Patent Description:
Instillation therapy is a type of wound therapy that involves applying a therapeutic fluid (e.g. a saline solution, a prescribed solution, an antibiotic, a cleaning fluid etc.) to a treatment site to promote wound healing and granulation, prevent the wound from drying out, prevent the wound from becoming infected by bacteria and/or treat an infected treatment site. Some instillation systems include an instillation fluid container and an instillation pump for providing instillation fluid to the treatment site. Instillation therapy can be used in conjunction with NPWT or can be used separately.

Negative pressure wound therapy (NPWT) is a type of wound therapy that involves applying negative pressure (pressure lower than atmospheric pressure) to a treatment site to promote wound healing. NPWT applies negative pressure to the wound to drain fluids from the wound as the wound heals. Some NPWT systems include a pump which operates to maintain the treatment site at negative pressure by removing wound exudate from the treatment site. The wound exudate is typically routed to a canister or other container fluidly connected to the pump where the wound exudate is stored until emptied by a user.

Both instillation therapy and NPWT can be used to treat deep abdominal wounds due to abdominal laparotomies, which are used to gain access to the abdominal cavity for surgery and/or to relieve intra-abdominal pressure by allowing the bowels to expand. In some instances, the laparotomy incision is not immediately closed, resulting in an "open abdomen," and instillation and/or NPWT may be used to treat the open abdomen. For example, instillation fluid can be used to irrigate the open abdomen, preventing the abdominal contents from drying out and can also be used to periodically wash out the open abdomen to potentially reduce a likelihood of sepsis. However, manual washouts can result in damage that requires further surgery.

Instillation and negative pressure systems adapted to treat the open abdomen are often complicated because of the need to maintain fluidly separated instillation and NWPT pathways, and the fluidly separate instillation and NPWT pathways may be difficult to identify in wound treatment systems that are deployed in a patient. Furthermore, the wound therapy system may expand and contract during cycles of instillation and NPWT, making it difficult to maintain fluid-tight seals on the instillation pathway and the NPWT pathway. Furthermore, hard instillation and/or NPWT connectors may contact the patient or otherwise cause patient discomfort during connection of the instillation and/or NPWT connectors or during the compression that occurs during NPWT.

<CIT> discloses a wound support for use in vacuum therapy of wounds including a wound filler with a passage for receiving a conduit.

The invention is defined by the claims, in which there is required a system for providing instillation fluid to a deep abdominal wound, the connection structure comprising: an instillation module defining a first surface and a second, abdominal contents-facing surface, the instillation module including a distribution hub configured to receive instillation fluid from an instillation fluid source; a negative pressure manifold including a first surface and a second, abdominal contents-facing surface; a connection structure comprising a first surface; a second, abdominal contents-facing surface; and a flow path extending between the first surface of the connection structure and the second surface of the connection structure, the flow path including an inlet configured to be in fluid communication with an instillation fluid conduit engaged with an instillation fluid source and an outlet in fluid communication with the distribution hub of the instillation module, the flow path defining an axis extending between the inlet and the outlet and configured to compress in a direction defined by the axis, wherein the second surface of the connection structure is secured to the first surface of the instillation module to provide a fluid-tight connection between the flow path and the instillation module; and a connection plate secured to the negative pressure manifold and including an instillation inlet connector having a first shape in fluid communication with the distribution hub via the flow path and a negative pressure inlet connector having a second shape different than the first shape, the negative pressure inlet connector in fluid communication with the negative pressure manifold.

A selection of optional features is set out in the dependent claims.

Referring generally to the FIGURES, a wound therapy system with instillation and negative pressure wound therapy (NPWT) systems and components thereof are shown, according to various exemplary embodiments. The wound therapy system may include a wound dressing, an instillation system, and a NPWT system. The wound therapy system may include an instillation module for delivering instillation fluid to a treatment site, a negative pressure manifold for providing NPWT to the treatment site, a connection plate for facilitating connection of the instillation system and/or NPWT system components to the wound dressing, and a sealing member for forming a substantially fluid-tight seal around the treatment site. The wound therapy system is configured to include an instillation flow path that is fluidly separate from the NPWT flow path. The instillation system may include an instillation fluid source and an instillation pump. The NPWT system may include a negative pressure source and a fluid collection container. The phrase "negative pressure" means a pressure less than an ambient or atmospheric pressure.

In some embodiments, the connection plate is configured to facilitate connecting the instillation system components to the wound dressing system and connecting the NPWT system components to the wound dressing system. For example, the connection plate may include an instillation inlet having a first shape and a NPWT inlet having a second shape different than the first shape. The instillation system may include an instillation conduit pad configured to engage the instillation inlet but the NPWT inlet. The NPWT system may include a NPWT conduit pad configured to engage the NPWT inlet but not the instillation inlet.

In some embodiments, the negative pressure manifold is configured to include an instillation flow path in fluid communication with the instillation module. The instillation flow path is fluidly separate from the negative pressure manifold such that the instillation fluid flowing along the instillation flow path does not flow into the negative pressure manifold. In some embodiments, the instillation flow path is configured to expand and compress with the negative pressure manifold during cycles of NPWT. In some embodiments, the instillation flow path may be a bellows structure made of an instillation-fluid impermeable material that is positioned within a through-hole in the negative pressure manifold. The bellows structure may be configured to extend or retract to accommodate different thicknesses and/or materials of negative pressure manifold. In some embodiments, the instillation flow path is made of the same material as the negative pressure manifold such that the instillation flow path has substantially the same compression and expansion as the negative pressure manifold during cycles of NPWT. In such embodiments, an first surface, a second, abdominal contents-facing surface, and a flow path (e.g., channel) formed within the instillation flow path are coated with an instillation fluid-impermeable material. The first surface is secured to the connection plate or the sealing member in a fluid-tight connection and the second surface is secured to the instillation module proximate an inlet of the instillation module in a fluid-tight connection to generate an instillation flow path that is fluidly separate from the NPWT flow path.

In some embodiments, the instillation module includes an integrated instillation conduit. The integrated instillation conduit may wrap around a side of the negative pressure manifold to abut the sealing member and/or pass through the negative pressure manifold. The integrated instillation conduit can be made of a tubing material that is impermeable to instillation fluid or can be positioned within an envelope that is impermeable to instillation fluid.

In some embodiments, the instillation module may include an integrated instillation conduit that is engaged with a sealing system for forming a substantially fluid-tight seal about a hole in the sealing member that receives the integrated instillation conduit. To deploy the instillation module and sealing system, the instillation module may be positioned in the treatment site such that the instillation module substantially overlies the abdominal contents. The instillation conduit is then passed around or through the negative pressure manifold and then through the hole in the sealing member. A sealing plate having an instillation conduit passageway is then slid along the instillation conduit until the sealing plate abuts the sealing member. The sealing plate is then secured to the sealing member using an adhesive. A locking collar is friction-fit about an exterior surface of the instillation conduit passageway to form a substantially fluid-tight seal between the instillation conduit passageway and the instillation conduit.

Additional features and advantages of the wound therapy system are described in detail below.

Referring to <FIG>, a section view of a wound therapy system <NUM> is shown, according to an exemplary embodiment. In the illustrated embodiment, the wound therapy system is configured to treat the abdominal cavity and is discussed in the context of treating an open abdomen. The wound therapy system <NUM> can be used to treat an "open abdomen" condition, in which a deep abdominal wound is left open for a period of time. The components described herein may be used in different configurations of instillation therapy systems and/or negative pressure wound therapy (NPWT) systems. The phrase "negative pressure" means a pressure less than an ambient or atmospheric pressure.

