Multilayer abdominal binder with instillation capability

Abstract

This application relates to multi-layered abdominal binding dressings with instillation capabilities. A therapy system for applying negative pressure therapy and fluid instillation therapy to a tissue site, particularly an abdominal tissue site, is disclosed. In some embodiments, the therapy system can include a dressing member, a plurality of fluid removal pathways, a fluid instillation matrix, a drape, a negative pressure source, and a fluid instillation source. Instillation fluid can be delivered from the fluid instillation source to the tissue site via the fluid instillation matrix, and negative pressure and extracted fluid can be communicated from the tissue site via the plurality of fluid removal pathways.

Description

[0001] This application is a divisional application of the application filed on January 23, 2018, with application number 201880008012.5 and invention title "Multilayer Abdominal Dressing with Drip Capability".

[0002] Cross-references to related applications This application claims priority to U.S. Provisional Application No. 62 / 451,284, filed January 27, 2017, entitled “Multi-Layer Abdominal Closure Dressing with Instillation Capabilities,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] The invention set forth in the appended claims generally relates to tissue treatment systems, and more specifically, but not limitingly, to abdominal treatment systems with negative pressure and infusion. Background Technology

[0004] Clinical research and practice have shown that reducing pressure near a tissue site can promote and accelerate the growth of new tissue at that site. This phenomenon has many applications, but it has proven particularly beneficial in wound treatment. Regardless of whether the wound is caused by trauma, surgery, or other factors, proper wound care is crucial to the outcome. The use of pressure reduction to treat wounds or other tissues is commonly referred to as "negative pressure therapy," but it also has other names, including "negative pressure wound therapy," "decompression therapy," "vacuum therapy," "vacuum-assisted closure," and "local negative pressure." Negative pressure therapy can provide many benefits, including the migration of epithelial and subcutaneous tissues, improved blood flow, and microdeformation of tissues at the wound site. These benefits can collectively increase granulation tissue development and reduce healing time.

[0005] It is also widely accepted that cleaning tissue sites is highly beneficial for new tissue growth. For example, a liquid solution can be used to rinse a wound, or a liquid solution can be used to clean cavities for therapeutic purposes. These practices are often referred to as “irrigation” and “cleaning,” respectively. “Infusion” is another practice, which typically refers to the process of slowly introducing a fluid into a tissue site and retaining the fluid for a specified period of time before removing it. For example, infusing a local treatment solution into a wound bed can be combined with negative pressure therapy to further promote wound healing by diluting soluble contaminants in the wound bed and removing infectious material. As a result, the burden of soluble bacteria can be reduced, contaminants can be removed, and the wound can be cleaned.

[0006] There can be challenges in dispensing and extracting fluid from tissue sites undergoing negative pressure therapy or fluid infusion. For example, tissue sites may vary in volume, size, geometry, orientation, and other factors. Furthermore, access to these tissue sites may be restricted. These or other factors may make it difficult to extract waste fluid from tissue sites and dispense therapeutic fluid in a consistent or uniform manner. Furthermore, once switching to a fluid infusion cycle, the change in direction of fluid flow between the negative pressure therapy cycle and the infusion fluid cycle may force waste fluid extracted during the negative pressure therapy cycle back into the tissue site.

[0007] Types of tissue sites that may present particular difficulties can include locations such as the peritoneal cavity, or more generally, the abdominal cavity. When the tissue site involves the abdominal cavity, treatment systems that allow for improved and effective care and can address complications that may inhibit eventual healing, such as peritonitis, abdominal compartment syndrome, and infection, can be particularly beneficial. Therefore, it is desirable to improve treatment systems that can accommodate a variety of different tissue sites and orientations to enhance the uniformity of waste fluid extraction and therapeutic fluid distribution, and to increase efficiency and the number of treatments. Summary of the Invention

[0008] Novel and useful systems, apparatus, and methods for cleaning the abdominal cavity in a negative pressure therapy environment are proposed in the following overview and description, as well as in the appended claims. Several illustrative embodiments are also provided to enable those skilled in the art to make and use the claimed subject matter.

[0009] For example, in some embodiments, a system for treating tissue sites may include a dressing, a negative pressure source fluidly coupled to the dressing, and a fluid source fluidly coupled to the dressing. The dressing may be configured for deployment in the abdominal cavity.

[0010] 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 an infusion matrix encapsulated within the chamber. In some embodiments, at least a portion of each of the first and second protective layers is connected to form a chamber encapsulated between a portion of the first and second protective layers.

[0011] In yet another embodiment, a dressing for treating a tissue site may include a first impermeable layer, a second impermeable layer positioned on and substantially co-extended with the first impermeable layer, a plurality of fluid removal pathways, and a plurality of fluid delivery channels. The plurality of fluid removal pathways and the plurality of fluid delivery channels may be positioned between the first impermeable layer and the second impermeable layer.

[0012] According to another embodiment, a dressing for treating a tissue site may include a plurality of fluid removal pathways and a fluid infusion matrix. The dressing may include a first impermeable layer and a second impermeable layer. The fluid infusion matrix may include a plurality of fluid delivery pathways, and the fluid infusion matrix may be adjacent to a first surface of the dressing.

[0013] In an additional embodiment, a dressing for treating a tissue site may include multiple fluid removal pathways, a fluid infusion matrix, a manifold assembly, and a cover. The dressing may include a first impermeable layer and a second impermeable layer, and a space between the first and second impermeable layers. The multiple fluid removal pathways may be positioned within the space between the first and second impermeable layers. The fluid infusion matrix may be associated with the dressing and may include multiple fluid delivery pathways. In some embodiments, the manifold assembly may be positioned adjacent to a central portion of the dressing. The cover may be adapted to form a fluid seal around the dressing and the manifold assembly.

[0014] In some other embodiments, a tissue treatment system may include: a treatment device configured for deployment in an abdominal cavity; a fluid infusion matrix associated with the treatment device; a manifold assembly; a cover; a negative pressure source fluidly connected to the treatment device; and a fluid source fluidly connected to the fluid infusion matrix. The treatment device may include multiple fluid removal pathways. The fluid infusion matrix may include multiple fluid delivery pathways. The manifold assembly may be positioned adjacent to a central portion of the treatment device. The cover may be adapted to form a fluid seal around the treatment device, the fluid infusion matrix, and the manifold assembly.

[0015] In other embodiments, a dressing for treating a tissue site may include: a protective layer, a fluid distribution center 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 catheter and a second catheter, the first catheter being adapted to deliver fluid from the fluid distribution center to the tissue site, and the second catheter being adapted to deliver fluid to the fluid distribution center.

[0016] In an additional embodiment, a system for treating a tissue site may include an occlusion layer, a fluid removal manifold, and a fluid dispensing vessel. The fluid removal manifold may be positioned adjacent to a first surface of the occlusion layer, and the fluid dispensing vessel may be positioned adjacent to a second surface of the occlusion layer.

[0017] In an additional embodiment, a device for treating a tissue site may include: a membrane having a first side and a second side; a fluid collection chamber; a fluid dispensing chamber; and a catheter. The fluid collection chamber may be formed by a second membrane welded to the first side of the membrane. The fluid dispensing chamber may be formed by a third membrane welded to the second side of the membrane around its outer periphery and includes an interface for fluid connection to a catheter. The catheter may extend from the fluid collection chamber through a hole in the membrane and through the fluid dispensing chamber to the interface.

[0018] In an additional embodiment, a system for treating a tissue site in the abdomen may include a dressing component, a fluid delivery dish, and a cover. The dressing component may include multiple fluid passages configured to deliver negative pressure to the tissue site. The fluid delivery dish may be adapted to be positioned adjacent to a first surface of the dressing component and may include a first side having multiple openings for delivering fluid to the tissue site. The cover may be adapted to be placed on a second surface of the multiple fluid passages.

[0019] The purpose, advantages, and preferred methods of creating and using the claimed subject matter can be best understood by referring to the accompanying drawings in conjunction with the following detailed description of illustrative embodiments.

[0020] This application also relates to the following: 1) A system for treating a tissue site, comprising: A dressing configured for deployment in the abdominal cavity; A negative pressure source fluidly connected to the dressing; and A fluid source is fluidly connected to the dressing.

[0021] 2) The system as described in 1) further includes a container fluidly connected to the negative pressure source and the dressing, and adapted to collect fluid.

[0022] 3) The system as described in 1) further includes a connection interface configured to fluidly connect the negative pressure source and the fluid source to the dressing.

[0023] 4) The system as described in 1), wherein the dressing comprises: A plurality of first fluid channels configured to be in fluid communication with the negative pressure source; and Multiple second fluid channels are configured to be in fluid communication with the fluid source.

[0024] 5) The system as described in 4), wherein the plurality of first fluid channels and the plurality of second fluid channels extend radially from the central portion of the dressing.

[0025] 6) The system as described in 1), wherein the dressing comprises: A dressing component, the dressing component comprising a first impermeable layer and a second impermeable layer, and a space encapsulated between the first impermeable layer and the second impermeable layer; Multiple fluid removal pathways, formed within the space and configured to be in fluid communication with the negative pressure source; and Multiple fluid delivery pathways are formed within the space and configured to be in fluid communication with the fluid source.

[0026] 7) The system as described in 6), wherein the plurality of fluid removal passages and the plurality of fluid delivery passages are formed between the portion where the first impermeable layer and the second impermeable layer are welded together.

[0027] 8) The system as described in 6), wherein the plurality of fluid removal passages include an opening at an outer peripheral end and a perforation along the length of the fluid removal passage.

[0028] 9) The system as described in 8), wherein the perforation along the length of the fluid removal pathway is formed by a pore in the first impermeable layer of the dressing member.

[0029] 10) The system as described in 6), wherein the plurality of fluid delivery passages include openings at the outer peripheral ends.

[0030] 11) The system as described in 6), wherein the plurality of fluid delivery passages include perforations along the length of the fluid delivery passages.

[0031] 12) The system as described in 11), wherein the perforation along the length of the fluid delivery pathway is formed by a pore in the first impermeable layer of the dressing member.

[0032] 13) The system as described in 1), wherein the fluid source includes a manual fluid pump.

[0033] 14) The system as described in 1), wherein the fluid source comprises a gravity-fed fluid vessel.

[0034] 15) The system as described in 1), wherein the negative pressure source and the fluid source are housed as part of the therapy unit.

[0035] 16) A dressing for treating a tissue site, comprising: A dressing component comprising a first protective layer and a second protective layer, wherein at least a portion of each of the first and second protective layers is connected to provide a cavity encapsulated between the first and second protective layers; Multiple fluid removal pathways formed within the cavity enclosed between the first and second protective layers; and The drip matrix is ​​enclosed within the chamber.

[0036] 17) The dressing as described in 16), wherein each of the plurality of fluid removal passages includes a manifold component.

[0037] 18) The dressing as described in 17), wherein the manifold component comprises an open-cell mesh polyurethane foam.

[0038] 19) The dressing as described in 18), wherein the open-cell mesh polyurethane foam has a thickness between 5 mm and 15 mm.

[0039] 20) The dressing as described in 16) further includes a central element located in the central region of the dressing component and in fluid communication with the drip matrix.

[0040] 21) The dressing as described in 16), wherein the drip matrix comprises a plurality of fluid delivery tubes.

[0041] 22) The dressing as described in 20), wherein, The drip matrix includes multiple fluid delivery tubes; and The central component includes a plurality of openings whose size and configuration are determined to control the flow rate of fluid into the plurality of fluid delivery tubes.

[0042] 23) The dressing as described in 16), wherein the size of the dressing can be reduced by removing a portion of the outer periphery of the dressing.

[0043] 24) The dressing as described in 16), wherein the drip matrix comprises a plurality of fluid delivery tubes containing silicone.

[0044] 25) The dressing as described in 16), wherein the drip matrix comprises a PVC pipe.

[0045] 26) The dressing as described in 16), wherein the drip matrix comprises a tube having an inner diameter of about 1 mm to 2 mm.

[0046] 27) The dressing as described in 20), wherein the central component comprises medical-grade silicone.

[0047] 28) The dressing as described in 20), wherein the central component comprises medical-grade PVC.

[0048] 29) The dressing as described in 22), wherein the plurality of fluid delivery tubes are connected to the plurality of openings of the central member by a medical-grade adhesive.

[0049] 30) The dressing as described in 22), wherein the plurality of fluid delivery tubes are connected to the plurality of openings of the central member via cyclohexanol.

[0050] 31) The dressing as described in 16), wherein the first protective layer and the second protective layer are ultrasonically welded together.

[0051] 32) A dressing for treating tissue sites, comprising: First impermeable layer; A second impermeable layer is positioned on top of and substantially extends along with the first impermeable layer; Multiple fluid removal pathways located between the first impermeable layer and the second impermeable layer; and Multiple fluid delivery channels are positioned between the first impermeable layer and the second impermeable layer.

[0052] 33) The dressing as described in 32), wherein the plurality of fluid removal pathways are oriented to extend radially outward from a central location between the first impermeable layer and the second impermeable layer.

[0053] 34) The dressing as described in 32), wherein each of the plurality of fluid delivery channels is positioned adjacent to and extends substantially parallel to one of the plurality of fluid removal channels.

[0054] 35) The dressing as described in 32), wherein the first impermeable layer is welded to the second impermeable layer.

[0055] 36) The dressing as described in 32), wherein the first impermeable layer and the second impermeable layer are attached by ultrasonic welding.

[0056] 37) The dressing as described in 36), wherein the ultrasonic welding is arranged to substantially define the plurality of fluid removal pathways and the plurality of fluid delivery channels in the space between the first impermeable layer and the second impermeable layer.

[0057] 38) The dressing as described in 36), wherein the first impermeable layer further includes perforations along the plurality of fluid removal pathways.

[0058] 39) The dressing as described in 36), wherein the first impermeable layer further includes perforations along the plurality of fluid delivery channels.

[0059] 40) The dressing as described in 32) further includes a plurality of fluid delivery tubes, wherein each of the plurality of fluid delivery tubes is positioned within one of the plurality of fluid delivery channels.

[0060] 41) The dressing as described in 32), wherein the first impermeable layer and the second impermeable layer include perforations.

[0061] 42) The dressing as described in 32), wherein the first impermeable layer and the second impermeable layer each comprise a polyurethane membrane.

[0062] 43) The dressing as described in 42), wherein the first impermeable layer and the second impermeable layer each have a thickness between 25 micrometers and 500 micrometers.

