Multi-layer abdominal closure dressing with a dripping function

Abstract

To provide a treatment system that applies a negative pressure treatment and fluid dripping treatment to a tissue site, particularly, an abdomen tissue site.SOLUTION: According to some embodiments, a treatment system can include a dressing member, a plurality of fluid removal paths, a fluid dripping matrix, a drape, a negative pressure source, and a fluid dripping source. Dripping fluid can be delivered to a tissue site from the fluid dripping source through the fluid dripping matrix, a negative pressure is transmitted, and the fluid can be drawn from the tissue site through the plurality of fluid removal paths.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 451,284, filed on January 27, 2017, entitled "Multi - Layer Abdominal Closure Dressing with Instillation Capabilities", which is hereby incorporated by reference in its entirety.

[0002] The invention described in the appended claims generally relates to tissue treatment systems, and more particularly, but not limited to, abdominal treatment systems using negative pressure and instillation.

Background Art

[0003] Clinical trials and medical practice have shown that by applying reduced pressure in the vicinity of a tissue site, the growth and acceleration of new tissue at the tissue site can be enhanced. Although there are many applications of this phenomenon, it has been found that this phenomenon is particularly advantageous for the treatment of wounds. Appropriate care of a wound, regardless of whether it is caused by trauma, surgery, or another cause, is important for the outcome. Treatment by applying reduced pressure to a wound or other tissue 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 "local negative pressure". Negative pressure therapy can provide many advantages, including the movement of epithelial and subcutaneous tissues, improvement in blood flow, and micro - deformation of tissues at the wound site. Together, these advantages can increase the generation of granulation tissue and shorten the healing time.

[0004] It is also widely accepted that cleaning tissue sites can be very beneficial for the growth of new tissue. For example, a wound can be washed with a flow of a liquid solution, or a cavity can be washed using a liquid solution for therapeutic purposes. These actions are generally referred to as "irrigation" and "lavage", respectively. "Instillation" is generally another action that refers to the process of gradually introducing a fluid to a tissue site and leaving the fluid in place for a predetermined period before removing the fluid. For example, instillation of a topical treatment solution onto a wound bed in combination with negative pressure therapy can further promote wound healing by loosening soluble contaminants in the wound bed and removing infectious substances. As a result, the soluble bacterial load can be reduced, contaminants can be removed, and the wound can be cleaned.

[0005] There can be challenges in distributing and extracting fluid to and from a tissue site that is undergoing negative pressure therapy or fluid instillation. For example, tissue sites can vary in volume, size, shape, orientation, and other factors. Additionally, access to these tissue sites can be restricted. These and other factors can make it difficult to perform the extraction of waste fluid from the tissue site and the distribution of therapeutic fluid to the tissue site uniformly or consistently. Further, due to changes in the direction of fluid flow between the negative pressure therapy cycle and the instilled fluid cycle, waste fluid that is being extracted during the negative pressure therapy cycle can be returned to the tissue site when switching to the fluid instillation cycle.

[0006] Examples of types of tissue sites that can present particular challenges include locations such as the peritoneal cavity, and more generally the abdominal cavity. When the tissue site is related to the abdominal cavity, a treatment system can be particularly beneficial as it can enable improved and efficient care and address complications such as peritonitis, abdominal compartment syndrome, and infections that can prevent ultimate healing. Thus, improvements to treatment systems that can conform to various types of tissue sites and orientations, improve the uniformity of exhaust fluid extraction and therapeutic fluid distribution, and improve efficiency and healing time may be desirable. SUMMARY OF THE INVENTION

[0007] In the following summary and description, and in the appended claims, a novel and useful system, apparatus, and method for irrigating the abdominal cavity in a negative pressure therapy environment are described. Exemplary embodiments are also provided so that those skilled in the art can 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 source of negative pressure fluidly coupled to the dressing, and a source of fluid 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 encapsulated 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 still other embodiments, a dressing for treating a tissue site can include a first impermeable layer, a second impermeable layer positioned in contact with the first impermeable layer and having a spread substantially the same as the first impermeable layer, a plurality of fluid removal paths, and a plurality of fluid delivery channels. The plurality of fluid removal paths and the plurality of fluid delivery channels can be positioned between the first impermeable layer and the second impermeable layer.

[0011] According to yet other embodiments, 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 can be adjacent to a first face of the dressing.

[0012] In further embodiments, a dressing for treating a tissue site can include a plurality of fluid removal pathways, a fluid dripping matrix, a manifold member, and a drape. The dressing can include a space between the first impermeable layer and the second impermeable layer, along with the first impermeable layer and the second impermeable layer. The plurality of fluid removal pathways can be positioned within the space between the first impermeable layer and the second impermeable layer. The fluid dripping matrix can be associated with the dressing and can include a plurality of 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 to be deployed within a body 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 a plurality of fluid removal pathways. The fluid dripping matrix can include a plurality of fluid delivery pathways. The manifold member can be positioned adjacent to 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 other embodiments, 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 the plurality of treatment tubes can include a first conduit adapted to deliver fluid from the fluid distribution hub to the tissue site and a second conduit adapted to transfer fluid to the fluid distribution hub.

[0015] In further embodiments, a system for treating a tissue site can include an occlusion layer, a fluid removal manifold, and a fluid distribution container. The fluid removal manifold can be positioned adjacent to a first surface of the occlusion layer, and the fluid distribution container can be positioned adjacent to a second surface of the occlusion layer.

[0016] In further embodiments, 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 outer periphery to the second side of the film layer and having 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 further embodiments, 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 positioned over a second surface of the plurality of fluid pathways.

[0018] The purpose, advantages, and preferred embodiments of creating and using the subject matter according to the claims can be best understood by referring to the accompanying drawings in conjunction with the following detailed description of the exemplary embodiments.

Brief Description of the Drawings

[0019]

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[0020] The following description of the example embodiments provides information that enables those skilled in the art to make and use the subject matter recited in the appended claims, but some details that are already well known in the art may be omitted. Therefore, the following detailed description should be construed as illustrative rather than limiting.

[0021] In this specification, the example embodiments may be described in relation to the spatial relationships between various elements shown in the accompanying drawings or the spatial orientations of various elements. Generally, such relationships or orientations correspond to a patient in situ to be treated or assume a reference system for such a patient. However, as should be recognized by those skilled in the art, this reference system is not a strict definition but merely a convenient means for explanation.

[0022] Figure 1 is a simplified functional block diagram of an example embodiment of a treatment system 100 that can provide negative pressure therapy along with the dropping of a topical treatment solution according to this specification. The treatment system can be applied to a human patient and can also be used for other types of subjects. The treatment system 100 can include a treatment device 101 that includes a dressing 102 and a treatment unit 104. In some embodiments, the treatment unit 104 can include a negative pressure source such as a negative pressure source 106, a fluid source such as a 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 separate, self - contained 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] The components of the treatment system 100 can be fluidly coupled to each other to provide a path for transferring fluid (i.e., liquid and / or gas) between the components. For example, the components can be fluidly coupled through a fluid conductor such as a tube. As used herein, "tube" broadly includes tubes, pipes, hoses, conduits, or other structures having one or more lumens adapted to convey fluid between two ends. Typically, a tube is an elongated cylindrical structure that is somewhat flexible, but the shape and rigidity can be altered. In some embodiments, the components can also be coupled by physical proximity, integration into a single structure, or formation from the same piece of material. Additionally, some fluid conductors can be molded or otherwise integrally coupled to other components. The coupling can be mechanical, thermal, electrical, or chemical (such as a chemical bond), 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. Generally, the components of the treatment system 100 can be coupled either directly or indirectly.

[0024] The treatment system 100 can include a negative pressure source, such as negative pressure source 106, configured to be coupled to a distribution component, such as a dressing. Generally, the distribution component can refer to any complementary or auxiliary component configured to be fluidly coupled to the negative pressure source in a fluid path between the negative pressure source and the 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, along with the dressing 102, additional tissue interfaces, fluid conduits, and / or covers. 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.R.A.C. (trademark) pad available from KCI of San Antonio, Texas.

[0025] Fluid 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 fluid mechanisms applicable to negative pressure therapy and instillation are generally well known to those of ordinary skill in the art, and the process of reducing pressure may be described herein, by way of example, as "delivering," "distributing," or "generating" negative pressure, for instance.

[0026] Generally, exudates and other fluids flow along a fluid path toward a lower pressure. Thus, the term "downstream" typically means something in the fluid path that is relatively close to a negative pressure source or farther from a positive pressure source. Conversely, the term "upstream" means something that is farther from a negative pressure source or closer to a positive pressure source. Similarly, it may be convenient to describe some features with respect to a fluid "inlet" or "outlet" in such a reference system. This orientation is generally assumed for the purpose of describing various features and components herein. However, in some applications, it is also possible to reverse the fluid path (such as by using a positive pressure source instead of a negative pressure source), and this descriptive convention should not be construed as a limiting convention.

