WOUND TREATMENT SYSTEMS, DEVICES, AND METHODS
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to Great Britain Provisional Application No. 2313507.2, filed September 5, 2023, and titled MEDIAL COMPRESSION and Great Britain Provisional Application 2313509.8, filed September 5, 2023, and titled ABDOMINAL WOUND TREATMENT. Each of the aforementioned applications is incorporated by reference herein in its entirety. The contents of the following applications and/or issued patents are hereby incorporated by reference in their entireties as if fully set forth herein: U.S. Patent Application No. US8791315, filed on September 20, 2010, entitled “SYSTEMS AND METHODS FOR USING NEGATIVE PRESSURE WOUND THERAPY TO MANAGE OPEN ABDOMINAL WOUNDS” and U.S. Pat. No. 8791315, “SYSTEMS AND METHODS FOR USING NEGATIVE PRESSURE WOUND THERAPY TO MANAGE OPEN ABDOMINAL WOUNDS,” issued July 29, 2014. Additional applications referenced herein this application are also hereby incorporated by reference in their entireties as if fully set forth herein.
BACKGROUND
Field of Use
[0002] Embodiments of the present invention relate generally to wound treatment systems, devices and methods, such as for cleaning and filling wounds for the treatment of wounds using negative pressure wound therapy, and more specifically to an improved apparatus and method thereof to manage open abdominal wounds.
Description of Related Art
[0003] The treatment of open or chronic wounds by means of applying negative pressure to the site of the wound, where the wounds are too large to spontaneously close or otherwise fail to heal is well known in the art. Negative pressure wound treatment systems currently known in the art commonly involve placing a cover that is impermeable to liquids over the wound, using various mechanisms to seal the cover to the tissue of the patient surrounding the wound, and connecting a source of negative pressure (such as a vacuum pump) to the cover whereby an area of negative pressure is created under the cover in the area of the wound.
SUMMARY
[0004] Embodiments of the invention disclosed herein are directed to a reduced pressure appliance and methods of treatment using a reduced pressure appliance, and may be useful in the treatment of wounds using reduced pressure.
[0005] Certain embodiments of the invention are directed to improved methods of treating abdominal wounds or incisions with negative pressure. For example and for illustrative purposes only, some embodiments employ a porous wound filler with detachable sections permitting desired sizing of the wound filler to the wound site. Sizing of the foam wound filler may in some embodiments be performed in a dimensionally-independent manner so that, for example, the width and/or length may be modified independently of each other. Further embodiments also provide for a wound contact layer to be placed in contact with the wound site, where the wound contact layer is preferably minimally or non-adherent to the wound site and provided with slits or other openings for the removal of wound exudate or fluids and the application of negative pressure to the wound site.
[0006] Certain embodiments provide for a negative pressure treatment system comprising a wound contact layer placed over the wound, a porous wound filler configured to be sized and positioned over the wound contact layer, a flexible drape configured to be placed above the wound and sealed to the skin surrounding the wound, and which further comprises a conduit configured to deliver negative pressure to the wound through an aperture in the flexible drape and through the porous wound filler and wound contact layer.
[0007] In an embodiment, a porous wound filler is provided for the treatment of wounds with negative pressure, wherein the porous wound filler is comprised of a porous material suitable for channeling wound exudate from a wound site to a source of negative pressure. The porous wound filler preferably comprises a generally planar shape with a thickness less than its width and length, and preferably comprises at least one cut extending through a least a portion of the thickness of the wound filler material, whereby the cut defines a wound filler section detachable from the remainder of the wound filler so as to permit modification of the size of the wound filler(for example its length and/or width). In certain embodiments, the cuts may be comprised of arcuate and/or elliptical cuts, and may further comprise additional inner and outer cuts. In further embodiments, additional intermediate cuts may also be present.
[0008] In certain embodiments, a system for the treatment of a wound site comprises a wound contact layer provided with openings for channeling wound exudate and distributing negative pressure, a generally planar porous wound filler suitable for transmitting negative pressure to a wound site and comprising at least one cut extending through a portion of the wound filler material’s thickness so as to define a detachable wound filler material, a flexible drape, a conduit, and a source of negative pressure configured to deliver negative pressure through the conduit to the wound site. In some embodiments, a method of treating a wound site using negative pressure may comprise placing a wound contact layer onto the wound site; placing a porous wound filler over the wound contact layer, where the porous wound filler is perforated to allow removal of wound filler portions so as to permit sizing of the wound filler in a dimensionally-independent manner to fit the wound site; sealing the wound site with a flexible drape configured to be positioned over the wound and sealed to the skin surrounding the wound; connecting a source of negative pressure to the wound site; and maintaining the application of negative pressure until the wound site has healed appropriately.
[0009] A system for providing medial compression to a wound site can include a wound filler. The wound filler can include a closure layer configured to be in contact with a fascia of a patient. The wound filler can include a rim extending from the closure layer, the rim configured to be positioned beneath the fascia. The wound filler can include a slit in the closure layer. The wound filler can be configured to apply medial tension to the fascia when negative pressure is applied to the wound filler.
[0010] The system for providing medial compression to a wound site of any of the preceding paragraphs and/or any of the apparatuses, systems, or devices disclosed herein can include one or more of the following features. The closure layer can include a plurality of slits. The closure layer can include three slits. The three slits can include one large slit and two small slits. The slit can be a pattern of holes. The slit can be an ovular hole. The rim can include a plurality of slits, individual slits configured to attach to the fascia. The rim can be integral with the closure layer. The system can include a source of negative pressure. The wound filler further can further include spacer material. The spacer material can be sandwiched between a top foam layer and a bottom foam layer. The wound filler can include foam. The system can include a wound contact layer configured to be positioned over the wound filler. The system can include an organ protection layer configured to be positioned beneath the wound filler. The organ protection layer can be cut by a user to adapt a size of the organ protection layer. The organ protection layer can include a spacer material. The spacer material may be positioned such that fluid is channeled from an edge of the organ protection layer to a central portion of the organ protection layer. The rim can be perforated to aid removal of the rim. The wound filler can include an open oval configured to allow a user to view a wound site.
[0011] In certain examples, a method of treating a wound site using negative pressure may comprise placing a wound contact layer onto the wound site; placing a porous pad over the wound contact layer, where the porous pad is perforated to allow removal of pad portions so as to permit sizing of the pad in a dimensionally-independent manner to fit the wound site; sealing the wound site with a flexible drape configured to be positioned over the wound and sealed to the skin surrounding the wound; connecting a source of negative pressure to the wound site; and maintaining the application of negative pressure until the wound site has healed appropriately.
[0012] A wound treatment system can include an organ protection layer suitable for contacting a wound site. The organ protection layer can include a plurality of delivery tubes in fluid communication with the wound site. The organ protection layer can include a connector. The connector can include an intake branch in fluid communication with a fluid source. The connector can include a delivery branch in fluid communication with the delivery tubes. The connector can include an output branch in fluid communication with a canister. The intake branch, the delivery branch, and the output branch of the connector can be in fluid communication.
[0013] The wound treatment system of any of the preceding paragraphs and/or any of the apparatuses, systems, or devices disclosed herein can include one or more of the following features. The wound treatment system can include a manifold connected to the delivery tubes and the delivery branch, wherein the manifold is configured to distribute fluid to the delivery tubes and receive fluid from the delivery tubes. The delivery tubes can be positioned between layers of spacer material. The intake branch, the delivery branch, and the output branch of the connector can connect at a junction point. The connector can be a Y- connector. The connector and the delivery tubes can remove fluid from the wound site. The connector and the delivery tubes can deliver fluid to the wound site. The connector and the delivery tubes can simultaneously deliver fluid to the wound site and remove fluid from the wound site. The connector can include a switch, the switch allowing a user to control flow of fluid in the connector. The switch can allow the user to restrict the intake branch or the output branch. The switch can be integrated with the connector. The organ protection layer can be transparent. The connector can be transparent. The delivery tubes can be transparent. The manifold can be transparent. The manifold can include vents configured to allow fluids to release from the manifold. The manifold can include an inner wall separating an inner cavity of the manifold. The inner wall can separate the inner cavity into a delivery portion and a removal portion. The delivery tubes can be round. The delivery tubes can be flat or oblong. The delivery tubes can include teeth inside the delivery tubes. The delivery tubes can include top teeth and bottom teeth inside the delivery tubes. The manifold can be made of any one of polyurethane, silicone, foam, rubber, and polyisoprene. The spacer material can be made of any one of foam, 3D fabric, silver, or a material with antimicrobial properties. The manifold can be any one of octagonal, disk-shaped, flower-shaped, rectangular, curved, circular, or ovoid.
[0014] A method for cleaning a wound site can include placing an organ protection layer on a wound site. The organ protection layer can include delivery tubes in fluid communication with the wound site. The organ protection layer can include an intake branch of a connector with a fluid source. The method for cleaning a wound site can include connecting a delivery branch of the connector with the delivery tubes. The method for cleaning a wound site can include connecting an output branch of the connector with a canister. The method for cleaning a wound site can include allowing fluid to pass from the fluid source to the intake branch of the connector to the delivery branch of the connector to the delivery tubes to the wound site to the delivery branch of the connector to the output branch of the connector to the canister.
[0015] The wound treatment method of any of the preceding paragraphs and/or any of the apparatuses, systems, or devices disclosed herein can include one or more of the following features. The wound treatment method can include connecting a manifold to the delivery tubes and the delivery branch, wherein the manifold is configured to distribute fluid to the delivery tubes and receive fluid from the delivery tubes. The delivery tubes can be positioned between layers of spacer material. The intake branch, the delivery branch, and the output branch of the connector can connect at a junction point. The connector can be a Y- connector. The connector and the delivery tubes can remove fluid from the wound site. The connector and the delivery tubes can deliver fluid to the wound site. The connector and the delivery tubes can simultaneously deliver fluid to the wound site and remove fluid from the wound site. The connector can include a switch, the switch allowing a user to control flow of fluid in the connector. The switch can allow the user to restrict the intake branch or the output branch. The switch can be integrated with the connector. The organ protection layer can be transparent. The connector can be transparent. The delivery tubes can be transparent. The manifold can be transparent. The manifold can include vents configured to allow fluids to release from the manifold. The manifold can include an inner wall separating an inner cavity of the manifold. The inner wall can separate the inner cavity into a delivery portion and a removal portion. The delivery tubes can be round. The delivery tubes can be flat or oblong. The delivery tubes can include teeth inside the delivery tubes. The delivery tubes can include top teeth and bottom teeth inside the delivery tubes. The manifold can be made of any one of polyurethane, silicone, foam, rubber, and polyisoprene. The spacer material can be made of any one of foam, 3D fabric, silver, or a material with antimicrobial properties. The manifold can be any one of octagonal, disk-shaped, flower-shaped, rectangular, curved, circular, or ovoid.
[0016] In some examples, a wound treatment system described herein can include: an organ protection layer suitable for contacting a wound site and configured to channel wound exudate and distribute negative pressure; an oculiform pad suitable for transmission of negative pressure to the wound site, the pad including: a plurality of arcuate cuts extending through at least a portion of a thickness of the pad to define a pad section detachable from the pad to permit the pad to be sized; and a plurality of apertures configured to allow negative pressure to reach the wound site, wherein the plurality of apertures are radially inward from the plurality of cuts; a source of negative pressure; and a conduit configured to transmit negative pressure from the source to the pad.
[0017] In some examples, the system can include a flexible drape configured to be placed over the pad. In some examples, each aperture of the plurality of apertures in the pad includes two linear apertures forming an acute angle. In some examples, the plurality of apertures are shaped to reduce tissue pullup while negative pressure is applied.
[0018] In some examples, an organ protection layer for contacting a wound site described herein can include: a plurality of curved spacer material portions positioned radially around the organ protection layer, the plurality of curved spacer material portions configured to transfer fluid across the organ protection layer. In some examples, the organ protection layer can include a top film layer and a bottom film layer disposed around the plurality of curved spacer material. In some examples, the plurality of curved spacer material portions are positioned in a plurality of rings on the organ protection layer.
[0019] In some examples, an organ protection layer for contacting a wound site described herein can include: a top film layer; a bottom film layer; and spacer material positioned between the top film layer and the bottom film layer, the spacer material including: a central spacer material portion; a plurality of innermost curved spacer material portions positioned radially around the central spacer material portion; a plurality of intermediate curved spacer material portions positioned radially around the plurality of innermost curved spacer material portions; and a plurality of outermost curved spacer material portions positioned radially around the plurality of intermediate curved spacer material portions, wherein the top film layer and the bottom film layer are welded together along a perimeter of the organ protection layer.
[0020] In some examples, the central spacer material portion is circular or ovoid. In some examples, the top 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. In some examples, the top 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. In some examples, the top 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. In some examples, the top film layer and the bottom film layer are welded together around a perimeter of each portion of spacer material. In some examples, the organ protection layer is configured to be cut along a welded portion to reduce a size of the organ protection layer. [0021] In some examples, an organ protection layer for contacting a wound site described herein can include: one or more film layers; and a plurality of slits in the one or more film layers, wherein each slit of the plurality of slits is positioned at an angle of between 30 degrees and about 60 degrees from a horizontal axis, wherein each slit of the plurality of slits is positioned at an angle of between about 30 degrees and about 60 degrees from a vertical axis, wherein each slit of the plurality of slits is oriented in an opposite direction of a slit in a horizontally adjacent quadrant, and wherein each slit of the plurality of slits is oriented in an opposite direction of a slit in a horizontally adjacent quadrant.
[0022] In some examples, a method of positioning an organ protection layer on a wound site described herein can include: providing an organ protection layer including a spacer material portion on a center of the organ protection layer; and positioning the organ protection layer on a wound site such that the spacer material portion is aligned with a center of the wound site.
[0023] In some examples, a suction adapter for applying negative pressure therapy described herein can include: a suction aperture configured to be positioned in fluid communication with a wound site; a suction port in fluid communication with the suction aperture through a suction channel, the suction port configured to receive a conduit for negative pressure; a leak aperture configured to be positioned in fluid communication with the wound site; and a leak port in fluid communication with the leak aperture 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 can include a base flange, wherein the suction aperture and leak aperture are on a bottom surface of the base flange. In some examples, the suction adapter can include an overhang portion over the base flange, wherein the suction port is on the overhang portion. In some examples, the suction adapter can include a filter in the leak channel. In some examples, the filter is vertically oriented. In some examples, the suction adapter can include indentations configured to receive a user's fingers. In some examples, the suction adapter can withstand about 250 mmHg of force.