In various embodiments, the wound therapy system <NUM> can be used to treat a deep abdominal incision. The wound therapy system <NUM> includes a wound dressing <NUM>, an instillation system <NUM>, and a NPWT system <NUM>. The wound dressing <NUM> includes an abdominal treatment device <NUM>, an instillation module <NUM>, a negative pressure manifold <NUM>, a sealing member <NUM>, and an optional connection plate <NUM> (<FIG>). The wound dressing <NUM> is intended for engagement with a treatment site of a patient, such as an abdominal cavity of a patient. The wound therapy system <NUM> can be used with the NPWT system <NUM> and/or the instillation system <NUM>. The NPWT system <NUM> may include a negative pressure source <NUM>, such as a pump, and a fluid collection chamber <NUM>. The instillation system <NUM> may include an instillation fluid source <NUM>. In some embodiments, the instillation system <NUM> may include an installation pump <NUM>.

Referring to <FIG>, the abdominal treatment device <NUM> is shown to include a first layer <NUM>, a second layer <NUM>, and a foam spacer <NUM>. The second layer <NUM> faces the abdominal contents and is generally opposite the first layer <NUM>. The foam spacer <NUM> includes a first surface <NUM> and a second, abdominal contents-facing surface <NUM>. The foam spacer <NUM> includes a hub <NUM> and a plurality of leg members <NUM> that extend generally radially from the hub <NUM>. The hub <NUM> includes a through-opening <NUM> for receiving at least portion of the instillation module <NUM>. The foam spacer <NUM> is generally in fluid communication with a negative pressure conduit <NUM> to receive negative pressure from the negative pressure source <NUM> and to receive fluids flowing from the treatment site towards the negative pressure source <NUM>. The plurality of elongate legs <NUM> are configured to distribute negative pressure throughout the treatment site. As illustrated in <FIG>, the first layer <NUM> and the second layer <NUM> encapsulate the leg members <NUM>, the hub <NUM>, and the intervening space between adjacent leg members <NUM>. In the illustrated embodiment, the hub <NUM> and the plurality of leg members <NUM> are made of a material that is substantially hydrophobic and structured for fluid flow under substantially atmospheric pressure conditions and under negative pressure conditions. In some embodiments, the hub <NUM> and the plurality of leg members <NUM> are made of a reticulated foam, such as the reticulated foam described below with respect to the negative pressure manifold <NUM>. In some embodiments, the leg members <NUM> may be cut to accommodate relatively small wounds. The first layer <NUM> and the second layer <NUM> of the abdominal treatment device <NUM> can made of a material that is fluid-impermeable and intended to not irritate the patient's fascia and internal organs. The abdominal treatment device <NUM> may include a plurality of fenestrations <NUM> (e.g., negative pressure inlets) for distribution of negative pressure by the plurality of leg members <NUM> and/or to permit fluid to flow into the plurality of leg members <NUM> and/or the space between the plurality of leg members <NUM> and the layers <NUM>, <NUM>. The fenestrations <NUM> may include through-holes, slits, or linear cuts. The fenestrations <NUM> may be circular, rectangular, polygonal, or be any other shape in cross-section.

Referring to <FIG>, the instillation module <NUM> is shown to include a first layer <NUM>, a second layer <NUM>, and a fluid distribution layer <NUM>. The second layer <NUM> faces the abdominal contents and is generally opposite the first layer <NUM>. The fluid distribution layer <NUM> includes a first surface <NUM> and a second, abdominal contents-facing surface <NUM>. The fluid distribution layer <NUM> includes a fluid distribution hub <NUM> and a plurality of fluid distribution structures <NUM> that extend generally radially from the fluid distribution hub <NUM>. The fluid distribution hub <NUM> is generally in fluid communication with an instillation conduit <NUM> to receive instillation fluid and in fluid communication with the fluid distribution structures to distribute instillation fluid to the fluid distribution structures <NUM>. For example, the first layer <NUM> may include an opening <NUM> (e.g., an instillation inlet) proximate the fluid distribution hub <NUM> for providing fluid communication between the fluid distribution hub <NUM> and the instillation connection structure. The first layer <NUM> and the second layer <NUM> are welded together along at least a portion of the edges of the first layer <NUM> and the second layer <NUM> to encapsulate the fluid distribution layer <NUM>. In some embodiments, the first layer <NUM> and the second layer <NUM> encapsulate the fluid distribution structures <NUM> and the fluid distribution hub <NUM>, but not the intervening space between adjacent fluid distribution structures <NUM> (<FIG>). In the illustrated embodiment, the fluid distribution hub <NUM> and the plurality of fluid distribution structures <NUM> are made of a material that is substantially hydrophobic and structured for fluid flow under substantially atmospheric pressure conditions and under negative pressure conditions. In some embodiments, the fluid distribution hub <NUM> and the plurality of fluid distribution structures <NUM> are made of a reticulated foam, such as the reticulate foam described below with respect to the negative pressure manifold <NUM>. In some embodiments, the fluid distribution structures <NUM> may be cut to accommodate relatively small wounds.

In other embodiments, the first layer <NUM> and the second layer <NUM> can be made of a material that is fluid-impermeable and intended to not irritate the patient's fascia and internal organs. As described in greater detail below, in such an embodiment, first layer <NUM> and the second layer may fluid distribution layer and include a plurality of fenestrations <NUM> (e.g., instillation outlets) for distribution of instillation fluid by the plurality of fluid distribution structures <NUM>. The fenestrations <NUM> may include through-holes, slits, or linear cuts. The fenestrations <NUM> may be circular rectangular, polygonal, or be any other shape in cross-section.

Referring to <FIG>, the negative pressure manifold <NUM> is shown to include a first surface <NUM> and a second, abdominal contents-facing surface <NUM> opposite the first surface <NUM>. When the negative pressure manifold <NUM> is applied the treatment site, the first surface <NUM> faces away from the abdominal contents, whereas the second surface <NUM> faces toward the abdominal contents. In some embodiments, the first surface <NUM> of the negative pressure manifold <NUM> contacts the second surface <NUM> of the sealing member <NUM>. In some embodiments, the negative pressure manifold <NUM> may include perforations <NUM> to facilitate removal of a portion of the negative pressure manifold <NUM> to accommodate different sizes of wounds. In some embodiments, the second surface <NUM> of the negative pressure manifold <NUM> contacts the instillation module <NUM>. The negative pressure manifold <NUM> is adapted to wick fluid (e.g. exudate) from the wound and includes in-molded manifold structures for distributing negative pressure throughout the negative pressure manifold <NUM> during negative pressure wound therapy treatments. The negative pressure manifold <NUM> is made from a material that allows fluid and/or negative pressure to pass from between at least a first portion of the negative pressure manifold <NUM> and a second portion of the negative pressure manifold <NUM>. In some embodiments, the negative pressure manifold <NUM> may include in-molded flow channels or pathways that can distribute the fluids provided to and removed around the manifold. In some embodiments, the in-molded flow channels or pathways can be formed by the cells in a porous foam material.

The negative pressure manifold <NUM> can be made from a porous and permeable foam-like material and, more particularly, a reticulated, open-cell polyurethane or polyether foam that allows good permeability of wound fluids while under a reduced pressure. One such foam material that has been used is the VAC® Granufoam® material that is available from Kinetic Concepts, Inc. (KCI) of San Antonio, Tex. Any material or combination of materials might be used for the negative pressure manifold <NUM> provided that the negative pressure manifold <NUM> is operable to distribute the reduced pressure and provide a distributed compressive force along the treatment site.