[0063] 44) The dressing as described in 32) further includes a fluid hub fluidly connected to each of the plurality of fluid delivery channels and configured to control fluid dispensing to each of the plurality of fluid delivery channels.

[0064] 45) The dressing as described in 40), wherein each of the plurality of fluid delivery tubes includes a perforation along its length.

[0065] 46) The dressing as described in 40), wherein each of the plurality of fluid delivery tubes includes an opening at the end furthest from the center of the first impermeable layer and the second impermeable layer.

[0066] 47) The dressing as described in 32), wherein, The plurality of fluid removal pathways extend radially outward from the center of the dressing; The plurality of fluid delivery channels extend radially outward from the center of the dressing; and The plurality of fluid removal pathways are positioned to alternate with the plurality of fluid delivery channels.

[0067] 48) The dressing as described in 47), wherein the plurality of fluid removal pathways and the plurality of fluid delivery channels are separated by approximately equal separation angles.

[0068] 49) The dressing as described in 40), wherein the plurality of fluid delivery tubes include smaller profile tubes.

[0069] 50) The dressing as described in 40), wherein each of the plurality of fluid delivery tubes includes a perforation along its length and has a closed end, the closed end being furthest from the center of the first impermeable layer and the second impermeable layer.

[0070] 51) The dressing as described in 32) further includes a fluid hub fluidly connected to each of the plurality of fluid removal pathways and the plurality of fluid delivery channels.

[0071] 52) The dressing as described in 51), wherein the fluid central component further comprises: A first set of check valves, wherein each check valve in the first set of check valves is positioned at a first end of one of the plurality of fluid removal passages; and The second set of check valves, wherein each check valve in the second set of check valves is positioned at the first end of one of the plurality of fluid delivery channels.

[0072] 53) The dressing as described in 52), wherein the first and second set of one-way valves include duckbill valves.

[0073] 54) The dressing as described in 52), wherein at least one of the first set of one-way valves and the second set of one-way valves includes a valve flap.

[0074] 55) The dressing as described in 44), wherein the fluid central component comprises two polyurethane membranes welded together.

[0075] 56) The dressing as described in 32), wherein the plurality of fluid removal pathways are formed by creases in at least one of the first impermeable layer and the second impermeable layer.

[0076] 57) The dressing as described in 32), wherein the plurality of fluid removal pathways include embossed channels.

[0077] 58) The dressing as described in 32), wherein the plurality of fluid removal passages include a plurality of fluid removal tubes.

[0078] 59) A dressing for treating tissue sites, comprising: A dressing component, the dressing component comprising a first impermeable layer and a second impermeable layer; Multiple fluid removal pathways associated with the dressing component; and A fluid drip matrix comprising multiple fluid delivery pathways, wherein the fluid drip matrix is ​​adjacent to a first surface of the dressing component.

[0079] 60) The dressing as described in 59) further includes a central fluid hub having a hub core member comprising an open-cell mesh polyurethane foam.

[0080] 61) The dressing as described in 59), wherein each of the plurality of fluid delivery pathways includes a core member adapted to maintain an open passage in each of the plurality of fluid delivery pathways.

[0081] 62) The dressing as described in 61), wherein each of the core components comprises an open-cell mesh polyurethane foam and has a thickness between 2 mm and 10 mm and a width between 5 mm and 10 mm.

[0082] 63) The dressing as described in 59), wherein the plurality of fluid removal passages and the plurality of fluid delivery passages are positioned adjacent to a first side of the dressing member and adapted to be independently movable.

[0083] 64) A dressing as described in 63), wherein each of the fluid removal pathways is coupled to one of the plurality of fluid delivery pathways to form a pathway pair.

[0084] 65) A dressing as described in 59), wherein each of the fluid removal passage and the fluid delivery passage is removably attached to the dressing component.

[0085] 66) A dressing for treating a tissue site, comprising: A dressing component, the dressing component including a first impermeable layer and a second impermeable layer, and a space between the first impermeable layer and the second impermeable layer; Multiple fluid removal pathways are positioned within the space of the dressing component; A fluid infusion matrix, which is associated with the dressing component and includes multiple fluid delivery pathways; A central manifold member positioned adjacent to the central portion of the dressing member; and A cover cloth adapted to form a fluid seal around the dressing member and the central manifold member.

[0086] 67) The dressing as described in 66), wherein the central manifold component comprises foam.

[0087] 68) The dressing as described in 67), wherein the foam is an open-cell mesh polyurethane foam.

[0088] 69) The dressing as described in 66), wherein, The fluid drip matrix is ​​positioned adjacent to the first side of the dressing component; and The central manifold component is positioned adjacent to the second side of the dressing component.

[0089] 70) A tissue treatment system, comprising: A treatment device configured for deployment in the abdominal cavity and including multiple fluid removal pathways; A fluid infusion matrix, which is associated with the treatment device and includes multiple fluid delivery pathways; A manifold component positioned adjacent to the central portion of the treatment device; A cover sheet adapted to form a fluid seal around the treatment device, the fluid infusion matrix, and the manifold component; A negative pressure source fluidly connected to the treatment device; and A fluid source is fluidly connected to the fluid dripping matrix.

[0090] 71) A dressing for treating tissue sites, comprising: Protective layer; A fluid distribution center configured to exchange fluid with the tissue site; and Multiple treatment tubes, wherein each of the multiple treatment tubes comprises: A central catheter, adapted to deliver fluid from the fluid distribution center to the tissue site, and An outer peripheral channel adapted to deliver fluid to the fluid distribution hub.

[0091] 72) The dressing as described in 71), wherein the peripheral channel includes a polyurethane membrane surrounding the outer diameter of the central conduit.

[0092] 73) The dressing as described in 71), wherein the central conduit includes a polyurethane membrane within its inner diameter.

[0093] 74) A system for treating a tissue site, comprising: Occlusion layer; A fluid removal manifold positioned adjacent to the first surface of the occlusion layer; and A fluid distribution vessel positioned adjacent to the second surface of the occlusion layer.

[0094] 75) The system as described in 74) further includes: A negative pressure source configured to be fluidly connected to the fluid removal manifold; and A fluid source configured to be fluidly connected to the fluid dispenser.

[0095] 76) The system as described in 74) further includes a conduit having a first fluid passage in fluid communication with the fluid removal manifold and a second fluid passage in fluid communication with the fluid dispensing vessel.

[0096] 77) The system as described in 74) further includes: A first conduit, extending through the fluid dispensing vessel and the occlusion layer, and in fluid communication with the removal manifold; and A second conduit is in fluid communication with the fluid dispensing vessel.

[0097] 78) The system as described in 74), wherein the occlusion layer includes a plurality of fluid removal pathways formed on a first surface of the occlusion layer.

[0098] 79) The system as described in 74), wherein the occlusion layer includes a plurality of fluid delivery pathways formed on a second surface of the occlusion layer.

[0099] 80) The system as described in 79) wherein the plurality of fluid delivery passages extend radially across the second surface of the occlusion layer.

[0100] 81) The system as described in 78) wherein the plurality of fluid removal passages extend radially across a first surface of the occlusion layer.

[0101] 82) The system as described in 74), wherein the fluid dispensing vessel includes a polyurethane membrane welded around the outer periphery to provide an internal volume.

[0102] 83) The system as described in 74), wherein the fluid dispenser includes multiple outlets.

[0103] 84) The system as described in 83) wherein the outlet is positioned on a first surface of the fluid distribution vessel, adapted to be positioned adjacent to a second surface of the occlusion layer.

[0104] 85) The system as described in 83), wherein the size of the outlet is determined to generate increased fluid pressure within the internal volume of the fluid distribution vessel.

[0105] 86) The system as described in 74), wherein the fluid dispenser includes a plurality of compartments formed by welding within the internal volume of the fluid dispenser.

[0106] 87) The system as described in 83), wherein the diameter of the plurality of outlets is approximately 0.2 mm to 1.0 mm.

[0107] 88) The system as described in 85), wherein the plurality of outlets are configured to withstand a predetermined outward fluid pressure before being opened.

[0108] 89) The system as described in 74), wherein the occlusion layer comprises a polyurethane membrane.

[0109] 90) The system as described in 74), wherein the occlusion layer includes a plurality of folds forming a plurality of fluid removal pathways on a first surface of the occlusion layer and a plurality of fluid delivery pathways on a second surface of the occlusion layer.

[0110] 91) The system as described in 74), wherein the fluid removal manifold comprises a plurality of welded polyurethane membranes.

[0111] 92) The system as described in 74) further includes a fluid collection reservoir in fluid communication with the fluid removal manifold.

[0112] 93) The system as described in 74), wherein the fluid removal manifold includes a first surface having a plurality of windows.

[0113] 94) The system as described in 93), wherein the size of the plurality of windows varies.

[0114] 95) The system as described in 74), wherein the fluid removal manifold comprises an open-cell foam having pores with an average diameter between 4 mm and 8 mm.

[0115] 96) A device for treating a tissue site, comprising: A membrane layer having a first side and a second side; A fluid collection chamber formed by a second membrane layer, wherein the second membrane layer is welded to a first side of the membrane layer; A fluid distribution chamber formed by a third membrane layer, the third membrane layer being welded to a second side of the membrane layer around its outer periphery, and including an interface for fluidly connecting to a conduit; and A conduit extends from the fluid collection chamber through a pore in the membrane and through the fluid distribution chamber to the interface.

[0116] 97) A system for treating tissue sites in the abdomen, comprising: A dressing component including a plurality of fluid passages configured to deliver negative pressure to the tissue site; A fluid delivery vessel adapted to be positioned adjacent to a first surface of the dressing member and having a first side, the first side including a plurality of openings for delivering fluid to the tissue site; and A cover cloth, which is adapted to be placed on the second surface of the plurality of fluid passages.

[0117] 98) The system as described in 97) further includes a negative pressure source configured to be in fluid communication with the plurality of fluid passages.

[0118] 99) The system as described in 97) further includes a fluid source configured to provide therapeutic fluid to the fluid delivery vessel.

[0119] 100) The system as described in 97), wherein the opening has a diameter between 0.2 mm and 1.5 mm.

[0120] 101) The system as described in 97), wherein the fluid delivery vessel includes a body formed of a polyurethane film with a thickness between 25 micrometers and 200 micrometers.

[0121] 102) The system as described in 97), wherein the fluid delivery vessel comprises: A first membrane layer, the first membrane layer including the plurality of openings; and The second film layer is positioned adjacent to the first film layer; The outer periphery of the first film layer is welded to the outer periphery of the second film layer to form the internal volume.

[0122] 103) The system as described in 102), wherein a portion of the first membrane layer is welded to a portion of the second membrane layer to form a network of fluid passages within the internal volume.

[0123] 104) The system as described in 97) wherein the fluid delivery vessel is formed of a first membrane layer and the outer periphery of the first membrane layer is fixed to a first side of the dressing member.

[0124] 105) The system as described in 97) further includes a fluid channel extending through the dressing member and adapted to fluidly connect the fluid delivery vessel to a fluid source.

[0125] 106) The system as described in 105), wherein the fluid channel includes an opening in the dressing member, wherein the outer periphery of the opening is formed by a sealing edge of the dressing member.

[0126] 107) The system as described in 97), wherein the plurality of fluid passages include windows.

[0127] 108) The system as described in 97), wherein each of the plurality of fluid passages includes a manifold component having an open-cell foam.

[0128] 109) The system as described in 108), wherein each of the plurality of fluid passages includes a manifold component having a nonwoven fabric.

[0129] 110) The system as described in 97), wherein the fluid delivery vessel comprises: Central chamber; and Multiple radial channels, the multiple radial channels including a first end fluidly connected to the central chamber and a second end having an open portion.

[0130] 111) The system as described in 110) further includes an internal manifold adapted to maintain the structure of the central chamber under negative pressure conditions.

[0131] 112) The system as described in 111), wherein the internal manifold comprises polyurethane foam.

[0132] 113) The system as described in 111), wherein the internal manifold includes a membrane.

[0133] 114) The system as described in 111), wherein the internal manifold is collapsible.

[0134] 115) The system as described in 97) wherein the fluid delivery vessel is formed of a first membrane layer and a second membrane layer, and the outer periphery of the first membrane layer is sealed to the outer periphery of the second membrane layer.

[0135] 116) The system as described in 102), wherein, The first membrane layer includes a occluded membrane; and The second membrane layer includes perforations.

[0136] 117) The systems, apparatus and methods are essentially as described herein. Attached Figure Description

[0137] Figure 1 This is a functional block diagram of an exemplary embodiment of a therapeutic system capable of delivering negative pressure and therapeutic fluid to a tissue site according to this specification; Figure 2 It is used to treat abdominal cavities and can be used with Figure 1 A schematic diagram of an illustrative device associated with some embodiments of the therapeutic system, and a cross-section of a portion thereof; Figure 3 It is possible to be with Figure 1 A schematic plan view illustrating an embodiment of an abdominal treatment device associated with some embodiments of the therapeutic system; Figure 4A A schematic plan view of an exemplary embodiment of an abdominal treatment device; Figure 4B yes Figure 4A A schematic side view of a portion of an illustrative embodiment of an abdominal treatment device; Figure 5 This is a schematic plan view of a portion of an abdominal treatment device according to another illustrative embodiment; Figure 6A This is a diagram illustrating what can be done with... Figure 1 Additional details related to the abdominal treatment device of the therapy system; Figure 6B This is a diagram illustrating what can be done with... Figure 1 Additional details associated with part of the therapy system; Figures 7A to 7C It is possible to be with Figure 1 A schematic plan view of an additional illustrative embodiment of an abdominal treatment device associated with a therapeutic system; Figure 8 It is possible to be with Figure 1 A schematic plan view of another demonstrative abdominal treatment device associated with the therapy system; Figure 9 This is a diagram illustrating what can be done with... Figure 1 Additional details about the fluid conduit associated with part of the abdominal treatment device of the therapy system; Figures 10A to 10C It is possible to be with Figure 1 A schematic diagram of another illustrative embodiment of an abdominal treatment device associated with a therapeutic system; Figures 11A to 11B It is possible to be with Figure 1 A schematic diagram of another illustrative embodiment of an abdominal treatment device associated with a therapeutic system; Figures 12A to 12B It is possible to be with Figure 1 A schematic diagram of another illustrative embodiment of an abdominal treatment device associated with a therapeutic system, and a cross-section of a portion thereof; Figures 13A to 13B It is possible to be with Figure 1 A schematic diagram of another illustrative embodiment of an abdominal treatment device associated with a therapeutic system, and a cross-section of a portion thereof; Figures 14A to 14B It is possible to be with Figure 1 A schematic diagram of another illustrative embodiment of an abdominal treatment device associated with a therapeutic system, and a cross-section of a portion thereof; Figure 15 It is possible to be with Figure 1 A schematic plan view of another illustrative embodiment of the abdominal treatment device associated with some embodiments of the therapy system; Figure 16 Based on some embodiments, Figure 15A schematic diagram of a portion of an exemplary embodiment of an abdominal treatment device and a cross-section thereof; Figure 17 Based on some additional embodiments, Figure 15 A schematic diagram of a portion of an exemplary embodiment of an abdominal treatment device and a cross-section thereof; Figures 18A to 18C yes Figure 15 A schematic plan view of an illustrative embodiment of a portion of an abdominal treatment device; Figures 19A to 19C This is a schematic diagram illustrating the function of a portion of a therapeutic system according to some exemplary embodiments of this specification; and Figures 20A to 20C This is a schematic diagram illustrating the functionality of a portion of a therapeutic system according to some additional exemplary embodiments of this specification. Detailed Implementation

[0138] The following description of exemplary embodiments provides information that enables those skilled in the art to make and use the subject matter set forth in the appended claims, but certain details already well known in the art may be omitted. Therefore, the following detailed description should be understood as illustrative rather than restrictive.

