Systems and methods for managing pneumatic pathways in integrated multi-layer wound dressings

Abstract

The invention relates to a system and method for managing pneumatic pathways in an integrated multi-layer wound dressing. A system for providing instillation fluid to a deep abdominal wound includes an instillation module and a connection structure. The instillation module defines a first surface and a second surface facing abdominal contents. The instillation module includes a distribution hub configured to receive instillation fluid from an instillation fluid source. The connecting structure comprises a first surface and a second surface facing abdominal contents; and a flow path extending between the first surface and the second surface. The flow path includes an inlet configured to receive an instillation fluid conduit engaged with an instillation fluid source and an outlet in fluid communication with the instillation module. The flow path defines an axis extending between the inlet and the outlet. The flow path is configured to compress in a direction defined by the axis.

Description

[0001] This application is a divisional application of an application filed on May 16, 2019, with application number 201980044434.2, and invention name “System and method for managing pneumatic pathways in integrated multi-layer wound dressings”. CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 674,970, filed May 22, 2018, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates generally to wound treatment systems, and more particularly to wound treatment systems configured to provide instillation therapy and negative pressure wound therapy to fascial incisions in deep abdominal incisions. Background Art

[0004] Instillation therapy is a type of wound treatment that involves administering a therapeutic fluid (e.g., saline solution, prescription solution, antibiotics, cleansing fluid, etc.) to the treatment site to promote wound healing and granulation, prevent the wound from drying out, protect the wound from bacterial infection, and / or treat an infected treatment site. Some instillation systems include an instillation fluid container and an instillation pump for delivering the instillation fluid to the treatment site. Instillation therapy can be used in conjunction with NPWT or on its own.

[0005] Negative pressure wound therapy (NPWT) is a type of wound therapy that involves applying negative pressure (pressure below atmospheric pressure) to the treatment site to promote wound healing. NPWT applies negative pressure to the wound, draining fluid from the wound as it heals. Some NPWT systems include a pump to maintain negative pressure at the treatment site by removing wound exudate from the site. Wound exudate is typically directed to a canister or other container fluidically connected to the pump, where it is stored until emptied by the user.

[0006] Both instillation therapy and NPWT can be used to treat deep abdominal wounds caused by laparotomy, which is used to gain access to the abdominal cavity for surgical procedures and / or to reduce intra-abdominal pressure by distending the intestine. In some cases, the laparotomy incision is not closed immediately, resulting in an "open abdomen," and instillation and / or NPWT can be used to treat the open abdomen. For example, instillation fluid can be used to perfuse the open abdomen, thereby preventing the abdominal contents from drying out, and can also be used to periodically flush the open abdomen to potentially reduce the possibility of sepsis. However, manual flushing may cause damage that requires further surgery. Summary of the Invention

[0007] Instillation and negative pressure systems suitable for treating an open abdominal cavity are often complex due to the need to maintain fluidly separate instillation and NPWT pathways, and identifying the fluidly separate instillation and NPWT pathways can be difficult in a wound therapy system deployed within a patient. Furthermore, the wound therapy system can expand and contract during cycles of instillation and NPWT, making it difficult to maintain a fluid-tight seal across the instillation and NPWT pathways. Furthermore, a rigid instillation and / or NPWT connector can contact the patient or otherwise cause discomfort to the patient during connection of the instillation and / or NPWT connector or during compression that occurs during NPWT.

[0008] One embodiment of the present disclosure is a system for providing an infusion fluid to a deep abdominal wound, the system comprising an infusion module and a connection structure. The infusion module defines a first surface and a second surface facing the abdominal contents. The infusion module comprises a distribution hub configured to receive an infusion fluid from an infusion fluid source. The connection structure comprises a first surface, a second surface facing the abdominal contents; and a flow path extending between the first surface and the second surface. The flow path comprises an inlet configured to receive an infusion fluid conduit engaged with the infusion fluid source and an outlet in fluid communication with the infusion module. The flow path defines an axis extending between the inlet and the outlet. The flow path is configured to compress in a direction defined by the axis.

[0009] Another embodiment of the present disclosure is a connection structure for providing an instillation fluid to a deep abdominal wound. The connection structure includes a first surface, a second surface facing the abdominal contents, and a flow path extending between the first and second surfaces. The flow path includes an inlet configured to receive an instillation fluid conduit engaged with an instillation fluid source, and an outlet configured for fluid communication with an instillation module positionable within the deep abdominal wound. The flow path defines an axis extending between the inlet and the outlet. The flow path is configured to compress in a direction defined by the axis.

[0010] Another embodiment of the present disclosure is a system for providing an instillation fluid to a deep abdominal wound. The system includes a sealing member and a wound dressing. The sealing member defines a first surface and a second surface facing the abdominal contents. The sealing member is configured to form a fluid-tight seal around the perimeter of the deep abdominal wound. The wound dressing includes a drip module, a drip conduit, and a sealing plate. The drip module defines a first surface and a second surface facing the abdominal contents. The drip module includes a distribution hub configured to receive an instillation fluid from an instillation fluid source. The drip conduit includes a first end in fluid communication with the drip module and a second end configured for fluid communication with the instillation fluid source. The sealing plate includes a drip conduit passage extending from the drip fluid plate. The sealing plate is configured to receive the drip conduit therethrough. The sealing plate is securable to the first surface of the sealing member.

[0011] Another embodiment of the present disclosure is a connection system for providing infusion therapy and negative pressure therapy to deep abdominal wounds. The connection system includes an infusion module, a negative pressure manifold, and a connection plate. The infusion module defines a first surface and a second surface facing the abdominal contents. The infusion module includes a distribution hub portion, which includes an infusion inlet configured to engage an infusion catheter of an infusion fluid source. The negative pressure manifold includes a first surface and a second surface facing the abdominal contents. The connection plate is fixed to the negative pressure manifold and includes a infusion inlet connector and a negative pressure inlet connector, the infusion inlet connector having a first shape that is in fluid communication with the infusion inlet of the infusion module, and the negative pressure inlet connector having a second shape that is different from the first shape. The negative pressure inlet connector is in fluid communication with the negative pressure manifold.

[0012] Specifically, this application provides the following: 1). A system for providing an instillation fluid to a deep abdominal wound, the system comprising: an instillation module defining a first surface and a second surface facing the abdominal contents, the instillation module including a distribution hub configured to receive an instillation fluid from an instillation fluid source; and A connection structure, comprising: a first surface; a second surface facing the abdominal contents; and A flow path extends between the first surface and the second surface, the flow path including an inlet configured to receive an infusion fluid conduit engaged with the infusion fluid source and an outlet connected to the infusion module fluid, the flow path defining an axis extending between the inlet and the outlet and being configured to compress in a direction defined by the axis.

[0013] 2). The system according to 1), wherein at least a portion of the flow path is articulated to facilitate compression.

[0014] 3) The system according to 2), wherein the hinged portion of the flow path has a bellows shape.

[0015] 4) The system according to 1), wherein at least the flow path is configured to be compressed under negative pressure provided by a negative pressure source.

[0016] 5). The system according to 1), wherein the second surface is fixed to the first surface of the drip module to provide a fluid-tight connection between the flow path and the drip module.

[0017] 6). The system according to 1), further comprising a negative pressure manifold defining a first surface and a second surface facing the abdominal contents, and wherein the flow path extends through the negative pressure manifold such that the flow path is positioned within the negative pressure manifold.

[0018] 7). The system according to 5), wherein the negative pressure manifold is configured to be compressed under negative pressure provided by a negative pressure source, and wherein the connecting structure is configured to be compressed under the negative pressure provided by the negative pressure source.

[0019] 8). The system of 6), wherein the negative pressure manifold is formed of a compressible material and the connecting structure is formed of the compressible material, such that the negative pressure manifold and the connecting structure collapse by substantially the same amount under negative pressure.

[0020] 9). The system according to 7), wherein the compressible material is a reticulated foam material.

[0021] 10) The system according to 1), further comprising a first bellows plate having the first surface, a second bellows plate having the second surface, and wherein the first bellows plate, the second bellows plate, and the flow path are integrally formed.

[0022] 11). The system according to 1), further comprising a connection plate positioned adjacent to the first surface of the connection structure, the connection plate comprising markings for accurately positioning the instillation fluid conduit.

[0023] 12). The system according to 1), wherein the first surface comprises a first fluid-impermeable coating, the second surface comprises a second fluid-impermeable coating, and the flow path comprises a flow path fluid-impermeable coating.

[0024] 13). The system according to 9), wherein the first fluid impermeable coating, the second fluid impermeable coating, and the flow path fluid impermeable coating are polyurethane.

[0025] 14). The system according to 9), further comprising a sealing member capable of being fixed around the periphery of the wound to provide a fluid-tight seal around the periphery of the wound, and wherein the sealing member is fixed to the connecting structure to form a fluid-tight connection between the first surface and the sealing member.

[0026] 15) The system according to 1), wherein the infusion module and the connection structure are positionable within an incision of the deep abdominal wound.

[0027] 16) A connection structure for providing an instillation fluid to a deep abdominal wound, the connection structure comprising: a first surface; a second surface facing the abdominal contents; and A flow path extends between the first surface and the second surface, the flow path including an inlet configured to receive an infusion fluid conduit engaged with an infusion fluid source and an outlet configured for fluid communication with an infusion module positionable within the deep abdominal wound, the flow path defining an axis extending between the inlet and the outlet and being configured to compress in a direction defined by the axis.