The reticulated pores of the Granufoam@ material that are in the range from about <NUM> to <NUM> microns, are preferred, but other materials may be used. The density of the absorbent layer material, e.g., Granufoam@ material, is typically in the range of about <NUM> lb/ft<NUM>-<NUM> lb/ft<NUM> (<NUM>/m<NUM>-<NUM>/m<NUM>). A material with a higher density (smaller pore size) than Granufoam@ material may be desirable in some situations. For example, the Granufoam® material or similar material with a density greater than <NUM> lb/ft<NUM> (<NUM>/m<NUM>) may be used. As another example, the Granufoam@ material or similar material with a density greater than <NUM> lb/ft<NUM> (<NUM>/m<NUM>) or <NUM> lb/ft<NUM> (<NUM>/m<NUM>) or even more may be used. The more dense the material is, the higher compressive force that may be generated for a given reduced pressure. If a foam with a density less than the tissue at the tissue site is used as the absorbent layer material, a lifting force may be developed. In one illustrative embodiment, a portion, e.g., the edges, of the wound dressing may exert a compressive force while another portion, e.g., a central portion, may provide a lifting force.

The absorbent layer material may be a reticulated foam that is later felted to thickness of about one third (⅓) of the foam's original thickness. Among the many possible absorbent layer materials, the following may be used: Granufoam® material or a Foamex® technical foam (www. In some instances, it may be desirable to add ionic silver to the foam in a microbonding process or to add other substances to the absorbent layer material such as antimicrobial agents. The absorbent layer material may be isotropic or anisotropic depending on the exact orientation of the compressive forces that are desired during the application of reduced pressure. The absorbent layer material may also be a bio-absorbable material.

Referring again to <FIG>, the sealing member <NUM> is shown to include a first surface <NUM> and a second, wound-facing, surface <NUM> opposite the first surface <NUM>. When the wound therapy system <NUM> is applied to a wound, the first surface <NUM> faces away from the wound, whereas the second surface <NUM> faces toward the wound. As is shown in <FIG>, at least a perimeter of the second surface <NUM> includes an adhesive. The adhesive is intended to secure sealing member <NUM> to the patient's skin and to form a fluid-tight seal about the incision. The sealing member <NUM> also provides a barrier to passage of microorganisms through the wound therapy system <NUM>.

In some embodiments, the sealing member <NUM> is an elastomeric material or may be any material that provides a fluid seal. "Fluid seal" means a seal adequate to hold pressure at a desired site given the particular reduced-pressure subsystem involved. The term "elastomeric" means having the properties of an elastomer and generally refers to a polymeric material that has rubber-like properties. Examples of elastomers may include, but are not limited to, natural rubbers, polyisoprene, styrene butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, butyl rubber, ethylene propylene rubber, ethylene propylene diene monomer, chlorosulfonated polyethylene, polysulfide rubber, polyurethane, EVA film, co-polyester, thermoplastic polyurethane (TPU), and silicones. As non-limiting examples, the sealing member <NUM> may be formed from materials that include a silicone, <NUM> Tegaderm® drape material, acrylic drape material such as one available from Avery, or an incise drape material. In some embodiments, the sealing member <NUM> may be at least partially transparent to facilitate viewing of the wound therapy system <NUM> through the sealing member <NUM> as described in greater detail below.

The sealing member <NUM> may be substantially impermeable to liquid and substantially permeable to water vapor. In other words, the sealing member <NUM> may be permeable to water vapor, but not permeable to liquid water or wound exudate. This increases the total fluid handling capacity (TFHC) of wound therapy system <NUM> while promoting a moist wound environment. In some embodiments, the sealing member <NUM> is also impermeable to bacteria and other microorganisms. In some embodiments, the sealing member <NUM> is configured to wick moisture from the negative pressure manifold <NUM> and distribute the moisture across the first surface <NUM>. In some embodiments, the adhesive applied to the second surface <NUM> of the sealing member <NUM> is moisture vapor transmitting and/or patterned to allow passage of water vapor therethrough.

Referring now to <FIG>, the connection plate <NUM> includes first surface <NUM> and a second, abdominal contents-facing surface <NUM>. The connection plate <NUM> includes an instillation inlet <NUM> and a NPWT inlet <NUM>. In the illustrated embodiment, the connection plate <NUM> is a relatively dense material that functions as a land for the instillation conduit pad <NUM> and the NPWT conduit pad <NUM>. The connection plate <NUM> also provides a visual indication of where to cut or pierce the sealing member <NUM> when connecting the instillation conduit pad <NUM> and the NPWT conduit pad. For example, the connection plate <NUM> may include markings (e.g., colors, patterns, words, etc.) to assist an operator in positioning the instillation conduit pad <NUM> and the NPWT conduit pad <NUM>. For example, in the illustrated embodiment, visual contrast between a color of the connection plate <NUM> and a color of the negative pressure manifold <NUM> may assist the operator in correctly positioning the instillation conduit pad <NUM> and the NPWT conduit pad <NUM>. In some embodiments, the connection plate <NUM> may include an adhesive layer on the second surface <NUM> of the connection plate <NUM> for securing the connection plate <NUM> to the negative pressure manifold <NUM> to prevent the connection plate <NUM> from slipping.

Referring now to <FIG>, a connection system <NUM> for the connecting the wound therapy dressing to the instillation system <NUM> and the NPWT system <NUM> is shown according to some embodiments. <FIG> illustrates a section view of the connection system <NUM> mounted on the negative pressure manifold <NUM>. <FIG> illustrates a perspective view of the connection system <NUM> engaged with the wound dressing <NUM>.

The connection system <NUM> is shown to include a connection plate <NUM>, an instillation conduit pad <NUM>, and a NPWT conduit pad <NUM>. The instillation conduit pad <NUM> is secured to an instillation conduit <NUM> of the instillation system <NUM> through a substantially fluid-tight connection. The instillation conduit pad <NUM> includes an instillation outlet connector <NUM> configured to engage the connection plate <NUM> as described in greater detail below. In the illustrated embodiment, the instillation outlet connector <NUM> is a hole. The NPWT conduit pad <NUM> is secured to a negative pressure conduit <NUM> of the NPWT system <NUM> through a substantially fluid-tight connection. The NPWT conduit pad <NUM> includes an NPWT outlet connector <NUM> configured to engage the connection plate <NUM> as described in greater detail below. In the illustrated embodiment, the NPWT outlet connector <NUM> is a protrusion. In some embodiments, the NPWT outlet connector <NUM> is a pointed protrusion (e.g., spear). In some embodiments, the NPET outlet connector includes a barb <NUM>. As shown in <FIG>, in some embodiments, the instillation conduit <NUM> and the negative pressure conduit <NUM> are made of low-profile and/or flexible tubing to reduce patient discomfort.

The connection plate <NUM> is secured to the first surface <NUM> of the negative pressure manifold <NUM>. The connection plate <NUM> includes an instillation connection structure <NUM> (<FIG>), an instillation inlet connector <NUM>, and a NPWT inlet connector <NUM>. The instillation connection structure <NUM> extends through the negative pressure manifold <NUM> (e.g., between the first surface <NUM> and the second surface <NUM>) to facilitate fluid communication between the instillation inlet connector <NUM> and the fluid distribution hub <NUM>. The instillation connection structure <NUM> is configured to prevent lateral flow of the instillation fluid into the negative pressure manifold <NUM>. For example, the instillation connection structure can be made of a material that is substantially impermeable to instillation fluid or can be coated with a material that is substantially impermeable to instillation fluid. More specifically, the instillation inlet connector <NUM> can be secured to the instillation connection structure <NUM> and to the instillation module <NUM> proximate the opening <NUM> to form an instillation fluid flow path that is fluidly separated from the NPWT flow path.