[0139] This document may also describe the exemplary embodiments with reference to the spatial relationships or spatial orientations of the different elements depicted in the accompanying drawings. Generally, such relationships or orientations assume a frame of reference consistent with or relative to the patient to be treated. However, those skilled in the art should recognize that this frame of reference is merely a descriptive provision and not a strict specification.

[0140] Figure 1 This is a simplified functional block diagram of an exemplary embodiment of a therapy system 100 that provides negative pressure therapy and local treatment solution infusion according to this specification. The therapy system can be applied to human patients, as well as to other types of subjects. The therapy system 100 may include a treatment device 101 having a dressing 102 and a therapy unit 104. In some embodiments, the therapy unit 104 may include a negative pressure source, such as negative pressure source 106, a fluid source, such as fluid source 108, and a controller 109. In other embodiments, the therapy unit 104 may include a negative pressure source 106, while the fluid source 108 and / or the controller 109 may be separate, independent units. The therapy 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 therapy unit 104.

[0141] Components of the therapy system 100 can be fluidly coupled to each other to provide pathways for the transfer of fluids (i.e., liquids and / or gases) between these components. For example, these components can be fluidly coupled via fluid conduits, such as tubes. As used herein, "tube" broadly includes pipes, conduits, hoses, catheters, or other structures having one or more lumens adapted to transfer fluid between two ends. Typically, a tube is an elongated cylindrical structure with some flexibility, but its geometry and rigidity can vary. In some embodiments, multiple components can also be coupled by physical proximity, become a single structure integrally, or be formed from the same material. Furthermore, some fluid conduits can be molded into other components or otherwise integrally combined with other components. In some cases, coupling can also include mechanical coupling, thermal coupling, electrical coupling, or chemical coupling (such as chemical bonds). For example, in some embodiments, a tube can mechanically and fluidly couple the treatment device 101 to the therapy unit 104. Generally, components of the therapy system 100 can be coupled directly or indirectly.

[0142] The therapy system 100 may include a negative pressure supply source, such as a negative pressure source 106, which may be configured to be coupled to a dispensing component, such as a dressing. Typically, the dispensing component can refer to any supplementary or auxiliary component configured to be fluidly coupled to the negative pressure supply source in a fluid path between the negative pressure supply source and the tissue site. The dispensing component is preferably detachable and may be disposable, reusable, or recyclable. For example, the dressing 102 of the therapy device 101 may be fluidly coupled to the negative pressure source 106 of the therapy unit 104, such as... Figure 1 As shown. In some embodiments, the treatment device 101 may include a dressing 102, as well as additional tissue interfaces, fluid conduits, and / or covers. In some embodiments, the dressing interface may facilitate the connection of a 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.

[0143] The fluid dynamics of using a negative pressure source to reduce pressure in another component or location (such as within a sealed treatment environment) can be mathematically complex. However, the basic principles of fluid dynamics applicable to negative pressure therapy and infusion are generally well known to those skilled in the art, and the process of reducing pressure can be illustratively described herein as, for example, “delivering,” “distributing,” or “generating” negative pressure.

[0144] Generally, exudates and other fluids flow along the fluid path toward lower pressure. Therefore, the term "downstream" typically refers to something relatively closer to a negative pressure source or further away from a positive pressure source in the fluid path. Conversely, the term "upstream" refers to something relatively further away from a negative pressure source or closer to a positive pressure source. Similarly, it may be appropriate to describe certain features in this frame of reference as fluid "inlet" or "outlet." This orientation is generally assumed to be for describing the different features and components described herein. However, in some applications the fluid path can be reversed (e.g., by replacing a negative pressure source with a positive pressure source), and this descriptive convention should not be construed as restrictive.

[0145] "Negative pressure" generally refers to pressure less than the local ambient pressure, which is the ambient pressure in a local environment outside the sealed treatment environment provided by treatment device 101. In many cases, the local ambient pressure can also be the atmospheric pressure at the location of the tissue site. Alternatively, the pressure can be less than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise stated, the pressure values ​​stated herein are gauge pressures. Similarly, references to an increase in negative pressure typically refer to a decrease in absolute pressure, while a decrease in negative pressure typically refers to an increase in absolute pressure. Although the amount and nature of the negative pressure applied to the tissue site can vary depending on the treatment requirements, the pressure is generally a low vacuum, also commonly referred to as a rough vacuum, between -5 mm Hg (-667 Pa) and -500 mm Hg (-66.7 kPa). Common treatment ranges are between -75 mm Hg (-9.9 kPa) and -300 mm Hg (-39.9 kPa).

[0146] The negative pressure supply source, such as the negative pressure source 106 of the therapy unit 104, can be an air reservoir under negative pressure, or it can be a manually or electrically driven device that can reduce the pressure in a sealed volume, such as a vacuum pump, a suction pump, a wall-mounted suction port, or a micropump, which can be used in many healthcare facilities. The negative pressure supply source can be housed within or combined with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or further user interfaces that facilitate treatment. The negative pressure supply source may also have one or more supply ports configured to facilitate connection and disconnection of the negative pressure supply source to one or more distribution components.

[0147] The therapy system 100 may also include an infusion solution source. For example, a fluid source 108 may be fluidly coupled to the treatment device 101 and thus to the dressing 102, such as... Figure 1As illustrated in the exemplary embodiments. In some embodiments, fluid source 108 may be fluidly connected to a positive pressure source or fluidly connected to a negative pressure source 106. A regulator, such as an infusion regulator, may also be fluidly connected to fluid source 108 and treatment device 101.

[0148] A fluid source, such as fluid source 108, may be housed within or used in conjunction with other components to facilitate fluid movement. Fluid source 108 may be a fluid pump, such as a peristaltic pump. Alternatively, in some embodiments, fluid source 108 may be a fluid reservoir capable of storing and delivering fluid. In any embodiment, fluid source 108, such as a fluid pump or fluid reservoir, may include a container, such as a tank, pouch, or other storage component.

[0149] Fluid source 108 may also refer to a container, canister, pouch, bag, or other storage component capable of providing a solution for infusion therapy. The composition of the solution may vary depending on the prescribed therapy, but examples of solutions suitable for some prescriptions include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanide, cation solutions, and isotonic solutions.

[0150] A controller, such as controller 109, may be a microprocessor or computer programmed to operate one or more components of the therapy system 100, such as negative pressure source 106 and fluid source 108. In some embodiments, for example, controller 109 may be a microcontroller that typically includes an integrated circuit including a processor core and memory programmed to directly or indirectly control one or more operating parameters of the therapy system 100. For example, operating parameters may include power applied to negative pressure source 106, pressure generated by negative pressure source 106, or pressure distributed to treatment device 101. Additional operating parameters may include power applied to fluid source 108, flow rate of infusion fluid provided by fluid source 108, or fluid volume distributed to treatment device 101. Controller 109 is also preferably configured to receive one or more input signals, such as feedback signals, and is programmed to modify one or more operating parameters based on the input signals.

[0151] Container 110 represents a container, canister, pouch, or other storage component that can be used to manage exudates and other fluids aspirated from tissue sites. In many settings, rigid containers may be preferred or necessary for the collection, storage, and treatment of fluids. In other settings, fluids can be properly disposed of without the need for rigid container storage, and reusable containers can reduce waste and costs associated with negative pressure therapy.

[0152] In this context, the term "tissue site" broadly refers to a wound, defect, or other therapeutic target located on or within tissue, including but not limited to bone, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. Wounds can include, for example, chronic, acute, traumatic, subacute, and laceration wounds; partial skin burns; ulcers (such as diabetic ulcers, pressure ulcers, or venous insufficiency ulcers); skin flaps; and grafts. The term "tissue site" can also refer to any area of ​​tissue that is not necessarily injured or defective, but rather to an area in which it may be desirable to increase or promote the growth of additional tissue. For example, negative pressure can be applied to a tissue site to encourage the growth of additional tissue that can be harvested and transplanted.

[0153] In some embodiments, the negative pressure source 106, fluid source 108, controller 109, and container 110 may be integrated within a single therapy unit, such as therapy unit 104. Thus, for example, therapy system 100 may include treatment device 101 and therapy unit 104, such as the VACULTA™ therapy unit, VACINSTILL™ wound care system, INFVO.AC™ therapy unit, or other suitable therapy unit. For example, in some embodiments, therapy unit 104 may include or be primarily composed of a VACULTA™ unit, which may include software modules specific to negative pressure therapy and fluid infusion therapy, and particularly for abdominal dressing systems, such as embodiments of treatment device 101. Alternatively, any other device capable of providing intermittent negative pressure therapy may be suitable for use with any mechanical fluid infusion device, or any negative pressure therapy device may be suitable for use with a manually managed fluid infusion source, such as a gravity-fed fluid vessel, a manual fluid pump, or a monitored IV bag or bottle.

[0154] Now, please refer to Figure 2 An illustrative embodiment of a treatment device 101 for treating the abdominal cavity 111 is presented. The treatment device 101 can be used to treat tissue sites 112. In this illustrative embodiment, tissue site 112 may include tissue within a body cavity, particularly the abdominal cavity 111. Tissue site 112 may include abdominal contents 113 or tissue adjacent to the abdominal cavity 111. Treatment of tissue site 112 may include the removal of fluids such as ascites, protection of the abdominal cavity, or negative pressure therapy.

[0155] The illustrative systems and apparatus described herein allow for the irrigation and flushing of abdominal cavities, such as abdominal cavity 111, via controlled and adjustable fluid introduction. In some cases, flushing or cleaning of contaminated abdominal cavities may be necessary due to perforated colon or sepsis. Therapeutic system 100 can provide means for infusing fluid into open abdominal cavities (including reaching areas such as small intestinal loops, pancreas, etc.) to clean abdominal contents. Furthermore, therapeutic device 101 and therapeutic system 100 can provide temporary closure of open abdominal cavities while removing fluid and reducing edema. Thus, therapeutic system 100 can provide the ability to perform flushing on tissue sites (e.g., abdominal cavity 111) without having to repeatedly remove one or more dressings applied to the patient's tissue sites or bring the patient to the operating room for manual fluid introduction. Therefore, therapeutic system 100 can provide controlled and adjustable whole-abdominal flushing, as well as targeted flushing of specific areas within the abdomen when needed. The disclosed embodiments can also provide support and maintenance of fascial regions of the abdominal cavity (e.g., abdominal cavity 111) and overall protection of abdominal contents.

[0156] like Figure 2 As shown, the treatment device 101 may include a dressing 102, which may be placed within the patient's abdominal cavity 111 to treat tissue site 112. The dressing 102 may be supported by abdominal contents 113. As depicted, a first dressing portion 114 of the dressing 102 may be positioned in or near a first paracolic gutter 115, and a second dressing portion 116 may be positioned in or near a second paracolic gutter 117. The first paracolic gutter 115 and the second paracolic gutter 117 may each be, for example, in an open space between the abdominal contents 113 on opposite sides of the abdominal cavity 111. The first paracolic gutter 115 may be positioned laterally or otherwise on the tissue site 112 opposite to the second paracolic gutter 117. Although Figure 2 The treatment device 101 is depicted as being deployed in the abdominal cavity 111, but the treatment device 101 and the therapy system 100 can be used at other types of tissue sites.

[0157] The dressing 102 may be formed having multiple liquid-impermeable layers, such as a first liquid-impermeable layer 118 and a second liquid-impermeable layer 120. These multiple liquid-impermeable layers, such as the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120, are respectively formed having openings 122 and 124. The term "liquid-impermeable layer" means that these layers are formed of a liquid-impermeable material. Therefore, although formed of a liquid-impermeable material, the layer is liquid-permeable when the openings are present, but it is still referred to as a liquid-impermeable layer. The openings 122 and 124 may take many shapes or combinations of shapes, including circular holes, rectangular openings, or polygons. In this illustrative embodiment, these 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 may be sealed together with each other in any suitable manner, such as, but not limited to, welding, bonding, adhesives, fasteners, or other adhesive devices. The first liquid-impermeable layer 118 may be adapted to be positioned between the second liquid-impermeable layer 120 and the tissue site 112 and / or abdominal contents 113. Figure 2 In an exemplary embodiment, chamber 125 is formed between at least two of the plurality of liquid-impermeable layers, for example, between a first liquid-impermeable layer 118 and a second liquid-impermeable layer 120. 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, capable of inhibiting tissue adhesion to the drape. For example, in some embodiments, the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120 may include a breathable polyurethane membrane. In some embodiments, chamber 125 formed between the liquid-impermeable layers 118 and 120 may include a fluid removal assembly 148 for delivering negative pressure and removing fluid (e.g., exudate from tissue site 112); and a drip matrix 152 for delivering drip fluid to tissue site 112.

