Multilayer abdominal closure dressing with drip function

Abstract

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source to a tissue site through the fluid instillation matrix, negative pressure may be communicated, and fluid may be withdrawn from the tissue site through the plurality of fluid removal pathways.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority 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, without limitation, to abdominal treatment systems using negative pressure and instillation.

Background Art

[0003] Clinical trials and medical practice have shown that by applying negative pressure in proximity to a tissue site, the growth of new tissue at the tissue site can be enhanced and accelerated. Although there are many applications of this phenomenon, it has been found that this phenomenon is particularly advantageous for the treatment of wounds. Regardless of whether the wound is caused by trauma, surgery, or another cause, proper care of the wound is important for the outcome. Treatment by applying negative 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", "decompression 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 of 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 a tissue site can be very beneficial for the growth of new tissue. For example, a wound can be washed with a stream of liquid solution, or a cavity can be washed with a liquid solution for therapeutic purposes. These actions are generally called "irrigation" and "lavage," respectively. "Dripping" is another action, generally referring to the process of gradually introducing a fluid into a tissue site and leaving the fluid in for a predetermined period before removing it. For example, dripping a topical therapeutic 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 material. As a result, the soluble bacterial load can be reduced, contaminants can be removed, and the wound can be cleansed.

[0005] Distributing and extracting fluid from tissue sites receiving negative pressure therapy or fluid infusion can present challenges. For example, tissue sites may vary in volume, size, shape, orientation, and other factors. Furthermore, access to these tissue sites may be limited. These and other factors can make it difficult to perform the extraction of waste fluid from tissue sites and the distribution of therapeutic fluid to tissue sites uniformly or evenly. Additionally, changes in the direction of fluid flow between negative pressure therapy cycles and fluid infusion cycles may cause waste fluid extracted during the negative pressure therapy cycle to be returned to the tissue site when switching to the fluid infusion cycle.

[0006] Types of tissue sites that may present specific challenges include the peritoneal cavity, and more generally, the abdominal cavity. When the tissue site is related to the abdominal cavity, a treatment system that can enable improved and efficient care and address complications such as peritonitis, abdominal compartment syndrome, and infections that may prevent ultimate healing may be particularly beneficial. Therefore, improvements to treatment systems that can adapt to various types of tissue sites and stereotactic locations, improve the uniformity of exhaust fluid extraction and treatment fluid distribution, and improve efficiency and healing time may be desirable. [Overview of the Initiative]

[0007] In the following summary and description, and in the attached claims, a novel and useful system, apparatus, and method for lavage of the abdominal cavity in a negative pressure therapy environment is described. Exemplary embodiments are also provided so that those skilled in the art may create and use the subject matter of the claims.

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

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

[0010] In yet another embodiment, a dressing for treating a tissue site may include a first impermeable layer, a second impermeable layer positioned adjacent to the first impermeable layer and having substantially the same extent 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 may be positioned between the first impermeable layer and the second impermeable layer.

[0011] In further embodiments, a dressing for treating a tissue site may include a plurality of fluid removal pathways and a fluid delivery matrix. The dressing may include a first impermeable layer and a second impermeable layer. The fluid delivery matrix may include a plurality of fluid delivery pathways, and the fluid delivery matrix may be adjacent to a first surface of the dressing.

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

[0013] In some further embodiments, the tissue treatment system may include a treatment device configured to be deployed in the abdominal cavity, a fluid drip matrix associated with the treatment device, a manifold member, a drape, a negative pressure source fluidically connected to the treatment device, and a fluid source fluidically connected to the fluid drip matrix. The treatment device may include multiple fluid removal pathways. The fluid drip matrix may include multiple fluid delivery pathways. The manifold member may be positioned adjacent to the central portion of the treatment device. The drape may be adapted to form a fluid seal around the treatment device, the fluid drip matrix, and the manifold member.

[0014] In other embodiments, a dressing for treating a tissue site may 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 may 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, the system for treating a tissue site may include an occlusion layer, a fluid removal manifold, and a fluid distribution container. The fluid removal manifold may be positioned adjacent to a first surface of the occlusion layer, and the fluid distribution container may be positioned adjacent to a second surface of the occlusion layer.

[0016] In further embodiments, a device for treating a tissue site may 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 may be formed by a second film layer welded to the first side of the film layer. The fluid distribution chamber may be formed by a third film layer welded to the second side of the film layer at its outer circumference and having an interface for fluid connection to the conduit. The conduit may 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 may include a dressing member, a fluid delivery container, and a drape. The dressing member may include a plurality of fluid pathways configured to deliver negative pressure to the tissue site. The fluid delivery container may be fitted to be positioned adjacent to a first surface of the dressing member and may include a first side having a plurality of openings for delivering fluid to the tissue site. The drape may be fitted to be positioned on a second surface of the plurality of fluid pathways.

[0018] The purpose, advantages, and preferred embodiments of the subject matter of the claims can be best understood by referring to the accompanying drawings together with the following detailed description of exemplary embodiments. [Brief explanation of the drawing]

[0019] [Figure 1] Figure 1 is a functional block diagram of an embodiment of a treatment system according to this specification, which can deliver treatment fluid to a tissue site along with negative pressure and can manage the fluid. [Figure 2] Figure 2 is a partially cross-sectional schematic view of an exemplary device for treating the abdominal cavity, which can be associated with several embodiments of the treatment system shown in Figure 1. [Figure 3] Figure 3 is a schematic plan view of an exemplary embodiment of an abdominal treatment device that can be associated with several embodiments of the treatment system shown in Figure 1. [Figure 4-1] Figure 4A is a schematic plan view of some exemplary embodiments of an abdominal treatment device. [Figure 4-2] Figure 4B is a schematic side view of a portion of an exemplary embodiment of the abdominal treatment device shown in Figure 4A. [Figure 5] Figure 5 is a schematic plan view of a portion of an abdominal treatment device according to another exemplary embodiment. [Figure 6] Figure 6A is a schematic diagram showing further details that can be associated with a part of the abdominal treatment device of the treatment system in Figure 1. Figure 6B is a schematic diagram showing further details that can be associated with a part of the treatment system in Figure 1. [Figure 7-1] Figure 7A is a schematic plan view of a further exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of Figure 1. [Figure 7-2] Figure 7B is a schematic plan view of a further exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of Figure 1. [Figure 7-3] Figure 7C is a schematic plan view of a further exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of Figure 1. [Figure 8] FIG. 8 is a schematic plan view of another exemplary abdominal treatment device that can be associated with the treatment system of FIG. 1. [Figure 9] FIG. 9 is a schematic view showing further details of a fluid conduit that can be associated with a part of the abdominal treatment device of the treatment system of FIG. 1. [Figure 10-1] FIG. 10A is a schematic view of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. 1. FIG. 10B is a schematic view of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. 1. [Figure 10-2] FIG. 10C is a schematic view of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. 1. [Figure 11-1] FIG. 11A is a schematic view of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. 1. [Figure 11-2] FIG. 11B is a schematic view of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. 1. [Figure 12] FIG. 12A is a schematic view of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. 1, with some parts in cross-section. FIG. 12B is a schematic view of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. 1, with some parts in cross-section. [Figure 13] FIG. 13A is a schematic view of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. 1, with some parts in cross-section. FIG. 13B is a schematic view of another exemplary embodiment of an abdominal treatment device that can be associated with the treatment system of FIG. 1, with some parts in cross-section. [Figure 14]Figure 14A is a schematic cross-sectional view of several parts of another exemplary embodiment of the abdominal treatment device that can be associated with the treatment system of Figure 1. Figure 14B is a schematic cross-sectional view of several parts of another exemplary embodiment of the abdominal treatment device that can be associated with the treatment system of Figure 1. [Figure 15] Figure 15 is a schematic plan view of another exemplary embodiment of an abdominal treatment device that can be associated with several embodiments of the treatment system shown in Figure 1. [Figure 16] Figure 16 is a schematic, partially cross-sectional view of some exemplary embodiments of the abdominal treatment device shown in Figure 15, according to several embodiments. [Figure 17] Figure 17 is a partially cross-sectional schematic view of some exemplary embodiments of the abdominal treatment device of Figure 15, according to several further embodiments. [Figure 18] Figure 18A is a schematic plan view of some exemplary embodiments of the abdominal treatment device shown in Figure 15. Figure 18B is a schematic plan view of some exemplary embodiments of the abdominal treatment device shown in Figure 15. Figure 18C is a schematic plan view of some exemplary embodiments of the abdominal treatment device shown in Figure 15. [Figure 19] Figure 19A is a schematic diagram showing some functions of the therapeutic system according to this specification, based on several embodiments. Figure 19B is a schematic diagram showing some functions of the therapeutic system according to this specification, based on several embodiments. Figure 19C is a schematic diagram showing some functions of the therapeutic system according to this specification, based on several embodiments. [Figure 20] Figure 20A is a schematic diagram illustrating some functions of the therapeutic system according to this specification, according to several further embodiments. Figure 20B is a schematic diagram illustrating some functions of the therapeutic system according to this specification, according to several further embodiments. Figure 20C is a schematic diagram illustrating some functions of the therapeutic system according to this specification, according to several further embodiments. [Modes for carrying out the invention]

[0020] The following description of embodiments provides information that will enable those skilled in the art to create and use the subject matter set forth in the appended claims, although some details already well known in the art may be omitted. Therefore, the following detailed description should be interpreted as illustrative rather than restrictive.

[0021] This specification may also describe embodiments relating to the spatial relationships between various elements or the spatial orientation of various elements shown in the accompanying drawings. Generally, such relationships or orientations correspond to or assume a reference system for a patient in the appropriate place to receive treatment. However, as will be recognized by those skilled in the art, this reference system is not a strict definition but merely a convenient means of explanation.

