Multi-layer abdominal closure dressing with instillation capabilities

Abstract

To provide a treatment system for applying negative pressure therapy and fluid instillation treatment to a tissue site, particularly an abdominal tissue site.SOLUTION: A treatment system 100 may include a dressing member 102, a plurality of fluid removal pathways, a fluid instillation matrix, a drape, a negative-pressure source, and a fluid instillation source. Instillation fluid may be delivered from the fluid instillation source to a tissue site through the fluid instillation matrix, negative pressure may be communicated, and fluid may be withdrawn from the tissue site through the plurality of fluid removal pathways.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 451,284, filed January 27, 2017, entitled "Multi-Layer Abdominal Closure Dressing with Instillation Capabilities," which is incorporated herein by reference in its entirety.

[0002] The invention as claimed herein relates generally to tissue treatment systems and more particularly, but not exclusively, to abdominal treatment systems using negative pressure and dripping. [Background technology]

[0003] Clinical trials and clinical practice have shown that applying reduced pressure proximate to a tissue site can enhance and accelerate the growth of new tissue at the tissue site. While the applications of this phenomenon are numerous, it has proven particularly advantageous in the treatment of wounds. Regardless of the etiology of the wound, whether traumatic, surgical, or otherwise, proper wound care is critical to the outcome. Treatment of wounds or other tissues with reduced pressure can generally be referred to as "negative pressure therapy," but is also known by other names, including, for example, "negative pressure wound therapy," "reduced pressure therapy," "vacuum therapy," "vacuum-assisted closure," and "topical negative pressure." Negative pressure therapy can provide many benefits, including mobilization of epithelial and subcutaneous tissue, improved blood flow, and microdeformation of tissue at the wound site. These benefits, combined, can increase the development of granulation tissue and shorten healing time.

[0004] It is also widely accepted that cleansing a tissue site can be highly beneficial for the growth of new tissue. For example, a wound can be washed with a stream of liquid solution, or a cavity can be washed using a liquid solution for therapeutic purposes. These actions are commonly referred to as "irrigation" and "lavage," respectively. "Dripping" is another action that generally refers to the process of gradually introducing a fluid into a tissue site and leaving the fluid for a predetermined period of time before removing it. For example, dripping a topical therapeutic solution onto a wound bed can be combined with negative pressure therapy to further promote wound healing by loosening soluble contaminants in the wound bed and removing infectious materials. This can result in a reduction in soluble bacterial load, removal of contaminants, and cleansing of the wound.

[0005] Distributing and extracting fluids from tissue sites undergoing negative pressure therapy or fluid dripping can be challenging. For example, tissue sites can vary in volume, size, shape, orientation, and other factors. Additionally, access to these tissue sites can be limited. These and other factors can make the extraction of waste fluids from and the distribution of treatment fluids to the tissue sites difficult to achieve uniformly or evenly. Furthermore, the change in fluid flow direction between the negative pressure therapy cycle and the dripping fluid cycle can cause waste fluid being extracted during the negative pressure therapy cycle to be returned to the tissue site when switching to the dripping fluid cycle.

[0006] Types of tissue sites that may present particular challenges may include locations such as the peritoneal cavity, or more generally, the abdominal cavity. Where the tissue site is associated with the abdominal cavity, a treatment system may be particularly beneficial that can enable improved and efficient care and address complications such as peritonitis, abdominal compartment syndrome, and infections that may prevent ultimate healing. Thus, improvements to treatment systems that can accommodate various types of tissue sites and orientations, improve uniformity of exhaust fluid extraction and treatment fluid distribution, and improve efficiency and healing times may be desirable. Summary of the Invention

[0007] In the following summary and description, and in the appended claims, new and useful systems, devices, and methods for irrigating the abdominal cavity in a negative pressure therapy environment are described. Exemplary embodiments are also provided to enable one of ordinary skill in the art to make and use the claimed subject matter.

[0008] For example, in some embodiments, a system for treating a tissue site can include a dressing, a negative pressure source fluidly coupled to the dressing, and a fluid source fluidly coupled to the dressing. The dressing can be configured to be deployed within the abdominal cavity.

[0009] In other embodiments, a dressing for treating a tissue site can include a dressing member having a first protective layer, a second protective layer, a chamber, a plurality of fluid removal paths formed within the chamber, and a drip matrix enclosed within the chamber. In some embodiments, at least a portion of each of the first protective layer and the second protective layer is joined to create a sealed chamber between a portion of the first protective layer and a portion of the second protective layer.

[0010] In yet another embodiment, a dressing for treating a tissue site can include a first impermeable layer, a second impermeable layer positioned against and substantially coextensive with the first impermeable layer, a plurality of fluid removal pathways, and a plurality of fluid delivery channels. The plurality of fluid removal pathways and the plurality of fluid delivery channels can be positioned between the first and second impermeable layers.

[0011] According to yet another embodiment, a dressing for treating a tissue site can include a plurality of fluid removal pathways and a fluid dripping matrix. The dressing can include a first impermeable layer and a second impermeable layer. The fluid dripping matrix can include a plurality of fluid delivery pathways, and the fluid dripping matrix can be adjacent to a first surface of the dressing.

[0012] In further embodiments, a dressing for treating a tissue site can include multiple fluid removal pathways, a fluid drip matrix, a manifold member, and a drape. The dressing can include a first impermeable layer and a second impermeable layer, as well as a space between the first and second impermeable layers. The multiple fluid removal pathways can be positioned within the space between the first and second impermeable layers. The fluid drip matrix can be associated with the dressing and can include multiple fluid delivery pathways. In some embodiments, the manifold member can be positioned adjacent to a central portion of the dressing. The drape can be adapted to form a fluid seal around the dressing and the manifold member.

[0013] In some further embodiments, a tissue treatment system can include a treatment device configured for deployment within the abdominal cavity, a fluid dripping matrix associated with the treatment device, a manifold member, a drape, a negative pressure source fluidly connected to the treatment device, and a fluid source fluidly connected to the fluid dripping matrix. The treatment device can include multiple fluid removal paths. The fluid dripping matrix can include multiple fluid delivery paths. The manifold member can be positioned adjacent a central portion of the treatment device. The drape can be adapted to form a fluid seal around the treatment device, the fluid dripping matrix, and the manifold member.

[0014] In another embodiment, a dressing for treating a tissue site can include a protective layer, a fluid distribution hub configured to exchange fluid with the tissue site, and a plurality of treatment tubes, each of which can include a first conduit adapted to deliver fluid from the fluid distribution hub to the tissue site and a second conduit adapted to transport fluid to the fluid distribution hub.

[0015] In a further embodiment, a system for treating a tissue site can include an occlusive layer, a fluid removal manifold, and a fluid distribution vessel. The fluid removal manifold can be positioned adjacent to a first side of the occlusive layer, and the fluid distribution vessel can be positioned adjacent to a second side of the occlusive layer.

[0016] In a further embodiment, a device for treating a tissue site can include a film layer having a first side and a second side, a fluid collection chamber, a fluid distribution chamber, and a conduit. The fluid collection chamber can be formed by a second film layer welded to the first side of the film layer. The fluid distribution chamber can be formed by a third film layer welded at its periphery to the second side of the film layer and including an interface for fluid connection to the conduit. The conduit can extend from the fluid collection chamber, through an aperture in the film layer, and through the fluid distribution chamber to the interface.

[0017] In a further embodiment, a system for treating a tissue site within the abdomen can include a dressing member, a fluid delivery container, and a drape. The dressing member can include a plurality of fluid pathways configured to transmit negative pressure to the tissue site. The fluid delivery container can be adapted to be positioned adjacent to a first surface of the dressing member and can include a first side having a plurality of openings for delivering fluid to the tissue site. The drape can be adapted to be disposed over a second surface of the plurality of fluid pathways.

[0018] The objects, advantages and preferred modes of making and using the claimed subject matter can best be understood by referring to the following detailed description of exemplary embodiments in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is a functional block diagram of an example embodiment of a treatment system capable of delivering treatment fluid along with negative pressure to a tissue site and managing the fluid in accordance with the present disclosure. [Figure 2] FIG. 2 is a schematic, partially cross-sectional view of an exemplary device for treating the abdominal cavity that can be associated with some embodiments of the treatment system of FIG. [Figure 3] FIG. 3 is a schematic plan view of an exemplary embodiment of an abdominal treatment device that can be associated with some embodiments of the treatment system of FIG. [Figure 4-1] FIG. 4A is a schematic plan view of an exemplary embodiment of a portion of an abdominal treatment device. [Figure 4-2] FIG. 4B is a schematic side view of a portion of the exemplary embodiment of the abdominal treatment device of FIG. 4A. [Figure 5] FIG. 5 is a schematic plan view of a portion of an abdominal treatment device, according to another exemplary embodiment. [Figure 6-1] FIG. 6A is a schematic diagram illustrating further details that may be associated with a portion of the abdominal treatment device of the treatment system of FIG. [Figure 6-2] FIG. 6B is a schematic diagram showing further details that may be associated with portions of the treatment system of FIG. [Figure 7-1] FIG. 7A is a schematic plan view of a further exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. [Figure 7-2] FIG. 7B is a schematic plan view of a further exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. [Figure 7-3]FIG. 7C is a schematic plan view of a further exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. [Figure 8] FIG. 8 is a schematic plan view of another exemplary abdominal treatment device that can be associated with the treatment system of FIG. [Figure 9] FIG. 9 is a schematic diagram showing further details of fluid conduits that may be associated with portions of the abdominal treatment device of the treatment system of FIG. [Figure 10-1] Figure 10A is a schematic diagram of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of Figure 1. Figure 10B is a schematic diagram of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of Figure 1. [Figure 10-2] FIG. 10C is a schematic diagram of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. [Figure 11-1] FIG. 11A is a schematic diagram of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. [Figure 11-2] FIG. 11B is a schematic diagram of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. [Figure 12] Figure 12A is a schematic view, in cross-section, of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of Figure 1. Figure 12B is a schematic view, in cross-section, of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of Figure 1. [Figure 13] Figure 13A is a schematic view, in cross section, of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of Figure 1. Figure 13B is a schematic view, in cross section, of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of Figure 1. [Figure 14]Figure 14A is a schematic view, in cross-section, of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of Figure 1. Figure 14B is a schematic view, in cross-section, of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of Figure 1. [Figure 15] FIG. 15 is a schematic plan view of another exemplary embodiment of an abdominal treatment device that can be associated with some embodiments of the treatment system of FIG. [Figure 16] 16 is a schematic, partially cross-sectional view of a portion of an exemplary embodiment of the abdominal treatment device of FIG. 15, according to some embodiments. [Figure 17] FIG. 17 is a schematic, partially cross-sectional view of a portion of the exemplary embodiment of the abdominal treatment device of FIG. 15, according to some further embodiments. [Figure 18] Figure 18A is a schematic plan view of an exemplary embodiment of a portion of the abdominal treatment device of Figure 15. Figure 18B is a schematic plan view of an exemplary embodiment of a portion of the abdominal treatment device of Figure 15. Figure 18C is a schematic plan view of an exemplary embodiment of a portion of the abdominal treatment device of Figure 15. [Figure 19] 19A, 19B, and 19C are schematic diagrams illustrating some features of a treatment system according to the present disclosure, according to some example embodiments. [Figure 20] Figures 20A, 20B, and 20C are schematic diagrams illustrating some features of a treatment system according to the present disclosure, according to some further example embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0020] The following description of example embodiments provides information to enable one skilled in the art to make and use the claimed subject matter, but may omit some details already known in the art. Thus, the following detailed description should be construed as illustrative rather than limiting.

[0021] Example embodiments may be described herein with reference to spatial relationships between or spatial orientations of various elements that are shown in the accompanying figures. Generally, these relationships or orientations assume a frame of reference that corresponds to or is relative to a patient in position to receive treatment. However, as those skilled in the art will recognize, this frame of reference is merely a convenient means of explanation, rather than a strict specification.

[0022] FIG. 1 is a simplified functional block diagram of an example embodiment of a treatment system 100 capable of providing negative pressure therapy in conjunction with the instillation of a topical treatment solution in accordance with the present disclosure. The treatment system can be applied to human patients and can be used with other types of subjects. The treatment system 100 can include a treatment device 101 including a dressing 102 and a treatment unit 104. In some embodiments, the treatment unit 104 can include a negative pressure source, such as negative pressure source 106, a fluid source, such as fluid source 108, and a controller 109. In other embodiments, the treatment unit 104 can include the negative pressure source 106, and the fluid source 108 and / or the controller 109 can be freestanding, separate units. The treatment system 100 can also include additional components, such as a container 110, which can also be in fluid communication with the treatment device 101, the dressing 102, and the treatment unit 104.

[0023] Components of the treatment system 100 can be fluidly coupled to one another to provide a path for transferring fluid (i.e., liquid and / or gas) between the components. For example, components can be fluidly coupled through a fluid conductor, such as a tube. As used herein, "tube" broadly includes a tube, pipe, hose, conduit, or other structure with one or more lumens adapted to transport fluid between two ends. Typically, a tube is an elongated, cylindrical structure with some flexibility, although the shape and stiffness can vary. In some embodiments, components can also be coupled by physical proximity, integration into a single structure, or formation from the same piece of material. Furthermore, some fluid conductors can be molded to or otherwise integrally coupled to other components. Coupling can include mechanical, thermal, electrical, or chemical (e.g., chemical) bonding, depending on the situation. For example, in some embodiments, a tube can mechanically and fluidly couple the treatment device 101 to the treatment unit 104. In general, components of the treatment system 100 can be coupled directly or indirectly.

[0024] The treatment system 100 can include a negative pressure source, such as a negative pressure source 106, that can be configured to be coupled to a distribution component, such as a dressing. Generally, a distribution component can refer to any complementary or auxiliary component configured to be fluidly coupled to a negative pressure source in a fluid path between the negative pressure source and a tissue site. The distribution component is preferably removable and can be disposable, reusable, or recyclable. For example, the dressing 102 of the treatment device 101 can be fluidly coupled to the negative pressure source 106 of the treatment unit 104, as shown in FIG. 1. In some embodiments, the treatment device 101 can include additional tissue interfaces, fluid conduits, and / or covers along with the dressing 102. In some embodiments, a dressing interface can facilitate coupling the negative pressure source 106 to the dressing 102 of the treatment device 101. For example, such a dressing interface can be a SENSAT.RAC™ pad available from KCI of San Antonio, Texas.