[0025] In some examples, the method for applying negative pressure wound therapy described herein can include positioning a foam pad on a wound site; positioning a suction adapter over the foam pad, the suction adapter including: a suction aperture; a suction port in fluid communication with the suction aperture through a suction channel; a leak aperture; and a leak port in fluid communication with the leak aperture through a leak channel, wherein the suction channel and the leak channel are separated by an inner wall; positioning a conduit for negative pressure in the suction port of the suction adapter; and detecting flow through the suction port to determine whether the suction adapter is in fluid communication with the foam pad.
[0026] In some examples, the method can include delivering negative pressure from a negative pressure source through the conduit.
In some examples, the organ protection layer described herein can include 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 can be positioned radially outward from the central spacer material portion.
In some examples, the central spacer material portion is circular or ovoid. In some examples, the central spacer material portion comprises a central aperture, and wherein the central aperture is circular or ovoid. In some examples, the plurality of spacer material portions are circular, ovoid, or stadium-shaped. In some examples, the plurality of spacer material portions are disposed in rings circumferentially around the central spacer portion. 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, semi-circular, ovoid, or semi-ovoid. In some examples, the plurality of spacer material portions comprise apertures.
[0027] Disclosed herein are systems and methods for providing medial compression to a wound site of any of the preceding paragraphs and/or any of the devices, apparatuses, or systems disclosed herein.
[0028] Any of the features, components, or details of any of the arrangements or embodiments disclosed in this application, including without limitation any of the apparatus embodiments and any of the wound site medial compression embodiments disclosed herein, are interchangeably combinable with any other features, components, or details of any of the arrangements or embodiments disclosed herein to form new arrangements and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS
[0029] FIG. 1A is a schematic illustration of a system for the treatment of abdominal wounds.
[0030] FIG. IB illustrates a negative pressure treatment system.
[0031] FIG. 2A is a perspective view of an embodiment of a wound filler comprising an elongate layer, a lip, and a slit.
[0032] FIG. 2B is a top view of the wound filler of FIG. 2A.
[0033] [0034] [0035] [0036] [0037] FIG. 3 A is a top view of the wound filler of FIG. 2A positioned within an open abdominal wound, covered with a drape and attached to the negative pressure system.
[0038] FIG. 3B is a cross-sectional view of the wound filler of FIG. 3 A.
[0039] FIG. 4 is a perspective view of a further embodiment of wound filler materials comprising a plurality of slits.
[0040] FIG. 5 is a perspective view of a further embodiment of wound filler materials comprising a central hole.
[0041] FIG. 6A is a top view of a further embodiment of wound filler materials comprising a rim with a plurality of slits and a center hole.
[0042] FIG. 6B is a perspective view of the wound filler of FIG. 6A.
[0043] [0044] [0045]
[0046] FIG. 7 is a top view of a wound filler comprising various fluidic stabilizing structures.
[0047] FIG. 8 is a top view of a further embodiment of a wound filler comprising various fluidic stabilizing structures.
[0048] FIG. 9 is a top view of a further embodiment of a wound filler with spacer material sandwiched between two foam layers cut across.
[0049] FIG. 10 is a top view of a further embodiment of a wound filler comprising patterns for medial compression.
[0050] FIG. 11 is a top view of a further embodiment of a wound filler comprising small holes and a larger central hole. [0051] FIG. 12 is a top view of a further embodiment of a wound filler with X- shaped holes.
[0052] FIG. 13 illustrates an organ protection layer comprising spacer material to facilitate medial tension and fluid management along with filler material.
[0053] FIG. 14 is a top view of a further embodiment of an organ protection layer comprising a criss cross design of filler material.
[0054] FIG. 15 illustrates a further embodiment of an organ protection layer comprising a plurality of rectangles of filler material arranged horizontally that are larger on the outside and can get smaller towards the center.
[0055] FIG. 16 illustrates a further embodiment of an organ protection layer comprising a plurality of rectangles of filler material arranged horizontally and vertically that are larger on the outside and can get smaller towards the center.
[0056] FIG. 17 is an example of stretchable compressible material.
[0057] FIG. 18 is an illustration of a connector for cleaning abdominal wounds.
[0058] FIG. 19 is an example of an organ protection layer for covering abdominal wounds.
[0059] FIG. 20A is a top view of delivery tubes positioned between layers of spacer material.
[0060] FIG. 20B is a perspective view of delivery tubes positioned between layers of spacer material.
[0061] FIG. 21 is an illustration of an organ protection layer for covering abdominal wounds.
[0062] FIG. 22 is an illustration of an example of a manifold for distributing liquid.
[0063] FIG. 23 is an illustration of another example of a manifold for distributing liquid.
[0064] FIG. 24 is an illustration of another example of a manifold for distributing liquid.
[0065] FIG. 25 is an illustration of another example of a manifold for distributing liquid.
[0066] FIG. 26 is an illustration of another example of a manifold for distributing liquid. [0067] FIG. 27 is an illustration of another example of a manifold for distributing liquid.
[0068] FIG. 28 is an illustration of another example of a manifold for distributing liquid.
[0069] FIG. 29 is an illustration of the manifold for distributing liquid of FIG. 22 connected to delivery tubes.
[0070] FIG. 30 is an illustration of the manifold for distributing liquid of FIG. 25 connected to delivery tubes.
[0071] FIG. 31 A is a perspective view of a flat delivery tube.
[0072] FIG. 3 IB is a front, cross-sectional view of a flat delivery tube.
[0073] FIG. 32 is an illustration of three flat delivery tubes on a bottom layer of spacer material.
[0074] FIG. 33 is an illustration of a flat delivery tube positioned between a bottom layer of spacer material and a cross-section of a top layer of spacer material.
[0075] FIG. 34 is a schematic illustration of a system for cleaning abdominal wounds.
[0076] FIG. 35 is an illustration of a connector for cleaning abdominal wounds with an integrated switch.
[0077] FIG. 36 is a front view of an example of an organ protection layer with slits.
[0078] FIG. 37A is a front view of an example of an organ protection layer with spacer material.
[0079] FIG. 37B is a perspective exploded view of the example of the organ protection layer with spacer material of FIG. 37A.
[0080] FIG. 37C is a front view of the example of the spacer material of FIG. 37A.
[0081] FIG. 38 shows another example of a pad.
[0082] FIG. 39A is a side view of an example of a suction adapter.
[0083] FIG. 39B is a top view of the example of the suction adapter of FIG. 39A.
[0084] FIG. 39C is a rear view of the example of the suction adapter of FIG. 39A.
[0085] FIG. 39D is a front view of the example of the suction adapter of FIG. 39 A.
[0086] FIG. 39E is a bottom view of the example of the suction adapter of FIG.
39 A. [0087] FIG. 39F is a cross-sectional view of the example of the suction adapter of FIG. 39A taken parallel to the X axis shown in FIG. 39B.
[0088] FIGs 40-48 show examples of organ protection layers with spacer material.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0089] Preferred embodiments disclosed herein relate to wound therapy for a human or animal body. Therefore, any reference to a wound herein can refer to a wound on a human or animal body, and any reference to a body herein can refer to a human or animal body. The term “wound” as used herein, in addition to having its broad ordinary meaning, includes any body part of a patient that may be treated using reduced pressure. Wounds and/or wound sites include, but are not limited to, open wounds, pressure sores, ulcers and burns. Open wounds and/or wound sites may also include incisions (e.g., abdominal incisions) or other openings, tears, or fistulas, for example, in the abdominal or peritoneal cavity. Treatment of such wounds can be performed using negative pressure wound therapy, wherein a reduced or negative pressure can be applied to the wound to facilitate and promote healing of the wound. It will also be appreciated that the negative pressure systems and methods as disclosed herein may be applied to other parts of the body, and are not necessarily limited to treatment of wounds.
[0090] Turning to FIG. 1 A, treatment of a wound with negative pressure in certain embodiments uses a negative pressure treatment system 101 as illustrated schematically here. In this embodiment, a wound site 111, illustrated here as an abdominal wound site, may benefit from treatment with negative pressure. Such abdominal wound sites may be a result of, for example, an accident or due to surgical intervention. In some cases, medical conditions such as abdominal compartment syndrome, abdominal hypertension, sepsis, or fluid edema may require decompression of the abdomen with a surgical incision through the abdominal wall to expose the peritoneal space, after which the opening may need to be maintained in an open, accessible state until the condition resolves. Other conditions may also necessitate that an opening — particularly in the abdominal cavity — remain open, for example if multiple surgical procedures are required (possibly incidental to trauma), or there is evidence of clinical conditions such as peritonitis or necrotizing fasciitis. In cases where there is a wound, particularly in the abdomen, management of possible complications relating to the exposure of organs and the peritoneal space is desired, whether or not the wound is to remain open or if it will be closed. Therapy, preferably using the application of negative pressure, can be targeted to minimize the risk of infection, while promoting tissue viability and the removal of deleterious substances from the wound site. The application of reduced or negative pressure to a wound site has been found to generally promote faster healing, increased blood flow, decreased bacterial burden, increased rate of granulation tissue formation, to stimulate the proliferation of fibroblasts, stimulate the proliferation of endothelial cells, close chronic open wounds, inhibit burn penetration, and/or enhance flap and graft attachment, among other things. It has also been reported that wounds that have exhibited positive response to treatment by the application of negative pressure include infected open wounds, decubitus ulcers, dehisced incisions, partial thickness burns, and various lesions to which flaps or grafts have been attached. Consequently, the application of negative pressure to a wound site 111 can be beneficial to a patient.
[0091] Accordingly, certain embodiments provide for a wound contact layer 105 to be placed over the wound site 111. One of skill in the art will understand that the wound contact layer 105 may function as an organ protection layer. Preferably, the wound contact layer or organ protection layer 105 can be a thin, flexible material which will not adhere to the wound site or the exposed viscera in close proximity. For example, polymers such as polyurethane, polyethylene, polytetrafluoroethylene, or blends thereof may be used. In one embodiment, the wound contact layer is permeable. For example, the wound contact layer 105 can be provided with openings, such as holes, slits, or channels, to allow the removal of fluids from the wound site 111 or the transmittal of negative pressure to the wound site 111. Additional embodiments of the wound contact layer 105 are described in further detail below. Certain embodiments of the negative pressure treatment system 101 may also use a porous pad 103, which can be disposed over the wound contact layer 105. This pad 103 can be constructed from a porous material, for example foam, that is soft, resiliently flexible, and generally conformable to the wound site 111. Such a foam can include an open-celled and reticulated foam made, for example, of a polymer. Suitable foams include foams composed of, for example, polyurethane, silicone, and polyvinyl alcohol. Preferably, this pad 103 can channel wound exudate and other fluids through itself when negative pressure is applied to the wound. Some pads 103 may include preformed channels or openings for such purposes. In certain embodiments, the pad 103 may have a thickness between about one inch and about two inches. The pad may also have a length of between about 16 and 17 inches, and a width of between about 11 and 12 inches. In other embodiments, the thickness, width, and/or length can have other suitable values. Other aspects of the pad 103 are discussed in further detail below.
[0092] Preferably, a drape 107 is used to seal the wound site 111. The drape 107 can be at least partially liquid impermeable, such that at least a partial negative pressure may be maintained at the wound site. Suitable materials for the drape 107 include, without limitation, synthetic polymeric materials that do not significantly absorb aqueous fluids, including polyolefins such as polyethylene and polypropylene, polyurethanes, polysiloxanes, polyamides, polyesters, and other copolymers and mixtures thereof. The materials used in the drape may be hydrophobic or hydrophilic. Examples of suitable materials include Transeal® available from DeRoyal and OpSite® available from Smith & Nephew. In order to aid patient comfort and avoid skin maceration, the drapes in certain embodiments are at least partly breathable, such that water vapor is able to pass through without remaining trapped under the dressing. An adhesive layer may be provided on at least a portion the underside of the drape 107 to secure the drape to the skin of the patient, although certain embodiments may instead use a separate adhesive or adhesive strip. Optionally, a release layer may be disposed over the adhesive layer to protect it prior to use and to facilitate handling the drape 107; in some embodiments, the release layer may be composed of multiple sections. The negative pressure system 101 can be connected to a source of negative pressure, for example a pump 114. One example of a suitable pump is the Renasys EZ pump available from Smith & Nephew. The drape 107 may be connected to the source of negative pressure 114 via a conduit 112. The conduit 112 may be connected to a port 113 situated over an aperture 109 in the drape 107, or else the conduit 112 may be connected directly through the aperture 109 without the use of a port. In a further alternative, the conduit may pass underneath the drape and extend from a side of the drape. U.S. Patent No. 7,524,315 discloses other similar aspects of negative pressure systems and is hereby incorporated by reference in its entirety and should be considered a part of this specification. In many applications, a container or other storage unit 115 may be interposed between the source of negative pressure 114 and the conduit 112 so as to permit wound exudate and other fluids removed from the wound site to be stored without entering the source of negative pressure. Certain types of negative pressure sources — for example, peristaltic pumps — may also permit a container 115 to be placed after the pump 114. Some embodiments may also use a filter to prevent fluids, aerosols, and other microbial contaminants from leaving the container 115 and/or entering the source of negative pressure 114. Further embodiments may also include a shut-off valve or occluding hydrophobic and/or oleophobic filter in the container to prevent overflow; other embodiments may include sensing means, such as capacitative sensors or other fluid level detectors that act to stop or shut off the source of negative pressure should the level of fluid in the container be nearing capacity. At the pump exhaust, it may also be preferable to provide an odor filter, such as an activated charcoal canister.
[0093] Of course, the foregoing description is that of certain features, aspects and advantages of the present invention, to which various changes and modifications can be made without departing from the spirit and scope of the present invention. Moreover, the negative pressure treatment system disclosed herein need not feature all of the objects, advantages, features and aspects discussed above. Those of skill in the art will recognize that the invention can be embodied or carried out in a manner that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein. For example, in some embodiments the pad 103 can be used without the wound contact layer 105 and/or drape 107. In addition, while a number of variations of the invention have been shown and described in detail, other modifications and methods of use, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is contemplated that various combinations or subcombinations of these specific features and aspects of embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the discussed negative pressure treatment system.