[0028] 17) The connection structure according to 15), wherein at least a portion of the flow path is hinged to facilitate compression.

[0029] 18) The connection structure according to 16), wherein the hinge portion of the flow path has a bellows shape.

[0030] 19). A connection structure according to 15), wherein the second surface is capable of being fixed to the first surface of the drip module, the drip module defining a first surface and a second surface facing the abdominal contents, the drip module including a distribution hub portion configured to receive drip fluid from a drip fluid source to provide a fluid-tight connection between the flow path and the drip module.

[0031] 20) The connection structure according to 15), wherein the first surface and the second surface are spaced apart and configured to receive a negative pressure manifold therebetween, such that the flow path extends through the negative pressure manifold.

[0032] 21). The connection structure according to 20), wherein the connection structure and the negative pressure manifold are configured to compress under negative pressure, and wherein the connection structure and the negative pressure manifold compress by substantially the same amount.

[0033] 22) The connection structure according to 15), wherein the connection structure is formed of a reticulated foam material.

[0034] 23) The connection structure according to 15), further comprising a first connection plate having the first surface, a second connection plate having the second surface, and wherein the first connection plate, the second connection plate, and the flow path are integrally formed.

[0035] 24). The connection structure according to 15), wherein the first surface includes a first fluid-impermeable coating, the second surface includes a second fluid-impermeable coating, and the flow path includes a flow path fluid-impermeable coating.

[0036] 25). The connection structure according to 24), wherein the first fluid-impermeable coating, the second fluid-impermeable coating, and the flow path fluid-impermeable coating are polyurethane.

[0037] 26). A connection structure according to 15), wherein the sealing member is securable to a sealing member securable around a periphery of the wound to provide a fluid-tight seal to the connection structure around the periphery of the wound, thereby forming a fluid-tight connection between the first surface and the sealing member.

[0038] 27) A system for providing an instillation fluid to a deep abdominal wound, the system comprising: a sealing member defining a first surface and a second surface facing the abdominal contents, the sealing member being configured to form a fluid-tight seal around a perimeter of the deep abdominal wound; and A wound dressing, comprising: an instillation module defining a first surface and a second surface facing the abdominal contents, the instillation module including a distribution hub portion configured to receive an instillation fluid from an instillation fluid source; an infusion conduit comprising a first end in fluid communication with the infusion module and a second end configured for fluid communication with a source of infusion fluid; and A sealing plate including a drip conduit passage extending from the drip fluid plate and configured to receive the drip conduit therethrough is securable to the first surface of the sealing member.

[0039] 28). The system according to 27), wherein the drip catheter passage comprises an outer surface and an inner surface defining a passage for receiving the drip catheter.

[0040] 29). The system according to 28), further comprising a locking collar capable of sliding along the drip catheter, the locking collar being configured to engage the outer surface of the drip catheter passage in a friction fit manner to form a fluid-tight seal between the slender rod and the drip catheter.

[0041] 30). The system according to 27), wherein the drip conduit extends through a hole in the sealing member, and wherein the sealing plate is configured to form a fluid-tight seal over the hole.

[0042] 31). The system of 27), wherein the drip conduit is positionable in a storage position and a deployment position, wherein in the storage position the drip conduit is positioned within the wound dressing and in the deployment position at least a portion of the drip conduit extends through the sealing member.

[0043] 32) A connection system for providing infusion therapy and negative pressure therapy to a deep abdominal wound, the connection system comprising: an instillation module defining a first surface and a second surface facing the abdominal contents, the instillation module including a distribution hub portion including an instillation inlet configured to engage an instillation conduit of an instillation fluid source; a negative pressure manifold comprising a first surface and a second surface facing the abdominal contents; A connecting plate is fixed to the negative pressure manifold and includes a drip inlet connector and a negative pressure inlet connector, wherein the drip inlet connector has a first shape that is fluidically connected to the drip inlet of the drip module, and the negative pressure inlet connector has a second shape different from the first shape, and the negative pressure inlet connector is fluidically connected to the negative pressure manifold.

[0044] 33). According to the connection system described in 32), the connection system also includes an infusion catheter pad, which is configured to receive the infusion catheter of the infusion fluid source, and the infusion catheter pad includes an infusion outlet connector, which is shaped to engage with the infusion inlet connector and prevent engagement with the negative pressure inlet connector.

[0045] 34). The connection system according to 33), wherein the drip inlet connector and the drip catheter pad include a pair of markings indicating that the drip catheter pad is configured to engage the drip inlet.

[0046] 35). According to the connection system described in 32), the connection system also includes a negative pressure catheter pad, which is configured to receive the negative pressure catheter connected to the negative pressure source fluid, and the negative pressure catheter pad includes a negative pressure outlet connector, which is formed to engage with the negative pressure inlet connector and prevent engagement with the drip inlet connector.

[0047] 36). The connection system according to 35), wherein the negative pressure inlet connector and the negative pressure catheter pad include a pair of markings indicating that the negative pressure catheter pad is configured to engage the negative pressure inlet connector.

[0048] 37). The connection system according to 32), further comprising an integrated infusion and NPWT catheter pad, wherein the integrated infusion and NPWT catheter pad comprises: a drip catheter pad configured to receive the drip catheter of the drip fluid source, the drip catheter pad including a drip outlet connector shaped to engage the drip inlet connector and prevent engagement with the negative pressure inlet connector; and A negative pressure catheter pad is configured to receive the negative pressure catheter in fluid communication with a negative pressure source, the negative pressure catheter pad including a negative pressure outlet connector shaped to engage the negative pressure inlet connector and prevent engagement with the drip inlet connector.

[0049] 38). The connection system according to 32), wherein the connection plate comprises markings to facilitate positioning of the drip catheter and / or the negative pressure catheter.

[0050] 39). The connection system according to 32), wherein one of the drip inlet connectors is one of an upwardly opening spear or a hole, and the negative pressure inlet connector is the other of the upwardly opening spear and the hole.

[0051] 40). According to the connection system described in 32), the connection system also includes a sealing member, which is capable of being fixed around the periphery of the wound to provide a fluid-tight seal around the periphery of the wound, and wherein the sealing member is fixed to the connection structure to form a fluid-tight connection between the first surface and the sealing member, and wherein the drip inlet connector and the negative pressure inlet connector are accessible through the sealing member.

[0052] Those skilled in the art will appreciate that the present disclosure is illustrative only and is not intended to be limiting in any way. Other aspects, inventive features, and advantages of the devices and / or processes described herein, as limited only by the claims, will become apparent from the detailed description set forth herein and in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Figure 1 is a cross-sectional view of a wound treatment system according to some embodiments.

[0054] Figure 2 According to some embodiments Figure 1 A perspective view of a connection system for use with a wound therapy system.

[0055] Figure 3 According to some embodiments Figure 1 A perspective view of a connection system for use with a wound therapy system.

[0056] Figure 4is an instillation fluid conduit for use with a wound treatment system, according to some embodiments.

[0057] Figure 5 According to some embodiments, Figure 4 Cross-sectional view of a wound therapy system with an instillation fluid conduit.

[0058] Figure 6 According to some embodiments, Figure 4 A perspective view of a wound therapy system with an instillation fluid conduit.

[0059] Figure 7 is a perspective view of an instillation fluid conduit for use with a wound treatment system, according to some embodiments.

[0060] Figure 8 According to some embodiments, Figure 7 Cross-sectional view of a wound therapy system with an instillation fluid conduit.

[0061] Figure 9 is a perspective view of an infusion module with an integrated infusion fluid connection interface according to some embodiments.

[0062] Figure 10 According to some embodiments, Figure 9 A perspective view of the wound therapy system with an infusion module.

[0063] Figure 11 is a perspective view of an infusion module with an integrated infusion fluid connection interface according to some embodiments.

[0064] Figure 12 According to some embodiments, Figure 11 A perspective view of the wound therapy system with an infusion module.

[0065] Figure 13 is a perspective view of a drip connection sealing system for a wound therapy system, according to some embodiments.

[0066] Figures 14 to 16 The process of securing a drip connection sealing system to create a fluid-tight seal is shown.

[0067] Figure 17 A perspective view of a wound therapy system including a drip connection sealing system is shown. DETAILED DESCRIPTION

[0068] Overview Referring generally to the accompanying drawings, there is shown a wound treatment system having an instillation and negative pressure wound therapy (NPWT) system and components thereof according to various exemplary embodiments. The wound treatment system may include a wound dressing, a drip system, and an NPWT system. The wound treatment system may include: an instillation module for delivering an instillation fluid to a treatment site; a negative pressure manifold for providing NPWT to the treatment site; a connector plate for facilitating connection of the drip system components 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 treatment system is configured to include a drip flow path that is fluidly separate from the NPWT flow path. The drip system may include a source of instillation fluid and a drip pump. The NPWT system may include a negative pressure source and a fluid collection container. The phrase "negative pressure" means a pressure that is less than ambient or atmospheric pressure.

[0069] In some embodiments, the connector plate is configured to facilitate connecting the drip system components to the wound dressing system and to facilitate connecting the NPWT system components to the wound dressing system. For example, the connector plate may include a drip inlet having a first shape and an NPWT inlet having a second shape different from the first shape. The drip system may include a drip catheter pad configured to engage the drip inlet but not the NPWT inlet. The NPWT system may include an NPWT catheter pad configured to engage the NPWT inlet but not the drip inlet.