[0027] "Negative pressure" generally refers to a pressure lower than a local ambient pressure, such as the ambient pressure in the local environment external to the sealed treatment environment provided by the treatment device 101. In many cases, the local ambient pressure can also be the atmospheric pressure at the tissue site. Alternatively, the pressure can be less than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise indicated, the pressure values described 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. The amount and nature of the negative pressure applied to the tissue site can be varied according to treatment requirements, but the pressure is generally a low vacuum (generally 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] The negative pressure supply unit, such as the negative pressure source 106 of the treatment unit 104, can be a reservoir of air at negative pressure or, for example, a manual or electric device that can reduce 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 unit can be housed within or used with other components, such as sensors, processing units, alarm indicators, memories, 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 easily couple and decouple the negative pressure supply unit to one or more distribution components.

[0029] The treatment system 100 can also include a drip solution source. For example, the fluid source 108 can be fluidly coupled to the treatment device 101 and thus the dressing 102, as shown in the embodiment of FIG. 1. The fluid source 108 can be fluidly coupled to a positive pressure source or, in some embodiments, to the negative pressure source 106 in some embodiments. 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 the fluid source 108, can be housed within or used with other components to facilitate the movement of fluid. The fluid source 108 can be a fluid pump, such as a peristaltic pump. Alternatively, in some embodiments, the fluid source 108 can be a fluid reservoir that can store and deliver fluid. In any embodiment, examples of the fluid source 108, such as a fluid pump or a fluid reservoir, can include containers such as canisters, pouches, or other storage components.

[0031] The fluid source 108 can also represent a container, canister, pouch, bag, or other storage component that can provide a solution for drip therapy. The composition of the solution can be changed according to the indicated therapy, but 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, can be a microprocessor or computer programmed to operate one or more components of the treatment system 100, such as the negative pressure source 106 and the fluid source 108. In some embodiments, for example, the controller 109 can be a microcontroller that generally includes a processor core and memory on an integrated circuit programmed to directly or indirectly control one or more operating parameters of the treatment system 100. Examples of operating parameters can include the power applied to the negative pressure source 106, the pressure generated by the negative pressure source 106, or the pressure distributed to the treatment device 101. Further examples of operating parameters can include the power applied to the fluid source 108, the flow rate of the drip fluid provided by the fluid source 108, or the volume of fluid distributed to the treatment device 101. The controller 109 is also preferably configured to receive one or more input signals, such as a feedback signal, and is programmed to change one or more operating parameters based on the input signals.

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

[0034] In this context, the term "tissue site" broadly refers to wounds, defects, or other treatment targets located on or within tissues, including but not limited to bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. Examples of wounds include chronic, acute, traumatic, subacute, and dehisced wounds, dermal burns, ulcers (such as diabetic ulcers, pressure ulcers, or venous stasis ulcers), flaps, and grafts. The term "tissue site" may also refer to any area of tissue that is not necessarily wounded or defective, but rather an area where it may be desirable to add additional tissue or promote its growth. For example, negative pressure can be applied to a tissue site to grow additional tissue that can be harvested and transplanted.

[0035] In some embodiments, the negative pressure source 106, fluid source 108, controller 109, and container 110 can be incorporated within a single treatment unit, such as treatment unit 104. Thus, for example, treatment system 100 can include treatment device 101 along with a treatment unit 104 such as a V.A.C. ULTA™ treatment unit, a V.A.C. INSTILL™ wound treatment system, an INOV.A.C.™ treatment unit, or other suitable treatment unit. For example, in some embodiments, treatment unit 104 can include a V.A.C. ULTA™ unit that can include, or can consist essentially of, software modules specific to negative pressure therapy in combination with fluid instillation therapy, and software modules specific to use with an abdominal dressing system, such as an embodiment of treatment device 101. Alternatively, any mechanical fluid instillation device, or any other device capable of providing intermittent negative pressure therapy, in combination with a manual fluid instillation source such as a gravity-fed fluid container, a manual fluid pump, or a monitored intravenous injection bag or bottle, can be suitable.

[0036] Reference will now be made primarily to FIG. 2 to present an exemplary embodiment of a treatment device 101 for treating the peritoneal cavity 111. The treatment device 101 can be for treating a tissue site 112. In this exemplary embodiment, the tissue site 112 can include tissue within a body cavity, particularly the peritoneal cavity 111. The tissue site 112 can include peritoneal contents 113 or tissue adjacent to the peritoneal cavity 111. Treatments of the tissue site 112 can include removal of fluid, such as ascites, peritoneal protection, or negative pressure therapy.

[0037] The exemplary systems and devices herein can enable perfusion and lavage of a peritoneal cavity, such as peritoneal cavity 111, by a controlled and regulated introduction of fluid. In some instances, it may be necessary to wash or irrigate a contaminated peritoneal cavity as a result of a colonic perforation or sepsis. The treatment system 100 can provide means for dripping fluid into the open abdomen to wash peritoneal contents, including areas of reach such as small bowel loops, pancreas, etc. Further, the treatment device 101 and treatment system 100 can provide a temporary closure of the open abdomen while removing fluid and reducing edema. Thus, the treatment system 100 can provide the possibility of performing lavage of a tissue site, such as peritoneal cavity 111, without the need to repeatedly remove one or more dressings applied to the patient's tissue site or bring the patient to the operating room for manual fluid introduction procedures. Thus, the treatment system 100 can have the function of providing a controlled and regulated full abdominal wash and, if necessary, a targeted wash for some areas within the abdomen. The disclosed embodiments can also provide support and maintenance of the fascial region of a peritoneal cavity, such as peritoneal cavity 111, and provide overall protection for peritoneal contents.

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

[0039] The dressing 102 can form a plurality of liquid-impermeable layers, for example, a first liquid-impermeable layer 118 and a second liquid-impermeable layer 120. Openings 122 and 124 are respectively formed in the plurality of liquid-impermeable layers, for example, the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120. "Liquid-impermeable" with respect to the "liquid-impermeable layer" means that the layer is formed of a liquid-impermeable material. Thus, although the layer is formed of a liquid-impermeable material, if it has openings, it can be liquid-permeable, but nevertheless, it is called a liquid-impermeable layer. The openings 122 and 124 can take many shapes or combinations of shapes, including, for example, circular apertures, rectangular openings or polygons. The openings 122 and 124 are presented as slits or linear cuts in this exemplary embodiment. In some embodiments, the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120 can be sealed and joined to each other in any suitable manner, without limitation, by welding, bonding, adhesives, cement or other joining devices, etc. 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 the abdominal cavity contents 113. In the exemplary embodiment of FIG. 2, a chamber 125 is formed between at least two of the plurality of liquid-impermeable layers, for example, 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 include a non-adhesive 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 can include a breathable polyurethane film. In some embodiments, the chamber 125 formed between the liquid-impermeable layers 118 and 120 can include a drip matrix 152 that delivers dripping fluid to the tissue site 112, together 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, the treatment system 100 can further include a sealing member 128 that provides a fluid seal over the peritoneal cavity 111. Additionally, one or more skin closure devices can be placed over the patient's epidermis 130. In some embodiments, the treatment system 100 can also include an interface 132 that fluidly connects the dressing 102 and other portions of the treatment device 101 to the conduit 134. The interface 132 can include a connector 136. Alternatively, the interface 132 can be partially or fully embedded within a portion of the dressing 102 or configured in any other manner possible to fluidly connect the treatment device 101 to a treatment unit such as the treatment unit 104 of FIG. 1. The conduit 134 can be fluidly coupled to the negative pressure source 106 and / or the fluid source 108 of the treatment unit 104 to respectively provide negative pressure and / or treatment fluid to the treatment device 101. In some embodiments, the conduit 134 can include two substantially parallel and fluidly isolated conduits, one of which is for fluidly coupling the treatment device 101 to the negative pressure source 106 and the other of which is for fluidly coupling the treatment device 101 to the fluid source 108. Thus, in some embodiments, the conduit 134 can be a multi-lumen conduit having both a negative pressure lumen 135 and a fluid supply lumen 137. In some other exemplary embodiments, the 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 protection from bacterial barriers and physical trauma. The sealing member 128 can also be composed of a material that can reduce losses due to evaporation 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 appropriate seal to maintain negative pressure at the tissue site against a given negative pressure source. The sealing member 128 can have a high water vapor transmission rate (MVTR) in some applications. For example, in some embodiments, the MVTR can be at least 300 g / m 2 / 24 hours. In some example embodiments, the sealing member 128 can be a polymeric 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. In the case of a permeable material, the transmission rate generally must be low enough to be able to maintain the desired negative pressure.