[0094] Figure IB illustrates another negative pressure wound treatment system 100. The negative pressure wound treatment system 100 can have any of the components, features, or other details of any of the other negative pressure wound treatment system disclosed herein, including without limitation the negative pressure wound treatment system illustrated in Figure, in combination with or in place of any of the components, features, or other details of the negative pressure wound treatment system 100 shown in Figure IB and/or described herein. The negative pressure wound treatment system 100 can have a wound cover 106 over a wound 104 that can seal the wound 104. A conduit 108, such as a single or multi lumen tube can be used to connect the wound cover 106 with a wound therapy device 110 (sometimes as a whole or partially referred to as a “pump assembly”) configured to supply reduced or negative pressure. The wound cover 106 can be in fluidic communication with the wound 104. With reference to Figure IB, the conduit 108 can have a bridge portion 130 that can have a proximal end portion and a distal end portion (the distal end portion being closer to the wound 104 than the proximal end portion, and an applicator 132 at the distal end of the bridge portion 130 forming the flexible suction adapter (or conduit) 108. A connector 134 can be disposed at the proximal end of the bridge portion 130, so as to connect to at least one of the channels that can extend along a length of the bridge portion 130 of the conduit 108 shown in Figure IB. A cap 140 can be coupled with a portion of the conduit 108 and can, in some cases, as illustrated, be attached to the connector 134. The cap 140 can be useful in preventing fluids from leaking out of the proximal end of the bridge portion 130. The conduit 108 can be a Soft Port manufactured by Smith & Nephew. As mentioned, the negative pressure wound treatment system 100 can include a source of negative pressure, such as the wound therapy device 110, capable of supplying negative pressure to the wound 104 through the conduit 108. Though not required, the wound therapy device 110 can also include a canister or other container for the storage of wound exudates and other fluids that can be removed from the wound. The wound therapy device 110 can be connected to the connector 134 via a conduit or tube 142. In use, the applicator 132 can be placed over an aperture formed in a wound cover 106 that is placed over a suitably-prepared wound or wound 104. Subsequently, with the wound therapy device 110 connected via the tube 142 to the connector 134, the wound therapy device 110 can be activated to supply negative pressure to the wound. Application of negative pressure can be applied until a desired level of healing of the wound is achieved. The bridge portion 130 can comprise an upper channel material or layer positioned between an upper layer and an intermediate layer, with a lower channel material or layer positioned between the intermediate layer and a bottom layer. The upper, intermediate, and lower layers can have elongate portions extending between proximal and distal ends and can include a material that is fluid-impermeable, for example polymers such as polyurethane. It will of course be appreciated that the upper, intermediate, and lower layers can each be constructed from different materials, including semi-permeable materials. In some cases, one or more of the upper, intermediate, and lower layers can be at least partially transparent. In some instances, the upper and lower layers can be curved, rounded or outwardly convex over a majority of their lengths.
[0095] The upper and lower channel layers can extend from the proximal end to the distal end of the bridge portion 130 and can each preferably comprise a porous material, including for example open-celled foams such as polyethylene or polyurethane. In some cases, one or more of the upper and lower channel layers can be comprised of a fabric, for example a knitted or woven spacer fabric (such as a knitted polyester 3D fabric, Baltex 7970.RTM., or Gehring 879.RTM.) or a nonwoven material, or terry-woven or loop-pile materials. The fibers may not necessarily be woven, and can include felted and flocked (including materials such as Flotex.RTM.) fibrous materials. The materials selected are preferably suited to channeling wound exudate away from the wound and for transmitting negative pressure or vented air to the wound site, and can also confer a degree of kinking or occlusion resistance to the channel layers. One of skill in the art will understand that such materials may also be referred to as spacer materials and may be present in a layer known as a spacer layer. In one example, the upper channel layer can include an open-celled foam such as polyurethane, and the lower channel layer can include a fabric. In another example, the upper channel layer is optional, and the system can instead be provided with an open upper channel. The upper channel layer can have a curved, rounded or upwardly convex upper surface and a substantially flat lower surface, and the lower channel layer can have a curved, rounded or downwardly convex lower surface and a substantially flat upper surface. The fabric or material of any components of the bridge portion 130 can have a three-dimensional (3D) structure, where one or more types of fibers form a structure where the fibers extend in all three dimensions. Such a fabric can in some cases aid in wicking, transporting fluid or transmitting negative pressure. In some cases, the fabric or materials of the channels can include several layers of material stacked or layered over each other, which can in some cases be useful in preventing the channel from collapsing under the application of negative pressure. The materials used in some implementations of the conduit 108 can be conformable and pliable, which can, in some cases, help to avoid pressure ulcers and other complications which can result from a wound treatment system being pressed against the skin of a patient. [0096] The distal ends of the upper, intermediate, and lower layers and the channel layers can be enlarged at their distal ends (to be placed over a wound site), and can form a "teardrop" or other enlarged shape. The distal ends of at least the upper, intermediate, and lower layers and the channel layers can also be provided with at least one through aperture. This aperture can be useful not only for the drainage of wound exudate and for applying negative pressure to the wound, but also during manufacturing of the device, as these apertures can be used to align these respective layers appropriately. In some implementations, a controlled gas leak 146 (sometimes referred to as gas leak, air leak, or controlled air leak) can be disposed on the bridge portion 130, for example at the proximal end thereof. This air leak 146 can comprise an opening or channel extending through the upper layer of the bridge portion 130, such that the air leak 146 is in fluidic communication with the upper channel of the bridge portion 130. Upon the application of suction to the conduit 108, gas (such, as air) can enter through the gas leak 146 and move from the proximal end of the bridge portion 130 to the distal end of the bridge portion along the upper channel of the bridge portion 130. The gas can then be suctioned into the lower channel of the bridge portion 130 by passing through the apertures through the distal ends of the upper, intermediate, and lower layers. The air leak 146 can include a filter. Preferably, the air leak 146 is located at the proximal end of the bridge portion 130 so as to minimize the likelihood of wound exudate or other fluids coming into contact and possibly occluding or interfering with the air leak 146 or the filter. In some instances, the filter can be a microporous membrane capable of excluding microorganisms and bacteria, and which may be able to filter out particles larger than 45 pm. Preferably, the filter can exclude particles larger than 1.0 pm, and more preferably, particles larger than 0.2 pm. Advantageously, some implementations can provide for a filter that is at least partially chemically-resistant, for example to water, common household liquids such as shampoos, and other surfactants. In some cases, reapplication of vacuum to the suction adapter or wiping of the exposed outer portion of the filter may be sufficient to clear any foreign substance occluding the filter. The filter can be composed of a suitably-resistant polymer such as acrylic, polyethersulfone, or polytetrafluoroethylene, and can be oleophobic or hydrophobic. In some cases, the gas leak 146 can supply a relatively constant gas flow that does not appreciably increase as additional negative pressure is applied to the conduit 108. In instances of the negative pressure wound treatment system 100 where the gas flow through the gas leak 146 increases as additional negative pressure is applied, preferably this increased gas flow will be minimized and not increase in proportion to the negative pressure applied thereto. Further description of such bridges, conduits, air leaks, and other components, features, and details that can be used with any implementations of the negative pressure wound treatment systems disclosed herein are found in U.S. Patent No. 8,801,685, which is incorporated by reference in its entirety as if fully set forth herein.
[0097] Any of the wound therapy devices (such as, the device 114 or 110) disclosed herein can provide continuous or intermittent negative pressure therapy. Continuous therapy can be delivered at above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, - 180 mmHg, -200 mmHg, or below -200 mmHg. Intermittent therapy can be delivered between low and high negative pressure set points (sometimes referred to as setpoint). Low set point can be set at above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, or below -180 mmHg. High set point can be set at above -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -200 mmHg. During intermittent therapy, negative pressure at low set point can be delivered for a first time duration, and upon expiration of the first time duration, negative pressure at high set point can be delivered for a second time duration. Upon expiration of the second time duration, negative pressure at low set point can be delivered. The first and second time durations can be same or different values. In operation, the wound filler 102 can be inserted into the cavity of the wound 104, and wound cover 106 can be placed so as to seal the wound 104. The wound therapy device 110’ can provide negative pressure to the wound cover 106, which can be transmitted to the wound 104 via the wound filler 102. Fluid (such as, wound exudate) can be drawn through the conduit 108’ and stored in a canister. In some cases, fluid is absorbed by the wound filler 102 or one or more absorbent layers (not shown). Wound dressings that can be utilized with the pump assembly and systems of the present application include Renasys-F, Renasys-G, Renasys AB, and Pico Dressings available from Smith & Nephew. Further description of such wound dressings and other components of a negative pressure wound therapy system that can be used with the pump assembly and systems of the present application are found in U.S. Patent Publication Nos. 2012/0116334, 2011/0213287, 2011/0282309, 2012/0136325, U.S. Patent No. 9,084,845, and International Patent Publication No. WO2021/069642, each of which is incorporated by reference in its entirety as if fully set forth herein. In some cases, other suitable wound dressings can be utilized.
[0098] FIGS. 2A-2B illustrate an embodiment of a wound filler 202 comprising an closure layer 210, a rim 212, and a slit 214. Such a wound filler is configured to be inserted into an abdominal incision, sealed with a drape, and connected to a source of negative pressure via a fluidic connection. While under negative pressure, the wound filler 202 can collapse and pull the abdominal walls toward the midline. As will be understood by one of skill in the art, the wound filler may collapse in an anisotropic manner. The wound filler 202 can provide medial tension and reduce the risk of long-term diastasis recti, or abdominal separation. In certain embodiments, the closure layer may collapse under negative pressure, thereby drawing the walls of the fascia together. The wound filler 202 can be interchangeable with the pad 103 of FIG. 1A. FIG. 2 A illustrates an embodiment of the wound filler 202 may be in an annular shape to fit different sizes of an abdominal wound. As illustrated in FIGS. 2A-B, the wound filler 202 can have an closure layer 210, a rim 212, and a slit 214. In certain embodiments, the rim 212 may be perforated to allow a user to remove the entire rim or a portion of the rim. In some embodiments, the closure layer can have a rim forming an L-shape cross section as illustrated in FIG. 2A-B.
[0099] The slit 214 may improve fluid management and provide for improved medial closure. The slit allows for lateral collapse of the wound filler, thereby drawing the tissue walls, such as the fascia toward one another. In some embodiments, the wound filler 202 is placed within the facia where the surgical incision has been made to pull the abdominal walls towards the midline and provide medial tension. The closure layer may protrude through an opening in the fascia, thereby sitting between sections of fascia. The wound filler 202 may be placed in the wound before or with an organ protection layer, such as shown in Figure 1 A. The wound filler 202 can have a rim 212 extending outwardly when the wound filler is in an annular shape. The rim 212 may be positioned beneath the fascia of the patient in order to secure the wound filler 202 within the wound, such as a wounded opening in the fascia. The rim may attach to the underside of the fascia and serve to grip the fascia and thereby apply tension to the fascia during collapse of the wound filler while under negative pressure. In some embodiments, the wound filler 202 can sit under the abdominal wall to assist with medial tension. In some embodiments, the surface of the closure layer 210 can sit between the facia. In some embodiments, the abdominal wall/peritoneum can sit under the facia.
[0100] In some examples, the wound fillers described herein designed to fit under and in-between an opening in the fascia. As described above, the closure layer 210 may extend through the fascia while the rim 212 extends underneath the fascia. As described elsewhere, the rim may anchor to the underside the of the fascia and assist in pulling the fascia closed when the closure layer collapses under negative pressure.
[0101] In certain embodiments, the rim 212 is flexible to accommodate the contours of the abdominal and fascia regions and becomes buried within the tissue at the wound margins and secures the wound filler 202 within the wound opening. In some embodiments, the rim can extend beneath the deep fascia, subserous fascia, serious membrane, peritoneum, or any other layer between the dermal layer and the viscera. For example, in one embodiment, for abdominal wounds, the rim can preferably be placed beneath the peritoneum. The use of the rim may therefore facilitate maintaining and retaining the wound filler at the correct vertical level within the wound, while anchoring to the fascia to assist the wound filler in providing medial tension to the fascia while under negative pressure, thereby facilitating closure of the wound. The closure layer 210 can extend centrally from the rim and sit in between the fascia. The slit 214 within the wound filler can constrict and expand to allow the wound filler 202 to adjust the size of the abdominal wound and pull the abdominal walls towards the middle to provide medial tension. The slit 214 can be advantageous to reduce the risk of diseases such as long-term diastasis recti.
[0102] In some examples, the rim 212 can be located outwardly from the wound edge and placed underneath the fascia. The wound filler 202 can sit within the abdomen.
[0103] FIG. 3 A is a top view of the wound filler 202 of FIG. 2A positioned within an open abdominal wound, covered with a drape and attached to the negative pressure system. Once the negative pressure is applied via the conduit 112, the margins 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 walls towards the midline. The wound filler can be in communication with the abdominal wound, and enable the application of negative pressure through the aperture 109 to provide a fluidic connection from the wound to a source of negative pressure such as a pump 114. The fluidic connection between the aperture 109 and the pump 114 can be made via a conduit 112. In some embodiments, the conduit 114 may comprise a RENASYS® Soft Port™, manufactured by Smith & Nephew. In some embodiments, the drape 107 may not necessarily comprise an aperture 109, and the fluidic connection to the pump 114 may be made by placing the conduit 114 below the drape. When under negative pressure, the wound filler 202 can pull the abdominal walls toward the midline and provides medial tension. The wound filler 202 can be biased toward the midline. The slit 214 can be shaped in a longitudinal strip, configured to allow the wound filler to collapse. The slit 214 may allow the stabilizing structure to flex more easily in the vertical plane. A single drape or multiple drapes may be placed over the wound filler 202, and can be preferably adhered or sealed to the skin on the periphery of the abdominal wound so as to create a fluid-tight seal.
[0104] FIG. 3B is a cross sectional view of the wound filler 202 positioned between the fascia and overlying tissue. In some embodiments, the wound filler may be positioned underneath the fascia. After insertion of the wound filler material, the drape 107 can cover the wound filler and the conduit 112 may be connected to the port 113 situated over the aperture 109 in the drape 107. The rim 212 can deform when placed in the wound site. The rim 212 can sit below the skin. The rim 212 can sit below the fatty tissue. The rim 212 can sit below the muscle. The rim 212 can sit in a layer with the abdomen organs. As will be understood by one of skill in the art, the wound filler 202 may improve primary closure rates and reduce pressure on organs. Further, the wound filler 202 can improve blood supply to the organs leading to improved outcomes.