[0070] In some embodiments, the negative pressure manifold is configured to include a drip flow path in fluid communication with the drip module. The drip flow path is fluidically separated from the negative pressure manifold so that the drip fluid flowing along the drip flow path does not flow into the negative pressure manifold. In some embodiments, the drip flow path is configured to expand and compress along with the negative pressure manifold during a cycle of NPWT. In some embodiments, the drip flow path may be a bellows structure made of a material impermeable to the drip fluid, which 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 the negative pressure manifold. In some embodiments, the drip flow path is made of the same material as the negative pressure manifold so that the drip flow path has substantially the same compression and expansion as the negative pressure manifold during a cycle of NPWT. In such embodiments, the first surface, the second surface facing the abdominal contents, and the flow path (e.g., channel) formed within the drip flow path are coated with a material impermeable to the drip fluid. The first surface is secured to the connection plate or sealing member in a fluid-tight connection, and the second surface is secured to the drip module proximate an inlet of the drip module in a fluid-tight connection to create a drip flow path fluidly separate from the NPWT flow path.

[0071] In some embodiments, the infusion module includes an integrated infusion conduit. The integrated infusion conduit can be wrapped on one side of the negative pressure manifold to abut the sealing member and / or pass through the negative pressure manifold. The integrated infusion conduit can be made of tubing material that is impermeable to the infusion fluid, or can be positioned within an envelope that is impermeable to the infusion fluid.

[0072] In some embodiments, the drip module may include an integrated drip catheter engaged with a sealing system for forming a substantially fluid-tight seal around a hole in a sealing member that receives the integrated drip catheter. To deploy the drip module and the sealing system, the drip module may be positioned in the treatment site so that the drip module substantially covers the abdominal contents. The drip catheter is then passed around or through the negative pressure manifold and then through the hole in the sealing member. A sealing plate having a drip catheter passage is then slid along the drip catheter 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 frictionally fitted around the outer surface of the drip catheter passage to form a substantially fluid-tight seal between the drip catheter passage and the drip catheter.

[0073] Additional features and advantages of the wound treatment system are described in detail below.

[0074] Wound treatment system See also Figure 1 , shows a cross-sectional view of a wound treatment system 10 according to an exemplary embodiment. In the illustrated embodiment, the wound treatment system is configured to treat the abdominal cavity and is discussed in the context of treating an open abdominal cavity. The wound treatment system 10 can be used to treat "open abdominal" conditions, in which a deep abdominal wound remains open for a period of time. The components described herein can be used in different configurations of an instillation therapy system and / or a negative pressure wound therapy (NPWT) system. The phrase "negative pressure" means a pressure that is less than ambient or atmospheric pressure.

[0075] In various embodiments, the wound treatment system 10 can be used to treat deep abdominal incisions. The wound treatment system 10 includes a wound dressing 14, an instillation system 22, and an NPWT system 26. The wound dressing 14 includes an abdominal treatment device 28, an instillation module 30, a negative pressure manifold 34, a sealing member 38, and an optional connecting plate 42 ( Figure 5 ). The wound dressing 14 is intended to be engaged with a treatment site of a patient, such as the patient's abdominal cavity. The wound treatment system 10 can be used with an NPWT system 26 and / or an instillation system 22. The NPWT system 26 can include a negative pressure source 46 (such as a pump) and a fluid collection chamber 50. The instillation system 22 can include an instillation fluid source 54. In some embodiments, the instillation system 22 can include a mounted pump 56.

[0076] Abdominal treatment device See also Figure 1 , the abdominal treatment device 28 is shown to include a first layer 57, a second layer 61, and a foam spacer 65. The second layer 61 faces the abdominal contents and is generally opposite the first layer 57. The foam spacer 65 includes a first surface 67 and a second surface 69 facing the abdominal contents. The foam spacer 65 includes a hub 71 and a plurality of leg members 73 extending generally radially from the hub 71. The hub 71 includes a through opening 75 for receiving at least a portion of the infusion module 30. The foam spacer 65 is generally in fluid communication with the negative pressure conduit 138 to receive negative pressure from the negative pressure source 46 and to receive fluid flowing from the treatment site toward the negative pressure source 46. The plurality of elongated legs 73 are configured to distribute the negative pressure throughout the treatment site. As shown Figure 12 As shown, the first layer 57 and the second layer 61 enclose the leg members 73, the hub 71, and the intermediate spaces between adjacent leg members 73. In the illustrated embodiment, the hub 71 and the plurality of leg members 73 are made of a substantially hydrophobic material and are configured for fluid flow under substantially atmospheric pressure conditions and under negative pressure conditions. In some embodiments, the hub 71 and the plurality of leg members 73 are made of a reticulated foam, such as the reticulated foam described below with respect to the negative pressure manifold 34. In some embodiments, the leg members 73 can be cut to accommodate relatively small wounds. The first layer 57 and the second layer 61 of the abdominal treatment device 28 can be made of a material that is fluid-impermeable and is intended not to irritate the patient's fascia and internal organs. The abdominal treatment device 28 can include a plurality of fenestrations 77 (e.g., negative pressure inlets) for distributing negative pressure from the plurality of leg members 73 and / or allowing fluid to flow into the plurality of leg members 73 and / or the spaces between the plurality of leg members 73 and the layers 57, 61. The fenestrations 77 can include through-holes, slits, or linear cuts. The cross-section of the window 77 may be circular, rectangular, polygonal, or any other shape.

[0077] Infusion module See also Figure 1, the drip module 30 is shown to include a first layer 58, a second layer 62, and a fluid distribution layer 66. The second layer 62 faces the abdominal contents and is generally opposite the first layer 58. The fluid distribution layer 66 includes a first surface 68 and a second surface 70 facing the abdominal contents. The fluid distribution layer 66 includes a fluid distribution hub 72 and a plurality of fluid distribution structures 74 extending generally radially from the fluid distribution hub 72. The fluid distribution hub 72 is generally in fluid communication with the drip conduit 130 to receive the drip fluid and in fluid communication with the fluid distribution structures to distribute the drip fluid to the fluid distribution structures 74. For example, the first layer 58 may include an opening 76 (e.g., a drip inlet) proximate the fluid distribution hub 72 for providing fluid communication between the fluid distribution hub 72 and the drip connection structures. The first layer 58 and the second layer 62 are welded together along at least a portion of the edges of the first layer 58 and the second layer 62 to enclose the fluid distribution layer 66. In some embodiments, the first layer 58 and the second layer 62 encapsulate the fluid distribution structures 74 and the fluid distribution hub 72, but do not encapsulate the intervening spaces between adjacent fluid distribution structures 74 ( Figure 5 ). In the illustrated embodiment, the fluid distribution hub 72 and the plurality of fluid distribution structures 74 are made of a substantially hydrophobic material and are configured for fluid flow under substantially atmospheric pressure conditions and under negative pressure conditions. In some embodiments, the fluid distribution hub 72 and the plurality of fluid distribution structures 74 are made of a reticulated foam, such as the reticulated foam described below with respect to the negative pressure manifold 34. In some embodiments, the fluid distribution structures 74 can be cut to accommodate relatively small wounds.

[0078] In other embodiments, the first and second layers 58, 62 may be made of a material that is fluid-impermeable and designed not to irritate the patient's fascia and internal organs. As described in detail below, in such embodiments, the first and second layers 58, 62 may be fluid distribution layers and include a plurality of fenestrations 78 (e.g., drip outlets) for distributing drip fluids from the plurality of fluid distribution structures 74. The fenestrations 78 may include through-holes, slits, or linear cuts. The cross-section of the fenestrations 78 may be circular, rectangular, polygonal, or any other shape.

[0079] Negative pressure manifold See also Figures 1 to 2, the negative pressure manifold 34 is shown to include a first surface 82 and a second surface 86 opposite the first surface 82 and facing the abdominal contents. When the negative pressure manifold 34 is applied to the treatment site, the first surface 82 faces away from the abdominal contents, while the second surface 86 faces the abdominal contents. In some embodiments, the first surface 82 of the negative pressure manifold 34 contacts the second surface 86 of the sealing member 38. In some embodiments, the negative pressure manifold 34 may include perforations 90 to facilitate removal of a portion of the negative pressure manifold 34 to accommodate wounds of varying sizes. In some embodiments, the second surface 86 of the negative pressure manifold 34 contacts the drip module 30. The negative pressure manifold 34 is adapted to wick fluid (e.g., exudate) from the wound and includes an in-mold manifold structure for distributing negative pressure throughout the negative pressure manifold 34 during negative pressure wound therapy treatment. The negative pressure manifold 34 is made of a material that allows fluid and / or negative pressure to pass between at least the first portion of the negative pressure manifold 34 and the second portion of the negative pressure manifold 34. In some embodiments, the negative pressure manifold 34 can include molded-in flow channels or passages that can distribute fluid provided to and removed from the manifold. In some embodiments, the molded-in flow channels or passages can be formed from cells in a porous foam material.

[0080] The negative pressure manifold 34 can be made of a porous and permeable foam-like material, and more specifically, a reticulated open-cell polyurethane or polyether foam that allows good permeability of wound fluid under reduced pressure. One such foam material that has been used is VAC® available from Kinetic Concepts, Inc. (KCI), San Antonio, Texas. ® Granufoam ® Materials. Any material or combination of materials may be used for the negative pressure manifold 34, provided that the negative pressure manifold 34 is operable to distribute reduced pressure and provide a distributed compressive force along the treatment site.