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

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

[0044] Referring mainly to FIG. 3 here, the treatment device 101 can be adapted to provide negative pressure from the negative pressure source 106 of the treatment unit 104 to tissue sites such as the tissue site 112 of the abdominal cavity 111 in FIG. 2, and collect and transfer the fluid extracted from the tissue site 112. Further, the treatment device 101 can also be adapted to deliver a fluid such as a treatment fluid or a drug from the fluid source 108 of the treatment unit 104 to the tissue site 112. As discussed with respect to FIG. 2, in some embodiments, the dressing 102 of the treatment device 101 can include a plurality of liquid-impermeable layers or visceral protection layers that protect the abdominal cavity contents 113 beneath 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, and each of the liquid-impermeable layers has a dimension of 20 to 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 can include openings 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 a plurality of fluid removal paths 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 transmits negative pressure from the interface 132 and the negative pressure source 106 to each of the fluid removal paths 150. The fluid removal paths 150 can take many different shapes or be formed from a variety of materials. For example, in some embodiments, the fluid removal paths 150 can be formed from portions of a first liquid-impermeable layer 118 and a second liquid-impermeable layer 120 that are welded together to form channels. Alternatively or additionally, the fluid removal paths 150 can include or consist essentially of folds or pleats in either or both of the liquid-impermeable layers 118 and 120. Other examples of embodiments of the fluid removal paths 150 can include channels formed by extruded materials, channels embossed on the liquid-impermeable layers 118 and 120, or separate tube materials that form individual tubes for use as the fluid removal paths 150. Multi-lumen tubes can also be used for the fluid removal paths 150. In various embodiments, as appropriate, each of the different forms and configurations of the fluid removal paths 150 can also be applied to the fluid delivery tubes of the drip matrix 152.

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

[0047] The manifold member 156 can generally include any substance or structure provided to assist in applying a 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 a plurality of flow channels or pathways for distributing the fluid provided to and removed around the manifold member 156. For example, the manifold member material can be adapted to receive a negative pressure from a negative pressure source and distribute the negative pressure across the tissue site through a plurality of apertures, which can have the effect of collecting fluid from across the tissue site and drawing the fluid towards the fluid source. In some embodiments, the fluid pathways can be reversed or secondary fluid pathways can be provided to facilitate delivering fluid across the tissue site.

[0048] In some exemplary embodiments, the paths of the manifold can be interconnected to improve the distribution or collection of fluid across the tissue site. In some exemplary embodiments, the manifold can be a porous foam material having interconnected air bubbles or pores. For example, cellular foams, open-cell foams, reticulated foams, porous tissue aggregates, 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 can also include or be cured to include apertures and fluid paths. In some embodiments, the manifold can further or alternatively include protrusions that form interconnected fluid paths. For example, the manifold can be shaped to provide surface protrusions that define interconnected fluid paths.

[0049] In some embodiments, the manifold member 156 includes a porous foam and includes a plurality of interconnected air bubbles or pores that act as flow paths. The average pore size of the foam can be varied according to the requirements of the indicated therapy. For example, in some embodiments, the manifold member 156 can be a foam having a pore size in the range of 400 - 600 microns. The tensile strength of the manifold member 156 can also be varied according to the requirements of the indicated therapy. For example, the tensile strength of the foam can be increased for the dripping of a topical treatment solution. In some embodiments, the manifold member 156 can include a polyurethane foam that can be 6 mm - 10 mm thick. In one non-limiting example, the manifold member 156 can be an open-cell, reticulated polyurethane foam such as the GRANUFOAM™ dressing or the V.A.C. VERAFLO™ dressing, both available from Kinetic Concepts, Inc., in San Antonio, Texas. Some embodiments can include the manifold member 156 having additional layers or materials such as absorbent materials, wicking materials, hydrophobic materials, and hydrophilic materials.

[0050] The droplet matrix 152 can include a plurality of fluid delivery tubes 158 and a distribution hub 160. The components of the droplet matrix 152 can be composed of a variety of different materials. For example, some or all of the components of the droplet matrix 152 can be composed of a soft medical grade silicone or PVC tubing material. The plurality of fluid delivery tubes 158 can be sized based on the particular size and use of the treatment device 101 and the condition of the tissue site 112 to which the treatment device 101 is to be applied. For example, each of the fluid delivery tubes 158 can have an inner diameter of 0.5 mm to 4 mm. In some embodiments, each of the fluid delivery tubes 158 can have an inner diameter of 1 mm to 2 mm. The somewhat smaller size of the fluid delivery tubes 158 can contribute to avoiding discomfort to the patient during treatment and facilitating removal of the treatment device 101 following completion of the treatment.

[0051] As shown in FIG. 3, but also referring again to FIG. 2, in some embodiments, the droplet matrix 152 can be substantially encapsulated within a plurality of layers of the dressing 102. For example, the fluid delivery tubes 158, along with the fluid removal path 150, can be positioned within a chamber 125 formed by a first liquid-impermeable layer 118 and a second liquid-impermeable layer 120. Optionally, during manufacture, the droplet matrix 152, along with the fluid removal path 150, can be inserted into the chamber 125 between the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120, for example, before the liquid-impermeable layers 118 and 120 are attached to each other by ultrasonic welding. By welding the liquid-impermeable layers 118 and 120 together along the boundaries of the fluid removal path 150 and the fluid delivery tubes 158, as indicated by the weld line 162, each of the fluid removal path 150 and the fluid delivery tubes 158 can be secured in place between the liquid-impermeable layers 118 and 120.

[0052] Here, mainly referring to FIGS. 4A and 4B, additional features that can be associated with some exemplary embodiments of the treatment device 101 of FIG. 3 are shown. For example, as shown in FIG. 4A, each fluid removal path 150 can include openings or apertures, such as removal path apertures 166, along the length of the fluid removal path 150, together with an open end 164. Thus, in such embodiments, the fluid removal path 150 can transmit negative pressure and draw in fluid through both ends and along the length of the fluid removal path 150. On the other hand, in this exemplary embodiment, the fluid delivery tube 158 can have only an open end, such as a delivery end 168, and in other ways, can be fluidly isolated from the surroundings along the length of the fluid delivery tube 158. In some embodiments, the treatment device 101 can be provided in a single size, and its size can be reduced by cutting and removing a portion of the treatment device 101, and thus, in some cases, there is an option to shorten the length of the fluid delivery tube 158 as needed for each individual patient. Thus, with the openings of the fluid delivery tube 158 being only at the ends of the individual tubes, the entire fluid delivery tube 158 and the drip matrix 152 do not rely on the set length of the fluid delivery tube 158 or the number or size of the perforations of the fluid delivery tube 158 to uniformly distribute the dripping fluid, and thus a higher level of customization can be achieved.

[0053] FIG. 5 shows additional features that may be associated with some embodiments of the treatment device 101 of FIG. 3. The components and features of the treatment device 101 as an example in FIG. 5 are mostly the same as or similar to some of the embodiments of the treatment device 101 shown in FIG. 4, 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 the delivery end 168 of FIG. 4 to deliver the dripping fluid to the tissue site, the fluid delivery tube 158 can instead have a closed end such as the delivery tube closed end 170. Alternatively, each of the fluid delivery tubes 158 can include an opening or perforation such as the delivery tube perforation 172 along its length. However, the embodiments shown in FIGS. 4 and 5 are for illustrative purposes only, and it is also contemplated that the fluid delivery tubes 158 can include perforations along their lengths with both open ends.

[0054] The dripping matrix 152 can be adapted to deliver fluid substantially uniformly across the tissue site 112. For example, each of the fluid delivery tube 158, the delivery end 168, and the delivery tube perforation 172 can be adapted to provide substantially the same backpressure. Such a configuration can prevent the fluid from moving more freely through one of the fluid delivery tubes 158 compared to another one of the fluid delivery tubes 158 or otherwise preferring it. As used herein, backpressure can refer to an increase in local pressure caused by resistance to fluid flow, such as through a narrow space of a lumen or aperture. Backpressure can result from, without limitation, the geometric configuration and material properties of the narrow space, such as the size of the space, the presence and shape of bends or junctions 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 the delivery tube perforation 172, are sized to provide substantially uniform distribution of the fluid through the abdomen, fluid hubs such as the distribution hub 160 can be dispensed with.

[0055] Fluids tend to follow the path of least resistance, and thus, insufficient 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, insufficient fluid distribution can result from one of the fluid delivery apertures, such as the delivery end 168 or the delivery tube aperture 172, having a lower backpressure or resistance to fluid flow than another of the fluid delivery apertures. For example, the size and configuration of the fluid delivery tubes 158, and the consistency of the number and size of the delivery ends 168 and the delivery tube apertures 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 the delivery tube apertures 172, can be substantially equal in number and size in each of the fluid delivery tubes 158. Additionally, 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 from about 2 millimeters to about 6 millimeters. Further, in some embodiments, the fluid delivery tube 158 can have an inner diameter of about 4 millimeters. In some other embodiments, the fluid delivery tube 158 can have an alternative tube outer shape, where a thinner, i.e., “flatter,” tube outer shape can be used to improve user comfort when the treatment device 101 is in place at the tissue site 112. Delivery apertures, such as the delivery end 168 and the delivery tube perforation 172, can have a diameter of from about 0.1 millimeter to about 0.8 millimeter in some embodiments. By making 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 perforation 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 can be substantially low or substantially static as compared to the high fluid flow rate through the delivery apertures such as the delivery end 168 and the delivery tube perforation 172.

[0057] Although not shown in the accompanying figures, in some embodiments, the drip matrix 152 can include an arrangement of fluid delivery tubes 158 arranged in a lattice or “spider web” form. Thus, optionally, the drip matrix 152 can include additional tube segments that fluidly connect each of the radially extending fluid delivery tubes 158, along with a plurality of fluid delivery tubes 158 that extend radially from a central hub. The perforations can be present along any or all portions of the connecting tube segments, along with the radially extending fluid delivery tubes 158.