[0105] FIG. 4 illustrates an embodiment of a wound filler 700 (similar to the wound fillers described herein) with a plurality of slits 714. In certain embodiments, the wound filler may have one, two, three, four, five, six, seven or more slits. As shown in the image, the wound filler 700 can have three slits 714. The wound filler 700 can preferentially collapse along one direction. Here, the wound filler 700 can comprise a porous wound filler (e.g., foam) into a plurality of slits 714 have been cut. This plurality of slits 714 can preferably extend longitudinally through the thickness of the wound filler 700. Accordingly, the empty space can permit the wound filler 700 to preferentially collapse in a direction when a force is applied in a direction perpendicular to the slits 714. Because the empty space is easier to compress than the remainder of the foam, the width and thickness of the foam will preferably not (or minimally) compress compared to the resulting compression perpendicular to the length of the wound filler 700. The plurality of slits 714 can be advantageous by assisting with the abdominal wound fluid management and medial closure of the abdomen.
[0106] FIG. 5 illustrates an embodiment of a wound filler 800 (similar to the other wound fillers described herein) comprising a center hole 814. The center hole 814 can be an ovular hole 814. The center hole 814 can allow the wound filler 800 to collapse under negative pressure, thereby drawing the tissue, such as the fascia, together. As a result, the empty space within the center hole 814 can pull the abdominal walls toward the midline and provide temporary closure of the abdominal wound. When negative pressure is paused and the abdomen returns to normal pressure, the center hole 814 can act as a window for the user to view the abdomen.
[0107] FIG. 6A-6B illustrate a top, a perspective, and an underside view of a further embodiment of wound filler 900 comprising a center hole 914, and a rim 912 with a plurality of slits 916, similar to the other wound fillers described herein. The wound filler in FIG. 6A illustrates a pre-compression stage without negative pressure application. The rim 912 can form an L-shape perpendicular to the closure layer 910, extending outwardly into the wound cavity. In some embodiments, the rim can extend beneath the deep fascia, subserous fascia, serous membrane, peritoneum, or any other layer between the dermal layers and the visceral. For example, in one embodiment, the rim can preferably be placed beneath the peritoneum. The rim 912 can comprise a plurality of slits 916 made to longitudinal strips, preferably extending longitudinally along the longitudinal axis of the wound. As described elsewhere herein, in certain embodiments, the rim 912 can have perforations such that the entire rim or a portion of the rim 912 can be removed if needed. The width of the rim 912 can be longer than the height of the closure layer 910, extending outwardly into the wound cavity. The width of the rim 912 can be longer than the height of the closure layer 910, contouring the shape of the organs. The configuration of the rim may therefore protect the organs and facilitate fluid communication with the abdominal would and the wound filler 900. In certain embodiments, the rim may include one or more slits on one or each portion of the rim extending outward, for example two portions as depicted in Figures 6A-6B. For example, each portion of the rim may include one, two, three, four, five, or more slits to facilitate anchoring to the tissue layer. [0108] Under negative pressure, the wound filler 900 may compress in a horizontal plane to cause the wound edges to draw closer together. Accordingly, the empty spaces created by the slits 916 can permit the wound filler to preferentially collapse in a direction when a negative pressure is applied in a direction perpendicular to the slits 916. As a result, the wound filler 900 can anchor to the underside of the facia and assist with fully temporary closure of the open abdomen.
[0109] FIG. 7 illustrates an embodiment of a wound filler 1000, similar to the wound fillers described elsewhere herein, comprising various patterned elements. As will be understood by one of skill in the art, the wound filler may be configured to collapse anisotropically when subjected to negative pressure, collapsing in the horizontal direction across the width of the wound filler. In embodiments, a diamond element 1010 forms a diamond shape in the center of the wound filler 1000. A plurality of the diamond elements 1010 may be arranged in a repeating pattern in the central location of the wound filler 1000, forming a lattice. The plurality of diamond elements 1010 in the central position of the wound filler 1000 can collapse and compress along the length and width of the wound filler material, while assisting in fluid communication with the abdominal wound An annular element 1012 may form an annular shape. A plurality of the annular element 1012 may be arranged in a repeating pattern in the proximal and distal part of the plurality of diamond elements 1010. An elongated element 1014 can form a longitudinal strip parallel to one another expending away from the diamond elements 1010 and annular element 1012 toward the outer edges of the wound filler 1000. The elongated elements 1014 can assist the diamond elements 1010 and annular elements 1012 to collapse anisotropically when subjected to negative pressure. As will be understood by one of skill in the art, the pattern of shapes may serve to enhance collapse of the wound filler 1000.
[0110] The wound filler 1000 can have concentrated shapes in the middle and spread across outside to create the effect of medical compression. The wound filler 1000 can have narrow slit patterns around the edge of the filler will allow of medial compression to occur in different directions. The shapes can be cut using a laser cutter. The elongated elements 1014 can collapse to assist the smaller elements in management and closing.
[0111] FIG. 8 illustrates a further embodiment of a 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 fan element 1114 assist in facilitating fluid management. The fan elements 1114 are configured to be compressed under negative pressure and assist with the slit 1110 to collapse and pull the abdominal walls towards the midline and provide medial tension. The smaller slits and the larger slit 1110 in the center can facilitate fluid management. The fan element 1114 can be compressible to help with foam medial compression.
[0112] FIG. 9 illustrates a further embodiment of a wound filler 1200 comprising a spacer material sandwiched between two foam layers 1240. The wound filler 1200 can pull the skin/fatty tissue as well as more or all of the abdominal layers. The plurality of holes allow fluid transfer through the cushion of the top foam layer 1240. In the center, circles 1242 can be cut to push out the fluid underneath. When compressed, the foam layer 1240 on top can collapse, which can allow fluid to travel through the foam. Cuts may also be present in the wound filler to allow for the wound filler to be shaped to a particular wound.
[0113] FIG. 10 illustrates a further embodiment of a wound filler 1300 comprising patterns for medial compression. The wound filler 1300 can have a concave lens shaped design slit 1352 in the center surrounded by triangles 1350 as a different way to facilitate medial compression. Narrow slits 1354 can surround the concave lens shaped design slit 1352 and the triangles 1350. The arrangement of shapes can be advantageous for medial compression.
[0114] FIG. 11 illustrates a further embodiment of a wound filler 1400 comprising small holes 1460 and a larger central hole 1462. The small holes 1460 can be spread across the wound filler material. The small holes 1460 can form an array. The large hole 1462 in the center can assist with medial pressure. In certain embodiments, the wound filler 1400 can have multiple overlapping perforation lines and/or shapes, to allow a user to choose the desired shape or size for the incision type.
[0115] FIG. 12 illustrates a further embodiment of a wound filler 1500 comprising X-shaped holes 1564. The X-shaped holes 1564 can be equally distributed across the surface of the wound filler 1500. The X-shaped holes 1564 can assist with medial compression. In certain embodiments, as disclosed elsewhere herein, the wound filler 1400 can have multiple overlapping perforation lines and/or shapes, to allow a user to choose the desired shape or size for the incision type. [0116] FIG. 13 illustrates an organ protection layer 1600 comprising spacer material 1670 (such as the spacer material described elsewhere herein) to facilitate medial tension and fluid management along with filler material 1672. The spacer material can be Id- shaped can facilitate fluid management from four sides of the abdomen and move fluid toward the center for fluid removal. The fluid can be removed by negative pressure wound therapy. The spacer material can be positioned between layers of film of the organ protection layer 1600. The spacer material can be sandwiched between the layers of film. The spacer material 1670 can have polyurethane directly behind fabric. The organ protection layer 1600 can have film layers, a protection layer, and a spacer layer. The film can be directly in contact with the spacer material 1670. The filler material 1672 can be sandwiched between the layers of film. The filler material 1672 can distribute fluid to and from the spacer material 1670. The spacer material 1670 can connect to a soft port.
[0117] FIG. 14 illustrates a further embodiment of organ protection layer 1700 configured in a criss cross design 1780 of filler material. The criss cross design 1780 of filler material can be a way of directing the fluid from all sides in abdomen towards the midline for fluid management. The criss cross design 1780 may mechanically facilitate medial compression.
[0118] FIG. 15 illustrates a further embodiment of organ protection layer 1800 comprising a plurality of rectangles 1882 of filler material arranged horizontally that are larger on the outside and can get smaller towards the center. In certain embodiments, this design may facilitate fluid transport and medial compression towards the center. The center can have a large rectangle 1884. The large rectangle 1884 can connect to the soft port. The rectangles 1882 and large rectangle 1884 can be spacer materials sandwiched between layers of film.
[0119] FIG. 16 illustrates a further embodiment of organ protection layer 1900 comprising a plurality of rectangles 1982 of filler material arranged horizontally and vertically that are larger on the outside and can get smaller towards the center. In certain embodiments, this design may facilitate fluid transport and medial compression towards the center. The center can have a large rectangle 1984. The large rectangle 1984 can connect to the soft port. The design can allow adaptability of the organ protection layer 1900 for various sizes. The rectangles 1982 and large rectangle 1984 can be spacer materials sandwiched between layers of film. A user can cut the organ protection layer 1900 between rectangles 1982. For example, the user can cut the film between the uppermost rectangle 1982. The organ protection layer 1900 can be cut to fit the size of the wound site. The organ protection layer 1900 can be thin. In some embodiments, the shape of the organ protection layer can assist with navigating and/or shaping the organ protection layer 1900 to fit centrally within the abdomen.
[0120] FIG. 17 is an example of stretchable compressible material 2000. The stretchable compressible material 2000 can act as a spacer material. The spacer material can be sandwiched in the organ protection layer and can help in fluid management and medial compression. The stretchable compressible material 2000 can be a double mesh spacer with mono filaments. The double mesh spacer can have mono filaments between the two mesh layers. The monofilaments can be manufactured at a 90° and 45° angle, or any suitable angle. The mono filaments manufactured at 45° angle can leave channels in the design. This can direct the user to cut the organ protection layer without shedding of fabric. The spacer can also be made of spun dyed yarn. The spacer can also be made of stretch spacer. The spacer fabric can also be used to help with fluid management by helping fluid move across and/or within the 3D fabric.
[0121] In certain embodiments, 3D spacer fabric can be moisture-wicking polyester. The stretchable spacer material, once stretched within the organ protection layer, can conform back to its original shape. This can help with medial compression and bringing the abdominal layers closer. The stretchable spacer material could be any stretchable material. The 3D spacer fabric can include silver. The fluid can stay within the material if negative pressure is no longer applied. In certain embodiments, silver may be added to prevent and limit bacterial growth.
[0122] FIG. 18 is an illustration of an example of a connector 3200 for cleaning abdominal wounds. The connector 3200 can irrigate a wound site with fluid and remove fluid from the wound site. The connector 3200 can be a Y-connector. Fluid can enter the connector 3200 at the intake port 3212, the intake port 3212 may be a luer connector with a one-way valve. Fluid can pass through the intake port 3212 into the intake branch 3202 of the connector 3200. The intake branch 3202 of the connector 3200 can be connected to a delivery branch 3204 and an output branch 3206 at a junction point 3208. The intake branch 3202 can allow for unidirectional flow. The intake branch 3202 can allow for inward flow. In certain embodiments, the connector 3200 can consist of a rotating valve that can allow fluid into the abdomen or fluid out of the abdomen. The valve can be configured to prevent fluid into the abdomen while allowing fluid out of the abdomen. The valve can be configured to allow fluid into the abdomen while preventing fluid out of the abdomen.
[0123] In some embodiments, fluid can flow from the intake branch 3202 through the junction point 3208 to the delivery branch 3204. The delivery branch 3204 can be connected to an organ protection layer covering the wound site at a delivery port 3214. Fluid can flow from the delivery branch 3204 through the delivery port 3214 into delivery tubes on the organ protection layer to irrigate the wound site. The delivery port 3214 can be a quick click connector. Fluid can flow from the wound site or delivery tubes 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.
[0124] In particular embodiments, fluid can flow from the delivery branch 3204 through the junction point 3208 to the output branch 3206. The output branch 3206 can be connected to a canister through a output port 3216. One example of a suitable canister is the RENASYS Device Canister available from Smith & Nephew. Fluid can flow from the output branch 3206 to the canister through the output port 3216. The output port 3216 can be a quick click connector. The output branch 3206 can allow for unidirectional flow. The output branch 3206 can allow for outward flow.
[0125] 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. Fluid can be delivered to the wound site and removed from the wound site to clean the wound site. The systems described herein can be used to clean the wound site during negative pressure treatment. As described further below in Figure 35, in certain embodiments a switch may be used to switch between the intake and output branches.
[0126] FIG. 19 is an example of an organ protection layer 3300 for covering abdominal wounds, such as described elsewhere herein. The organ protection layer 3300 can be placed on the wound site. In certain embodiments, the organ protection layer 3300 can seal to the wound site or may simply overlie the underlying tissue. The organ protection layer may serve to protect the underlying tissues from damage caused by the other components of an abdominal treatment system. The delivery port 3214 can connect the connector 3200 to the delivery tubes 3310. The delivery port 3214 can be a soft port. The delivery tubes 3310 can transfer fluid to the wound site. The delivery tubes 3310 can transfer fluid to the paracolic gutters of the abdomen. The delivery tubes 3310 can be made of spacer material, such as any suitable spacer material described herein. The organ protection layer 3300 can be transparent. The delivery tubes 3310 can be transparent.
[0127] In certain embodiments, the organ protection layer 3300 can be interchangeable with the pad 103. The organ protection layer 3300 can be interchangeable with the wound contact layer 105. The organ protection layer 3300 can be interchangeable with both the pad 103 and the wound contact layer 105. The organ protection layer 3300 can be rectangular. The organ protection layer 3300 can have round corners. The organ protection layer 3300 can have delivery tubes 3310 that extend to the corners of the organ protection layer 3300. The organ protection layer 3300 can have delivery tubes 3310 that extend to the sides of the organ protection layer 3300. In some examples, the organ protection layer may include one, two, three, four, five, six, seven, eight, nine, ten, fifteen, twenty or more delivery tubes. In certain embodiments, the organ protection layer 3300 can 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.