The instillation inlet connector <NUM> is in fluid communication with the instillation connection structure <NUM>. The instillation inlet connector <NUM> is configured to engage the instillation conduit pad <NUM>. In the illustrated embodiment, the instillation inlet connector <NUM> is a protrusion that extends from the connection plate <NUM>. In some embodiments, a distal end of the instillation inlet connector <NUM> is pointed (e.g., a spear). In some embodiments, the instillation inlet connector includes a barb <NUM> for engaging the instillation outlet connector <NUM> in a friction fit. Although in the illustrated embodiment the instillation inlet connector <NUM> is shown as a protrusion and the instillation outlet connector <NUM> is shown as a hole, in different embodiments, the instillation inlet connector <NUM> and the instillation outlet connector <NUM> can have different shapes as long as the instillation inlet connector <NUM> and the instillation outlet connector <NUM> remain capable of engagement. For example, in some embodiments, the instillation inlet connector <NUM> can be a hole and the instillation outlet connector <NUM> can be a protrusion.

As is best shown in <FIG>, the NPWT inlet connector <NUM> is in fluid communication with the negative pressure manifold <NUM>. In the illustrated embodiment, the NPWT inlet connector <NUM> is a through hole in the connection plate <NUM> configured to engage the NPWT outlet connector <NUM> in a friction fit. Although in the illustrated embodiment the NPWT inlet connector <NUM> is shown as a through hole and the NPWT outlet connector <NUM> is shown as a protrusion, in different embodiments, the NPWT inlet connector <NUM> and the NPWT outlet connector <NUM> can have different shapes as long as the NPWT inlet connector <NUM> and the NPWT outlet connector <NUM> remain capable of engagement. For example, in some embodiments, the NPWT inlet connector <NUM> can be a protrusion and the NPWT outlet connector <NUM> can be a hole.

As is apparent from <FIG> and <FIG>, the instillation inlet connector <NUM> and the NPWT inlet connector <NUM> are different shapes. This is intended to prevent the instillation outlet connector <NUM> from engaging the NPWT inlet connector <NUM> and to prevent the NPWT outlet connector <NUM> from engaging the instillation inlet connector <NUM>. As is best shown in <FIG>, the connection plate <NUM> is positioned beneath the sealing member <NUM> and is visible through the sealing member <NUM>. The connection plate is configured to guide an operator of the wound therapy system <NUM> to correctly connect the instillation conduit pad <NUM> and the NPWT conduit pad <NUM>. For example, the instillation inlet connector <NUM> and the instillation outlet connector <NUM> include a first pair of markings <NUM> that indicate that the instillation outlet connector <NUM> should be connected to the instillation inlet connector <NUM>. The NPWT inlet connector <NUM> and the NPWT outlet connector <NUM> include a second pair of markings <NUM> that are different than the first pair of markings <NUM> to indicate that the NPWT outlet connector <NUM> should be connected to the NPWT inlet connector <NUM>. In some embodiments, the first pair of markings <NUM> and the second pair of markings <NUM> may be colors, patterns, or shapes.

As is shown in <FIG>, the connection plate <NUM> is positioned beneath the sealing member <NUM> when the wound dressing <NUM> is deployed within the patient. The instillation inlet connector <NUM> and the instillation outlet connector <NUM> are accessible through the sealing member <NUM> (e.g., by piercing the sealing member <NUM>). The instillation inlet connector <NUM> pierces through the sealing member <NUM> as the sealing member <NUM> is secured to the patient. The NPWT outlet connector <NUM> on the NPWT conduit pad <NUM> pierces through the sealing member <NUM> to connect to the NPWT inlet connector <NUM> of the connection plate <NUM>. Accordingly, a first surface <NUM> of the connection plate <NUM> may be coated with an adhesive for securing the connection plate <NUM> to the second surface <NUM> of the sealing member <NUM> to maintain a fluid-tight seal of the abdominal cavity. The adhesive can prevent the connection plate <NUM> from shifting as the instillation conduit pad <NUM> and the NPWT conduit pad <NUM> are engaged with the connection plate <NUM>. In some embodiments, the instillation conduit pad <NUM> and the NPWT conduit pad <NUM> may include an adhesive layer surrounding the instillation outlet connector <NUM> and the NPWT outlet connector <NUM>, respectively, for forming a fluid-tight seal with the first surface of the sealing member <NUM>. The connection plate <NUM> has a density that is high enough and/or a thickness that is thick enough to prevent the protrusion of the NPWT outlet connector <NUM> from contacting the patient and causing patient discomfort. In some embodiments, the connection plate is made of a dense open cell foam. In other embodiments, the connection plate can be made of a plastic material. In some embodiments, the connection plate <NUM> is made of a deformable material and/or the negative pressure manifold <NUM> is sized to be thicker than the connection plate <NUM> such that the pressure applied to the connection plate <NUM> as the instillation conduit pad <NUM> and the NPWT conduit pad <NUM> are connected, and compression within the abdominal cavity during NPWT does not cause the connection plate <NUM> and/or the NPWT outlet connector <NUM> to cause patient discomfort.

As illustrated in <FIG>, the wound therapy system <NUM> includes an instillation flow path (arrows <NUM>) that is fluidly separate from a negative pressure flow path (arrows <NUM>). As illustrated by the arrows <NUM>, instillation fluid enters the wound therapy system <NUM> from the instillation system <NUM> and travels along the instillation conduit <NUM> to the instillation conduit pad <NUM>. The instillation fluid then flows through the instillation inlet connector <NUM> of the connection plate <NUM> to the instillation connection structure <NUM>. The instillation fluid then enters the fluid distribution hub <NUM> of the instillation module <NUM> and travels along the fluid distribution structures <NUM>. The instillation fluid exits the fluid distribution structures <NUM> through the fenestrations <NUM> and travels to the treatment site.

As illustrated by the arrows <NUM>, the negative pressure generated by the negative pressure source <NUM> of the NPWT system <NUM> causes fluid (e.g., instillation fluid, wound exudate, etc.) to enter the plurality of elongate legs <NUM> of the abdominal treatment device <NUM> through the fenestrations <NUM>. As shown by the arrows <NUM>, fluid travels through at least a portion of the elongate legs <NUM> and exits the abdominal treatment device through the fenestrations <NUM>. The fluid then travels through the negative pressure manifold <NUM> to the NPWT inlet connector <NUM> of the connection plate <NUM>. The fluid then travels along the NPWT conduit pad <NUM> to the negative pressure conduit <NUM> and into the fluid collection chamber <NUM> of the NPWT system <NUM>.

<FIG> illustrates a connection system <NUM> for the connecting the wound therapy system <NUM> to the instillation system <NUM> and the NPWT system <NUM>, according to some embodiments. The connection system <NUM> is shown to include the connection plate <NUM> and an integrated conduit pad <NUM>. The integrated conduit pad <NUM> includes an instillation outlet portion <NUM> and a NPWT outlet portion <NUM>. The instillation outlet portion <NUM> is secured to the instillation conduit <NUM> of the instillation system <NUM> through a substantially fluid-tight connection. The instillation outlet portion <NUM> includes an instillation outlet connector <NUM> configured to engage the instillation inlet connector <NUM> of the connection plate <NUM>. In the illustrated embodiment, the instillation outlet connector <NUM> is a hole. The NPWT outlet portion <NUM> is secured to the negative pressure conduit <NUM> of the NPWT system <NUM> through a substantially fluid-tight connection. The NPWT outlet portion <NUM> includes an NPWT outlet connector <NUM> configured to engage the NPWT inlet connector <NUM> of the connection plate <NUM> as described in greater detail below. In the illustrated embodiment, the NPWT outlet connector <NUM> is a protrusion. In some embodiments, the NPWT outlet connector <NUM> is a pointed protrusion (e.g., spear). In some embodiments, the NPWT outlet connector includes a barb <NUM>. As shown in <FIG>, in some embodiments, the instillation conduit <NUM> and the negative pressure conduit <NUM> are made of low-profile and/or flexible tubing to reduce patient discomfort.