[0058] FIG. 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 a first liquid-impermeable layer 118 and a second liquid-impermeable layer 120 and can be positioned to be in fluid communication with a fluid delivery path 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 outwardly 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 the 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 a plurality of openings such as distribution ports 261 positioned around its lower surface. In some embodiments, these distribution ports 261 can be for fluidly coupling to the 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 settings or design parameters. For example, some examples of the fluid source 108 may each require an opening of a predetermined size 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 dripping path.

[0059] As shown in FIG. 6A, the dispensing hub 160 can include materials useful for dispensing a dripping fluid, such as a dispensing member 176. The dispensing member 176 can include a porous or fluid-permeable material, such as a foam for example. Further, the dispensing hub 160 can generally be elongate and cylindrical or bell-shaped in shape, although other shapes can also be had. In other embodiments, the dispensing hub 160 can comprise a fixture such as a tube, a tubular fitting, a pipe, a latching connection or a similar structure. In such embodiments, the fixture 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 dispensing hub 160 can likewise be cast or injection molded from a soft medical grade silicone or PVC material. In some other embodiments, the dispensing hub 160 can be manufactured from two sheets of polyurethane film that are welded together. In some further embodiments, the dispensing hub 160 can actually serve as a combined fluid dripping and fluid removal hub, in which case the dispensing hub 160 can be fluidly connected to both the fluid delivery conduit and the fluid removal conduit of the treatment device 101. In the case of such a combined fluid dripping and fluid removal hub, the dispensing hub 160 can include a series of one-way valves. Such one-way valves can be of any form of one-way valve, such as a commercially available duckbill valve or a custom flap valve. These one-way valves can be disposed at the openings of the dispensing hub 160, such as the dispensing port 261, to the fluid delivery tube 158 and to a fluid removal path, such as the fluid removal path 150. In some embodiments of the combined hub, a common dispensing material can be included as part of the hub while still allowing fluid communication with separate fluid delivery tubes 158 and fluid removal paths 150.

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

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

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

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

[0065] In other embodiments (not shown), interface 132 can 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, the negative pressure lumen 135 can be fluidically coupled directly to the fluid removal hub 154, and the fluid supply lumen 137 can be fluidically coupled directly to the distribution hub 160 without an interface 132.

[0066] In some alternative embodiments, the treatment device 101 can include a fluid hub that functions as both a mechanism for dispensing a dripping fluid through a dispensing pathway and for dispensing a negative pressure through a fluid removal pathway and collecting fluid from the fluid removal pathway. For example, the fluid hub can comprise two layers or chambers separated by a film membrane such as a polyurethane film membrane. The upper layer or chamber can receive a clean dripping fluid and direct it through an open pathway matrix towards a fluid delivery tube. The upper chamber can also include a floor having ridges or pleats to help direct the fluid. In some embodiments, the floor can provide a continuous film layer during the fluid dripping phase of treatment, but when negative pressure is applied, the pleats or flaps of the floor can be pulled upwards to provide small openings through which the fluid can pass upwards from the lower chamber and out of the fluid hub. The upper chamber can also include a porous foam ring across the inner perimeter of the chamber to provide a filter for relatively large contaminants exiting through the fluid dripping pathway. The foam ring can also function as a seal when compressed under applied negative pressure to close the fluid dripping pathway. The lower layer or chamber of the fluid hub can be connected to the fluid removal pathway, and the lower chamber can include a manifold material to ensure that 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, minimizing the likelihood of mixing of the clean dripping fluid and the soiled fluid from the tissue site. In some embodiments, the fluid hub can include one or more valves within the upper chamber, such as an O-ring seal valve, which can block the opening from the upper chamber to the fluid dripping pathway when negative pressure is applied.

[0067] Generally referring to FIGS. 1-6B, in some exemplary embodiments of the operation of the treatment system 100, the treatment device 101 is sized to fit over the tissue site 112 and can be placed on or within the tissue site 112, such as the peritoneal cavity 111. If sizing of the treatment device 101 is required, for example, with the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120 of the treatment device 101, the excess portion of the treatment device 101 can be removed by cutting or tearing it to the desired size through the fluid removal pathway 150 and the fluid delivery tube 158.

[0068] The treatment device 101 can be positioned to contact the peritoneal contents 113, and a portion of the treatment device 101 is pushed into the patient's paracolic gutter. Specifically, the fluid removal pathway 150 can be positioned proximate to the first paracolic gutter 115 and the second paracolic gutter 117. When deployed, the treatment device 101 can cover all exposed viscera and can separate the viscera so as not to contact the walls of the peritoneal cavity 111. The treatment device 101 can be sized and shaped to allow such coverage.

[0069] The treatment device 101 can be covered with a sealing member 128 at the tissue site 112 so as to provide a sealed space for housing the treatment device 101. As described above, the sealing member 128 can be positioned around the tissue site 112 by the attachment device 142 and fluidly sealed. If the aperture of the sealing member 128 has not yet been provided as part of the sealing member 128, it can be cut through the sealing member 128 or otherwise disposed as needed. The negative pressure connection and the fluid supply connection can be made, for example, by the interface 132 or through the direct connection of the negative pressure lumen 135 to the fluid removal assembly 148 and the direct connection of the fluid supply lumen 137 to the drip matrix 152. It is important to note that the dripping fluid can be independently supplied from a fluid source such as the fluid source 108 into the drip matrix 152 through the fluid supply lumen. Thus, in some embodiments, the dripping fluid can be directly supplied to a fluid hub such as the distribution hub 160, and thus the fluid dripping path and the fluid removal path can be controlled as separate elements. Thus, the possibility of contamination of the clean fluid dripping path can be reduced or substantially eliminated, and a more efficient cleaning cycle can be obtained. Depending on how the components of the treatment device 101 are specifically configured, in some embodiments, the fluid can be directly supplied through the fluid dripping tube into the lower part of the abdomen, such as the paracolic gutters, for example, the first paracolic gutter 115 and the second paracolic gutter 117.

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

[0071] When the negative pressure source 106 is activated, the negative pressure lumen 135 of the conduit 134 can distribute the negative pressure to the fluid removal hub 154 and to the fluid removal path 150 of the fluid removal assembly 148. As shown by the draw arrows 169 in FIGS. 4A-5, fluid from the tissue site 112 can be drawn or extracted into the fluid removal path 150 through the open end 164 and the removal path aperture 166. The fluid within the fluid removal path 150 can be transmitted through the fluid removal path 150 into the fluid removal hub 154, where the fluid can be drawn into the negative pressure lumen 135 of the conduit 134 and ultimately into the container 110.

[0072] When the fluid source 108 is activated or when the dripping fluid is being delivered to the treatment device 101 in some other way, the dripping fluid can proceed into the distribution hub 160 of the dripping matrix 152. As shown by the arrow 161, from the distribution hub 160, the dripping fluid can be transmitted to the tissue site 112 through the fluid delivery tube 158 and the delivery end 168 of the fluid delivery tube 158 and / or the delivery tube perforation 172. The configuration of the dripping matrix 152 and the associated back pressure as described above can facilitate the delivery of a substantially uniform dripping fluid to the tissue site 112.

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

[0074] Furthermore, separation of the fluid removal assembly 148 from the drip matrix 152 can facilitate efficient use of the dripping fluid. For example, as described above, the fluid removal hub 154 and the fluid removal path 150 can include a porous, fluid-permeable material such as a 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. Additionally, the 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. In order to provide fluid storage and permeability while negative pressure is applied, the fluid removal assembly 148 may need to have a higher volume of fluid capacity compared to the drip matrix 152, which may be under positive pressure. Fluids dripped or delivered to the tissue site 112 through a 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 have a higher volume. Such a configuration can facilitate the distribution and efficient use of the dripping fluid.

[0075] Continuing generally with FIGS. 1-6B, a method for providing fluid instillation and negative pressure treatment at a tissue site will be further described. In some embodiments, a method for providing fluid instillation and negative pressure treatment at a tissue site can include positioning a treatment device 101 adjacent to the tissue site 112. The treatment device 101 can include a drip matrix 152 and a fluid removal assembly 148 separate from the drip matrix 152. As described above, in some embodiments, the tissue site 112 can be the peritoneal 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 to a paracolic gutter within the peritoneal cavity 111, such as the first paracolic gutter 115 and / or the second paracolic gutter 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 to customize the treatment device to a desired size.

[0076] The method can further include coupling a fluid source 108 in fluid communication with the drip matrix 152 and coupling a negative pressure source 106 in fluid communication with the fluid removal assembly 148. The method can further include supplying instillation fluid from the fluid source 108 to the tissue site 112 through the drip matrix 152. Further, the method can include providing a 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 instillation therapy, the user can remove the treatment device 101 as a substantially intact structure, and thus maintain the ease of use of the treatment device 101.

[0077] Referring now to FIG. 7A, another example embodiment of the treatment device 201 used in the treatment system 100 is shown. In this embodiment, the treatment device 201 can include substantially the same components as the treatment device 101 of FIG. 3, although the arrangement and function of the individual features can be different. For example, the treatment device 201 can include a plurality of fluid removal paths 150, which can be positioned between the plurality of liquid-impermeable layers of the dressing 202 and fluidly connected to the fluid removal hub 154. However, in this example embodiment, the treatment device 201 can include a drip matrix 252 having a plurality of fluid delivery tubes 258 that can be attached to the distribution hub 260, and the fluid delivery tubes 258 can hang loosely below the dressing 202. In this embodiment of the treatment device 201, the user can also position each of the fluid delivery tubes 258 individually within the patient's abdominal cavity. Thus, the user can choose to spread the fluid delivery tubes 258 uniformly through the abdominal cavity to provide a complete and uniform rinse of the abdomen, or alternatively, the user can choose to concentrate the fluid delivery tubes 258 in any particular area of interest to provide a more thorough wash. The treatment device 201 can enable the user to determine this individually. In some embodiments, the plurality of fluid delivery tubes 258 can comprise a perforated polyurethane film or a foam bag. For example, the fluid delivery tubes 258 can be constructed using two layers of polyurethane film having a thickness of about 100 micrometers, with the edges welded together. The fluid delivery tubes 258 can have open ends for targeted fluid delivery. Similarly, in such embodiments, the distribution hub 260 can be constructed from two layers of polyurethane film having a combined thickness of about 100 micrometers, welded together. In some embodiments, a central core, which can be, for example, a continuous bubble network polyurethane foam, can be provided within each of the fluid delivery tubes 258 and the distribution hub 260 to ensure that an open path is maintained and to be adapted to assist the user during handling during placement.The dimensions of the central core material positioned within the fluid delivery tube 258 can be varied. For example, the central core material can range from about 2 mm to 10 mm in thickness × about 5 mm to 15 mm in width. In some embodiments, the central core material can be about 6 mm in thickness × 10 mm in width. The length of the central core material can be varied based on the overall sizing considerations of the treatment device 201. Some embodiments of the treatment device 201 can include a central core material having a width that varies along its length, thereby enabling a breaking point that provides for 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 a 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 that the volume of drip fluid provided during a treatment cycle is more appropriately regulated.

[0078] Figure 7B shows an embodiment of a treatment device 301 similar to the embodiment of Figure 7A, but the treatment device 301 includes both a fluid removal path and a fluid dripping path that can be individually positioned, rather than including a plurality of fluid removal paths positioned between the liquid-impermeable layers of the dressing 202. 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 freely extending below the liquid-impermeable layer of the dressing 302. Further, in some embodiments, the treatment device 301 can also include a dripping matrix 252 having a fluid delivery tube 258 that can similarly extend freely from the underside of the dressing 302. Thus, in such embodiments, the user can select to focus the fluid delivery tube 258 together with the fluid removal path 250 on any area of interest within the patient's abdominal cavity. The user can also select to spread the fluid removal path 250 and the fluid delivery tube 258 uniformly within the patient's abdomen to provide a complete rinse of the abdominal cavity. In such embodiments, the dressing 302 can be provided with the fluid removal path 250 and the fluid delivery tube 258 attached to the liquid-impermeable layer of the dressing 302 or separately for the user to assemble.

[0079] FIG. 7C also shows another embodiment of the treatment device 401, which can include both a plurality of fluid removal pathways 350 and a drip matrix 352 having a fluid delivery tube 358 that is adjacent to or loosely extends beneath the liquid-impermeable layer of the dressing 402, similar to the treatment device 301 of FIG. 7B. However, in some embodiments, as shown in FIG. 7C, each of the fluid removal pathways 350 can be paired with the fluid delivery tube 358 for positioning in the same region within the patient's abdominal cavity. In such embodiments, the fluid removal pathways 350 can be paired with the fluid delivery tubes 358, but two separate fluid pathways are still maintained. Such an arrangement can provide the advantage of being able to later remove the fluid dripped into a location within the abdominal cavity (which can be important if the region of the abdominal cavity is highly contaminated) from the same region and avoid cross-contamination with other regions of the abdominal cavity. Since neither the fluid removal pathways 350 nor the fluid delivery tubes 358 are positioned within the liquid-impermeable layer of the dressing 402, the treatment device 401 may thus require a separate dressing 402 that includes the liquid-impermeable layer, which can be applied to the patient's abdominal cavity after the combined fluid removal pathways 350 and fluid delivery tubes 358 are positioned. Depending on specific manufacturing and user requirements, the dressing 402 can be attached to the fluid removal pathways 350 and the drip matrix 352 or provided separately for the user to assemble.

[0080] Referring now to FIG. 8, another exemplary embodiment of the treatment device 501 is shown. In this embodiment, the fluid removal path 450 and the fluid delivery tube 458 of the drip matrix 452 are formed as part of the dressing 502, and each fluid removal path 450 extends adjacent to and parallel to the fluid delivery tube 458, thus forming parallel paths 590. In some embodiments, the parallel paths 590, each of which can include a fluid removal path 450 and a fluid delivery tube 458, can be connected between segments of the liquid-impermeable layer of the dressing 502 by a perforated joint such as the perforation 592 in the liquid-impermeable layer of the dressing 502. Thus, each parallel path 590 is individually movable by cutting or tearing along the surrounding perforations 592 and can be placed within a predetermined region of the abdominal cavity, such as adjacent to a small bowel loop, paracolic gutter, retroperitoneal space, lymphatic system, etc. Further, some embodiments of the dressing 502 can also include additional perforated joints or perforation lines between each of the fluid removal paths 450 and each of the fluid delivery tubes 458 within the parallel paths 590. Thus, each of the fluid removal paths 450 is also individually movable away from the corresponding paired fluid delivery tube 458 and can be positioned as needed within the abdominal cavity. Regardless of position, each of the fluid removal paths 450 can remain fluidly connected to the fluid removal hub 454, and each of the fluid delivery tubes 458 can remain fluidly connected to the distribution hub 460.

[0081] FIG. 9 shows the features of some example embodiments of a treatment device that can combine a fluid removal path and a fluid dripping path into a single path. For example, a single fluid removal path and a single fluid dripping path can be combined into a single tubular structure such as a coupling tube 694. The coupling 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 coupling 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 dripping path.

[0082] Reference is now made to FIGS. 10A - 10C to illustrate another exemplary embodiment of the treatment device 701 used with the treatment system 100. In some embodiments, the treatment device 701 can include a dressing 702 that can be formed from a plurality of liquid - impermeable layers or visceral protection layers, such as a first liquid - impermeable layer 718 and a second liquid - impermeable layer 720. The treatment device 701 can also include a delivery connector 763 for delivering a dripping fluid to the treatment device 701. The treatment device can also include a fluid removal hub 754 that transmits negative pressure to a portion of the treatment device 701 and removes fluid from the treatment device 701 and the abdominal cavity. As shown in FIG. 10A, the treatment device 701 can further include a fluid delivery container 760 for distributing the dripping fluid. The fluid delivery container 760 can be a flexible container that is fluidly connected to a dripping source, such as the fluid source 108 of the treatment system 100. In some embodiments, the body of the fluid delivery container 760 can be composed of one or more portions of a film material having a thickness in the range of 25 micrometers to 500 micrometers. For example, the fluid delivery container 760 can be composed of a polyurethane film having a thickness in the range of 50 micrometers to 200 micrometers. Optionally, the fluid delivery container 760 can be a peripherally - welded structure having a predetermined volume. Some embodiments of the fluid delivery container 760 can include internal welds between portions of the polyurethane film forming the body of the fluid delivery container 760 so as to reduce the expansion of the container when pressure is applied. The internal welds can also be incorporated to direct the dripping fluid within the fluid delivery container 760 so as to reduce the internal volume of the fluid delivery container 760 or to ensure uniform distribution into the abdominal cavity exiting from the fluid delivery container 760.

[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. Optionally, the dressing 702 and the 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 a 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 dripping fluid source, through an opening in the dressing 702 that is sealed and welded, such as a dressing opening 779, through the visceral protective layer, the first liquid-impermeable layer 718, and the second liquid-impermeable layer 720 of the dressing 702.

[0084] The container layer 780 can include perforations, windows, or openings, such as a container aperture 781, to allow for the transfer of dripping fluid exiting the fluid delivery container 760. The container aperture 781 can be sized to provide backpressure while the fluid delivery container 760 is being filled by ensuring that the flow rate exiting the fluid delivery container 760 is less than the filling flow rate. For example, the container aperture 781 can have a diameter in the range of 0.2 mm to 1.0 mm. The container aperture 781 can also have a diameter outside of this range, depending on the number and / or pattern of container apertures 781 within the container layer 780. As shown in FIG. 10A, the volume or size of the fluid delivery container 760 can expand or inflate during the dripping or fluid delivery phase of the treatment.

[0085] During operation, the dripping fluid can enter the fluid delivery container 760, and when the fluid delivery container 760 is filled, it can generate backpressure. Thus, the backpressure pressurizes the fluid delivery container 760 before the dripping fluid can actually be released from the fluid delivery container 760. This function can help ensure that the fluid is more uniformly dispersed through the container aperture 781 and thus can provide a uniform distribution of the dripping fluid from the entire area of the fluid delivery container 760. However, the fluid delivery container 760 can be designed such that the level of backpressure generated by the fluid delivery container 760 remains below the threshold pressure for triggering an alarm in a fluid dripping system, such as the fluid source 108 of the treatment system 100. Further, the container aperture 781 can be arranged to provide a relatively high flow rate at some locations of the fluid delivery container 760 and a relatively low flow rate at other locations, such as by including an asymmetric pattern of the container aperture 781. Thus, the pattern of the container aperture 781 can influence fluid distribution and can be used to manufacture different versions of the fluid delivery container 760 that are designed to target some regions or organs of the abdominal cavity or other tissue sites. Further, in some embodiments, the container layer 780 of the fluid delivery container 760 can incorporate welds or other means that reduce the internal volume of the fluid delivery container 760, eliminate expansion due to backpressure, or provide a quilting effect within the fluid delivery container 760 to aid in fluid distribution. Thus, this feature can help reduce patient discomfort and associated risks.

[0086] When dripping fluid is released from the fluid delivery container 760 into the abdominal cavity or other tissue site, the possible delay can provide the advantage that the temperature of the dripping fluid equilibrates with the body's core temperature, reducing the risk of thermal shock. When released from the fluid delivery container 760, the dripping fluid flows into the paracolic gutter through the abdominal cavity and is washed through that path. Further, since some dripping fluid may remain in the fluid delivery container 760 following the dripping cycle, there may be a residence time for the dripping fluid. When negative pressure is applied to the treatment device 701, the dripping fluid can be removed through the fluid removal path 750 (shown in FIG. 10B) and can continue to wash out abdominal contents when removed from the abdominal cavity. Optionally, the dripping fluid remaining in the fluid delivery container 760 can be removed while negative pressure is applied, as described above, and can act as a bolus of clean rinse fluid when removed. For example, after most of the dripping fluid has been removed from the abdominal cavity and negative pressure begins to accumulate within the cavity, the components of the treatment device 701 can be pulled downward, and the remaining fluid in the fluid delivery container 760 is removed as a bolus of rapidly moving fluid and can thus act as a final and secondary rinse. The fluid dripping and negative pressure cycles can be repeated as necessary and desired.

[0087] Here, mainly referring to FIG. 10B which is similar to the other embodiments described in detail above, the treatment device 701 can include a plurality of fluid removal paths 750, each of which can be fluidly coupled to a fluid removal hub 754. Thus, the fluid removal hub 754 can serve as a distribution mechanism for transmitting negative pressure to each of the fluid removal paths 750. Each of the fluid removal paths 750 can include a manifold member that transmits negative pressure and draws fluid through the fluid removal path 750. For example, the manifold member can be composed of an open-cell foam or non-woven fabric such as GRANUFOAM (trademark). The fluid removal paths 750 can be incorporated within the dressing 702 and thus between the visceral protection layer, the first liquid-impermeable layer 718, and the second liquid-impermeable layer 720. Incorporating the fluid removal paths 750 between the visceral protection layers can help protect the abdominal cavity from the manifold member which may otherwise present a risk of granulation. In some embodiments, the fluid removal paths 750 can be formed by welding together portions of the first liquid-impermeable layer 718 and the second liquid-impermeable layer 720 to form fluid channels between the film layers. Here mainly referring to FIG. 10C, the first liquid-impermeable layer 718, and perhaps also the second liquid-impermeable layer 720, can also include openings such as apertures 766 that can be positioned along each of the fluid removal paths 750. Fluid can be drawn into the fluid removal paths 750 through the apertures 766 in the first liquid-impermeable layer 718 below each of the fluid removal paths 750. Each of the fluid removal paths 750 can also include an opening at its end, thereby enabling a significant degree of fluid removal from the patient's paracolic gutter. Providing fluid removal concentrated in the lower part of the patient's abdomen, such as the paracolic gutter, can help ensure that the abdomen is thoroughly washed during the drip and removal therapy cycles.

[0088] Figures 11A and 11B illustrate another exemplary embodiment of treatment device 701, which 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, treatment device 701 can incorporate a fluid delivery container 760 that includes a radial channel 784 for extending along the inner side of the abdominal wall and into the paracolic gutter of the patient's abdomen, together with a container chamber 782. This embodiment can enable a uniform distribution of the instilled fluid into the abdominal cavity, while simultaneously providing a concentrated wash of the paracolic gutter with a clean instilled fluid. The radial channel 784 can have a channel aperture 786 along the length of each of the radial channels 784, together with an open end 785. In some embodiments, the radial channels 784 can be designed to restrict flow into the paracolic gutter. The open end design of the radial channels 784 also allows the radial channels 784 to be cut and sized to fit the needs and proportions of individual patients.

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

[0090] Figures 13A and 13B illustrate another exemplary embodiment of treatment device 801 used with treatment system 100, which may be similar in many respects to the embodiments of the treatment devices described above. In some embodiments, treatment device 801 can be a separate component that can be provided without being attached to the liquid-impermeable layer of dressing 702 for assembly by the user during application, and can include a dressing 702 and a fluid delivery container such as fluid delivery container 860. For example, in some embodiments, fluid delivery container 860 can be formed by two layers such as lower container layer 880 and upper container layer 883. In some embodiments, fluid delivery container 860 can be in the form of a bag or a sealed foam. Container layer 880 can include an opening such as lower container aperture 881 on the lower surface of fluid delivery container 860 for delivering fluid from fluid delivery container 860 into the patient's abdominal cavity. In some embodiments, fluid delivery container 860 can be fluidly connected to a drip source such as fluid source 108 through an opening in upper container layer 883 that can be physically and fluidly connected to the end of delivery connector 763. Similar to other embodiments described above, fluid delivery container 860 can expand when fluid can be delivered under pressure into fluid delivery container 860 to fill it during the fluid drip cycle of treatment.

[0091] Importantly, by enabling fluid delivery container 860 to be provided separately from other parts such as dressing 702 of treatment device 801, a surgeon or other caregiver may be able to more appropriately determine the fluid drip requirements within the patient's abdomen individually and apply a fluid delivery container of appropriate size or appropriately configured. It is also possible that some embodiments of fluid delivery containers such as fluid delivery container 860 are provided as accessories for current abdominal dressings, such as ABThera® commercially available from Kinetic Concepts, Inc. in San Antonio, Texas.

[0092] Figures 14A and 14B refer to an exemplary embodiment of treatment device 801, which may be similar to the exemplary embodiment of treatment device 801 shown in Figures 13A and 13B. However, in the exemplary embodiments of Figures 14A and 14B, fluid delivery container 860 can incorporate additional components that can be a foldable or non-foldable matrix, such as manifold matrix 884, which allows fluid delivery container 860 to be filled with a dripping fluid. In some embodiments, fluid delivery container 860 can include a lower layer that can be occlusive, i.e., container layer 880, and an upper layer, such as upper container layer 883, that can incorporate perforations, windows, or openings, such as container upper aperture 885. Container upper aperture 885 can allow a flow of dripping fluid to exit from the upper surface of fluid delivery container 860, which may occur after fluid delivery container 860 is filled with a dripping fluid during a treatment cycle. Optionally, by ensuring that fluid delivery container 860 is completely filled with a dripping fluid before the fluid exits into the abdominal cavity, it is possible to eliminate the need to generate backpressure within fluid delivery container 860 to ensure uniform fluid distribution.

[0093] Referring now to Figure 15, an illustration of another exemplary embodiment of treatment device 1001 used with treatment system 100 is shown. In one embodiment, treatment device 1001 can include a single layer, such as occlusion 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 the central portion of occlusion layer 1002, which can fluidly transmit a negative pressure to the channels of occlusion layer 1002 to collect and remove fluid from the abdominal cavity. Further, treatment device 1001 can include a pressurized distribution container 1006 that can distribute a dripping fluid to regions of the abdominal cavity across occlusion layer 1002. As described above with respect to other embodiments, at interface 132, a conduit 134 for transferring negative pressure and / or a dripping fluid can be fluidly connected to treatment device 1001.

[0094] During operation, as described above with respect to other embodiments, a suitable fluid source can deliver the dripping fluid, and when the dripping fluid is delivered to the pressurized distribution container 1006 of the treatment device 1001, it can be forced to spread over the surface of the occlusion layer 1002. The dripping fluid can reach the farthest range of the occlusion layer 1002 and flow over the occlusion layer 1002 through the formed path until it contacts the abdominal cavity contents, and finally the paracolic gutter. When the dripping fluid flows over the upper surface of the occlusion layer 1002, it can be heated to body temperature by body heat and spread over a wide area. As described above, a residence time of the dripping fluid occurs, and a part of the dripping fluid remains in the pressurized distribution container 1006 above the dripping surface of the occlusion layer 1002, which can act as a bolus of clean fluid when removed later.