[0081] Granufoam ® Materials with mesh pores in the range of about 400 microns to 600 microns are preferred, but other materials may be used. Absorbent layer materials (e.g. Granufoam ® The density of the material is usually around 1.3 lb / ft 3 Up to 1.6 lb / ft 3 (20.8kg / m 3 Up to 25.6kg / m 3 ) range. In some cases, it has a higher ® A higher density (smaller pore size) material may be desirable. For example, Granufoam® Materials or densities greater than 1.6 lb / ft 3 (25.6kg / m 3 ) or similar materials. For example, Granufoam ® Materials or densities greater than 2.0 lb / ft 3 (32kg / m 3 ) or 5.0 lb / ft 3 (80.1kg / m 3 ) or even larger, similar materials. The denser the material, the higher the compressive force that can be generated for a given reduced pressure. If a foam with a lower density than the tissue at the tissue site is used as the absorbent layer material, a lifting force can be generated. In an exemplary embodiment, a portion of the wound dressing (e.g., the edge) can apply a compressive force, while another portion (e.g., the center) can provide a lifting force.

[0082] The absorbent layer material may be a reticulated foam that is then felted to a thickness of about one-third (½) the original thickness of the foam. Among the many possible absorbent layer materials, the following may be used: Granufoam ® Material or Foamex ® Technical foams (www.foamex.com). In some cases, it may be desirable to add ionic silver to the foam during the micro-bonding process or to add other substances, such as antimicrobial agents, to the absorbent layer material. The absorbent layer material can be isotropic or anisotropic, depending on the exact orientation of the compressive force required during the application of reduced pressure. The absorbent layer material can also be bioabsorbable.

[0083] Sealing components See again Figure 1 , the sealing member 38 is shown to include a first surface 94 and a second surface 98 facing the wound opposite the first surface 94. When the wound treatment system 10 is applied to the wound, the first surface 94 faces away from the wound and the second surface 98 faces the wound. Figure 1 As shown, at least the periphery of the second surface 98 includes an adhesive. The adhesive is intended to secure the sealing member 38 to the patient's skin and form a fluid-tight seal around the incision. The sealing member 38 also provides a barrier to prevent microorganisms from passing through the wound treatment system 10.

[0084] In some embodiments, the sealing member 38 is an elastomeric material or any material that can provide a fluid tight seal. "Fluid tight" means a seal that is sufficient to maintain pressure at the desired location, taking into account the particular reduced pressure subsystem involved. The term "elastomer" means having the properties of an elastomer, and generally refers to a polymeric material with rubber-like properties. Examples of elastomers can include, but are not limited to, natural rubber, 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, copolyester, thermoplastic polyurethane (TPU), and as an example, non-limiting example, the sealing member 38 can be constructed from materials including silicone, 3M Tegaderm ® The sealing member 38 can be formed of a drape material, an acrylic drape material (such as one available from Avery), or an incise drape material. In some embodiments, the sealing member 38 can be at least partially transparent to facilitate viewing of the wound treatment system 10 through the sealing member 38, as described in detail below.

[0085] The sealing member 38 can be substantially liquid-impermeable and substantially water vapor-permeable. In other words, the sealing member 38 is permeable to water vapor but impermeable to liquid water or wound exudate. This enhances the total fluid handling capacity (TFHC) of the wound therapy system 10 while promoting a moist wound environment. In some embodiments, the sealing member 38 is also impermeable to bacteria and other microorganisms. In some embodiments, the sealing member 38 is configured to wick moisture from the negative pressure manifold 34 and distribute the moisture across the first surface 94. In some embodiments, the adhesive applied to the second surface 98 of the sealing member 38 is moisture vapor permeable and / or patterned to allow water vapor to pass through the adhesive.

[0086] Connecting plate Now see Figure 6The connecting plate 42 includes a first surface 102 and a second surface 106 facing the abdominal contents. The connecting plate 42 includes an instillation inlet 110 and an NPWT inlet 114. In the illustrated embodiment, the connecting plate 42 is a relatively dense material that serves as a base for the instillation catheter pad 118 and the NPWT catheter pad 122. The connecting plate 42 also provides a visual indication of where to cut or pierce the sealing member 38 when connecting the instillation catheter pad 118 and the NPWT catheter pad. For example, the connecting plate 42 may include indicia (e.g., color, pattern, wording, etc.) to help the operator locate the instillation catheter pad 118 and the NPWT catheter pad 122. For example, in the illustrated embodiment, the visual contrast between the color of the connecting plate 42 and the color of the negative pressure manifold 34 may help the operator correctly locate the instillation catheter pad 118 and the NPWT catheter pad 122. In some embodiments, the connecting plate 42 may include an adhesive layer on the second surface 106 of the connecting plate 42 for securing the connecting plate 42 to the negative pressure manifold 34 to prevent the connecting plate 42 from slipping.

[0087] Infusion and NPWT Catheter Connection System - Separate Infusion Pads and NPWT Pads Now see Figures 1 to 2 , shows a connection system 124 for connecting a wound therapy dressing to the instillation system 22 and the NPWT system 26, according to some embodiments. Figure 1 A cross-sectional view of the connection system 124 mounted on the negative pressure manifold 34 is shown. Figure 2 A perspective view of the connection system 124 engaged with the wound dressing 14 is shown.

[0088] The connection system 124 is shown to include a connection plate 126, a drip catheter pad 118, and a NPWT catheter pad 122. The drip catheter pad 118 is secured to the drip catheter 130 of the drip system 22 by a substantially fluid-tight connection. The drip catheter pad 118 includes a drip outlet connector 134 configured to engage the connection plate 126, as described in detail below. In the illustrated embodiment, the drip outlet connector 134 is a hole. The NPWT catheter pad 122 is secured to the negative pressure catheter 138 of the NPWT system 26 by a substantially fluid-tight connection. The NPWT catheter pad 122 includes a NPWT outlet connector 142 configured to engage the connection plate 126, as described in detail below. In the illustrated embodiment, the NPWT outlet connector 142 is a protrusion. In some embodiments, the NPWT outlet connector 142 is a pointed protrusion (e.g., a spear). In some embodiments, the NPWT outlet connector includes a barb 146. As Figure 1 As shown, in some embodiments, the infusion catheter 130 and the negative pressure catheter 138 are made of thin and / or flexible tubing to reduce patient discomfort.

[0089] The connection plate 126 is fixed to the first surface 82 of the negative pressure manifold 34. The connection plate 126 includes a drip connection structure 150 ( Figure 1 ), a drip inlet connector 154, and an NPWT inlet connector 158. The drip connection structure 150 extends through the negative pressure manifold 34 (e.g., between the first surface 82 and the second surface 86) to facilitate fluid communication between the drip inlet connector 154 and the fluid distribution hub 72. The drip connection structure 150 is configured to prevent lateral flow of the drip fluid into the negative pressure manifold 34. For example, the drip connection structure can be made of, or can be coated with, a material that is substantially impermeable to the drip fluid. More specifically, the drip inlet connector 154 can be secured to the drip connection structure 150 and to the drip module 30 proximate the opening 76 to form a drip fluid flow path that is fluidly separate from the NPWT flow path.

[0090] The drip inlet connector 154 is in fluid communication with the drip connection structure 150. The drip inlet connector 154 is configured to engage the drip catheter pad 118. In the illustrated embodiment, the drip inlet connector 154 is a protrusion extending from the connecting plate 126. In some embodiments, the distal end of the drip inlet connector 154 is pointed (e.g., a spear). In some embodiments, the drip inlet connector includes a barb 162 for frictionally engaging the drip outlet connector 134. Although the drip inlet connector 154 is shown as a protrusion and the drip outlet connector 134 is shown as a hole in the illustrated embodiment, in different embodiments, the drip inlet connector 154 and the drip outlet connector 134 may have different shapes, as long as the drip inlet connector 154 and the drip outlet connector 134 remain engageable. For example, in some embodiments, the drip inlet connector 154 may be a hole, and the drip outlet connector 134 may be a protrusion.

[0091] like Figure 1 As best shown, the NPWT inlet connector 158 is in fluid communication with the negative pressure manifold 34. In the illustrated embodiment, the NPWT inlet connector 158 is a through-hole in the connecting plate 126 that is configured to engage the NPWT outlet connector 142 in a friction fit manner. Although in the illustrated embodiment, the NPWT inlet connector 158 is shown as a through-hole and the NPWT outlet connector 142 is shown as a protrusion, in different embodiments, the NPWT inlet connector 158 and the NPWT outlet connector 142 can have different shapes so long as the NPWT inlet connector 158 and the NPWT outlet connector 142 remain engageable. For example, in some embodiments, the NPWT inlet connector 158 can be a protrusion and the NPWT outlet connector 142 can be a hole.