The connection plate <NUM> and the integrated instillation and NPWT conduit pad <NUM> are substantially the same shape to facilitate alignment of the instillation outlet connector <NUM> with the instillation inlet connector <NUM> and the NPWT outlet connector <NUM> with the NPWT inlet connector <NUM>. For example, the connection plate <NUM> is structured so that the instillation inlet connector <NUM> and the NPWT inlet connector <NUM> have a fixed spacing therebetween. The integrated NPWT conduit pad <NUM> is structured so that the instillation outlet connector <NUM> and the NPWT outlet connector <NUM> have the same fixed spacing therebetween as the spacing between the instillation inlet connector <NUM> and the NPWT inlet connector <NUM>. Accordingly, the integrated instillation and NPWT conduit pad <NUM> can be configured (e.g., have a size and a spacing) to engage a connection plate <NUM> having specific dimensions (e.g., corresponding to a specific size and/or type of wound dressing <NUM>).

As shown in <FIG>, the instillation inlet connector <NUM> and the NPWT inlet connector <NUM> are different shapes. This is intended to prevent the instillation outlet connector <NUM> from engaging the NPWT inlet connector <NUM> and to prevent the NPWT outlet connector <NUM> from engaging the instillation inlet connector <NUM>. As is best shown in <FIG>, the instillation inlet connector <NUM> and the instillation outlet connector <NUM> include a first pair of markings <NUM> that indicate that the instillation outlet connector <NUM> should be connected to the instillation inlet connector <NUM>. The NPWT inlet connector <NUM> and the NPWT outlet connector <NUM> include a second pair of markings <NUM> that are different than the first pair of markings <NUM> to indicate that the NPWT outlet connector <NUM> should be connected to the NPWT inlet connector <NUM>. In some embodiments, the first pair of markings <NUM> and the second pair of markings <NUM> may be colors, patterns, shapes, and/or words.

<FIG> illustrate the negative pressure manifold <NUM> including a compressible instillation connection structure <NUM>. The compressible instillation connection structure <NUM> is intended to expand and contract with the negative pressure manifold <NUM> as the negative pressure manifold <NUM> expands and contracts during cycles of NPWT therapy (e.g., the negative pressure manifold <NUM> and the compressible instillation connection structure <NUM> are expanded when not under negative pressure and compressed when under negative pressure). The compressible instillation connection structure <NUM> is also intended to expand and contract to accommodate different thicknesses of negative pressure manifold <NUM>. As is best shown in <FIG>, the compressible instillation connection structure <NUM> includes a first connection plate <NUM>, a second connection plate <NUM>, and a flow path <NUM> extending between the first connection plate <NUM> and the second connection plate <NUM>. The first connection plate <NUM> includes a first connection surface <NUM> and a second, negative pressure manifold-facing, surface <NUM>. The first connection plate <NUM> includes a flow path inlet <NUM>. The second connection plate <NUM> includes a second connection surface <NUM> and a first, negative pressure manifold-facing, surface <NUM>. The second connection plate <NUM> includes a flow path outlet <NUM>. As is best shown in <FIG>, the first connection plate <NUM> and the second connection plate <NUM> are spaced apart to receive the negative pressure manifold <NUM> therebetween.

The flow path <NUM> extends between the flow path inlet <NUM> and the flow path outlet <NUM> to direct instillation fluid from the instillation conduit <NUM> of the instillation system <NUM> to the fluid distribution hub <NUM> of the instillation module <NUM>. The flow path <NUM> defines a longitudinal axis A. The flow path <NUM> is flexible and is configured to expand and contract in a direction substantially defined by the longitudinal axis A. The flow path <NUM> is formed of a plurality of angled walls <NUM>. The plurality of angled walls <NUM> are oriented to form adjacent thick and thin sections to form a bellows structure. Under negative pressure, the angled walls <NUM> deflect towards the horizontal, resulting in contraction in the direction defined by the longitudinal axis A. In the illustrated embodiment, the plurality of angled walls <NUM> includes four angled walls <NUM>. In other embodiments, the plurality of angled walls <NUM> may include more or fewer angled walls. In the illustrated embodiments, plurality of angled walls <NUM> form conical segments. In other embodiments, the plurality of angled walls may form segments of other shapes, such as pyramidal shapes.

In some embodiments, the first connection plate <NUM>, the second connection plate <NUM>, and the flow path <NUM> are integrally formed as a single part. In other embodiments, the first connection plate <NUM>, the second connection plate <NUM>, and the flow path <NUM> may be formed separately and then secured together to form the compressible instillation connection structure <NUM>. The compressible instillation connection structure <NUM> is made of a flexible material that is capable of withstanding cycles of expansion and contraction. The compressible instillation connection structure <NUM> is configured to prevent lateral flow of the instillation fluid into the negative pressure manifold <NUM>. For example, the compressible instillation connection structure can be made of a material that is substantially impermeable to instillation fluid or can be coated with a material that is substantially impermeable to instillation fluid.

<FIG> and <FIG> illustrate the compressible instillation connection structure <NUM> deployed in the wound therapy system <NUM>. As shown in <FIG>, the compressible instillation connection structure <NUM> can be received within and extend through a hole in the negative pressure manifold <NUM>. The second connection surface <NUM> of the second connection plate <NUM> is secured to the instillation module <NUM> proximate the fluid distribution hub <NUM> such that the flow path outlet <NUM> is in fluid communication with the opening <NUM> of the fluid distribution hub <NUM> to generate an instillation flow path that is fluidly separate from a NPWT flow path. In some embodiments, the second connection surface <NUM> may be welded to the instillation module <NUM>. In other embodiments, the second connection surface <NUM> may be secured to the instillation module <NUM> by an adhesive. In some embodiments, such as the embodiment illustrated in <FIG>, the first connection surface <NUM> of the compressible instillation connection structure <NUM> is securable to the second surface <NUM> of the sealing member <NUM> by an adhesive. In such an embodiment, the first connection surface <NUM> of the compressible instillation connection structure <NUM> can include markings (not shown) to facilitate placement of the instillation conduit pad <NUM> (e.g., provide an indication of where to cut a hole into or pierce the sealing member <NUM>). The compressible instillation connection structure <NUM> can contract in response to the forces exerted by the operator when securing the instillation conduit pad <NUM>, preventing patient discomfort during placement of the instillation conduit pad <NUM>.

In other embodiments, such as the embodiment of <FIG>, the first connection surface <NUM> is securable to the connection plate <NUM> by an adhesive. In some embodiments, the first connection surface <NUM> may include a marking <NUM> indicating that the first connection surface <NUM> should be secured to the connection plate <NUM>. In some embodiments, the first connection surface <NUM> may include an adhesive for securing the first connection surface <NUM> to the connection plate <NUM>. In such embodiments, the first connection surface may include a removable backing and the marking <NUM> may be positioned on the removable backing.

As illustrated in <FIG>, the wound therapy system <NUM> includes an instillation flow path (arrows <NUM>) that is fluidly separate from a negative pressure flow path (arrows <NUM>). As illustrated by the arrows <NUM>, instillation fluid enters the wound therapy system <NUM> from the instillation system <NUM> and travels along the instillation conduit <NUM> to the instillation conduit pad <NUM>. The instillation fluid then flows through the instillation inlet <NUM> of the connection plate <NUM> to the flow path inlet <NUM> of the compressible instillation connection structure <NUM>. The instillation fluid travels along the flow path <NUM> and exits the compressible instillation connection structure <NUM> through the flow path outlet <NUM>. The instillation fluid then enters the fluid distribution hub <NUM> of the instillation module <NUM> and travels along the fluid distribution structures <NUM>. The instillation fluid exits the fluid distribution structures <NUM> through the fenestrations <NUM> and travels to the treatment site.