[0095] During negative pressure, i.e., during the fluid removal cycle, the dripping fluid can be withdrawn from the body cavity by being drawn along the formed path on the lower side, i.e., the bottom surface, of the occlusion layer 1002. When negative pressure is applied, the occlusion layer 1002 can be pulled downward and tightly compressed against the body cavity contents. This movement allows the abdominal cavity contents, such as internal organs, to contact the dripping fluid withdrawn along the formed path on the lower side of the occlusion layer 1002. As described above with respect to other embodiments, during the application of negative pressure, the remaining fluid in the pressurized distribution container 1006 can be removed as a rapidly moving bolus of fluid and thus can act as a final rinse.

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

[0097] Referring again to both FIGS. 15 and 16, in some embodiments, the occlusion layer 1002 can be formed from a single piece or sheet of film, such as a polyurethane film. In some embodiments, the occlusion layer 1002 can provide fluid paths both below the occlusion layer 1002 in the fluid removal chamber 1008 and above the occlusion layer 1002 in the fluid drip chamber 1010. For example, the fluid paths can be formed by folds 1012 of the occlusion layer 1002 that can be generated using high-frequency welding techniques. For example, high-frequency (HF) or radio-frequency (RF) welding can include using high-frequency electromagnetic energy to melt a portion of the material of the occlusion layer 1002 and joining together a portion of the occlusion layer 1002. The folds 1012 can be arranged to uniformly distribute fluid to the distal edge of the occlusion layer 1002. The number of folds 1012 can be varied to further control the flow of the dripped fluid within the abdominal cavity, as needed or required.

[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 a plurality of films welded together, which can be polyurethane films welded to each other at their outer peripheries. 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 an opening or aperture that can be included as an inlet 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 the fluid removal chamber 1008 and replenishing fluid from the fluid removal chamber 1008. The inlet 1018 can be sized according to specific suction requirements. In some embodiments, the fluid removal manifold 1004 can include a manifold material 1019 that can be housed within the upper manifold film 1014 and the lower manifold film 1016. The manifold material 1019 can include a variety of different materials suitable for transmitting or transferring fluid. For example, in some embodiments, the manifold material 1019 can include an open cell foam having pores with a diameter of about 6 mm.

[0099] In some embodiments, the pressurized dispensing container 1006 can be a flexible container in fluid communication with the fluid source 108 through the drip path of the conduit 134. The volume of the pressurized dispensing container 1006 can be changed and, in some embodiments, can be reduced using internal welds, which can also serve to increase local pressure to improve the dispensing of the dripping fluid. Suitable materials for forming the structure of the pressurized dispensing container 1006 can include sheets of film, such as polyurethane film, that can be welded together at the outer periphery. For example, the pressurized dispensing container 1006 can include an upper container film 1020 and a lower container film 1022. As shown in FIG. 16, in some embodiments, the pressurized dispensing container 1006 can include a smaller-than-standard outlet 1024 as part of the lower container film 1022 to allow the dripping fluid to exit the pressurized dispensing container 1006 when a specific internal pressure within the pressurized dispensing container 1006 is reached. For example, the outlet 1024 is small enough to generate a back pressure that helps drive the uniform dispensing of the dripping fluid from the pressurized dispensing container 1006, but not so small as to cause a possible occlusion alarm in the treatment system 100. In some embodiments, the outlet 1024 can have a diameter of about 0.2 mm to 1 mm. The outlet 1024 can be in the form of a perforation or a window. The outlet 1024 can also be arranged in one or more patterns that help direct the dispensing, and different versions of the pressurized dispensing container 1006 with different arrangements of the outlet 1024 designed to target different regions or organs can be manufactured. For example, in some embodiments, the outlet 1024 can be arranged in a uniformly spaced pattern around the outer periphery of the pressurized dispensing container 1006.

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

[0101] Referring further to FIG. 17, some embodiments of treatment device 2001 can include a manifold, such as fluid removal manifold 2004, that is coupled to or formed as part of occlusion layer 2002. For example, in some embodiments, fluid removal manifold 2004 can be formed from only a lower manifold film 2016 that is attached or welded to the underside of occlusion 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 occlusion layer 2002, and thus the lower manifold film 2016 having an inlet 2018 can actually be formed as part of the lower layer of multi-layer occlusion layer 2002. In such embodiments, the fluid removal path can exist between the various layers of multi-layer occlusion layer 2002 through outer peripheral inlet 2026 of fluid removal manifold 2004 and beneath multi-layer occlusion layer 2002 through directly beneath fluid removal manifold 2004 and inlet 2018. Fluid removal manifold 2004 can include a manifold material 2019 capable of transmitting negative pressure and fluid and can include materials such as three-dimensionally formed films, wicking materials, and molded manifolds.

[0102] In some embodiments, the pressurized dispensing container 2006 can be coupled to or formed as part of the closure layer 2002. For example, in some embodiments, the pressurized dispensing container 2006 can be formed from only the upper container film 2020 that is attached or welded to the upper surface of the closure layer 2002, and thus the lower container film, such as the lower container film 1022 of FIG. 16, can be eliminated. In some embodiments, the upper container film 2020 can be formed integrally with the closure layer 2002 as a single structure instead of being formed and joined from multiple flexible components. Optionally, the upper container film 2020 and the closure layer 2002 can be gusseted to ensure an open path from the pressurized dispensing container 2006. For example, a portion of the upper container film 2020 and the closure layer 2002 can be welded together, such as a welded outer periphery around a portion of the upper container film 2020 and the closure layer 2002. Additionally, a portion of the upper container film 2020 and the closure layer 2002 can be spot welded in a pattern across both material layers to provide a gusseting effect. As a result, in some embodiments, the height and volume of the pressurized dispensing container 2006 can be restricted when filled with fluid. The pressurized dispensing container 2006 can be formed using a variety of materials, including, but not limited to, small inner diameter tubing. In some exemplary embodiments, the flow distribution of the dispensed fluid can be controlled by an outer peripheral outlet 2024 positioned at the periphery of the pressurized dispensing container 2006. Similar to other embodiments, such outer peripheral outlets 2024 can be created using techniques such as high frequency welding. The exemplary embodiment of FIG. 17 shows a modified version of the closure layer 2002, the fluid removal manifold 2004, and the pressurized dispensing container 2006, but any combination of these features can be incorporated into a single embodiment.

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

[0104] FIG. 18B shows another exemplary embodiment of the occlusion layer 4002, where instead of a fluid path formed from accordion pleats 3012 as shown in FIG. 18A, a fluid path is formed by tubular pleats 4012. In such an embodiment, the occlusion layer 4002 can be formed from a base layer 4030 having a plurality of tubular pleats 4012, and the plurality of tubular pleats 4012 are formed on the upper 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 as an integral tubular structure, such as by joining or clamping together a part of the base layer 4030 to form the tubular pleats 4012. In any case, a fluid removal path 4032 can be provided inside the tubular pleats 4012, and the fluid delivery path 4034 can extend along the upper surface of the base layer 4030 between the tubular pleats 4012 that include the fluid removal path 4032.

[0105] FIG. 18C shows another exemplary embodiment of the occlusion layer 5002, which is similar to the embodiment of the occlusion layer 4002, but includes an accordion fold 5012 for a fluid path. Thus, in some embodiments, the occlusion layer 5002 can be formed from a base layer 5030 having a plurality of accordion folds 5012, and the plurality of accordion folds 5012 are formed on the upper surface of the base layer 5030 by separate fold layers 5036. The removal path 5032 can be included below the fold layer 5036 or within a space created between the base layer 5030 and the fold layer 5036. The fluid delivery path 5034 can extend along the upper surface of the fold layer 5036.

[0106] Reference is now made primarily to FIGS. 19A-19C to further describe additional embodiments of a method of providing negative pressure therapy and fluid instillation treatment at a tissue site. For example, in some embodiments, the treatment system 6000 can include a treatment device 6001, a negative pressure source 6006, and a fluid source 6008 that is a separate stand-alone device from the negative pressure source 6006. The fluid source 6008 can be a separate mechanical instillation device. In some embodiments that include a separate mechanical instillation 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 instillation fluid ultimately delivered to the tissue site 112. As shown in FIGS. 19A-19C, some of the disclosed methods can include a treatment cycle that includes three phases or intervals. For example, as shown in FIG. 19A, the 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 the fluidly connected path of the treatment system 6000 and ultimately reach the drip regulator 6019 and the fluid source 6008. Thus, this transmitted negative pressure can prime the fluid source 6008, which can be a mechanical instillation device. Continuing with FIG. 19B, the method can further include a second phase of the treatment cycle, which can include pausing or ending 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 instillation device, can deliver instillation fluid to the drip regulator 6019 and ultimately to the treatment device 6001. As shown in FIG. 19C, following the designated interval for delivering instillation fluid from the fluid source 6008 to the treatment device 6001, a third phase of the treatment cycle can be initiated. During this third phase, the fluid instillation 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, instillation fluid can be removed from the tissue site 112, such as the abdominal cavity 111, along with the treatment device 6001.Furthermore, the fluid source 6008 can be primed again and be made ready to deliver the dripping fluid to the treatment device 6001 again when the second stage of the treatment cycle can be repeated.

