the length of the resulting wound filler 700. Multiple slits 714 may be advantageous by assisting in the management of abdominal wound fluid and internal closure of the abdomen.

[0049] Figure 5 illustrates an embodiment of a wound filler 800 (similar to other wound fillers described herein) having a central hole 814. The central hole 814 may be an oval-shaped hole 814. The central hole 814 allows the wound filler 800 to fold under negative pressure, thereby drawing tissues such as fascia together. As a result, the space within the central hole 814 can pull the abdominal wall toward the midline, providing temporary closure of the abdominal wound. When the negative pressure is temporarily released and the abdomen returns to normal pressure, the central hole 814 can function as a window for the user to view the abdomen.

[0050] Figures 6A and 6B show top, perspective, and bottom views of further embodiments of a wound filler 900 comprising a central hole 914 and a rim 912 having a plurality of slits 916, similar to other wound fillers described herein. Figure 6A shows the stage before compression without negative pressure application. The rim 912 can form an L-shape perpendicular to a closure layer 910 extending outward into the wound cavity. In some embodiments, the rim may extend beneath the deep fascia, subserosal fascia, serosa, peritoneum, or any other layer between the skin layer and the viscera. For example, in one embodiment, the rim may preferably be located beneath the peritoneum. The rim 912 may include a plurality of slits 916 made in a longitudinal strip, preferably extending longitudinally along the longitudinal axis of the wound. As described elsewhere herein, in certain embodiments, the rim 912 may have perforations so that, if necessary, the entire rim or a portion of the rim 912 can be removed. The width of the rim 912 may be greater than the height of the closure layer 910 and extend outward into the wound cavity. The width of the rim 912 may be greater than the height of the closure layer 910 and may contour the shape of the organ. Thus, the rim configuration can protect the organ and facilitate fluid communication with the abdomen and the wound filler 900. In certain embodiments, the rim may include one or more slits on one or each portion of the outwardly extending rim, for example, on the two portions shown in Figures 6A and 6B. For example, each portion of the rim may include one, two, three, four, five, or more slits to facilitate fixation to the tissue layer.

[0051] Under negative pressure, the wound filler 900 can be compressed in the horizontal plane, drawing the wound edges together closer. Thus, the space created by the slit 916 can allow the wound filler to preferentially fold in a certain direction when negative pressure is applied perpendicular to the slit 916. As a result, the wound filler 900 can adhere to the underside of the fascia, assisting in the complete temporary closure of the open abdomen.

[0052] Figure 7 illustrates an embodiment of wound filler 1000 similar to wound fillers described elsewhere in this specification, including various patterned elements. As will be understood by those skilled in the art, wound fillers may be configured to fold anisotropically when subjected to negative pressure and to fold horizontally across the width of the wound filler. In an embodiment, rhombic elements 1010 form a diamond shape at the center of the wound filler 1000. Multiple rhombic elements 1010 may be arranged in a repeating pattern at the central position of the wound filler 1000 to form a grid. Multiple rhombic elements 1010 at the central position of the wound filler 1000 can be folded and compressed along the length and width of the wound filler, while facilitating fluid communication with the abdominal wound. Annular elements 1012 may form an annular shape. Multiple annular elements 1012 may be arranged in a repeating pattern in the proximal and distal portions of the multiple rhombic elements 1010. The elongated elements 1014 can form parallel longitudinal strips that discharge away from the rhombic elements 1010 and annular elements 1012 toward the outer edge of the wound filler 1000. The elongated elements 1014 can assist the anisotropic folding of the rhombic elements 1010 and annular elements 1012 when subjected to negative pressure. As will be understood by those skilled in the art, the pattern of the shape can play a role in reinforcing the folding of the wound filler 1000.

[0053] The wound filler 1000 has a concentrated shape in the middle and spreads outwards, creating a medical compression effect. The wound filler 1000 may have a narrow slit pattern around the edges of the filler, allowing internal compression to occur in different directions. The shape can be cut using a laser cutter. The elongated elements 1014 can be folded to assist smaller elements in management and closure.

[0054] Figure 8 illustrates a further embodiment of the wound filler 1100, comprising a slit 1110, a plurality of longitudinal strips 1112 positioned surrounding the slit, a fan element 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 element 1114 assist in facilitating fluid management. The fan element 1114 is compressed under negative pressure and is configured to help the slit 1110 fold and pull the abdominal wall toward the midline, providing internal tension. Smaller slits and a larger central slit 1110 can facilitate fluid management. The fan element 1114 may be compressible to assist in internal compression of the foam.

[0055] Figure 9 illustrates a further embodiment of the wound filler 1200, which includes a spacer material sandwiched between two foam layers 1240. The wound filler 1200 can pull more or all of the skin / fat tissue and abdominal layers. Multiple pores allow fluid movement through the cushion of the upper foam layer 1240. In the center, a circle 1242 can be cut to push out the fluid underneath. When compressed, the upper foam layer 1240 may fold, which may allow fluid to move through the foam. Cuts may be present within the wound filler to allow it to shape for a particular wound.

[0056] Figure 10 illustrates a further embodiment of the wound filler 1300 including a pattern for internal compression. The wound filler 1300 may have a concave lens-shaped design slit 1352 in the center surrounded by a triangle 1350, as a different method to facilitate internal compression. A narrow slit 1354 may surround the concave lens-shaped design slit 1352 and the triangle 1350. The arrangement of the shapes may be advantageous for internal compression.

[0057] Figure 11 illustrates a further embodiment of the wound filler 1400 having small holes 1460 and a larger central hole 1462. The small holes 1460 may extend throughout the wound filler. The small holes 1460 may form an array. The larger central hole 1462 can support internal pressure. In certain embodiments, the wound filler 1400 may have multiple overlapping perforation lines and / or shapes so that the user can select a desired shape or size for the incision type.

[0058] Figure 12 illustrates a further embodiment of the wound filler 1500 having X-shaped holes 1564. The X-shaped holes 1564 may be evenly distributed across the surface of the wound filler 1500. The X-shaped holes 1564 may assist in internal compression. In certain embodiments, as disclosed elsewhere herein, the wound filler 1400 may have multiple overlapping perforation lines and / or shapes so that the user can select a desired shape or size for the incision type.

[0059] Figure 13 illustrates a visceral protective layer 1600 that includes a spacer material 1670 (such as a spacer material described elsewhere in this specification) to facilitate internal tension and fluid management together with a filler material 1672. The spacer material may be H-shaped to facilitate fluid management from the four sides of the abdomen and to move the fluid toward the center for fluid removal. The fluid can be removed by negative pressure wound therapy. The spacer material may be placed between layers of film of the visceral protective layer 1600. The spacer material may be sandwiched between layers of film. The spacer material 1670 may have polyurethane immediately behind the fabric. The visceral protective layer 1600 may have a film layer, a protective layer, and a spacer layer. The film may be in direct contact with the spacer material 1670. The filler material 1672 may be sandwiched between layers of film. The filler material 1672 can distribute fluid to and from the spacer material 1670. Spacer material 1670 can be connected to a soft port.

[0060] Figure 14 illustrates a further embodiment of the visceral protective layer 1700, which is composed of a cross-cross design 1780 of the filler material. The cross-cross design 1780 of the filler material may be a method of directing fluid from all sides of the abdomen toward the midline for fluid management. The cross-cross design 1780 can facilitate internal compression mechanically.

[0061] Figure 15 illustrates a further embodiment of the internal protective layer 1800, which includes a plurality of horizontally arranged rectangles 1882 of filler material that may be larger on the outside and smaller towards the center. In certain embodiments, this design may facilitate fluid transport toward the center and internal compression. The center may have a large rectangle 1884. The large rectangle 1884 may be connected to a soft port. The rectangles 1882 and the large rectangle 1884 may be spacer material sandwiched between layers of film.

[0062] Figure 16 illustrates a further embodiment of the visceral protective layer 1900, which includes multiple rectangles 1982 of filler arranged horizontally and vertically, which may be larger on the outside and smaller towards the center. In certain embodiments, this design can facilitate fluid transport toward the center and internal compression. The center may have a large rectangle 1984. The large rectangle 1984 can be connected to a soft port. The design can allow for adaptability of the visceral protective layer 1900 to various sizes. The rectangles 1982 and the large rectangle 1984 may be spacer material sandwiched between layers of film. The user can cut the visceral protective layer 1900 between the rectangles 1982. For example, the user can cut the film between the topmost rectangles 1982. The visceral protective layer 1900 can be cut to fit the size of the wound site. The visceral protective layer 1900 may be thin. In some embodiments, the shape of the visceral protective layer may help navigate and / or shape the visceral protective layer 1900 to fit into the center of the abdominal cavity.

[0063] Figure 17 shows an example of a stretchable, compressible material 2000. The stretchable, compressible material 2000 can act as a spacer material. The spacer material can be sandwiched between internal protective layers and can be useful for fluid management and internal compression. The stretchable, compressible material 2000 may also be a double mesh spacer having monofilaments. The double mesh spacer may have monofilaments between two mesh layers. The monofilaments can be manufactured at angles of 90° and 45°, or any suitable angle. Monofilaments manufactured at a 45° angle can leave a channel in the design. This allows the user to be instructed to cut through the internal protective layer without shedding the fabric. The spacer can also be made from spun dyed yarn. The spacer can also be made from stretchable spacers. The spacer fabric can also be used to assist in fluid management by facilitating the movement of fluid throughout and / or within the 3D fabric.

[0064] In certain embodiments, the 3D spacer fabric may be a moisture-wicking polyester. When stretched within the visceral protective layer, the stretchable spacer material can reconform to its original shape. This can help bring the internal compression and abdominal layer closer together. The stretchable spacer material may be any stretchable material. The 3D spacer fabric may contain silver. When negative pressure is no longer applied, fluid can remain within the material. In certain embodiments, silver may be added to prevent and limit bacterial growth.