[0025] Fluidic mechanisms that use a negative pressure source to reduce pressure in another component or location, such as within a sealed treatment environment, can be mechanically complex. However, the basic principles of fluidic mechanisms applicable to negative pressure therapy and instillation are generally well known to those skilled in the art, and the process of reducing pressure may be illustratively described herein as, for example, "delivering," "distributing," or "generating" negative pressure.

[0026] Generally, exudate and other fluids flow along a fluid path toward lower pressure. Thus, the term "downstream" typically refers to a location in a fluid path that is relatively closer to a negative pressure source or further from a positive pressure source. Conversely, the term "upstream" refers to a location relatively further from a negative pressure source or closer to a positive pressure source. Similarly, it may be convenient to describe some features in terms of a fluid "inlet" or "outlet" in this frame of reference. This orientation is generally assumed for purposes of describing various features and components herein. However, in some applications, the fluid path may be reversed (such as by using a positive pressure source instead of a negative pressure source), and this descriptive convention should not be construed as limiting.

[0027] "Negative pressure" generally refers to a pressure lower than the local ambient pressure, such as the ambient pressure in the local environment outside the sealed treatment environment provided by the treatment device 101. In many cases, the local ambient pressure can also be atmospheric pressure where the tissue site is located. Alternatively, the pressure can be less than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise indicated, pressure values ​​stated herein are gauge pressures. Similarly, when referring to an increase in negative pressure, it typically refers to a decrease in absolute pressure, and a decrease in negative pressure typically refers to an increase in absolute pressure. While the amount and nature of negative pressure applied to a tissue site can vary according to treatment requirements, the pressure is generally a low vacuum (commonly also referred to as a rough vacuum) of -5 mmHg (-667 Pa) to -500 mmHg (-66.7 kPa). A typical treatment range is -75 mmHg (-9.9 kPa) to -300 mmHg (-39.9 kPa).

[0028] A negative pressure supply, such as the negative pressure source 106 of the treatment unit 104, can be a reservoir of air at negative pressure or can be a manual or powered device capable of reducing pressure within a sealed volume, such as a vacuum pump, a suction pump, a wall suction port available in many medical institutions, or a micropump. The negative pressure supply can be housed within or used with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate treatment. The negative pressure source can also have one or more supply ports configured to facilitate coupling and decoupling of the negative pressure supply to one or more dispensing components.

[0029] The treatment system 100 can also include a source of drip solution. For example, a fluid source 108 can be fluidly coupled to the treatment device 101 and thus the dressing 102, as shown in the example embodiment of FIG. 1. The fluid source 108 can, in some embodiments, be fluidly coupled to a positive pressure source or can be fluidly coupled to a negative pressure source 106. A regulator, such as a drip regulator, can also be fluidly coupled to the fluid source 108 and the treatment device 101.

[0030] A fluid source, such as fluid source 108, may be contained within or used with other components to facilitate fluid movement. Fluid source 108 may be a fluid pump, such as a peristaltic pump. Alternatively, in some embodiments, fluid source 108 may be a fluid reservoir capable of storing and delivering fluid. In any embodiment, fluid source 108, such as a fluid pump or fluid reservoir, may include a container, such as a canister, pouch, or other storage component.

[0031] Fluid source 108 may also represent a container, canister, pouch, bag, or other storage component capable of providing a solution for instillation therapy. While the composition of the solution may vary according to the prescribed therapy, examples of solutions that may be suitable for some indications include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanides, cationic solutions, and isotonic solutions.

[0032] A controller, such as controller 109, may be a microprocessor or computer programmed to operate one or more components of treatment system 100, such as negative pressure source 106 and fluid source 108. In some embodiments, for example, controller 109 may generally be a microcontroller including an integrated circuit with a processor core and memory programmed to directly or indirectly control one or more operating parameters of treatment system 100. Operating parameters may include, for example, power applied to negative pressure source 106, pressure generated by negative pressure source 106, or pressure delivered to treatment device 101. Additional operating parameters may include power applied to fluid source 108, the flow rate of the drip fluid provided by fluid source 108, or the volume of fluid delivered to treatment device 101. Controller 109 is also preferably configured to receive one or more input signals, such as feedback signals, and is programmed to modify one or more operating parameters based on the input signals.

[0033] Container 110 represents a container, canister, pouch, or other storage component that can be used to manage exudate and other fluids drawn from a tissue site. In many environments, a rigid container may be preferred or necessary to collect, store, and discard fluids. In other environments, fluids can be properly discarded without storage in a rigid container, and a reusable container can reduce waste and costs associated with negative pressure therapy.

[0034] In this context, the term "tissue site" broadly refers to a wound, defect, or other treatment target located on or within tissue, including, but not limited to, bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament. Wounds can include, for example, chronic, acute, traumatic, subacute, and dehiscent wounds, partial-thickness burns, ulcers (such as diabetic ulcers, pressure ulcers, or venous insufficiency ulcers), flaps, and grafts. The term "tissue site" can also refer to any region of tissue that is not necessarily a wound or defect, but instead is an area where it may be desirable to add or promote the growth of additional tissue. For example, negative pressure can be applied to a tissue site to grow additional tissue, which can be harvested and transplanted.

[0035] In some embodiments, the negative pressure source 106, fluid source 108, controller 109, and reservoir 110 can be combined into a single treatment unit, such as treatment unit 104. Thus, for example, treatment system 100 can include treatment device 101 in conjunction with treatment unit 104, such as a VACULTA™ treatment unit, a VACINSTILL™ wound treatment system, an INFOV.AC™ treatment unit, or other suitable treatment unit. For example, in some embodiments, treatment unit 104 can include or consist essentially of a VACULTA™ unit, which can include software modules specific to negative pressure therapy in combination with fluid instillation therapy, as well as software modules specific to use with abdominal dressing systems, such as embodiments of treatment device 101. Alternatively, any other device capable of providing intermittent negative pressure therapy may be suitable, along with any mechanical fluid instillation device, or any negative pressure therapy device in combination with a manually administered fluid instillation source, such as a gravity-fed fluid reservoir, a manual fluid pump, or a monitored intravenous bag or bottle.

[0036] 2 , an exemplary embodiment of a treatment device 101 for treating the abdominal cavity 111 is presented. The treatment device 101 may be for treating a tissue site 112. In this exemplary embodiment, the tissue site 112 may include tissue within a body cavity, particularly the abdominal cavity 111. The tissue site 112 may include abdominal contents 113 or tissue proximate to the abdominal cavity 111. Treatment of the tissue site 112 may include removal of fluid, e.g., ascites, protection of the abdominal cavity, or negative pressure therapy.

[0037] The exemplary systems and devices herein can enable irrigation and flushing of an abdominal cavity, such as the abdominal cavity 111, through the controlled and regulated introduction of fluid. In some instances, a contaminated abdominal cavity, such as the result of a colon perforation or sepsis, may need to be washed or cleaned. The treatment system 100 can provide a means for dripping fluid into an open abdomen to flush the abdominal contents, including access areas such as small intestinal loops, the pancreas, etc. Additionally, the treatment device 101 and treatment system 100 can provide temporary closure to the open abdomen while fluid is removed and edema is reduced. Thus, the treatment system 100 can provide the possibility of performing flushing of a tissue site, such as the abdominal cavity 111, without having to repeatedly remove one or more dressings applied to the patient's tissue site or bringing the patient into an operating room for a manual fluid introduction procedure. Thus, the treatment system 100 can provide a controlled and regulated complete abdominal flushing, as well as the ability to provide targeted flushing to several areas within the abdomen, if needed. The disclosed embodiments can also provide support and maintenance of the fascial region of an abdominal cavity, such as abdominal cavity 111, to provide overall protection to the abdominal contents.

[0038] As shown in FIG. 2 , the treatment device 101 can include a dressing 102 that can be placed within a patient's abdominal cavity 111 to treat a tissue site 112. The dressing 102 can be supported by abdominal contents 113. As shown, a first dressing portion 114 of the dressing 102 can be positioned within or adjacent to a first paracolic groove 115, and a second dressing portion 116 can be positioned within or adjacent to a second paracolic groove 117. The first paracolic groove 115 and the second paracolic groove 117 can each be, for example, an open space on either side of the abdominal cavity 111 between the abdominal contents 113. The first paracolic groove 115 can be positioned laterally from the second paracolic groove 117 or otherwise positioned on the opposite side of the tissue site 112 from the second paracolic groove. Although FIG. 2 shows the treatment device 101 deployed in the abdominal cavity 111, the treatment device 101 and treatment system 100 can be used at other types of tissue sites.

[0039] The dressing 102 can be formed with multiple liquid-impermeable layers, e.g., a first liquid-impermeable layer 118 and a second liquid-impermeable layer 120. The multiple liquid-impermeable layers, e.g., the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120, have fenestrations 122 and 124 formed therein, respectively. "Liquid-impermeable" with respect to a "liquid-impermeable layer" means that the layer is formed of a liquid-impermeable material. Thus, a layer may be liquid-permeable if it is formed of a liquid-impermeable material but is fenestrated, but is still referred to as a liquid-impermeable layer. The fenestrations 122 and 124 can take many shapes or combinations of shapes, including, for example, circular apertures, rectangular openings, or polygons. In this exemplary embodiment, the fenestrations 122 and 124 are presented as slits or linear cuts. In some embodiments, the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120 can be sealingly bonded to one another in any suitable manner, such as, without limitation, by welding, bonding, adhesives, cement, or other bonding devices. The first liquid-impermeable layer 118 can be adapted to be positioned between the second liquid-impermeable layer 120 and the tissue site 112 and / or abdominal cavity contents 113. In the example embodiment of FIG. 2 , a chamber 125 is formed between at least two of the plurality of liquid-impermeable layers, e.g., the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120. The dressing 102 has a first side 126 and a second side 127. The first liquid-impermeable layer 118 and the second liquid-impermeable layer 120 can comprise a non-stick material, such as a medical drape, which can prevent tissue from adhering to the medical drape. For example, in some embodiments, the first liquid impermeable layer 118 and the second liquid impermeable layer 120 may comprise a breathable polyurethane film. In some embodiments, the chamber 125 formed between the liquid impermeable layers 118 and 120 may comprise a drip matrix 152 that delivers a drip fluid to the tissue site 112, along with a fluid removal assembly 148 that transmits negative pressure and removes fluids, such as exudate, from the tissue site 112.

[0040] In some embodiments, treatment system 100 may further include a sealing member 128 that provides a fluid seal over abdominal cavity 111. Additionally, one or more skin closure devices may be positioned over the patient's epidermis 130. In some embodiments, treatment system 100 may also include an interface 132 that fluidly connects dressing 102 and other portions of treatment device 101 to a conduit 134. Interface 132 may include a connector 136. Alternatively, interface 132 may be partially or completely embedded within a portion of dressing 102 or configured in any other manner that allows for fluidly connecting treatment device 101 to a treatment unit, such as treatment unit 104 of FIG. 1 . Conduit 134 may be fluidly coupled to negative pressure source 106 and / or fluid source 108 of treatment unit 104 to provide negative pressure and / or treatment fluid, respectively, to treatment device 101. In some embodiments, conduit 134 can include two substantially parallel, fluidly isolated conduits, one for fluidly coupling treatment device 101 to negative pressure source 106 and the other for fluidly coupling treatment device 101 to fluid source 108. Thus, in some embodiments, conduit 134 can be a multi-lumen conduit with both negative pressure lumen 135 and fluid supply lumen 137. In some other exemplary embodiments, conduit 134 can be replaced with two separate conduits, one of which includes a negative pressure lumen and the other of which includes a fluid supply lumen.

[0041] In some embodiments, the sealing member 128 can provide a microbial barrier and protection from physical trauma. The sealing member 128 can also be constructed from a material that can reduce evaporative loss and provide a fluid seal between two components or two environments, such as between a treatment environment and a local external environment. The sealing member 128 can be, for example, an elastomeric film or membrane that can provide an adequate seal to maintain negative pressure at the tissue site for a given negative pressure source. The sealing member 128 can have a high moisture vapor transmission rate (MVTR) for some applications. For example, in some embodiments, the MVTR is at least 300 g / m 2 For example, the sealing member 128 may be a polymer drape, such as a polyurethane film, that is permeable to water vapor but impermeable to liquids. Such drapes typically have a thickness in the range of 25-50 microns. For permeable materials, the permeability must generally be low enough to maintain the desired negative pressure.

[0042] An attachment device, such as attachment device 142, can be used to attach sealing member 128 to a mounting surface, such as the patient's epidermis 130. Attachment device 142 can also be used to attach sealing member 128 to a gasket or another sealing member or cover. Attachment devices can take many forms. For example, the attachment device can be a medically acceptable pressure-sensitive adhesive that extends around the periphery, a portion, or the entire sealing member. In some embodiments, for example, some or all of sealing member 128 can be coated with an acrylic adhesive having a coating weight of 25 to 65 grams per square meter (gsm). In some embodiments, a thicker adhesive or adhesive combination can be applied to improve the seal and reduce leakage. Other exemplary embodiments of attachment devices can include double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, or organogel.

[0043] Although not necessarily shown in FIG. 2 , in some embodiments, treatment system 100 can further include a filler material, such as a portion of foam, disposed between second liquid-impermeable layer 120 and sealing member 128. The filler material can be sized to fill a portion of the abdominal volume directly below or surrounding the incision, such as a portion of abdominal cavity 111, or leading from the skin layer into the abdomen. In some embodiments, the filler material can act as a distribution manifold for negative pressure. For example, in some embodiments, the filler material can be positioned between second liquid-impermeable layer 120 and sealing member 128, and can pneumatically connect a negative pressure lumen or conduit, such as negative pressure lumen 135, to sealing member 128. As a result, fluid removal can occur from the layers of treatment device 101, through the filler material positioned on second liquid-impermeable layer 120, and into negative pressure lumen 135. In some embodiments, the filler material can include an open-cell, reticulated polyurethane foam, such as GRANUFOAM™ dressing available from Kinetic Concepts, Inc. of San Antonio, Texas.