[0158] In some embodiments, the therapy system 100 may further include a sealing member 128 for providing a fluid seal over the abdominal cavity 111. Additionally, one or more skin closure devices may be placed on the patient's epidermis 130. In some embodiments, the therapy system 100 may also include an interface 132 for fluidly connecting the dressing 102 and other portions 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 in any other manner capable of fluidly connecting the treatment device 101 to the therapy unit, such as... Figure 1The catheter 134 is configured in a manner consistent with the treatment unit 104. The catheter 134 may be fluidly coupled to the negative pressure source 106 and / or the fluid source 108 of the treatment unit 104 to provide negative pressure and / or therapeutic fluid to the treatment device 101, respectively. In some embodiments, the catheter 134 may comprise two substantially parallel, fluid-isolated catheters, one for fluidly coupling the treatment device 101 to the negative pressure source 106 and the other for fluidly coupling the treatment device 101 to the fluid source 108. Thus, in some embodiments, the catheter 134 may be a multi-lumen catheter having a negative pressure lumen 135 and a fluid supply lumen 137. In some other illustrative embodiments, the catheter 134 may be replaced by two separate catheters, one containing the negative pressure lumen and the other containing the fluid supply lumen.

[0159] In some embodiments, the sealing member 128 can provide a bacterial barrier and protection against physical trauma. The sealing member 128 may also be made of a material that reduces evaporation loss and provides a fluid seal between two components or two environments, such as between a treatment environment and a local external environment. The sealing member 128 may be, for example, an elastomeric membrane or film that can provide a seal sufficient to maintain negative pressure at the tissue site for a given negative pressure source. In some applications, the sealing member 128 may have a high moisture vapor transmission rate (MVTR). For example, in some embodiments, the MVTR may be at least 300 g / m² per 24 hours. In some exemplary embodiments, the sealing member 128 may be a water vapor permeable but liquid impermeable polymer cover, such as a polyurethane membrane. Such cover typically has a thickness in the range of 25 to 50 micrometers. For permeable materials, the permeability should be generally low enough to maintain the desired negative pressure.

[0160] An attachment device, such as attachment device 142, can be used to attach the sealing member 128 to an attachment surface, such as the patient's epidermis 130. Attachment device 142 can also be used to attach the sealing member 128 to a gasket, or another sealing member or cover. The attachment device can take many forms. For example, the attachment device can be a medically acceptable pressure-sensitive adhesive that extends around the periphery of the sealing member, a portion of the sealing member, or the entire sealing member. In some embodiments, for example, a portion or all of the sealing member 128 can be coated with an acrylic adhesive having a coating weight between 25 and 65 grams per square meter (gsm). In some embodiments, a thicker adhesive or adhesive combination can be applied to improve sealing and reduce leakage. Other exemplary embodiments of the attachment device may include double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, or organic gel.

[0161] Although not necessarily as Figure 2As depicted, but in some embodiments, the therapy system 100 may further include a filler material, such as a foam portion, positioned between the second liquid-impermeable layer 120 and the sealing member 128. The size of the filler material may be determined to fill the abdominal volume below or around the incision or opening into the abdomen from the skin layer (e.g., a portion of the abdominal cavity 111). In some embodiments, the filler material may serve 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. Thus, fluid removal may occur from these layers of the treatment device 101, through the filler material positioned on top of the second liquid-impermeable layer 120, and into the negative pressure lumen 135. In some embodiments, the filler material may include an open-cell mesh polyurethane foam, such as GRANUFOAM™ dressings available from Kinetic Concepts, Inc. of San Antonio, Texas.

[0162] Now, please refer to Figure 3 The treatment device 101 can be adapted to apply pressure from the negative pressure source 106 of the treatment unit 104 to tissue sites, such as... Figure 2 The tissue site 112 of the abdominal cavity 111 is provided with negative pressure, and fluid extracted from the tissue site 112 is collected and delivered. Additionally, the treatment device 101 may also be adapted to deliver fluid, such as a therapeutic fluid or medication, from the fluid source 108 of the therapy unit 104 to the tissue site 112. (See also: Regarding...) Figure 2 As discussed, in some embodiments, the dressing 102 of the treatment device 101 may include multiple liquid-impermeable layers or visceral protective layers that protect the abdominal contents 113 beneath the tissue site 112. For example, in some embodiments, the dressing 102 may include a first liquid-impermeable layer 118 and a second liquid-impermeable layer 120 formed of a polyurethane material, wherein the thickness of each of these liquid-impermeable layers is measured to be between 20 and 400 micrometers. Figure 3 As shown, one or both of these liquid-impermeable layers, such as the second liquid-impermeable layer 120, may include a window 124 to facilitate fluid removal throughout the abdominal cavity 111.

[0163] like Figure 3As shown, some embodiments of the treatment device 101 may further 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 passages 150, each fluidly coupled to a fluid removal hub 154. The fluid removal hub 154 may serve as a dispensing mechanism for delivering negative pressure from the interface 132 and the negative pressure source 106 to each fluid removal passage 150. The fluid removal passages 150 may take a variety of different shapes or be formed of a variety of materials. For example, in some embodiments, the fluid removal passage 150 may be formed from a portion of a first liquid-impermeable layer 118 and a second liquid-impermeable layer 120 that have been welded together to form a channel. Alternatively or additionally, the fluid removal passage 150 may include, or be substantially composed of, creases or folds in any one or both of the liquid-impermeable layers 118 and 120. Other exemplary embodiments of the fluid removal passage 150 may include channels formed of extruded material, channels embossed onto liquid-impermeable layers 118 and 120, or separate tubing material formed as a separate tube for use as the fluid removal passage 150. Multi-lumen tubing may also be used for the fluid removal passage 150. In several different embodiments, each different form and configuration of the fluid removal passage 150 may also be applied, where appropriate, to the fluid delivery tubing of the drip matrix 152.

[0164] In some embodiments, each fluid removal passage 150 may include a manifold component, such as a manifold component 156, for delivering negative pressure and extracting fluid through the fluid removal passage 150. For example, in some embodiments, each manifold component 156 may be a single sheet of manifold component material extending the length of the fluid removal passage 150, while some embodiments include manifold components 156 formed by discrete portions or segments made of manifold component material. In either case, the manifold component 156 may include a series of notches 159 that may assist in the compliance (including size and flexibility) of the manifold component 156 and the fluid removal passage 150, as well as the delivery of negative pressure and / or collected fluid.

[0165] Manifold component 156 may typically include any material or structure provided to assist in applying negative pressure to, delivering fluid to, or removing fluid from tissue site 112 or other locations. Manifold component 156 may typically be a manifold component material having multiple flow channels or pathways for distributing fluid supplied to and removed from the manifold component 156. For example, the manifold component material may be adapted to receive negative pressure from a source and distribute negative pressure throughout the tissue site through multiple orifices, which may have the effect of collecting fluid from the entire tissue site and drawing fluid toward the source. In some embodiments, the fluid path may be reversed or secondary fluid paths may be provided to facilitate fluid delivery throughout the tissue site.

[0166] In some illustrative embodiments, these pathways of the manifold may be interconnected to improve the distribution or collection of fluid throughout the tissue site. In some illustrative embodiments, the manifold may be a porous foam material with interconnected cells or pores. For example, honeycomb foams, open-cell foams, mesh foams, porous tissue aggregates, and other porous materials such as gauze or felt pads typically include pores, edges, and / or walls adapted to form interconnected fluid channels. Liquids, gels, and other foams may also include or be cured to include multiple pores and multiple fluid pathways. In some embodiments, the manifold may additionally or alternatively include protrusions forming interconnected fluid paths. For example, the manifold may be molded to provide surface protrusions defining interconnected fluid paths.

[0167] In some embodiments, manifold component 156 comprises a porous foam and includes a plurality of interconnected chambers or pores serving as flow channels. The average pore size of the foam can vary depending on the needs of the prescribed therapy. For example, in some embodiments, manifold component 156 may be a foam with a pore size in the range of about 400 micrometers to 600 micrometers. The tensile strength of manifold component 156 can also vary depending on the needs of the prescribed therapy. For example, the tensile strength of the foam can be increased to infuse a topical treatment solution. In some embodiments, manifold component 156 may include a polyurethane foam with a thickness between 6 mm and 10 mm. In a non-limiting example, manifold component 156 may be an open-cell mesh polyurethane foam, such as GRANUFOAM™ dressing or VAC VERAFLO™ dressing, both available from Kinetic Concepts, Inc. of San Antonio, Texas. Some embodiments may include manifold component 156 having additional layers or materials, such as absorbent materials, wicking materials, hydrophobic materials, and hydrophilic materials.

[0168] The infusion matrix 152 may include a plurality of fluid delivery tubes 158 and a dispensing hub 160. The components of the infusion matrix 152 may be constructed from a variety of different materials. For example, some or all of the components of the infusion matrix 152 may be constructed from soft medical-grade silicone or PVC tubing. The size of the plurality of fluid delivery tubes 158 may vary based on the specific size and application of the treatment device 101 and the conditions under which the treatment device 101 is applied to the tissue site 112. For example, each fluid delivery tube 158 may have an inner diameter between 0.5 mm and 4 mm. In some embodiments, each fluid delivery tube 158 may have an inner diameter between 1 mm and 2 mm. The relatively small size of the fluid delivery tubes 158 can help avoid patient discomfort during therapy and facilitate removal of the treatment device 101 after therapy is completed.

[0169] like Figure 3 As shown, but also see again Figure 2 In some embodiments, the infusion matrix 152 may be substantially encapsulated within multiple layers of the dressing 102. For example, the fluid delivery tube 158, together with the fluid removal passage 150, is positioned within a chamber 125 formed by the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120. In some cases, the infusion matrix 152 and the fluid removal passage 150 may be inserted into the chamber 125 between the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120 during manufacturing, before the liquid-impermeable layers 118 and 120 are attached together, for example, by ultrasonic welding. The fluid removal passage 150 and the fluid delivery tube 158 may each be secured in place between the liquid-impermeable layers 118 and 120 by welding the liquid-impermeable layers 118 and 120 together along the boundary between the fluid removal passage 150 and the fluid delivery tube 158, as shown by weld line 162.

[0170] Currently, the main reference is... Figures 4A to 4B It shows that it can be used with Figure 3 Additional features associated with some exemplary embodiments of the treatment device 101. For example, such as Figure 4AAs shown, each fluid removal passage 150 may include an open end 164 and an opening or hole, such as a removal passage hole 166, along its length. Therefore, in such an embodiment, the fluid removal passage 150 can pass through both ends and along its length to deliver negative pressure and extract fluid. Meanwhile, in this exemplary embodiment, the fluid delivery tube 158 may have only an open end, such as the delivery end 168, and may otherwise be fluidly isolated from the surrounding environment along its length. In some embodiments, the treatment device 101 may be provided in a single size by cutting and removing a portion of the treatment device 101 to reduce its size, thereby potentially shortening the length of the fluid delivery tube 158 according to the needs of an individual patient. Therefore, by having the fluid delivery tube 158 have openings only at both ends of a separate tube, a higher level of customization can be achieved because the fluid delivery tube 158 and the entire drip matrix 152 are independent of the set length of the fluid delivery tube 158 or the number or size of the perforations along the fluid delivery tube 158 for uniformly distributing the drip fluid.

[0171] Figure 5 It shows that it can be used with Figure 3 Additional features associated with some exemplary embodiments of the treatment device 101. Figure 5 The components and features of the exemplary treatment device 101 are largely the same as Figure 4A and Figure 4B The components and features of the illustrated treatment device 101 are the same or similar, except for certain aspects of the fluid delivery tube 158. For example, as Figure 5 As shown, instead of having an open end, such as delivery end 168 in FIG4, to deliver the infusion fluid to the tissue site, the fluid delivery tube 158 may have a closed end, such as delivery tube closed end 170. Alternatively, each of the fluid delivery tubes 158 may include an opening or perforation, such as delivery tube perforation 172, along its length. However, Figure 4A , Figure 4B and Figure 5 The embodiments shown are for illustrative purposes only, and it is also contemplated that the fluid delivery tube 158 may include both an open end and a perforation along its length.

[0172] The infusion matrix 152 can be adapted to deliver fluid to tissue site 112 in a substantially uniform manner. For example, the fluid delivery tube 158, delivery end 168, and delivery tube perforation 172 can each be adapted to provide substantially the same back pressure. Such a configuration prevents fluid from traveling more freely through one fluid delivery tube 158 than another, or from being more favorable to one fluid delivery tube than the other. Here, back pressure can refer to the increase in local pressure caused by the resistance to fluid flow through a confined space, such as through a lumen or orifice. Back pressure can arise from the geometry and material properties of the confined space, such as, but not limited to, the size of the space, the presence and shape of bends or joints in the space, the surface finish within the space, and other characteristics. In some embodiments, if the size of the perforation (e.g., delivery tube perforation 172) along the length of the fluid delivery tube 158 is determined to provide substantially uniform fluid distribution throughout the abdomen, a fluid hub, such as a dispensing hub 160, may not be necessary.

[0173] Fluids tend to follow the path of least resistance, and therefore poor fluid distribution may arise from one of these fluid delivery tubes 158 having less back pressure or fluid flow resistance than the other. Similarly, poor fluid distribution may arise from one of these fluid delivery orifices (e.g., delivery end 168 or delivery tube perforation 172) having less back pressure or fluid flow resistance than the other. Consistency in the size and configuration of these fluid delivery tubes 158, and in the number and size of delivery ends 168 and delivery tube perforations 172 in each fluid delivery tube 158, can, for example, enhance the uniformity of fluid delivery to the tissue site 112. Therefore, in some embodiments, the number and size of these delivery orifices (e.g., delivery ends 168 and delivery tube perforations 172) on each fluid delivery tube 158 are substantially equal. Additionally, each of these fluid delivery tubes 158 may have substantially the same dimensions.

[0174] For example, in some embodiments, the fluid delivery tube 158 may have a cylindrical tube shape and may have an inner diameter between about 2 mm and about 6 mm. Additionally, 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 profile, wherein a smaller profile or a “flatter” tube profile may be used to improve user comfort when the treatment device 101 is positioned in the tissue site 112. In some embodiments, these delivery orifices (e.g., delivery tip 168 and delivery tube perforation 172) may have a diameter between about 0.1 mm and about 0.8 mm. Determining the size of the inner diameter or cross-section of these fluid delivery tubes 158 to be significantly larger than the size, cross-section, or diameter of the delivery tip 168 and delivery tube perforation 172 can provide substantially uniform pressure within each fluid delivery tube 158. In such embodiments, the fluid flow rate within the fluid delivery tube 158 may be significantly lower or substantially stationary relative to the high fluid flow rate through the delivery orifices (e.g., delivery tip 168 and delivery tube perforation 172).