[0065] Figure 18 shows an example of a connector 3200 for cleaning an abdominal wound. The connector 3200 can clean the wound site with fluid and remove the fluid from the wound site. The connector 3200 may be a Y-connector. Fluid can enter the connector 3200 at an intake port 3212, which may be a Luer connector with a one-way valve. Fluid can pass through the intake port 3212 and enter the intake branch 3202 of the connector 3200. The intake branch 3202 of the connector 3200 may be connected to a delivery branch 3204 and an output branch 3206 at a joint 3208. The intake branch 3202 may allow one-way flow. The intake branch 3202 may allow inward flow. In certain embodiments, the connector 3200 may consist of a rotary valve that can allow fluid into or out of the abdomen. The valve may be configured to allow fluid to be discharged from the abdomen while preventing fluid from entering the abdomen. The valve may be configured to allow fluid into the abdomen while preventing fluid from being discharged from the abdomen.

[0066] In some embodiments, fluid can flow from the intake branch 3202 through the junction 3208 to the delivery branch 3204. The delivery branch 3204 may be connected to an internal protective layer covering the wound site at a delivery port 3214. Fluid can flow from the delivery branch 3204 through the delivery port 3214 into a delivery tube on the internal protective layer to clean the wound site. The delivery port 3214 may be a quick-click 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 for multidirectional flow. The delivery branch 3204 can allow for inward and outward flow.

[0067] In certain embodiments, fluid can flow from delivery branch 3204 through junction 3208 to output branch 3206. Output branch 3206 may be connected to a canister through output port 3216. A suitable example of a canister is the RENASYS device canister available from Smith & Nephew. Fluid can flow from output branch 3206 to the canister through output port 3216. Output port 3216 may be a quick-click connector. Output branch 3206 can enable unidirectional flow. Output branch 3206 can enable outward flow.

[0068] The connector 3200 can facilitate the removal of fluid from the wound site. The connector 3200 can deliver fluid to the wound site. The connector 3200 can simultaneously deliver fluid to the wound site and remove fluid from the wound site. The fluid can be delivered to the wound site and removed from the wound site to cleanse the wound site. The system described herein can be used to clean a wound site during negative pressure therapy. In certain embodiments, as further described in Figure 35, a switch may be used to switch between the intake branch and the output branch.

[0069] Figure 19 shows an example of a visceral protective layer 3300 for covering an abdominal wound, as described elsewhere in this specification. The visceral protective layer 3300 may be placed over the wound site. In certain embodiments, the visceral protective layer 3300 may be sealed to the wound site or simply over the underlying tissue. The visceral protective layer may serve to protect the underlying tissue from damage caused by other components of the abdominal treatment system. A delivery port 3214 may connect the connector 3200 to a delivery tube 3310. The delivery port 3214 may be a soft port. The delivery tube 3310 may deliver fluid to the wound site. The delivery tube 3310 may deliver fluid to the paracolonic groove of the abdomen. The delivery tube 3310 may be made of a spacer material, such as any preferred spacer material described herein. The visceral protective layer 3300 may be transparent. The delivery tube 3310 may be transparent.

[0070] In certain embodiments, the visceral protective layer 3300 may be compatible with the pad 103. The visceral protective layer 3300 may be compatible with the wound contact layer 105. The visceral protective layer 3300 may be compatible with both the pad 103 and the wound contact layer 105. The visceral protective layer 3300 may be rectangular. The visceral protective layer 3300 may have rounded corners. The visceral protective layer 3300 may have delivery tubes 3310 extending to the corners of the visceral protective layer 3300. The visceral protective layer 3300 may have delivery tubes 3310 extending to the sides of the visceral protective layer 3300. In some examples, the visceral protective layer may include one, two, three, four, five, six, seven, eight, nine, ten, fifteen, twenty or more delivery tubes. In certain embodiments, the internal protective layer 3300 may have six delivery tubes 3310. The delivery tubes 3310 can facilitate the removal of fluid from the wound site. The delivery tubes 3310 can deliver fluid to the wound site. The delivery tubes 3310 can simultaneously deliver fluid to the wound site and remove fluid from the wound site.

[0071] Figure 20A is a top view of an embodiment of the delivery tube 1710 positioned between layers of spacer material. Figure 20B is a perspective view of the delivery tube 1710 positioned between layers of spacer material. The delivery tube 1710 can communicate fluidly with the interior of the spacer manifold 3400. The delivery tube 1710 may be positioned below the upper layer 4524 of the spacer material. The delivery tube 1710 may be positioned above the lower layer (not shown) of the spacer material. The delivery tube 1710 can deliver fluid from the spacer material to the wound site. The delivery tube 1710 can deliver fluid from the wound site to the spacer material.

[0072] Figure 21 shows one embodiment of a visceral protective layer 3300' for covering an abdominal wound. The visceral protective layer 3300' may be circular. The visceral protective layer 3300' may have delivery tubes 3310' that extend along the radius of the visceral protective layer 3300' to the edge of the visceral protective layer 3300'. The visceral protective layer 3300' may have eight delivery tubes 3310' as shown in the figure. However, those skilled in the art will understand that the visceral protective layer may have any appropriate number of delivery tubes.

[0073] Figure 22 shows an example of a manifold 3500 for distributing 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 cavity that communicates with the fluid to the internal cavity of the manifold 3500. The manifold 3500 may have a vent 3560 that can assist in internal compression. The vent 3560 can allow fluid that may have seeped into the filler to be released from the manifold 3500. The manifold 3500 may be octagonal. The manifold 3500 may have any appropriate number of ports 3550. For example, the manifold in Figure 5 and any of the manifolds described herein may include one, two, three, four, five, six, seven, eight, nine, ten, fifteen, twenty, or more ports.

[0074] Figure 23 shows an example of a manifold 3600 for distributing fluid to the abdomen and / or removing fluid or exudate from the abdomen. The manifold 3600 may have ports 3650 that can be connected to a delivery tube. The ports 3650 may extend from the outside of the manifold 3600. The ports 3650 may have cavities that communicate with the fluid to an internal cavity of the manifold 3600. The ports 3650 can be connected to a round tube. The manifold 3600 may be octagonal and may have any suitable number of ports, such as eight ports 3650.

[0075] Figure 24 illustrates another example of a manifold 3700 for distributing fluid to and / or removing fluid or exudate from the abdomen. The manifold 3700 may have ports 3750 that can be connected to a delivery tube. The ports 3750 may extend from the outside of the manifold 3700. The ports 3750 may have cavities that communicate with the fluid to an internal cavity of the manifold 3700. The ports 3750 can be connected to a flat or elongated elliptical tube. The manifold 3700 may be octagonal and may have any suitable number of ports, such as eight ports 3750.

[0076] Figure 25 illustrates another example of a manifold 3800 for distributing fluid to and / or removing fluid or exudate from the abdomen. The manifold 3800 may have ports 3850 that can be connected to a delivery tube. The ports 3850 may be coplanar with the outside of the manifold 3800. The ports 3850 may have cavities that are in fluid communication with the inner cavity 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 cavity divided by an inner wall 3870. The manifold 3800 may be a partitioned manifold. The inner wall 3870 of the manifold 3800 can separate the fluid removal section from the fluid delivery section. The manifold 3800 may have one side of the inner cavity for cleaning techniques. The manifold 3800 may have one side of an inner cavity for fluid removal. In certain embodiments, the inner wall 3870 may be removed if not required during use.

[0077] Figure 26 shows another example of a manifold 3900 for distributing liquid. The manifold 3900 may have ports 3950 that can be connected to a delivery tube. The ports 3950 may be coplanar with the outside of the manifold 3900. The ports 3950 may have cavities that are in fluid communication with the internal cavities of the manifold 3900. The manifold 3900 may be disc-shaped. The manifold 3900 may be flower-shaped. The manifold 3900 may be disc-flower-shaped. The shape of the manifold 3900 can allow for flexibility. The manifold 3900 can be pushed under fascia. The manifold 3900 may have eight ports 3950. The manifold 3900 may have a gap 980 in the center. The gap 980 can be connected to a delivery port 214.

[0078] Figure 27 illustrates another example of a manifold 4000 for distributing fluid to the abdomen and / or removing fluid or exudate from the abdomen. The manifold 4000 may have ports 4050 that can be connected to a delivery tube. The ports 4050 may be coplanar with the outside of the manifold 4000. The ports 4050 may have cavities that communicate with the internal cavity 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 fitting through openings in tissue layers such as fascia.

[0079] Figure 28 illustrates another example of a manifold 4100 for distributing fluid to and / or removing fluid or exudate from the abdomen. The manifold 4100 may have ports 4150 that can be connected to a delivery tube. The ports 4150 may be coplanar with the outside of the manifold 4100. The ports 4150 may have cavities that communicate with the internal cavity 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 flat floor manifold. The manifold 4100 can allow for variations in the position of the delivery ports 214.

[0080] Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 can be connected to the delivery port 214. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 can distribute fluid from the connector 200 to the wound site. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 can remove fluid from the wound site to the connector 200. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 may have 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 ports. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 may be made from one of the following: polyurethane, silicone, foam, rubber, and polyisoprene. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 may be colored or transparent. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 may be of varying depths and may be located within the filler and directly connected to a drape or delivery port. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 may be located below the filler. Manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100 may come in various colors to improve visibility. Using manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100, along with delivery tubes, fluid can be distributed to draw fluid from different areas of the wound site.

[0081] Figure 29 shows an example of a manifold 3500 for distributing the liquid from Figure 5, connected to a delivery tube 4210. The delivery tube 4210 can be sealed to port 3550.

[0082] Figure 30 shows an example of a manifold 3800 for distributing the fluid of Figure 8, connected to delivery tubes 4310 and 4320. The delivery tubes 4310 and 4320 can be sealed to port 3550. Delivery tube 4310 can deliver fluid to the wound site. Delivery tube 4320 can remove fluid from the wound site. Delivery tube 4310 can be connected to a cavity on one side of the inner wall 3870. Delivery tube 4320 can be connected to a cavity on the other side of the inner wall 3870. The manifold 3800 can be connected to two, four, or more delivery tubes 4310. The manifold 3800 can be connected to two, four, or more delivery tubes 4320.