[0044] Referring now primarily to FIG. 3 , the treatment device 101 can be adapted to provide negative pressure from a negative pressure source 106 of the treatment unit 104 to a tissue site, such as a tissue site 112 of the abdominal cavity 111 of FIG. 2 , and to collect and transport fluids extracted from the tissue site 112. Additionally, the treatment device 101 can also be adapted to deliver a fluid, such as a treatment fluid or a medication, to the tissue site 112 from a fluid source 108 of the treatment unit 104. As discussed with respect to FIG. 2 , in some embodiments, the dressing 102 of the treatment device 101 can include multiple liquid-impermeable or visceral protective layers that protect the abdominal cavity contents 113 underlying the tissue site 112. For example, in some embodiments, the dressing 102 can include a first liquid-impermeable layer 118 and a second liquid-impermeable layer 120 formed from a polyurethane material, each measuring between 20 and 400 micrometers in thickness. As shown in FIG. 3, one or both of the liquid impermeable layers, such as the second liquid impermeable layer 120, may include fenestrations 124 to facilitate fluid removal through the abdominal cavity 111.

[0045] As shown in FIG. 3 , some embodiments of the treatment device 101 can also include a fluid removal assembly 148 and a drip matrix 152. For example, in some embodiments, the fluid removal assembly 148 can include multiple fluid removal pathways 150, each of which is fluidly coupled to a fluid removal hub 154. The fluid removal hub 154 can serve as a distribution mechanism that transfers negative pressure from the interface 132 and the negative pressure source 106 to each of the fluid removal pathways 150. The fluid removal pathways 150 can take the form of many different shapes or be formed from a variety of materials. For example, in some embodiments, the fluid removal pathways 150 can be formed from portions of the first and second liquid-impermeable layers 118 and 120 welded together to form channels. Alternatively, or in addition, the fluid removal pathways 150 can include, or consist essentially of, folds or pleats in either or both of the liquid-impermeable layers 118 and 120. Other exemplary embodiments of fluid removal pathways 150 include channels formed by extruded material, channels embossed on liquid impermeable layers 118 and 120, or separate tubing forming individual tubes for use as fluid removal pathways 150. Multi-lumen tubing can also be used for fluid removal pathways 150. In various embodiments, each of the different forms and configurations of fluid removal pathways 150 can also be applied to the fluid delivery tubes of dripping matrix 152, as appropriate.

[0046] In some embodiments, each of the fluid removal paths 150 can include a manifold member, such as manifold member 156, that transmits negative pressure and draws fluid through the fluid removal paths 150. For example, in some embodiments, each manifold member 156 can be a single piece of manifold member material that extends the length of the fluid removal paths 150, while some embodiments include manifold members 156 that are made from separate pieces or sections of manifold member material. In either case, the manifold member 156 can include a series of indentations 159, which, along with the sizing and conformability, including flexibility, of the manifold member 156 and the fluid removal paths 150, can aid in the transmission of negative pressure and / or collected fluid.

[0047] The manifold member 156 can generally include any substance or structure provided to aid in applying negative pressure to, delivering fluid to, or removing fluid from the tissue site 112 or other location. The manifold member 156 can typically be a manifold member material having multiple flow channels or pathways for providing negative pressure to the manifold member 156 and distributing removed fluid therearound. For example, the manifold member material can be adapted to receive negative pressure from a negative pressure source and distribute the negative pressure across the tissue site through multiple apertures, which can have the effect of collecting fluid from throughout the tissue site and drawing the fluid toward the fluid source. In some embodiments, the fluid path can be reversed or secondary flow channels can be provided to facilitate delivering fluid across the tissue site.

[0048] In some exemplary embodiments, the channels of the manifold can be interconnected to improve fluid distribution or collection across the tissue site. In some exemplary embodiments, the manifold can be a porous foam material having interconnected cells or pores. For example, cellular foams, open-cell foams, reticulated foams, porous tissue masses, and other porous materials such as gauze or felt mats generally include pores, edges, and / or walls adapted to form interconnected fluid channels. Liquids, gels, and other foams also include, or can be hardened to include, apertures and fluid pathways. In some embodiments, the manifold can additionally or alternatively include protrusions that form the interconnected fluid pathways. For example, the manifold can be molded to provide surface protrusions that define the interconnected fluid pathways.

[0049] In some embodiments, the manifold member 156 comprises a porous foam, including a plurality of interconnected cells or pores that act as flow channels. The average pore size of the foam can be varied according to the needs of the prescribed therapy. For example, in some embodiments, the manifold member 156 can be a foam having a pore size ranging from 400 to 600 microns. The tensile strength of the manifold member 156 can also be varied according to the needs of the prescribed therapy. For example, the tensile strength of the foam can be increased for instillation of a topical treatment solution. In some embodiments, the manifold member 156 can comprise a polyurethane foam that can be 6 mm to 10 mm thick. In one non-limiting example, the manifold member 156 can be an open-cell, reticulated polyurethane foam, such as a GRANUFOAM™ dressing or a VACVERAFLO™ dressing, both available from Kinetic Concepts, Inc., San Antonio, Texas. Some embodiments may include a manifold member 156 with additional layers or materials, such as absorbent materials, wicking materials, hydrophobic materials, and hydrophilic materials.

[0050] The drip matrix 152 can include multiple fluid delivery tubes 158 and a distribution hub 160. The components of the drip matrix 152 can be constructed from a variety of different materials. For example, some or all of the components of the drip matrix 152 can be constructed from soft medical-grade silicone or PVC tubing. The multiple fluid delivery tubes 158 can vary in size based on the condition of the tissue site 112 to which the treatment device 101 is to be applied, as well as the particular size and use of the treatment device 101. For example, the fluid delivery tubes 158 can each have an inner diameter of 0.5 mm to 4 mm. In some embodiments, the fluid delivery tubes 158 can each have an inner diameter of 1 mm to 2 mm. The somewhat smaller size of the fluid delivery tubes 158 can help avoid patient discomfort during treatment and facilitate removal of the treatment device 101 following completion of treatment.

[0051] As shown in FIG. 3 , but again referring to FIG. 2 , in some embodiments, the drip matrix 152 can be substantially enclosed within the multiple layers of the dressing 102. For example, the fluid delivery tube 158, along with the fluid removal pathway 150, can be positioned with the chamber 125 formed by the first and second liquid impermeable layers 118, 120. Optionally, during manufacture, the drip matrix 152 along with the fluid removal pathway 150 can be inserted into the chamber 125 between the first and second liquid impermeable layers 118, 120 before the liquid impermeable layers 118, 120 are attached to one another, for example, by ultrasonic welding. The fluid removal pathway 150 and the fluid delivery tube 158 can each be secured in place between the liquid impermeable layers 118, 120 by welding the liquid impermeable layers 118, 120 together along the boundary of the fluid removal pathway 150 and the fluid delivery tube 158, as indicated by weld line 162.

[0052] 4A and 4B , additional features that may be associated with some example embodiments of the treatment device 101 of FIG. 3 are illustrated. For example, as shown in FIG. 4A , each fluid removal path 150 may include an open end 164 as well as an opening or aperture, such as removal path aperture 166, along the length of the fluid removal path 150. Thus, in such an embodiment, the fluid removal path 150 may transmit negative pressure and draw fluid through both ends and along the length of the fluid removal path 150. Meanwhile, in this example embodiment, the fluid delivery tube 158 may have only an open end, such as delivery end 168, and may otherwise be fluidly isolated from the environment along the length of the fluid delivery tube 158. In some embodiments, the treatment device 101 may be provided in a single size, with the option to reduce its size by cutting and removing portions of the treatment device 101, thus shortening the length of the fluid delivery tube 158, possibly as needed for an individual patient. Therefore, by having openings in the fluid delivery tubes 158 only at the ends of the individual tubes, a greater level of customization can be achieved because the fluid delivery tubes 158 and the entire drip matrix 152 do not rely on a set length of the fluid delivery tubes 158 or the number or size of the perforations in the fluid delivery tubes 158 to uniformly distribute the drip fluid.

[0053] FIG. 5 illustrates additional features that may be associated with some example embodiments of the treatment device 101 of FIG. 3. The components and features of the example treatment device 101 of FIG. 5 are largely the same as or similar to some of the embodiments of the treatment device 101 shown in FIG. 4 (collectively), except for some aspects of the fluid delivery tube 158. For example, as shown in FIG. 5, rather than having an open end, such as delivery end 168 of FIG. 4, for delivering a drip fluid to a tissue site, the fluid delivery tube 158 can instead have a closed end, such as delivery tube closed end 170. Instead, each of the fluid delivery tubes 158 can include openings or perforations, such as delivery tube perforations 172, along its length. However, the embodiments illustrated in FIGS. 4 and 5 are for illustrative purposes only, and it is contemplated that the fluid delivery tubes 158 can include perforations along their length as well as both open ends.

[0054] The drip matrix 152 can be adapted to deliver fluid substantially uniformly across the tissue site 112. For example, each of the fluid delivery tubes 158, delivery end 168, and delivery tube perforations 172 can be adapted to provide substantially the same backpressure. Such a configuration can prevent fluid from moving more freely through or otherwise favoring one of the fluid delivery tubes 158 compared to another of the fluid delivery tubes 158. As used herein, backpressure can refer to an increase in localized pressure caused by resistance to fluid flow, such as through a confined space such as a lumen or aperture. Backpressure can result from the geometry and material properties of the confined space, such as, without limitation, the size of the space, the presence and shape of bends or joints within the space, the surface finish within the space, and other features. In some embodiments, if the perforations along the length of the fluid delivery tube 158, such as delivery tube perforations 172, are sized to provide a substantially uniform distribution of fluid throughout the abdomen, a fluid hub, such as distribution hub 160, can be unnecessary.

[0055] Fluid tends to follow the path of least resistance; therefore, inadequate fluid distribution can result from one of the fluid delivery tubes 158 having a lower backpressure or resistance to fluid flow than another of the fluid delivery tubes 158. Similarly, inadequate fluid distribution can result from one of the fluid delivery apertures, such as the delivery ends 168 or delivery tube perforations 172, having a lower backpressure or resistance to fluid flow than another of the fluid delivery apertures. For example, consistency in the size and configuration of the fluid delivery tubes 158 and the number and size of the delivery ends 168 and delivery tube perforations 172 in each of the fluid delivery tubes 158 can improve the uniformity of fluid delivery to the tissue site 112. Thus, in some embodiments, the delivery apertures, such as the delivery ends 168 and delivery tube perforations 172, can be substantially equal in number and size in each of the fluid delivery tubes 158. Furthermore, each of the fluid delivery tubes 158 can have substantially the same dimensions.

[0056] For example, in some embodiments, the fluid delivery tube 158 can have a cylindrical tube shape and can have an inner diameter of about 2 millimeters to about 6 millimeters. Additionally, in some embodiments, the fluid delivery tube 158 can have an inner diameter of about 4 millimeters. In other embodiments, the fluid delivery tube 158 can have an alternative tube profile, where a thinner, or "flatter," tube profile can be used to improve user comfort when the treatment device 101 is in place at the tissue site 112. The delivery end 168 and delivery apertures, such as the delivery tube perforations 172, can have a diameter of about 0.1 millimeters to about 0.8 millimeters in some embodiments. By sizing the inner diameter or cross-section of the fluid delivery tube 158 substantially larger than the size, cross-section, or diameter of the delivery end 168 and the delivery tube perforations 172, a substantially uniform pressure can be provided within each of the fluid delivery tubes 158. In such embodiments, the fluid flow rate within the fluid delivery tube 158 may be substantially low or substantially static compared to the higher fluid flow rate through the delivery end 168 and delivery apertures, such as the delivery tube perforations 172 .

[0057] Although not shown in the accompanying figures, in some embodiments, the drip matrix 152 may include an arrangement of fluid delivery tubes 158 arranged in a lattice or "spider web" configuration. Thus, in some cases, the drip matrix 152 may include multiple fluid delivery tubes 158 extending radially from a central hub, as well as additional pipe segments fluidly connecting each of the radially extending fluid delivery tubes 158. Perforations may be present along any or all portions of the radially extending fluid delivery tubes 158 and connecting pipe segments.

[0058] 6A shows a more detailed view of a hub, such as the distribution hub 160 of FIG. 3. In some embodiments, at least a portion of the distribution hub 160 can be positioned between the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120 and can be positioned to be in fluid communication with a fluid delivery pathway, such as the fluid delivery tube 158. In some embodiments, the height of the distribution hub 160 can be such that the distribution hub 160 can extend outward above the surface of the second liquid-impermeable layer 120 of the treatment device 101. The distribution hub 160 can include a hub port 174 that can be positioned on an upper surface of the distribution hub 160. The size and dimensions of the distribution hub 160 can be such that the hub port 174 can be positioned above the upper surface of the second liquid-impermeable layer 120 and the hub port 174 can provide fluid communication between the fluid supply lumen of the conduit 134 and the distribution hub 160. In some embodiments, the distribution hub 160 can include multiple openings, such as distribution ports 261, positioned around its lower surface. In some embodiments, these distribution ports 261 can be for fluidly coupling to fluid delivery tubes 158 of the drip matrix 152. The predetermined size of the openings or distribution ports 261 can be calibrated to a particular drip fluid source, such as the fluid source 108, and its specific configuration or design parameters. For example, several instances of the fluid source 108 may each require a predetermined size opening due to a predetermined pump flow rate. In some embodiments, the fluid delivery tubes 158 can be positioned circumferentially and substantially symmetrically about the distribution hub 160. Thus, the distribution hub 160 and the fluid delivery tubes 158 can define a fluid drip path.

[0059] As shown in FIG. 6A , the distribution hub 160 can include a material useful for distributing the drip fluid, such as a distribution member 176. The distribution member 176 can include a porous or fluid-permeable material, such as foam. Furthermore, the distribution hub 160 can generally be elongated and cylindrical or bell-shaped in shape, although it can have other shapes. In other embodiments, the distribution hub 160 can include fittings, such as tubes, tubular fittings, pipes, barbed connections, or similar structures. In such embodiments, the fittings can be pre-bonded or molded directly to the first liquid-impermeable layer 118 or the second liquid-impermeable layer 120 and configured to be fluidly coupled between the fluid supply lumen of the conduit 134 and the fluid delivery tube 158.