[0175] Although not shown in the accompanying drawings, in some embodiments, the drip matrix 152 may include an arrangement of fluid delivery tubes 158 in a grid or "spider web" pattern. Therefore, in some cases, the drip matrix 152 may include a plurality of fluid delivery tubes 158 extending radially from a central hub, and additional tube sections fluidly connecting each radially extending fluid delivery tube 158. Perforations may be present along any or all portions of these radially extending fluid delivery tubes 158 and the connecting tube sections.

[0176] Figure 6A It shows the central components, such as Figure 3A more detailed view of the dispensing hub 160. In some embodiments, at least a portion of the dispensing hub 160 may be positioned between the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120 and may be positioned in fluid communication with these fluid delivery pathways, such as the fluid delivery tube 158. In some embodiments, the height of the dispensing hub 160 may allow the dispensing hub 160 to extend outwardly on the surface of the second liquid-impermeable layer 120 of the treatment device 101. The dispensing hub 160 may include a hub port 174, which may be positioned on the top surface of the dispensing hub 160. The size and dimensions of the dispensing hub 160 may allow the hub port 174 to be positioned above the upper surface of the second liquid-impermeable layer 120 and to provide fluid communication between the fluid supply lumen of the conduit 134 and the dispensing hub 160. In some embodiments, the dispensing hub 160 may include a plurality of openings, such as dispensing port 261, positioned around its lower surface. In some embodiments, these dispensing ports 261 may be used for fluid coupling to the fluid delivery tube 158 of the drip matrix 152. These openings, or the specific size of the dispensing ports 261, may be calibrated relative to a particular drip fluid source, such as fluid source 108, and its specific settings or design parameters. For example, some instances of fluid source 108 may each require a specific size opening due to a particular pump flow rate. In some embodiments, the fluid delivery tube 158 may be positioned circumferentially and substantially symmetrically around the dispensing hub 160. Thus, the dispensing hub 160 and the fluid delivery tube 158 may define a fluid drip path.

[0177] like Figure 6A As shown, the dispensing hub 160 may include a material for assisting in the dispensing of the dripping fluid, such as a dispensing member 176. The dispensing member 176 may include a porous or fluid-permeable material, such as foam. Additionally, the shape of the dispensing hub 160 may be generally elongated and cylindrical, or bell-shaped, but may also have other shapes. In other embodiments, the dispensing hub 160 may include fittings, such as tubes, tubular fittings, pipes, barbed connections, or similar structures. In such embodiments, the fitting may be pre-bonded to or directly molded to the first liquid-impermeable layer 118 or the second liquid-impermeable layer 120 and configured for fluidly connecting the fluid supply lumen of the conduit 134 to the fluid delivery tube 158.

[0178] In some embodiments, the dispensing hub 160 can be cast or injection molded from a similar soft medical-grade silicone or PVC material. In some other embodiments, the dispensing hub 160 can be made from two polyurethane diaphragms welded together. In some additional embodiments, the dispensing hub 160 can actually be used as a fluid infusion and fluid removal combination hub, in which case the dispensing hub 160 can be fluidly connected to both the fluid delivery catheter and the fluid removal catheter of the treatment device 101. In such a case of a fluid infusion and fluid removal combination hub, the dispensing hub 160 can include a series of one-way valves. Such one-way valves can be any type of one-way valve, such as an off-the-shelf duckbill valve or a custom-made valve. These one-way valves can be located on an opening (e.g., dispensing port 261) of the dispensing hub 160, leading to the fluid delivery tube 158 and the fluid removal passage, such as the fluid removal passage 150. In some embodiments of the combined central component, a common dispensing material may be included as part of the central component, while also enabling fluid communication with separate fluid delivery tubes 158 and fluid removal passages 150.

[0179] In some cases, these fluid delivery tubes 158 may be formed from a dispensing hub 160 and subsequently attached to the dispensing hub 160 by medical-grade adhesive or cyclohexanol or by welding. In other exemplary embodiments, the fluid delivery tubes 158 and the dispensing hub 160 of the drip matrix 152 may be formed substantially as a single structure.

[0180] See Figure 6B However, overall it is still referred to here. Figure 2 Interface 132 can provide a negative pressure connection and a fluid supply connection to treatment device 101. Interface 132 can be sized, shaped, or otherwise adapted to fluidly connect the negative pressure lumen 135 and the fluid supply lumen 137 of catheter 134 to treatment device 101 in any suitable manner. In some embodiments, interface 132 can fluidly connect the negative pressure lumen 135 and the fluid supply lumen 137 via a sealing member 128. For example, one or more sealing member holes can be arranged through the sealing member 128 to provide fluid communication and access to components of treatment device 101 located within a sealed space.

[0181] In some embodiments, interface 132 may be formed or molded as part of negative pressure lumen 135 and fluid supply lumen 137. In other embodiments, negative pressure lumen 135 and fluid supply lumen 137 may be bonded or fastened to interface 132, for example, by interference fit. In some embodiments, a portion of interface 132 (e.g., a flange) may be coupled to sealing member 128 to position interface 132 in fluid communication with treatment device 101 via sealing member 128. Interface 132 may be coupled to sealing member 128 in any suitable manner, such as by adhesive or other bonding means. For example, in some embodiments, the adhesive used to couple interface 132 to sealing member 128 may be the same as the attachment means 142 (described above) used for sealing member 128.

[0182] In some embodiments, such as Figure 6B As shown, interface 132 can be a multi-port interface for providing a negative pressure connection and a fluid supply connection as separate, fluid-isolated ports within the multi-port interface (e.g., interface 132). In such an embodiment, the wall of one of these independent lumens (e.g., 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 for maintaining fluid isolation between the negative pressure lumen 135 and the fluid supply lumen 137 are also possible.

[0183] In other embodiments (not shown), interface 132 may be a single-port interface that can provide a negative pressure connection or a fluid supply connection. Thus, a first single-port interface can provide a negative pressure connection, and a second single-port interface can provide a fluid supply connection. In other embodiments, without interface 132, negative pressure lumen 135 can be directly fluidly connected to fluid removal hub 154, and fluid supply lumen 137 can be directly fluidly connected to distribution hub 160.

[0184] In some alternative embodiments, the treatment device 101 may include a fluid hub that serves as a mechanism for dispensing infusion fluid through a dispensing pathway and dispensing and collecting fluid through a fluid removal pathway under negative pressure. For example, the fluid hub may include two layers or chambers separated by a membrane, such as a polyurethane membrane. The top or upper chamber may receive and guide clean infusion fluid via a matrix of open pathways leading to the fluid delivery tube. The top chamber may also include a base plate with serrated sections or pleats to aid in fluid guidance. In some embodiments, the base plate may provide a continuous membrane layer during the fluid infusion phase of the therapy, but when negative pressure is applied, the pleats or flaps of the base plate may be pulled upward to provide small openings for fluid to pass upward through the lower chamber and exit the fluid hub. The top chamber may also include a porous foam ring surrounding the inner periphery of the chamber to provide filtration of larger contaminants flowing out of the fluid infusion pathway. When compressed under negative pressure, the foam ring may also function as a seal to close the fluid infusion channel. The lower or lower chamber of the fluid central component may be connected to a fluid removal passage, and the lower chamber may include manifold material to ensure that the fluid passage remains open under negative pressure. Fluid can be removed from the treatment device 101 and through the fluid central component under negative pressure, where the chance of clean infusion fluid mixing with dirty fluid from the tissue site is minimized. In some embodiments, the fluid central component may include one or more valves, such as O-ring seal valves, in the upper chamber, which can block the opening from the upper chamber to the fluid infusion passage when negative pressure is applied.

[0185] See in general Figures 1 to 6B In some illustrative embodiments of the operation of the therapy system 100, the size of the treatment device 101 may be determined to match the tissue site 112 and disposed at or within the tissue site 112, such as the abdominal cavity 111. If it is necessary to determine the size of the treatment device 101, excess portions of the treatment device 101 may be removed, for example, by cutting or tearing the first liquid-impermeable layer 118 and the second liquid-impermeable layer 120 of the treatment device 101, as well as the fluid removal passage 150 and the fluid delivery tube 158, to obtain the desired size.

[0186] The treatment device 101 can be positioned to contact the abdominal contents 113, with a portion of the treatment device 101 pushed downward into the patient's paracolic gutter. Specifically, the fluid removal pathway 150 can be positioned at or near the first paracolic gutter 115 and the second paracolic gutter 117. Upon deployment, the treatment device 101 can cover all exposed viscera and can separate the viscera without contacting the wall of the abdominal cavity 111. The size and shape of the treatment device 101 can be determined to allow for such coverage.

[0187] Treatment device 101 may be covered at tissue site 112 by sealing member 128 to provide a sealed space for receiving treatment device 101. Sealing member 128 may be positioned and fluidly sealed around tissue site 112 by attachment means 142 as described above. Holes in sealing member 128, if not already provided as part of sealing member 128, may be cut through or otherwise arranged as needed. Negative pressure connection and fluid supply connection may be generated, for example, through interface 132 or through direct connection of negative pressure lumen 135 to fluid removal assembly 148 and fluid supply lumen 137 to drip matrix 152. Importantly, drip fluid may be supplied independently from a fluid source, such as fluid source 108, through the fluid supply lumen and into drip matrix 152. Therefore, in some embodiments, drip fluid may be supplied directly to a fluid hub, such as dispensing hub 160, and thus, the fluid drip path and fluid removal path may be controlled as separate entities. Therefore, potential contamination of the clean fluid infusion pathway can be reduced or largely eliminated, and a more efficient clean cycle can be achieved. In some embodiments, depending on the exact configuration of the components of the treatment device 101, fluid can be delivered directly to the lower part of the abdomen, such as the paracolic gutter, for example, the first paracolic gutter 115 and the second paracolic gutter 117, via the fluid infusion tube.

[0188] Activating the negative pressure source 106 provides negative pressure to the fluid removal assembly 148 via the negative pressure lumen 135 of the conduit 134. The fluid source 108 can provide the infusion fluid to the infusion matrix 152 via the fluid supply lumen 137, for example, by activating a pump or a positive pressure source in the fluid source 108, or by operating gravity or user manual force acting on the infusion fluid. Negative pressure and infusion fluid can be provided to the treatment device 101 simultaneously or periodically at alternating times. Alternatively, depressurization and infusion fluid can be applied to the treatment device 101 intermittently or continuously.

[0189] When the negative pressure source 106 is activated, the negative pressure lumen 135 of the conduit 134 can distribute negative pressure to the fluid removal hub 154 and fluid removal passage 150 of the fluid removal assembly 148. For example... Figures 4A to 5 As indicated by extraction arrow 169, fluid can be drawn or extracted from tissue site 112 through open end 164 and removal path hole 166 into fluid removal passage 150. Fluid in fluid removal passage 150 can be passed through fluid removal passage 150 into fluid removal hub 154, where fluid can be drawn into negative pressure lumen 135 of catheter 134 and finally into container 110.

[0190] When fluid source 108 is activated, or when infusion fluid is otherwise delivered to treatment device 101, infusion fluid can flow into dispensing center 160 of infusion matrix 152. Infusion fluid can be delivered from dispensing center 160 through fluid delivery tube 158, and delivery end 168 and / or delivery tube perforation 172 in fluid delivery tube 158 to tissue site 112, as indicated by arrow 161. The configuration of infusion matrix 152 and associated back pressure as described above helps to deliver infusion fluid to tissue site 112 in a substantially uniform manner.

[0191] Fluid dripped or delivered to tissue site 112 via infusion matrix 152 can remain physically and fluidly separated from fluid removal component 148 until it reaches or directly contacts tissue site 112. Once delivered to tissue site 112, the infusion fluid may combine with, for example, previously infused fluid, wound fluid, tissue fluid, and other fluids that can be considered waste fluid. When negative pressure is applied to treatment device 101, tissue or wound fluid from tissue site 112, as well as any previously delivered infusion fluid to tissue site 112, can be extracted via separate fluid removal component 148. Fluid extracted from tissue site 112 via fluid removal component 148 can remain physically and fluidly separated from infusion matrix 152. This separation between fluid removal component 148 and infusion matrix 152 prevents fluid that may remain in fluid removal passage 150 or fluid removal hub 154 after or during extraction from tissue site 112 from the infusion site from being forced back into tissue site 112 during the fluid infusion process.

[0192] Furthermore, the separation of the fluid removal assembly 148 from the infusion matrix 152 can facilitate the efficient use of the infusion fluid. For example, as described above, the fluid removal hub 154 and the fluid removal passage 150 can include a porous, fluid-permeable material, such as foam. This fluid-permeable material can include fluid flow passages that can remain open or fluid-permeable while under negative pressure for extracting fluid from tissue site 112. Further, the fluid extracted from tissue site 112 can be stored within the fluid removal assembly 148 of the treatment device 101 before being drawn into the negative pressure lumen 135. The ability to provide fluid storage and permeability while under negative pressure may require the fluid removal assembly 148 to have a larger fluid capacity compared to the infusion matrix 152, which may be under positive pressure. Fluid infused or delivered to tissue site 112 by the separated infusion matrix 152 does not need to pass through potentially larger portions of the treatment device 101, such as the fluid removal assembly 148. This configuration can enhance the dispensing and efficient use of the infusion fluid.

[0193] Overall, continue Figures 1 to 6BThe text further describes a method for providing fluid infusion and negative pressure therapy at a tissue site. In some embodiments, a method for providing fluid infusion and negative pressure therapy at a tissue site may include positioning a treatment device 101 adjacent to a tissue site 112. The treatment device 101 may include an infusion matrix 152 and a fluid removal assembly 148 separate from the infusion matrix 152. As previously discussed, in some embodiments, the tissue site 112 may be an abdominal cavity 111, and positioning the treatment device 101 adjacent to the tissue site 112 may include placing at least a portion of the treatment device 101 near a paracolic gutter in the abdominal cavity 111, such as a first paracolic gutter 115 and / or a second paracolic gutter 117. Additionally, in some embodiments, the method may include covering the treatment device 101 with a sealing member 128 to provide a sealed space between the sealing member 128 and the tissue site 112. In some embodiments, the method may include sizing the treatment device 101 for placement at the tissue site 112. As previously mentioned, sizing the treatment device 101 may include cutting or tearing the treatment device 101. In some cases, the treatment device 101 may include visual markers to guide the user to customize the treatment device to the desired size.