[0128] FIG. 20A is a top view of an embodiment of delivery tubes 1710 positioned between layers of spacer material. FIG. 20B is a perspective view of delivery tubes 1710 positioned between layers of spacer material. The delivery tubes 1710 can be in fluid communication with the interior of a spacer manifold 3400. The delivery tubes 1710 can be positioned beneath a top layer 4524 of spacer material. The delivery tubes 1710 can be positioned above a bottom layer (not pictured) of spacer material. The delivery tubes 1710 can carry fluid from the spacer material to the wound site. The delivery tubes 1710 can carry fluid from the wound site to the spacer material.
[0129] FIG. 21 is an illustration of an embodiment of an organ protection layer 3300’ for covering abdominal wounds. The organ protection layer 3300’ can be circular. The organ protection layer 3300’ can have delivery tubes 3310’ that extend along the radii of the organ protection layer 3300’ to the edge of the organ protection layer 3300’. The organ protection layer 3300’ can have eight delivery tubes 3310’ such as shown in the figure. However, one of skill in the art will understand that the organ protection layer may comprise any suitable number of delivery tubes.
[0130] FIG. 22 is an illustration of an example of a manifold 3500 for distributing liquid to the abdomen and/or removing fluid or exudate from the abdomen. The manifold 3500 can have ports 3550 that can connect to delivery tubes. The ports 3550 can extend from the exterior of the manifold 3500. The ports 3550 can have cavities in fluid communication with an inner cavity of the manifold 3500. The manifold 3500 can have vents 3560 that can aid with medial compression. The vents 3560 can allow fluids which may have seeped into the filler to release from the manifold 3500. The manifold 3500 can be octagonal. The manifold 3500 can have any suitable number of ports 3550. For example, the manifold of 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.
[0131] FIG. 23 is an illustration of an example of a manifold 3600 for distributing liquid to the abdomen and/or removing fluid or exudate from the abdomen. The manifold 3600 can have ports 3650 that can connect to delivery tubes. The ports 3650 can extend from the exterior of the manifold 3600. The ports 3650 can have cavities in fluid communication with an inner cavity of the manifold 3600. The ports 3650 can connect to round tubes. The manifold 3600 can be octagonal and may have any suitable number of ports, such as 8 ports 3650.
[0132] FIG. 24 is an illustration of another example of a manifold 3700 distributing liquid to the abdomen and/or removing fluid or exudate from the abdomen. The manifold 3700 can have ports 3750 that can connect to delivery tubes. The ports 3750 can extend from the exterior of the manifold 3700. The ports 3750 can have cavities in fluid communication with an inner cavity of the manifold 3700. The ports 3750 can connect to flat or oblong tubes. The manifold 3700 can be octagonal and may have any suitable number of ports, such as 8 ports 3750.
[0133] FIG. 25 is an illustration of another example of a manifold 3800 for distributing liquid to the abdomen and/or removing fluid or exudate from the abdomen. The manifold 3800 can have ports 3850 that can connect to delivery tubes. The ports 3850 can be flush with the exterior of the manifold 3800. The ports 3850 can have cavities in fluid communication with an inner cavity of the manifold 3800. The manifold 3800 can be kiteshaped. The manifold 3800 can have rounded corners. The manifold 3800 can have 6 ports 3850. The manifold 3800 can have an inner cavity that is divided by an inner wall 3870. The manifold 3800 can be a divider manifold. The inner wall 3870 of the manifold 3800 can separate a fluid removal portion and a fluid delivery portion. The manifold 3800 can have one side of the inner cavity for irrigation techniques. The manifold 3800 can have one side of the inner cavity for fluid removal. In certain embodiments, the inner wall 3870 may be removed if not required during use.
[0134] FIG. 26 is an illustration of another example of a manifold 3900 for distributing liquid. The manifold 3900 can have ports 3950 that can connect to delivery tubes. The ports 3950 can be flush with the exterior of the manifold 3900. The ports 3950 can have cavities in fluid communication with an inner cavity of the manifold 3900. The manifold 3900 can be disk-shaped. The manifold 3900 can be flower-shaped. The manifold 3900 can be flower disk-shaped. The shape of the manifold 3900 can allow for flexibility. The manifold 3900 can be tucked under the facia. The manifold 3900 can have 8 ports 3950. The manifold 3900 can have a gap 980 in the center. The gap 980 can connect with the delivery port 214.
[0135] FIG. 27 is an illustration of another example of a manifold 4000 for distributing liquid to the abdomen and/or removing fluid or exudate from the abdomen. The manifold 4000 can have ports 4050 that can connect to delivery tubes. The ports 4050 can be flush with the exterior of the manifold 4000. The ports 4050 can have cavities in fluid communication with an inner cavity of the manifold 4000. The manifold 4000 can be ovoid. The manifold 4000 can have 6 ports 4050. The manifold 4000 can be a filler manifold. Such a manifold 4000 can remove the need for a filler, by fitting through an opening in a tissue layer, such as the fascia.
[0136] FIG. 28 is an illustration of another example of a manifold 4100 for distributing liquid to the abdomen and/or removing fluid or exudate from the abdomen. The manifold 4100 can have ports 4150 that can connect to delivery tubes. The ports 4150 can be flush with the exterior of the manifold 4100. The ports 4150 can have cavities in fluid communication with an inner cavity of the manifold 4100. The manifold 4100 can be rectangular. The manifold 4100 can be curved. The manifold 4100 can have rounded corners. The manifold 4100 can have 6 ports 4150. The manifold 4100 can be a flat-bed manifold. The manifold 4100 can allow for variability of the location of the delivery port 214. [0137] The manifolds 3500, 3600, 3700, 3800, 3900, 4000, 4100 can connect with the delivery port 214. The manifolds 3500, 3600, 3700, 3800, 3900, 4000, 4100 can distribute fluid from the connector 200 to the wound site. The manifolds 3500, 3600, 3700, 3800, 3900, 4000, 4100 can remove fluid from the wound site to the connector 200. The manifolds 3500, 3600, 3700, 3800, 3900, 4000, 4100 can have 1 port, 2 ports, 3 ports, 4 ports, 5 ports, 6 ports, 7 ports, 8 ports, 9 ports, 10 ports, or more than 10 ports. The manifolds 3500, 3600, 3700, 3800, 3900, 4000, 4100 can be made of any one of polyurethane, silicone, foam, rubber, and polyisoprene. The manifolds 3500, 3600, 3700, 3800, 3900, 4000, 4100 can be colored or transparent. The manifolds 3500, 3600, 3700, 3800, 3900, 4000, 4100 can be of varying depths, this could sit within the filler and link directly with a drape or delivery port. The manifolds 3500, 3600, 3700, 3800, 3900, 4000, 4100 can under filler material. The manifolds 3500, 3600, 3700, 3800, 3900, 4000, 4100 can be various colors for improved visibility. The manifolds 3500, 3600, 3700, 3800, 3900, 4000, 4100 and delivery tubes can be used to distribute fluids and intake fluids from different areas of the wound site.
[0138] FIG. 29 is an illustration of an example of the manifold 3500 for distributing liquid of FIG. 5 connected to delivery tubes 4210. The delivery tubes 4210 can seal to the ports 3550.
[0139] FIG. 30 is an illustration of an example of the manifold 3800 for distributing liquid of FIG. 8 connected to delivery tubes 4310, 4320. The delivery tubes 4310, 4320 can seal to the ports 3550. The delivery tubes 4310 can deliver fluid to the wound site. The delivery tubes 4320 can remove fluid from the wound site. Delivery tubes 4310 can connect to the cavity on one side of the inner wall 3870. Delivery tubes 4320 can connect to the cavity on the other side of the inner wall 3870. The manifold 3800 can connect to two, four or more delivery tubes 4310. The manifold 3800 can connect to two, four, or more delivery tubes 4320.
[0140] In certain embodiments, delivery tubes can have varying diameter based on how well they handle various fluid viscosities. The shape of the tubing can be oblong, round, or triangular. The delivery tubes can have colors that make the organ protection layer more visible. The delivery tubes can be glued or welded to a manifold. The delivery tubes can be tacked to the organ protection layer film. The delivery tubes can sit between two layers of the organ protection layer film. A manifold can be adhered to the center of the organ protection layer film. The delivery tubes can be loose, allowing for a user to place the tubing where it is most required.
[0141] In some embodiments, transparent delivery tubes can allow surgeons to better see the wound site. A transparent organ protection layer can allow surgeons to better see the wound site. A transparent manifold can allow surgeons to better see the wound site. Using tubing, spacers, and manifolds can mitigate flow restriction, and provide a faster and more efficient evacuation of fluid.
[0142] FIG. 31 A is a perspective view of an embodiment of a flat delivery tube 4410. FIG. 3 IB is a front, cross-sectional view of a flat delivery tube 4410. The flat delivery tube 4410 can be oblong. The flat delivery tube 4410 can allow for pressure distribution on organs during use. The flat delivery tube 4410 can have teeth 4402, 4404. The teeth 4402, 4404 can be extruded through the center. The teeth 4402, 4404 can restrict the flat delivery tube 4410 from fully closing. The teeth 4402, 4404 can allow for improved fluid management from the gutters to the center of the organ protection layer. When the flat delivery tube 4410 is compressed, the bottom tooth 4402 can impact the top inner wall of the flat delivery tube 4410. Once the bottom tooth 4402 impacts the top inner wall, the bottom tooth is restricted from moving horizontally by the top teeth 4404.
[0143] FIG. 32 is an illustration of an embodiment of three flat delivery tubes 4410 on a bottom layer 4522 of spacer material. FIG. 33 is an illustration of an embodiment of a flat delivery tube 4410 positioned between a bottom layer 4522 of spacer material and a crosssection of a top layer 4524 of spacer material. In some embodiments, delivery tubes positioned between layers of spacer material can be in fluid communication without a manifold 3500, 3600, 3700, 3800, 3900, 4000, 4100. The top layer 4524 and bottom layer 4522 of spacer material can form a spacer manifold 3400. A flat delivery tube 4410, for example, can be compressed between two layers of spacer material, or spacers, to assist with fluid evacuation. A flat delivery tube 4410, for example, can be compressed between two layers of spacer material, or spacers, to assist with fluid transfer. The top layer 4524 and bottom layer 4522 of spacer material can be 3D printed.
[0144] In certain embodiments, the spacer manifold 3400, or flexible manifold, can be made of foam, 3D fabric, silver, or other materials with antimicrobial properties. The spacer manifold 3400 can be of varying depths. The spacer manifold 3400 can sit within the filler and link directly with the drape or delivery port. The spacer manifold 3400 can sit under the filler material. Using the spacer manifold 3400 can remove the need for an additional filler material to sit between the facia.
[0145] FIG. 34 is a schematic illustration of an embodiment of a system for cleaning abdominal wounds. Fluid can flow from a fluid source 4804 through an intake tube 4802. The fluid source 4804 can be a container of saline. 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 the delivery port 214 or soft port. Fluid can flow from the spacer manifold 3400 to delivery tubes 4810. The delivery tubes 4810 can be positioned across the organ protection layer 4800. Fluid can flow from the delivery tubes 4810 to the wound site. The fluid can, for example, enter the abdomen and spread evenly in the abdominal cavity. Fluid can flow from the wound site back into the delivery tubes 4810, and into the spacer manifold 3400. Fluid can flow from the spacer manifold 3400 through the delivery port 214 into the connector 200. Fluid can flow from the connector 200 through the output tube 4812 into the canister 4814. The canister 4814 can store fluid.
[0146] FIG. 35 is an illustration of an embodiment of a connector 4900 for cleaning abdominal wounds with an integrated switch 4912. The connector 4900 can include an intake branch 4902, a delivery branch 4904, and an output branch 4906 connected at a junction point 4908, similar to FIG. 18. The junction point 4908 can have an integrated switch 4912 or valve that allows a user to choose a direction of flow. The integrated switch 4912 can be replaced with a removable switch. The integrated switch 4912 or valve can restrict flow in a direction. For example, flow can be allowed into the delivery branch 4904, from the delivery branch 4904 to the output branch 4906, and outward from the output branch 4906 while flow is restricted into the intake branch 4902, from the intake branch 4902 to the delivery branch 4904, and outward from the delivery branch 4904. Conversely, flow can be restricted into the delivery branch 4904, from the delivery branch 4904 to the output branch 4906, and outward from the output branch 4906 while flow is allowed into the intake branch 4902, from the intake branch 4902 to the delivery branch 4904, and outward from the delivery branch 4904. In certain embodiments, the user can control whether fluid is removed from the wound site or delivered to the wound site. [0147] FIG. 36 is a front view of an example of an organ protection layer 5000 with slits 5060.
[0148] In some examples, the organ protection layer 5000 can be similar to the wound contact layers and organ protection layers described above. The organ protection layer 5000 can be placed in contact with the wound site. In some implementations, the organ protection layer 5000 can be minimally or non-adherent to the wound site and provided with slits 5060 or other openings for the removal of wound exudate or fluids and the application of negative pressure to the wound site. The slits 5060 can all point toward the center of the organ protection layer 5000 for visual guidance. A user may be able to identify a center of the organ protection layer 5000 based on the slits 5060 direction. One of skill in the art will understand that the slits described herein may be constructed as holes, openings, perforations, cuts, or other suitable structures.
[0149] In some examples, the slits 5060 can be formed through a depth along axis Z of the organ protection layer 5000. The slits 5060 can be linear slits. The organ protection layer 5000 can have four quadrants, or quarters. The slits 5060 can be directionally aligned with other slits in the same quadrant of the organ protection layer 5000. The slits 5060 can be directionally opposite to other slits in vertically and/or horizontally adjacent quadrants. Each slit 5060 can be disposed at an angle with respect to the horizontal axis X and vertical axis Y of the organ protection layer 5000. For example, each slit 5060 can be disposed at an angle of about 45 degrees with respect to the horizontal axis X of the organ protection layer 5000. In some implementations, each slit 5060 can be disposed at an angle between about 30 degrees and about 60 degrees with respect to the horizontal axis X of the organ protection layer 5000. In some implementations, each slit 5060 can be disposed at an angle between about 10 degrees and about 80 degrees with respect to the horizontal axis X of the organ protection layer 5000. In some implementations, each slit 5060 can be disposed at an angle of about 45 degrees with respect to the vertical axis Y of the organ protection layer 5000. In some implementations, each slit 5060 can be disposed at an angle of between about 30 degrees and about 60 degrees with respect to the vertical axis Y of the organ protection layer 5000. In some implementations, each slit 5060 can be disposed at an angle of between about 10 degrees and about 80 degrees with respect to the vertical axis Y of the organ protection layer 5000. For example, about 20 degrees, about 40 degrees, or about 70 degrees. [0150] In some examples, the slits 5060 in horizontally or vertically adjacent quadrants of the organ protection layer 5000 can be angled away from each other. For example, slits 5060 in horizontally or vertically adjacent quadrants of the organ protection layer 5000 can be facing away from one another at an angle B of about 90 degrees. In some implementations, the angle B can be between about 80 degrees and about 100 degrees. In some implementations, the angle B can be between about 50 degrees and about 130 degrees.