[0060] In some embodiments, the distribution hub 160 can be cast or injection molded from a similarly soft, medical-grade silicone or PVC material. In other embodiments, the distribution hub 160 can be fabricated from two sheets of polyurethane film welded together. In some further embodiments, the distribution hub 160 can actually serve as a combined fluid drip and fluid removal hub, in which case the distribution hub 160 can be fluidly connected to both the fluid delivery and fluid removal conduits of the treatment device 101. In such a combined fluid drip and fluid removal hub, the distribution hub 160 can include a series of one-way valves. These one-way valves can be any form of one-way valve, such as commercially available duckbill valves or custom flap valves. These one-way valves can be located at openings in the distribution hub 160, such as distribution ports 261, to the fluid delivery tube 158 and to the fluid removal pathway, e.g., the fluid removal pathway 150. Some embodiments of the combined hub may include a common distribution material as part of the hub while still allowing fluid communication with the separate fluid delivery tubes 158 and fluid removal pathways 150 .

[0061] In some cases, the fluid delivery tube 158 can be formed separately from the distribution hub 160 and then attached to the distribution hub 160 with a medical grade adhesive or cyclohexanol, or by welding. In other example embodiments, the fluid delivery tube 158 and the distribution hub 160 of the drip matrix 152 can be formed as a substantially unitary structure.

[0062] 6B , but also generally referring back to FIG. 2 , interface 132 can provide both a negative pressure connection and a fluid supply connection to treatment device 101. Interface 132 can be sized, shaped, or otherwise adapted to fluidly connect negative pressure lumen 135 and fluid supply lumen 137 of conduit 134 to treatment device 101 in any suitable manner. In some embodiments, interface 132 can fluidly couple negative pressure lumen 135 and fluid supply lumen 137 through sealing member 128. For example, one or more sealing member apertures can be disposed through sealing member 128 to provide fluid communication and access to components of treatment device 101 positioned within the sealed space.

[0063] In some embodiments, interface 132 can be formed or molded as part of vacuum lumen 135 and fluid supply lumen 137. In other embodiments, vacuum lumen 135 and fluid supply lumen 137 can be joined or secured, for example, by an interference fit to interface 132. In some embodiments, a portion of interface 132, such as a flange, can be coupled to sealing member 128 to position interface 132 in fluid communication with treatment device 101 through sealing member 128. Interface 132 can be coupled to sealing member 128 in any suitable manner, such as, for example, by adhesive or other bonding device. For example, in some embodiments, the adhesive that bonds interface 132 to sealing member 128 can be the same as that used for attachment device 142 for sealing member 128 described above.

[0064] 6B, interface 132 can be a multi-port interface that provides both a negative pressure connection and a fluid supply connection as individual fluidically isolated ports within the multi-port interface, such as interface 132. In such embodiments, a wall of one of the individual lumens, such as fluid supply lumen 137, can be coupled to distribution hub 160 to fluidly isolate the fluid supply connection from the negative pressure connection. Other configurations that maintain fluid isolation of negative pressure lumen 135 and fluid supply lumen 137 are possible.

[0065] In other embodiments (not shown), interface 132 may be a single port interface that can provide either a negative pressure connection or a fluid supply connection. Thus, a first single port interface can provide a negative pressure connection, and a second single port interface can provide a fluid supply connection. In other embodiments, negative pressure lumen 135 can be fluidly coupled directly to fluid removal hub 154, and fluid supply lumen 137 can be fluidly coupled directly to distribution hub 160 without interface 132.

[0066] In some alternative embodiments, the treatment device 101 can include a fluid hub that can function both to distribute the drip fluid through the distribution channels and to distribute negative pressure through and collect fluid from the fluid removal channels. For example, the fluid hub can include two layers or chambers separated by a film membrane, such as a polyurethane film membrane. The upper layer or chamber can receive clean drip fluid and direct it through a matrix of open channels to the fluid delivery tube. The upper chamber can also include a floor with indentations or pleats to help direct the fluid. In some embodiments, the floor can provide a continuous film layer during the fluid drip phase of treatment, but when negative pressure is applied, pleats or flaps in the floor can be pulled upward to provide small openings through which fluid can pass from the lower chamber upward and exit the fluid hub. The upper chamber can also include a porous foam ring around the inner periphery of the chamber to provide a filter for larger contaminants exiting through the fluid drip channels. The foam ring can also function as a seal when compressed under negative pressure to close the fluid drip channels. The lower layer or chamber of the fluid hub can be connected to the fluid removal pathway, and the lower chamber can include manifold material to ensure the fluid pathway remains open when negative pressure is applied. When negative pressure is applied, fluid can be removed from the treatment device 101 through the fluid hub, with minimal chance of mixing of clean dripping fluid with dirty fluid from the tissue site. In some embodiments, the fluid hub can include one or more valves, such as O-ring seal valves, in the upper chamber that can block the opening from the upper chamber to the fluid drip pathway when negative pressure is applied.

[0067] 1-6B , in some exemplary embodiments of the operation of treatment system 100, treatment device 101 can be sized to fit into tissue site 112 and placed at or within tissue site 112, such as abdominal cavity 111. If sizing of treatment device 101 is necessary, excess portions of treatment device 101 can be removed, for example, by cutting or tearing to the desired size through fluid removal pathway 150 and fluid delivery tube 158, along with first and second liquid impermeable layers 118, 120 of treatment device 101.

[0068] The treatment device 101 can be positioned to contact the abdominal cavity contents 113, with a portion of the treatment device 101 being forced into the patient's paracolic groove. Specifically, the fluid removal pathway 150 can be positioned proximate the first paracolic groove 115 and the second paracolic groove 117. When deployed, the treatment device 101 can cover all exposed viscera and separate the viscera from contact with the wall of the abdominal cavity 111. The treatment device 101 can be sized and shaped to allow for such coverage.

[0069] The treatment device 101 can be covered by a sealing member 128 at the tissue site 112 to provide a sealed space to accommodate the treatment device 101. The sealing member 128 can be positioned and fluidly sealed around the tissue site 112 by an attachment device 142, as described above. Apertures in the sealing member 128 can be cut or otherwise disposed through the sealing member 128, as needed, if not already provided as part of the sealing member 128. The negative pressure and fluid supply connections can be made, for example, by the interface 132 or through direct coupling of the negative pressure lumen 135 to the fluid removal assembly 148 and the fluid supply lumen 137 to the drip matrix 152. It is important to note that the drip fluid can be independently supplied from a fluid source, such as the fluid source 108, through the fluid supply lumen into the drip matrix 152. Thus, in some embodiments, the drip fluid can be supplied directly to a fluid hub, such as the distribution hub 160, thereby allowing the fluid drip path and the fluid removal path to be controlled as separate elements. Thus, the likelihood of contamination of the clean fluid drip path can be reduced or substantially eliminated, resulting in a more efficient cleaning cycle. Depending on how the components of the treatment device 101 are specifically configured, in some embodiments, fluid can be delivered through a fluid drip tube directly into the lower abdominal region, such as the paracolic sulcus, e.g., the first paracolic sulcus 115 and the second paracolic sulcus 117.

[0070] Negative pressure can be provided to the fluid removal assembly 148 through the negative pressure lumen 135 of the conduit 134 by activating the negative pressure source 106. The fluid source 108 can provide dripping fluid to the dripping matrix 152 through the fluid supply lumen 137, for example, by activating a pump or positive pressure source in the fluid source 108, or by the action of gravity or manual user force acting on the dripping fluid. The negative pressure and dripping fluid can be provided to the treatment device 101 simultaneously or periodically at alternating times. Furthermore, the negative pressure and dripping fluid can be applied to the treatment device 101 intermittently or continuously.

[0071] When negative pressure source 106 is activated, negative pressure lumen 135 of conduit 134 can distribute negative pressure to fluid removal hub 154 and to fluid removal pathway 150 of fluid removal assembly 148. As shown in Figures 4A-5 by lead arrow 169, fluid from tissue site 112 can be drawn or extracted into fluid removal pathway 150 through open end 164 and removal pathway aperture 166. Fluid in fluid removal pathway 150 can be communicated through fluid removal pathway 150 and into fluid removal hub 154, where it can be drawn into negative pressure lumen 135 of conduit 134 and ultimately into container 110.

[0072] When the fluid source 108 is activated or a drip fluid is otherwise being delivered to the treatment device 101, the drip fluid may travel into the distribution hub 160 of the drip matrix 152. From the distribution hub 160, the drip fluid may be transferred to the tissue site 112 through the fluid delivery tube 158 and the delivery end 168 and / or delivery tube perforations 172 of the fluid delivery tube 158, as indicated by arrow 161. The configuration of the drip matrix 152 and associated back pressure, as described above, may facilitate substantially uniform delivery of the drip fluid to the tissue site 112.

[0073] Fluid being dripped or delivered to the tissue site 112 through the dripping matrix 152 may remain physically and fluidically separate from the fluid removal assembly 148 until it reaches or directly contacts the tissue site 112. Once delivered to the tissue site 112, the dripping fluid may become mixed with, for example, previously dripped fluids, wound fluids, tissue fluids, and other fluids that may be considered waste fluids. When negative pressure is applied to the treatment device 101, tissue or wound fluids from the tissue site 112, and any dripping fluids previously delivered to the tissue site 112, may be extracted through the separate fluid removal assembly 148. Fluid being extracted from the tissue site 112 through the fluid removal assembly 148 may remain physically and fluidically separate from the dripping matrix 152. Such separation between the fluid removal assembly 148 and the drip matrix 152 can, for example, prevent fluid that may remain in the fluid removal path 150 or fluid removal hub 154 after or during extraction from the tissue site 112 from being pushed back into the tissue site 112 during fluid dripping.

[0074] Furthermore, separation of the fluid removal assembly 148 from the drip matrix 152 can facilitate efficient use of the drip fluid. For example, as described above, the fluid removal hub 154 and the fluid removal pathway 150 can comprise a porous, fluid-permeable material, such as foam. This fluid-permeable material can include a fluid flow path that can remain open or fluid-permeable while negative pressure is applied to extract fluid from the tissue site 112. Furthermore, fluid extracted from the tissue site 112 can be stored within the fluid removal assembly 148 of the treatment device 101 before being drawn into the negative pressure lumen 135. To be able to provide fluid storage and permeability while negative pressure is applied, the fluid removal assembly 148 may need to have a higher volumetric fluid capacity compared to the drip matrix 152, which may be under positive pressure. Fluid being dripped or delivered to the tissue site 112 through the separate drip matrix 152 may not need to pass through portions of the treatment device 101, such as the fluid removal assembly 148, which may be at a higher volume. Such a configuration can facilitate distribution and efficient use of the drip fluid.

[0075] Continuing generally with FIGS. 1-6B , methods of providing fluid dripping and negative pressure treatment at a tissue site will be further described. In some embodiments, the methods of providing fluid dripping and negative pressure treatment at a tissue site can include positioning a treatment device 101 adjacent to a tissue site 112. The treatment device 101 can include a dripping matrix 152 and a fluid removal assembly 148 separate from the dripping matrix 152. As described above, in some embodiments, the tissue site 112 can be the abdominal cavity 111, and positioning the treatment device 101 adjacent to the tissue site 112 can include disposing at least a portion of the treatment device 101 proximate a paracolic groove in the abdominal cavity 111, such as the first paracolic groove 115 and / or the second paracolic groove 117. Further, in some embodiments, the method can include covering the treatment device 101 with a sealing member 128 to provide a sealed space between the sealing member 128 and the tissue site 112. In some embodiments, the method can include sizing the treatment device 101 for placement at the tissue site 112. As described above, sizing the treatment device 101 can include cutting or tearing the treatment device 101. Optionally, the treatment device 101 can include visual indicia to guide the user in customizing the treatment device to a desired size.

[0076] The method may further include coupling a fluid source 108 in fluid communication with the dripping matrix 152 and coupling a negative pressure source 106 in fluid communication with the fluid removal assembly 148. The method may further include supplying dripping fluid from the fluid source 108 to the tissue site 112 through the dripping matrix 152. Additionally, the method may include providing negative pressure from the negative pressure source 106 to the tissue site 112 through the fluid removal assembly 148 and extracting fluid from the tissue site 112 through the fluid removal assembly 148. Following completion of the negative pressure and / or fluid dripping therapy, the user may remove the treatment device 101 as a largely intact structure, thus maintaining ease of use of the treatment device 101.

[0077] 7A, another example embodiment of a treatment device 201 for use in the treatment system 100 is shown. In this embodiment, the treatment device 201 may include substantially similar components to the treatment device 101 of FIG. 3, although the arrangement and function of individual features may differ. For example, the treatment device 201 may include multiple fluid removal paths 150, which may be positioned between multiple liquid-impermeable layers of a dressing 202 and fluidly connected to a fluid removal hub 154. However, in this example embodiment, the treatment device 201 may include a drip matrix 252 having multiple fluid delivery tubes 258 that may be attached to a distribution hub 260, and the fluid delivery tubes 258 may hang loosely below the dressing 202. In this embodiment of the treatment device 201, the user may also individually position each of the fluid delivery tubes 258 within the patient's abdominal cavity. Thus, the user can choose to spread the fluid delivery tube 258 evenly throughout the abdominal cavity to provide a thorough, uniform rinsing of the abdomen, or alternatively, the user can choose to focus the fluid delivery tube 258 on any particular area of ​​interest to provide a more thorough wash. The treatment device 201 can allow the user to make this decision individually. In some embodiments, the multiple fluid delivery tubes 258 can comprise perforated polyurethane film or foam bags. For example, the fluid delivery tubes 258 can be constructed using two layers of polyurethane film approximately 100 micrometers thick, with the edges welded together. The fluid delivery tubes 258 can have open ends for targeted fluid delivery. Similarly, in such an embodiment, the distribution hub 260 can be constructed from two layers of polyurethane film approximately 100 micrometers thick, welded together. In some embodiments, the fluid delivery tubes 258 and the distribution hub 260 can each have a central core adapted to ensure an open pathway is maintained and to aid the user in handling during placement. For example, the central core may be an open-cell reticulated polyurethane foam.The dimensions of the central core material positioned within the fluid delivery tube 258 can vary; for example, the central core material can range from about 2 mm to 10 mm thick by about 5 mm to 15 mm wide. In some embodiments, the central core material can be about 6 mm thick by 10 mm wide. The length of the central core material can vary based on overall sizing considerations of the treatment device 201. Some embodiments of the treatment device 201 can include a central core material with a width that varies along its length, thereby allowing for break points that provide user customization and sizing. Optionally, the fluid delivery tube 258 can be adapted such that any drip fluid remaining within the fluid delivery tube 258 following delivery of the drip fluid by the fluid source 108 can be squeezed out of the fluid delivery tube 258 when negative pressure is applied to the treatment device 201, thus ensuring that substantially all of the drip fluid is emptied from the fluid delivery tube 258 and better regulating the volume of drip fluid provided during a treatment cycle.