[0092] like Figure 1 and Figure 2 It is apparent that the drip inlet connector 154 and the NPWT inlet connector 158 are different shapes. This is intended to prevent the drip outlet connector 134 from engaging the NPWT inlet connector 158 and to prevent the NPWT outlet connector 142 from engaging the drip inlet connector 154. Figure 1 As best shown, the connection plate 126 is positioned below and visible through the sealing member 38. The connection plate is configured to guide an operator of the wound treatment system 10 in properly connecting the drip catheter pad 118 and the NPWT catheter pad 122. For example, the drip inlet connector 154 and the drip outlet connector 134 include a first pair of markings 166 indicating that the drip outlet connector 134 should be connected to the drip inlet connector 154. The NPWT inlet connector 158 and the NPWT outlet connector 142 include a second pair of markings 170 that are different from the first pair of markings 166 to indicate that the NPWT outlet connector 142 should be connected to the NPWT inlet connector 158. In some embodiments, the first pair of markings 166 and the second pair of markings 170 can be colors, patterns, or shapes.

[0093] like Figure 1As shown, when the wound dressing 14 is deployed within a patient, the connector plate 126 is positioned below the seal member 38. The drip inlet connector 154 and the drip outlet connector 134 are accessible through the seal member 38 (e.g., by piercing the seal member 38). With the seal member 38 secured to the patient, the drip inlet connector 154 pierces the seal member 38. The NPWT outlet connector 142 on the NPWT catheter pad 122 pierces the seal member 38 to connect to the NPWT inlet connector 158 of the connector plate 126. Accordingly, the first surface 174 of the connector plate 126 can be coated with an adhesive for securing the connector plate 126 to the second surface 98 of the seal member 38 to maintain a fluid-tight seal with the peritoneal cavity. With the drip catheter pad 118 and the NPWT catheter pad 122 engaged with the connector plate 126, the adhesive can prevent displacement of the connector plate 126. In some embodiments, the drip catheter pad 118 and the NPWT catheter pad 122 may include an adhesive layer surrounding the drip outlet connector 134 and the NPWT outlet connector 142, respectively, for forming a fluid-tight seal with the first surface of the sealing member 38. The connecting plate 126 has a sufficiently high density and / or a sufficiently thick thickness to prevent the protrusion of the NPWT outlet connector 142 from contacting the patient and causing patient discomfort. In some embodiments, the connecting plate is made of a dense open-cell foam. In other embodiments, the connecting plate may be made of a plastic material. In some embodiments, the connecting plate 126 is made of a deformable material and / or the negative pressure manifold 34 is sized to be thicker than the connecting plate 126 so that pressure is applied to the connecting plate 126 as the drip catheter pad 118 and the NPWT catheter pad 122 are connected, and compression within the abdominal cavity during NPWT does not cause the connecting plate 126 and / or the NPWT outlet connector 142 to cause patient discomfort.

[0094] like Figure 1 As shown, the wound therapy system 10 includes a drip flow path (arrow 172) that is fluidically separate from a negative pressure flow path (arrow 176). As indicated by arrow 172, the drip fluid enters the wound therapy system 10 from the drip system 22 and travels along the drip conduit 130 to the drip conduit pad 118. The drip fluid then flows through the drip inlet connector 154 of the connection plate 126 to the drip connection structure 150. The drip fluid then enters the fluid distribution hub 72 of the drip module 30 and travels along the fluid distribution structure 74. The drip fluid exits the fluid distribution structure 74 through the fenestration 78 and travels to the treatment site.

[0095] As indicated by arrows 176, the negative pressure generated by the negative pressure source 46 of the NPWT system 26 causes fluid (e.g., instillation fluid, wound exudate, etc.) to enter the plurality of elongated legs 73 of the abdominal treatment device 28 through the fenestrations 77. As indicated by arrows 176, the fluid travels through at least a portion of the elongated legs 73 and exits the abdominal treatment device through the fenestrations 77. The fluid then travels through the negative pressure manifold 34 to the NPWT inlet connector 158 of the connection plate 126. The fluid then travels along the NPWT catheter pad 122 to the negative pressure catheter 138 and into the fluid collection chamber 50 of the NPWT system 26.

[0096] Infusion and NPWT Catheter Connection System - Integrated Infusion Pad and NPWT Pad Figure 3 A connection system 178 for connecting the wound treatment system 10 to the drip system 22 and the NPWT system 26 is shown in accordance with some embodiments. The connection system 178 is shown to include a connection plate 126 and an integrated catheter pad 182. The integrated catheter pad 182 includes a drip outlet portion 186 and an NPWT outlet portion 190. The drip outlet portion 186 is secured to the drip conduit 130 of the drip system 22 via a substantially fluid-tight connection. The drip outlet portion 186 includes a drip outlet connector 194 configured to engage the drip inlet connector 154 of the connection plate 126. In the illustrated embodiment, the drip outlet connector 194 is an aperture. The NPWT outlet portion 190 is secured to the negative pressure conduit 138 of the NPWT system 26 via a substantially fluid-tight connection.

[0097] The NPWT outlet portion 190 includes an NPWT outlet connector 196 configured to engage the NPWT inlet connector 158 of the connection plate 126, as described in detail below. In the illustrated embodiment, the NPWT outlet connector 196 is a protrusion. In some embodiments, the NPWT outlet connector 196 is a pointed protrusion (e.g., a spear). In some embodiments, the NPWT outlet connector includes a barb 198. Figure 3 As shown, in some embodiments, the infusion catheter 130 and the negative pressure catheter 138 are made of thin and / or flexible tubing to reduce patient discomfort.

[0098] The connection plate 126 and the integrated drip and NPWT catheter pad 182 have substantially the same shape to facilitate alignment of the drip outlet connector 194 with the drip inlet connector 154 and alignment of the NPWT outlet connector 196 with the NPWT inlet connector 158. For example, the connection plate 126 is configured to provide a fixed spacing between the drip inlet connector 154 and the NPWT inlet connector 158. The integrated NPWT catheter pad 182 is configured to provide a fixed spacing between the drip outlet connector 194 and the NPWT outlet connector 196 that is the same spacing between the drip inlet connector 154 and the NPWT inlet connector 158. Thus, the integrated drip and NPWT catheter pad 182 can be configured (e.g., sized and spaced) to engage a connection plate 126 having a specific size (e.g., corresponding to a specific size and / or type of wound dressing 14).

[0099] like Figure 3 As shown, the drip inlet connector 154 and the NPWT inlet connector 158 are different shapes. This is intended to prevent the drip outlet connector 194 from engaging the NPWT inlet connector 158 and to prevent the NPWT outlet connector 196 from engaging the drip inlet connector 154. Figure 3 As best shown, the drip inlet connector 154 and the drip outlet connector 134 include a first pair of markings 202 that indicate that the drip outlet connector 134 should be connected to the drip inlet connector 154. The NPWT inlet connector 158 and the NPWT outlet connector 142 include a second pair of markings 206 that are different from the first pair of markings 202 to indicate that the NPWT outlet connector 142 should be connected to the NPWT inlet connector 158. In some embodiments, the first pair of markings 202 and the second pair of markings 206 can be colors, patterns, shapes, and / or words.

[0100] Compressible infusion catheter-bellows Figures 4 to 6 The negative pressure manifold 34 is shown to include a compressible drip connection structure 210. The compressible drip connection structure 210 is intended to expand and contract with the negative pressure manifold 34 as the negative pressure manifold 34 expands and contracts during a cycle of NPWT therapy (e.g., the negative pressure manifold 34 and the compressible drip connection structure 210 expand when not under negative pressure and compress when under negative pressure). The compressible drip connection structure 210 is also intended to expand and contract to accommodate varying thicknesses of the negative pressure manifold 34. Figure 4As best shown, the compressible drip connection structure 210 includes a first connection plate 214, a second connection plate 218, and a flow path 222 extending between the first connection plate 214 and the second connection plate 218. The first connection plate 214 includes a first connection surface 226 and a second surface 230 facing the negative pressure manifold. The first connection plate 214 includes a flow path inlet 234. The second connection plate 218 includes a second connection surface 238 and a first surface 242 facing the negative pressure manifold. The second connection plate 218 includes a flow path outlet 246. Figure 5 As best shown, the first connecting plate 214 and the second connecting plate 218 are spaced apart to receive the negative pressure manifold 34 therebetween.

[0101] The flow path 222 extends between the flow path inlet 234 and the flow path outlet 246 to guide the infusion fluid from the infusion conduit 130 of the infusion system 22 to the fluid distribution hub 72 of the infusion module 30. The flow path 222 defines a longitudinal axis A. The flow path 222 is flexible and is configured to expand and contract in a direction substantially defined by the longitudinal axis A. The flow path 222 is formed by a plurality of angled walls 250. The plurality of angled walls 250 are oriented to form adjacent thick sections and thin sections to form a bellows structure. Under negative pressure, the angled walls 250 deflect toward the horizontal plane, thereby causing contraction in the direction defined by the longitudinal axis A. In the illustrated embodiment, the plurality of angled walls 250 includes four angled walls 250. In other embodiments, the plurality of angled walls 250 may include more or fewer angled walls. In the illustrated embodiment, the plurality of angled walls 250 form a tapered segment. In other embodiments, the plurality of angled walls may form segments of other shapes, such as pyramidal shapes.

[0102] In some embodiments, the first connecting plate 214, the second connecting plate 218, and the flow path 222 are integrally formed as a single component. In other embodiments, the first connecting plate 214, the second connecting plate 218, and the flow path 222 can be formed separately and then secured together to form the compressible drip connection structure 210. The compressible drip connection structure 210 is made of a flexible material that can withstand cycles of expansion and contraction. The compressible drip connection structure 210 is configured to prevent the drip fluid from flowing laterally into the negative pressure manifold 34. For example, the compressible drip connection structure can be made of a material that is substantially impermeable to the drip fluid, or can be coated with a material that is substantially impermeable to the drip fluid.