[0083] In certain embodiments, the delivery tubes may have varying diameters based on how well they handle different fluid viscosities. The shape of the tubes may be elliptical, circular, or triangular. The delivery tubes may have a color that makes the internal protective layer more visible. The delivery tubes may be bonded or welded to the manifold. The delivery tubes may be adhered to the internal protective layer film. The delivery tubes may be positioned between two layers of the internal protective layer film. The manifold may be bonded to the center of the internal protective layer film. The delivery tubes may be loose, allowing the user to position the tubes wherever they are most needed.

[0084] In some embodiments, transparent delivery tubes can allow surgeons to better view the wound site. Transparent visceral protective layers can allow surgeons to better view the wound site. Transparent manifolds can allow surgeons to better view the wound site. The use of tubes, spacers, and manifolds can reduce flow limitations and provide faster and more efficient fluid discharge.

[0085] Figure 31A is a perspective view of one embodiment of the flat delivery tube 4410. Figure 31B 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 can allow pressure distribution to organs during use. The flat delivery tube 4410 may have teeth 4402, 4404. The teeth 4402, 4404 can be pushed through the center. The teeth 4402, 4404 can limit the flat delivery tube 4410 from closing completely. The teeth 4402, 4404 can allow improved fluid management from the gutta to the center of the visceral protective layer. When the flat delivery tube 4410 is compressed, the bottom teeth 4402 may collide with the upper inner wall of the flat delivery tube 4410. When the bottom teeth 4402 contact the upper inner wall, the bottom teeth are restricted from moving horizontally by the upper teeth 4404.

[0086] Figure 32 shows one embodiment of three flat delivery tubes 4410 on a lower layer 4522 of spacer material. Figure 33 shows one embodiment of flat delivery tubes 4410 positioned between the cross sections of the lower layer 4522 and the upper layer 4524 of spacer material. In some embodiments, delivery tubes positioned between layers of spacer material can communicate fluids without manifolds 3500, 3600, 3700, 3800, 3900, 4000, and 4100. The upper layer 4524 and lower layer 4522 of spacer material can form a spacer manifold 3400. The flat delivery tubes 4410 can be compressed between two layers of spacer material or spacers, for example, to assist in fluid discharge. The flat delivery tubes 4410 can be compressed between two layers of spacer material or spacers, for example, to assist in fluid movement. The upper layer 4524 and lower layer 4522 of spacer material can be 3D printed.

[0087] In certain embodiments, the spacer manifold 3400, or flexible manifold, may be made from foam, 3D fabric, silver, or other material having antimicrobial properties. The spacer manifold 3400 may be of varying depths. The spacer manifold 3400 may seat within the filler and be directly connected to the drape or delivery port. The spacer manifold 3400 may be placed beneath the filler. The use of the spacer manifold 3400 can eliminate the need for additional filler to be positioned between the fascia.

[0088] Figure 34 is a schematic diagram of one embodiment of a system for cleaning an abdominal wound. Fluid can flow from a fluid source 4804 through an intake tube 4802. The fluid source 4804 may be a container of saline solution. Fluid can flow from the intake tube 4802 to the connector 200. Fluid can flow from the connector 200 to the spacer manifold 3400 through a delivery port 214 or a soft port. Fluid can flow from the spacer manifold 3400 to a delivery tube 4810. The delivery tube 4810 may be positioned across the visceral protective layer 4800. Fluid can flow from the delivery tube 4810 to the wound site. The fluid can enter, for example, the abdomen and spread evenly within the abdominal cavity. Fluid can flow 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. The fluid can flow from the connector 200 through the output tube 4812 into the canister 4814. The canister 4814 can store the fluid.

[0089] Figure 35 shows one embodiment of a connector 4900 for cleaning an abdominal wound, having an integrated switch 4912. The connector 4900 may include an intake branch 4902, a delivery branch 4904, and an output branch 4906, connected at a junction 4908, similar to Figure 18. The 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 valve can restrict flow to one direction. For example, flow may be restricted to enter the intake branch 4902, from the intake branch 4902 to the delivery branch 4904, and outward from the delivery branch 4904, while flow may be restricted to enter the delivery branch 4904, from the delivery branch 4904 to the output branch 4906, and outward from the output branch 4906. Conversely, it is possible for the flow to enter the intake branch 4902, from the intake branch 4902 to the delivery branch 4904, and outward from the delivery branch 4904, while it may be restricted from entering the delivery branch 4904, from the delivery branch 4904 to the output branch 4906, and outward from the output branch 4906. In certain embodiments, the user can control whether the fluid is removed from or delivered to the wound site.

[0090] Figure 36 is a front view of an example of an internal protective layer 5000 having a slit 5060.

[0091] In some examples, the visceral protective layer 5000 may be similar to the wound contact layer and visceral protective layer described above. The visceral protective layer 5000 may be positioned in contact with the wound site. In some implementations, the visceral protective layer 5000 may be minimally or non-adherent to the wound site and may have slits 5060 or other openings for removing wound exudate or fluid and applying negative pressure to the wound site. All slits 5060 may be oriented toward the center of the visceral protective layer 5000 for visual guidance. The user may be able to identify the center of the visceral protective 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, notches or other suitable structures.

[0092] In some examples, the slit 5060 may be formed through the depth along axis Z of the visceral protection layer 5000. The slit 5060 may be a linear slit. The visceral protection layer 5000 may have four quadrants or quarters. The slit 5060 may be directionally aligned with other slits within the same quadrant of the visceral protection layer 5000. The slit 5060 may be directionally opposed to other slits in vertically and / or horizontally adjacent quadrants. Each slit 5060 may be positioned at an angle with respect to the horizontal axis X and vertical axis Y of the visceral protection layer 5000. For example, each slit 5060 may be positioned at an angle of about 45 degrees with respect to the horizontal axis X of the visceral protection layer 5000. In some implementations, each slit 5060 may be positioned at an angle of about 30 to about 60 degrees with respect to the horizontal axis X of the visceral protection layer 5000. In some implementations, each slit 5060 may be positioned at an angle of approximately 10 to 80 degrees with respect to the horizontal axis X of the visceral protection layer 5000. In some implementations, each slit 5060 may be positioned at an angle of approximately 45 degrees with respect to the vertical axis Y of the visceral protection layer 5000. In some implementations, each slit 5060 may be positioned at an angle of approximately 30 to 60 degrees with respect to the vertical axis Y of the visceral protection layer 5000. In some implementations, each slit 5060 may be positioned at an angle of approximately 10 to 80 degrees with respect to the vertical axis Y of the visceral protection layer 5000. For example, approximately 20 degrees, approximately 40 degrees, or approximately 70 degrees.

[0093] In some examples, adjacent quadrant slits 5060 of the visceral protective layer 5000, either horizontally or vertically, may be angled away from each other. For example, adjacent quadrant slits 5060 of the visceral protective layer 5000 may face each other at an angle B of about 90 degrees. In some implementations, angle B may be between about 80 and 100 degrees. In some implementations, angle B may be between about 50 and 130 degrees.

[0094] In some examples, the visceral protection layer 5000 may have a width of 660 mm along the horizontal axis X. In some implementations, the visceral protection layer 5000 may have a width of approximately 655 mm to approximately 665 mm along the horizontal axis X. In some implementations, the visceral protection layer 5000 may have a width of approximately 600 mm to approximately 700 mm along the horizontal axis X. In some implementations, the visceral protection layer 5000 may have a width of approximately 400 mm to approximately 900 mm along the horizontal axis X. In some implementations, the visceral protection layer 5000 may have a width of approximately 100 mm to approximately 1200 mm along the horizontal axis X.

[0095] In some embodiments, the visceral protective layer 5000 may have a length of approximately 800 mm along the vertical axis Y. In some embodiments, the visceral protective layer 5000 may have a length of approximately 795 mm to approximately 805 mm along the vertical axis Y. In some embodiments, the visceral protective layer 5000 may have a length of approximately 700 mm to approximately 900 mm along the vertical axis Y. In some embodiments, the visceral protective layer 5000 may have a length of approximately 500 mm to approximately 1100 mm along the vertical axis Y. In some embodiments, the visceral protective layer 5000 may have a length of approximately 100 mm to approximately 1500 mm along the vertical axis Y.

[0096] In some examples, the visceral protective layer 5000 may have a depth along axis Z (not shown). In some implementations, the depth along axis Z may be 0.1 mm. In some implementations, the depth along axis Z may be approximately 0.05 mm to approximately 0.5 mm. In some implementations, the depth along axis Z may be approximately 0.01 mm to approximately 1 mm. In some implementations, the depth along axis Z may be approximately 0.001 mm to approximately 10 mm.

[0097] In some examples, each slit 5060 may have a length. In some implementations, each slit 5060 may have a length of 4 mm. In some implementations, each slit 5060 may have a length of approximately 3 mm to approximately 5 mm. In some implementations, each slit 5060 may have a length of approximately 1 mm to approximately 7 mm. In some implementations, each slit 5060 may have a length of approximately 0.1 mm to approximately 10 mm.

[0098] In some examples, the same quadrant slits 5060 may be separated by a first space from one end of slit 5060 to the end of an adjacent slit. The same quadrant slits 5060 may be separated by a second space from one edge of slit 5060 to the edge of an adjacent slit. In some implementations, the same quadrant slits 5060 may have a first space of 16 mm between them. In some implementations, the same quadrant slits 5060 may have a first space of about 11 mm to about 21 mm between them. In some implementations, the same quadrant slits 5060 may have a first space of about 1 mm to about 30 mm between them. In some implementations, the same quadrant slits 5060 may have a second space of 10 mm between them. In some implementations, the same quadrant slits 5060 may have a second space of about 5 mm to about 25 mm between them. In some implementations, the same quadrant slits 5060 may have a second space between them of about 1 mm to about 30 mm.

[0099] Figure 37A is a front view of an example of an internal protective layer 5100 having a spacer material 5170. Figure 37B is an exploded perspective view of the example of the internal protective layer 5100 having the spacer material 5170 in Figure 37A. Figure 37C is a front view of the example of the spacer material 5170 in Figure 37A.