As illustrated by the arrows <NUM>, the negative pressure generated by the negative pressure source <NUM> of the NPWT system <NUM> causes fluid (e.g., instillation fluid, wound exudate, etc.) to enter the plurality of elongate legs <NUM> of the abdominal treatment device <NUM> through the fenestrations <NUM>. As shown by the arrows <NUM>, fluid travels through at least a portion of the elongate legs <NUM> and exits the abdominal treatment device <NUM> through the fenestrations <NUM>. The fluid then travels through the negative pressure manifold <NUM> to the NPWT inlet connector <NUM> of the connection plate <NUM>. The fluid then travels along the NPWT conduit pad <NUM> to the negative pressure conduit <NUM> and into the fluid collection chamber <NUM> of the NPWT system <NUM>.

<FIG> illustrate the negative pressure manifold <NUM> including a compressible instillation connection structure <NUM>. The compressible instillation connection structure <NUM> is positionable within the negative pressure manifold <NUM> and intended to expand and contract with the negative pressure manifold <NUM> as the negative pressure manifold <NUM> expands and contracts during cycles of NPWT therapy (e. g the negative pressure manifold <NUM> and the compressible instillation connection structure <NUM> are expanded when not under negative pressure and compressed when under negative pressure) to reduce patient discomfort during NPWT. The compressible instillation connection structure <NUM> can be made of the same material as the negative pressure manifold <NUM> such that the compressible instillation connection structure <NUM> compresses and expands substantially a same amount as the negative pressure manifold <NUM> during NPWT therapy. As is best shown in <FIG>, the compressible instillation connection structure <NUM> includes a first surface <NUM>, a second, abdominal contents-facing surface <NUM>, and a flow path <NUM> extending between the first surface <NUM> and the second surface <NUM>.

The flow path <NUM> extends between a flow path inlet <NUM> formed in the first surface <NUM> and a flow path outlet <NUM> formed in the second surface to direct instillation fluid from the instillation conduit <NUM> of the instillation system <NUM> to the fluid distribution hub <NUM> of the instillation module <NUM>. The flow path <NUM> defines a longitudinal axis B. A fluid impermeable layer <NUM> is formed on at least a portion of the first surface <NUM>, along the flow path <NUM>, and on at least a portion of the second surface <NUM> to prevent lateral flow of the instillation fluid into the negative pressure manifold <NUM>. In some embodiments, the fluid impermeable layer <NUM> In the illustrated embodiment, the fluid impermeable layer <NUM> is made of a polyurethane material. In other embodiments, the fluid impermeable layer <NUM> can be made of another material that is substantially impermeable to instillation fluid.

The compressible instillation connection structure <NUM> can be made of a compressive material, such that the compressible instillation connection structure <NUM> compresses along the longitudinal axis B under negative pressure conditions. For example, the compressive instillation connection structure can be made of the compressive reticulated foam material discussed above with respect the negative pressure manifold <NUM>. In some embodiments, the compressible instillation connection structure <NUM> can be made of the same material as the negative pressure manifold <NUM> such that the compressible instillation connection structure <NUM> compresses and expends with the negative pressure manifold <NUM> during cycles of NPWT.

<FIG> illustrates the compressible instillation connection structure <NUM> deployed in the wound therapy system <NUM>. The compressible instillation connection structure <NUM> can be received within and extend through the negative pressure manifold <NUM>. The second surface <NUM> is secured in a fluid-tight seal to the instillation module <NUM> proximate the fluid distribution hub <NUM> such that the flow path outlet <NUM> is in fluid communication with the fluid distribution hub <NUM> to form a fluid-tight instillation flow path that is fluidly separate from the NPWT flow path. In some embodiments, the second surface <NUM> may be welded to the instillation module <NUM>. In other embodiments, the second surface <NUM> may be secured to the instillation module <NUM> by an adhesive. In some embodiments, the first surface <NUM> is secured with a fluid-tight seal to the connection plate <NUM> by an adhesive. In some embodiments, the first surface <NUM> is secured with a fluid-tight seal to the second surface <NUM> of the sealing member <NUM>. In some embodiments, the first surface <NUM> may include a marking <NUM> indicating that the first surface <NUM> should be secured to the connection plate <NUM>. In some embodiments, the first surface <NUM> may include an adhesive for securing the first surface <NUM> to the connection plate <NUM>. In such embodiments, the first surface <NUM> may include a removable backing and the marking <NUM> may be positioned on the removable backing. In embodiments in which the second surface <NUM> is securable to the instillation module <NUM> by an adhesive, second surface <NUM> may include a marking (not shown) indicating that the second surface <NUM> should be secured to the instillation module <NUM>. In some embodiments, the second surface <NUM> may include an adhesive for securing the second surface <NUM> to the instillation module <NUM>. In such embodiments, the second surface <NUM> may include a removable backing and the marking <NUM> may be positioned on the removable backing. In some embodiments, the marking <NUM> may be a color, a pattern, shapes, and/or words.

<FIG> illustrate an instillation module <NUM> including an integrated instillation conduit <NUM> according to some embodiments. The instillation module <NUM> is configured to facilitate substantially even distribution of the instillation fluid independently of a position of the patient (e.g., supine or lying on a side). The instillation module <NUM> includes a first layer <NUM>, a second layer <NUM>, and a fluid distribution layer <NUM>. The fluid distribution layer <NUM> includes a first surface <NUM> and a second, abdominal contents-facing, surface <NUM>. The fluid distribution layer <NUM> includes a fluid distribution hub <NUM>, a plurality of fluid distribution structures <NUM> that extend radially from the fluid distribution hub <NUM>, and the integrated instillation conduit <NUM> that extends from the fluid distribution hub <NUM>. The first layer <NUM>, the second layer <NUM>, the fluid distribution hub <NUM>, and the plurality of fluid distribution structures <NUM> are substantially similar to the first layer <NUM>, the second layer <NUM>, the fluid distribution hub <NUM>, and the plurality of fluid distribution structures <NUM> described above with respect to the instillation module <NUM> and will not be described in detail herein for the sake of brevity.

The instillation conduit <NUM> includes a generally elongate portion <NUM> that extends from the fluid distribution hub <NUM>. A distal end <NUM> of the generally elongate portion <NUM> may be enlarged to form an instillation conduit land portion <NUM>. The instillation conduit land portion <NUM> is configured to engage the connection plate <NUM> and/or form a surface for engagement with the instillation conduit <NUM>. A portion of the first layer <NUM> and the second layer <NUM> encapsulates the instillation conduit (e.g., the generally elongate portion <NUM> and the instillation conduit land portion <NUM>). The portion is made of a fluid-impermeable material and does not include the fenestrations <NUM> such that instillation fluid may enter the instillation conduit <NUM> at the instillation conduit land portion <NUM> and/or the distal end <NUM> and travel along the elongate portion <NUM> to the fluid distribution hub <NUM> for distribution to fluid distribution structures <NUM>.