[0078] 7B shows an embodiment of a treatment device 301 similar to that of FIG. 7A , except that rather than including multiple fluid removal paths positioned between the liquid-impermeable layers of the dressing 202, the treatment device 301 includes both fluid removal paths and fluid drip paths that can be individually positioned. In some embodiments, the treatment device 301 can include a dressing 302 having a fluid removal path 250 attached to a fluid removal hub 254 and extending freely below the liquid-impermeable layer of the dressing 302. Additionally, in some embodiments, the treatment device 301 can also include a drip matrix 252 having a fluid delivery tube 258 that can also extend freely from the underside of the dressing 302. Thus, in such embodiments, a user can select to focus the fluid removal path 250, as well as the fluid delivery tube 258, on any area of ​​interest within the patient's abdominal cavity. A user can also select to spread the fluid removal path 250 and the fluid delivery tube 258 evenly within the patient's abdomen to provide thorough rinsing of the abdominal cavity. In such an embodiment, the dressing 302 may be provided with a fluid removal pathway 250 and a fluid delivery tube 258 either attached to the liquid impermeable layer of the dressing 302 or separately for assembly by the user.

[0079] FIG. 7C also shows another embodiment of a treatment device 401, which, like the treatment device 301 of FIG. 7B, can include both multiple fluid removal paths 350 and a drip matrix 352 with fluid delivery tubes 358 that extend loosely adjacent to or below the liquid-impermeable layer of the dressing 402. However, in some embodiments, as shown in FIG. 7C, each of the fluid removal paths 350 can be paired with a fluid delivery tube 358 for positioning in the same region within the patient's abdominal cavity. In such embodiments, the fluid removal paths 350 can be paired with the fluid delivery tubes 358, while still maintaining two separate fluid paths. This arrangement can provide the advantage that fluids dripped into a location within the abdominal cavity can later be removed from the same region (which can be important if the region of the abdominal cavity is highly contaminated) and can avoid cross-contamination with other regions of the abdominal cavity. Because neither the fluid removal pathway 350 nor the fluid delivery tube 358 are positioned within the liquid impermeable layer of the dressing 402, the treatment device 401 may therefore require a separate dressing 402 including a liquid impermeable layer, which can be applied to the patient's abdominal cavity after the combined fluid removal pathway 350 and fluid delivery tube 358 are positioned. Depending on specific manufacturing and user requirements, the dressing 402 can be provided attached to the fluid removal pathway 350 and drip matrix 352 or separately for assembly by the user.

[0080] 8 , another illustrative embodiment of treatment device 501 is shown. In this embodiment, fluid removal pathways 450 and fluid delivery tubes 458 of drip matrix 452 are formed as part of dressing 502, with each fluid removal pathway 450 extending adjacent to and parallel to fluid delivery tube 458, thus forming parallel pathways 590. In some embodiments, parallel pathways 590, each of which may include a fluid removal pathway 450 and a fluid delivery tube 458, may be connected between segments of the liquid-impermeable layer of dressing 502 by perforated joints, such as perforations 592 in the liquid-impermeable layer of dressing 502. Thus, each parallel pathway 590 may be individually movable by cutting or tearing along its peritoneal perforations 592 and positioned within a predetermined region of the abdominal cavity, such as adjacent to a small intestinal loop, the paracolic groove, the retroperitoneal cavity, the lymphatic system, etc. Additionally, some embodiments of the dressing 502 may also include additional perforated joints or lines between each of the fluid removal paths 450 and each of the fluid delivery tubes 458 in the parallel paths 590. Thus, each of the fluid removal paths 450 may also be separately movable from its corresponding paired fluid delivery tube 458 and positioned as needed within the abdominal cavity. Regardless of location, each of the fluid removal paths 450 may remain fluidly connected to the fluid removal hub 454, and each of the fluid delivery tubes 458 may remain fluidly connected to the distribution hub 460.

[0081] 9 illustrates features of some example embodiments of treatment devices in which the fluid removal path and the fluid drip path can be combined into a single path. For example, the single fluid removal path and the single fluid drip path can be combined into a single tubular structure, such as a combined tube 694. The combined tube 694 can include a central bore 696 that can be formed by an inner lining 697, which can be a film, such as a polyurethane film. The combined tube 694 can also include an outer lumen 698 that can be formed by an outer lining 699, which can also be a film, such as a polyurethane film. Depending on the specific embodiment, either the central bore 696 or the outer lumen 698 can be used for either the fluid removal path or the fluid drip path.

[0082] 10A-10C, another example embodiment of a treatment device 701 for use with treatment system 100 is illustrated. In some embodiments, treatment device 701 can include a dressing 702, which can be formed from multiple liquid-impermeable or visceral protective layers, such as a first liquid-impermeable layer 718 and a second liquid-impermeable layer 720. Treatment device 701 can also include a delivery connector 763 that delivers a drip fluid to treatment device 701. Treatment device can also include a fluid removal hub 754 that transmits negative pressure to a portion of treatment device 701 and removes fluid from treatment device 701 and the abdominal cavity. As shown in FIG. 10A, treatment device 701 can further include a fluid delivery container 760 that dispenses the drip fluid. Fluid delivery container 760 can be a flexible container that is fluidly connected to a drip source, such as fluid source 108 of treatment system 100. In some embodiments, the body of the fluid delivery vessel 760 can be constructed from one or more sections of film material having a thickness ranging from 25 micrometers to 500 micrometers. For example, the fluid delivery vessel 760 can be constructed from a polyurethane film having a thickness ranging from 50 micrometers to 200 micrometers. Optionally, the fluid delivery vessel 760 can be a perimeter welded construction having a predetermined volume. Some embodiments of the fluid delivery vessel 760 can include internal welds between the sections of polyurethane film forming the body of the fluid delivery vessel 760 to reduce expansion of the vessel when pressure is applied. Internal welds can also be incorporated to reduce the internal volume of the fluid delivery vessel 760 or to help direct the drip flow within the fluid delivery vessel 760 to help ensure uniform distribution of fluid out of the fluid delivery vessel 760 into the abdominal cavity.

[0083] As shown in FIGS. 10A-10C , the fluid delivery container 760 can be integrated with the dressing 702 as part of the treatment device 701. In some cases, the dressing 702 and fluid delivery container 760 can essentially form a two-chamber structure, with the two chambers arranged in a vertical stack. As shown in FIGS. 10A-10C , the fluid delivery container 760 can be formed from a container layer 780 that is adhered or welded to the underside of the dressing 702, such as the first liquid-impermeable layer 718. In some embodiments, the fluid delivery container 760 can be fluidly coupled to a delivery connector 763, and thus a drip fluid source, through the dressing 702 via a sealed, welded opening, such as a dressing opening 779, that can penetrate the viscera protective layer, the first liquid-impermeable layer 718, and the second liquid-impermeable layer 720 of the dressing 702.

[0084] The reservoir layer 780 may include perforations, fenestrations, or openings, such as reservoir apertures 781, to allow for the transfer of drip fluid exiting the fluid delivery reservoirs 760. The reservoir apertures 781 may be sized to provide backpressure while the fluid delivery reservoirs 760 are filling by ensuring that the flow rate exiting the fluid delivery reservoirs 760 is less than the fill rate. For example, the reservoir apertures 781 may have diameters in the range of 0.2 mm to 1.0 mm. The reservoir apertures 781 may also have diameters outside of this range, depending on the number and / or pattern of reservoir apertures 781 in the reservoir layer 780. As shown in FIG. 10A, the volume or size of the fluid delivery reservoirs 760 may expand or distend during the drip or fluid delivery phase of the procedure.

[0085] During operation, the drip fluid can enter the fluid delivery vessel 760, and as the fluid delivery vessel 760 fills, it can create backpressure, which thus pressurizes the fluid delivery vessel 760 before the drip fluid can actually be released from the fluid delivery vessel 760. This feature can help ensure that the fluid is more evenly distributed through the vessel aperture 781, thus providing an even distribution of dripped fluid from the entire area of ​​the fluid delivery vessel 760. However, the fluid delivery vessel 760 can be designed such that the level of backpressure created by the fluid delivery vessel 760 remains below a threshold pressure for triggering an alarm in a fluid drip system, such as the fluid source 108 of the treatment system 100. Furthermore, the vessel aperture 781 can be arranged to provide a relatively high flow rate in some locations of the fluid delivery vessel 760 and a relatively low flow rate in other locations, such as by including an asymmetric pattern of the vessel aperture 781. Thus, the pattern of reservoir apertures 781 affects fluid distribution, allowing different versions of fluid delivery reservoir 760 to be manufactured that are designed to target certain areas or organs of the abdominal cavity or other tissue site. Additionally, in some embodiments, reservoir layer 780 of fluid delivery reservoir 760 can incorporate welds or other methods that create a quilting effect within fluid delivery reservoir 760 to reduce the internal volume of fluid delivery reservoir 760, eliminate expansion due to back pressure, or aid in fluid distribution. This feature can therefore help reduce patient discomfort and associated risks.

[0086] A possible delay in releasing the drip fluid from the fluid delivery container 760 into the peritoneal cavity or other tissue site can provide the advantage of allowing the drip fluid's temperature to equilibrate with the body's core temperature, reducing the risk of thermal shock. Upon release from the fluid delivery container 760, the drip fluid flows through the peritoneal cavity and into the paracolic groove, washing through its path. Additionally, some drip fluid may remain in the fluid delivery container 760 following a drip cycle, creating a dwell time for the drip fluid. When negative pressure is applied to the treatment device 701, the drip fluid can be removed through the fluid removal path 750 (shown in FIG. 10B ) and can continue to flush out peritoneal contents as it is removed from the peritoneal cavity. Optionally, any drip fluid remaining in the fluid delivery container 760 can be removed during negative pressure application, as described above, and act as a bolus of clean rinse fluid as it is removed. For example, after the majority of the dripping fluid has been removed from the abdominal cavity and negative pressure has begun to build within the cavity, components of the treatment device 701 can be pulled downward, removing any remaining fluid in the fluid delivery container 760 as a rapidly moving bolus of fluid, thus acting as a final and secondary rinse. The fluid dripping and negative pressure cycle can be repeated as needed and desired.

[0087] Referring now primarily to FIG. 10B , similar to the other embodiments detailed above, treatment device 701 can include multiple fluid removal pathways 750, each of which can be fluidly coupled to a fluid removal hub 754. Fluid removal hub 754 can thus serve as a distribution mechanism for transmitting negative pressure to each of fluid removal pathways 750. Each of fluid removal pathways 750 can include a manifold member that transmits negative pressure and draws fluid through fluid removal pathway 750. For example, manifold member can be constructed from an open-cell foam or nonwoven fabric, such as GRANUFOAM™. Fluid removal pathway 750 can be incorporated within dressing 702, and thus between the visceral protective layer, first liquid-impermeable layer 718, and second liquid-impermeable layer 720. Incorporating fluid removal pathway 750 between the visceral protective layers can help protect the abdominal cavity from the manifold member, which may otherwise present a risk of granulation tissue formation. In some embodiments, the fluid removal pathways 750 can be formed by welding portions of the first liquid-impermeable layer 718 and the second liquid-impermeable layer 720 together to form fluid channels between the film layers. Referring now primarily to FIG. 10C , the first liquid-impermeable layer 718, and possibly also the second liquid-impermeable layer 720, can include fenestrations, such as apertures 766, that can be positioned along each of the fluid removal pathways 750. Fluid can be drawn into the fluid removal pathways 750 through the apertures 766 in the first liquid-impermeable layer 718 on the underside of each of the fluid removal pathways 750. Each of the fluid removal pathways 750 can also include openings at its ends, which can allow for a significant degree of fluid removal from the patient's paracolic sulcus. Providing fluid removal concentrated in a lower portion of the patient's abdomen, such as the paracolic sulcus, can help ensure that the abdomen is thoroughly flushed during the drip and removal therapy cycle.

[0088] 11A and 11B illustrate another example embodiment of a treatment device 701 that may be similar in many respects to the embodiment of treatment device 701 discussed with respect to FIGS. 10A-10C. However, in the exemplary embodiment shown in FIGS. 11A and 11B, the treatment device 701 may incorporate a fluid delivery container 760 that includes a container chamber 782 as well as radial channels 784 that may be for extending down the inside of the abdominal wall into the paracolic groove of the patient's abdomen. This embodiment may, among other things, enable uniform distribution of dripped fluid into the abdominal cavity while simultaneously providing focused irrigation of the paracolic groove with clean dripped fluid. The radial channels 784 may have open ends 785 as well as channel apertures 786 along the length of each of the radial channels 784. In some embodiments, the radial channels 784 may be designed to restrict flow into the paracolic groove. The open-ended design of the radial channels 784 may also allow the radial channels 784 to be cut and sized to fit the needs and proportions of an individual patient.