[0151] In some examples, the organ protection layer 5000 can have a width along the horizontal axis X of 660 mm. In some implementations, the organ protection layer 5000 can have a width along the horizontal axis X of between about 655 mm and about 665 mm. In some implementations, the organ protection layer 5000 can have a width along the horizontal axis X of between about 600 mm and about 700 mm. In some implementations, the organ protection layer 5000 can have a width along the horizontal axis X of between about 400 mm and about 900 mm. In some implementations, the organ protection layer 5000 can have a width along the horizontal axis X of between about 100 mm and about 1200 mm.
[0152] In some implementations, the organ protection layer 5000 can have a length along the vertical axis Y of about 800 mm. In some implementations, the organ protection layer 5000 can have a length along the vertical axis Y of between about 795 mm and about 805 mm. In some implementations, the organ protection layer 5000 can have a length along the vertical axis Y of between about 700 mm and about 900 mm. In some implementations, the organ protection layer 5000 can have a length along the vertical axis Y of between about 500 mm and about 1100 mm. In some implementations, the organ protection layer 5000 can have a length along the vertical axis Y of between about 100 mm and about 1500 mm.
[0153] In some examples, the organ protection layer 5000 can have a depth along axis Z (not shown). In some implementations, the depth along axis Z can be 0.1 mm. In some implementations, the depth along axis Z can be between about 0.05 mm and about 0.5 mm. In some implementations, the depth along axis Z can be between about 0.01 mm and about 1 mm. In some implementations, the depth along axis Z can be between about 0.001 mm and about 10 mm.
[0154] In some examples, each slit 5060 can have a length. In some implementations, each slit 5060 can have a length of 4 mm. In some implementations, each slit 5060 can have a length of between about 3 mm and about 5 mm. In some implementations, each slit 5060 can have a length of between about 1 mm and about 7 mm. In some implementations, each slit 5060 can have a length of between about 0.1 mm and about 10 mm.
[0155] In some examples, the slits 5060 in the same quadrant can be separated by a first space from an end of the slit 5060 to the end of the adjacent slit. The slits 5060 in the same quadrant can be separated by a second space from an edge of the slit 5060 to the edge of the adjacent slit. In some implementations, slits 5060 in the same quadrant can have a first space between them of 16 mm. In some implementations, slits 5060 in the same quadrant can have a first space between them of between about 11 mm and about 21 mm. In some implementations, slits 5060 in the same quadrant can have a first space between them of between about 1 mm and about 30 mm. In some implementations, slits 5060 in the same quadrant can have a second space between them of 10 mm. In some implementations, slits 5060 in the same quadrant can have a second space between them of between about 5 mm and about 25 mm. In some implementations, slits 5060 in the same quadrant can have a second space between them of between about 1 mm and about 30 mm.
[0156] FIG. 37A is a front view of an example of an organ protection layer 5100 with spacer material 5170. FIG. 37B is a perspective exploded view of the example of the organ protection layer 5100 with spacer material 5170 of FIG. 37A. FIG. 37C shows a front view of the example of the spacer material 5170 of FIG. 37A.
[0157] In some examples, the organ protection layer 5100 can be similar to the wound contact layers and organ protection layers described above. The organ protection layer 5100 can include a top film layer 5172 and a bottom film layer 5174. The film layers 5172, 5174 can be bonded at welded areas 5176. In some implementations, the film layers 5172, 5174 can be bonded at welded areas 5176 using welding, adhesive, and/or another method of bonding. Spacer material 5170 can be sealed between the top film layer 5172 and bottom film layer 5174. In some implementations, the spacer material 5170 can be sealed within welded areas 5176 to prevent the spacer material 5170 from moving in the interior of the organ protection layer 5100. The spacer material 5170 can assist with fluid evacuation by transferring fluid across the organ protection layer 5100.
[0158] In some examples, the top film layer 5172 and bottom film layer 5174 can be sealed around the entire perimeter of the organ protection layer 5100. The organ protection layer 5100 can include slits in the film layers 5172, 5174, for example those described with respect to FIG. 36. In some implementations, the organ protection layer 5100 can include a welded area radially outward from the outermost spacer material 5170d. In some implementations, the organ protection layer 5100 can include a welded area around the perimeter of the organ protection layer 5100.
[0159] In some examples, the spacer material 5170 can include a central spacer material 5170a positioned at the center of the organ protection layer 5100. The central spacer material 5170a can be circular or ovoid. Around the central spacer material 5170a, the organ protection layer 5100 can include three rings of spacer material 5170b,c,d., which may be curved or straight. These rings of spacer material can include innermost spacer material 5170b, intermediate spacer material 5170c, and outermost spacer material 5170d. In some implementations, the organ protection layer 5100 can include between 1 and 5 rings of spacer material around the center. In some implementations, the organ protection layer 5100 can include between 1 and 10 rings of spacer material around the center. Advantageously, the central spacer material 5170a can indicate where the organ protection layer 5100 should be placed on a wound site. For example, the organ protection layer 5100 can be positioned such that the central spacer material 5170a is approximately aligned with a center of the wound site.
[0160] In certain examples, the spacer material 5170 can include innermost spacer material 5170b. The innermost spacer material 5170b can be positioned radially around the central spacer material 5170a. The innermost spacer material 5170b can be shaped as a curved line or semicircle. In some implementations, the organ protection layer 5100 can include 8 pieces of innermost spacer material 5170b. In some implementations, the organ protection layer 5100 can include between 4 and 12 pieces of innermost spacer material 5170b. In some implementations, the organ protection layer 5100 can include between 1 and 15 pieces of innermost spacer material 5170b. In some implementations, the organ protection layer 5100 can include between 1 and 20 pieces of innermost spacer material 5170b. The innermost spacer material 5170b, intermediate spacer material 5170c, and/or outermost spacer material 5170d can be curved or arcuate in shape.
[0161] In some examples, the spacer material 5170 can include intermediate spacer material 5170c. The intermediate spacer material 5170c can be positioned radially around the innermost spacer material 5170b. The intermediate spacer material 5170c can be shaped as a curved line or semicircle. In some implementations, the organ protection layer 5100 can include 8 pieces of intermediate spacer material 5170c. In some implementations, the organ protection layer 5100 can include between 4 and 12 pieces of intermediate spacer material 5170c. In some implementations, the organ protection layer 5100 can include between 1 and 15 pieces of intermediate spacer material 5170c.
[0162] In some examples, the spacer material 5170 can include outermost spacer material 5170d. The outermost spacer material 5170d can be positioned radially around the intermediate spacer material 5170c. The outermost spacer material 5170d can be shaped as a curved line or semicircle. In some implementations, the organ protection layer 5100 can include 8 pieces of outermost spacer material 5170d. In some implementations, the organ protection layer 5100 can include between 4 and 12 pieces of outermost spacer material 5170d. In some implementations, the organ protection layer 5100 can include between 1 and 15 pieces of outermost spacer material 5170d.
[0163] In some examples, the organ protection layer 5100 can include a welded area 5176 between the central spacer material 5170a and the innermost spacer material 5170b. The organ protection layer 5100 can include a welded area 5176 between the innermost spacer material 5170b and the intermediate spacer material 5170c. The organ protection layer 5100 can include a welded area 5176 between the intermediate spacer material 5170c and the outermost spacer material 5170d. In some implementations, the organ protection layer 5100 can include a welded area 5177 radially outward from the outermost spacer material 5170d. The welded area 5177 can be along the perimeter of the organ protection layer 5100.
[0164] As shown in FIG. 37C, in certain examples, each level of spacer material can be arranged along a ring or oval. In some examples, each level of spacer material can be arranged along a triangle, square, or rectangle. Each ring of spacer material can have an advantageous major diameter and minor diameter for transfer of fluid. The major diameter of each ring of spacer material can be the largest diameter, while the minor diameter of each ring of spacer material can be the smallest diameter. The major diameters and minor diameters can be measured from the centers of the rings of spacer material.
[0165] In some implementations, the minor diameter DB 1 of the innermost spacer material 5170b is 228 mm. In some implementations, the minor diameter DB1 of the innermost spacer material 5170b is between 200 and 250 mm. In some implementations, the minor diameter DB1 of the innermost spacer material 5170b is between 100 and 400 mm. In some implementations, the major diameter DB2 of the innermost spacer material 5170b is 271 mm. In some implementations, the major diameter DB2 of the innermost spacer material 5170b is between 250 and 300 mm. In some implementations, the major diameter DB2 of the innermost spacer material 5170b is between 150 and 450 mm.
[0166] In some implementations, the minor diameter DC1 of the intermediate spacer material 5170c is 390 mm. In some implementations, the minor diameter DC1 of the intermediate spacer material 5170c is between 350 and 400 mm. In some implementations, the minor diameter DC1 of the intermediate spacer material 5170c is between 200 and 550 mm. In some implementations, the major diameter DC2 of the intermediate spacer material 5170c is 463 mm. In some implementations, the major diameter DC2 of the intermediate spacer material 5170c is between 450 and 500 mm. In some implementations, the major diameter DC2 of the intermediate spacer material 5170c is between 300 and 650 mm.
[0167] In some implementations, the minor diameter DD1 of the outermost spacer material 5170d is 567 mm. In some implementations, the minor diameter DD1 of the outermost spacer material 5170d is between 550 and 600 mm. In some implementations, the minor diameter DD1 of the outermost spacer material 5170d is between 400 and 750 mm. In some implementations, the major diameter DD2 of the outermost spacer material 5170d is 683 mm. In some implementations, the major diameter DD2 of the outermost spacer material 5170d is between 650 and 700 mm. In some implementations, the major diameter DD2 of the outermost spacer material 5170d is between 500 and 850 mm.
[0168] The spacer material 5170 can have a depth along dimension Z (not shown). In some implementations, the spacer material 5170 can have a depth along dimension Z of 3 mm. In some implementations, the spacer material 5170 can have a depth along dimension Z of between about 1 mm and about 5 mm. In some implementations, the spacer material 5170 can have a depth along dimension Z of between about 0.1 mm and about 10 mm.
[0169] In some examples, the innermost spacer material 5170b can have a curvature degree. The innermost spacer material 5170b can have a radius at each rounded end. In some implementations, the curvature degree is about 20 degrees. In some implementations, the curvature degree is between about 10 degrees and about 30 degrees. In some implementations, the curvature degree is between about 0 degrees and 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 between about 5 mm and about 25 mm. In some implementations, the radius at the rounded end is between about 1 mm and about 30 mm.
[0170] In some examples, the intermediate spacer material 5170c can have a curvature degree. The intermediate spacer material 5170c can have a radius at each rounded end. In some implementations, the curvature degree is about 32 degrees. In some implementations, the curvature degree is between about 20 degrees and about 40 degrees. In some implementations, the curvature degree is between 0 degrees and 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 between about 5 mm and about 25 mm. In some implementations, the radius at the rounded end is between about 1 mm and about 30 mm.
[0171] In some examples, the outermost spacer material 5170d can have a curvature degree. The outermost spacer material 5170d can have a radius at each rounded end. In some implementations, the curvature degree is about 11 degrees. In some implementations, the curvature degree is between about 5 degrees and 20 about degrees. In some implementations, the curvature degree is between about 0 degrees and about 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 between about 5 mm and about 25 mm. In some implementations, the radius at the rounded end is between about 1 mm and about 30 mm.
[0172] FIG. 38 is a top view of an example of a pad 2203.
[0173] In some examples, the pad 5203 can be used in the negative pressure wound treatment systems described herein, for example with respect to FIGs. 1A and IB. In certain implementations of the negative pressure treatment system, the pad 5203 can be disposed over a wound contact layer. This pad 5203 can be constructed from a porous material, for example foam, that is soft, resiliently flexible, and generally conformable to the wound site. Such a foam can include an open-celled and reticulated foam made, for example, of a polymer. Suitable foams include foams composed of, for example, polyurethane, silicone, and polyvinyl alcohol. Preferably, this pad 5203 can channel wound exudate and other fluids through itself when negative pressure is applied to the wound. The pad 5203 may include preformed channels or openings 2384 for such purposes.
[0174] In certain implementations, the pad 5203 may have a thickness of about 25 mm. In some implementations, the pad 5203 may have a thickness of between about 10 mm and about 40 mm. In some implementations, the pad 5203 may have a thickness of between about 5 mm and about 60 mm. In some implementations, the pad 5203 may have a thickness of between about 1 mm and about 80 mm.
[0175] In some examples, the pad 5203 may have a length of between about 400 mm and about 450 mm. In some implementations, the pad 5203 may have a length of between about 350 mm and about 500 mm. In some implementations, the pad 5203 may have a length of between about 300 mm and about 600 mm. In some implementations, the pad 5203 may have a length of between about 100 mm and about 1,000 mm.
[0176] In some examples, the pad 5203 may have a width of between about about 525 mm and about 275 mm. In some implementations, the pad 5203 may have a length of between about 200 mm and about 300 mm. In some implementations, the pad 5203 may have a length of between about 100 mm and about 400 mm. In some implementations, the pad 5203 may have a length of between about 50 mm and about 800 mm. In other implementations, the thickness, width, and/or length can have other suitable values.
[0177] In some examples, the pad 5203 can be oculiform. In some implementations, the pad 5203 can be round or ovoid. The pad 5203 can have corners 5280 on both sides of the pad 5203. The corners 5280 can be rounded corners.