[0194] The method may further include connecting a fluid source 108 to a drip matrix 152 in fluid communication and connecting a negative pressure source 106 to a fluid removal assembly 148 in fluid communication. The method may further include supplying drip fluid from the fluid source 108 through the drip matrix 152 to the tissue site 112. Furthermore, the method may include providing negative pressure from the negative pressure source 106 through the fluid removal assembly 148 to the tissue site 112 and extracting fluid from the tissue site 112 through the fluid removal assembly 148. After completing the negative pressure and / or fluid drip therapy, the user can remove the treatment device 101 as a substantially intact structure, thereby maintaining the usability of the treatment device 101.

[0195] See now Figure 7A This illustrates another exemplary embodiment of a treatment device 201 for use in a therapy system 100. In this embodiment, the treatment device 201 may include substantially similar to... Figure 3The treatment device 201 may be a component of the treatment device 101, but may differ in the arrangement and function of individual features. For example, the treatment device 201 may include multiple fluid removal channels 150 positioned between multiple liquid-impermeable layers of the dressing 202 and fluidly connected to a fluid removal hub 154. However, in this exemplary embodiment, the treatment device 201 may include a drip matrix 252 with multiple fluid delivery tubes 258 attached to a dispensing hub 260, and these fluid delivery tubes 258 may be loosely suspended below the dressing 202. In this embodiment of the treatment device 201, the user can independently position each fluid delivery tube 258 within the patient's abdominal cavity. Thus, the user may choose to distribute these fluid delivery tubes 258 evenly throughout the abdominal cavity to provide a completely uniform rinse of the abdomen, or alternatively, the user may choose to focus the fluid delivery tubes 258 on any area of ​​particular interest to provide a more thorough rinse. The treatment device 201 allows the user to determine this based on the specific circumstances. In some embodiments, the plurality of fluid delivery tubes 258 may comprise a perforated polyurethane membrane or foam. For example, the fluid delivery tubes 258 may be constructed using two layers of polyurethane membrane approximately 100 micrometers thick, welded together at the edges. The fluid delivery tubes 258 may have an open end to achieve targeted fluid delivery. Similarly, in such embodiments, the dispensing hub 260 may be constructed of two layers of polyurethane membrane approximately 100 micrometers thick, welded together. In some embodiments, a central core may be located within each of the fluid delivery tubes 258 and the dispensing hub 260, the central core being adapted to ensure that an open passage is maintained and to assist the user in operation during placement. For example, this central core may be an open-cell mesh polyurethane foam. The dimensions of the central core material located within the fluid delivery tubes 258 may vary, for example, the central core material may be in the range of approximately 2 mm to 10 mm thickness multiplied by 5 mm to 15 mm width. In some embodiments, the central core material may be approximately 6 mm thick multiplied by 10 mm wide. The length of the central core material may vary based on the overall size of the treatment device 201. Some embodiments of the treatment device 201 may include a central core material whose width varies along its length, which may allow for user-customizable and size-determined breakpoints. In some cases, the fluid delivery tubes 258 may be adapted such that any drip fluid remaining in the fluid delivery tubes 258 after the fluid source 108 has delivered the drip fluid can be expelled from the fluid delivery tubes 258 when a negative pressure is applied to the treatment device 201, thereby ensuring that substantially all drip fluid is emptied from these fluid delivery tubes 258 for better regulation of the volume of drip fluid supplied during the therapy cycle.

[0196] Figure 7B It shows something similar to Figure 7AThe treatment device 301 is an embodiment of a treatment device 301, but instead of comprising multiple fluid removal pathways positioned between a plurality of liquid-impermeable layers of a dressing 202, the treatment device 301 includes both independently locatable fluid removal pathways and fluid infusion pathways. In some embodiments, the treatment device 301 may include a dressing 302 having fluid removal pathways 250 attached to a fluid removal hub 254 and extending freely beneath the liquid-impermeable layer of the dressing 302. Furthermore, in some embodiments, the treatment device 301 may also include an infusion matrix 252 having fluid delivery tubes 258, which may also extend freely from the underside of the dressing 302. Thus, in such embodiments, the user can select to focus these fluid removal pathways 250 and fluid delivery tubes 258 on any area of ​​interest within the patient's abdominal cavity. The user can also select to distribute the fluid removal pathways 250 and fluid delivery tubes 258 evenly within the patient's abdomen to provide complete rinsing of the abdominal cavity. In such embodiments, the dressing 302 may be provided with a fluid removal passage 250 and a fluid delivery tube 258 attached to a liquid-impermeable layer of the dressing 302, or provided separately for user assembly.

[0197] Figure 7C Another embodiment of the treatment device 401 is also shown, which is similar to Figure 7B The treatment device 301 may include multiple fluid removal channels 350 and a drip matrix 352 having fluid delivery tubes 358 loosely adjacent to or beneath a liquid-impermeable layer of dressing 402. However, in some embodiments, such as Figure 7C As shown, each fluid removal pathway 350 can 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 pathway 350 can be paired with the fluid delivery tube 358, but two separate fluid pathways are still maintained. This arrangement provides the benefit that fluid infused to a location within the abdominal cavity can subsequently be removed from the same area, which can be important in cases where the abdominal cavity is highly contaminated to avoid cross-contamination with other areas of the abdominal cavity. Since neither the fluid removal pathway 350 nor the fluid delivery tube 358 is positioned within the liquid-impermeable layer of the dressing 402, the treatment device 401 may require a separate dressing 402 including a liquid-impermeable layer, which can be applied to the patient's abdominal cavity after the combined fluid removal pathway 350 and fluid delivery tube 358 have been positioned. Depending on specific manufacturing and user requirements, the dressing 402 may be provided as an attachment to the fluid removal pathway 350 and the infusion matrix 352, or separately for user assembly.

[0198] See now Figure 8Another exemplary embodiment of the treatment device 501 is shown. In this embodiment, the fluid removal pathway 450 and the fluid delivery tube 458 of the drip matrix 452 are formed as part of the dressing 502, wherein each fluid removal pathway 450 extends adjacent to and parallel to the fluid delivery tube 458, thereby forming parallel pathways 590. In some embodiments, these parallel pathways 590 (each of which may include the fluid removal pathway 450 and the fluid delivery tube 458) can be connected between multiple segments of the liquid-impermeable layer of the dressing 502 through perforated connectors (e.g., perforations 592) in the liquid-impermeable layer of the dressing 502. Thus, each parallel pathway 590 can be independently movable and placed within a specific area of ​​the abdominal cavity, such as adjacent to the small intestinal ring, paracolic gutter, retroperitoneal space, lymphatic system, etc., by cutting or tearing along its periphery with the perforation 592. Furthermore, some embodiments of the dressing 502 may also include additional perforated connectors or perforated lines located between each fluid removal passage 450 and fluid delivery tube 458 within the parallel passage 590. Thus, each fluid removal passage 450 may also be individually movable from its corresponding mating fluid delivery tube 458 and, as desired, positioned within the abdominal cavity. Regardless of location, each fluid removal passage 450 may remain fluidly connected to the fluid removal hub 454, and each fluid delivery tube 458 may remain fluidly connected to the dispensing hub 460.

[0199] Figure 9 Features of some exemplary embodiments of the treatment device are shown, wherein a fluid removal pathway and a fluid infusion pathway can be combined into a single pathway. For example, a single fluid removal pathway and a single fluid infusion pathway can be combined into a single tubular structure, such as a combination tube 694. The combination tube 694 may include a central aperture 696, which may be formed by an inner liner 697 (which may be a membrane, such as a polyurethane membrane). The combination tube 694 may also include an outer lumen 698, which may be formed by an outer liner 699 (which may also be a membrane, such as a polyurethane membrane). Depending on the specific embodiment, either the central aperture 696 or the outer lumen 698 may be used for the fluid removal pathway or the fluid infusion pathway.

[0200] See now Figures 10A to 10CThe illustration shows another exemplary embodiment of a treatment device 701 used with the therapy system 100. In some embodiments, the treatment device 701 may include a dressing 702, which may be formed of multiple 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 infusion fluid to the treatment device 701. The treatment device may also include a fluid removal hub 754 for transmitting negative pressure to a portion of the treatment device 701 and removing fluid from the treatment device 701 and the abdominal cavity. Figure 10A The depicted treatment device 701 may further include a fluid delivery vessel 760 for dispensing infusion fluid. The fluid delivery vessel 760 may be a flexible vessel fluidly connected to an infusion source, such as a fluid source 108 of the therapy system 100. In some embodiments, the body of the fluid delivery vessel 760 may be composed of one or more portions of a membrane material with a thickness ranging from 25 micrometers to 500 micrometers. For example, the fluid delivery vessel 760 may be composed of a polyurethane membrane with a thickness ranging from 50 micrometers to 200 micrometers. In some cases, the fluid delivery vessel 760 may be a peripherally welded structure with a predetermined volume. Some embodiments of the fluid delivery vessel 760 may include internal welds between the polyurethane membrane portions forming the body of the fluid delivery vessel 760 to reduce vessel bulging under pressure. Internal welds may also be introduced to reduce the internal volume of the fluid delivery vessel 760 or to help guide the infusion fluid into the fluid delivery vessel 760, thereby helping to ensure uniform distribution of fluid leaving the fluid delivery vessel 760 and entering the abdominal cavity.

[0201] like Figures 10A to 10C As shown, the fluid delivery vessel 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 vessel 760 can essentially form a two-chamber structure, wherein the two chambers are arranged in a vertically stacked manner. Figures 10A to 10C As depicted, the fluid delivery vessel 760 may be formed of a vessel layer 780, which is adhered or welded to the underside of the dressing 702, such as to a first liquid-impermeable layer 718. In some embodiments, the fluid delivery vessel 760 may be fluidly coupled through the dressing 702 to a delivery connector 763 and thus to a drip fluid source via a sealed welded opening (e.g., a dressing opening 779), which may pass through the visceral protective layers of the dressing 702, namely the first liquid-impermeable layer 718 and the second liquid-impermeable layer 720.

[0202] The vessel layer 780 may include perforations, windows, or openings, such as vessel orifice 781, to allow the dripping fluid to be delivered from the fluid delivery vessel 760. The size of the vessel orifice 781 can be determined to provide back pressure when filling the fluid delivery vessel 760 by ensuring that the outflow rate of the fluid delivery vessel 760 is less than the filling flow rate. For example, the vessel orifice 781 may have a diameter in the range of 0.2 mm to 1.0 mm. The vessel orifice 781 may also have a diameter outside this range, depending on the number and / or pattern of the vessel orifices 781 in the vessel layer 780. Figure 10A The volume or size of the fluid delivery vessel 760 depicted may expand or bulge during the infusion or fluid delivery phase of treatment.

[0203] During operation, infusion fluid can enter the fluid delivery vessel 760, and as the fluid delivery vessel 760 is filled, back pressure can be generated, which thus pressurizes the fluid delivery vessel 760 before the infusion fluid can actually be released from it. This feature helps ensure that the fluid can be more evenly dispersed through the vessel orifice 781 and thus provide a uniform distribution of infusion fluid from the entire area of ​​the fluid delivery vessel 760. However, it is important to note that the fluid delivery vessel 760 can be designed such that the back pressure level generated by the fluid delivery vessel 760 is always less than the threshold pressure that triggers an alarm on the fluid source 108 of the fluid infusion system, such as the therapy system 100. Furthermore, the vessel orifice 781 can be arranged in a way that, for example, by including an asymmetrical pattern of the vessel orifice 781, provides a larger flow rate at some locations and a smaller flow rate at others in the fluid delivery vessel 760. Therefore, the pattern of the orifice 781 can determine the fluid distribution and can produce different forms of fluid delivery vessels 760, which are designed to target specific areas of the abdominal cavity or organs or other tissue sites. Furthermore, in some embodiments, the vessel layer 780 of the fluid delivery vessel 760 can be quilted within the vessel 760 using welding or other methods to reduce its internal volume, thereby eliminating bulging due to back pressure or aiding in fluid distribution. This feature can thus help reduce patient discomfort and associated risks.

[0204] The potential delay in releasing the infusion fluid from the fluid delivery vessel 760 into the abdominal cavity or other tissue sites can provide the following benefits: allowing the temperature of the infusion fluid to balance with the body's core temperature, thus reducing the risk of thermal shock. Once released from the fluid delivery vessel 760, the infusion fluid can flow through the abdominal cavity and into the paracolic gutter, thus clearing its entire path. Additionally, there may be a stagnation time in the infusion fluid, as some fluid may remain in the fluid delivery vessel 760 after the infusion cycle. With the application of negative pressure to the treatment device 701, the infusion fluid can pass through the fluid removal pathway 750 (… Figure 10B The fluid (shown in the diagram) is removed, thus continuing to flush the abdominal contents as it is removed from the abdominal cavity. In some cases, as mentioned above, the infusion fluid remaining in the fluid delivery vessel 760 can be removed during the application of negative pressure, thus acting as a clean rinsing fluid upon removal. For example, after most of the infusion fluid has been removed from the abdominal cavity and negative pressure has begun to be established within the abdominal cavity, a component of the treatment device 701 can be pulled downwards, and the fluid remaining in the fluid delivery vessel 760 can be removed as a rapidly moving fluid, thereby acting as a final and secondary rinse. The fluid infusion cycle and negative pressure cycle can be repeated as needed or desired.