[0022] Figure 1 is a simplified functional block diagram of an embodiment of a therapeutic system 100 capable of providing negative pressure therapy along with the dripping of a topical treatment solution according to this specification. The therapeutic system can be applied to human patients and can also be used for other types of subjects. The therapeutic system 100 may include a treatment device 101 including a dressing 102 and a therapeutic unit 104. In some embodiments, the therapeutic unit 104 may 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 therapeutic unit 104 may include a negative pressure source 106, and the fluid source 108 and / or controller 109 may be separate, self-contained units. The therapeutic system 100 may also include additional components such as a container 110, which may also be in fluid communication with the treatment device 101, the dressing 102, and the therapeutic unit 104.

[0023] The components of the treatment system 100 can be fluidically coupled to one another to provide a pathway for the transfer of fluids (i.e., liquids and / or gases) between the components. For example, components can be fluidically coupled through fluid conductors such as tubes. “Tube” as used herein broadly includes tubes, pipes, hoses, conduits, or other structures having one or more lumens adapted to transport fluid between two ends. Typically, a tube is an elongated cylindrical structure with some flexibility, although its shape and rigidity can be modified. In some embodiments, components can also be coupled by physical proximity, integration into a single structure, or formation from the same material piece. Furthermore, some fluid conductors can be molded into other components or otherwise integrally coupled. Depending on the context, couplings may include mechanical, thermal, electrical, or chemical (e.g., chemical bonding). For example, in some embodiments, tubes 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 directly or indirectly.

[0024] The treatment system 100 may include a negative pressure source, such as a negative pressure source 106, which can be configured to be coupled to a distribution component, such as a dressing. Generally, a distribution component can refer to any complementary or auxiliary component configured to be fluidically 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 may be disposable, reusable, or recyclable. For example, the dressing 102 of the treatment device 101 may be fluidically coupled to the negative pressure source 106 of the treatment unit 104, as shown in Figure 1. In some embodiments, the treatment device 101 may include further tissue interfaces, fluid conduits, and / or covers together with the dressing 102. In some embodiments, the dressing interface may facilitate coupling the negative pressure source 106 to the dressing 102 of the treatment device 101. For example, such a dressing interface may be a SENSAT.RAC® pad, available from KCI in 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 therapeutic environment, can be mechanically complex. However, the basic principles of fluid mechanisms applicable to negative pressure therapy and dripping are generally well known to those skilled in the art, and the process of reducing pressure may be described herein exemplary, for example, as “delivering,” “distributing,” or “generating” negative pressure.

[0026] Generally, exudates and other fluids flow along fluid pathways toward lower pressures. Therefore, the term “downstream” typically refers to a fluid pathway that is relatively close to a negative pressure source or even further away from a positive pressure source. Conversely, the term “upstream” refers to a fluid pathway that is relatively further away from a negative pressure source or closer to a positive pressure source. Similarly, it may be convenient to describe certain features with respect to the fluid “inlet” or “outlet” in these reference systems. This orientation is generally assumed in this specification for the purpose of describing various features and components. However, in some applications, it is possible to reverse the fluid pathway (e.g., by using a positive pressure source instead of a negative pressure source), and this descriptive convention should not be interpreted as a restrictive convention.

[0027] "Negative pressure" generally refers to a pressure lower than the local ambient pressure, such as the ambient pressure in the local environment outside the sealing therapeutic environment provided by the treatment device 101. Often, the local ambient pressure can also be the atmospheric pressure where the tissue site is located. Alternatively, the pressure may 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 modified according to therapeutic requirements, but the pressure is generally a low vacuum (also commonly called a rough vacuum) of -5 mmHg (-667 Pa) to -500 mmHg (-66.7 kPa). A typical therapeutic 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, may be a reservoir of air under negative pressure, or it may be a manual or electric device that can reduce pressure within a sealed volume, such as a vacuum pump, suction pump, wall suction port available in many medical facilities, or micropump. The negative pressure supply unit may be housed in or used with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate treatment. The negative pressure source may also have one or more supply ports configured to facilitate coupling and disconnecting the negative pressure supply unit to one or more distribution components.

[0029] The treatment system 100 may also include a dripping solution source. For example, a fluid source 108 can be fluidically coupled to the treatment device 101 and therefore to the dressing 102, as shown in the embodiment example of Figure 1. In some embodiments, the fluid source 108 can be fluidically coupled to a positive pressure source or to a negative pressure source 106. Regulators such as drip regulators can also be fluidically coupled to the fluid source 108 and the treatment device 101.

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

[0031] The fluid source 108 may also represent a container, canister, pouch, bag, or other storage component that can provide a solution for drip therapy. The composition of the solution may be modified according to the indicated therapy, but examples of solutions that may be suitable for some indications include hypochlorite solutions, silver nitrate (0.5%), sulfur solutions, biguanides, cationic solutions, and isotonic solutions.

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

[0033] Container 110 represents a container, canister, pouch, or other storage component that can be used to manage exudate and other fluids drawn from a tissue site. In many environments, rigid containers may be preferred or necessary for collecting, storing, and disposing of fluids. In other environments, fluids can be properly disposed of without being stored in rigid containers, and reusable containers can reduce waste and costs associated with negative pressure therapy.

[0034] In this context, the term “tissue site” broadly refers to any wound, defect, or other treatment target located on or within tissue, including but not limited to bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. Examples of wounds include chronic, acute, traumatic, subacute, and dehiscent wounds, intermediate burns, ulcers (such as diabetic ulcers, pressure ulcers, or venous insufficiency ulcers), valves, and grafts. The term “tissue site” may also refer to any area of ​​tissue that is not necessarily wound or defect, but instead may be desirable to add or promote the growth of additional tissue. For example, negative pressure may be applied to a tissue site to promote the growth of 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 into a single treatment unit, such as a treatment unit 104. Thus, for example, the treatment system 100 may include a treatment device 101 together with a treatment unit 104, such as a VACULTA® treatment unit, a VACINSTILL® wound treatment system, an INFOV.AC® treatment unit, or other suitable treatment unit. For example, in some embodiments, the treatment unit 104 may include, or essentially consist of, a VACULTA® unit, which may include software modules specific to negative pressure therapy in combination with fluid drip therapy, and software modules specific to use with an abdominal dressing system, such as embodiments of the treatment device 101. Alternatively, any other device capable of providing intermittent negative pressure therapy may be preferred, along with any mechanical fluid drip device, or any other negative pressure therapy device in combination with a manually controlled fluid drip source, such as a gravity-feed fluid container, a manual fluid pump, or a monitored intravenous bag or bottle.

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

[0037] The exemplary systems and devices described herein can enable irrigation and flushing of the peritoneal cavity, such as the abdominal cavity 111, through controlled and regulated introduction of fluid. In some cases, it may be necessary to wash or irrigate a contaminated abdominal cavity as a result of colonic perforation or sepsis. The treatment system 100 can provide means for dripping fluid into an open abdomen to flush out the contents of the abdominal cavity, including reachable areas such as the small intestine loop and pancreas. Furthermore, the treatment device 101 and the treatment system 100 can provide temporary closure to the open abdomen while fluid is removed and edema is reduced. Thus, the treatment system 100 can provide the possibility of performing flushing of tissue sites such as the abdominal cavity 111 without the need to repeatedly remove one or more dressings applied to the patient's tissue sites or without bringing the patient into the operating room for a manual fluid introduction procedure. Thus, the treatment system 100 can have the ability to provide controlled and regulated complete abdominal flushing, as well as targeted flushing to several areas within the abdomen, if necessary. The disclosed embodiments can also provide support and maintenance of fascial areas of the abdominal cavity, such as the abdominal cavity 111, and provide overall protection to the contents of the abdominal cavity.

[0038] As shown in Figure 2, the treatment device 101 may include a dressing 102, which can be placed in the patient's abdominal cavity 111 to treat a 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 may be positioned in or near a first paracolonic groove 115, and a second dressing portion 116 may be positioned in or near a second paracolonic groove 117. The first paracolonic groove 115 and the second paracolonic groove 117 may, for example, be open spaces on either side of the abdominal cavity 111 between the abdominal contents 113. The first paracolonic groove 115 may be positioned laterally from the second paracolonic groove 117, or otherwise positioned on the opposite side of the tissue site 112 from the second paracolonic groove. Figure 2 shows the treatment device 101 deployed in the abdominal cavity 111, but the treatment device 101 and treatment system 100 can be used in other types of tissue sites.