[0089] 12A and 12B, another exemplary embodiment of a treatment device 701 is shown. Again, many of the features of the treatment device 701 of FIGS. 12A and 12B may be the same or similar to the features of the embodiment of the treatment device 701 discussed with respect to FIGS. 10 and 11. In the example embodiment of FIGS. 12A and 12B, the fluid delivery vessel 760 may incorporate an internal manifold or matrix, such as an internal manifold matrix 788, to help ensure that the fluid drip path from the delivery connector 763, through the fluid delivery vessel 760, and out the vessel aperture 781 remains open and unobstructed or sealed when negative pressure is applied. Example materials for the internal manifold matrix 788 may include a foam such as polyurethane foam, Libeltex TDL2, an embossed film, or some other molded structure.

[0090] 13A and 13B illustrate another example embodiment of a treatment device 801 for use with therapy system 100, which may be similar in many respects to the treatment device embodiments described above. In some embodiments, treatment device 801 may include dressing 702 and a fluid delivery reservoir, such as fluid delivery reservoir 860, which may be separate components that may be provided unattached to the liquid-impermeable layer of dressing 702 for assembly by the user during application. For example, in some embodiments, fluid delivery reservoir 860 may be formed by two layers, such as lower reservoir layer 880 and upper reservoir layer 883. In some embodiments, fluid delivery reservoir 860 may be in the form of a bag or sealed foam. Reservoir layer 880 may include an opening, such as reservoir aperture 881 on the underside or lower side of fluid delivery reservoir 860, for delivery of fluid from fluid delivery reservoir 860 into the patient's abdominal cavity. In some embodiments, the fluid delivery vessel 860 can be fluidly connected to a drip source, such as fluid source 108, through an opening in the upper vessel layer 883, which can be physically and fluidly connected to the end of the delivery connector 763. As with the other embodiments described above, the fluid delivery vessel 860 can expand during the fluid drip cycle of the treatment when fluid is delivered under pressure to the fluid delivery vessel 860 and can fill the fluid delivery vessel 860.

[0091] Importantly, by allowing the fluid delivery container 860 to be provided separately from other portions of the treatment device 801, such as the dressing 702, a surgeon or other caregiver may be able to individually better determine the fluid instillation requirements within the patient's abdomen and apply an appropriately sized or configured fluid delivery container. Some embodiments of fluid delivery containers, such as the fluid delivery container 860, may also be provided as an attachment to existing abdominal dressings, such as ABThera®, available from Kinetic Concepts, Inc. of San Antonio, Texas.

[0092] 14A and 14B refer to an example embodiment of a treatment device 801 that may be similar to the exemplary embodiment of the treatment device 801 shown in FIGS. 13A and 13B. However, in the example embodiment of FIGS. 14A and 14B, the fluid delivery vessel 860 may incorporate an additional component, which may be a collapsible or non-collapsible matrix, such as a manifold matrix 884, that may allow the fluid delivery vessel 860 to be filled with dripping fluid. In some embodiments, the fluid delivery vessel 860 may include a lower layer, i.e., vessel layer 880, that may be occlusive, and an upper layer, such as upper vessel layer 883, that may incorporate perforations, fenestrations, or openings, such as vessel top aperture 885. The vessel top aperture 885 may allow the flow of dripping fluid out of the top surface of the fluid delivery vessel 860, which may occur after the fluid delivery vessel 860 is filled with dripping fluid during a treatment cycle. In some cases, ensuring that the fluid delivery container 860 is completely filled with dripping fluid before the fluid exits the abdominal cavity can eliminate the need to create back pressure within the fluid delivery container 860 to ensure uniform fluid distribution.

[0093] 15 , an illustration of another example embodiment of a treatment device 1001 for use with treatment system 100 is shown. In one embodiment, treatment device 1001 can include a single layer, such as occlusive layer 1002, that divides the abdominal cavity into two vertically stacked chambers or compartments. Treatment device 1001 can also include a fluid removal manifold 1004 that can be positioned within a central portion of occlusive layer 1002, which can fluidly transmit negative pressure to channels in occlusive layer 1002 for collecting and removing fluid from the abdominal cavity. Additionally, treatment device 1001 can include a pressurized dispensing container 1006 that can distribute a drip fluid across occlusive layer 1002 to regions of the abdominal cavity. As described above with respect to other embodiments, conduits 134 that deliver negative pressure and / or drip fluid can be fluidly connected to treatment device 1001 at interface 132.

[0094] In operation, a drip fluid can be delivered by a suitable fluid source, as described above with respect to other embodiments, and once delivered to the pressurized dispensing container 1006 of the treatment device 1001, the drip fluid can be forced across the surface of the occlusive layer 1002. The drip fluid can flow over the occlusive layer 1002 through the formed channels until it reaches the furthest extent of the occlusive layer 1002 and contacts the abdominal contents, ultimately the paracolic groove. As the drip fluid flows across the top surface of the occlusive layer 1002, it can be warmed to body temperature by body heat and spread over a wide area. As described above, a dwell time for the drip fluid occurs, and a portion of the dripped fluid remains in the pressurized dispensing container 1006 above the drip surface of the occlusive layer 1002, which can later act as a bolus of clean fluid when removed.

[0095] During the negative pressure or fluid removal cycle, dripping fluid can be drawn from the body cavity by being drawn along the formed path on the underside or bottom surface of the occlusive layer 1002. When negative pressure is applied, the occlusive layer 1002 can be drawn downward and pressed tightly against the body cavity contents. This movement can bring abdominal cavity contents, such as visceral organs, into contact with the dripping fluid that is drawn along the formed path on the underside of the occlusive layer 1002. As described above with respect to other embodiments, while negative pressure is applied, any remaining fluid in the pressurized dispensing container 1006 can be removed as a rapidly moving bolus of fluid, thus acting as a final rinse.

[0096] Referring now also to FIG. 16 , a schematic cross-sectional view of a portion of the treatment device 1001 and conduit 134 of FIG. 15 is shown. In this exemplary illustration, it can be seen how the occlusion layer 1002 can divide the abdominal cavity into two distinct chambers or compartments. For example, below the occlusion layer 1002 there can be a fluid removal chamber 1008 that is located adjacent to the visceral organs, and above the occlusion layer 1002 there can be a fluid drip chamber 1010 that can be in close proximity to the patient's skin. By dividing the abdominal cavity in this manner, the occlusion layer 1002 can ensure that dripped fluid can reach the furthest extent of the treatment device 1001 within the abdomen before being removed. Importantly, the occlusion layer 1002 can also act as a viscera protective barrier. In some embodiments, the occlusion layer 1002 can be biased to collapse downward and substantially form a seal when negative pressure is applied, which can help minimize cross-contamination between the fluid drip chamber 1010 and the fluid removal chamber 1008.

[0097] 15 and 16 , in some embodiments, the occlusive layer 1002 can be formed from a single piece or sheet of film, such as a polyurethane film. In some embodiments, the occlusive layer 1002 can provide a fluid path both below the occlusive layer 1002 in the fluid removal chamber 1008 and above the occlusive layer 1002 in the fluid drip chamber 1010. For example, the fluid path can be formed by pleats 1012 in the occlusive layer 1002, which can be created using radio frequency welding techniques. For example, radio frequency (HF) or radio frequency (RF) welding can include using high frequency electromagnetic energy to melt material in portions of the occlusive layer 1002 to bond portions of the occlusive layer 1002 together. The pleats 1012 can be positioned to evenly distribute fluid to the distal edge of the occlusive layer 1002. The number of pleats 1012 can be varied to further control the flow of dripping fluid within the abdominal cavity, as needed or desired.

[0098] In some embodiments, the fluid removal manifold 1004 can be a flexible container pneumatically or fluidly connected to the container 110 and the negative pressure source 106 through the removal path of the conduit 134. The fluid removal manifold 1004 can be made from multiple films welded together, which can be polyurethane films welded together at their perimeters. For example, the fluid removal manifold 1004 can include an upper manifold film 1014 and a lower manifold film 1016. As shown in FIG. 16 , in some embodiments, the fluid removal manifold 1004 can include openings or fenestrations that can be included as inlets 1018 as part of the lower manifold film 1016. These inlets 1018 on the underside of the fluid removal manifold 1004 can be for distributing negative pressure to and replenishing fluid from the fluid removal chambers 1008. The inlets 1018 can be sized according to particular aspiration needs. In some embodiments, the fluid removal manifold 1004 can include a manifold material 1019, which can be contained within an upper manifold film 1014 and a lower manifold film 1016. The manifold material 1019 can include a variety of different materials suitable for transmitting or transporting fluids. For example, in some embodiments, the manifold material 1019 can include an open-cell foam having pores about 6 mm in diameter.

[0099] In some embodiments, the pressurized dispensing vessel 1006 can be a flexible vessel in fluid communication with the fluid source 108 through the drip path of the conduit 134. The volume of the pressurized dispensing vessel 1006 can be varied and, in some embodiments, reduced using internal welds, which can also serve to increase local pressure to improve dispensing of the dripping fluid. Suitable materials for forming the structure of the pressurized dispensing vessel 1006 can include sheets of film, such as polyurethane film, that can be welded together at their periphery. For example, the pressurized dispensing vessel 1006 can include an upper vessel film 1020 and a lower vessel film 1022. As shown in FIG. 16 , in some embodiments, the pressurized dispensing vessel 1006 can include an undersized outlet 1024 as part of the lower vessel film 1022 to allow the dripping fluid to exit the pressurized dispensing vessel 1006 when a certain internal pressure within the pressurized dispensing vessel 1006 is reached. For example, the outlets 1024 may be small enough to create back pressure to help drive even distribution of dripping fluid from the pressurized dispensing container 1006, but not so small that the outlets 1024 result in possible occlusion alarms in the treatment system 100. In some embodiments, the outlets 1024 may have a diameter of approximately 0.2 mm to 1 mm. The outlets 1024 may be in the form of perforations or fenestrations. The outlets 1024 may also be arranged in one or more patterns to help influence distribution, allowing different versions of the pressurized dispensing container 1006 to be manufactured with different arrangements of the outlets 1024 designed to target certain areas or organs. For example, in some embodiments, the outlets 1024 may be arranged in a uniformly spaced pattern around the periphery of the pressurized dispensing container 1006.

[0100] 17 shows a schematic cross-sectional view of a portion of another exemplary embodiment of treatment device 2001 and conduit 134. In this exemplary view, it can be seen how multiple layers can be included to create an occlusive layer 2002 and an additional pathway from the distal portion and tip of the paracolic groove of the abdominal cavity to fluid removal manifold 2004. In the case of such a multi-layer occlusive layer, such as occlusive layer 2002, the structure can be made from a film material and formed in three dimensions, such as by heat, vacuum, or compression molding.

[0101] 17, some embodiments of treatment device 2001 can include a manifold, such as a fluid removal manifold 2004, that is coupled with or formed as part of occlusive layer 2002. For example, in some embodiments, fluid removal manifold 2004 can be formed solely from a lower manifold film 2016 that is attached or welded to the underside of occlusive layer 2002, thus eliminating the need for an upper manifold film, such as upper manifold film 1014 of FIG. 16. In some further embodiments, as shown in FIG. 17, fluid removal manifold 2004 can be positioned within multiple layers of multi-layer occlusive layer 2002, such that lower manifold film 2016 with inlet 2018 can actually be formed as part of a lower layer of multi-layer occlusive layer 2002. In such embodiments, fluid removal paths can exist between the various layers of the multi-layer occlusive layer 2002 through the perimeter inlets 2026 of the fluid removal manifold 2004, and underneath the multi-layer occlusive layer 2002 through the inlets 2018 and beneath the fluid removal manifold 2004. The fluid removal manifold 2004 can include a manifold material 2019 capable of transmitting negative pressure and fluid, and can include materials such as three-dimensional formed films, wicking materials, and molded manifolds.

[0102] In some embodiments, the pressurized dispensing vessel 2006 can be bonded to or formed as part of the closure layer 2002. For example, in some embodiments, the pressurized dispensing vessel 2006 can be formed solely from an upper container film 2020 that is attached or welded to the top surface of the closure layer 2002, thus eliminating the need for a lower container film, such as the lower container film 1022 in FIG. 16 . In some embodiments, the upper container film 2020 can be molded with the closure layer 2002 as a unitary structure, instead of being molded and joined from many flexible pieces. Optionally, the upper container film 2020 and the closure layer 2002 can be quilted to ensure an open path from the pressurized dispensing vessel 2006. For example, portions of the upper container film 2020 and the closure layer 2002 can be welded together, such as a weld perimeter around portions of the upper container film 2020 and the closure layer 2002. Additionally, portions of the upper container film 2020 and the closure layer 2002 can be spot welded in a pattern across both layers of material to create a quilted effect. As a result, in some embodiments, the height and volume of the pressurized dispensing vessel 2006 can be limited when filled with fluid. A variety of materials can be used to form the pressurized dispensing vessel 2006, including, but not limited to, small inner diameter tubing. In some example embodiments, the flow distribution of dripping fluid can be controlled by peripheral outlets 2024, which can be positioned on the periphery of the pressurized dispensing vessel 2006. As with other embodiments, such peripheral outlets 2024 can be created by techniques such as radio frequency welding. While the exemplary embodiment of FIG. 17 shows modified versions of the closure layer 2002, fluid removal manifold 2004, and pressurized dispensing vessel 2006, any combination of these features can be incorporated into a single embodiment.

[0103] 18A-18C show further details relating to features according to some exemplary embodiments of an occlusive layer, such as occlusive layer 1002 of FIG. 15. For example, as shown in FIG. 18A, the occlusive layer may be formed from a single base layer 3030 that is formed with a plurality of accordion pleats 3012, which may be equivalent to the pleats 1012 of occlusive layer 1002 of FIG. 15. The accordion pleats 3012 may form both fluid removal pathways 3032 that may be included below the lower surface of base layer 3030, and delivery pathways 3034 that may extend along the upper surface of base layer 3030 to form the accordion pleats 3012.

[0104] 18B shows another exemplary embodiment of the occlusive layer 4002 in which the fluid pathways are formed by tubular pleats 4012, instead of the fluid pathways formed by accordion pleats 3012 as shown in FIG. 18A . In such an embodiment, the occlusive layer 4002 can be formed from a base layer 4030 with a plurality of tubular pleats 4012 formed on the top surface of the base layer 4030 by a separate capillary layer 4036. Alternatively, the tubular pleats 4012 can be formed from a single base layer 4030 formed of a unitary tubular structure, such as by joining or clamping portions of the base layer 4030 together to form the tubular pleats 4012. In either case, fluid removal pathways 4032 can be provided within the tubular pleats 4012, and fluid delivery pathways 4034 can extend along the top surface of the base layer 4030 between the tubular pleats 4012 that include the fluid removal pathways 4032.