[0205] Now, please refer to Figure 10B Similar to other embodiments described in detail above, the treatment device 701 may include a plurality of fluid removal passages 750, each fluidly coupled to a fluid removal hub 754. Thus, the fluid removal hub 754 may serve as a dispensing mechanism for delivering negative pressure to each fluid removal passage 750. Each fluid removal passage 750 may include a manifold member to deliver negative pressure and aspirate fluid through the fluid removal passage 750. For example, the manifold member may be constructed of open-cell foam or a nonwoven fabric, such as GRANUFOAM™. The fluid removal passages 750 may be incorporated within a dressing 702 and thus between visceral protection layers, namely a first liquid-impermeable layer 718 and a second liquid-impermeable layer 720. Incorporating the fluid removal passages 750 between visceral protection layers helps protect the abdominal cavity from the influence of the manifold member, which could otherwise pose a risk of granulation tissue formation. In some embodiments, the fluid removal passages 750 may be formed by welding portions of the first liquid-impermeable layer 718 and the second liquid-impermeable layer 720 together to form a fluid channel between these membrane layers. See now primarily. Figure 10CThe first liquid-impermeable layer 718 and possibly the second liquid-impermeable layer 720 may include apertures, such as orifices 766, which may be positioned along each fluid removal pathway 750. Fluid may be drawn into the fluid removal pathway 750 through the orifices 766 in the first liquid-impermeable layer 718 on the underside of each fluid removal pathway 750. Each fluid removal pathway 750 may also include an opening at one end that may allow for the removal of large amounts of fluid from the patient's paracolic gutter. Providing concentrated fluid removal at a low point in the patient's abdomen, such as the paracolic gutter, helps ensure complete flushing of the abdomen during the infusion and removal therapy cycle.

[0206] Figures 11A to 11B Another exemplary embodiment of the treatment device 701 is shown, which may be similar in many respects to the treatment device described above. Figures 10A to 10C An embodiment of the treatment device 701 is discussed. However, in Figures 11A to 11B In the illustrated embodiment, the treatment device 701 may incorporate a fluid delivery vessel 760, which includes a vessel chamber 782 and radial channels 784 that extend downward along the interior of the abdominal wall and into the paracolic gutter of the patient's abdomen. This embodiment may particularly allow for uniform distribution of the infused fluid into the abdominal cavity while providing targeted flushing of the paracolic gutter with a cleansing infusion fluid. These radial channels 784 may have an open end 785 and a channel orifice 786 along the length of each radial channel 784. In some embodiments, these radial channels 784 may be designed to limit flow, for example, into the paracolic gutter. The open end design of these radial channels 784 may also allow these radial channels 784 to be cut and their size determined to suit the needs and proportions of an individual patient.

[0207] See now Figures 12A to 12B Another illustrative embodiment of the treatment device 701 is shown. Again, Figures 12A to 12B Many features of the treatment device 701 can be related to the features of the treatment device 701. Figures 10A to 11B The features of the embodiments of the treatment device 701 discussed are the same or similar. Figures 12A to 12B In an exemplary embodiment, the fluid delivery vessel 760 may incorporate an internal manifold or matrix, such as an internal manifold matrix 788, to help ensure that the fluid dripping pathway from the delivery connector 763 through the fluid delivery vessel 760 and out of the vessel orifice 781 remains open and is not blocked or sealed when subjected to negative pressure. Exemplary materials for the internal manifold matrix 788 may include foam, such as polyurethane foam, Libeltex TDL2, embossed film, or some other form of structure.

[0208] Figures 13A to 13BAnother exemplary embodiment of a treatment device 801 for use with a therapy system 100 is shown, which may be similar in many respects to embodiments of the treatment devices previously discussed. In some embodiments, the treatment device 801 may include a dressing 702 and a fluid delivery vessel, such as a fluid delivery vessel 860, which may be supplied as a separate component in a state not attached to a liquid-impermeable layer of the dressing 702, and is assembled by the user during application. For example, in some embodiments, the fluid delivery vessel 860 may be formed of two layers, such as a lower vessel layer 880 and an upper vessel layer 883. In some embodiments, the fluid delivery vessel 860 may be in the form of a bag or encapsulated foam. The vessel layer 880 may include an opening, such as a vessel orifice 881, on the lower surface or bottom side of the fluid delivery vessel 860 for delivering fluid out of the fluid delivery vessel 860 and into the patient's abdominal cavity. In some embodiments, the fluid delivery vessel 860 may be fluidly connected to an infusion source, such as a fluid source 108, through an opening in the upper layer 883, which may be physically and fluidly connected to an end of the delivery connector 763. Similar to other embodiments described previously, the fluid delivery vessel 860 may bulge during a fluid infusion cycle of therapy as fluid is delivered to the fluid delivery vessel 860 and it is filled under pressure.

[0209] Importantly, by allowing the fluid delivery vessel 860 to be supplied separately from other parts of the treatment device 801, such as the dressing 702, surgeons or other caregivers are better able to determine fluid infusion requirements in the patient's abdomen and apply a fluid delivery vessel of appropriate size or configuration based on the specific situation. Some embodiments of the fluid delivery vessel (e.g., fluid delivery vessel 860) may also be provided as an accessory to current abdominal dressings, such as ABThera® dressings available from Dynamic Concepts, Inc. in San Antonio, Texas.

[0210] Figures 14A to 14B An exemplary embodiment relating to a treatment device 801, the treatment device may be similar to Figures 13A to 13B The illustrated embodiment of the treatment device 801 is shown. However, in Figures 14A to 14BIn an exemplary embodiment, the fluid delivery vessel 860 may incorporate additional components, such as a collapsed or non-collapsed matrix, like a manifold matrix 884, which allows the fluid delivery vessel 860 to be filled with infusion fluid. In some embodiments, the fluid delivery vessel 860 may include a lower vessel layer 880 (which may be closed) and an upper layer, such as an upper vessel layer 883 (which may incorporate perforations, windows, or openings, such as an upper vessel orifice 885). The upper vessel orifice 885 allows infusion fluid to flow out of the upper surface of the fluid delivery vessel 860, which may occur after the fluid delivery vessel 860 has been filled with infusion fluid during a therapeutic cycle. In some cases, by ensuring that the fluid delivery vessel 860 is filled with fluid before it moves into the peritoneum, the need to generate back pressure within the fluid delivery vessel 860 to ensure uniform fluid distribution can be eliminated.

[0211] See now Figure 15 The illustration shows another exemplary embodiment of a treatment device 1001 used with the therapy system 100. In one embodiment, the treatment device 1001 may include a single layer, such as an occlusion layer 1002, to divide the abdominal cavity into two vertically stacked chambers or compartments. The treatment device 1001 may also include a fluid removal manifold 1004, which may be positioned within a central portion of the occlusion layer 1002 and may fluidly deliver negative pressure to the channels of the occlusion layer 1002 to collect and remove fluid from the abdominal cavity. Furthermore, the treatment device 1001 may include a pressurized dispensing vessel 1006, which may dispense infusion fluid across the occlusion layer 1002 to a region of the abdominal cavity. As previously discussed with respect to other embodiments, a conduit 134 for delivering negative pressure and / or infusion fluid may be fluidly connected to the treatment device 1001 at an interface 132.

[0212] In operation, the infusion fluid can be delivered via a suitable fluid source (as previously discussed with respect to other embodiments), and when delivered to the pressurized dispensing vessel 1006 of the treatment device 1001, the infusion fluid can be forced to flow across the entire surface of the occlusion layer 1002. The infusion fluid can flow through pathways formed on the occlusion layer 1002 until it reaches the furthest extent of the occlusion layer 1002, and comes into contact with abdominal contents, and ultimately with the paracolic gutter. As the infusion fluid flows across the top surface of the occlusion layer 1002, it can be warmed to body temperature due to body heat and spread over a large area. As previously described, there may be periods of stagnation in the infusion fluid, with some of the infusion fluid remaining in the pressurized dispensing vessel 1006 on the infusion surface of the occlusion layer 1002; this infusion fluid can then act as a cleansing fluid upon removal.

[0213] During negative pressure or fluid removal cycles, the infusion fluid can be aspirated from the abdominal cavity by suction along a pathway formed on the underside or bottom surface of the occlusion layer 1002. With the application of negative pressure, the occlusion layer 1002 can be pulled downwards and pressed tightly against the abdominal contents. This movement allows the abdominal contents, such as internal organs, to come into contact with the infusion fluid as it is aspirated along the pathway formed on the underside of the occlusion layer 1002. During the application of negative pressure, the fluid remaining in the pressurized dispensing vessel 1006 can be removed as a rapidly moving stream of fluid, thereby serving as a final rinse, as previously discussed with respect to other embodiments.

[0214] See also Figure 16 , showed Figure 15 A schematic cross-sectional view of a portion of the treatment device 1001 and catheter 134. This illustration shows how the occlusion layer 1002 can divide the abdominal cavity into two distinct chambers or compartments. For example, a fluid removal chamber 1008 may be located below the occlusion layer 1002, resting on internal organs, and a fluid infusion chamber 1010 may be located above the occlusion layer 1002, close to the patient's skin. By dividing the abdominal cavity in this way, the occlusion layer 1002 ensures that the infused fluid reaches the furthest extent of the treatment device 1001 within the abdomen before being removed. Importantly, the occlusion layer 1002 also acts as a visceral protective barrier. In some embodiments, the occlusion layer 1002 may be biased to collapse downwards and substantially form a seal under negative pressure, which helps minimize cross-contamination between the fluid infusion chamber 1010 and the fluid removal chamber 1008.

[0215] See you again Figure 15 and Figure 16 In some embodiments, the occlusion layer 1002 may be formed from a single piece or a monolithic membrane, such as a polyurethane membrane. In some embodiments, the occlusion layer 1002 may provide fluid pathways both below the occlusion layer 1002 in the fluid removal chamber 1008 and above the occlusion layer 1002 in the fluid infusion chamber 1010. For example, these fluid pathways may be formed by pleats 1012 in the occlusion layer 1002, which may be formed using high-frequency welding techniques. For example, high-frequency (HF) or radio-frequency (RF) welding may involve using high-frequency electromagnetic energy to fuse multiple portions of material of the occlusion layer 1002 to bond these portions of the occlusion layer 1002 together. These pleats 1012 may be arranged to uniformly distribute fluid to the distal edge of the occlusion layer 1002. The number of pleats 1012 may be varied to further control the flow rate of the infused fluid into the peritoneal cavity as needed or desired.

[0216] In some embodiments, the fluid removal manifold 1004 may be a flexible vessel pneumatically or fluidly connected to the container 110 and the negative pressure source 106 via a removal passage of the conduit 134. The fluid removal manifold 1004 may be made of multiple membranes welded together, and may be a polyurethane membrane welded together around its outer periphery. For example, the fluid removal manifold 1004 may include an upper manifold membrane 1014 and a lower manifold membrane 1016. Figure 16 As shown, in some embodiments, the fluid removal manifold 1004 may include openings or windows that may be included as inlets 1018 as part of the lower manifold membrane 1016. These inlets 1018 on the underside of the fluid removal manifold 1004 can be used to distribute negative pressure to the fluid removal chamber 1008 and to draw fluid from the fluid removal chamber 1008. The size of the inlets 1018 can be determined according to specific suction requirements. In some embodiments, the fluid removal manifold 1004 may include a manifold material 1019, which may be contained within the upper manifold membrane 1014 and the lower manifold membrane 1016. The manifold material 1019 may include a wide variety of materials suitable for conveying or transporting fluid. For example, in some embodiments, the manifold material 1019 may include an open-cell foam with pores having a diameter of approximately 6 mm.

[0217] In some embodiments, the pressurized dispensing vessel 1006 may be a flexible vessel in fluid communication with a fluid source 108 via a drip passage of conduit 134. The volume of the pressurized dispensing vessel 1006 may vary and, in some embodiments, may be reduced by using internal welding, which can further help build local pressure to achieve improved dispensing of the drip fluid. Suitable materials for forming the structure of the pressurized dispensing vessel 1006 may include multiple membranes, such as polyurethane membranes, which may be welded together around the outer periphery. For example, the pressurized dispensing vessel 1006 may include an upper membrane 1020 and a lower membrane 1022. Figure 16As shown, in some embodiments, the pressurized dispensing vessel 1006 may include undersized outlets 1024 as part of the lower membrane 1022 of the vessel to allow infusion fluid to exit the pressurized dispensing vessel 1006 when a specific internal pressure is reached within the pressurized dispensing vessel 1006. For example, these outlets 1024 may be small enough to create a backflow that helps drive the infusion fluid to be evenly distributed from the pressurized dispensing vessel 1006, but not so small that these outlets 1024 would cause a potential blockage alarm in the therapy system 100. In some embodiments, these outlets 1024 may have a diameter between about 0.2 mm and 1 mm. These outlets 1024 may be in the form of perforations or windows. These outlets 1024 may also be arranged in one or more patterns to help determine dispensing, and different arrangements of outlets 1024 may result in different forms of pressurized dispensing vessels 1006 designed to target certain areas or organs. For example, in some embodiments, these outlets 1024 may be arranged in a uniformly spaced pattern around the outer periphery of the pressurized dispensing vessel 1006.

[0218] Figure 17 A schematic cross-sectional view of a portion of another illustrative embodiment of the treatment device 2001 and catheter 134 is shown. In this illustrative figure, it can be seen how the occlusion layer 2002 can include multiple layers to create additional pathways from the distal portion and ends of the occlusion layer 2002 and the paracolic gutter in the abdominal cavity to the fluid removal manifold 2004. In such cases of multi-layered occlusion layers, such as occlusion layer 2002, the structure can be made of membrane material and can be formed three-dimensionally, for example, by heating, vacuum, or compression molding.

[0219] See still Figure 17 Some embodiments of the treatment device 2001 may include a manifold, such as a fluid removal manifold 2004, which is combined with or forms part of the occlusion layer 2002. For example, in some embodiments, the fluid removal manifold 2004 may be formed solely of a lower manifold membrane 2016 attached or welded to the underside of the occlusion layer 2002, thereby eliminating the need for an upper manifold membrane, such as... Figure 16 The need for the upper manifold membrane 1014. In some additional embodiments, such as Figure 17As shown, the fluid removal manifold 2004 can be positioned within multiple layers of the occlusion layer 2002, and thus the lower manifold membrane 2016 with inlet 2018 can actually be formed as part of the lower layer of the multilayer occlusion layer 2002. In such embodiments, the fluid removal passage can be presented as a peripheral inlet 2026 through the fluid removal manifold 2004 between multiple different layers of the multilayer occlusion layer 2002, and through inlet 2018 below the fluid removal manifold 2004 and on the bottom side 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 three-dimensionally formed membranes, wicking materials, and molded manifolds.