[0103] Figure 5 and Figure 6 A compressible drip connection structure 210 is shown deployed in the wound treatment system 10. Figure 5As shown, the compressible drip connection structure 210 can be received within and extend through a hole in the negative pressure manifold 34. The second connection surface 238 of the second connection plate 218 is secured to the drip module 30 proximate the fluid distribution hub 72 such that the flow path outlet 246 is in fluid communication with the opening 76 of the fluid distribution hub 72 to create a drip flow path that is fluidly separate from the NPWT flow path. In some embodiments, the second connection surface 238 can be welded to the drip module 30. In other embodiments, the second connection surface 238 can be secured to the drip module 30 by an adhesive. In some embodiments, such as Figure 5 In the illustrated embodiment, the first connection surface 226 of the compressible drip connection structure 210 can be secured to the second surface 98 of the sealing member 38 by an adhesive. In such an embodiment, the first connection surface 226 of the compressible drip connection structure 210 can include markings (not shown) to facilitate placement of the drip catheter pad 118 (e.g., providing instructions for where to cut a hole into or pierce the sealing member 38). The compressible drip connection structure 210 can contract in response to force applied by an operator when securing the drip catheter pad 118, thereby preventing discomfort to the patient during placement of the drip catheter pad 118.

[0104] In other embodiments, such as Figure 6 In some embodiments, the first connecting surface 226 can be secured to the connecting plate 42 by an adhesive. In some embodiments, the first connecting surface 226 can include an indicia 254 indicating that the first connecting surface 226 should be secured to the connecting plate 42. In some embodiments, the first connecting surface 226 can include an adhesive for securing the first connecting surface 226 to the connecting plate 42. In such embodiments, the first connecting surface can include a removable backing, and the indicia 254 can be positioned on the removable backing.

[0105] like Figure 5 As shown, the wound therapy system 10 includes a drip flow path (arrow 252) that is fluidically separate from the negative pressure flow path (arrow 256). As indicated by arrow 252, the drip fluid enters the wound therapy system 10 from the drip system 22 and travels along the drip conduit 130 to the drip conduit pad 118. The drip fluid then flows through the drip inlet 110 of the connector plate 42 to the flow path inlet 234 of the compressible drip connection structure 210. The drip fluid travels along the flow path 222 and exits the compressible drip connection structure 210 through the flow path outlet 246. The drip fluid then enters the fluid distribution hub 72 of the drip module 30 and travels along the fluid distribution structure 74. The drip fluid exits the fluid distribution structure 74 through the fenestration 78 and travels to the treatment site.

[0106] As indicated by arrows 256, the negative pressure generated by the negative pressure source 46 of the NPWT system 26 causes fluid (e.g., instillation fluid, wound exudate, etc.) to enter the plurality of elongated legs 73 of the abdominal treatment device 28 through the fenestrations 77. As indicated by arrows 256, the fluid travels through at least a portion of the elongated legs 73 and exits the abdominal treatment device 28 through the fenestrations 77. The fluid then travels through the negative pressure manifold 34 to the NPWT inlet connector 158 of the connection plate 126. The fluid then travels along the NPWT catheter pad 122 to the negative pressure catheter 138 and into the fluid collection chamber 50 of the NPWT system 26.

[0107] Infusion Catheter - Compressible Foam Figures 7 and 8 A negative pressure manifold 34 including a compressible drip connection structure 258 is shown. The compressible drip connection structure 258 is positionable within the negative pressure manifold 34 and is intended to expand and contract with the negative pressure manifold 34 as the negative pressure manifold 34 expands and contracts during a cycle of NPWT therapy (e.g., the negative pressure manifold 34 and the compressible drip connection structure 258 expand when not under negative pressure and compress when under negative pressure) to reduce discomfort for the patient during NPWT. The compressible drip connection structure 258 can be made of the same material as the negative pressure manifold 34 so that during NPWT therapy, the compressible drip connection structure 258 compresses and expands substantially the same amount as the negative pressure manifold 34. Figure 4 As best shown, the compressible drip connection 258 includes a first surface 262 , a second surface 266 facing the abdominal contents, and a flow path 270 extending between the first surface 262 and the second surface 266 .

[0108] The flow path 270 extends between a flow path inlet 274 formed in the first surface 262 and a flow path outlet 278 formed in the second surface to guide the drip fluid from the drip conduit 130 of the drip system 22 to the fluid distribution hub 72 of the drip module 30. The flow path 270 defines a longitudinal axis B. A fluid-impermeable layer 282 is formed on at least a portion of the first surface 262 along the flow path 270 and on at least a portion of the second surface 266 to prevent the drip fluid from flowing laterally into the negative pressure manifold 34. In some embodiments, the fluid-impermeable layer 282 is made of a polyurethane material. In other embodiments, the fluid-impermeable layer 282 can be made of another material that is substantially impermeable to the drip fluid.

[0109] The compressible drip connection structure 258 can be made of a compressible material such that the compressible drip connection structure 258 compresses under negative pressure along the longitudinal axis B. For example, the compressible drip connection structure can be made of the compressible reticulated foam material described above with respect to the negative pressure manifold 34. In some embodiments, the compressible drip connection structure 258 can be made of the same material as the negative pressure manifold 34 such that the compressible drip connection structure 258 compresses and expands along with the negative pressure manifold 34 during an NPWT cycle.

[0110] Figure 8 1 and 2. A compressible drip connection structure 258 is shown deployed in the wound therapy system 10. The compressible drip connection structure 258 can be received within and extend through the negative pressure manifold 34. The second surface 266 is secured to the drip module 30 proximate the fluid distribution hub 72 with a fluid-tight seal such that the flow path outlet 278 is in fluid communication with the fluid distribution hub 72 to form a fluid-tight drip flow path that is fluidly separate from the NPWT flow path. In some embodiments, the second surface 266 can be welded to the drip module 30. In other embodiments, the second surface 266 can be secured to the drip module 30 with an adhesive. In some embodiments, the first surface 262 is secured to the connector plate 42 with an adhesive with a fluid-tight seal. In some embodiments, the first surface 262 is secured to the second surface 266 of the sealing member 38 with a fluid-tight seal. In some embodiments, the first surface 262 can include an indicia 286 indicating that the first surface 262 should be secured to the connector plate 42. In some embodiments, the first surface 262 may include an adhesive for securing the first surface 262 to the connecting plate 42. In such embodiments, the first surface 262 may include a removable backing, and the indicia 286 may be positioned on the removable backing. In embodiments where the second surface 266 is capable of being secured to the drip module 30 by an adhesive, the second surface 266 may include an indicia (not shown) indicating that the second surface 266 should be secured to the drip module 30. In some embodiments, the second surface 266 may include an adhesive for securing the second surface 266 to the drip module 30. In such embodiments, the second surface 266 may include a removable backing, and the indicia 286 may be positioned on the removable backing. In some embodiments, the indicia 286 may be a color, pattern, shape, and / or word.

[0111] like Figure 8As shown, the wound therapy system 10 includes a drip flow path (arrow 284) that is fluidically separate from the negative pressure flow path (arrow 286). As indicated by arrow 284, the drip fluid enters the wound therapy system 10 from the drip system 22 and travels along the drip conduit 130 to the drip conduit pad 118. The drip fluid then flows through the drip inlet 110 of the connector plate 42 to the flow path inlet 274 of the compressible drip connection structure 258. The drip fluid travels along the flow path 270 and exits the compressible drip connection structure 258 through the flow path outlet 278. The drip fluid then enters the fluid distribution hub 72 of the drip module 30 and travels along the fluid distribution structure 74. The drip fluid exits the fluid distribution structure 74 through the fenestration 78 and travels to the treatment site.

[0112] As indicated by arrows 286, the negative pressure generated by the negative pressure source 46 of the NPWT system 26 causes fluid (e.g., instillation fluid, wound exudate, etc.) to enter the plurality of elongated legs 73 of the abdominal treatment device 28 through the fenestrations 77. As indicated by arrows 286, the fluid travels through at least a portion of the elongated legs 73 and exits the abdominal treatment device through the fenestrations 77. The fluid then travels through the negative pressure manifold 34 to the NPWT inlet connector 158 of the connection plate 126. The fluid then travels along the NPWT catheter pad 122 to the negative pressure catheter 138 and into the fluid collection chamber 50 of the NPWT system 26.

[0113] Integrated infusion catheter Figures 9 and 10 An infusion module 288 including an integrated infusion conduit 290 is shown, according to some embodiments. The infusion module 288 is configured to facilitate substantially uniform distribution of the infusion fluid regardless of the patient's position (e.g., supine or side-lying). The infusion module 288 includes a first layer 292, a second layer 294, and a fluid distribution layer 298. The fluid distribution layer 298 includes a first surface 300 and a second surface 302 facing the abdominal contents. The fluid distribution layer 298 includes a fluid distribution hub 304, a plurality of fluid distribution structures 308 extending radially from the fluid distribution hub 304, and the integrated infusion conduit 290 extending from the fluid distribution hub 304. The first layer 292, the second layer 294, the fluid distribution hub 304, and the plurality of fluid distribution structures 308 are substantially similar to the first layer 58, the second layer 62, the fluid distribution hub 72, and the plurality of fluid distribution structures 74 described above with respect to the infusion module 30, and for the sake of brevity, will not be described in detail herein.

[0114] The drip conduit 290 includes a generally elongated portion 312 extending from the fluid distribution hub 304. A distal end 316 of the generally elongated portion 312 can be enlarged to form a drip conduit base portion 320. The drip conduit base portion 320 is configured to engage the connector plate 42 and / or form a surface for engaging the drip conduit 290. A portion of the first layer 292 and the second layer 294 encapsulates the drip conduit (e.g., the generally elongated portion 312 and the drip conduit base portion 320). This portion is made of a fluid-impermeable material and does not include the fenestration 78, so that the drip fluid can enter the drip conduit 290 at the drip conduit base portion 320 and / or the distal end 316 and travel along the elongated portion 312 to the fluid distribution hub 304 for distribution to the fluid distribution structure 308.

[0115] Figure 10 The infusion module 288 and the negative pressure manifold 34 are shown positioned to treat a patient's open abdominal cavity. In the illustrated embodiment, the elongated portion 312 of the infusion catheter 290 is wrapped around the negative pressure manifold 34 such that the first layer 292 and the first surface 300 of the elongated portion 312 abut the negative pressure manifold 34. In some embodiments, the portion of the first layer 292 abutting the negative pressure manifold 34 may include an adhesive for securing the first layer 292 to the negative pressure manifold 34 to prevent the infusion catheter 290 from sliding. The second layer 294 of the integrated infusion catheter 290 (e.g., the second surface 302 of the infusion catheter base portion 320) faces away from the first surface 82 of the negative pressure manifold 34. In some embodiments, at least a portion of the second layer 294 includes an adhesive for securing the second layer 294 to the second surface 98 of the sealing member 38. In the illustrated embodiment, the connecting plate 42 is secured to the infusion catheter base portion 320, for example, by welding and / or an adhesive. In other embodiments, the elongated portion 312 of the drip conduit can extend through a hole in the negative pressure manifold 34. Thus, the drip conduit 290 forms a flow path between the drip conduit 290, which is engaged with the drip system 22, and the fluid distribution hub 304 that is fluidly separate from the flow path between the negative pressure manifold 34 and the NPWT system 26.

[0116] The wound therapy system 10 includes a drip flow path that is fluidly separate from the negative pressure flow path. The drip fluid enters the wound therapy system 10 from the drip system 22 and travels along the drip conduit 130 to the drip conduit pad 118. The drip fluid then flows through the drip inlet 110 of the connector plate 42 to the drip conduit base portion 320 of the drip conduit 290 of the drip module 30. The drip fluid travels along the generally elongated portion 312 of the drip conduit 290 and then enters the fluid distribution hub 72. The drip fluid then enters and travels along the fluid distribution structure 74. The drip fluid exits the fluid distribution structure 74 through the fenestration 78 and travels to the treatment site.

[0117] The negative pressure generated by the negative pressure source 46 of the NPWT system 26 causes fluid (e.g., instillation fluid, wound exudate, etc.) to enter the plurality of elongated legs 73 of the abdominal treatment device 28 through the fenestrations 77. The fluid travels through at least a portion of the elongated legs 73 and exits the abdominal treatment device through the fenestrations 77. The fluid then travels through the negative pressure manifold 34 to the NPWT inlet connector 158 of the connection plate 126. The fluid then travels along the NPWT catheter pad 122 to the negative pressure catheter 138 and into the fluid collection chamber 50 of the NPWT system 26.

[0118] Integrated infusion catheter Figures 11 to 12 A drip module 328 including an integrated drip conduit 332 is shown, according to some embodiments. The drip module 328 includes a first layer 336, a second layer 340, and a fluid distribution layer 344. The fluid distribution layer 344 includes a first layer 345 and a second layer 346 that faces the abdominal contents. The fluid distribution layer 344 includes a fluid distribution hub 348 and a plurality of fluid distribution structures 352 extending radially from the fluid distribution hub 348, as well as the drip conduit 332 extending from the fluid distribution hub 348. The first layer 336, the second layer 340, and the plurality of fluid distribution structures 352 are substantially similar to the first layer 58, the second layer 62, and the plurality of fluid distribution structures 74 described above with respect to the drip module 30, and for the sake of brevity, will not be described in detail herein.

[0119] The drip conduit 332 includes a fluid distribution hub engaging portion 356 and a flow path portion 360. The flow path portion 360 is engaged with the fluid distribution hub engaging portion 356 and the connecting plate 42. In the illustrated embodiment, the flow path portion 360 is a flexible tubing. The flow path portion 360 is configured to enable the drip module 328 and the negative pressure manifold 34 to move during the NPWT cycle. More specifically, the end of the flow path portion 360 is molded into the fluid distribution hub engaging portion 356 and the connecting plate 42. The fluid distribution hub engaging portion 356 includes a drip fluid inlet portion 364 engaged with the flow path portion 360 and a plurality of channels 368 in fluid communication with each of the fluid distribution structures of the plurality of fluid distribution structures 352. In the illustrated embodiment, the plurality of channels 368 are molded into the fluid distribution hub engaging portion 356.

[0120] The fluid distribution hub 348 includes an aperture 372 sized to receive the fluid distribution hub engagement portion 356. The fluid distribution hub engagement portion 356 is secured within the aperture 372. In some embodiments, the first layer 336 and the second layer 340 can extend over (e.g., envelop) the fluid distribution hub engagement portion 356. In other embodiments, the first layer 336 and the second layer 340 envelop the fluid distribution layer 344, including the walls of the aperture 372. In such embodiments, the fluid distribution hub engagement portion 356 can be welded to the first layer 336 and the second layer 340, and the first layer 336 and the second layer 340 can include windows aligned with the plurality of channels 368 to allow drip fluid to enter the fluid distribution hub 348.

[0121] Figure 12 The infusion module 328 and the negative pressure manifold 34 are shown positioned to treat the open abdominal cavity of a patient. The flow path portion 360 of the infusion conduit 332 is wrapped around the negative pressure manifold 32 so that the flow path portion 360 and the connecting plate 42 cover the first surface 82 of the negative pressure manifold 34. The connecting plate 42 can be fixed to the first surface of the negative pressure manifold 34, for example, by welding and / or adhesive. Thus, the infusion conduit 332 forms a flow path with a fluidly separated flow path between the infusion conduit 332 and the fluid distribution hub 348 engaged with the infusion system 22. Figure 12 As shown, in some embodiments, a second infusion module can be used.

[0122] The wound therapy system 10 includes a drip flow path that is fluidly separate from the negative pressure flow path. The drip fluid enters the wound therapy system 10 from the drip system 22 and travels along the drip conduit 130 to the drip conduit pad 118. The drip fluid then flows through the drip inlet 110 of the connector plate 42 to the flow path portion 360 of the drip conduit 332. The drip fluid travels along the flow path portion 360 of the drip conduit 332 and then enters the fluid distribution hub 72. The drip fluid then enters and flows along the plurality of channels 368 to the plurality of fluid distribution structures 352. The drip fluid exits the fluid distribution structure 352 through the fenestration 78 and travels to the treatment site.

[0123] The negative pressure generated by the negative pressure source 46 of the NPWT system 26 causes fluid (e.g., instillation fluid, wound exudate, etc.) to enter the plurality of elongated legs 73 of the abdominal treatment device 28 through the fenestrations 77. The fluid travels through at least a portion of the elongated legs 73 and exits the abdominal treatment device through the fenestrations 77. The fluid then travels through the negative pressure manifold 34 to the NPWT inlet connector 158 of the connection plate 126. The fluid then travels along the NPWT catheter pad 122 to the negative pressure catheter 138 and into the fluid collection chamber 50 of the NPWT system 26.

[0124] One-piece drip catheter with friction-fit seal Figures 13 to 17Shown are a drip module 376 and a drip connection sealing system 380. The drip module 376 and the drip connection sealing system 380 may be used in conjunction with the abdominal treatment device 28. Figure 13 A top perspective view of the drip module 376 and the drip connection sealing system 380 is shown in a stored position. Figures 14 to 16 Steps in a process for deploying the drip module 376 and the drip connection sealing system 380 are shown.

[0125] like Figures 14 to 17 As best shown, the drip module 376 includes an integrated drip conduit 436, a first layer 388, a second layer 392, and a fluid distribution layer 396. The fluid distribution layer 396 includes a fluid distribution hub 400 and a plurality of fluid distribution structures 404 extending radially from the fluid distribution hub 400. The first layer 388, the second layer 392, the fluid distribution hub 400, and the plurality of fluid distribution structures 404 are substantially similar to the first layer 58, the second layer 62, the fluid distribution hub 72, and the plurality of fluid distribution structures 74 described above for the drip module 30 and, for the sake of brevity, will not be described in detail herein. The integrated drip conduit 436 is in fluid communication with the fluid distribution hub 400 and is secured to the drip module 376 using a fluid-tight connection. In some embodiments, the integrated drip conduit 436 may be secured to the drip module 376 using a fluid-tight connection as described above for the drip module 30. Figures 11 to 12 The fluid distribution hub engagement portion 356 is secured to the infusion module 376. In the illustrated embodiment, the integrated infusion conduit 436 is a flexible tube. In some embodiments, the integrated infusion conduit 436 can be provided in a storage position, wherein the integrated infusion conduit 436 is provided in a loop adjacent to the infusion module 376. Once positioned in the abdominal cavity, the integrated infusion conduit 436 can be expanded and deployed within the patient, as described in detail below.