[0105] 18C shows another exemplary embodiment of an occlusive layer 5002 that is similar to the embodiment of the occlusive layer 4002, but includes accordion pleats 5012 for a fluid pathway. Thus, in some embodiments, the occlusive layer 5002 can be formed from a base layer 5030 with a plurality of accordion pleats 5012 formed on an upper surface of the base layer 5030 by a separate pleat layer 5036. The removal pathway 5032 can be contained below the pleat layer 5036 or in the space created between the base layer 5030 and the pleat layer 5036. The fluid delivery pathway 5034 can extend along an upper surface of the pleat layer 5036.

[0106] 19A-19C , additional embodiments of methods for providing negative pressure therapy and fluid drip treatment at a tissue site will be further described. For example, in some embodiments, a treatment system 6000 can include a treatment device 6001, a negative pressure source 6006, and a fluid source 6008 that is a stand-alone device separate from the negative pressure source 6006. The fluid source 6008 can be a separate mechanical dripping device. In some embodiments that include a separate mechanical dripping device for the fluid source 6008, the treatment system 6000 can also include a drip regulator 6019 that monitors and / or controls the amount of drip fluid delivered to the treatment device 6001 and ultimately the tissue site 112. As shown in FIGS. 19A-19C , some disclosed methods can include a treatment cycle including three phases or intervals. For example, as shown in FIG. 19A , a first phase of the treatment cycle can include activating the negative pressure source 6006 to apply negative pressure therapy to the treatment device 6001 and the tissue site 112. The negative pressure applied by the negative pressure source 6006 can be transmitted through fluidly connected pathways in the treatment system 6000 and ultimately reach the drip regulator 6019 and the fluid source 6008. This transmitted negative pressure can thus prime the fluid source 6008, which can be a mechanical drip device. Continuing with FIG. 19B , the method can further include a second phase of the treatment cycle, which can include pausing or terminating negative pressure delivery from the negative pressure source 6006 for a predetermined time interval. During this interval, the fluid source 6008, such as a mechanical drip device, can deliver dripping fluid to the drip regulator 6019 and ultimately to the treatment device 6001. As shown in FIG. 19C , following the specified interval of delivering drip fluid from the fluid source 6008 to the treatment device 6001, a third phase of the treatment cycle can begin. During this third phase, the fluid drip can be paused and the negative pressure source 6006 can be reactivated to provide a further interval of negative pressure therapy. At this point in the treatment cycle, the dripping fluid can be removed from the tissue site 112, such as the abdominal cavity 111, along with the treatment device 6001.Additionally, the fluid source 6008 can be re-primed and again ready to deliver a drip fluid to the treatment device 6001, at which time the second phase of the treatment cycle can be repeated.

[0107] 20A-20C illustrate another example embodiment of a method for providing negative pressure therapy and fluid drip treatment to a tissue site. The method illustrated by FIGS. 20A-20C may include various modifications and be substantially similar to the method described above with respect to FIGS. 19A-19C. For example, as shown in FIG. 20A, a treatment system 6000 may include a treatment device 6001, a negative pressure source 6006, a fluid source 6008, and a drip regulator 6019. Additionally, the treatment system 6000 may further include a pressure release unit 6021. In some embodiments, the negative pressure source 6006 may be activated to apply negative pressure therapy to the treatment device 6001 during a first phase of a treatment cycle. The negative pressure exerted by the negative pressure source 6006 may be transmitted through fluidly connected pathways in the treatment system 6000 and ultimately to the drip regulator 6019 and the fluid source 6008. This transmitted negative pressure may prime the fluid source 6008, which may be a mechanical drip device. Continuing with FIG. 20B , the method can further include a second stage of the treatment cycle, during which the pressure release unit 6021 opens and the delivery of negative pressure to the treatment device 6001 is stopped. In some embodiments, the pressure release unit 6021 can open according to a predetermined or pre-determined timing schedule. During the second stage of the treatment cycle, the fluid source 6008 can deliver a drip fluid to the drip regulator 6019 and ultimately to the treatment device 6001, which can occur while the pressure release unit 6021 is open, thus preventing negative pressure from being transmitted to the treatment device 6001 and the fluid source 6008 and the drip regulator 6019. As shown in FIG. 20C , following the second stage of the treatment cycle, a third stage of the treatment cycle can be initiated, during which the pressure release unit 6021 can close, again according to a timed interval schedule. During the third phase of the treatment cycle, the fluid drip can be paused and the negative pressure source 6006 can be reactivated to provide a further interval of negative pressure therapy.The dripping fluid can be removed from the treatment device 6001 and the fluid source 6008 can be primed and ready to deliver drip fluid to the treatment device 6001 again.

[0108] Some additional methods of providing negative pressure therapy and fluid dripping to a tissue site may incorporate a manually controlled drip container, such as a fluid bag, bottle, or other container, rather than an automated or other form of mechanical drip device. Thus, in some embodiments, during a first phase of a treatment cycle, a negative pressure source may apply negative pressure therapy to the treatment device and tissue site, while a device, such as a clamp, valve, or other form of closure device, may prevent fluid from being transferred from the manually controlled drip container to the treatment device and tissue site. In some embodiments, during a subsequent phase of the treatment cycle, a user may release the clamp or other form of closure device and manually adjust the volume of fluid being dripped. During this dripping phase, the negative pressure source may remain activated, thus providing immediate removal of the dripped fluid from the treatment device and tissue site. Thus, according to some embodiments of the present methods, fluid dwell time at the tissue site may be substantially eliminated. The user may then re-tighten or otherwise close the closure device, thereby stopping the flow of dripping fluid from the manually controlled drip container. The negative pressure source can then continue to remove exudate, along with any excess or remaining dripping fluid, from the treatment device and tissue site. In some other embodiments of the disclosed methods, rather than allowing the negative pressure source to remain active while fluid is dripping from the manual control drip container, the negative pressure source can be paused, thus allowing the drip fluid to remain at the tissue site for a predetermined period of time. If appropriate, the user can close the manual control drip container to prevent the drip fluid from being delivered. Before or following the dripping being stopped, negative pressure therapy can be resumed, during which any excess or remaining fluid can be removed from the treatment device and tissue site.

[0109] The systems, apparatus, and methods described herein can provide significant advantages. As discussed above, the disclosed systems and devices can provide a combined temporary abdominal closure dressing system with an independent matrix of fluid delivery tubes, along with fluid dripping capabilities through negative pressure fluid removal pathways for the removal of contaminating fluids. Thus, the disclosed embodiments can support and protect the abdominal contents, remove contaminating fluids, and inhibit and / or reduce edema while providing a means for irrigating and cleansing the abdominal cavity. Furthermore, the various layers and components of the disclosed dressings can apply tension and closure forces to the abdominal contents, facilitating more rapid primary face closure of the abdominal cavity.

[0110] As described herein, the disclosed solutions can provide a means to irrigate all areas of the abdominal cavity, including small bowel loops, paraperitoneal sulci, the retroperitoneal cavity, portions of the lymphatic system, etc., all while the dressing system is in place, thereby reducing the time required for the patient and clinical staff in the operating room. The various described embodiments provide various fluid pathway configurations designed to maximize exposure of the internal organs of the abdominal tissue site to fluid instillation therapy. The disclosed dressing components can also allow for longer dressing application times without adhering to the fascia of the abdominal tissue site. Therefore, repeatable and reliable fluid instillation can be provided that can be uniformly applied to various portions of the tissue site. As a result, fluid irrigation and cleansing can be more consistent, thereby reducing the mortality rate for patients suffering from septic abdominal cavities. Fluid instillation can be administered at the patient's bedside and can be tailored and adjusted individually.

[0111] The disclosed systems and devices can drain exudates and infectious materials from a tissue site, such as the abdominal cavity, thereby reducing the presence of contaminated abdominal fluids to promote healing. Furthermore, the disclosed solutions can provide separate drip and negative pressure paths to ensure that contaminated or "dirty" fluids are completely removed from the abdomen. Furthermore, in preferred embodiments of the disclosed systems, the drip fluid does not recirculate back to the tissue site. As a result, the clinical benefit of irrigating the tissue site can be increased.

[0112] Importantly, the design of the disclosed devices can also allow for user sizing and / or customization at the time of application to the patient in the operating room. In some embodiments, improved ease of use for dressing placement, sizing, and removal can be provided by incorporated sizing or placement visual marks or indicators to guide the user. Some embodiments of the disclosed dressing systems can also include various components, such as fluid drip and / or fluid removal paths already pre-attached to the structural dressing layer to further streamline and simplify use. This can not only enable improved fluid delivery and removal compared to existing dressing systems, but can also facilitate increased ease of use.

[0113] While shown with a few exemplary embodiments, those skilled in the art will recognize that the systems, devices, and methods described herein are susceptible to various modifications and variations. Furthermore, descriptions of various alternatives using terms such as "or" are not necessarily mutually exclusive unless clearly required by context, and the indefinite article "a" or "an" does not limit subject matter to a single example unless clearly required by context. Furthermore, any feature described in connection with any one embodiment may also be applicable to any other component. Components may be combined or removed in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, the treatment device 101, including the dressing 102, the container 110, or both, may be eliminated or separated from the other components for manufacture or sale.

[0114] The appended claims set forth novel and inventive aspects of the subject matter described above, but may also encompass additional subject matter not specifically described in detail. For example, the claims may omit certain features, elements, or aspects if they are not necessary to identify novel and inventive features because they are already known to those skilled in the art. Features, elements, and aspects described herein may be combined or replaced by alternative features serving the same, equivalent, or similar purpose without departing from the scope of the invention as defined by the appended claims.

Claims

1. 1. A system for treating a tissue site, comprising: a dressing configured to be deployed within the abdominal cavity; a negative pressure source fluidly coupled to the dressing; a fluid source fluidly coupled to the dressing; A system comprising:

2. 10. The system of claim 1, further comprising a container fluidly coupled to the negative pressure source and the dressing and adapted to collect fluid.

3. 10. The system of claim 1, further comprising a connection interface configured to fluidly connect the negative pressure source and the fluid source to the dressing.

4. 10. The system of claim 1, wherein the dressing comprises: a first plurality of fluid channels configured to be in fluid communication with the negative pressure source; a second plurality of fluid channels configured to be in fluid communication with the fluid source; A system comprising:

5. 5. The system of claim 4, wherein the first plurality of fluid channels and the second plurality of fluid channels extend radially from a central portion of the dressing.

6. 10. The system of claim 1, wherein the dressing comprises: a dressing member comprising a first impermeable layer and a second impermeable layer and an enclosed space between said first impermeable layer and said second impermeable layer; a plurality of fluid removal paths formed within the space and configured to be in fluid communication with the negative pressure source; a plurality of fluid delivery paths formed within the space and configured to be in fluid communication with the fluid source; A system comprising:

7. 7. The system of claim 6, wherein the plurality of fluid removal paths and the plurality of fluid delivery paths are formed between portions of the first impermeable layer and portions of the second impermeable layer that are welded together.

8. 7. The system of claim 6, wherein the plurality of fluid removal paths include openings at peripheral edges and perforations along the length of the fluid removal paths.

9. 9. The system of claim 8, wherein the perforations along the length of the fluid removal path are formed by apertures in the first impermeable layer of the dressing member.

10. 7. The system of claim 6, wherein the plurality of fluid delivery paths include openings at peripheral edges.

11. 7. The system of claim 6, wherein the plurality of fluid delivery paths comprises perforations along the length of the fluid delivery paths.

12. 12. The system of claim 11, wherein the perforations along the length of the fluid delivery pathway are formed by apertures in the first impermeable layer of the dressing member.

13. 10. The system of claim 1, wherein the fluid source comprises a manual fluid pump.

14. 10. The system of claim 1, wherein the fluid source comprises a gravity-fed fluid container.

15. 10. The system of claim 1, wherein the negative pressure source and the fluid source are contained as part of a treatment unit.

16. 1. A dressing for treating a tissue site, comprising: a dressing member comprising a first protective layer and a second protective layer, at least a portion of each of the first protective layer and the second protective layer being joined to provide a sealed chamber between the first protective layer and the second protective layer; a plurality of fluid removal paths formed within the chamber sealed by the first protective layer and the second protective layer; a drop matrix sealed within the chamber; A dressing comprising:

17. 17. The dressing of claim 16, wherein each of the plurality of fluid removal paths comprises a manifold member.

18. 18. The dressing of claim 17, wherein the manifold member comprises open-cell reticulated polyurethane foam.

19. 19. A dressing according to claim 18, wherein the open-cell reticulated polyurethane foam has a thickness of between 5 mm and 15 mm.

20. 17. The dressing of claim 16, further comprising a hub positioned in a central region of the dressing element and in fluid communication with the drip matrix.

21. 17. The dressing of claim 16, wherein the drip matrix comprises a plurality of fluid delivery tubes.

22. 21. The dressing of claim 20, the drip matrix comprising a plurality of fluid delivery tubes; The hub includes a plurality of openings sized and configured to control fluid flow into the plurality of fluid delivery tubes. A dressing characterized by:

23. 17. The dressing of claim 16, wherein the size of the dressing can be reduced by removing a portion of the periphery of the dressing.

24. 17. The dressing of claim 16, wherein the drip matrix comprises a plurality of fluid delivery tubes comprising silicone.

25. 17. The dressing of claim 16, wherein the drip matrix comprises PVC tubing.

26. 17. The dressing of claim 16, wherein the drip matrix comprises a tube having an inner diameter of about 1 mm to 2 mm.

27. 21. The dressing of claim 20, wherein the hub comprises medical grade silicone.

28. 21. The dressing of claim 20, wherein the hub comprises medical grade PVC.

29. 23. The dressing of claim 22, wherein the plurality of fluid delivery tubes are connected to the plurality of openings in the hub by a medical grade adhesive.