[0220] In some embodiments, the pressurized dispensing vessel 2006 may be combined with or formed as part of the occlusion layer 2002. For example, in some embodiments, the pressurized dispensing vessel 2006 may be formed solely of the upper membrane 2020, which is attached or welded to the upper surface of the occlusion layer 2002, thereby eliminating interference with the lower membrane, such as... Figure 16 The lower membrane 1022 of the vessel is required. In some embodiments, the upper membrane 2020 of the vessel may be molded into a single structure with the occlusion layer 2002, as an alternative to being molded and connected from a plurality of flexible parts. In some cases, the upper membrane 2020 and the occlusion layer 2002 may be quilted to ensure that the passage leading out of the pressurized dispensing vessel 2006 is open. For example, a portion of the upper membrane 2020 and the occlusion layer 2002 may be welded together, including the welded periphery surrounding a portion of the upper membrane 2020 and the occlusion layer 2002. Furthermore, a portion of the upper membrane 2020 and the occlusion layer 2002 may be patterned and spot-welded on two material layers to create a quilted effect. Thus, in some embodiments, the height and volume of the pressurized dispensing vessel 2006 when filled with fluid may be limited. A wide variety of materials may be used to form the pressurized dispensing vessel 2006, including but not limited to tubes with small lumens. In some exemplary embodiments, the flow rate distribution of the dripping fluid can be controlled by peripheral outlets 2024, which can be positioned on the outer peripheral edge(s) of the pressurized dispensing vessel 2006. Similar to other embodiments, such peripheral outlets 2024 can be produced using techniques such as high-frequency welding. Although Figure 17 The illustrative embodiments show an improved form of the occlusion layer 2002, the fluid removal manifold 2004, and the pressurized dispensing vessel 2006, but any combination of these features may be introduced in a single embodiment.

[0221] Figures 18A to 18C It demonstrates the relationship with the occlusion layer, Figure 15 Further details associated with features of some exemplary embodiments of the occlusion layer 1002. For example, such as Figure 18A As shown, the occlusion layer 3002 can be formed from a single base layer 3030, which is formed to have a plurality of accordion pleats 3012, these pleats being equivalent to Figure 15 The accordion folds 1012 of the occlusion layer 1002. The accordion folds 3012 can form a fluid removal passage 3032 and a delivery passage 3034, the fluid removal passage being contained below the lower surface of the base layer 3030, and the delivery passage extending along the upper surface of the base layer 3030 to form the accordion folds 3012.

[0222] Figure 18B Another illustrative embodiment of the occlusion layer 4002 is shown, wherein instead of being composed of, as Figure 18A The fluid pathways formed by the accordion pleats 3012 shown are formed by tubular pleats 4012. In such embodiments, the occlusion layer 4002 may be formed of a base layer 4030 having a plurality of tubular pleats 4012 formed on the upper surface of the base layer 4030 by individual tubular layers 4036. Alternatively, the tubular pleats 4012 may be formed of a single base layer 4030, which is formed, for example, by linking or clamping multiple portions of the base layer 4030 together to form the tubular pleats 4012, to have an integral tubular structure. In any case, a fluid removal passage 4032 may be disposed inside the tubular pleats 4012, and a fluid delivery passage 4034 may traverse along the upper surface of the base layer 4030 between the tubular pleats 4012 containing the fluid removal passage 4032.

[0223] Figure 18C Another illustrative embodiment of an occlusion layer 5002, similar to an occlusion layer 4002 but including accordion pleats 5012 for fluid pathways, is shown. Thus, in some embodiments, the occlusion layer 5002 may be formed of a base layer 5030 having a plurality of accordion pleats 5012 formed by individual pleat layers 5036 on the upper surface of the base layer 5030. These removal pathways 5032 may be contained beneath the pleat layers 5036 or within the spaces(s) created between the base layer 5030 and the pleat layers 5036. These fluid delivery pathways 5034 may extend along the upper surface of the pleat layers 5036.

[0224] Now, please refer to Figures 19A to 19CFurther embodiments of methods for providing negative pressure therapy and fluid infusion therapy at a tissue site are described. For example, in some embodiments, the therapy system 6000 may include a treatment device 6001, a negative pressure source 6006, and a fluid source 6008, which is a separate device from the negative pressure source 6006. The fluid source 6008 may be a separate mechanical infusion device. In some embodiments that include a separate mechanical infusion device for the fluid source 6008, the therapy system 6000 may also include an infusion regulator 6019 for monitoring and / or controlling the amount of infusion fluid delivered to the treatment device 6001 and ultimately to the tissue site 112. Figures 19A to 19C As shown, some of the disclosed methods may include a therapeutic cycle with three phases or intervals. For example, such as Figure 19A As shown, the first stage of the therapy cycle may include: activating a negative pressure source 6006 to apply negative pressure therapy to the treatment device 6001 and the tissue site 112. The negative pressure applied by the negative pressure source 6006 can be transmitted through a fluidly connected pathway of the therapy system 6000 and ultimately reach the infusion regulator 6019 and the fluid source 6008. Therefore, the transmitted negative pressure can infuse the fluid source 6008 (which may be a mechanical infusion device). Continue Figure 19B The method may further include a second phase of the therapeutic cycle, which may include pausing or stopping the negative pressure delivery from the negative pressure source 6006 for a predetermined time interval. During this interval, the fluid source 6008 (e.g., a mechanical infusion device) may deliver the infusion fluid to the infusion regulator 6019 and finally to the treatment device 6001. Figure 19C As depicted, after a specific interval in which the infusion fluid is delivered from the fluid source 6008 to the treatment device 6001, the third phase of the therapy cycle can begin. During this third phase, the fluid infusion can be paused, and the negative pressure source 6006 can be reactivated to provide negative pressure therapy for another interval. At this point in the therapy cycle, the infusion fluid can be removed from the treatment device 6001 and the tissue site 112 (e.g., the abdominal cavity 111). Furthermore, the fluid source 6008 can be re-infused and prepared to deliver the infusion fluid to the treatment device 6001 again, as the second phase of the therapy cycle can be repeated.

[0225] Figures 20A to 20C Another exemplary embodiment of a method for providing negative pressure therapy and fluid infusion therapy to a tissue site is shown. Figures 20A to 20C The (multiple) methods of presentation can be essentially similar to those regarding... Figures 19A to 19C The improvements described are varied. For example, such as... Figure 20AThe depicted therapy system 6000 may include a treatment device 6001, a negative pressure source 6006, a fluid source 6008, and an infusion regulator 6019. Furthermore, the therapy system 6000 may further include a pressure relief unit 6021. In some embodiments, during the first phase of a therapy cycle, the negative pressure source 6006 may be activated to apply negative pressure therapy to the treatment device 6001. The negative pressure applied by the negative pressure source 6006 can be transmitted through the fluid connection pathway of the therapy system 6000 and ultimately reach the infusion regulator 6019 and the fluid source 6008. This transmitted negative pressure can infuse the fluid source 6008 (which may be a mechanical infusion device). Figure 20B The method may further include a second phase of the therapy cycle during which pressure relief unit 6021 opens and stops the delivery of negative pressure to treatment device 6001. In some embodiments, pressure relief unit 6021 may open according to a specific or predetermined timing schedule. During the second phase of the therapy cycle, fluid source 6008 may deliver infusion fluid to infusion regulator 6019 and ultimately to treatment device 6001, which may occur when pressure relief unit 6021 is open, thereby preventing negative pressure from being transmitted to treatment device 6001, fluid source 6008, and infusion regulator 6019. Figure 20C As depicted, after the second phase of the therapy cycle, a third phase of the therapy cycle can begin, during which the pressure relief unit 6021 can again be shut off according to the timed interval schedule. During the third phase of the therapy cycle, the fluid infusion can be paused, and the negative pressure source 6006 can be reactivated to provide negative pressure therapy for another interval. The infusion fluid can be removed from the treatment device 6001, and the fluid source 6008 can be infused and prepared to deliver the infusion fluid to the treatment device 6001 again.

[0226] In some additional methods for providing negative pressure therapy and fluid infusion to tissue sites, in addition to automated or other forms of mechanical infusion devices, manually controlled infusion vessels, such as fluid bags, bottles, or other vessels, may be incorporated. Thus, in some embodiments, during the first phase of a therapy cycle, a negative pressure source may apply negative pressure therapy to the treatment device and tissue site, while devices such as clamps, valves, or other forms of closure prevent fluid from flowing from the manually controlled infusion vessel to the treatment device and tissue site. In some embodiments, during subsequent phases of the therapy cycle, the user may open the clamp or other form of closure and manually adjust the volume of the infused fluid. During this infusion phase, the negative pressure source may remain active, thereby providing immediate removal of the infused fluid from the treatment device and tissue site. Thus, according to some embodiments of the method, there may be virtually no time for fluid to remain in the tissue site. The user may then re-clamp or otherwise close the closure, thereby preventing the infused fluid from flowing from the manually controlled infusion vessel. The negative pressure source may then continue to remove excess or residual infused fluid and exudate from the treatment device and tissue site. In some other embodiments of the disclosed method, in addition to allowing the negative pressure source to remain active while fluid is being infused from a manually controlled drip vessel, the negative pressure source can be paused, thereby allowing the infusion fluid to remain in the tissue site for a predetermined period of time. When appropriate, the user can turn off the manually controlled drip vessel to prevent delivery of the infusion fluid. The negative pressure therapy can be restarted before or after the infusion is stopped, during which time any excess or residual fluid can be removed from the treatment device and the tissue site.

[0227] The systems, devices, and methods described herein offer significant advantages. As previously discussed, the disclosed systems and apparatus provide fluid infusion capability to a combined temporary abdominal dressing system via an independent matrix of fluid delivery tubes and a negative pressure fluid removal pathway for removing contaminated fluid. Therefore, the disclosed embodiments can provide means for irrigating and cleaning the abdominal cavity while supporting and protecting abdominal contents, removing contaminated fluid, and controlling and / or reducing edema. Furthermore, because the various layers and components of the disclosed dressing apply tension and closing force to the abdominal contents, faster closure of the main surfaces of the abdominal cavity can be facilitated.

[0228] As described herein, the disclosed solution provides a means of irrigating the entire peritoneal cavity (including the small bowel ring, paracolic gutter, retroperitoneal space, multiple parts of the lymphatic system, etc.) when the dressing system is in place, thereby reducing the time required for patients and clinical staff in the operating room. Several different embodiments described provide fluid pathways with different configurations designed to maximize the exposure of internal organs of the abdominal tissue site to fluid infusion therapy. The disclosed dressing components also allow for longer dressing application times without adhering to the fascia of the abdominal tissue site. Therefore, repeatable and reliable fluid infusions that can be uniformly delivered to various parts of the tissue site can be provided. Consequently, fluid irrigation and cleaning can be more consistent, resulting in reduced mortality in patients with septic peritoneum. Fluid infusions can be managed at the patient's bedside and can be customized and tailored to specific circumstances.

[0229] The disclosed systems and devices can drain exudates and infectious materials from tissue sites (e.g., the abdominal cavity), thereby reducing the presence of contaminated abdominal fluid and promoting healing. Furthermore, the disclosed solutions can provide separate infusion and negative pressure pathways to ensure complete removal of contaminated or “dirty” fluid from the abdomen. Additionally, in a preferred embodiment of the disclosed system, the infusion fluid is not recirculated back to the tissue site. Therefore, the clinical benefits of perfusing the tissue site can be increased.

[0230] Importantly, the disclosed device is designed to allow for user-defined and / or customized dressing placement when applied to a patient in the operating room. In some embodiments, user guidance can be provided through built-in size-determining markers or visual placement markers or indicators to facilitate dressing placement, size determination, and removal. Some embodiments of the disclosed dressing system may also include multiple different components, such as fluid infusion and / or fluid removal pathways pre-attached to the structural dressing layer, to further streamline and simplify use. Thus, compared to existing dressing systems, not only improved fluid delivery and removal are achieved, but increased ease of use is also facilitated.

[0231] Although illustrated in some illustrative embodiments, those skilled in the art will recognize that the systems, devices, and methods described herein are readily adaptable and subject to various changes and modifications. Furthermore, descriptions using different alternatives to terms such as “or” need not be mutually exclusive unless the context clearly requires it, and the indefinite articles “a” or “an” do not limit the subject matter to a single instance unless the context clearly requires it. Furthermore, any feature described in connection with any embodiment may also be applicable to any other embodiment. Components can also be combined or excluded in different configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, a treatment device 101 including dressing 102, container 110, or both may be excluded or separated from other components for manufacture or sale.

[0232] The appended claims set forth the novelty and inventive step of the subject matter described above; however, the claims may also cover other subject matter not explicitly enumerated in detail. For example, certain features, elements, or aspects may be omitted from the claims if it is not necessary to distinguish novel and inventive features from those known to a person skilled in the art. The features, elements, and aspects described herein may also be combined or replaced with alternative features for the same, equivalent, or similar purpose without departing from the scope of the invention as defined by the appended claims.

Claims

1. A system for treating a tissue site, comprising: Occlusion layer; A fluid removal manifold positioned adjacent to the first surface of the occlusion layer; as well as A fluid distribution vessel positioned adjacent to the second surface of the occlusion layer.

2. The system of claim 1, further comprising: A negative pressure source configured to be fluidly connected to the fluid removal manifold; as well as A fluid source configured to be fluidly connected to the fluid dispenser.

3. The system of claim 1, further comprising a catheter, wherein, The catheter has a first fluid channel in fluid communication with the fluid removal manifold and a second fluid channel in fluid communication with the fluid dispensing vessel.

4. The system as claimed in claim 1, wherein, The occlusion layer includes a plurality of fluid removal pathways formed on a first surface of the occlusion layer.

5. The system as described in claim 4, wherein, The plurality of fluid removal pathways extend radially across the first surface of the occlusion layer.

6. The system of claim 1, wherein, The fluid dispenser includes multiple outlets.

7. The system of claim 6, wherein, The outlet is located on the first surface of the fluid distribution vessel, which is adapted to be positioned adjacent to the second surface of the occlusion layer.

8. The system of claim 6, wherein, The size of the outlet is determined to generate increased fluid pressure within the internal volume of the fluid distributor.

9. The system of claim 1, wherein, The fluid dispenser includes multiple compartments formed by welding within the internal volume of the fluid dispenser.

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

11. The system of claim 1, wherein, The occlusion layer includes a polyurethane membrane.

12. The system of claim 1, wherein, The occlusion layer includes multiple folds that form multiple fluid removal pathways on a first surface of the occlusion layer.

13. The system of claim 1, wherein, The fluid removal manifold comprises multiple welded polyurethane membranes.

14. The system of claim 1, wherein, The fluid removal manifold includes a first surface having a plurality of windows.

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