[0126] The drip connection sealing system 380 includes a sealing plate 408, a sealing gasket 410, and a locking collar 412. The sealing plate 408 includes a first surface 416 and a second surface 420 facing the wound. The sealing plate 408 also includes a drip conduit passage 424 extending between the first surface 416 and the second surface 420. A portion of the drip conduit passage 424 extends above the first surface 416. The drip conduit passage 424 includes an outer surface 438 and an inner surface 440 defining a passage for receiving a drip conduit 436. At least a portion of the second surface 420 includes an adhesive for securing the second surface 420 of the sealing plate 408 to the first surface 416 of the sealing member 38 in a fluid-tight seal.

[0127] The sealing gasket 410 includes a first surface 437 and a second surface 439 facing the wound. The second surface 439 includes an adhesive coating. The sealing gasket 410 is sized to form a seal around a hole formed in the sealing member 38 to retract the drip tube 436, as described in detail below. In some embodiments, the sealing gasket 410 can be made of the same material as the sealing member 38.

[0128] The locking collar 412 includes an outer surface 441 and an inner surface 442 that define a passageway 444. The passageway 444 is sized so that the locking collar 412 can move freely along the drip conduit 436. The passageway 444 is sized to form a tight friction fit against the outer surface 440 of the drip conduit passageway 444 of the sealing plate 408 to form a fluid-tight seal around the perimeter of the drip conduit 436. In some embodiments, the locking collar 412 is more rigid than the drip conduit passageway 424 and is sized so that engagement of the locking collar 412 with the drip conduit passageway 424 causes the drip conduit passageway 424 to deform inwardly against the drip conduit 436, thereby forming a tight seal around the perimeter of the drip conduit 436. In some embodiments, the locking collar 412 also includes a flange 448 formed around a portion of the outer surface 441 of the locking collar 412 to assist an operator in gripping the locking collar 412.

[0129] Figures 14 to 16 The process for deploying the drip module 376 and the drip connection sealing system 380 is shown. Figure 14 As shown, the operator positions the drip module 376 against the patient's abdominal contents. The operator then removes the drip module 376 from the storage position ( Figure 13 ) deploy the drip catheter 436 and extend the drip catheter 436 through the hole in the negative pressure manifold 34 or wrap the drip catheter 436 around one side of the negative pressure manifold 34. The operator then secures the sealing member 38 to the patient's skin around the abdominal incision. The operator then forms a hole in the sealing member 38 and passes the drip catheter 436 through the hole in the sealing member 38. The user then positions the sealing gasket 405, the sealing plate 408, and the locking collar 412 along the drip catheter 436 so that the second surface 98 of the sealing member 38 is oriented toward the first surface 416 of the sealing member 38. The user then slides the sealing gasket 410 toward the sealing member 38 and secures the second surface 407 of the sealing gasket 410 around the hole in the sealing member 38. The user then slides the sealing plate 408 and the locking collar toward the sealing member 38 as indicated by arrow 452. The user secures the second surface 420 of the sealing plate 408 to the first surface 437 of the sealing gasket 410 with a fluid-tight seal. As Figure 15As shown, the user then slides the locking collar 412 toward the first surface 416 of the sealing plate as indicated by arrow 456, thereby engaging the locking collar 412 in a friction fit and establishing a fluid-tight seal between the drip conduit passage 424 and the drip conduit 436, as shown. Figure 16 The operator can then connect the infusion catheter 436 to the infusion system 22 and start the infusion therapy.

[0130] Figure 17 A perspective view of the wound therapy system 10 is shown, which includes a drip module 376 and a drip connection sealing system 380 (interfacing with the drip system 22 for providing drip therapy), and a negative pressure manifold 34 (interfacing with the NPWT system 26 for providing NPWT). Figure 17 As shown, when the wound therapy system 10 is deployed in a patient, the wound therapy system includes a drip flow path (arrow 460) that is fluidically separate from a negative pressure flow path (arrow 464). As shown by arrow 460, the drip fluid enters the wound therapy system 10 from the drip system 22 and travels along the drip conduit 130 to the fluid distribution hub 400 of the drip module 376. The drip fluid then flows along the fluid distribution structure 404. The drip fluid exits the fluid distribution structure 404 through the fenestration 78 and travels to the treatment site.

[0131] As indicated by arrows 464, the negative pressure generated by the negative pressure source 46 of the NPWT system 26 causes fluid (e.g., instillation fluid, wound exudate, etc.) to enter the plurality of elongated legs 73 of the abdominal treatment device 28 through the fenestrations 77. As indicated by arrows 176, the fluid travels through at least a portion of the elongated legs 73 and exits the abdominal treatment device through the fenestrations 77. The fluid then travels through the negative pressure manifold 34 to the NPWT inlet connector 158 of the connection plate 126. The fluid then travels along the NPWT catheter pad 122 to the negative pressure catheter 138 and into the fluid collection chamber 50 of the NPWT system 26.

[0132] Combination of parts While 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 various ways.

[0133] Configuration of the exemplary embodiment The construction and arrangement of the systems and methods shown in the various exemplary embodiments are merely illustrative. Although only a few embodiments are described in detail in this disclosure, many modifications are possible (e.g., changes in the size, dimensions, structure, shape, and proportion of the various elements, parameter values, mounting arrangements, use of materials, colors, orientations, etc.). For example, the position of the elements may be reversed or otherwise changed, and the nature, quantity, or position of the discrete elements may be altered or changed. Therefore, all such modifications are intended to be included within the scope of this disclosure. The order or sequence of any process or method steps may be changed or reordered according to alternative embodiments. Without departing from the scope of this disclosure, other replacements, modifications, changes, and omissions may be made to the design, operating conditions, and arrangement of the exemplary embodiments.

Claims

1. A system for providing an instillation fluid to a deep abdominal wound, the system comprising: a sealing member defining a first surface and a second surface facing toward abdominal contents, the sealing member being configured to form a fluid-tight seal around a perimeter of the deep abdominal wound; a distribution hub configured to receive an instillation fluid from an instillation fluid source; an instillation conduit including a first end in fluid communication with the distribution hub and a second end configured for fluid communication with the instillation fluid source; as well as A sealing plate including a drip conduit passage configured to receive at least a portion of the drip conduit is securable to the first surface of the sealing member.

2. The system of claim 1, wherein the drip catheter passageway comprises an outer surface and an inner surface defining a passageway for receiving the drip catheter.

3. The system according to claim 2 further includes a locking collar capable of sliding along the infusion catheter, and the locking collar is configured to engage the outer surface of the infusion catheter passage in a friction fit manner to form a fluid-tight seal between the passage and the infusion catheter.

4. The system of claim 1, wherein the drip conduit extends through a hole in the sealing member, and wherein the sealing plate is configured to form a fluid-tight seal over the hole.

5. The system of claim 1 , wherein the drip conduit is positionable in a storage position and a deployed position, wherein in the storage position the drip conduit is positioned within the wound dressing and in the deployed position at least a portion of the drip conduit extends through the sealing member.

6. A connection system for providing infusion therapy and negative pressure therapy to a deep abdominal wound, the connection system comprising: a distribution hub comprising an instillation inlet configured to engage an instillation conduit of an instillation fluid source; a negative pressure manifold comprising a first surface and a second surface facing the abdominal contents; A connecting plate, the connecting plate comprising a drip inlet connector and a negative pressure inlet connector, the drip inlet connector having a first shape connected to the drip inlet fluid of the distribution hub, the negative pressure inlet connector having a second shape different from the first shape, and the negative pressure inlet connector connected to the negative pressure manifold fluid.

7. A connection system according to claim 6, further comprising a drip catheter pad, the drip catheter pad being configured to receive the drip catheter of the drip fluid source, the drip catheter pad comprising a drip outlet connector, the drip outlet connector being shaped to engage the drip inlet connector and prevent engagement with the negative pressure inlet connector.

8. The connection system of claim 7, wherein the drip inlet connector and the drip catheter pad include a pair of markings indicating that the drip catheter pad is configured to engage the drip inlet.

9. A connection system according to claim 6, wherein the connection system also includes a negative pressure catheter pad, which is configured to receive a negative pressure catheter connected to the negative pressure source fluid, and the negative pressure catheter pad includes a negative pressure outlet connector, which is formed to engage the negative pressure inlet connector and prevent engagement with the drip inlet connector.

10. The connection system of claim 6, further comprising an integrated instillation and NPWT catheter pad, the integrated instillation and NPWT catheter pad comprising: a drip catheter pad configured to receive the drip catheter of the drip fluid source, the drip catheter pad including a drip outlet connector shaped to engage the drip inlet connector and prevent engagement with the negative pressure inlet connector; as well as A negative pressure catheter pad is configured to receive a negative pressure catheter in fluid communication with a negative pressure source, the negative pressure catheter pad comprising a negative pressure outlet connector shaped to engage the negative pressure inlet connector and prevent engagement with the drip inlet connector.

11. The connection system of claim 6, wherein the drip inlet connector is one of an upwardly opening spear or a hole, and the negative pressure inlet connector is the other of the upwardly opening spear and the hole.

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