[0178] In some examples, the pad 5203 can include slits or cuts 5282. The cuts 5282 may provide regions of flexibility for the pad 5203 and/or make portions of the pad 5203 easily separable. The cuts 5282 may be arcuate perforations formed in an elliptical pattern. The cuts 5282 can extend through at least a portion of the thickness of the pad to define a pad section detachable from the pad to permit the pad to be sized. In some implementations, the cuts 5282 may allow removal of portions of the porous pad 5203 in a dimensionally- independent manner wherein a length and a width of the pad 5203 can be modified independently of each other. A user can remove portions of the pad 5203 along the cuts 5282 such that the pad 5203 fits on the wound site. The pad 5203 preferably comprises a generally planar shape with a thickness less than its width and length, and preferably comprises at least one cut 5282 extending through a least a portion of the thickness of the pad 5203, whereby the cut 5282 defines a pad section detachable from the remainder of the pad 5203 so as to permit modification of the size of the pad 5203 (for example its length and/or width). In certain implementations, the cuts 5282 may be comprised of arcuate and/or elliptical cuts, and may further comprise additional inner and outer cuts. In further implementations, additional intermediate cuts may also be present.
[0179] In some examples, the pad 5203 may include outer cuts 5282a around the pad 5203. The outer cuts 5282a can allow an outermost portion 5286 of the pad 5203 to be removed. The outer cuts 5282a can be parallel to the corresponding edge of the pad 5203. The outer cuts 5282a can be curved lines. The outer cuts 5282a can be arranged in an oculiform shape. The pad 5203 can include four outer cuts 5282a. In some implementations, the pad 5203 can include 2-6 outer cuts 5282a. In some implementations, the pad 5203 can include 1-10 outer cuts 5282a.
[0180] In some examples, the pad 5203 may include inner cuts 5282b around the pad 5203. The inner cuts 5282b may be radially between the outer cuts 5282a and the openings 5284. The inner cuts 5282b can allow an outermost portion 5286 and intermediate portion 5288 of the pad 5203 to be removed. The inner cuts 5282b can be parallel to the corresponding edge of the pad 5203. The inner cuts 5282b can be curved lines. The inner cuts 5282b can be arranged in an oculiform shape. The pad 5203 can include four inner cuts 5282b. In some implementations, the pad 5203 can include 2-6 inner cuts 5282b. In some implementations, the pad 5203 can include 1-10 inner cuts 5282b.
[0181] In some examples, the pad 5203 can include openings 5284. The openings 5284 may be used for channeling wound exudate and distributing negative pressure through the pad 5203. The openings 5284 can extend entirely through the thickness of the pad 5203. Each opening 5284 can have a length along the outer edge of the opening 5284 of between about 13 mm and 14 mm. In some implementations, each opening 5284 can have a length along the outer edge of the opening 5284 of between about 10 mm and 20 mm. In some implementations, each opening 5284 can have a length along the outer edge of the opening 5284 of between about 5 mm and 30 mm. Each opening 5284 can have a length along the inner edge of the opening 5284 of between about 5 mm and 6 mm. In some implementations, each opening 5284 can have a length along the inner edge of the opening 5284 of between about 2 mm and 9 mm. In some implementations, each opening 5284 can have a length along the inner edge of the opening 5284 of between about 0.5 mm and 20 mm.
[0182] In some examples, each opening 5284 can be shaped as two linear apertures forming an acute angle. In some implementations, each opening 5284 can be triangular or arrowhead shaped. The openings 5284 can be shaped to reduce tissue pullup while applying negative pressure. Each opening 5284 can have a broader end closer to the center of the pad 5203 along the X axis. Each opening 5284 can have a point further from the center of the pad 5203 along the X axis. The pad 5203 can have 88 openings 5284. In some implementations, the pad 5203 can have 50 to 100 openings 5284. In some implementations, the pad 5203 can have 25 to 125 openings 5284. In some implementations, the pad 5203 can have 10 to 150 openings 5284. Each opening 5284 can point toward the center of the pad 5203.
[0183] In some examples, the openings 5284 can be arranged in a diamond shape. The openings 5284 can be arranged in the center of the pad 5203. The openings 5284 can be arranged in columns. The columns of openings 5284 toward the center along the X axis can include more openings 5284 than the columns of openings 5284 at the ends further from the center. The number of openings 5284 in each column can gradually decrease in each column further from the center along the X axis.
[0184] FIG. 39A is a side view of an example of a suction adapter 5313. FIG. 39B is a top view of the example of the suction adapter 5313 of FIG. 39A. FIG. 39C is a rear view of the example of the suction adapter 5313 of FIG. 39A. FIG. 39D is a front view of the example of the suction adapter 5313 of FIG. 39A. FIG. 39E is a bottom view of the example of the suction adapter 5313 of FIG. 39A. FIG. 39F is a cross-sectional view of the example of the suction adapter 5313 of FIG. 39A taken parallel to the X axis shown in FIG. 39B.
[0185] In some examples, the suction adapter 5313 may be used as a port as described with respect to FIGs. 1A and IB. The suction adapter 5313 may be a rigid or hard port. The suction adapter 5313 may be an applicator or fluidic connector for negative pressure to a wound site.
[0186] In some examples, the suction adapter 5313 can include a base flange 5390, a suction port 5392, and an air leak port 5396. The base flange 5390 can be positioned on a wound site to enable negative pressure therapy. In some examples, the base flange 5390 can be positioned on a hole in a drape. Negative pressure may be applied to a dressing, pad, and/or wound site through the suction channel 5393, which can cause air to flow through the air leak channel 5397 to the dressing, pad, and/or wound site.
[0187] In certain examples, the suction adapter 5313 can include an overhang portion 5399, or shroud. The overhang portion 5399 can include the suction port 5392. The overhang portion 5399 can be disposed above the base flange 5390. The overhang portion 5399 can prevent a user’s finger from blocking the flow through the suction adapter 5313. The suction adapter 5313 can be sloped upward in shape from the overhang portion 5399 to the air leak port 5396.
[0188] In some examples, the overhang portion 5399 can be about 5 mm long. In some implementations, the overhang portion 5399 can be between about 2 mm and about 8 mm long. In some implementations, the overhang portion 5399 can be between about 1 mm and about 10 mm long. In some implementations, the overhang portion 5399 can be between about 0.1 mm and about 20 mm long. The overhang portion 5399 can have an increased length to increase the depth of the suction channel 5393. Advantageously, a deeper suction channel 5393 can engage the conduit along a greater length.
[0189] As shown in FIG. 39E, the suction adapter 5313 may comprise at least one suction aperture 5394 designed to be placed over a wound site, and which can serve to fluidically connect the wound site to the source of negative pressure. The suction adapter 5313 may comprise at least one air leak aperture 5398 designed to be placed over a wound site, and which can serve as an air leak and a conduit to draw air to the wound site.
[0190] In some examples, the suction channel 5393 may fluidically connect the suction aperture 5394 to the suction port 5392. The suction adapter 5313 may be connected to the source of negative pressure via a conduit. The conduit can connect to the suction port 5392 of the suction adapter 5313. The suction adapter 5313 may be situated such that the suction aperture 5394 is positioned over an aperture in a drape. The suction aperture 5394 can be D shaped or at least partially semicircular. In some examples, the suction aperture 5394 can be a rectangle with two rounded corners.
[0191] In some examples, the air leak channel 5397, or air bleed channel, may fluidically connect the air leak aperture 5398 to the air leak port 5396. The suction adapter 5313 may be situated such that the air leak aperture 5398 is positioned over an aperture in a drape. Air can flow through the air leak port 5396, through the air leak channel 5397, to the air leak aperture 5398. Air from the air leak aperture 5398 can aerate the wound site and then flow through the suction aperture 5394.
[0192] In some examples, the air leak port 5396 can have a larger diameter than the suction port 5392. For example, the air leak port 5396 may be approximately twice as large as the suction port 5392. In some implementations, the air leak port 5396 may be between approximately 1.5 times and approximately 3 times as large as the suction port 5392. In some implementations, the air leak port 5396 may be between approximately 1.25 times and approximately 5 times as large as the suction port 5392.
[0193] In some examples, the air leak port 5396 can have an inner diameter of approximately 52 mm. In some implementations, the air leak port 5396 can have an inner diameter of between approximately 40 mm and approximately 60 mm. In some implementations, the air leak port 5396 can have an inner diameter of between approximately 20 mm and approximately 80 mm. In some implementations, the air leak port 5396 can have an inner diameter of between approximately 10 mm and approximately 100 mm.
[0194] In some examples, the suction port 5392 can have an inner diameter of approximately 25 mm. In some implementations, the suction port 5392 can have an inner diameter of between approximately 15 mm and approximately 35 mm. In some implementations, the suction port 5392 can have an inner diameter of between approximately 5 mm and approximately 50 mm. In some implementations, the suction port 5392 can have an inner diameter of between approximately 1 mm and approximately 75 mm.
[0195] In some examples, the air leak channel 5397 can include a filter. For example, the air leak channel 5397 can include a vertically oriented filter. The filter may be positioned adjacent to the air leak port 5396. In some examples, the filter can be thermally welded to the suction adapter 5313. The filter can filter particles from the air as they enter the suction adapter 5313. This filter arrangement may improve the safety and effectiveness of the negative pressure wound treatment by preventing certain particles from entering the wound site.
[0196] In some examples, the source of negative pressure may be a vacuum source. Vacuuming from the suction aperture 5394 to the wound site can cause wound exudate to flow through the suction adapter 5313.
[0197] As shown in FIG. 39F, the suction adapter 5313 can have an inner wall 5391 separating the suction channel 5393 from the air leak channel 5397. The inner wall 5391 can prevent the wound exudate from entering the air leak channel 5397 from the suction channel 5393. A user can determine whether the suction adapter 5313 is in fluid communication with the wound site by flow through the suction channel 5393 or suction port 5392. The presence of flow in the suction channel 5393 or suction port 5392 can indicate proper fluid communication with the wound site, as the air leak channel 5397 is separated from the suction channel 5393 by the inner wall 5391, so flow through the suction channel 5393 would be obstructed if the suction aperture 5394 were blocked, for instance by a drape. Conversely, other suction adapters would still have flow through the suction channel 5393 when the suction aperture 5394 is blocked due to the lack of the inner wall 5391, as air would still flow from the air leak channel 5397 to the suction channel 5393. Fluid communication with the wound site can include fluid communication with a foam pad in contact with the wound site.
[0198] In some examples, the suction adapter 5313 may be used to detect whether the negative pressure system is connected with the foam pad. If there is a blockage in the suction adapter 5313 or the negative pressure system, or if the suction adapter 5313 is not positioned over a hole in the drape, the suction aperture 5394 would not drain wound exudate. In this example, a user may determine that a lack of wound exudate indicates a blockage or improper positioning of the suction adapter 5313.
[0199] In some examples, the suction adapter 5313 may be comprised of molded plastic. The suction adapter 5313 may be rigid enough to prevent collapse of the suction adapter 5313. For example, the suction adapter 5313 may withstand about 250 mmHg. In some implementations, the suction adapter 5313 may withstand between about 200 mmHg and about 300 mmHg. In some implementations, the suction adapter 5313 may withstand between about 100 mmHg and about 500 mmHg.
[0200] In certain examples, the suction adapter 5313 can include indentations 5387 for handling by a user. For example, the indentations 5387 can be sized to receive a user’s fingers. A user can grip the indentations 5387 with the user’s fingers to move and/or position the suction adapter 5313.
[0201] FIGs. 40-48 show examples of organ protection layers with spacer material positioned between film layers. Any of the features of FIGs. 40-48 can be combinable with other embodiments/examples described herein.
[0202] FIG. 40 shows an example of an organ protection layer 5400 with spacer material 5470.
[0203] The organ protection layer 5400 can include any of the features of the organ protection layer 5100 of FIG. s 37A-C. The organ protection layer 5400 can have welded areas 5476 separating areas of the organ protection layer 5400. The organ protection layer 5400 can include film layers 5472 with spacer material 5470 disposed between the layers. The spacer material 5470 can be elliptical, for example circular or ovoid. The organ protection layer 5400 can include an outermost ring, a middle ring, and a central portion of spacer material. In some examples, the central portion of spacer material can be shaped as a ring, for example a circle or oval with a space in the center.
[0204] In some examples, the organ protection layer 5400 can include 8 portions of spacer material in the outermost ring. The organ protection layer 5400 can include 4-12 portions of spacer material in the outermost ring. The organ protection layer 5400 can include 2-15 portions of spacer material in the outermost ring.
[0205] In some examples, the organ protection layer 5400 can include 8 portions of spacer material in the middle ring. The organ protection layer 5400 can include 4-12 portions of spacer material in the middle ring. The organ protection layer 5400 can include 2-15 portions of spacer material in the middle ring.
[0206] FIG. 41 shows an example of an organ protection layer 5500 with spacer material 5570.
[0207] The organ protection layer 5500 can include any of the features of the organ protection layer 5100 of FIG.s 37A-C. Th The organ protection layer 5500 can include film layers 5572 with spacer material 5570 disposed between the layers. The spacer material 5570 can be elliptical, for example circular or ovoid. The spacer material 5570 can be arranged in a cruciform or asterix shape. The spacer material 5570 can include one central portion, multiple portions aligned vertically above and below the central portion, multiple portions aligned horizontally on either side of the central portion, and/or multiple portions arranged diagonally from the central portion.
[0208] In some examples, the spacer material 5570 can include 3 portions aligned vertically above and 3 portions vertically below the central portion. The spacer material 5570 can include 1-5 portions aligned vertically above and 1-5 portions vertically below the central portion. In some examples, the spacer material 5570 can include 3 portions aligned horizontally on one side and 3 portions horizontally on the other side the central portion. The spacer material 5570 can include 1-5 portions aligned horizontally on one side and 1-5 portions horizontally on the other side of the central portion. In some examples, the spacer material 5570 can include 2 portions aligned diagonally in each of four directions from the central portion. The spacer material 5570 can include 1-5 portions aligned diagonally in each of four directions from the central portion.
[0209] FIG. 42 shows an example of an organ protection layer 5600 with spacer material 5670.
[0210] The organ protection layer 5600 can include any of the features of the organ protection layer 5100 of FIG. s 37A-C. The organ protection layer 5600 can include spacer material 5670 disposed between film layers 5672. In some examples, the organ protection layer 5600 can include 21 portions of spacer material 5670. The organ protection layer 5600 can include 10-30 portions of spacer material 5670. The organ protection layer 5600 can include 5-40 portions of spacer material 5670.
[0211] FIG. 43 shows an example of an organ protection layer 5700 with spacer material 5770.