[0039] The dressing 102 may have multiple liquid-impermeable layers, for example, a first liquid-impermeable layer 118 and a second liquid-impermeable layer 120. The multiple liquid-impermeable layers, for example, the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120, have openings 122 and 124, respectively. "Liquid-impermeable" in relation to "liquid-impermeable layer" means that the layer is formed of a liquid-impermeable material. Therefore, a layer formed of a liquid-impermeable material, but which is liquid-permeable if it has windows, is nevertheless referred to as 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. In this exemplary embodiment, the openings 122 and 124 are presented as slits or linear cuts. In some embodiments, the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120 can be sealed and joined to each other in any preferred manner, without limitation, by welding, joining, adhesive, cement or other joining devices. The first liquid-impermeable layer 118 can be adapted to be positioned between the second liquid-impermeable layer 120 and the tissue site 112 and / or abdominal contents 113. In the embodiment example of Figure 2, a chamber 125 is formed between at least two of the multiple 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 may 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 may include a breathable polyurethane film. In some embodiments, the chamber 125 formed between the liquid-impermeable layers 118 and 120 may include a dropping matrix 152 that delivers the dropping body 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 may further include a sealing member 128 that provides a fluid seal over the abdominal cavity 111. Furthermore, one or more skin closure devices may be placed over the patient's epidermis 130. In some embodiments, the treatment system 100 may also include an interface 132 that fluidly connects the dressing 102 and the rest of the treatment device 101 to a conduit 134. The interface 132 may include a connector 136. Alternatively, the interface 132 may be partially or completely embedded within a portion of the dressing 102, or configured in any other way possible for fluidly connecting the treatment device 101 to a treatment unit such as the treatment unit 104 in Figure 1. The conduit 134 may be fluidly coupled to a negative pressure source 106 and / or a fluid source 108 of the treatment unit 104 to provide negative pressure and / or treatment fluid to the treatment device 101, respectively. In some embodiments, the conduit 134 may include two substantially parallel, fluidically isolated conduits, one of which is for fluidically coupling the treatment device 101 to a negative pressure source 106, and the other for fluidically coupling the treatment device 101 to a fluid source 108. Thus, in some embodiments, the conduit 134 may be a multi-lubricated conduit having both a negative pressure lumen 135 and a fluid supply lumen 137. In some other exemplary embodiments, the conduit 134 may be replaced with two separate conduits, one of which includes a negative pressure lumen and the other including a fluid supply lumen.

[0041] In some embodiments, the sealing member 128 can provide a bacterial barrier and protection from physical trauma. The sealing member 128 may also be composed of a material that can reduce loss due to evaporation and provide a fluid seal between two components or two environments, such as between a therapeutic environment and a local external environment. The sealing member 128 may be, for example, an elastomer film or membrane that can provide a suitable seal to maintain negative pressure at a tissue site relative to a given negative pressure source. In some applications, the sealing member 128 may have a high water vapor transmission rate (MVTR). For example, in some embodiments, the MVTR is at least 300 g / m². 2 This can be 24 hours. In some embodiments, the sealing member 128 may be a polymer drape, such as a polyurethane film, that is permeable to water vapor but impermeable to liquids. Such drapes typically have a thickness in the range of 25 to 50 microns. In the case of permeable materials, the transmittance must generally be low enough to maintain the desired negative pressure.

[0042] The sealing member 128 can be attached to a mounting surface such as the patient's epidermis 130 using an attachment device such as 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 may be a medically acceptable pressure-sensitive adhesive extending around the periphery, in part, or over the entire sealing member. In some embodiments, for example, part or all of the sealing member 128 may be coated with an acrylic adhesive having a coating weight of 25 to 65 grams / square meter (gsm). In some embodiments, a thicker adhesive or combination of adhesives may be applied to improve the seal and reduce leakage. Other examples of attachment devices include double-sided tape, paste, hydrophilic colloid, hydrogel, silicone gel, or organogel.

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

[0044] Referring primarily to Figure 3, the treatment device 101 can be adapted to provide negative pressure from the negative pressure source 106 of the treatment unit 104 to a tissue site such as the tissue site 112 in the abdominal cavity 111 in Figure 2, and to collect and transfer fluid extracted from the tissue site 112. Furthermore, the treatment device 101 can also be adapted to deliver fluid, such as a treatment fluid or drug, from the fluid source 108 of the treatment unit 104 to the tissue site 112. As discussed with respect to Figure 2, in some embodiments, the dressing 102 of the treatment device 101 can include multiple liquid-impermeable or visceral protective layers to protect the abdominal 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, each liquid-impermeable layer having dimensions of 20 to 400 micrometers in thickness. As shown in Figure 3, one or both of the liquid-impermeable layers, such as the second liquid-impermeable layer 120, may include an opening 124 to facilitate fluid removal through the abdominal cavity 111.

[0045] As shown in Figure 3, some embodiments of the treatment device 101 may also include a fluid removal assembly 148 and a drip matrix 152. For example, in some embodiments, the fluid removal assembly 148 may include a plurality of fluid removal paths 150, each of which is fluidically coupled to a fluid removal hub 154. The fluid removal hub 154 can act 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 may take many different shapes or be formed from various materials. For example, in some embodiments, the fluid removal path 150 may be formed from portions of a first liquid-impermeable layer 118 and a second liquid-impermeable layer 120, which are welded together to form a channel. Alternatively or further, the fluid removal path 150 may include, or be essentially, folds or folds in either or both of the liquid-impermeable layers 118 and 120. Other embodiments of the fluid removal pathway 150 include channels formed from extruded material, channels embossed on liquid-impermeable layers 118 and 120, or separate tubular materials forming individual tubes for use as the fluid removal pathway 150. Multi-lumen tubes can also be used for the fluid removal pathway 150. In various embodiments, each of the different forms and configurations of the fluid removal pathway 150 can also be applied to the fluid delivery tubes of the drip matrix 152, as is preferred.

[0046] In some embodiments, each of the fluid removal paths 150 may include manifold members, such as manifold members 156, that transmit negative pressure and draw fluid through the fluid removal path 150. For example, in some embodiments, each manifold member 156 may be a single piece of manifold member material extending over the length of the fluid removal path 150, while in some embodiments, the manifold members 156 may be made from separate parts or sections of manifold member material. In any case, the manifold members 156 may include a series of recesses 159, which can help transmit negative pressure and / or collected fluid, along with conformability including sizing and flexibility of the manifold members 156 and the fluid removal path 150.

[0047] The manifold member 156 can generally include any material or structure that is configured to help apply negative pressure to a tissue site 112 or other location, deliver fluid, or remove fluid from there. The manifold member 156 is typically a manifold member material having multiple channels or paths for distributing fluid supplied to and removed around the manifold member 156. For example, the manifold member material can be adapted to receive negative pressure from a negative pressure source and distribute the negative pressure across the tissue site through multiple apertures, which may have the effect of collecting fluid from the entire tissue site and drawing the fluid towards the fluid source. In some embodiments, the fluid paths can be reversed, or secondary channels can be provided to facilitate the delivery of fluid across the tissue site.

[0048] In some exemplary embodiments, the manifold's pathways can be interconnected to improve the distribution or collection of fluids across tissue sites. In some exemplary embodiments, the manifold may be a porous foam material having interconnected bubbles or pores. For example, cellular foam, open-cell foam, mesh foam, 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 also include or can be cured to include apertures and fluid pathways. In some embodiments, the manifold may further or alternatively include protrusions that form interconnected fluid pathways. For example, the manifold may be molded to provide surface protrusions that define interconnected fluid pathways.

[0049] In some embodiments, the manifold member 156 comprises a porous foam containing multiple interconnected bubbles or pores that act as flow channels. The average pore size of the foam can be modified according to the requirements of the indicated therapy. For example, in some embodiments, the manifold member 156 may be a foam having a pore size in the range of 400 to 600 microns. The tensile strength of the manifold member 156 can also be modified according to the requirements of the indicated therapy. For example, the tensile strength of the foam can be increased for the dripping of topical treatment solutions. In some embodiments, the manifold member 156 may include a polyurethane foam that may be 6 mm to 10 mm thick. In one non-limiting example, the manifold member 156 may be an open-cell, mesh-like polyurethane foam such as GRANUFOAM® dressing or VACVERAFLO® dressing, both available from Kinetic Concepts, Inc. in San Antonio, Texas. Some embodiments may include a manifold member 156 having an additional layer or material, such as an absorbent material, a wicking material, a hydrophobic material, or a hydrophilic material.

[0050] The drip matrix 152 may include a plurality of fluid delivery tubes 158 and a distribution hub 160. The components of the drip matrix 152 can be made from a variety of different materials. For example, some or all of the components of the drip matrix 152 may be made from soft medical-grade silicone or PVC tubing material. The plurality of fluid delivery tubes 158 can be sized according to the condition of the tissue site 112 to which the treatment device 101 is to be applied, along with the specific size and application of the treatment device 101. For example, each fluid delivery tube 158 may have an inner diameter of 0.5 mm to 4 mm. In some embodiments, each fluid delivery tube 158 may have an inner diameter of 1 mm to 2 mm. The somewhat smaller size of the fluid delivery tubes 158 can help avoid patient discomfort during treatment and facilitate the removal of the treatment device 101 following the completion of treatment.

[0051] As shown in Figure 3, but again referring to Figure 2, in some embodiments the drip matrix 152 can be substantially enclosed within multiple layers of the dressing 102. For example, the fluid delivery tube 158 can be positioned together with the fluid removal path 150 within a chamber 125 formed by the first impermeable layer 118 and the second impermeable layer 120. In some cases, the drip matrix 152 can be inserted together with the fluid removal path 150 within the chamber 125 between the first impermeable layer 118 and the second impermeable layer 120 during manufacturing, for example, before the impermeable layers 118 and 120 are joined to each other by ultrasonic welding. The fluid removal path 150 and the fluid delivery tube 158 can be fixed in place between the impermeable layers 118 and 120 by welding the impermeable layers 118 and 120 together along the boundary of the fluid removal path 150 and the fluid delivery tube 158, as shown by the weld line 162.

[0052] Here, referring primarily to Figures 4A and 4B, further features that can be related to several embodiments of the treatment device 101 in Figure 3 are shown. For example, as shown in Figure 4A, each fluid removal path 150, along with its open end 164, may include an opening or aperture such as a removal path aperture 166 along the length of the fluid removal path 150. 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 embodiment, the fluid delivery tube 158 may have only an open end such as a delivery end 168, or it may be fluidically isolated from the surroundings along the length of the fluid delivery tube 158. In some embodiments, the treatment device 101 may be provided in a single size, and its size may be reduced by cutting and removing a portion of the treatment device 101, thus providing the option to shorten the length of the fluid delivery tube 158 as needed for individual patients in some cases. Therefore, because the openings of the fluid delivery tubes 158 are located only at the ends of individual tubes, the entire fluid delivery tubes 158 and the drip matrix 152 do not rely on the set length of the fluid delivery tubes 158 or the number or size of the perforations in the fluid delivery tubes 158 to uniformly distribute the dripping fluid, thus achieving a higher level of customization.

[0053] Figure 5 shows further features that can be associated with several embodiments of the treatment device 101 of Figure 3. The components and features of the treatment device 101 as an example in Figure 5 are largely the same as or similar to some of the embodiments of the treatment device 101 shown in Figure 4 (collectively), with the exception of some aspects of the fluid delivery tube 158. For example, as shown in Figure 5, instead of having an open end such as the delivery end 168 in Figure 4 to deliver a dripping fluid to a tissue site, the fluid delivery tube 158 may instead have a closed end such as the delivery tube closed end 170. Alternatively, each of the fluid delivery tubes 158 may include an opening or perforation such as a delivery tube perforation 172 along its length. However, the embodiments shown in Figures 4 and 5 are for illustrative purposes only, and it is intended that the fluid delivery tubes 158 may also include perforations along their length as well as both open ends.

[0054] The drip matrix 152 can be adapted to deliver fluid substantially uniformly across the tissue site 112. For example, each of the fluid delivery tubes 158, delivery end 168, and delivery tube perforations 172 can be adapted to provide substantially the same back pressure. Such configurations can prevent the fluid from moving more freely through one of the fluid delivery tubes 158 than another of the fluid delivery tubes 158, or otherwise preferentially. Hereinafter, back pressure can refer to the rise in local pressure caused by resistance to fluid flow, such as through a narrow space in a lumen or aperture. Back pressure can result from the geometric configuration and material properties of a narrow space, without limitation, such as the size of the space, the presence and shape of bends or joints within the space, the surface finish within the space, and other features. In some embodiments, if 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 fluid through the abdomen, a fluid hub such as the distribution hub 160 may be unnecessary.

[0055] Fluids tend to follow the path of least resistance, and therefore, insufficient fluid distribution may result from one of the fluid delivery tubes 158 having lower back pressure or resistance to fluid flow than another of the fluid delivery tubes 158. Similarly, insufficient fluid distribution may result from one of the fluid delivery apertures, such as the delivery end 168 or delivery tube perforation 172, having lower back pressure or resistance to fluid flow than another of the fluid delivery apertures. For example, uniformity of fluid delivery to the tissue site 112 can be improved by the size and configuration of the fluid delivery tubes 158, as well as by the number and size of the delivery ends 168 and delivery tube perforations 172 in each of the fluid delivery tubes 158. Therefore, in some embodiments, the number and size of the delivery apertures, such as the delivery ends 168 and delivery tube perforations 172, may be substantially equal in each of the fluid delivery tubes 158. Furthermore, each of the fluid delivery tubes 158 may have substantially the same dimensions.

[0056] For example, in some embodiments, the fluid delivery tube 158 may have a cylindrical tube shape and an inner diameter of about 2 mm to about 6 mm. Furthermore, in some embodiments, the fluid delivery tube 158 may have an inner diameter of about 4 mm. In some other embodiments, the fluid delivery tube 158 may have an alternative tube shape, where a thinner, i.e., a "flatter" tube 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 may have a diameter of about 0.1 mm to about 0.8 mm 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, substantially uniform pressure can be provided within each of the fluid delivery tubes 158. In these embodiments, the fluid velocity within the fluid delivery tube 158 may be substantially low or substantially static compared to the high fluid velocity passing through delivery apertures such as the delivery end 168 and the delivery tube perforation 172.

[0057] Although not shown in the attached figures, in some embodiments the drip matrix 152 may include an arrangement of fluid delivery tubes 158 arranged in the form of a grid or "spiderweb". Thus, the drip matrix 152 may, in some cases, include a plurality of fluid delivery tubes 158 extending radially from a central hub, along with further tubular segments that fluidically connect each of the radially extending fluid delivery tubes 158. Perforations may be present along any or all of the connecting tubular segments, along with the radially extending fluid delivery tubes 158.

[0058] Figure 6A shows a more detailed view of the hub, such as the distribution hub 160 in Figure 3. In some embodiments, at least a portion of the distribution hub 160 can be positioned between the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120, and can be positioned to communicate fluidly with a fluid delivery path, such as a fluid delivery tube 158. In some embodiments, the height of the distribution hub 160 may be such that the distribution hub 160 can extend outward above the surface of the second liquid-impermeable layer 120 of the treatment device 101. The distribution hub 160 may 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 may 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 may include a number of openings, such as distribution ports 261, positioned around its lower surface. In some embodiments, these distribution ports 261 may be for fluid coupling to fluid delivery tubes 158 of the drip matrix 152. A predetermined size of the opening or distribution port 261 can be calibrated to a specific dripping fluid source, such as a fluid source 108, and its specific settings or design parameters. For example, several 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 may be positioned circumferentially and substantially symmetrically around the distribution hub 160. Thus, the distribution hub 160 and the fluid delivery tubes 158 can define the fluid dripping path.

[0059] As shown in Figure 6A, the distribution hub 160 may include materials that help distribute the dripping downstream body, such as a distribution member 176. The distribution member 176 may include porous or fluid-permeable materials, such as foam. Furthermore, the distribution hub 160 may generally be elongated and cylindrical or bell-shaped, but may have other shapes. In other embodiments, the distribution hub 160 may include fittings such as tubes, tubular fittings, pipes, latched connectors, or similar structures. In such embodiments, the fittings may be pre-bonded or molded directly to the first liquid-impermeable layer 118 or the second liquid-impermeable layer 120 and configured to be fluidly coupled between the fluid supply lumen of the conduit 134 and the fluid delivery tube 158.

[0060] In some embodiments, the distribution hub 160 can be cast or injection molded from a similarly flexible medical-grade silicone or PVC material. In some other embodiments, the distribution hub 160 can be manufactured from two sheets of polyurethane film that are welded together. In some further embodiments, the distribution hub 160 can actually function as a combined fluid dripping and fluid removal hub, in which case the distribution hub 160 can be fluidically 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 distribution hub 160 may include a series of one-way valves. These one-way valves can be any form of one-way valve, such as a commercially available duckbill valve or a custom flap valve. These one-way valves can be located at openings of the distribution hub 160, such as the distribution port 261, to the fluid delivery tube 158 and to the fluid removal path, for example, the fluid removal path 150. In some embodiments of the coupled hub, a common distribution 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] In some cases, the fluid delivery tube 158 may be formed separately from the distribution hub 160 and then attached to the distribution hub 160 by medical-grade adhesive or cyclohexanol, or by welding. In other embodiments, the fluid delivery tube 158 and the distribution hub 160 of the dropper matrix 152 may be formed as a substantially single structure.

[0062] Referring to Figure 6B, but also generally again to Figure 2, the interface 132 can provide both negative pressure and fluid supply connections 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 preferred manner. In some embodiments, the interface 132 can fluidly couple the negative pressure lumen 135 and the fluid supply lumen 137 through a sealing member 128. For example, one or more sealing member apertures can be positioned 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 may 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 may be joined or secured to the interface 132, for example, by a press-fit. In some embodiments, a portion of the interface 132, such as a flange, may be joined to the sealing member 128 in order to position the interface 132 to be in fluid communication with the treatment device 101 through the sealing member 128. The interface 132 may be joined to the sealing member 128 in any preferred manner, such as by an adhesive or other bonding device. For example, in some embodiments, the adhesive used to join the interface 132 to the sealing member 128 may be the same as the one used for the mounting device 142 for the sealing member 128 described above.

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

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

[0066] In some alternative embodiments, the treatment device 101 may include a fluid hub that can function as both a mechanism for distributing the dripping fluid through a distribution path and a mechanism for distributing negative pressure through a fluid removal path and collecting fluid from the fluid removal path. For example, the fluid hub may comprise two layers or chambers separated by a film membrane, such as a polyurethane film membrane. The upper layer or chamber may receive the clean dripping fluid and direct it through a matrix of open paths to a fluid delivery tube. The upper chamber may also include a base with ridges or folds to help direct the fluid. In some embodiments, the base may provide a continuous film layer during the fluid dripping stage of the treatment, but when negative pressure is applied, the folds or flaps of the base may be pulled upward to provide a small opening through which the fluid passes to proceed upward from the lower chamber and exit through the fluid hub. The upper chamber may also include a porous foam ring around the inner circumference of the chamber to provide a filter for relatively large contaminants coming through the fluid dripping path. The foam ring may also function as a seal when compressed under negative pressure to close the fluid dripping path. The lower layer or chamber of the fluid hub can be connected to a fluid removal path, and the lower chamber may include manifold material to ensure that the fluid path 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 possibility of mixing clean dripping fluid with contaminated fluid from the tissue site. In some embodiments, the fluid hub may include one or more valves, such as O-ring seal valves, within the upper chamber, which can block the opening from the upper chamber to the fluid dripping path when negative pressure is applied.

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

[0068] The treatment device 101 can be positioned to contact the contents of the abdominal cavity 113, and a portion of the treatment device 101 can be pushed into the patient's paracolonic groove. Specifically, the fluid removal pathway 150 can be positioned close to the first paracolonic groove 115 and the second paracolonic groove 117. When deployed, the treatment device 101 can cover all exposed viscera and separate them from contact with the wall of the abdominal cavity 111. The treatment device 101 can be sized and shaped to enable such covering.

[0069] The treatment device 101 can be covered with a sealing member 128 at the tissue site 112 to provide a sealing space for housing the treatment device 101. The sealing member 128 can be positioned around the tissue site 112 and fluidically sealed by the mounting device 142 as described above. If the aperture of the sealing member 128 is not already provided as part of the sealing member 128, it can be cut through the sealing member 128 or otherwise positioned as needed. Negative pressure and fluid supply connections can be made, for example, by the interface 132, or through direct coupling of the negative pressure lumen 135 to the fluid removal assembly 148 and the fluid supply lumen 137 to the drip matrix 152. It is important to note that the dripping body can be independently supplied into the drip matrix 152 from a fluid source such as the fluid source 108 through the fluid supply lumen. Therefore, 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. Therefore, the possibility of contamination of the clean fluid dripping pathway can be reduced or significantly eliminated, resulting in a more efficient cleaning cycle. Depending on how the components of the treatment device 101 are specifically configured, in some embodiments, the fluid can be supplied directly through the fluid dripping tube into the lower part of the abdomen, such as the paracolonic grooves, for example, the first paracolonic groove 115 and the second paracolonic groove 117.

[0070] By activating the negative pressure source 106, negative pressure can be supplied to the fluid removal assembly 148 through the negative pressure lumen 135 of the conduit 134. The fluid source 108 can supply dripping fluid to the dripping matrix 152 through the fluid supply lumen 137, for example, by activating a pump or positive pressure source in the fluid source 108, or by the action of gravity acting on the dripping body or by manual force from the user. Negative pressure and the dripping body can be supplied to the treatment device 101 simultaneously or periodically at alternating times. Furthermore, negative pressure and the dripping body 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 lead arrow 169 in Figures 4A to 5, fluid from the tissue site 112 can be drawn into or extracted into the fluid removal path 150 through the open end 164 and the removal path aperture 166. The fluid in the fluid removal path 150 can be transmitted through the fluid removal path 150 to the fluid removal hub 154, where it can be drawn into the negative pressure lumen 135 of the conduit 134 and finally into the container 110.

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

[0073] Fluid being dropped or delivered to the tissue site 112 through the drop matrix 152 may remain physically and fluidly separate from the fluid removal assembly 148 until it reaches or directly contacts the tissue site 112. Upon delivery to the tissue site 112, the dropped fluid may mix with other fluids that can be considered, for example, previously dropped fluid, wound fluid, tissue fluid, and waste fluid. When negative pressure is applied to the treatment device 101, tissue or wound fluid from the tissue site 112, and any dropped fluid delivered prior to the tissue site 112, can be extracted through a separate fluid removal assembly 148. Fluid extracted from the tissue site 112 through the fluid removal assembly 148 may remain physically and fluidly separate from the drop matrix 152. This separation between the fluid removal assembly 148 and the drip matrix 152 prevents any fluid that may remain in the fluid removal pathway 150 or fluid removal hub 154, for example, after or during extraction from the tissue site 112, from being pushed back into the tissue site 112 during fluid dripping.

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

[0075] Generally, Figures 1 to 6B continue to further describe a method for providing fluid infusion and negative pressure treatment at a tissue site. In some embodiments, the method for providing fluid infusion and negative pressure treatment at a tissue site may include positioning a treatment device 101 adjacent to the tissue site 112. The treatment device 101 may 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 may be the abdominal cavity 111, and positioning the treatment device 101 adjacent to the tissue site 112 may include positioning at least a portion of the treatment device 101 close to the paracolonic grooves in the abdominal cavity 111, such as the first paracolonic groove 115 and / or the second paracolonic groove 117. Furthermore, in some embodiments, the method may include covering the treatment device 101 with a sealing member 128 to provide a sealing space between the sealing member 128 and the tissue site 112. In some embodiments, the method may include sizing the treatment device 101 to be placed on the tissue site 112. As described above, sizing the treatment device 101 may include cutting or tearing the treatment device 101. Optionally, the treatment device 101 may include visual markings to guide the user to customize the treatment device to the desired size.

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

[0077] Referring here to Figure 7A, another embodiment of the treatment device 201 used in the treatment system 100 is shown. In this embodiment, the treatment device 201 may include substantially the same components as the treatment device 101 in Figure 3, although the arrangement and function of the individual features may differ. For example, the treatment device 201 may include a plurality of fluid removal pathways 150, which can be positioned between a plurality of fluid-impermeable layers of the dressing 202 and fluidically connected to a fluid removal hub 154. However, in this embodiment, the treatment device 201 may include a drip matrix 252 having a plurality of fluid delivery tubes 258 that can be attached to a 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 individually position each of the fluid delivery tubes 258 within the patient's abdominal cavity. Therefore, the user may choose to uniformly spread the fluid delivery tube 258 through the abdominal cavity to provide a thorough, uniform rinse of the abdomen, or alternatively, the user may choose to concentrate the fluid delivery tube 258 on any particular area of ​​interest to provide a more thorough wash. The treatment device 201 may allow the user to make this decision individually. In some embodiments, the fluid delivery tubes 258 may comprise a perforated polyurethane film or foam bag. For example, the fluid delivery tube 258 may be constructed using two layers of polyurethane film about 100 micrometers thick, joined together at the edges. The fluid delivery tube 258 may have an open end for targeted fluid delivery. Similarly, in such embodiments, the distribution hub 260 may be constructed from two layers of polyurethane film about 100 micrometers thick, joined together and welded. In some embodiments, within each of the fluid delivery tube 258 and the distribution hub 260, there may be a central core adapted to ensure that an open path is maintained and to assist the user in handling during placement. For example, this central core could be an open-cell network polyurethane foam.The dimensions of the central core material positioned within the fluid delivery tube 258 can be modified; for example, the central core material may range from approximately 2 mm to 10 mm thick × approximately 5 mm to 15 mm wide. In some embodiments, the central core material may be approximately 6 mm thick × 10 mm wide. The length of the central core material can be modified based on the overall sizing considerations of the treatment device 201. Some embodiments of the treatment device 201 may include a central core material having a width that varies along its length, thereby allowing for breakpoints that provide customization and sizing for the user. In some cases, the fluid delivery tube 258 can be adapted so that any dripping fluid remaining in the fluid delivery tube 258 following the delivery of the dripping fluid by the fluid source 108 can be squeezed out of the fluid delivery tube 258 when negative pressure is applied to the treatment device 201, thus ensuring that substantially all of the dripping fluid is emptied from the fluid delivery tube 258 and that the volume of dripping fluid provided during the treatment cycle is better regulated.

[0078] Figure 7B shows an embodiment of the treatment device 301 similar to the embodiment in Figure 7A, but the treatment device 301 includes both fluid removal paths and fluid delivery paths that can be individually positioned, rather than including multiple fluid removal paths positioned between the liquid-impermeable layers of the dressing 202. In some embodiments, the treatment device 301 may 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. Furthermore, in some embodiments, the treatment device 301 may also include a delivery 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 may choose to concentrate the fluid delivery tube 258 together with the fluid removal path 250 to any region of interest within the patient's abdominal cavity. The user may also choose 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 these embodiments, the dressing 302 can be provided with a fluid removal path 250 and a fluid delivery tube 258, either attached to the liquid-impermeable layer of the dressing 302 or separately assembled by the user.

[0079] Figure 7C also illustrates another embodiment of the treatment device 401, which, like the treatment device 301 in Figure 7B, may include both a drip matrix 352 having multiple fluid removal pathways 350 and fluid delivery tubes 358 that loosely extend adjacent to or below the fluid-impermeable layer of the dressing 402. However, in some embodiments, as shown in Figure 7C, each of the fluid removal pathways 350 may be paired with a fluid delivery tube 358 to be positioned in the same area within the patient's abdominal cavity. In such embodiments, the fluid removal pathways 350 may be paired with fluid delivery tubes 358, but two separate fluid pathways are still maintained. Such an arrangement can offer the advantage that fluids dripped into locations within the abdominal cavity can later be removed from the same area (which can be important if the area of ​​the abdominal cavity is highly contaminated) and cross-contamination with other areas of the abdominal cavity can be avoided. Since neither the fluid removal pathway 350 nor the fluid delivery tube 358 are positioned within the fluid-impermeable layer of the dressing 402, the treatment device 401 may therefore require a separate dressing 402 containing a fluid-impermeable layer, which can then be applied to the patient's abdominal cavity after the combined fluid removal pathway 350 and fluid delivery tube 358 have been positioned. Depending on specific manufacturing and user requirements, the dressing 402 may be provided attached to the fluid removal pathway 350 and the drip matrix 352, or separately for user assembly.

[0080] Referring here to Figure 8, another exemplary embodiment of the treatment device 501 is shown. In this embodiment, the fluid removal pathways 450 and fluid delivery tubes 458 of the drip matrix 452 are formed as part of the dressing 502, and each fluid removal pathway 450 extends adjacent to and parallel to the fluid delivery tubes 458, thus forming parallel pathways 590. In some embodiments, the parallel pathways 590, each of which may include a fluid removal pathway 450 and a fluid delivery tube 458, can be connected between segments of the fluid-impermeable layer of the dressing 502 by perforated joints such as perforations 592 in the fluid-impermeable layer of the dressing 502. Thus, each parallel pathway 590 is individually movable by cutting or tearing along the perforations 592 around it and can be positioned within a predetermined region of the abdominal cavity, such as adjacent to the small intestinal loop, paracolonic groove, retroperitoneal space, lymphatic system, etc. Furthermore, some embodiments of the dressing 502 may also include additional perforated joints or perforated lines between each of the fluid removal paths 450 in the parallel path 590 and each of the fluid delivery tubes 458. Thus, each of the fluid removal paths 450 is also independently movable from the corresponding pair of fluid delivery tubes 458 and can be positioned as needed within the abdominal cavity. Regardless of position, each of the fluid removal paths 450 can remain fluidically connected to the fluid removal hub 454, and each of the fluid delivery tubes 458 can remain fluidically connected to the distribution hub 460.