[0100] In some examples, the internal protective layer 5100 may be similar to the wound contact layer and internal protective layer described above. The internal protective layer 5100 may include an upper film layer 5172 and a bottom film layer 5174. The film layers 5172 and 5174 may be joined at a weld area 5176. In some embodiments, the film layers 5172 and 5174 may be joined at the weld area 5176 using welding, adhesive, and / or other joining methods. The spacer material 5170 may be sealed between the upper film layer 5172 and the bottom film layer 5174. In some embodiments, the spacer material 5170 may be sealed within the weld area 5176 to prevent the spacer material 5170 from moving inside the internal protective layer 5100. The spacer material 5170 can assist in fluid discharge by transporting fluid across the internal protective layer 5100.

[0101] In some examples, the upper film layer 5172 and the bottom film layer 5174 may be sealed around the entire perimeter of the internal protective layer 5100. The internal protective layer 5100 may include slits in the film layers 5172 and 5174, for example, as described with respect to Figure 36. In some embodiments, the internal protective layer 5100 may include a welded area radially outward from the outermost spacer material 5170d. In some embodiments, the internal protective layer 5100 may include a welded area around the perimeter of the internal protective layer 5100.

[0102] In some examples, the spacer material 5170 may include a central spacer material 5170a positioned at the center of the visceral protective layer 5100. The central spacer material 5170a may be circular or oval in shape. Around the central spacer material 5170a, the visceral protective layer 5100 may include three rings of spacer material 5170b, c, and d, which may be curved or straight. These rings of spacer material may include the innermost spacer material 5170b, the middle spacer material 5170c, and the outermost spacer material 5170d. In some embodiments, the visceral protective layer 5100 may include 1 to 5 rings of spacer material around the center. In some embodiments, the visceral protective layer 5100 may include 1 to 10 rings of spacer material around the center. Advantageously, the central spacer material 5170a may indicate where the visceral protective layer 5100 should be positioned over the wound site. For example, the visceral protective layer 5100 may be positioned such that the central spacer material 5170a is substantially aligned with the center of the wound site.

[0103] In certain examples, the spacer material 5170 may include an innermost spacer material 5170b. The innermost spacer material 5170b may be arranged radially around the central spacer material 5170a. The innermost spacer material 5170b may be formed as a curve or a semicircle. In some embodiments, the visceral protection layer 5100 may include eight pieces of innermost spacer material 5170b. In some embodiments, the visceral protection layer 5100 may include four to twelve pieces of innermost spacer material 5170b. In some embodiments, the visceral protection layer 5100 may include one to fifteen pieces of innermost spacer material 5170b. In some embodiments, the visceral protection layer 5100 may include one to twenty pieces of innermost spacer material 5170b. The innermost spacer material 5170b, the intermediate spacer material 5170c, and / or the outermost spacer material 5170d may be curved or bow-shaped.

[0104] In some examples, the spacer material 5170 may include intermediate spacer material 5170c. The intermediate spacer material 5170c may be arranged radially around the innermost spacer material 5170b. The intermediate spacer material 5170c may be formed as a curve or a semicircle. In some embodiments, the visceral protective layer 5100 may include eight pieces of intermediate spacer material 5170c. In some embodiments, the visceral protective layer 5100 may include four to twelve pieces of intermediate spacer material 5170c. In some embodiments, the visceral protective layer 5100 may include one to fifteen pieces of intermediate spacer material 5170c.

[0105] In some examples, the spacer material 5170 may include an outermost spacer material 5170d. The outermost spacer material 5170d may be arranged radially around an intermediate spacer material 5170c. The outermost spacer material 5170d may be formed as a curve or a semicircle. In some embodiments, the visceral protection layer 5100 may include eight pieces of the outermost spacer material 5170d. In some embodiments, the visceral protection layer 5100 may include four to twelve pieces of the outermost spacer material 5170d. In some embodiments, the visceral protection layer 5100 may include one to fifteen pieces of the outermost spacer material 5170d.

[0106] In some examples, the internal protective layer 5100 may include a welded area 5176 between the central spacer material 5170a and the innermost spacer material 5170b. The internal protective layer 5100 may include a welded area 5176 between the innermost spacer material 5170b and the intermediate spacer material 5170c. The internal protective layer 5100 may include a welded area 5176 between the intermediate spacer material 5170c and the outermost spacer material 5170d. In some implementations, the internal protective layer 5100 may include a welded area 5177 radially outward from the outermost spacer material 5170d. The welded area 5177 may run along the perimeter of the internal protective layer 5100.

[0107] As shown in Figure 37C, in certain examples, each level of the spacer material may be arranged along a ring or an ellipse. In some examples, each level of the spacer material may be arranged along a triangle, square, or rectangle. Each ring of the spacer material may have a large diameter and a small diameter that are advantageous for fluid movement. The large diameter of each ring of the spacer material may be the maximum diameter, and 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 ring of the spacer material.

[0108] In some implementations, the smallest diameter DB1 of the innermost spacer material 5170b is 228 mm. In some implementations, the smallest diameter DB1 of the innermost spacer material 5170b is 200-250 mm. In some implementations, the smallest diameter DB1 of the innermost spacer material 5170b is 100-400 mm. In some implementations, the largeest diameter DB2 of the innermost spacer material 5170b is 271 mm. In some implementations, the largeest diameter DB2 of the innermost spacer material 5170b is 250-300 mm. In some implementations, the largeest diameter DB2 of the innermost spacer material 5170b is 150-450 mm.

[0109] In some implementations, the small diameter DC1 of the intermediate spacer material 5170c is 390 mm. In some implementations, the small diameter DC1 of the intermediate spacer material 5170c is 350-400 mm. In some implementations, the small diameter DC1 of the intermediate spacer material 5170c is 200-550 mm. In some implementations, the large diameter DC2 of the intermediate spacer material 5170c is 463 mm. In some implementations, the large diameter DC2 of the intermediate spacer material 5170c is 450-500 mm. In some implementations, the large diameter DC2 of the intermediate spacer material 5170c is 300-650 mm.

[0110] In some implementations, the small diameter DD1 of the outermost spacer material 5170d is 567 mm. In some implementations, the small diameter DD1 of the outermost spacer material 5170d is 550-600 mm. In some implementations, the small diameter DD1 of the outermost spacer material 5170d is 400-750 mm. In some implementations, the large diameter DD2 of the outermost spacer material 5170d is 683 mm. In some implementations, the large diameter DD2 of the outermost spacer material 5170d is 650-700 mm. In some implementations, the large diameter DD2 of the outermost spacer material 5170d is 500-850 mm.

[0111] 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 of about 1 mm to about 5 mm along dimension Z. In some embodiments, the spacer material 5170 may have a depth of about 0.1 mm to about 10 mm along dimension Z.

[0112] In some examples, the innermost spacer material 5170b may have a curvature. The innermost spacer material 5170b may have a radius at each rounded end. In some implementations, the curvature is about 20 degrees. In some implementations, the curvature is about 10 degrees to about 30 degrees. In some implementations, the curvature is about 0 degrees to about 45 degrees. In some implementations, the radius at the rounded end is about 15 mm. In some implementations, the radius at the rounded end is about 5 mm to about 25 mm. In some implementations, the radius at the rounded end is about 1 mm to about 30 mm.

[0113] In some examples, the intermediate spacer material 5170c may have a curvature. The intermediate spacer material 5170c may have a radius at each rounded end. In some implementations, the curvature is about 32 degrees. In some implementations, the curvature is about 20 degrees to about 40 degrees. In some implementations, the curvature is 0 degrees to about 60 degrees. In some implementations, the radius at the rounded end is about 18 mm. In some implementations, the radius at the rounded end is about 5 mm to about 25 mm. In some implementations, the radius at the rounded end is about 1 mm to about 30 mm.

[0114] In some examples, the outermost spacer material 5170d may have a curvature. The outermost spacer material 5170d may have a radius at each rounded end. In some implementations, the curvature is about 11 degrees. In some implementations, the curvature is about 5 to 20 degrees. In some implementations, the curvature is about 0 to 30 degrees. In some implementations, the radius at the rounded end is about 18 mm. In some implementations, the radius at the rounded end is about 5 mm to 25 mm. In some implementations, the radius at the rounded end is about 1 mm to 30 mm.

[0115] Figure 38 is a top view of an example of pad 2203.

[0116] In some examples, the pad 5203 can be used in a negative pressure wound healing system described in this disclosure with respect to Figures 1A and 1B, for example. In a particular implementation of the negative pressure healing system, the pad 5203 may be placed on the wound contact layer. The pad 5203 may be constructed from a porous material, such as a foam, which is soft, elastic, flexible, and generally conforms to the wound site. Such foams may include, for example, open-cell mesh foams made from polymers. Suitable foams include, for example, foams made of polyurethane, silicone, and polyvinyl alcohol. The pad 5203 is preferably capable of guiding wound exudate and other fluids through the pad when negative pressure is applied to the wound. Some pads 5203 may have pre-formed channels 2384 or openings for such purposes.

[0117] In certain implementations, the pad 5203 may have a thickness of approximately 25 mm. In some implementations, the pad 5203 may have a thickness of approximately 10 mm to approximately 40 mm. In some implementations, the pad 5203 may have a thickness of approximately 5 mm to approximately 60 mm. In some implementations, the pad 5203 may have a thickness of approximately 1 mm to approximately 80 mm.

[0118] In some examples, the pad 5203 may have a length of approximately 400 mm to approximately 450 mm. In some implementations, the pad 5203 may have a length of approximately 350 mm to approximately 500 mm. In some implementations, the pad 5203 may have a length of approximately 300 mm to approximately 600 mm. In some implementations, the pad 5203 may have a length of approximately 100 mm to approximately 1,000 mm.

[0119] In some examples, the pad 5203 may have a width of approximately 525 mm to approximately 275 mm. In some implementations, the pad 5203 may have a length of approximately 200 mm to approximately 300 mm. In some implementations, the pad 5203 may have a length of approximately 100 mm to approximately 400 mm. In some implementations, the pad 5203 may have a length of approximately 50 mm to approximately 800 mm. In other implementations, the thickness, width and / or length may have other preferred values.

[0120] In some examples, the pad 5203 may be eye-shaped. In some implementations, the pad 5203 may be circular or oval-shaped. The pad 5203 may have corners 5280 on both sides. The corners 5280 may be rounded.

[0121] In some examples, the pad 5203 may include a slit or cut 5282. The cut 5282 may provide a flexible area in the pad 5203 and / or allow a portion of the pad 5203 to be easily separated. The cut 5282 may be an arch-shaped perforation formed in an elliptical pattern. The cut 5282 may extend through at least a portion of the thickness of the pad to define a removable pad section from the pad, thereby allowing for adjustment of the pad size. In some implementations, the cut 5282 may allow portions of the porous pad 5203 to be removed in a dimensionally independent manner, such that the length and width of the pad 5203 can be changed independently of each other. The user can remove a portion of the pad 5203 along the cut 5282 so that the pad 5203 fits into the wound site. The pad 5203 preferably has a substantially 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, thereby defining a pad section that is removable from the rest of the pad 5203 to allow for changes in the size (e.g., its length and / or width) of the pad 5203. In certain embodiments, the cut 5282 may consist of arcuate and / or elliptical cuts and may further include additional inner and outer cuts. In further embodiments, additional intermediate cuts may also be present.

[0122] In some examples, the pad 5203 may include outer cuts 5282a around the pad 5203. The outer cuts 5282a may allow the outermost part 5286 of the pad 5203 to be removed. The outer cuts 5282a may be parallel to the corresponding edges of the pad 5203. The outer cuts 5282a may be curved. The outer cuts 5282a may be arranged in an eye-like shape. The pad 5203 may include four outer cuts 5282a. In some implementations, the pad 5203 may include two to six outer cuts 5282a. In some implementations, the pad 5203 may include one to ten outer cuts 5282a.

[0123] In some examples, the pad 5203 may include an inner cut 5282b around the pad 5203. The inner cut 5282b may be radially positioned between the outer cut 5282a and the opening 5284. The inner cut 5282b may allow the outermost 5286 and intermediate portions 5288 of the pad 5203 to be removed. The inner cut 5282b may be parallel to the corresponding edge of the pad 5203. The inner cut 5282b may be curved. The inner cut 5282b may be arranged in an eye-like shape. The pad 5203 may include four inner cuts 5282b. In some implementations, the pad 5203 may include two to six inner cuts 5282b. In some implementations, the pad 5203 may include one to ten inner cuts 5282b.

[0124] In some examples, the pad 5203 may include an opening 5284. The opening 5284 may be used to guide wound exudate and distribute negative pressure through the pad 5203. The opening 5284 may extend completely through the thickness direction of the pad 5203. Each opening 5284 may have a length of about 13 mm to 14 mm along its outer edge. In some implementations, each opening 5284 may have a length of about 10 mm to 20 mm along its outer edge. In some implementations, each opening 5284 may have a length of about 5 mm to 30 mm along its outer edge. Each opening 5284 may have a length of about 5 mm to 6 mm along its inner edge. In some implementations, each opening 5284 may have a length of about 2 mm to 9 mm along its inner edge. In some implementations, each opening 5284 may have a length of approximately 0.5 mm to 20 mm along the inner edge of the opening 5284.

[0125] In some examples, each opening 5284 may be formed as two straight openings forming an acute angle. In some implementations, each opening 5284 may be triangular or arrow-shaped. The openings 5284 may be shaped to reduce tissue pull-up while applying negative pressure. Each opening 5284 may have wider ends as it approaches the center of the pad 5203 along the X-axis. Each opening 5284 may have a point further away from the center of the pad 5203 along the X-axis. The pad 5203 may have 88 openings 5284. In some implementations, the pad 5203 may have 50 to 100 openings 5284. In some implementations, the pad 5203 may have 25 to 125 openings 5284. In some implementations, the pad 5203 may have 10 to 150 openings 5284. Each opening 5284 can be directed toward the center of the pad 5203.

[0126] In some examples, 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. A column of openings 5284 toward the center along the X-axis may contain more openings 5284 than a column of openings 5284 at the ends further away from the center. The number of openings 5284 in each column may gradually decrease in each column as you move away from the center along the X-axis.

[0127] Figure 39A is a side view of an example of the suction adapter 5313. Figure 39B is a top view of the example of the suction adapter 5313 in Figure 39A. Figure 39C is a rear view of the example of the suction adapter 5313 in Figure 39A. Figure 39D is a front view of the example of the suction adapter 5313 in Figure 39A. Figure 39E is a bottom view of the example of the suction adapter 5313 in Figure 39A. Figure 39F is a cross-sectional view of the example of the suction adapter 5313 in Figure 39A, taken along a line parallel to the X-axis shown in Figure 39B.

[0128] In some examples, the suction adapter 5313 may be used as a port, as described with respect to Figures 1A and 1B. The suction adapter 5313 may be a rigid or stiff port. The suction adapter 5313 may be an applicator or fluid connector for negative pressure to the wound site.

[0129] In some examples, 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 over the wound site to allow negative pressure therapy. In some examples, the base flange 5390 may be positioned over a hole in the drape. Negative pressure may be applied to the dressing, pad, and / or wound site through the suction channel 5393, which may cause air to flow to the dressing, pad, and / or wound site through the air leak channel 5397.

[0130] In certain examples, the suction adapter 5313 may include a protruding portion 5399 or shroud. The protruding portion 5399 may include a suction port 5392. The protruding portion 5399 may be located above the base flange 5390. The protruding portion 5399 may prevent a user's finger from obstructing the flow through the suction adapter 5313. The shape of the suction adapter 5313 may be sloped upward from the protruding portion 5399 to the air leak port 5396.

[0131] In some examples, the protruding portion 5399 may be about 5 mm in length. In some implementations, the protruding portion 5399 may be about 2 mm to about 8 mm in length. In some implementations, the protruding portion 5399 may be about 1 mm to about 10 mm in length. In some implementations, the protruding portion 5399 may be about 0.1 mm to about 20 mm in length. The length of the protruding portion 5399 may be increased to increase the depth of the suction channel 5393. Advantageously, a deeper suction channel 5393 can engage with the conduit along a longer length.

[0132] As shown in Figure 39E, the suction adapter 5313 may have at least one suction opening 5394 designed to be positioned over the wound site and capable of functioning to fluidly connect the wound site to a negative pressure source. The suction adapter 5313 may also have at least one air leak opening 5398 designed to be positioned over the wound site, which can function as an air leak and conduit to draw air into the wound site.

[0133] In some examples, the suction channel 5393 may have a suction opening 5394 fluidly connected to a suction port 5392. The suction adapter 5313 may 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 may be positioned such that the suction opening 5394 is located above the opening of the drape. The suction opening 5394 may be D-shaped or at least partially semicircular. In some examples, the suction opening 5394 may be rectangular with two rounded corners.

[0134] In some examples, an air leak channel 5397, or air bleed channel, may fluidly connect the air leak opening 5398 to the air leak port 5396. The suction adapter 5313 may be positioned so that the air leak opening 5398 is located above the opening of the drape. Air can flow through the air leak port 5396, through the air leak channel 5397, and into the air leak opening 5398. The air from the air leak opening 5398 can aerate the wound site and then flow through the suction opening 5394.

[0135] In some examples, 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 implementations, the air leak port 5396 may be approximately 1.5 to 3 times the size of the suction port 5392. In some implementations, the air leak port 5396 may be approximately 1.25 to 5 times the size of the suction port 5392.

[0136] In some examples, the air leak port 5396 may have an inner diameter of approximately 52 mm. In some implementations, the air leak port 5396 may have an inner diameter of approximately 40 mm to approximately 60 mm. In some implementations, the air leak port 5396 may have an inner diameter of approximately 20 mm to approximately 80 mm. In some implementations, the air leak port 5396 may have an inner diameter of approximately 10 mm to approximately 100 mm.

[0137] In some examples, the suction port 5392 may have an inner diameter of approximately 25 mm. In some implementations, the suction port 5392 may have an inner diameter of approximately 15 mm to approximately 35 mm. In some implementations, the suction port 5392 may have an inner diameter of approximately 5 mm to approximately 50 mm. In some implementations, the suction port 5392 may have an inner diameter of approximately 1 mm to approximately 75 mm.

[0138] In some examples, 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 examples, the filter may be heat-welded to the suction adapter 5313. The filter can filter particles from the air as it enters the suction adapter 5313. This filter arrangement can improve the safety and effectiveness of negative pressure wound therapy by preventing certain particles from entering the wound site.

[0139] In some cases, the negative pressure source may be a vacuum source. By creating a vacuum from the suction opening 5394 to the wound site, wound exudate may flow through the suction adapter 5313.

[0140] As shown in Figure 39F, the suction adapter 5313 may have an inner wall 5391 that separates the suction channel 5393 from the air leak channel 5397. The inner wall 5391 can prevent wound exudate from entering the air leak 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. The presence of flow in the suction channel 5393 or the suction port 5392 indicates proper fluid communication with the wound site because the air leak channel 5397 is separated from the suction channel 5393 by the inner wall 5391. Therefore, if the suction opening 5394 is blocked, for example by a drape, the flow through the suction channel 5393 will be blocked. Conversely, since air still flows from the air leak channel 5397 to the suction channel 5393, when the suction opening 5394 is blocked due to the absence of the inner wall 5391, the other suction adapters still flow through the suction channel 5393. Fluid communication with the wound site may include fluid communication with a foam pad in contact with the wound site.

[0141] In some examples, the suction adapter 5313 may be used to detect whether a negative pressure system is connected to the foam pad. If there is an obstruction in the suction adapter 5313 or the negative pressure system, or if the suction adapter 5313 is not positioned over the drape opening, the suction opening 5394 will not drain wound exudate. In this example, the user may determine that the absence of wound exudate indicates an obstruction or improper positioning of the suction adapter 5313.

[0142] In some examples, the suction adapter 5313 may be made of molded plastic. The suction adapter 5313 may be rigid enough to prevent it from folding. For example, the suction adapter 5313 can withstand approximately 250 mmHg. In some implementations, the suction adapter 5313 can withstand approximately 200 mmHg to approximately 300 mmHg. In some implementations, the suction adapter 5313 can withstand approximately 100 mmHg to approximately 500 mmHg.

[0143] In certain examples, the suction adapter 5313 may include a recess 5387 for user handling. For example, the recess 5387 may be sized to accommodate the user's finger. The user can grasp the recess 5387 with their finger to move and / or position the suction adapter 5313.

[0144] Figures 40, 41, 42, 43, 44, 45, 46, 47, and 48 show examples of internal protective layers having spacer material positioned between film layers. Any of the features in Figures 40, 41, 42, 43, 44, 45, 46, 47, and 48 may be combined with other embodiments / examples described herein.

[0145] Figure 40 shows an example of an internal protective layer 5400 having a spacer material 5470.

[0146] The internal protective layer 5400 may include any of the features of the internal protective layer 5100 shown in Figures 37A, 37B, and 37C. The internal protective layer 5400 may have a welded area 5476 separating the area of ​​the internal protective layer 5400. The internal protective layer 5400 may include a film layer 5472 having a spacer material 5470 positioned between the layers. The spacer material 5470 may be elliptical, for example, circular or oval. The internal protective layer 5400 may include an outermost ring, an intermediate ring, and a central portion of the spacer material. In some examples, the central portion of the spacer material may be formed as a ring, for example, a circle or ellipse with a space in the center.

[0147] In some examples, the internal protective layer 5400 may contain eight portions of spacer material within the outermost ring. The internal protective layer 5400 may contain four to twelve portions of spacer material within the outermost ring. The internal protective layer 5400 may contain two to fifteen portions of spacer material within the outermost ring.

[0148] In some examples, the internal protective layer 5400 may contain eight parts of spacer material within the intermediate ring. The internal protective layer 5400 may contain four to twelve parts of spacer material within the intermediate ring. The internal protective layer 5400 may contain two to fifteen parts of spacer material within the intermediate ring.

[0149] Figure 41 shows an example of an internal protective layer 5500 having a spacer material 5570.

[0150] The internal protective layer 5500 may include any of the features of the internal protective layer 5100 shown in Figures 37A, 37B, and 37C. The internal protective layer 5500 may include a film layer 5572 having a spacer material 5570 disposed between the layers. The spacer material 5570 may be elliptical, for example, circular or egg-shaped. The spacer material 5570 may be arranged in a cross shape or asterisk shape. The spacer material 5570 may include one central portion, multiple portions aligned vertically above and below the central portion, multiple portions aligned horizontally on both sides of the central portion, and / or multiple portions arranged diagonally from the central portion.

[0151] In some examples, the spacer material 5570 may include three parts aligned vertically above the central portion and three parts aligned vertically below the central portion. The spacer material 5570 may include one to five parts aligned vertically above the central portion and one to five parts aligned vertically below the central portion. In some examples, the spacer material 5570 may include three parts aligned horizontally on one side and three parts aligned horizontally on the other side of the central portion. The spacer material 5570 may include one to five parts aligned horizontally on one side of the central portion and one to five parts aligned horizontally on the other side. In some examples, the spacer material 5570 may include two parts aligned diagonally in each of the four directions from the central portion. The spacer material 5570 may include one to five parts aligned diagonally in each of the four directions from the central portion.

[0152] Figure 42 shows an example of an internal protective layer 5600 having a spacer material 5670.

[0153] The internal protective layer 5600 may include any of the features of the internal protective layer 5100 shown in Figures 37A, 37B, and 37C. The internal protective layer 5600 may include spacer material 5670 placed between film layers 5672. In some examples, the internal protective layer 5600 may include 21 portions of spacer material 5670. The internal protective layer 5600 may include 10 to 30 portions of spacer material 5670. The internal protective layer 5600 may include 5 to 40 portions of spacer material 5670.

[0154] Figure 43 shows an example of an internal protective layer 5700 having a spacer material 5770.

[0155] In some examples, the internal protective layer 5700 may include any of the features of the internal protective layer 5100 shown in Figures 37A, 37B, and 37C. The internal protective layer 5700 may include spacer material 5770 placed between film layers 5772. In some examples, the internal protective layer 5700 may include 25 portions of spacer material 5770. The internal protective layer 5700 may include 10 to 30 portions of spacer material 5770. The internal protective layer 5700 may include 5 to 40 portions of spacer material 5770.

[0156] In some examples, the internal protective layer 5700 may include three rings of spacer material 5770 and one central portion of spacer material 5770. The internal protective layer 5700 may include one to five rings of spacer material 5770 and one central portion of spacer material 5770. The film layer 5772 around each ring of spacer material 5770 may include a welded area 5776. In some examples, each ring of spacer material 5770 may include eight portions of spacer material 5770. Each ring of spacer material 5770 may include five to ten portions of spacer material 5770. Each ring of spacer material 5770 may include two to fifteen portions of spacer material 5770. The spacer material 5770 within a ring may be oval-shaped. The central spacer material 5770 may be oval-shaped. The spacer material 5770 within a ring may be narrower than the central spacer material 5770.

[0157] Figure 44 shows an example of an internal protective layer 5800 having a spacer material 5870.

[0158] In some examples, the internal protective layer 5800 may include any of the features of the internal protective layer 5100 shown in Figures 37A, 37B, and 37C. The internal protective layer 5800 may include spacer material 5870 placed between film layers 5872. In some examples, the internal protective layer 5800 may include 25 portions of spacer material 5870. The internal protective layer 5800 may include 10 to 30 portions of spacer material 5870. The internal protective layer 5800 may include 5 to 40 portions of spacer material 5870.

[0159] In some examples, the internal protective layer 5800 may include three rings of spacer material 5870 and one central portion of spacer material 5870. The internal protective layer 5800 may include one to five rings of spacer material 5870 and one central portion of spacer material 5870. The film layer 5872 around each ring of spacer material 5870 may include a welded area 5876. In some examples, each ring of spacer material 5870 may include eight portions of spacer material 5870. Each ring of spacer material 5870 may include five to ten portions of spacer material 5870. Each ring of spacer material 5870 may include two to fifteen portions of spacer material 5870. The spacer material 5870 within the ring may be curved, pill-shaped, and / or stadium-shaped. The central spacer material 5870 may be oval-shaped.

[0160] Figure 45 shows an example of an internal protective layer 5900 having a spacer material 5970.

[0161] In some examples, the internal protective layer 5900 may include any of the features of the internal protective layer 5100 shown in Figures 37A, 37B, and 37C. The internal protective layer 5900 may include spacer material 5970 placed between film layers 5972. In some examples, the internal protective layer 5900 may include 32 portions of spacer material 5970. The internal protective layer 5900 may include 25 to 50 portions of spacer material 5970. The internal protective layer 5900 may include 10 to 80 portions of spacer material 5970.

[0162] In some examples, the internal protective layer 5900 may include four rings of the spacer material 5970 and one central portion of the spacer material 5970. The internal protective layer 5900 may include 1 to 10 rings of the spacer material 5970 and one central portion of the spacer material 5970. In some examples, the film layer 5972 between the second outermost ring and the third outermost ring of the spacer material 5970 may be separated by a welded area 5976. In some examples, the film layer 5972 between the central spacer material 5970 and the innermost ring of the spacer material 5970 may be separated by a welded area 5976. In some examples, each ring of the spacer material 5970 may include eight portions of the spacer material 5970. Each ring of the spacer material 5970 may include 5 to 10 portions of the spacer material 5970. Each ring of the spacer material 5970 may include 2 to 15 portions of the spacer material 5970. The spacer material 5970 inside the ring may be circular. The central spacer material 5970 may be ring-shaped, for example, circular or oval with a space in the center.

[0163] Figure 46 shows an example of an internal protective layer 6000 having a spacer material 6070.

[0164] In some examples, the internal protective layer 6000 may include any of the features of the internal protective layer 5100 shown in Figures 37A, 37B, and 37C. The internal protective layer 6000 may include a spacer material 6070 placed between the film layers 6072. In some examples, the internal protective layer 6000 may include six parts of the spacer material 6070. The internal protective layer 6000 may include three to ten parts of the spacer material 6070. The internal protective layer 6000 may include one to fifteen parts of the spacer material 6070.

[0165] In some examples, the internal protective layer 6000 may include two rings of the spacer material 6070 and one central portion of the spacer material 6070. The internal protective layer 6000 may include 1 to 10 rings of the spacer material 6070 and one central portion of the spacer material 6070. In some examples, the outermost ring of the spacer material 6070 may include four portions of the spacer material 6070. The outermost ring of the spacer material 6070 may include 1 to 8 portions of the spacer material 6070. The outermost ring of the spacer material 6070 may be formed as a curved rectangle, semicircle, or semiellipse having an oval space therein. In some examples, each curved rectangle of the spacer material 6070 may include two oval spaces. Each curved rectangle of the spacer material 6070 may include 1 to 5 oval spaces. In some examples, the second outermost ring of the spacer material 6070 may include one portion of the spacer material 6070. The second outermost ring of the spacer material 6070 may include 1 to 5 parts of the spacer material 6070. The second outermost ring of the spacer material 6070 may be formed as a circle or ellipse having an egg-shaped space within the ring. In some examples, the second outermost ring of the spacer material 6070 may include 8 egg-shaped spaces. The second outermost ring of the spacer material 6070 may include 5 to 10 egg-shaped spaces. The central spacer material 6070 may be ring-shaped, for example, circular or egg-shaped with a space in the center.

[0166] Figure 47 shows an example of an internal protective layer 6100 having a spacer material 6170.

[0167] In some examples, the internal protective layer 6100 may include any of the features of the internal protective layer 5100 shown in Figures 37A, 37B, and 37C. The internal protective layer 6100 may include spacer material 6170 placed between film layers 6172. In some examples, the internal protective layer 6100 may include 17 portions of spacer material 6170. The internal protective layer 6100 may include 10 to 20 portions of spacer material 6170. The internal protective layer 6100 may include 5 to 30 portions of spacer material 6170.

[0168] In some examples, the internal protective layer 6100 may include two rings of the spacer material 6170 and one central portion of the spacer material 6170. The internal protective layer 6100 may include 1 to 10 rings of the spacer material 6170 and one central portion of the spacer material 6170. In some examples, the outermost ring of the spacer material 6170 may include four portions of the spacer material 6170. The outermost ring 6170 of the spacer material may include 1 to 8 portions of the spacer material 6170. The outermost ring 6170 of the spacer material may be formed as a curved rectangle, semicircle, or semiellipse having circular spaces within it. In some examples, each curved rectangle of the spacer material 6170 may include three circular spaces. Each curved rectangle of the spacer material 6170 may include 1 to 5 circular spaces. In some examples, the second outermost ring of the spacer material 6170 may include 12 portions of the spacer material 6170. The second outermost ring 6170 of the spacer material may include 5 to 15 parts of the spacer material 6170. The second outermost ring 6170 of the spacer material may include circular parts of the spacer material 6170. The central spacer material 6170 may be ring-shaped, for example, circular or oval with a space in the center.

[0169] Figure 48 shows an example of an internal protective layer 6200 having a spacer material 6270.

[0170] In some examples, the internal protective layer 6200 may include any of the features of the internal protective layer 5100 shown in Figures 37A, 37B, and 37C. The internal protective layer 6200 may include spacer material 6270 placed between film layers 6272. In some examples, the internal protective layer 6200 may include 24 portions of spacer material 6270. The internal protective layer 6200 may include 20 to 30 portions of spacer material 6270. The internal protective layer 6200 may include 15 to 40 portions of spacer material 6270.

[0171] In some examples, the internal protective layer 6200 may include the outer ring and the central portion of the spacer material 6270. The internal protective layer 6200 may include 1 to 10 rings of the spacer material 6270. In some examples, the rings of the spacer material 6270 may include 16 portions of the spacer material 6270. The outermost ring of the spacer material 6270 may include 10 to 20 portions of the spacer material 6270. The rings of the spacer material 6270 may be formed as curved rectangles or trapezoids. In some examples, the central spacer material 6270 may include 8 portions of the spacer material 6270. The central spacer material 6270 may include 5 to 15 portions of the spacer material 6270. The central spacer material 6270 may include triangular portions of the spacer material 6270. The central spacer material 6270 may consist of a rectangle aligned with the center of the film layer 6200.

[0172] Embodiment Certain additional, non-limiting embodiments encompassed herein are provided below.

[0173] Embodiment 1. A method for positioning an internal organ protective layer on a wound site, the method comprising: providing an internal organ protective layer including a spacer material portion on the center of the internal organ protective layer; and positioning the internal organ protective layer on the wound site such that the spacer material portion is aligned with the center of the wound site.

[0174] Embodiment 2. A method for applying negative pressure wound therapy, the method comprising: positioning a foam pad on a wound site; positioning a suction adapter on the foam pad, the suction adapter having a suction opening, a suction port that fluidly communicates with the suction opening through a suction channel, a leak opening, and a leak port that fluidly communicates with the leak opening through a leak channel, wherein the suction channel and the leak channel are separated by an inner wall; positioning a conduit for negative pressure within the suction port of the suction adapter; and detecting the flow through the suction port to determine whether the suction adapter is in fluid communication with the foam pad.

[0175] Embodiment 3. The method according to Embodiment 2, further comprising delivering negative pressure from a negative pressure source through a conduit.

[0176] Embodiment 4. A method for cleaning a wound site, the method comprising: placing an internal protective layer, including a delivery tube that communicates with the wound site, on the wound site; connecting the intake branch of a connector to a fluid source; connecting the delivery branch of a connector to a delivery tube; connecting the output branch of a connector to a canister; and enabling a fluid to pass from the fluid source to the intake branch of the connector, the delivery branch of the connector, the delivery tube, the wound site, the delivery branch of the connector, the output branch of the connector, and the canister.

[0177] Embodiment 5. The method according to Embodiment 4, further comprising connecting a manifold to a delivery pipe and a delivery branch, wherein the manifold is configured to distribute fluid to and from the delivery pipe.

[0178] Embodiment 6. The method according to either Embodiment 4 or 5, wherein the delivery tube is positioned between layers of spacer material.

[0179] Embodiment 7. The method according to any one of Embodiments 4 to 6, wherein the intake branch, delivery branch, and output branch of the connector are connected at the junction.

[0180] Embodiment 8. The method according to any one of Embodiments 4 to 7, wherein the connector is a Y-connector.

[0181] Embodiment 9. The method according to any one of Embodiments 4 to 8, wherein the connector and delivery tube are configured to remove fluid from the wound site.

[0182] Embodiment 10. The method according to any one of Embodiments 4 to 9, wherein the connector and delivery tube are configured to deliver fluid to the wound site.

[0183] Embodiment 11. The method according to any one of Embodiments 4 to 10, wherein the connector and delivery tube are configured to simultaneously deliver fluid to the wound site and remove fluid from the wound site.

[0184] Embodiment 12. The method according to any one of Embodiments 4 to 11, wherein the connector further comprises a switch, the switch enabling a user to control the flow of fluid within the connector.

[0185] Embodiment 13. The method according to Embodiment 12, wherein the switch allows the user to restrict intake or output branching.

[0186] Embodiment 14. The method according to Embodiment 12, wherein the switch is integrated with the connector.

[0187] Embodiment 15. The method according to any one of Embodiments 4 to 14, wherein the internal organ protective layer is transparent.

[0188] Embodiment 16. The method according to any one of Embodiments 4 to 15, wherein the connector is transparent.

[0189] Embodiment 17. The method according to any one of Embodiments 4 to 16, wherein the delivery tube is transparent.

[0190] Embodiment 18. The method according to Embodiment 5, wherein the manifold is transparent.

[0191] Embodiment 19. The method according to Embodiment 5, wherein the manifold has vents configured to allow fluid to be discharged from the manifold.

[0192] Embodiment 20. The method according to Embodiment 5, wherein the manifold comprises an inner wall that separates the inner cavity of the manifold.

[0193] Embodiment 21. The method according to Embodiment 20, wherein the inner wall separates the inner cavity into a delivery portion and a removal portion.

[0194] Embodiment 22. The method according to any one of Embodiments 4 to 21, wherein the delivery tube is circular.

[0195] Embodiment 23. The method according to any one of Embodiments 4 to 22, wherein the delivery tube is flat or oblong.

[0196] Embodiment 24. The method according to any one of Embodiments 4 to 23, wherein the delivery tube includes teeth inside the delivery tube.

[0197] Embodiment 25. The method according to Embodiment 24, wherein the delivery tube includes upper teeth and lower teeth inside the delivery tube.

[0198] Embodiment 26. The method according to Embodiment 5, wherein the manifold is made of one of polyurethane, silicone, foam, rubber, and polyisoprene.

[0199] Embodiment 27. The method according to Embodiment 6, wherein the spacer material is made of one of the following: foam, 3D fabric, silver, or a material having antimicrobial properties.

[0200] Embodiment 28. The method according to Embodiment 5, wherein the manifold is one of the following: octagonal, disc-shaped, flower-shaped, rectangular, curved, circular, or oval-shaped.

[0201] The foregoing description represents specific configurations, aspects, and advantages of the present invention, which can be modified in various ways without departing from the spirit and scope of the invention. Furthermore, the negative pressure therapy systems disclosed herein do not necessarily have to feature all of the above-mentioned objects, advantages, configurations, and aspects. Those skilled in the art will recognize that it is not necessary to achieve other objects or advantages as may be taught or suggested herein, and that the present invention can be embodied or performed in a manner that achieves or optimizes one or more advantages as taught herein. For example, in some embodiments, the pad 103 can be used without the visceral protective layer 105 and / or the drape 107. Advantageously, the systems and methods described herein can operate without the drape 107. Since the systems herein can deliver fluid to the wound site, there is no need to obstruct the wound by requiring an incision in the drape 107 to insert an additional connector. In addition, while numerous variations of the present invention have been shown and described in detail, other modifications and uses that fall within the scope of the invention will be readily apparent to those skilled in the art based on this disclosure. It is expected that various combinations or subcombinations of these particular features and embodiments will be created and further fall within the scope of the invention. Therefore, it should be understood that the various configurations and aspects of the disclosed embodiments can be combined or substituted for each other to form various modes of the negative pressure therapy system considered.

[0202] While this disclosure describes a particular embodiment, those skilled in the art will understand that many aspects of the methods and devices shown and described herein can be combined and / or modified in different ways to form yet another embodiment or acceptable example. All such modifications and variations are intended to be included herein within the scope of this disclosure. Indeed, a wide range of designs and techniques are feasible and they fall within the scope of this disclosure. The configurations, structures, or processes disclosed herein are essential or indispensable. Furthermore, while exemplary embodiments are described herein, the scope of any and all embodiments having equivalents, modifications, omissions, combinations (e.g., aspects across various embodiments), substitutions, applications, and / or changes will be understood by those skilled in the art based on this disclosure. While specific embodiments have been described, these embodiments are presented merely as examples and are not intended to limit the scope of protection.

[0203] Any properties, substances, features, or groups described in relation to a particular aspect, embodiment, or example should be understood to be applicable to any other aspect, embodiment, or example described in this section or other parts of this specification, insofar as they are not incompatible. All features disclosed herein (including any claims, abstract, and drawings) and / or all steps of any method or process disclosed herein may be combined in any combination, except for any combination in which at least some of such features and / or steps are mutually exclusive. The subject matter of protection is not limited to the details of any embodiment described herein. The subject matter of protection extends to any novel features or any novel combination of features disclosed herein (including any appended claims, abstract, and drawings), or to any novel steps or any novel combination of any method or process disclosed herein.

[0204] Furthermore, certain features described herein in the context of individual embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented separately or in any suitable subcombination in multiple embodiments. Furthermore, configurations acting on a particular combination may be described above, but in some cases, one or more configurations from a combination that may be claimed may be decoupled from the combination, and the combination may be claimed as a subcombination or a variation of a subcombination.