<FIG> illustrates the instillation module <NUM> and the negative pressure manifold <NUM> positioned to treat an open abdomen of a patient. In the illustrated embodiment, the elongate portion <NUM> of the instillation conduit <NUM> is wrapped around the negative pressure manifold <NUM> such that the first layer <NUM> and the first surface <NUM> of the elongate portion <NUM> abuts the negative pressure manifold <NUM>. In some embodiments, the portion of the first layer <NUM> abutting the negative pressure manifold <NUM> may include an adhesive for securing the first layer <NUM> to the negative pressure manifold <NUM> to prevent the instillation conduit <NUM> from slipping. The second layer <NUM> of the integrated instillation conduit <NUM> (e.g., the second surface <NUM> of the instillation conduit land portion <NUM>) faces away from the first surface <NUM> of the negative pressure manifold <NUM>. In some embodiments, at least a portion of the second layer <NUM> includes an adhesive for securing the second layer <NUM> to the second surface <NUM> of the sealing member <NUM>. In the illustrated embodiment, the connection plate <NUM> is secured to the instillation conduit land portion <NUM>, for example by welding and/or an adhesive. In other embodiments, the elongate portion <NUM> of the instillation conduit may extend through a hole in the negative pressure manifold <NUM>. Accordingly, the instillation conduit <NUM> forms a flow path between the instillation conduit <NUM> engaged with the instillation system <NUM> and the fluid distribution hub <NUM> in a fluidly separated flow path from the flow path between the negative pressure manifold <NUM> and the NPWT system <NUM>.

The wound therapy system <NUM> includes an instillation flow path that is fluidly separate from a negative pressure flow path. The instillation fluid enters the wound therapy system <NUM> from the instillation system <NUM> and travels along the instillation conduit <NUM> to the instillation conduit pad <NUM>. The instillation fluid then flows through the instillation inlet <NUM> of the connection plate <NUM> to the instillation conduit land portion <NUM> of the instillation conduit <NUM> of the instillation module <NUM>. The instillation fluid travels along the generally elongate portion <NUM> of the instillation conduit <NUM> and then enters the fluid distribution hub <NUM>. The instillation fluid then enters and travels along the fluid distribution structures <NUM>. The instillation fluid exits the fluid distribution structures <NUM> through the fenestrations <NUM> and travels to the treatment site.

The negative pressure generated by the negative pressure source <NUM> of the NPWT system <NUM> causes fluid (e.g., instillation fluid, wound exudate, etc.) to enter the plurality of elongate legs <NUM> of the abdominal treatment device <NUM> through the fenestrations <NUM>. Fluid travels through at least a portion of the elongate legs <NUM> and exits the abdominal treatment device through the fenestrations <NUM>. The fluid then travels through the negative pressure manifold <NUM> to the NPWT inlet connector <NUM> of the connection plate <NUM>. The fluid then travels along the NPWT conduit pad <NUM> to the negative pressure conduit <NUM> and into the fluid collection chamber <NUM> of the NPWT system <NUM>.

<FIG> illustrate an instillation module <NUM> including an integrated instillation conduit <NUM> according to some embodiments. The instillation module includes <NUM> a first layer <NUM>, a second layer <NUM>, and a fluid distribution layer <NUM>. The fluid distribution layer <NUM> includes a first layer <NUM> and a second, abdominal contents-facing, later <NUM>. The fluid distribution layer <NUM> includes a fluid distribution hub <NUM> and a plurality of fluid distribution structures <NUM> that extend radially from the fluid distribution hub <NUM>, and the instillation conduit <NUM> that extends from the fluid distribution hub <NUM>. The first layer <NUM>, the second layer <NUM>, and the plurality of fluid distribution structures <NUM> are substantially similar to the first layer <NUM>, the second layer <NUM>, and the plurality of fluid distribution structures <NUM> described above with respect to the instillation module <NUM> and will not be described in detail herein for the sake of brevity.

The instillation conduit <NUM> includes a fluid distribution hub engagement portion <NUM> and flow path portion <NUM>. The flow path portion <NUM> is engaged with the fluid distribution hub engagement portion <NUM> and the connection plate <NUM>. In the illustrated embodiment, the flow path portion <NUM> is flexible tubing. The flow path portion <NUM> is configured to enable motion of the instillation module <NUM> and the negative pressure manifold <NUM> during cycles of NPWT. More specifically, the ends of the flow path portion <NUM> are in-molded into the fluid distribution hub engagement portion <NUM> and the connection plate <NUM>. The fluid distribution hub engagement portion <NUM> includes instillation fluid inlet portion <NUM> engaged with the flow path portion <NUM> and a plurality of channels <NUM> in fluid communication with each of the fluid distribution structures of the plurality of fluid distribution structures <NUM>. In the illustrated embodiment, the plurality of channels <NUM> are molded into the fluid distribution hub engagement portion <NUM>.

The fluid distribution hub <NUM> includes a hole <NUM> sized to receive the fluid distribution hub engagement portion <NUM>. The fluid distribution hub engagement portion <NUM> is secured within the hole <NUM>. In some embodiments, the first layer <NUM> and the second layer <NUM> may extend over (e.g., encapsulate) the fluid distribution hub engagement portion <NUM>. In other embodiments, the first layer <NUM> and the second layer <NUM> encapsulate the fluid distribution layer <NUM>, including the walls of the hole <NUM>. In such an embodiment, the fluid distribution hub engagement portion <NUM> may be welded to the first layer <NUM> and the second layer <NUM>, and the first layer <NUM> and the second layer <NUM> may include fenestrations aligned with the plurality of channels <NUM> to allow instillation fluid to enter the fluid distribution hub <NUM>.

<FIG> illustrates the instillation module <NUM> and the negative pressure manifold <NUM> positioned to treat an open abdomen of a patient. The flow path portion <NUM> of the instillation conduit <NUM> is wrapped around the negative pressure manifold <NUM> such that the flow path portion <NUM> and the connection plate <NUM> overlie the first surface <NUM> of the negative pressure manifold <NUM>. The connection plate <NUM> may be secured to the first surface of the negative pressure manifold <NUM>, for example by welding and/or an adhesive. Accordingly, the instillation conduit <NUM> forms a flow path between the instillation conduit <NUM> engaged with the instillation system <NUM> and the fluid distribution hub <NUM> in a fluidly separated flow path. As illustrated in <FIG> in some embodiments, a second instillation module can be used.

The wound therapy system <NUM> includes an instillation flow path that is fluidly separate from a negative pressure flow path. The instillation fluid enters the wound therapy system <NUM> from the instillation system <NUM> and travels along the instillation conduit <NUM> to the instillation conduit pad <NUM>. The instillation fluid then flows through the instillation inlet <NUM> of the connection plate <NUM> to the flow path portion <NUM> of the instillation conduit <NUM>. The instillation fluid travels along flow path portion <NUM> of the instillation conduit <NUM> and then enters the fluid distribution hub <NUM>. The instillation fluid then enters and flows along the plurality of channels <NUM> to the plurality of fluid distribution structures <NUM>. The instillation fluid exits the fluid distribution structures <NUM> through the fenestrations <NUM> and travels to the treatment site.

<FIG> illustrate an instillation module <NUM> and an instillation connection sealing system <NUM>. The instillation module <NUM> and the instillation connection sealing system <NUM> can be used in conjunction with the abdominal treatment device <NUM>. <FIG> illustrates a top perspective view of the instillation module <NUM> and the instillation connection sealing system <NUM> in a storage position. <FIG> illustrate steps in a process for deploying the instillation module <NUM> and the instillation connection sealing system <NUM>.