[0107] Figures 20A - 20C illustrate another example embodiment of a method for providing negative pressure therapy and fluid dripping treatment to a tissue site. The method exemplified by Figures 20A - 20C may include various modifications and may be substantially similar to the method described above with respect to Figures 19A - 19C. For example, as shown in Figure 20A, the treatment system 6000 can include a treatment device 6001, a negative pressure source 6006, a fluid source 6008, and a dripping regulator 6019. Further, the treatment system 6000 can further include a pressure release unit 6021. In some embodiments, during the first stage of the treatment cycle, the negative pressure source 6006 can be activated to apply negative pressure therapy to the treatment device 6001. The negative pressure applied by the negative pressure source 6006 is transmitted through the fluidly connected path of the treatment system 6000 and can ultimately reach the dripping regulator 6019 and the fluid source 6008. This transmitted negative pressure can prime the fluid source 6008, which can be a mechanical dripping device. Continuing with Figure 20B, the method can further include a second stage of the treatment cycle, during which the pressure release unit 6021 is opened and the delivery of negative pressure to the treatment device 6001 is stopped. In some embodiments, the pressure release unit 6021 can be opened according to a predetermined or pre - determined timing schedule. During the second stage of the treatment cycle, the fluid source 6008 can deliver dripping fluid to the dripping regulator 6019 and ultimately to the treatment device 6001, which can occur while the pressure release unit 6021 is open, and thus, the transmission of negative pressure to the treatment device 6001, the fluid source 6008, and the dripping regulator 6019 can be prevented. As shown in Figure 20C, following the second stage of the treatment cycle, a third cycle of the treatment cycle can be initiated, during which, again according to a timed interval schedule, the pressure release unit 6021 can be closed. During the third stage of the treatment cycle, the fluid dripping can be temporarily stopped, and the negative pressure source 6006 can be re - activated to provide further intervals of negative pressure therapy.The disposal device 6001 can remove the dripping fluid, and the fluid source 6008 can be primed and be ready to redeliver the dripping fluid to the disposal device 6001 again.

[0108] In some further methods of providing negative pressure therapy and fluid dripping to a tissue site, instead of automating or other forms of mechanical dripping devices, a manually controlled dripping container such as a fluid bag, bottle or other container can be incorporated. Thus, in some embodiments, during the first stage of the treatment cycle, the negative pressure source can apply negative pressure therapy to the disposal device and the tissue site, during which a device such as a clamp, valve or other form of closure device can prevent the fluid from being transmitted from the manually controlled dripping container to the disposal device and the tissue site. In some embodiments, during subsequent stages of the treatment cycle, the user can open the clamp or other form of closure device and manually adjust the volume of the dripping fluid. During this dripping stage, the negative pressure source can continue to be in an operating state, and thus can provide immediate removal of the dripping fluid from the disposal device and the tissue site. Thus, according to some embodiments of the present method, the residence time of the fluid at the tissue site can be substantially eliminated. And the user can tighten or otherwise close the closure device again, thus stopping the flow of the dripping fluid from the manually controlled dripping container. And the negative pressure source can continue to remove the exudate from the disposal device and the tissue site together with any excess or remaining dripping fluid. In some other embodiments of the disclosed method, instead of allowing the negative pressure source to remain in an operating state while the fluid is dripping from the manually controlled dripping container, the negative pressure source can be temporarily stopped, thus allowing the dripping fluid to remain at the tissue site for a predetermined period. If appropriate, the user can close the manually controlled dripping container so as not to deliver the dripping fluid. Before or subsequent to the dripping being stopped, the negative pressure therapy can be restarted, during which any excess or remaining fluid from the disposal device and the tissue site can be removed.

[0109] The systems, devices, and methods described herein can provide significant advantages. As described above, the disclosed systems and devices can provide an integrated temporary abdominal closure dressing system with a fluid dripping function through a negative pressure fluid removal pathway for the removal of contaminated fluid, along with an independent matrix of fluid delivery tubes. Thus, the disclosed embodiments can provide a means to support and protect abdominal contents while removing contaminated fluid, suppressing and / or reducing edema, and perfusing and washing the abdominal cavity. Further, as a result of the various layers and components of the disclosed dressing applying tension and closure forces to the abdominal contents, more rapid primary fascial closure of the abdominal cavity can be facilitated.

[0110] As described herein, the disclosed solution can provide a means to perfuse all regions of the abdominal cavity, including the small bowel loops, paracolic gutters, retroperitoneal space, portions of the lymphatic system, etc., while the dressing system remains in place, thus shortening the time required for the patient and clinical staff in the operating room. The various described embodiments provide various configurations of fluid pathways designed to maximize the exposure of visceral organs of the abdominal tissue site to fluid drip therapy. The disclosed dressing components can also enable longer dressing application times without adhering to the fascia of the abdominal tissue site. Thus, repeatable and reliable fluid dripping can be provided that can be uniformly provided to various portions of the tissue site. As a result, fluid perfusion and washing can be made more consistent, and thus the mortality rate of patients suffering from septic abdomens will be reduced. Fluid dripping can be managed at the patient's bedside and can be individually and specially adapted and adjusted.

[0111] The disclosed systems and devices can drain exudate and infectious substances from tissue sites such as the abdominal cavity, and thus can reduce the presence of contaminated abdominal fluid to promote healing. Further, the disclosed solution can provide separate drip and negative pressure pathways to ensure that contaminated or "dirty" fluid is completely removed from the abdomen. Further, in a preferred embodiment of the disclosed system, the drip fluid does not recirculate back to the tissue site. As a result, the clinical benefits of perfusing the tissue site can be increased.

[0112] Importantly, the design of the disclosed device can also enable sizing and / or customization by the user 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 built-in sizing or placement visual marks or indicators to guide the user. Some embodiments of the disclosed dressing system can also include various components such as fluid drip and / or fluid removal pathways already pre-attached to the structural dressing layer to make use more efficient and simplified. As a result, not only can improved fluid delivery and removal be enabled compared to existing dressing systems, but also the ease of use can be enhanced.

[0113] Although shown in a few exemplary embodiments, those skilled in the art will understand that the systems, devices, and methods described herein are capable of various modifications and changes. Further, the description of various alternatives using terms such as "or" need not be mutually exclusive unless clearly required by the context, and the indefinite article "a" or "an" does not limit the object to a single instance unless clearly required by the context. Additionally, any feature described in connection with any one embodiment may also be applicable to any other component. It is also possible to combine or remove components in various configurations for the purpose of sale, manufacture, assembly, or use. For example, in some configurations, the treatment device 101, which includes the dressing 102, the container 110, or both, can be eliminated or separated from other components for manufacture or sale.

[0114] The appended claims describe the novel and inventive aspects of the above-described subject matter, but may also encompass additional subject matter that is not specifically described in detail. For example, some features, elements, or aspects may be omitted from the claims if they are not necessary to identify novel and inventive features that are already known to those skilled in the art. The features, elements, and aspects described herein can be combined or replaced with alternative features that serve the same, equivalent, or similar purpose without departing from the scope of the invention as defined by the appended claims.

Claims

1. In a system for treating a tissue site, a drape configured to provide an enclosed space at the tissue site, an occlusion layer configured to be disposed within the enclosed space, a fluid removal manifold disposed adjacent to a first surface of the occlusion layer and configured to face the tissue site, a fluid distribution container disposed adjacent to a second surface of the occlusion layer, which is opposite to the first surface of the occlusion layer, and disposed between the second surface of the occlusion layer and the drape, A system characterized by comprising the above.

2. In the system according to claim 1, 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 distribution container, A system further characterized by comprising the above.

3. In the system according to claim 1, 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. A system characterized by this.

4. In the system according to claim 1, the occlusion layer comprises a plurality of fluid removal paths formed on the first surface of the occlusion layer. A system characterized by this.

5. In the system according to claim 4, the plurality of fluid removal paths extend radially across the second surface of the occlusion layer. A system characterized by this.

6. In the system according to claim 1, the fluid distribution container comprises a tube having a plurality of outlets. A system characterized by this.

7. In the system according to claim 6, the outlets are disposed on a first surface of the fluid distribution container, and the fluid distribution container is configured to be disposed adjacent to the second surface of the occlusion layer. A system characterized by this.

8. In the system according to claim 6, the outlets are sized to generate an increased fluid pressure within the internal volume of the fluid distribution container. A system characterized by this.

9. In the system according to claim 1, the fluid distribution container comprises a plurality of compartments formed by welds within the internal volume of the fluid distribution container. A system characterized by this.

10. The system according to claim 8, wherein the plurality of outlets are configured to withstand a predetermined outward fluid pressure before opening.

11. The system according to claim 1, wherein the blocking layer comprises a polyurethane film.

12. The system according to claim 1, wherein the blocking layer comprises a plurality of pleats forming a plurality of fluid removal paths on the first surface of the blocking layer.

13. The system according to claim 1, wherein the fluid removal manifold comprises a plurality of welded polyurethane films.

14. The system according to claim 1, wherein the fluid removal manifold comprises a first surface having a plurality of openings.

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