[0205] Furthermore, while operations may be shown in the drawings or described herein in a specific order, such operations do not necessarily have to be performed in a specific or sequential order shown, or not all operations need to be performed, in order to achieve the desired result. Other operations not shown or described may be incorporated into exemplary methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Furthermore, operations may be reconfigured or rearranged in other implementations. Those skilled in the art will recognize that in some embodiments, the actual steps performed in the illustrated and / or disclosed processes may differ from the steps shown in the drawings. In some embodiments, certain steps from the steps described above may be omitted, or others may be added. Furthermore, the features and attributes of certain embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of this disclosure. Also, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described components and systems may generally be integrated into a single product or packaged in multiple products.

[0206] For the purposes of this disclosure, specific aspects, advantages, and novel configurations are described herein. Not all such advantages can necessarily be achieved according to any particular embodiment. Therefore, for example, a person skilled in the art will recognize that this disclosure can be embodied or implemented in a manner that achieves one or a group of advantages as taught herein, without necessarily achieving other advantages as may be taught or suggested herein.

[0207] Conditional phrases such as “can,” “could,” “might,” or “may” are typically intended to convey that a particular embodiment includes certain features, elements, and / or processes, while other embodiments do not, unless otherwise specifically stated or interpreted within the context in which they are used. Therefore, such conditional phrases are not necessarily intended to suggest that features, elements, and / or processes are required to some extent in one or more embodiments, or that logic for determining, with or without user input or instruction, whether these features, elements, and / or processes are included in or should be implemented in any particular embodiment is necessarily included in one or more embodiments.

[0208] Conjunctional phrases such as "at least one of X, Y, and Z" are to be interpreted separately, in the context generally used to indicate that an item, term, etc., may be configured as either X, Y, or Z, unless otherwise specifically stated. Therefore, such conjunctional phrases are not typically intended to suggest that a particular embodiment must include at least one of X, at least one of Y, and at least one of Z.

[0209] As used herein, terms expressing degree, such as “approximately,” “about,” “generally,” and “substantially,” when used herein, represent values, quantities, or characteristics that still approximate the stated values, quantities, or characteristics that perform the desired function or produce the desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may refer to quantities that are less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated quantity. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” mean values, quantities, or characteristics that are 15 degrees or less, 10 degrees or less, 5 degrees or less, 3 degrees or less, 1 degree or less, 0.1 degrees or less, or otherwise deviate from a state of being exactly parallel.

[0210] The scope of this disclosure is not intended to be limited by any specific disclosure of preferred embodiments in this section or elsewhere in this specification, but may be defined by the claims presented in this section or elsewhere in this specification, or presented hereafter. The language of these claims should be interpreted broadly based on the language used in these claims, and should not be limited to the examples described herein or during the proceedings of this application, and such examples should be interpreted non-exclusively.

Claims

1. A protective layer for internal organs that comes into contact with the wound site, The first film layer, The second film layer, A central spacer material portion is disposed between the first film layer and the second film layer, An internal protective layer comprising a plurality of spacer material portions disposed between the first film layer and the second film layer, wherein the plurality of spacer material portions are positioned radially outward from the central spacer material portion.

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

3. The internal protective layer according to any one of claims 1 or 2, wherein the central spacer material portion has a central opening, and the central opening is circular or oval in shape.

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

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

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

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

8. The internal protective layer according to claim 7, wherein the plurality of spacer material portions include openings.

9. A protective layer for internal organs that comes into contact with the wound site, An internal protective layer comprising a plurality of curved spacer material portions radially positioned around the internal protective layer, wherein the plurality of curved spacer material portions are configured to transport fluid across the internal protective layer.

10. The internal protective layer according to claim 9, further comprising an upper film layer and a bottom film layer arranged around the plurality of curved spacer materials.

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

12. A protective layer for internal organs that comes into contact with the wound site, The upper film layer, The bottom film layer, A spacer material positioned between the upper film layer and the bottom film layer, The central spacer material section, Multiple innermost curved spacer material portions are positioned radially around the central spacer material portion, A plurality of intermediate curved spacer material portions are radially positioned around the plurality of innermost curved spacer material portions, A spacer material comprising: a plurality of outermost curved spacer material portions radially positioned around the plurality of intermediate curved spacer material portions; An internal protective layer in which the upper film layer and the bottom film layer are welded together along the perimeter of the internal protective layer.

13. The internal protective layer according to claim 12, wherein the central spacer material portion is circular or oval-shaped.

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

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

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

17. The internal organ protection layer according to any one of claims 12 to 16, wherein the internal organ protection layer is configured to be cut along the welded portion in order to reduce the size of the internal organ protection layer.

18. A suction adapter for negative pressure wound therapy, A suction opening is configured to be positioned to communicate with the wound site and fluid, A suction port that communicates fluid with the suction opening through a suction channel, and is configured to receive a conduit for negative pressure, A leak opening is configured to be positioned in fluid communication with the wound site, It comprises a leak port that communicates fluid with the leak opening through a leak channel, A suction adapter in which the suction channel and the leak channel are separated by an inner wall.

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

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

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

22. The suction adapter according to claim 21, further comprising a protruding portion on the base flange, wherein the suction port is located on the protruding portion.

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

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

25. The suction adapter according to any one of claims 18 to 24, wherein the suction adapter can withstand a force of approximately 250 mmHg.

26. A wound healing system, A visceral protective layer suitable for contact with the wound site, configured to guide wound exudate and distribute negative pressure, A pad suitable for transmitting negative pressure to the wound site, A plurality of arc-shaped cuts extending through at least a portion of the thickness of the pad, defining a pad section detachable from the pad, thereby enabling size adjustment of the pad, A pad comprising a plurality of openings configured to allow negative pressure to reach the wound site, wherein the plurality of openings are located radially from the plurality of cut portions, Negative pressure supply source and A wound healing system comprising a conduit configured to transmit negative pressure from the supply source to the pad.

27. The system according to claim 26, wherein each of the plurality of openings in the pad comprises two straight openings that form an acute angle.

28. The system according to claim 26 or 27, wherein the plurality of openings are shaped to reduce tissue pull-up while negative pressure is applied.

29. A protective layer for internal organs that comes into contact with the wound site, One or more film layers, The film layer comprises a plurality of slits within one or more film layers, Each of the aforementioned multiple slits is positioned at an angle of approximately 30 to 60 degrees from the horizontal axis. Each of the aforementioned multiple slits is positioned at an angle of approximately 30 to 60 degrees from the vertical axis. Each of the aforementioned multiple slits is oriented in the opposite direction to the slits within the horizontally adjacent quadrant. An internal protective layer in which each of the aforementioned multiple slits is oriented in the opposite direction to the slit in a horizontally adjacent quadrant.

30. A wound healing system, An internal protective layer suitable for contact with a wound site, comprising an internal protective layer including a plurality of delivery tubes that are in fluid communication with the wound site, It is a connector, A fluid source and an intake branch that communicates with the fluid, A delivery branch that is in fluid communication with the aforementioned delivery pipe, It includes a connector with an output branch that communicates with a canister and fluid, A wound treatment system in which the intake branch, delivery branch, and output branch of the connector are in fluid communication.

31. The system according to claim 30, further comprising a manifold connected to the delivery pipe and the delivery branch, wherein the manifold is configured to distribute fluid to the delivery pipe and receive fluid from the delivery pipe.

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

33. The system according to any one of claims 30 to 32, wherein the intake branch, the delivery branch, and the output branch of the connector are connected at a junction.

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

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

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

39. The system according to claim 38, wherein the switch allows the user to restrict the intake branch or the output branch.

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

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

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

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

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

45. The system according to claim 31, wherein the manifold comprises vents configured to allow fluid to be discharged from the manifold.

46. The system according to claim 31, wherein the manifold comprises an inner wall that separates the inner cavity of the manifold.

47. The system according to claim 46, wherein the inner wall separates the inner cavity into a delivery portion and a removal portion.

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

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

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

51. The system according to claim 50, wherein the delivery tube is provided with upper teeth and lower teeth inside the delivery tube.

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

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

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

55. A system for providing internal compression to the wound site, It is a wound filling material, A closed layer configured to contact the patient's fascia, A rim extending from the closed layer, configured to be positioned beneath the fascia, A wound filling material comprising a slit in the closed layer, A system wherein the wound filling material is configured to apply internal tension to the fascia when negative pressure is applied to the wound filling material.

56. The system according to claim 55, wherein the closed layer comprises a plurality of slits.

57. The system according to claim 56, wherein the closed layer comprises three slits.

58. The system according to claim 57, wherein the three slits comprise one large slit and two small slits.

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

60. The system according to any one of claims 55 to 59, wherein the slit is an egg-shaped hole.

61. The system according to any one of claims 55 to 60, wherein the rim is provided with a plurality of slits, and each slit is configured to adhere to the fascia.

62. The system according to any one of claims 55 to 61, wherein the rim is integrated with the closing layer.

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

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

65. The system according to claim 64, wherein the spacer material is sandwiched between the upper foam layer and the bottom foam layer.

66. The system according to any one of claims 55 to 65, wherein the wound filling material includes a foam.

67. The system according to any one of claims 55 to 66, further comprising a wound contact layer configured to be positioned on the wound filling material.

68. The system according to any one of claims 55 to 67, further comprising an internal organ protection layer configured to be positioned beneath the wound filling material.

69. The system according to claim 68, wherein the internal protective layer is configured to be cut by the user to fit the size of the internal protective layer.

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

71. The system according to claim 70, wherein the spacer material can be positioned so that the fluid is guided from the edge of the internal protective layer to the central portion of the internal protective layer.

72. The system according to any one of claims 55 to 71, wherein the rim is perforated so as to remove the entire rim or a portion of the rim.

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

74. A pad for transmitting negative pressure to the wound site, A plurality of arc-shaped cuts extending through at least a portion of the thickness of the pad, defining a pad section detachable from the pad, thereby enabling size adjustment of the pad, A plurality of openings configured to allow negative pressure to reach the wound site, wherein the plurality of openings are radially adjacent to the plurality of cuts, each of the plurality of openings is formed as two lines forming an acute angle, and the plurality of openings are shaped to reduce tissue pull-up while negative pressure is applied, The aforementioned pad is shaped like an eye.

75. Apparatus as substantially illustrated and / or described.

76. A method that is substantially illustrated and / or described.

77. A system that is substantially illustrated and / or described.

Images