[0081] Figure 9 features some embodiments of a treatment device in which a fluid removal path and a fluid dripping path can be combined 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 connecting tube 694. The connecting tube 694 may include a central bore 696 which can be formed by an inner lining 697, which may be a film such as a polyurethane film. The connecting tube 694 may also include an outer lumen 698 which can be formed by an outer lining 699, which may 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] Referring here to Figures 10A to 10C, an example of another embodiment of the treatment system 100 and the treatment device 701 used therein is shown. In some embodiments, the treatment device 701 may include a dressing 702 which may be formed from a plurality of liquid-impermeable layers or visceral protective layers, such as a first liquid-impermeable layer 718 and a second liquid-impermeable layer 720. The treatment device 701 may also include a delivery connector 763 for delivering a dripping downstream substance to the treatment device 701. The treatment device may also include a fluid removal hub 754 which 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 Figure 10A, the treatment device 701 may further include a fluid delivery container 760 for distributing the dripping downstream substance. The fluid delivery container 760 may be a flexible container fluidly connected to a dripping source, such as a fluid source 108 of the treatment system 100. In some embodiments, the body of the fluid delivery container 760 may consist 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 may consist of a polyurethane film having a thickness in the range of 50 micrometers to 200 micrometers. Optionally, the fluid delivery container 760 may be a perimeter welded structure having a predetermined volume. Some embodiments of the fluid delivery container 760 may include internal welds between the portions of the polyurethane film forming the body of the fluid delivery container 760 to reduce the expansion of the container when pressure is applied. The internal welds may also be incorporated to help direct the dripping downstream body into the fluid delivery container 760 to reduce the internal volume of the fluid delivery container 760 or to help ensure uniform distribution into the peritoneal cavity from the fluid delivery container 760.

[0083] As shown in Figures 10A to 10C, the fluid delivery container 760 can be integrated with the dressing 702 as part of the treatment device 701. In some cases, the dressing 702 and the fluid delivery container 760 can essentially form a two-chamber structure, with the two chambers arranged in a vertical stack. As shown in Figures 10A to 10C, the fluid delivery container 760 can be formed from a container layer 780 that is bonded 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 to a dripping fluid source, through the dressing 702, via sealed and welded openings such as a dressing opening 779, which can penetrate the dressing 702's internal protective layer, the first liquid-impermeable layer 718, and the second liquid-impermeable layer 720.

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

[0085] During operation, the dripping body can enter the fluid delivery container 760, and once the fluid delivery container 760 is filled, back pressure can be generated, and thus the back pressure pressurizes the fluid delivery container 760 before the dripping body can actually be released from the fluid delivery container 760. This function can help ensure that the fluid is dispersed more uniformly through the container aperture 781, and thus can provide a uniform distribution of dripping fluid from the entire area of ​​the fluid delivery container 760. However, the fluid delivery container 760 can be designed so that the level of back pressure generated by the fluid delivery container 760 remains below a threshold pressure for triggering an alarm in the fluid delivery system, such as the fluid source 108 of the treatment system 100. Furthermore, the container aperture 781 can be arranged to provide relatively high flow rates in some places and relatively low flow rates in other places, for example, by including an asymmetrical pattern of the container aperture 781. Therefore, the pattern of the container aperture 781 can influence fluid distribution, allowing for the manufacture of different versions of the fluid delivery container 760 designed to target specific areas or organs of the abdominal cavity or other tissue sites. Furthermore, in some embodiments, the container layer 780 of the fluid delivery container 760 can incorporate welds or other methods to create a quilting effect within the fluid delivery container 760, thereby reducing the internal volume of the fluid delivery container 760, eliminating expansion due to back pressure, or facilitating fluid distribution. Thus, this feature can help reduce patient discomfort and associated risks.

[0086] The potential delay in releasing the dripping fluid from the fluid delivery container 760 into the peritoneal cavity or other tissue site can offer the advantage of allowing the temperature of the dripping fluid to equilibrium with the body's core temperature, thereby reducing the risk of thermal shock. Once released from the fluid delivery container 760, the dripping fluid flows through the peritoneal cavity into the paracolonic groove, flushing through that pathway. Furthermore, some dripping fluid may remain in the fluid delivery container 760 following the dripping cycle, resulting in a possible 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 pathway 750 (shown in Figure 10B), continuing to flush out the peritoneal contents as it is removed from the peritoneal cavity. In some cases, any 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 as it is removed. For example, after most of the dripping fluid has been removed from the abdominal cavity and negative pressure has begun to build up in the cavity, the components of the treatment device 701 can be pulled down, and the remaining fluid in the fluid delivery container 760 can be removed as a bolus of rapidly moving fluid, and thus can act as a final and secondary rinse. The fluid dripping and negative pressure cycle can be repeated as needed and required.

[0087] Here, primarily referring to Figure 10B, similar to the other embodiments described in detail above, the treatment device 701 may include a plurality of fluid removal pathways 750, each of which may be fluidically coupled to a fluid removal hub 754. Thus, the fluid removal hub 754 can act as a distribution mechanism that transmits negative pressure to each of the fluid removal pathways 750. Each of the fluid removal pathways 750 may include a manifold member that transmits negative pressure and draws fluid through the fluid removal pathway 750. For example, the manifold member may be made of open-cell foam or nonwoven fabric, such as GRANUFOAM®. The fluid removal pathways 750 may be incorporated within the dressing 702, and therefore between the visceral protective layer, the first fluid-impermeable layer 718, and the second fluid-impermeable layer 720. Incorporating the fluid removal pathways 750 between the visceral protective layers can help protect the abdominal cavity from the manifold member, which may otherwise pose a risk of granulation tissue formation. In some embodiments, the fluid removal pathway 750 can be formed by welding together portions of a first liquid-impermeable layer 718 and a second liquid-impermeable layer 720 to form a fluid channel between the film layers. Referring primarily to Figure 10C, the first liquid-impermeable layer 718, and possibly the second liquid-impermeable layer 720 as well, may also include openings such as apertures 766, which can be positioned along each of the fluid removal pathways 750. Below each of the fluid removal pathways 750, fluid can be drawn into the fluid removal pathway 750 through the apertures 766 of the first liquid-impermeable layer 718. Each of the fluid removal pathways 750 may also include an opening at its end, thereby allowing for a considerable amount of fluid removal from the patient's paracolonic groove. Providing fluid removal concentrated in the lower parts of the patient's abdomen, such as the paracolonic groove, can help ensure that the abdomen is thoroughly washed during the drip and removal therapy cycle.

[0088] Figures 11A and 11B show another embodiment of the treatment device 701, which in many respects may be similar to the embodiment of the treatment device 701 discussed with respect to Figures 10A–10C. However, in the exemplary embodiment shown in Figures 11A and 11B, the treatment device 701 may incorporate a fluid delivery container 760, which, together with a container chamber 782, includes a radial channel 784 that may extend down the medial side of the abdominal wall into the paracolonic groove of the patient's abdomen. This embodiment can, in particular, enable uniform distribution of the dripping fluid into the abdominal cavity while simultaneously providing concentrated washing of the paracolonic groove with a clean dripping fluid. The radial channel 784 may have a channel aperture 786 along each length of the radial channel 784, along with an open end 785. In some embodiments, the radial channel 784 may be designed to restrict flow into the paracolonic groove. The open-end design of the radial channel 784 allows the radial channel 784 to be cut to fit the individual patient's needs and proportions, and to be sized accordingly.

[0089] Referring here to Figures 12A and 12B, another exemplary embodiment of the treatment device 701 is shown. In this case as well, many of the features of the treatment device 701 in Figures 12A and 12B may be the same as or similar to the features of the embodiments of the treatment device 701 considered with respect to Figures 10 and 11. In the embodiment examples in Figures 12A and 12B, the fluid delivery container 760 may 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 unblocked or sealed. Examples of materials for the internal manifold matrix 788 include foams such as polyurethane foam, Libeltex TDL2, embossed film, or any other molded structure.

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

[0091] Importantly, by allowing the fluid delivery container 860 to be supplied separately from other parts of the treatment device 801, such as the dressing 702, surgeons or other caregivers may be able to individually and more appropriately determine the fluid delivery requirements within the patient's abdomen and apply a fluid delivery container that is of the appropriate size or appropriately configured. Some embodiments of fluid delivery containers, such as the fluid delivery container 860, may also be supplied as accessories to existing abdominal dressings, such as ABThera®, which is commercially available from Kinetic Concepts, Inc. in San Antonio, Texas.

[0092] Figures 14A and 14B refer to examples of embodiments of the treatment device 801, which may be similar to exemplary embodiments of the treatment device 801 shown in Figures 13A and 13B. However, in the embodiments shown in Figures 14A and 14B, the fluid delivery container 860 may incorporate further components, which may be foldable or non-foldable matrices, such as a manifold matrix 884, that can allow the fluid delivery container 860 to be filled with dripping fluid. In some embodiments, the fluid delivery container 860 may include a lower layer, i.e., a container layer 880, which may be occludable, and an upper layer, such as an upper container layer 883, which may incorporate perforations, windows or openings, such as an upper container aperture 885. The upper container aperture 885 can allow the flow of dripping fluid out from the top surface of the fluid delivery container 860, which may occur after the fluid delivery container 860 has been filled with dripping fluid during a treatment cycle. In some cases, by ensuring that the fluid delivery container 860 is completely filled with the dripping fluid before the fluid enters the abdominal cavity, it is possible to eliminate the need to generate back pressure within the fluid delivery container 860 to ensure uniform fluid distribution.