As is best shown in <FIG>, the instillation module <NUM> including an integrated instillation conduit <NUM>, a first layer <NUM>, a second layer <NUM>, and a fluid distribution layer <NUM>. The fluid distribution layer <NUM> includes a fluid distribution hub <NUM>, anda plurality of fluid distribution structures <NUM> that extend radially from the fluid distribution hub <NUM>. The first layer <NUM>, the second layer <NUM>, the fluid distribution hub <NUM>, and the plurality of fluid distribution structures <NUM> are substantially similar to the first layer <NUM>, the second layer <NUM>, the fluid distribution hub <NUM>, and the plurality of fluid distribution structures <NUM> described above with respect to the instillation module <NUM> and will not be described in detail herein for the sake of brevity. The integrated instillation conduit <NUM> is in fluid communication with the fluid distribution hub <NUM> and is secured to the instillation module <NUM> using a fluid-tight connection. In some embodiments, the integrated instillation conduit <NUM> may be secured to the instillation module <NUM> using the fluid distribution hub engagement portion <NUM> described above with respect to <FIG>. In the illustrated embodiment, the integrated instillation conduit <NUM> is a flexible tube. In some embodiments, the integrated instillation conduit <NUM> may be provided in a storage position in which the integrated instillation conduit <NUM> is provided in a coil abutting the instillation module <NUM>. Once positioned in the abdominal cavity, the integrated instillation conduit <NUM> can be uncoiled and deployed in the patient as described in greater detail below.

The instillation connection sealing system <NUM> includes a sealing plate <NUM>, a sealing pad <NUM> and a locking collar <NUM>. The sealing plate <NUM> includes a first surface <NUM> and a second, wound-facing surface <NUM>. The sealing plate <NUM> further includes an instillation conduit passage <NUM> that extends between the first surface <NUM> and the second surface <NUM>. A portion of the instillation conduit passage <NUM> extends above the first surface <NUM>. The instillation conduit passage <NUM> includes an exterior surface <NUM> and an interior surface <NUM> that defines a passageway for receiving the instillation conduit <NUM>. At least a portion of the second surface <NUM> includes an adhesive for securing the second surface <NUM> of the sealing plate <NUM> to the first surface <NUM> of the sealing member <NUM> in a fluid-tight seal.

The sealing pad <NUM> includes a first surface <NUM> and a second, wound-facing, surface <NUM>. The second surface <NUM> includes an adhesive coating. The sealing pad <NUM> is sized to form a seal around a hole formed in the sealing member <NUM> to retrieve the instillation conduit <NUM> as described in greater detail below. In some embodiments, the sealing pad <NUM> can be made from the same material as the sealing member <NUM>.

The locking collar <NUM> includes an exterior surface <NUM> and an interior surface <NUM> that define a passageway <NUM>. The passageway <NUM> is sized such that the locking collar <NUM> can move freely along the instillation conduit <NUM>. The passageway <NUM> is sized to form a tight, friction fit against the exterior surface <NUM> of the instillation conduit passageway <NUM> of the sealing plate <NUM> to form a fluid-tight seal about a perimeter of the instillation conduit <NUM>. In some embodiments, the locking collar <NUM> is more rigid than the instillation conduit passageway <NUM> and is sized such that engagement of the locking collar <NUM> with the instillation conduit passageway <NUM> causes the instillation conduit passageway <NUM> to deform inwards against the instillation conduit <NUM>, forming a tight seal about the perimeter of the instillation conduit <NUM>. In some embodiments, the locking collar <NUM> further includes a flange <NUM> formed about a portion of the exterior surface <NUM> of the locking collar <NUM> to assist an operator in grasping the locking collar <NUM>.

<FIG> illustrate a process for deploying the instillation module <NUM> and the instillation connection sealing system <NUM>. As shown in <FIG>, the operator positions the instillation module <NUM> against the abdominal contents of the patient. The operator then uncoils the instillation conduit <NUM> from the storage position (<FIG>) and extends the instillation conduit <NUM> through a hole in the negative pressure manifold <NUM> or wraps the instillation conduit <NUM> around a side of the negative pressure manifold <NUM>. The operator then secures the sealing member <NUM> to the skin of the patient surrounding the abdominal incision. The operator then makes a hole in the sealing member <NUM> and passes the instillation conduit <NUM> through the hole in the sealing member <NUM>. The user then positions the sealing pad <NUM>, the sealing plate <NUM> and the locking collar <NUM> along the instillation conduit <NUM> such that the second surface <NUM> of the sealing member <NUM> is oriented toward the first surface <NUM> of the sealing member <NUM>. The user then slides the sealing pad <NUM> towards the sealing member <NUM> and secures the second surface <NUM> of the sealing pad <NUM> around the hole in the sealing member <NUM>. The user then slides the sealing plate <NUM> and the locking collar towards the sealing member <NUM> as indicated by the arrows <NUM>. The user secures the second surface <NUM> of the sealing plate <NUM> to the first surface <NUM> of the sealing pad <NUM> in a fluid-tight seal. As shown in <FIG>, the user then slides the locking collar <NUM> towards the first surface <NUM> of the sealing plate, as shown by the arrows <NUM>, to engage the locking collar <NUM> in a friction-fit and establish a fluid-tight seal between the instillation conduit passage <NUM> and the instillation conduit <NUM>, as shown in <FIG>. The operator may then connect the installation conduit <NUM> to the instillation system <NUM> and begin instillation therapy.

<FIG> illustrates a perspective view of the wound therapy system <NUM> including the instillation module <NUM> and instillation connection sealing system <NUM> engaged with the instillation system <NUM> for providing instillation therapy and the negative pressure manifold <NUM> engaged with the NPWT system <NUM> for providing NPWT. As illustrated in <FIG>, when the wound therapy system <NUM> is deployed in the patient, the wound therapy system includes an instillation flow path (arrows <NUM>) that is fluidly separate from a negative pressure flow path (arrows <NUM>). As illustrated by the arrows <NUM>, instillation fluid enters the wound therapy system <NUM> from the instillation system <NUM> and travels along the instillation conduit <NUM> to the fluid distribution hub <NUM> of the instillation module <NUM>. The instillation fluid then flows along the fluid distribution structures <NUM>. The instillation fluid exits the fluid distribution structures <NUM> through the fenestrations <NUM> and travels to the treatment site.

Although the systems and methods disclosed herein are described in the context of the various embodiments illustrated herein, it is contemplated that any of the systems and methods disclosed herein can be combined in different manners.

Claim 1:
A system for providing instillation fluid to a deep abdominal wound, comprising :
an instillation module (<NUM>, <NUM>) defining a first surface and a second, abdominal contents-facing surface, the instillation module including a distribution hub (<NUM>, <NUM>) configured to receive instillation fluid from an instillation fluid source (<NUM>);
a negative pressure manifold (<NUM>) including a first surface (<NUM>) and a second, abdominal contents-facing surface (<NUM>);
a connection structure (<NUM>, <NUM>, <NUM>) comprising
a first surface;
a second, abdominal contents-facing surface; and
a flow path extending between the first surface of the connection structure (<NUM>, <NUM>, <NUM>) and the second surface of the connection structure (<NUM>, <NUM>,<NUM>), the flow path including an inlet configured to be in fluid communication with an instillation fluid conduit (<NUM>) engaged with an instillation fluid source (<NUM>) and an outlet in fluid communication with the distribution hub (<NUM>, <NUM>) of the instillation module (<NUM>, <NUM>) , the flow path defining an axis extending between the inlet and the outlet and configured to compress in a direction defined by the axis, wherein the second surface of the connection structure (<NUM>, <NUM>, <NUM>) is secured to the first surface of the instillation module (<NUM>, <NUM>) to provide a fluid-tight connection between the flow path and the instillation module (<NUM>, <NUM>); and
a connection plate (<NUM>, <NUM>) secured to the negative pressure manifold (<NUM>) and including an instillation inlet connector (<NUM>) having a first shape in fluid communication with the distribution hub (<NUM>, <NUM>) via the flow path and a negative pressure inlet connector having a second shape different than the first shape, the negative pressure inlet connector in fluid communication with the negative pressure manifold (<NUM>).