30. 23. The dressing of claim 22, wherein the plurality of fluid delivery tubes are connected to the plurality of openings in the hub by cyclohexanol.

31. 17. The dressing of claim 16, wherein the first protective layer and the second protective layer are ultrasonically welded together.

32. 1. A dressing for treating a tissue site, comprising: a first impermeable layer; and a second impermeable layer positioned adjacent to and substantially coextensive with said first impermeable layer; a plurality of fluid removal paths positioned between the first impermeable layer and the second impermeable layer; a plurality of fluid delivery channels positioned between the first impermeable layer and the second impermeable layer; A dressing comprising:

33. 33. The dressing of claim 32, wherein the plurality of fluid removal paths are oriented to extend radially outward from a central location between the first and second impermeable layers.

34. 33. The dressing of claim 32, wherein each of the plurality of fluid delivery channels is positioned alongside one of the plurality of fluid removal paths and extends substantially parallel to one of the plurality of fluid removal paths.

35. 33. The dressing of claim 32, wherein the first impermeable layer is welded to the second impermeable layer.

36. 33. The dressing of claim 32, wherein the first impermeable layer and the second impermeable layer are attached by an ultrasonic weld.

37. 37. The dressing of claim 36, wherein the ultrasonic welds are positioned to substantially define the plurality of fluid removal paths and the plurality of fluid delivery channels in a space between the first impermeable layer and the second impermeable layer.

38. 37. The dressing of claim 36, wherein the first impermeable layer further comprises perforations along the plurality of fluid removal paths.

39. 37. The dressing of claim 36, wherein the first impermeable layer further comprises perforations aligned with the plurality of fluid delivery channels.

40. 33. The dressing of claim 32, further comprising a plurality of fluid delivery tubes, each of said plurality of fluid delivery tubes positioned within one of said plurality of fluid delivery channels.

41. 33. The dressing of claim 32, wherein the first impermeable layer and the second impermeable layer comprise perforations.

42. 33. The dressing of claim 32, wherein the first impermeable layer and the second impermeable layer each comprise a polyurethane film.

43. 43. The dressing of claim 42, wherein the first impermeable layer and the second impermeable layer each have a thickness of between 25 micrometers and 500 micrometers.

44. 33. The dressing of claim 32, further comprising a fluid hub fluidly connected to each of the plurality of fluid delivery channels and configured to control the distribution of fluid to each of the plurality of fluid delivery channels.

45. 41. The dressing of claim 40, wherein each of the plurality of fluid delivery tubes includes perforations along its length.

46. 41. The dressing of claim 40, wherein each of the plurality of fluid delivery tubes comprises an opening at an end of the first and second impermeable layers furthest from the center.

47. 33. The dressing of claim 32, the plurality of fluid removal paths extend radially outward from a center of the dressing; the plurality of fluid delivery channels extend radially outward from the center of the dressing; A dressing, wherein the plurality of fluid removal paths are positioned in an interleaved arrangement with the plurality of fluid delivery channels.

48. 48. The dressing of claim 47, wherein the plurality of fluid removal paths and the plurality of fluid delivery channels are spaced approximately equally apart angularly.

49. 41. The dressing of claim 40, wherein the plurality of fluid delivery tubes comprises thinner tubes.

50. 41. The dressing of claim 40, wherein each of the plurality of fluid delivery tubes comprises perforations along its length and has a closed end furthest from the center of the first and second impermeable layers.

51. 33. The dressing of claim 32, further comprising a fluid hub fluidly connected to each of the plurality of fluid removal paths and the plurality of fluid delivery channels.

52. 52. The dressing of claim 51, wherein the fluid hub comprises: a first set of one-way valves, each of the first set of one-way valves positioned at a first end of one of the plurality of fluid removal paths; a second set of one-way valves, each of the second set of one-way valves positioned at a first end of one of the plurality of fluid delivery channels; A dressing further comprising:

53. 53. The dressing of claim 52, wherein the first group of one-way valves and the second group of one-way valves comprise duckbill valves.

54. 53. The dressing of claim 52, wherein at least one of the first group of one-way valves and the second group of one-way valves comprises a flap valve.

55. 45. The dressing of claim 44, wherein the fluid hub comprises two sheets of polyurethane film welded together.

56. 33. The dressing of claim 32, wherein the plurality of fluid removal paths are formed from folds in at least one of the first impermeable layer and the second impermeable layer.

57. 33. The dressing of claim 32, wherein the plurality of fluid removal paths comprise embossed channels.

58. 33. The dressing of claim 32, wherein the plurality of fluid removal paths comprises a plurality of fluid removal tubes.

59. 1. A dressing for treating a tissue site, comprising: a dressing member comprising a first impermeable layer and a second impermeable layer; a plurality of fluid removal pathways associated with said dressing member; a fluid dripping matrix adjacent to the first surface of the dressing member, the fluid dripping matrix comprising a plurality of fluid delivery paths; A dressing comprising:

60. 60. The dressing of claim 59, further comprising a central fluid hub having a hub core member comprising open-cell reticulated polyurethane foam.

61. 60. The dressing of claim 59, wherein each of the plurality of fluid delivery pathways comprises a core member adapted to maintain an open passageway in each of the plurality of fluid delivery pathways.

62. 62. A dressing according to claim 61, wherein each of the core members comprises an open cell reticulated polyurethane foam and has a thickness of from 2mm to 10mm and a width of from 5mm to 10mm.

63. 60. The dressing of claim 59, wherein the plurality of fluid removal paths and the plurality of fluid delivery paths are positioned adjacent a first side of the dressing member and adapted to be independently movable.

64. 64. The dressing of claim 63, wherein each of the fluid removal pathways is coupled to one of the plurality of fluid delivery pathways to form a pathway pair.

65. 60. The dressing of claim 59, wherein each of the fluid removal pathway and the fluid delivery pathway is removably attached to the dressing member.

66. 1. A dressing for treating a tissue site, comprising: a dressing member comprising a first impermeable layer and a second impermeable layer and a space between the first and second impermeable layers; a plurality of fluid removal paths positioned within the space of the dressing element; a fluid dripping matrix associated with the dressing member and comprising a plurality of fluid delivery paths; a central manifold member positioned adjacent a central portion of said dressing member; a drape adapted to form a fluid seal around the dressing member and the central manifold member; A dressing comprising:

67. 67. The dressing of claim 66, wherein the central manifold member comprises foam.

68. 68. The dressing of claim 67, wherein the foam is an open-cell reticulated polyurethane foam.

69. 67. The dressing of claim 66, the fluid dripping matrix is ​​positioned adjacent a first side of the dressing member; The dressing, wherein the central manifold member is positioned adjacent a second side of the dressing member.

70. In a tissue treatment system, a treatment device configured to be deployed within the abdominal cavity and comprising a plurality of fluid removal paths; a fluid dripping matrix associated with the treatment device and comprising a plurality of fluid delivery paths; a manifold member positioned adjacent a central portion of the treatment device; a drape adapted to form a fluid seal around the treatment device, the fluid dripping matrix, and the manifold member; a negative pressure source fluidly connected to the treatment device; a fluid source fluidly connected to the fluid drop matrix; A tissue treatment system comprising:

71. 1. A dressing for treating a tissue site, comprising: A protective layer; a fluid distribution hub configured to exchange fluid with the tissue site; A plurality of treatment tubes, each of the plurality of treatment tubes comprising: a central conduit adapted to deliver fluid from the fluid distribution hub to the tissue site; a peripheral channel adapted to transport fluid to the fluid distribution hub; a plurality of treatment tubes comprising: A dressing comprising:

72. 72. The dressing of claim 71, wherein the peripheral channel comprises a polyurethane film surrounding the outer diameter of the central conduit.

73. 72. The dressing of claim 71, wherein the central conduit comprises a polyurethane film within its inner diameter.

74. 1. A system for treating a tissue site, comprising: a blocking layer; a fluid removal manifold positioned adjacent to the first surface of the occlusive layer; a fluid distribution vessel positioned adjacent the second surface of the closure layer; A system comprising:

75. 75. The system of claim 74, a negative pressure source configured to be fluidly connected to the fluid removal manifold; a fluid source configured to be fluidly connected to the fluid dispensing vessel; The system further comprising:

76. 75. The system of claim 74, further comprising a conduit, the conduit having a first fluid channel in fluid communication with the fluid removal manifold and a second fluid channel in fluid communication with the fluid distribution container.

77. 75. The system of claim 74, a first conduit extending through the fluid distribution vessel and the occlusive layer and in fluid communication with the removal manifold; a second conduit in fluid communication with the fluid dispensing vessel; The system further comprising:

78. 75. The system of claim 74, wherein the occlusive layer comprises a plurality of fluid removal channels formed in the first surface of the occlusive layer.

79. 75. The system of claim 74, wherein the occlusive layer comprises a plurality of fluid delivery pathways formed in the second surface of the occlusive layer.

80. 80. The system of claim 79, wherein the plurality of fluid delivery paths extend radially across the second surface of the occlusive layer.

81. 79. The system of claim 78, wherein the plurality of fluid removal paths extend radially across the first surface of the occlusive layer.

82. 75. The system of claim 74, wherein the fluid dispensing vessel comprises a polyurethane film welded at its periphery to provide an interior volume.

83. 75. The system of claim 74, wherein the fluid dispensing vessel comprises multiple outlets.

84. 84. The system of claim 83, wherein the outlet is positioned on a first surface of the fluid distribution vessel adapted to be positioned adjacent the second surface of the occlusive layer.

85. 84. The system of claim 83, wherein the outlet is sized to generate elevated fluid pressure within the interior volume of the fluid dispensing vessel.

86. 75. The system of claim 74, wherein the fluid distribution vessel comprises a plurality of compartments formed by welds within an interior volume of the fluid distribution vessel.

87. 84. The system of claim 83, wherein the plurality of outlets have a diameter of between about 0.2 mm and 1.0 mm.

88. 86. The system of claim 85, wherein the plurality of outlets are configured to withstand a predetermined outward fluid pressure before opening.

89. 75. The system of claim 74, wherein the occlusive layer comprises a polyurethane film.

90. 75. The system of claim 74, wherein the occlusive layer comprises a plurality of pleats that form a plurality of fluid removal paths on the first surface of the occlusive layer and a plurality of fluid delivery paths on the second surface of the occlusive layer.

91. 75. The system of claim 74, wherein the fluid removal manifold comprises a plurality of welded polyurethane films.

92. 75. The system of claim 74, further comprising a fluid collection reservoir in fluid communication with the fluid removal manifold.

93. 75. The system of claim 74, wherein the fluid removal manifold comprises a first surface having a plurality of fenestrations.

94. 94. The system of claim 93, wherein the plurality of fenestrations vary in size.

95. 75. The system of claim 74, wherein the fluid removal manifold comprises open-cell foam having pores with an average diameter of between 4 mm and 8 mm.

96. 1. A device for treating a tissue site, comprising: a film layer having a first side and a second side; a fluid collection chamber formed by a second film layer welded to the first side of the film layer; a fluid distribution chamber formed by a third film layer welded at its periphery to the second side of the film layer and comprising an interface for fluid connection to a conduit; a conduit extending from the fluid collection chamber through an aperture in the film layer and through the fluid distribution chamber to the interface; A device comprising:

97. 1. A system for treating a tissue site within an abdominal region, comprising: a dressing member comprising a plurality of fluid pathways configured to deliver negative pressure to the tissue site; a fluid delivery container adapted to be positioned adjacent the first surface of the dressing member and having a first side with a plurality of openings for delivering fluid to the tissue site; a drape adapted to be positioned over a second surface of the plurality of fluid pathways; A system comprising:

98. 98. The system of claim 97, further comprising a negative pressure source configured in fluid communication with the plurality of fluid pathways.

99. 98. The system of claim 97, further comprising a fluid source configured to provide treatment fluid to the fluid delivery container.

100. 98. The system of claim 97, wherein the opening has a diameter of between 0.2 mm and 1.5 mm.

101. 98. The system of claim 97, wherein the fluid delivery vessel comprises a body formed from a polyurethane film having a thickness between 25 micrometers and 200 micrometers.

102. 98. The system of claim 97, wherein the fluid delivery container comprises: a first film layer having the plurality of openings; a second film layer positioned adjacent to the first film layer; Equipped with The system, wherein a periphery of the first film layer is welded to a periphery of the second film layer to form an interior volume.

103. 103. The system of claim 102, wherein a portion of the first film layer is welded to a portion of the second film layer to form a fluid pathway network inside the interior volume.

104. 98. The system of claim 97, wherein the fluid delivery container is formed from a first film layer, the periphery of the first film layer being secured to the first side of the dressing member.

105. 98. The system of claim 97, further comprising a fluid channel extending through the dressing member and adapted to fluidly connect the fluid delivery container with a fluid source.

106. 106. The system of claim 105, wherein the fluid channel comprises an opening in the dressing member, the periphery of the opening being defined by a sealed edge of the dressing member.

107. 98. The system of claim 97, wherein the plurality of fluid pathways comprises fenestrations.

108. 98. The system of claim 97, wherein each of the plurality of fluid pathways comprises a manifold member comprising open-cell foam.

109. 109. The system of claim 108, wherein each of the plurality of fluid pathways comprises a manifold member comprising a nonwoven fabric.

110. 98. The system of claim 97, wherein the fluid delivery container comprises: a central chamber; a plurality of radial channels having a first end fluidly connected to the central chamber and a second end having an open portion; A system comprising:

111. 111. The system of claim 110, further comprising an internal manifold adapted to maintain the structure of the central chamber under negative pressure conditions.

112. 112. The system of claim 111, wherein the internal manifold comprises polyurethane foam.

113. 112. The system of claim 111, wherein the internal manifold comprises a film.

114. 112. The system of claim 111, wherein the internal manifold is collapsible.

115. 98. The system of claim 97, wherein the fluid delivery container is formed from a first film layer and a second film layer, and the periphery of the first film layer is sealed to the periphery of the second film layer.

116. 103. The system of claim 102, the first film layer comprises an occlusive film; the second film layer having perforations A system characterized by:

117. 10. A system, apparatus and method substantially as described herein.

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