[0093] Referring here to Figure 15, an example of another embodiment of the treatment system 100 and the treatment device 1001 used therein is shown. In one embodiment, the treatment device 1001 may include a single layer, such as an occlusion layer 1002, which divides the abdominal cavity into two vertically stacked chambers or compartments. The treatment device 1001 may also include a fluid removal manifold 1004 that can be positioned within the central portion of the occlusion layer 1002, which can fluidly transfer negative pressure to the channels of the occlusion layer 1002 in order to collect and remove fluid from the abdominal cavity. Furthermore, the treatment device 1001 may include a pressurized distribution container 1006 that can distribute dripping fluid to a region of the abdominal cavity across the occlusion layer 1002. As described above with respect to other embodiments, at interface 132, a conduit 134 for transporting negative pressure and / or dripping fluid can be fluidly connected to the treatment device 1001.

[0094] During operation, as described above with respect to other embodiments, the dripping fluid can be delivered by a suitable fluid source, and once delivered to the pressurized dispensing container 1006 of the treatment device 1001, it can be forced to cross the surface of the occlusion layer 1002. The dripping fluid can flow over the occlusion layer 1002 through the formed path until it reaches the furthest extent of the occlusion layer 1002 and comes into contact with the abdominal contents, and ultimately the paracolonic groove. As the dripping fluid flows across the upper surface of the occlusion layer 1002, it can be warmed to body temperature by body heat and spread over a wide area. As described above, a residence time occurs for the dripping fluid, and a portion of the dripping fluid remains in the pressurized dispensing container 1006 above the dripping surface of the occlusion layer 1002, which can later act as a bolus of clean fluid when removed.

[0095] During negative pressure, i.e., the fluid removal cycle, the dripping fluid can be drawn out of the body cavity by being drawn along the path formed on the underside, i.e., bottom surface, of the occlusion layer 1002. When negative pressure is applied, the occlusion layer 1002 can be pulled downward and compressed tightly against the body cavity contents. This movement allows the contents of the abdominal cavity, such as internal organs, to come into contact with the dripping fluid being drawn along the path formed on the underside of the occlusion layer 1002. As described above in relation to other embodiments, while negative pressure is applied, any 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 here to Figure 16, a schematic cross-sectional view of part of the treatment device 1001 and conduit 134 of Figure 15 is shown. 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 may be a fluid removal chamber 1008 located in contact with the internal organs, and above the occlusion layer 1002 there may be a fluid dripping chamber 1010 that can be brought close 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 furthest extent of the treatment device 1001 in the abdomen before being removed. Importantly, the occlusion layer 1002 can also act as a visceral protective barrier. In some embodiments, the occlusion layer 1002 can be biased to collapse downward and substantially form a seal when negative pressure is applied, and the seal can help minimize cross-contamination between the fluid dripping chamber 1010 and the fluid removal chamber 1008.

[0097] Referring again to both Figures 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 pathways both below the occlusion layer 1002 in the fluid removal chamber 1008 and above the occlusion layer 1002 in the fluid dripping chamber 1010. For example, the fluid pathways can be formed by folds 1012 of the occlusion layer 1002, which can be generated using high-frequency welding techniques. For example, high-frequency (HF) or high-frequency (RF) welding may include joining portions of the occlusion layer 1002 together by using high-frequency electromagnetic energy to melt some of the material of the occlusion layer 1002. The folds 1012 can be arranged to uniformly distribute the fluid to the distal edge of the occlusion layer 1002. The number of folds 1012 can be modified as needed or required to further control the flow of dripping fluid within the peritoneal cavity.

[0098] In some embodiments, the fluid removal manifold 1004 may be a flexible container pneumatically or fluidly connected to the container 110 and negative pressure source 106 through the removal path of the conduit 134. The fluid removal manifold 1004 may be a polyurethane film welded to each other at its outer circumference, and can be made from multiple films welded together. For example, the fluid removal manifold 1004 may include an upper manifold film 1014 and a lower manifold film 1016. As shown in Figure 16, in some embodiments, the fluid removal manifold 1004 may include openings or windows, which may be included as inlets 1018 as part of the lower manifold film 1016. These inlets 1018 on the underside of the fluid removal manifold 1004 may be for distributing negative pressure to the fluid removal chamber 1008 and for replenishing fluid from the fluid removal chamber 1008. The inlets 1018 may be sized according to the specific suction requirements. In some embodiments, the fluid removal manifold 1004 may include a manifold material 1019 that can be housed within an upper manifold film 1014 and a lower manifold film 1016. The manifold material 1019 may include various different materials suitable for transmitting or transferring fluids. For example, in some embodiments, the manifold material 1019 may include an open-cell foam having pores with a diameter of about 6 mm.

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

[0100] Figure 17 shows a schematic cross-sectional view of part of another exemplary embodiment of the treatment device 2001 and conduit 134. This exemplary figure shows how multiple layers can be included to generate the occlusion layer 2002 and further pathways from the distal portion and tip of the paracolic groove in the abdominal cavity to the fluid removal manifold 2004. In the case of such multilayer occlusion layers, such as the occlusion layer 2002, the structure can be fabricated from a film material and can be formed in three dimensions by heat, vacuum or compression molding, etc.

[0101] Referring further to Figure 17, some embodiments of the treatment device 2001 may include a manifold, such as a fluid removal manifold 2004, which is coupled to or formed as part of the occlusion layer 2002. For example, in some embodiments, the fluid removal manifold 2004 may be formed from only a lower manifold film 2016 which is attached to or welded to the underside of the occlusion layer 2002, thus eliminating the need for an upper manifold film, such as the upper manifold film 1014 in Figure 16. In some further embodiments, as shown in Figure 17, the fluid removal manifold 2004 may be positioned within multiple layers of the multilayer occlusion layer 2002, so that the lower manifold film 2016 having an inlet 2018 can actually be formed as part of the lower layer of the multilayer occlusion layer 2002. In these embodiments, the fluid removal path may exist between the various layers of the multilayer occlusion layer 2002 through the outer periphery inlet 2026 of the fluid removal manifold 2004, and below the fluid removal manifold 2004 and through the inlet 2018 on the underside of the multilayer occlusion layer 2002. The fluid removal manifold 2004 may include a manifold material 2019 capable of transmitting negative pressure and fluid, and may include materials such as a three-dimensionally formed film, wicking material, and molded manifold.

[0102] In some embodiments, the pressurized distribution container 2006 can be bonded to or formed as part of the closure layer 2002. For example, in some embodiments, the pressurized distribution container 2006 can be formed from only an upper container film 2020 that is attached to or welded to the upper surface of the closure layer 2002, thus eliminating the need for a lower container film, such as the lower container film 1022 in Figure 16. In some embodiments, the upper container film 2020 can be molded together with the closure layer 2002 as a single structure, instead of being molded and joined from many flexible parts. Optionally, the upper container film 2020 and the closure layer 2002 can be quilted to ensure an opening path from the pressurized distribution container 2006. For example, parts of the upper container film 2020 and the closure layer 2002 can be welded together, such as around the welded outer periphery of the upper container film 2020 and parts of the closure layer 2002. Furthermore, portions of the upper container film 2020 and the occlusion layer 2002 can be spot-welded in a pattern across both material layers to produce a quilting effect. As a result, in some embodiments, the height and volume of the pressurized distribution container 2006 can be limited when filled with fluid. Using a variety of materials, the pressurized distribution container 2006 can be formed, including, but not limited to, small inner diameter tubes. In some embodiments, the flow distribution of the dripping fluid can be controlled by an outer peripheral outlet 2024 that can be positioned at the periphery of the pressurized distribution container 2006. As in other embodiments, such an outer peripheral outlet 2024 can be produced by techniques such as high-frequency welding. The exemplary embodiments in Figure 17 show modified versions of the occlusion layer 2002, fluid removal manifold 2004, and pressurized distribution container 2006, but any combination of these features can be incorporated into a single embodiment.

[0103] Figures 18A to 18C show further details relating to features by several exemplary embodiments of the closure layer, such as the closure layer 1002 in Figure 15. For example, as shown in Figure 18A, it can be formed from a single base layer 3030, which is formed to have a plurality of accordion folds 3012, which may be equivalent to the folds 1012 of the closure layer 1002 in Figure 15. The accordion folds 3012 can be formed by forming both a fluid removal path 3032 that can be included below 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.

[0104] Figure 18B shows another exemplary embodiment of the occlusion layer 4002, in which the fluid path is formed by tubular folds 4012 instead of the accordion folds 3012 shown in Figure 18A. In this embodiment, the occlusion layer 4002 can be formed from a base layer 4030 having a plurality of tubular folds 4012, the plurality of tubular folds 4012 formed on the upper surface of the base layer 4030 by a separate tubular layer 4036. Alternatively, the tubular folds 4012 can be formed from a single base layer 4030 formed as an integral tubular structure, for example, by joining or tightening portions of the base layer 4030 together to form the tubular folds 4012. In either case, a fluid removal path 4032 can be provided inside the tubular folds 4012, and a fluid delivery path 4034 can extend along the upper surface of the base layer 4030 between the tubular folds 4012 containing the fluid removal path 4032.

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

[0106] Further embodiments of methods for providing negative pressure therapy and fluid drip treatment at a tissue site will be described here, primarily with reference to Figures 19A to 19C. For example, in some embodiments, the treatment system 6000 may include a treatment device 6001, a negative pressure source 6006, and a fluid source 6008, which is a separate, independent device from the negative pressure source 6006. The fluid source 6008 may be a separate mechanical drip device. In some embodiments including a separate mechanical drip device for the fluid source 6008, the treatment system 6000 may also include a drip regulator 6019 that monitors and / or controls the amount of drip fluid delivered to the treatment device 6001 and ultimately to the tissue site 112. As shown in Figures 19A to 19C, some disclosed methods may include a treatment cycle comprising three stages or intervals. For example, as shown in Figure 19A, the first stage of the treatment cycle may 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 is transmitted through the fluidically connected pathways of the treatment system 6000 and can eventually reach the drip regulator 6019 and the fluid source 6008. Thus, this transmitted negative pressure can prime the fluid source 6008, which may be a mechanical drip device. Continuing with Figure 19B, the method may further include a second stage of the treatment cycle, which may include pausing or terminating negative pressure delivery from the negative pressure source 6006 at predetermined time intervals. During this interval, the fluid source 6008, such as a mechanical drip device, can deliver the dripping fluid to the drip regulator 6019 and ultimately to the treatment device 6001. As shown in Figure 19C, a third stage of the treatment cycle can be initiated following a specified interval of delivery of the dripping fluid from the fluid source 6008 to the treatment device 6001. During this third stage, fluid delivery may be paused, and the negative pressure source 6006 can be reactivated to provide further intervals of negative pressure therapy. At this point in the treatment cycle, the dripping fluid can be removed from tissue sites 112, such as the abdominal cavity 111, along with the treatment device 6001.Furthermore, the fluid source 6008 can be reprimed and prepared to deliver the dripping fluid to the treatment device 6001 again when the second stage of the treatment cycle may be repeated.

[0107] Figures 20A–20C illustrate another embodiment of a method for providing negative pressure therapy and fluid drip treatment to a tissue site. The method illustrated by Figures 20A–20C may be substantially similar to the method described above with respect to Figures 19A–19C, with various modifications. For example, as shown in Figure 20A, the treatment system 6000 may include a treatment device 6001, a negative pressure source 6006, a fluid source 6008, and a drip regulator 6019. Furthermore, the treatment system 6000 may further include a pressure relief unit 6021. In some embodiments, the negative pressure source 6006 can be activated to apply negative pressure therapy to the treatment device 6001 during the first stage of the treatment cycle. The negative pressure applied by the negative pressure source 6006 can be transmitted through the fluidically connected pathways of the treatment system 6000 and eventually reach the drip regulator 6019 and the fluid source 6008. This transmitted negative pressure can prime the fluid source 6008, which may be a mechanical drip device. Continuing with Figure 20B, the method may further include a second stage of the treatment cycle, during which the pressure relief unit 6021 is opened and negative pressure delivery to the treatment device 6001 is stopped. In some embodiments, the pressure relief unit 6021 may be opened according to a predetermined or pre-determined timing schedule. During the second stage of the treatment cycle, the fluid source 6008 may deliver the dripping body to the drip regulator 6019 and ultimately to the treatment device 6001, which may occur while the pressure relief unit 6021 is open, thus preventing negative pressure from being transmitted to the treatment device 6001 and the fluid source 6008 and drip regulator 6019. As shown in Figure 20C, following the second stage of the treatment cycle, a third cycle of the treatment cycle may be initiated, during which the pressure relief unit 6021 may be closed, in this case also according to a time-determined interval schedule. During the third stage of the treatment cycle, fluid dripping can be paused, and the negative pressure source 6006 can be reactivated to provide further intervals in negative pressure therapy.The dripping fluid can be removed from the treatment device 6001, and the fluid source 6008 can be primed and prepared to deliver the dripping fluid back to the treatment device 6001.

[0108] In some further methods of providing negative pressure therapy and fluid dripping to a tissue site, a manually controlled dripping container, such as a fluid bag, bottle, or other container, can be incorporated, rather than an automated or otherwise modified mechanical dripping device. Thus, in some embodiments, during the first stage of the treatment cycle, the negative pressure source can apply negative pressure therapy to the treatment device and tissue site, while a device such as a clamp, valve, or other form of closure device can prevent fluid from being transferred from the manually controlled dripping container to the treatment device and tissue site. In some embodiments, during a subsequent stage of the treatment cycle, the user can release the clamp or other form of closure device and manually adjust the volume of fluid being dripped. During this dripping stage, the negative pressure source can remain operational and thus provide immediate removal of the dripped fluid from the treatment device and tissue site. Thus, according to some embodiments of this method, the residence time of the fluid at the tissue site can be substantially eliminated. The user can then tighten the closure device again or otherwise close it, thus stopping the flow of dripping fluid from the manually controlled dripping container. The negative pressure source can then continue to remove exudate, along with any excess or remaining dripping fluid, from the treatment device and tissue site. In some other embodiments of the disclosed method, the negative pressure source can be paused rather than allowing the negative pressure source to remain active while fluid is being dripped from a manually controlled drip container, thus allowing the dripping fluid to remain at the tissue site for a predetermined period. Where appropriate, the user can close the manually controlled drip container to prevent the delivery of the dripping fluid. Negative pressure therapy can be restarted before or after the dripping is stopped, during which time any excess or remaining fluid can be removed from the treatment device and tissue site.

[0109] The systems, apparatus, and methods described herein can offer significant advantages. As stated above, the disclosed systems and devices can provide a combined temporary abdominal closure dressing system with a fluid drip 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 for irrigating and washing the abdominal cavity while supporting and protecting the abdominal contents and removing contaminated fluid to suppress and / or reduce edema. Furthermore, the various layers and components of the disclosed dressing can facilitate more rapid primary facial closure of the abdominal cavity as a result of applying tension and closure forces to the abdominal contents.

[0110] As described herein, the disclosed solution can provide a means of irrigating all areas of the abdominal cavity, including the small intestinal loop, parasulcus, retroperitoneal space, and parts of the lymphatic system, all while the dressing system is in place, thus reducing the time required for patients and clinical staff in the operating room. The various embodiments described provide various configurations of fluid pathways designed to maximize the exposure of visceral organs of abdominal tissue sites to fluid drip therapy. The disclosed dressing components can also allow for longer dressing application times without adhering to the fascia of the abdominal tissue site. Thus, it is possible to provide repeatable and reliable fluid drip that can be uniformly delivered to various parts of the tissue site. As a result, fluid irrigation and lavage can be made more consistent, thus reducing mortality in patients with septic abdominal cavity. Fluid drip can be managed at the patient's bedside and can be individually and specifically adapted and adjusted.

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

[0112] Importantly, the disclosed device design may also allow for user sizing and / or customization at the time of application to the patient in the operating room. In some embodiments, improved ease of use for dressing placement, sizing, and removal can be provided by built-in sizing or placement visual marks or indicators to guide the user. Some embodiments of the disclosed dressing system may also include various components, such as fluid dripping and / or fluid removal pathways already pre-attached to the structural dressing layer, to make use even more efficient and simplified. As a result, improved fluid delivery and removal can be enabled compared to existing dressing systems, as well as improved ease of use.

[0113] Although only a few exemplary embodiments have been shown, those skilled in the art will understand that the systems, apparatus, and methods described herein are subject to various modifications and changes. Furthermore, descriptions of various alternatives using terms such as “or” do not need to be mutually exclusive unless clearly required by the context, and the indefinite article “one (a, an)” does not limit the subject to a single example unless clearly required by the context. Moreover, any feature described in relation to any one embodiment may also be applicable to any other component. Components can also be combined or omitted in various configurations for the purpose of sale, manufacture, assembly, or use. For example, in some configurations, the treatment device 101, including the dressing 102, the container 110, or both, can be omitted or separated from other components for manufacture or sale.

[0114] The attached claims describe novel and inventive aspects of the subject matter described above, but may also include further 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 already known to those skilled in the art and therefore not necessary to identify novel and inventive features. The features, elements, and aspects described herein may be combined or replaced by alternative features that serve the same, equivalent, or similar purposes without departing from the scope of the invention as defined by the attached claims.

Claims

1. A system for treating tissue sites within the abdominal cavity, A film layer configured to be positioned over internal organs in the abdominal cavity, wherein the film layer has a first surface and a second surface opposite to the first surface, the first surface facing the internal organs in the abdominal cavity and the second surface facing away from the internal organs, A fluid removal manifold is disposed adjacent to the first surface of the film layer and configured to face the internal organs, A system comprising a fluid distribution container including a tube disposed adjacent to a second surface of the film layer, the fluid distribution container being separated from the fluid removal manifold by the film layer.

2. In the system described in Claim 1, A system characterized in that, when the film layer is placed in the abdominal cavity, the film layer defines a fluid removal chamber between the first surface of the film layer and the internal organs, and defines a fluid dripping chamber surrounding the abdominal cavity between the second surface of the film layer and the skin.

3. In the system described in Claim 2, The system is characterized in that the tube of the fluid distribution container is arranged to communicate with the fluid dropping chamber located on the film layer.

4. In the system described in Claim 1, The system is characterized in that the film layer contains a sealing material.

5. The system according to claim 1 is further, A negative pressure source configured to be fluidly connected to the fluid removal manifold, A system characterized by comprising a fluid source configured to be fluidly connected to the fluid distribution container.

6. In the system described in Claim 1, A system further comprising a conduit, wherein the conduit has a first fluid channel that is in fluid communication with the fluid removal manifold and a second fluid channel that is in fluid communication with the fluid distribution container.

7. In the system described in Claim 1, The system is characterized in that the fluid distribution container has multiple outlets.

8. In the system described in Claim 7, The system is characterized in that the outlet is located adjacent to the second surface of the film layer.

9. In the system described in Claim 7, The system is characterized in that the outlet is sized to generate the increased fluid pressure within the internal volume of the fluid distribution container.

10. In the system described in Claim 7, The system is characterized in that the outlet is configured to withstand a predetermined outward fluid pressure before opening.

11. In the system described in Claim 1, A system characterized in that the aforementioned film layer includes a polyurethane film.

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