[0212] In some examples, the organ protection layer 5700 can include any of the features of the organ protection layer 5100 of FIGs 37A-C. The organ protection layer 5700 can include spacer material 5770 disposed between film layers 5772. In some examples, the organ protection layer 5700 can include 25 portions of spacer material 5770. The organ protection layer 5700 can include 10-30 portions of spacer material 5770. The organ protection layer 5700 can include 5-40 portions of spacer material 5770.
[0213] In some examples, the organ protection layer 5700 can include 3 rings of spacer material 5770 and one central portion of spacer material 5770. The organ protection layer 5700 can include 1-5 rings of spacer material 5770 and one central portion of spacer material 5770. The film layers 5772 around each ring of spacer material 5770 can include welded areas 5776. In some examples, each ring of spacer material 5770 can include 8 portions of spacer material 5770. Each ring of spacer material 5770 can include 5-10 portions of spacer material 5770. Each ring of spacer material 5770 can include 2-15 portions of spacer material 5770. The spacer material 5770 in the rings can be ovoid. The central spacer material 5770 can be ovoid. The spacer material 5770 in the rings can be narrower than the central spacer material 5770.
[0214] FIG. 44 shows an example of an organ protection layer 5800 with spacer material 5870. [0215] In some examples, the organ protection layer 5800 can include any of the features of the organ protection layer 5100 of FIG.s 37A-C. The organ protection layer 5800 can include spacer material 5870 disposed between film layers 5872. In some examples, the organ protection layer 5800 can include 25 portions of spacer material 5870. The organ protection layer 5800 can include 10-30 portions of spacer material 5870. The organ protection layer 5800 can include 5-40 portions of spacer material 5870.
[0216] In some examples, the organ protection layer 5800 can include 3 rings of spacer material 5870 and one central portion of spacer material 5870. The organ protection layer 5800 can include 1-5 rings of spacer material 5870 and one central portion of spacer material 5870. The film layers 5872 around each ring of spacer material 5870 can include welded areas 5876. In some examples, each ring of spacer material 5870 can include 8 portions of spacer material 5870. Each ring of spacer material 5870 can include 5-10 portions of spacer material 5870. Each ring of spacer material 5870 can include 2-15 portions of spacer material 5870. The spacer material 5870 in the rings can be curved, pill-shaped, and/or stadium-shaped. The central spacer material 5870 can be ovoid.
[0217] FIG. 45 shows an example of an organ protection layer 5900 with spacer material 5970.
[0218] In some examples, the organ protection layer 5900 can include any of the features of the organ protection layer 5100 of FIG.s 37A-C. The organ protection layer 5900 can include spacer material 5970 disposed between film layers 5972. In some examples, the organ protection layer 5900 can include 32 portions of spacer material 5970. The organ protection layer 5900 can include 25-50 portions of spacer material 5970. The organ protection layer 5900 can include 10-80 portions of spacer material 5970.
[0219] In some examples, the organ protection layer 5900 can include 4 rings of spacer material 5970 and one central portion of spacer material 5970. The organ protection layer 5900 can include 1-10 rings of spacer material 5970 and one central portion of spacer material 5970. In some examples, the film layers 5972 between the second outermost ring and the third outermost ring of spacer material 5970 can be separated by a welded area 5976. In some examples, the film layers 5972 between the central spacer material 5970 and the innermost ring of spacer material 5970 can be separated by a welded area 5976. In some examples, each ring of spacer material 5970 can include 8 portions of spacer material 5970. Each ring of spacer material 5970 can include 5-10 portions of spacer material 5970. Each ring of spacer material 5970 can include 2-15 portions of spacer material 5970. The spacer material 5970 in the rings can be circular. The central spacer material 5970 can be ring-shaped, for example circular or ovoid with a space in the center.
[0220] FIG. 46 shows an example of an organ protection layer 6000 with spacer material 6070.
[0221] In some examples, the organ protection layer 6000 can include any of the features of the organ protection layer 5100 of FIG.s 37A-C. The organ protection layer 6000 can include spacer material 6070 disposed between film layers 6072. In some examples, the organ protection layer 6000 can include 6 portions of spacer material 6070. The organ protection layer 6000 can include 3-10 portions of spacer material 6070. The organ protection layer 6000 can include 1-15 portions of spacer material 6070.
[0222] In some examples, the organ protection layer 6000 can include 2 rings of spacer material 6070 and one central portion of spacer material 6070. The organ protection layer 6000 can include 1-10 rings of spacer material 6070 and one central portion of spacer material 6070. In some examples, the outermost ring of spacer material 6070 can include 4 portions of spacer material 6070. The outermost ring of spacer material 6070 can include 1-8 portions of spacer material 6070. The outermost ring of spacer material 6070 can be shaped as curved rectangles, semi-circles, or semi-ovals with ovoid spaces within them. In some examples, each curved rectangle of spacer material 6070 can include 2 ovoid spaces. Each curved rectangle of spacer material 6070 can include 1-5 ovoid spaces. In some examples, the second outermost ring of spacer material 6070 can include 1 portion of spacer material 6070. The second outermost ring of spacer material 6070 can include 1-5 portions of spacer material 6070. The second outermost ring of spacer material 6070 can be shaped as a circle or oval with ovoid spaces within the ring. In some examples, the second outermost ring of spacer material 6070 can include 8 ovoid spaces. The second outermost ring of spacer material 6070 can include 5-10 ovoid spaces. The central spacer material 6070 can be ring-shaped, for example circular or ovoid with a space in the center.
[0223] FIG. 47 shows an example of an organ protection layer 6100 with spacer material 6170. [0224] In some examples, the organ protection layer 6100 can include any of the features of the organ protection layer 5100 of FIG.s 37A-C. The organ protection layer 6100 can include spacer material 6170 disposed between film layers 6172. In some examples, the organ protection layer 6100 can include 17 portions of spacer material 6170. The organ protection layer 6100 can include 10-20 portions of spacer material 6170. The organ protection layer 6100 can include 5-30 portions of spacer material 6170.
[0225] In some examples, the organ protection layer 6100 can include 2 rings of spacer material 6170 and one central portion of spacer material 6170. The organ protection layer 6100 can include 1-10 rings of spacer material 6170 and one central portion of spacer material 6170. In some examples, the outermost ring of spacer material 6170 can include 4 portions of spacer material 6170. The outermost ring of spacer material 6170 can include 1-8 portions of spacer material 6170. The outermost ring of spacer material 6170 can be shaped as curved rectangles, semi-circles, or semi-ovals with circular spaces within them. In some examples, each curved rectangle of spacer material 6170 can include 3 circular spaces. Each curved rectangle of spacer material 6170 can include 1-5 circular spaces. In some examples, the second outermost ring of spacer material 6170 can include 12 portions of spacer material 6170. The second outermost ring of spacer material 6170 can include 5-15 portions of spacer material 6170. The second outermost ring of spacer material 6170 can include circular portions of spacer material 6170. The central spacer material 6170 can be ring-shaped, for example circular or ovoid with a space in the center.
[0226] FIG. 48 shows an example of an organ protection layer 6200 with spacer material 6270.
[0227] In some examples, the organ protection layer 6200 can include any of the features of the organ protection layer 5100 of FIG.s 37A-C. The organ protection layer 6200 can include spacer material 6270 disposed between film layers 6272. In some examples, the organ protection layer 6200 can include 24 portions of spacer material 6270. The organ protection layer 6200 can include 20-30 portions of spacer material 6270. The organ protection layer 6200 can include 15-40 portions of spacer material 6270.
[0228] In some examples, the organ protection layer 6200 can include an outer ring of spacer material 6270 and central portions of spacer material 6270. The organ protection layer 6200 can include 1-10 rings of spacer material 6270. In some examples, the ring of spacer material 6270 can include 16 portions of spacer material 6270. The outermost ring of spacer material 6270 can include 10-20 portions of spacer material 6270. The ring of spacer material 6270 can be shaped as curved rectangles or trapezoids. In some examples, the central spacer material 6270 can include 8 portions of spacer material 6270. The central spacer material 6270 can include 5-15 portions of spacer material 6270. The central spacer material 6270 can include triangular portions of spacer material 6270. The central spacer material 6270 can be arranged in a rectangle aligned with the center of the film layers 6200.
Embodiments
[0229] Provided below are certain additional, non-limiting Embodiments encompassed by this application.
[0230] Embodiment 1. A method of positioning an organ protection layer on a wound site, the method comprising: providing an organ protection layer comprising a spacer material portion on a center of the organ protection layer; and positioning the organ protection layer on a wound site such that the spacer material portion is aligned with a center of the wound site.
[0231] 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 over the foam pad, the suction adapter comprising: a suction aperture; a suction port in fluid communication with the suction aperture through a suction channel; a leak aperture; and a leak port in fluid communication with the leak aperture through a leak channel, wherein the suction channel and the leak channel are separated by an inner wall; positioning a conduit for negative pressure in the suction port of the suction adapter; and detecting flow through the suction port to determine whether the suction adapter is in fluid communication with the foam pad.
[0232] Embodiment 3. The method of embodiment 2, further comprising delivering negative pressure from a negative pressure source through the conduit.
[0233] Embodiment 4. A method for cleaning a wound site, the method comprising: placing an organ protection layer on a wound site, the organ protection layer comprising delivery tubes in fluid communication with the wound site; connecting an intake branch of a connector with a fluid source; connecting a delivery branch of the connector with the delivery tubes; connecting an output branch of the connector with a canister; and allowing fluid to pass from the fluid source to the intake branch of the connector to the delivery branch of the connector to the delivery tubes to the wound site to the delivery branch of the connector to the output branch of the connector to the canister.
[0234] Embodiment 5. The method of embodiment 4, further comprising connecting a manifold to the delivery tubes and the delivery branch, wherein the manifold is configured to distribute fluid to the delivery tubes and from the delivery tubes.
[0235] Embodiment 6. The method of any one of embodiments 4 or 5, wherein the delivery tubes are positioned between layers of spacer material.
[0236] Embodiment 7. The method of any one of embodiments 4-6, wherein the intake branch, the delivery branch, and the output branch of the connector connect at a junction point.
[0237] Embodiment 8. The method of any one of embodiments 4-7, wherein the connector is a Y-connector.
[0238] Embodiment 9. The method of any one of embodiments 4-8, wherein the connector and the delivery tubes are configured to remove fluid from the wound site.
[0239] Embodiment 10. The method of any one of embodiments 4-9, wherein the connector and the delivery tubes are configured to deliver fluid to the wound site.
[0240] Embodiment I E The method of any one of embodiments 4-10, wherein the connector and the delivery tubes are configured to simultaneously deliver fluid to the wound site and remove fluid from the wound site.
[0241] Embodiment 12. The method of any one of embodiments 4-11, wherein the connector further comprises a switch, the switch allowing a user to control flow of fluid in the connector.
[0242] Embodiment 13. The method of embodiment 12, wherein the switch allows the user to restrict the intake branch or the output branch.
[0243] Embodiment 14. The method of embodiment 12, wherein the switch is integrated with the connector.
[0244] Embodiment 15. The method of any one of embodiments 4-14, wherein the organ protection layer is transparent.
[0245] Embodiment 16. The method of any one of embodiments 4-15, wherein the connector is transparent. [0246] Embodiment 17. The method of any one of embodiments 4-16, wherein the delivery tubes are transparent.
[0247] Embodiment 18. The method of embodiment 5, wherein the manifold is transparent.
[0248] Embodiment 19. The method of embodiment 5, wherein the manifold comprises vents configured to allow fluids to release from the manifold.
[0249] Embodiment 20. The method of embodiment 5, wherein the manifold comprises an inner wall separating an inner cavity of the manifold.
[0250] Embodiment 21. The method of embodiment 20, wherein the inner wall separates the inner cavity into a delivery portion and a removal portion.
[0251] Embodiment 22. The method of any one of embodiments 4-21, wherein the delivery tubes are round.
[0252] Embodiment 23. The method of any one of embodiments 4-22, wherein the delivery tubes are flat or oblong.
[0253] Embodiment 24. The method of any one of embodiments 4-23, wherein the delivery tubes comprise teeth inside the delivery tubes.
[0254] Embodiment 25. The method of embodiment 24, wherein the delivery tubes comprise top teeth and bottom teeth inside the delivery tubes.
[0255] Embodiment 26. The method of embodiment 5, wherein the manifold is made of any one of polyurethane, silicone, foam, rubber, and polyisoprene.
[0256] Embodiment 27. The method of embodiment 6, wherein the spacer material is made of any one of foam, 3D fabric, silver, or a material with antimicrobial properties.
[0257] Embodiment 28. The method of embodiment 5, wherein the manifold is any one of octagonal, disk-shaped, flower-shaped, rectangular, curved, circular, or ovoid.
[0258] The foregoing description is that of certain features, aspects and advantages of the present invention, to which various changes and modifications can be made without departing from the spirit and scope of the present invention. Moreover, the negative pressure treatment system disclosed herein need not feature all of the objects, advantages, features and aspects discussed above. Those of skill in the art will recognize that the invention can be embodied or carried out in a manner that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein. For example, in some embodiments the pad 103 can be used without the organ protection layer 105 and/or drape 107. Advantageously, the systems and methods described herein can operate without the drape 107. There is no need to disturb the wound by having to cut into the drape 107 to input additional connectors, as the system herein can deliver fluid to the wound site. In addition, while a number of variations of the invention have been shown and described in detail, other modifications and methods of use, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is contemplated that various combinations or subcombinations of these specific features and aspects of embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the discussed negative pressure treatment system.
[0259] Although this disclosure describes certain embodiments/examples, it will be understood by those skilled in the art that many aspects of the methods and devices shown and described in the present disclosure may be differently combined and/or modified to form still further embodiments or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. Indeed, a wide variety of designs and approaches are possible and are within the scope of this disclosure. No feature, structure, or step disclosed herein is essential or indispensable. Moreover, while illustrative embodiments have been described herein, the scope of any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), substitutions, adaptations and/or alterations as would be appreciated by those in the art based on the present disclosure. While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of protection.
[0260] Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.
[0261] Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as a subcombination or variation of a subcombination.
[0262] Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, or that all operations be performed, to achieve desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, the operations may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and/or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products.
[0263] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
[0264] Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment.
[0265] Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.
[0266] Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degree, or otherwise.
[0267] The scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments in this section or elsewhere in this specification, and may be defined by claims as presented in this section or elsewhere in this specification or as presented in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive.