Wound Exudate Management Systems

Abstract

According to an embodiment, the wound dressing includes an adhesive layer for adhering the wound dressing adjacent to the wound, a wound contact layer for contacting the wound, a backing layer including a port, tubing having a first end connected to the port and an opposite second end, a first fitting connected to the second end of the tubing, the first fitting configured to connect to a second fitting of a reduced pressure occlusive wound therapy system to apply negative pressure via the port, and a filter disposed within the first fitting. In one embodiment, the filter is formed of polyethersulfone (PESU) and has an average pore size of at least 2 microns.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 62 / 912,372, filed October 8, 2019, the contents of which are incorporated herein by reference in their entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to wound exudate management systems and, more particularly, but not exclusively, to in-line filters for such wound exudate management systems. [Background technology]

[0003] Wound healing consists of four phases: hemostatic, inflammatory, proliferative, and maturation. Management of exudate during the hemostatic and proliferative phases of wound healing is essential to prevent dissection, recurrent infection, and other adverse outcomes for the patient. Wound dressings that provide negative pressure at the wound site absorb excess exudate and promote healing. Applying and maintaining negative pressure on wound dressings is ideal for treating and managing various types of chronic or acute skin wounds resulting from infection, ulcers, burns, abrasions, incisions, lacerations, punctures, avulsions, and amputations.

[0004] A wound exudate management system including a negative pressure generating system, such as a pump or vacuum source, can be used in combination with a wound dressing to achieve negative pressure at the wound site without the need for a canister. However, exudate from the wound can exceed the absorption capacity of the wound dressing and subsequently enter the wound exudate management system, damaging components of the system, including the pump unit. Furthermore, excess exudate can clog the wound exudate management system, preventing the maintenance of negative pressure. For these and other reasons, further development is needed in the art. Summary of the Invention [Problem to be solved by the invention]

[0005] FIELD OF THE DISCLOSURE This disclosure describes an in-line filter as part of a wound exudate management system, and a method of using the in-line filter as part of a wound exudate management system.

[0006] Disclosed herein are in-line filter systems and processes, the in-line filter comprising an inlet opening having a first connector, an outlet opening having a second connector, and a cartridge adjacent to the inlet and outlet openings at a side. The cartridge has a cavity, a one-way check valve, and at least one filter membrane. In some embodiments, the one-way check valve and the at least one filter membrane are housed within the cavity and perpendicular to the inlet and outlet openings. In other embodiments, the at least one filter membrane is disposed between the one-way check valve and the outlet opening. In yet other embodiments, the at least one filter membrane is disposed between the inlet opening and the one-way check valve.

[0007] In some embodiments, the filter membrane comprises a hydrophilic material. In some embodiments, the hydrophilic material comprises silver, aluminum, cellulose acetate, ceramic, glass fiber, mixed cellulose ester (MCE), nylon, polyacrylonitrile (PAN), hydrophilic polycarbonate (PCTE), polyethersulfone (PESU), hydrophilic polytetrafluoroethylene (PTFE), hydrophilic polyvinylidene difluoride (PVDF), nitrocellulose, or hydrophilic glass fiber. In some examples, the filter membrane comprises a hydrophobic material. In some examples, the hydrophobic material includes polyether ether ketone (PEEK), hydrophobic polycarbonate (PCTE), polyester (PETE), polypropylene, hydrophobic polytetrafluoroethylene (PTFE), hydrophobic polyvinylidene difluoride (PVDF), or hydrophobic fiberglass. In some examples, the filter membrane has a pore size of at least 0.2 microns.

[0008] Also disclosed herein are methods and processes for a wound exudate management system. The wound exudate management system includes a pump for generating negative pressure, a wound dressing for covering and protecting the wound, an in-line filter, a first pressure tube having a lumen, a second pressure tube having a lumen, and a flexible connector. The first pressure tube is disposed between the pump and the in-line filter, the second pressure tube is disposed between the in-line filter and the flexible connector, and the flexible connector is disposed between the second pressure tube and the wound dressing such that fluid flows between the pump and the wound dressing via the lumen. In an example, the wound dressing includes an adhesive layer for adhering the wound dressing adjacent to the wound. In one example, the wound dressing includes a wound contact layer for contacting the wound, a pressure distribution layer, a plurality of absorbent material layers disposed between the wound contact layer and the pressure distribution layer, and a backing layer having a first surface and a second surface, the first surface of the backing layer being adjacent to and in contact with the pressure distribution layer and the adhesive layer. In one example, the wound dressing includes a thermoplastic spunlace layer connected to the pressure distribution layer and a nonwoven spunlace layer connected to the wound contact layer, and an envelope structure is formed by joining peripheral portions of the thermoplastic spunlace layer and the nonwoven spunlace layer, whereby the plurality of absorbent material layers are disposed substantially within an internal cavity of the envelope structure. In one embodiment, the absorbent material is disposed within an internal cavity of the envelope structure. In one embodiment, the absorbent material includes carboxymethylated cellulose fiber. In some cases, the wound contact layer includes carboxymethylated cellulose fiber. In some cases, the wound contact layer includes a reinforcing nylon stitching. In some cases, the pressure distribution layer comprises a reticulated foam.

[0009] In some embodiments, the wound exudate management system disclosed herein further comprises fenestrations in one or more of the plurality of absorbent material layers. In some embodiments, the wound exudate management system further comprises a pressure transfer member disposed within the flexible connector. In some embodiments, the wound exudate management system further comprises an absorption indicator and an adhesive member, the adhesive member attaching the flexible connector and the absorption indicator to the wound dressing. In some embodiments, the absorption indicator of the wound exudate management system disclosed herein is disposed in a pathway located between the absorbent layer and the flexible connector, the absorption indicator absorbs exudate to indicate the presence of exudate on the side of the absorbent layer furthest from the wound. In some embodiments, the absorption indicator visually indicates the presence of exudate on the side of the absorbent layer furthest from the wound. In some embodiments, the wound exudate management system disclosed herein further comprises a status indicator, the status indicator providing a visual cue to indicate when the pump is off, on, or on but malfunctioning.

[0010] The present specification also discloses a method and process of using an in-line filter to maintain a negative pressure in a wound dressing and protect a wound exudate management system from wound exudate. The method includes obtaining an in-line filter including an inlet opening, an outlet opening, and a cartridge adjacent to the inlet and outlet openings at sides, the cartridge having a cavity housing a one-way check valve and at least one filter membrane, and connecting the outlet opening to a first pressure tube. The first pressure tube is connected to a pump at an end opposite the end connected to the outlet opening, and connecting the inlet opening to a second pressure tube. The second pressure tube is connected to the wound dressing at an end opposite the end connected to the inlet opening. The pump is activated to draw air from the wound dressing, thereby generating a negative pressure in the wound dressing. In some embodiments, the pump maintains a negative pressure of 40 mmHg to 200 mmHg in the wound dressing. In some embodiments, the pump maintains a negative pressure of 80 mmHg in the wound dressing. In some embodiments, the pump maintains a negative pressure of 100 mmHg to 150 mmHg. In some embodiments, the pump maintains a negative pressure of 125 mmHg at the wound dressing. In some cases, wound exudate is prevented from being absorbed by at least one filter membrane of the in-line filter and entering the pump. In some cases, the pump includes a status indicator that provides a visual cue that the pump is off, on, or on but malfunctioning. In some embodiments, the pump malfunctions due to a negative pressure at the wound dressing outside of a negative pressure range between 40 mmHg and 200 mmHg, or between 100 mmHg and 150 mmHg. [Brief description of the drawings]

[0011] [Figure 1A] FIG. 1 illustrates an embodiment of an in-line filter as disclosed herein, showing an example of an in-line filter (left) next to an example of a luer fitting without the in-line filter (right). [Figure 1B]11B shows an embodiment of an in-line filter as disclosed herein, and illustrates an exemplary design cross-section of an in-line filter as disclosed herein, with fluid flowing from left to right in the orientation shown in FIG. [Diagram 2] FIG. 1 is a schematic diagram of an exemplary wound dressing for use in combination with the in-line filter disclosed herein. [Diagram 3] FIG. 3 is an exploded view of the exemplary wound dressing shown in FIG. 2. [Figure 4] FIG. 3 is a partial cross-sectional view of the wound dressing shown in FIG. 2. [Diagram 5] 1 is a schematic diagram of a wound exudate management system according to an embodiment. [Figure 6] FIG. 1 shows a schematic flow chart of a process according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] While the concepts of the present disclosure may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail herein. It should be understood, however, that there is no intention to limit the concepts of the present disclosure to the specific forms disclosed, but rather, the invention is intended to cover all modifications, equivalents, and alternatives consistent with the scope of the present disclosure and the appended claims.

[0013] References herein to "one embodiment," "embodiment," "exemplary embodiment," and the like indicate that the described embodiment may include a particular feature, structure, or characteristic, but that each embodiment may or may not include that particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Also, references to "preferred" components or features indicate that a particular component or feature with respect to one embodiment is desirable, but it should be understood that the present disclosure is not limited thereto and may omit such component or feature with respect to other embodiments. Moreover, if a particular feature, structure, or characteristic is described with respect to one embodiment, it is within the knowledge of one of ordinary skill in the art to implement such feature, structure, or characteristic with respect to other embodiments, regardless of whether such feature, structure, or characteristic is explicitly described.

[0014] Additionally, items listed in the form "at least one of A, B, and C" are to be understood to mean (A), (B), (C), (A and B), (B and C), (A and C), or (A, B, and C). Similarly, items listed in the form "at least one of A, B, or C" are to be understood to mean (A), (B), (C), (A and B), (B and C), (A and C), or (A, B, and C). Additionally, items listed in the form "A, B, and / or C" are to be understood to mean (A), (B), (C), (A and B), (B and C), (A and C), or (A, B, and C). Additionally, with respect to the claims, use of words and phrases such as "a," "an," "at least one," and / or "at least a portion" should not be construed as limiting such elements to only one, unless specifically stated to the contrary. Additionally, use of phrases such as "at least a portion" and / or "a portion" should be construed to encompass both embodiments including only a portion of that element as well as embodiments including the entire element, unless specifically stated to the contrary.

[0015] In the figures, some structural or method features may be shown in a certain specific arrangement and / or order. However, it should be understood that such specific arrangement and / or order may not necessarily be required. Rather, in some embodiments, such features may be arranged in a different manner and / or order than that shown in the example figures, unless otherwise noted to the contrary. Furthermore, the inclusion of a structural or method feature in a particular figure does not imply that such feature is required in all embodiments, and in some embodiments, it may be omitted or combined with other features.

[0016] The present disclosure provides in-line filters in some embodiments, including in-line filters suitable for use in negative-pressure wound therapy (NPWT) systems and in-line filters suitable for use in wound exudate management systems for treating various types of wounds. In some embodiments, the wound exudate management system includes a wound dressing and a portable pump. In some embodiments, the wound exudate management system generates and maintains negative pressure at the wound site as part of the NPWT. In some embodiments, the wound dressing is applied to the wound site as part of the wound exudate management system that includes a portable pump, and negative pressure is applied and maintained at the wound by the portable pump. The appropriate level of negative pressure at the wound dressing can be continuously monitored by the pump, and the in-line filter prevents excess exudate from entering the pump and its associated tubing.

[0017] Provided herein are in-line filters for use with wound exudate management systems, as well as methods of using the in-line filters as part of the wound exudate management systems for treating various types of wounds. In some embodiments, the in-line filters disclosed herein include an inlet opening with a fitting or tubing connector, an outlet opening with a fitting or tubing connector, and a cartridge adjacent the inlet and outlet openings at a side. In some embodiments, the cartridge includes a cavity, a one-way check valve, and at least one filter membrane. In some embodiments, the one-way check valve and the at least one filter membrane are housed within the cavity of the cartridge and perpendicular to the inlet and outlet openings. In some embodiments, the at least one filter membrane is disposed between the inlet opening and the one-way check valve. In some embodiments, the at least one filter membrane is disposed between the one-way check valve and the outlet opening. In some embodiments, a first filter membrane is disposed between the inlet opening and the one-way check valve, and a second filter membrane is disposed between the one-way check valve and the outlet opening. In some cases, disclosed herein is an in-line filter having a filter membrane that includes a hydrophilic material.In some cases, disclosed herein is an in-line filter having a filter membrane that includes a hydrophobic material. In some embodiments, the in-line filters disclosed herein have a pore size of at least 0.15 microns, 0.2 microns, 0.3 microns, 0.4 microns, 0.5 microns, 0.6 microns, 0.7 microns, 0.8 microns, 0.9 microns, 1.0 microns, 1.1 microns, 1.2 microns, 1.3 microns, 1.4 microns, 1.5 microns, 1.6 microns, 1.7 microns, 1.8 microns, 1.9 microns, 2.0 microns, 2.1 microns, 2.2 microns, 2.3 microns, 2.4 microns, 2.5 microns, 2.6 microns, 2.7 microns, 2.8 microns, 2.9 microns, 3.0 microns, 3.1 microns, 3.2 microns, 3.3 microns, 3.4 microns, 3.5 microns, 3.6 microns, 3.7 microns, 3.8 microns, 3.9 microns, 4.0 microns, 4.5 microns, or 5.0 microns.

[0018] In some embodiments herein, a method is disclosed for maintaining negative pressure in a wound dressing and protecting the wound exudate management system from wound exudate using an in-line filter. In some embodiments, wound exudate is absorbed or prevented from entering the pump by the in-line filter. In some embodiments, a method for using an in-line filter as described herein ensures that negative pressure is created and maintained in the wound exudate management system during use. In some embodiments, the maintenance of negative pressure is monitored by a status indicator.

[0019] Illustrated embodiment 1A and 1B, an embodiment of an in-line filter as disclosed herein is shown. FIG 1A shows an exemplary in-line filter 100 adjacent to a luer fitting 90 without an in-line filter. FIG 1B shows an exemplary design cross-section of an in-line filter 200 as disclosed herein. Fluid flows from left to right in the orientation shown in FIG 11B.

[0020] In one embodiment, the in-line filter 200 includes an inlet opening 210 having a first connector 212, an outlet opening 220 having a second connector 222, and a cartridge 230 laterally adjacent the inlet opening 210 and the outlet opening 202. The cartridge 230 includes a cavity 232, a one-way check valve 234, and at least one filter membrane 236.

[0021] In one embodiment, a one-way check valve 234 and at least one filter membrane 236 are housed within the cavity 232 and are perpendicular to the inlet opening 210 and the outlet opening 220 .

[0022] In one embodiment, at least one filter membrane 236 is disposed between the one-way check valve 234 and the outlet opening 220. Additionally or alternatively, at least one filter membrane 236 can be disposed between the inlet opening 210 and the one-way check valve 234. In one embodiment, the filter membrane 236 has a pore size of at least 0.2 microns.

[0023] In some embodiments, the filter membrane 236 includes a hydrophilic material, which may include, for example, silver, aluminum, cellulose acetate, ceramic, fiberglass, mixed cellulose ester (MCE), nylon, polyacrylonitrile (PAN), hydrophilic polycarbonate (PCTE), polyethersulfone (PESU), hydrophilic polytetrafluoroethylene (PTFE), hydrophilic polyvinylidene fluoride (PVDF), nitrocellulose, or hydrophilic fiberglass.

[0024] In some embodiments, the at least one filter membrane 236 includes a hydrophobic material, which may include, for example, polyetheretherketone (PEEK), hydrophobic polycarbonate (PCTE), polyester (PETE), polypropylene, hydrophobic polytetrafluoroethylene (PTFE), hydrophobic polyvinylidene fluoride (PVDF), or hydrophobic fiberglass.

[0025] 2 and 3, a schematic diagram of an exemplary wound dressing 300 for use in combination with the in-line filters disclosed herein is shown.

[0026] The illustrated wound dressing 300 generally includes a backing layer 310 and an adhesive layer 320 for adhering the wound dressing 300 adjacent to the wound. In one embodiment, the wound dressing 300 further includes a wound contact layer 330 for contacting the wound, a pressure distribution layer 340, and a number of absorbent material layers 350 disposed between the wound contact layer 330 and the pressure distribution layer 340.

[0027] The backing layer 310 has a first surface 311 and a second surface 312, with the first surface 351 adjacent to the pressure distribution layer 340 and in contact with the pressure distribution layer 340 and the adhesive layer 320. In one embodiment, the backing layer 310 is formed of a polyurethane film. The backing layer 310 includes a port 314 through which exudate can flow to the tube 360.

[0028] The adhesive layer 320 generally defines a boundary around an opening 322 for receiving a wound. In some embodiments, the adhesive layer 320 comprises a silicone adhesive. In some embodiments, the adhesive layer 320 can be perforated.

[0029] The wound contact layer 330 is configured to overlap the boundary defined by the adhesive layer 320 and contact the wound through the openings 322. In an embodiment, the wound contact layer 330 can comprise Medicel™. In an embodiment, the wound contact layer 330 comprises carboxymethyl cellulose fibers. In an embodiment, the wound contact layer 330 can comprise HYDROFIBER®. In an embodiment, the wound contact layer 330 can be reinforced, for example, by nylon stitching. Thus, the wound contact layer 330 can comprise a reinforcing nylon stitch 332.

[0030] The pressure distribution layer 340 is adjacent to and in contact with the first surface 311 of the backing layer 310. In one embodiment, the pressure distribution layer 340 can be provided as a polyester foam layer. In one embodiment, the pressure distribution layer 340 comprises a reticulated foam.

[0031] The absorbent material layer 350 is disposed between the wound contact layer 330 and the pressure distribution layer 340. The wound dressing 300 may include, for example, eight absorbent material layers 350. In an embodiment, one or more of the absorbent material layers 350 may include carboxymethyl cellulose fibers. In an embodiment, one or more of the absorbent material layers 350 may include Medicel™. In an embodiment, one or more of the absorbent material layers 350 may include HYDROFIBER®. In an embodiment, one or more of the absorbent material layers 350 may further include fenestrations 352.

[0032] A tube 360 ​​is connected to a port 314 in the backing layer 310. An adhesive ring 366 can form a seal between one end 361 of the tube 360 ​​and the port 314. The opposite end 362 of the tube 360 ​​can be connected to a fitting, such as a luer lock 364. A disk 368, such as one containing Medicel™, can be placed in the port 314.

[0033] In some embodiments, the wound dressing 300 may include an additional layer 370 between the pressure distribution layer 330 and the top absorbent layer 350. The additional layer 370 may be formed, for example, of a thermoplastic. In some embodiments, the additional layer 370 may be provided as a thermoplastic spunlace layer. In some embodiments, the wound dressing 300 may further include a nonwoven spunlace layer 372 connected to the wound contact layer 330. In some embodiments, as shown in FIG. 4, the envelope structure 374 is formed by joining peripheral portions 373 of the thermoplastic spunlace layer 370 and the nonwoven spunlace layer 372 such that the multiple absorbent material layers 350 are substantially disposed within the internal cavity 375 of the envelope structure 374. In some embodiments, the absorbent material layers 350 are disposed within the internal cavity 375 of the envelope structure 374.

[0034] In one embodiment, the wound dressing 300 may include a further layer 380 disposed between the wound contact layer 330 and the bottom absorbent layer 350. The further layer 380 may be, for example, a polyester / viscosity layer.

[0035] 5, an embodiment of a wound exudate management system 400 is shown. The wound exudate management system 400 includes a pump 510 for generating negative pressure, a wound dressing 420 for covering and protecting a wound, an in-line filter 430, a first pressure tube 440 having a first lumen 442, and a second pressure tube 450 having a second lumen 452 and a flexible connector 460. The first pressure tube 440 is disposed between the pump 510 and the in-line filter 430. The second pressure tube 450 is disposed between the in-line filter 430 and the flexible connector 460. The flexible connector 460 is disposed between the second pressure tube 450 and the wound dressing 420 such that fluid flows between the pump 410 and the wound dressing 420 via the lumens 442, 452. In one embodiment, wound dressing 420 may be provided along the lines of wound dressing 300 described above. In one embodiment, in-line filter 430 may be provided along the lines of in-line filter 200 described above.

[0036] In one embodiment, the pressure transmission member 462 is disposed within the flexible connector 460 .

[0037] As described herein, some embodiments further include an absorbency indicator 470, e.g., disk 368, and an adhesive member 480, e.g., adhesive ring 366. The adhesive member 480 can adhere the flexible connector 460 and the absorbency indicator 480 to the wound dressing 420. In some embodiments, the absorbency indicator is disposed in a passageway located between the absorbent layer 350 and the flexible connector 460. The absorbency indicator 470 can absorb exudate to indicate the presence of exudate on the side of the absorbent layer 350 furthest from the wound. In some embodiments, the absorbency indicator 470 can visually indicate the presence of exudate on the side of the absorbent layer 350 furthest from the wound.

[0038] Some embodiments of the system 400 further include a status indicator 490 configured to provide a visual cue to indicate when the pump is off, on, and / or on but malfunctioning.

[0039] With further reference to FIG. 6, an exemplary process 500 that may be performed using the system 400 is shown. It is understood that the illustrated blocks of the processes of the present disclosure are merely exemplary, and that, unless expressly stated to the contrary, the blocks may be combined or divided, added or removed, and arranged in a wholly or partially out-of-order order. Furthermore, while the blocks are shown relatively sequential, it should be understood that two or more blocks may be performed simultaneously or in parallel with one another. Also, the process 500 is described herein with specific reference to an implementation of the system 400 in which the in-line filter 430 is provided as the in-line filter 200 and the wound dressing 420 is provided in the form of the wound dressing 300. It should be understood that the process 500 may be performed using a system having an in-line filter, a wound dressing 300, and / or additional or alternative features.

[0040] Process 500 may begin at block 510, which generally includes obtaining an in-line filter, such as in-line filter 200. The in-line filter obtained at block 510 generally includes an inlet opening 210, an outlet opening 220, and a cartridge 230 laterally adjacent the inlet opening 210 and the outlet opening 220. Cartridge 230 has a cavity 232 that houses a one-way check valve 234 and at least one filter membrane 236.

[0041] Process 500 may include block 520, which generally includes connecting the outlet opening to a first pressure tube. For example, block 520 may include connecting outlet opening 220 to a first pressure tube 440, which is connected to a pump 410, which is connected to an end of first pressure tube 440 opposite the end connected to outlet opening 220.

[0042] The process 500 may include a block 530, which generally includes connecting the inlet opening to a second pressure tube. For example, the block 530 may include connecting the inlet opening 210 to a second pressure tube 450, which is connected to the wound dressing 300 at an end opposite the end of the second pressure tube 450 that is connected to the inlet opening 210.

[0043] The process 500 may further include block 540, which generally includes generating a negative pressure at the wound dressing by activating a pump to draw air from the wound dressing. For example, block 540 may include generating a negative pressure in the wound dressing 300 / 420 by activating a pump 410 to draw air from the wound dressing 300 / 420. In an embodiment, the pump 410 maintains a negative pressure of 40 mmHg to 125 mmHg at the wound dressing 300 / 420. In an embodiment, the pump 410 maintains a negative pressure of 80 mmHg at the wound dressing 300 / 420. In an embodiment, the pump maintains a negative pressure of 125 mmHg at the wound dressing 300 / 420.

[0044] In one embodiment, wound exudate is prevented from entering the pump 410 by being absorbed by at least one filter membrane 236 of the in-line filter 200 / 430.

[0045] In one embodiment, the pump 410 includes a status indicator 490 that provides a visual cue to indicate when the pump 410 is off, on, and / or on but malfunctioning. In one embodiment, the malfunction of the pump 410 is caused by the creation of a negative pressure at the wound dressing 300 / 420 that is outside the negative pressure range of between 40 mmHg and 125 mmHg. In one embodiment, the malfunction of the pump 410 is caused by the creation of a negative pressure at the wound dressing 300 / 420 that is outside the negative pressure range of between 100 mmHg and 150 mmHg.

[0046] (In-line filter) As will become apparent from the foregoing, embodiments of the present application relate to an in-line filter 200 that includes an inlet opening 210 having a fitting or tube connector 212, an outlet opening 220 having a fitting or tube connector 222, and a cartridge 230 laterally adjacent the inlet opening 210 and the outlet opening 220. Non-limiting examples of fittings or tube connectors 212, 222 for the inlet opening 210 and the outlet opening 220 include compression fittings, quick disconnect fittings, cam fittings, bite-type fittings, mechanical grip fittings, flare fittings, flange fittings, luer locks, push-to-connect connectors, quick couplers, threaded fittings, nipples, barbs, and valves. In some embodiments, the fittings or tube connectors of the inlet and outlet openings further include an adapter, coupling, sleeve, union, cap, plug, reducer, olet, or combinations thereof. In some embodiments, the inlet and outlet openings include a luer lock that is connected to a pressure tube, and the pressure tube includes complementary ends of the luer lock to the inlet and outlet openings. In some cases, the fittings or tube connectors of the inlet and outlet openings can include additional or redirecting fittings, such as an elbow adapter, a "T" adapter, a "Y" adapter, or a cross adapter.

[0047] In some embodiments, the cartridge 230 adjacent the inlet opening 210 and the outlet opening 220 includes a cavity 232 and a one-way check valve 234. In some embodiments, the one-way check valve 234 is housed within the cavity 232 of the cartridge 230 and is perpendicular to the inlet opening 210 and the outlet opening 220. Non-limiting examples of the one-way check valve 234 housed within the cavity 232 can include a diaphragm check valve, a swing check valve, a tilted disk check valve, a plug-type check valve, a ball-type check valve, a dual disk check valve, a clapper valve, a stop check valve, a life-check valve, an in-line check valve, a duckbill valve, a pneumatic no-return valve, and the like.

[0048] In some embodiments, the cartridge 230 adjacent to the inlet opening 210 and the outlet opening 220 comprises a cavity 232, a one-way check valve 234, and at least one filter membrane 236. In some embodiments, the one-way check valve 234 and the at least one filter membrane 236 are housed within the cavity 232 of the cartridge 230 and are perpendicular to the inlet opening 210 and the outlet opening 220. In some embodiments, the at least one filter membrane 236 is disposed between the inlet opening 210 and the one-way check valve 234. In some embodiments, the at least one filter membrane 236 is disposed between the one-way check valve 234 and the outlet opening 220. In some embodiments, a first filter membrane 236A is disposed between the inlet opening 210 and the one-way check valve 234, and a second filter membrane 236B is disposed between the one-way check valve 234 and the outlet opening 220.

[0049] In some embodiments, the filter membrane 236 of the in-line filter 200 disclosed herein can have a diameter of less than 50 mm, less than 45 mm, less than 40 mm, less than 35 mm, less than 30 mm, less than 25 mm, less than 24 mm, less than 23 mm, less than 22 mm, less than 21 mm, less than 20 mm, less than 19 mm, less than 18 mm, less than 17 mm, less than 16 mm, less than 15 mm, less than 14 mm, less than 13 mm, less than 12 mm, less than 11 mm, less than 10 mm, less than 9 mm, less than 8 mm, less than 7 mm, less than 6 mm, or less than 5 mm.

[0050] In some embodiments, the filter membrane 236 of the in-line filter 200 has a thickness of less than 50 mm, less than 45 mm, less than 40 mm, less than 35 mm, less than 30 mm, less than 25 mm, less than 24 mm, less than 23 mm, less than 22 mm, less than 21 mm, less than 20 mm, less than 19 mm, less than 18 mm, less than 17 mm, less than 16 mm, less than 15 mm, less than 14 mm, less than 13 mm, less than 12 mm, less than 11 mm, less than 10 mm, less than 9 mm, less than 8 mm, less than 7 mm, less than 6 mm, less than 5 mm, or less than 4 mm, or less than 3 mm, or less than 2 mm, or less than 1 mm, or less than 0.5 mm, or less than 0.4 mm, or less than 0.3 mm, or less than 0.2 mm, or less than 0.1 mm, or less than 0.05 mm. In some embodiments, the filter membrane 236 of the in-line filter 200 can have a pore size of at least 0.15 microns, 0.2 microns, 0.3 microns, 0.4 microns, 0.5 microns, 0.6 microns, 0.7 microns, 0.8 microns, 0.9 microns, 1.0 microns, 1.1 microns, 1.2 microns, 1.3 microns, 1.4 microns, 1.5 microns, 1.6 microns, 1.7 microns, 1.8 microns, 1.9 microns, 2.0 microns, 2.1 microns, 2.2 microns, 2.3 microns, 2.4 microns, 2.5 microns, 2.6 microns, 2.7 microns, 2.8 microns, 2.9 microns, 3.0 microns, 3.1 microns, 3.2 microns, 3.3 microns, 3.4 microns, 3.5 microns, 3.6 microns, 3.7 microns, 3.8 microns, 3.9 microns, 4.0 microns, 4.5 microns, or 5.0 microns.

[0051] In some cases, the filter membrane 236 includes a hydrophilic material. Non-limiting examples of hydrophilic materials for the filter membrane can include silver, aluminum, cellulose acetate, ceramic, fiberglass, mixed cellulose ester (MCE), nylon, polyacrylonitrile (PAN), hydrophilic polycarbonate (PCTE), polyethersulfone (PESU), hydrophilic polytetrafluoroethylene (PTFE), hydrophilic polyvinylidene fluoride (PVDF), nitrocellulose, or hydrophilic fiberglass.

[0052] In some cases, the filter membrane 236 includes a hydrophobic material. Non-limiting examples of the hydrophobic material of the filter membrane can include polyetheretherketone (PEEK), hydrophobic polycarbonate (PCTE), polyester (PETE), polypropylene, hydrophobic polytetrafluoroethylene (PTFE), hydrophobic polyvinylidene fluoride (PVDF), or hydrophobic glass fiber. In some embodiments, the first filter membrane and the second filter membrane are made of the same material. In some embodiments, the first filter membrane and the second filter membrane are made of different materials.

[0053] In some embodiments, the in-line filters disclosed herein are compliant with standards that define usability requirements for the development and use of medical devices, such as IEC 62366-1. In some embodiments, the in-line filters disclosed herein are biocompatible for their intended use and meet animal-derived component requirements. In some embodiments, the in-line filters disclosed herein are configured for single use. In some embodiments, the in-line filters disclosed herein are configured for use with only one patient.

[0054] In some embodiments, the in-line filters disclosed herein can be sterilized. In some embodiments, the in-line filters are sterilized by electron beam (E-beam), gamma sterilization, or ethylene oxide sterilization. In some embodiments, the in-line filters function to desired specifications after sterilization. In some embodiments, the in-line filters disclosed herein are latex-free. In some embodiments, the in-line filters disclosed herein are bis(2-ethylhexyl) phthalate (DEHP)-free.

[0055] In some embodiments, the in-line filters disclosed herein include an outlet opening 220 with a fitting or connector 212 configured to form an airtight connection with a first pressure tube 450 that connects the in-line filter 200 to a pump portion 410 of the wound exudate management system 400. In some embodiments, the in-line filters disclosed herein include an inlet opening 210 with a fitting or connector 212 for forming an airtight connection with a second pressure tube 450 connected to a flexible connector 460, which is connected to the wound dressing 300 / 420. In some embodiments, the pump 410, the first pressure tube 440, the in-line filter 430, the second pressure tube 450, and the flexible connector 460 form a continuous lumen 401 within the wound exudate management system 460. Operation of the pump 410 draws air from the wound dressing 420 creating a negative pressure within the wound dressing 420 and the continuous lumen 401 .

[0056] In some embodiments, the in-line filter disclosed herein prevents exudate from accidentally entering the first pressure line connected to the pump, preventing the pump from malfunctioning. For example, the in-line filter 200 / 430 can prevent exudate from accidentally entering the first pressure line 440, thereby preventing the pump 410 from malfunctioning due to exudate entering the first pressure line 440. Exudate coming into contact with the disclosed in-line filter 430 can also cause a drop in negative pressure across the wound exudate management system 400 during use. If the drop in negative pressure exceeds a predetermined range, the status indicator 490 of the pump 410 can alert the user to a possible malfunction of the wound exudate system 400. This allows the user to replace the wound dressing 420 and / or the blocked in-line filter 430 with a new in-line filter 430 to restore negative pressure in the wound dressing 420.

[0057] In some embodiments, the in-line filters disclosed herein are included in a reduced pressure closed wound therapy system, such as reduced pressure closed wound therapy system 400. In some embodiments, the in-line filters disclosed herein include an in-line filter packaging system. Suitable materials for the in-line filter packaging system are easily torn, including, by way of non-limiting example, paper and waxed paper. In some embodiments, the in-line filter packaging system protects the product from physical damage during shipping and storage. In some embodiments, the in-line filter packaging system can be opened by hand. In some embodiments, the in-line filter packaging system has a clearly identifiable open end. In some embodiments, the in-line filter packaging system exhibits shipping and storage conditions between -29°C and 60°C. In some embodiments, the in-line filters disclosed herein are suitable for storage at temperatures between -29°C and 60°C. In some embodiments, the in-line filters disclosed herein have a minimum shelf life of 12 months.

[0058] In some embodiments, the in-line filters disclosed herein are configured for use as or with a standalone infection detection (SID) device. Current practices of identifying wound infection / bioburden (including clinical signs and microbiology) are subjective and may lead to erroneous diagnosis. The in-line filters disclosed herein allow for early detection of wound infection leading to faster treatment of infection, more appropriate use of antibiotics, and improved clinical and economic outcomes. In some embodiments, the in-line filters can be wiped and swabs contacted with indicator strips to allow detection of infection markers such as pH, myeloperoxidase (MPO), and human neutrophil elastase (HNE). In some embodiments, the in-line filters are in direct contact with the indicator strips to allow detection of infection markers. In some embodiments, the in-line filters disclosed herein include a removable cartridge 230 for sampling. In some embodiments, the in-line filters disclosed herein include a Y-connector or a straight in-line SID system, or a combination of one or more systems.

[0059] (Wound Exudate Management System) In some embodiments, the wound exudate management system provided herein comprises a pump for generating negative pressure, a wound dressing for covering and protecting the wound, an in-line filter, a first pressure tube for connecting the pump to the in-line filter, and a first pressure tube for connecting the in-line filter to a flexible connector. For example, the wound exudate management system 400 comprises a pump 410 for generating negative pressure, a wound dressing 420 for covering and protecting the wound, an in-line filter 430, a first pressure tube 440 for connecting the pump 410 to the in-line filter 430, and a second pressure tube 450 for connecting the in-line filter 430 to a flexible connector 460. The flexible connector 460 is connected to the wound dressing 420 at an end opposite to the end connected to the second pressure tube 450. In some embodiments, the first pressure tube 440 and / or the second pressure tube 450 have a length of 300 mm or more. In some embodiments, the pump unit 410 includes an indicator 490 that indicates when the target pressure (e.g., -80 mmHg) has been established. In some embodiments, the pump unit 410 includes an indicator 490 that indicates when the target pressure (e.g., -80±10 mmHg) cannot be maintained. In some embodiments, the pump unit 410 establishes negative pressure within 60 seconds of connection to the wound dressing 420.

[0060] In some embodiments, the wound exudate management system 400 includes a pump 410 for generating negative pressure, a wound dressing 420 (e.g., wound dressing 300) for covering and protecting a wound, first and second pressure tubes 440, 450 having lumens 442, 452 and disposed between the pump 410 and the wound dressing 420, a flexible connector 460 connecting the wound dressing 420 to the second pressure tube 450, and an indicator 470 (e.g., disk 368) disposed between the wound dressing 420 and the flexible connector 460. In some embodiments, the flexible connector 460 is 25 mm or less in any dimension. In some embodiments, the total tubular length of the wound exudate management system is 1500mm or less, 2000mm or less, 2500mm or less, 3000mm or less, 3500mm or less, 4000mm or less, 4500mm or less, or 5000mm or less.

[0061] In some embodiments, the pressure tubes 440, 450 between the wound dressing 420 and the pump 410 can withstand the maximum negative pressure generated by the pump unit 410 in a failure mode. In some embodiments, the wound exudate management system disclosed herein includes a pump for generating negative pressure, and the pump 410 includes a status indicator 490. In some embodiments, the status indicator 490 provides a visual cue to indicate when the pump is off, on, and / or on but malfunctioning. Malfunctioning includes when the pump 410 does not maintain a negative pressure within a predetermined range. In some embodiments, the pressure generated and maintained by the pump 410 during use of the wound exudate management system is measured barometrically. In some embodiments, the pressure is measured mechanically or digitally.

[0062] In some embodiments, the pump 410 includes a status indicator 490 that indicates whether the negative pressure is less than about 40 mmHg, less than about 50 mmHg, less than about 60 mmHg, less than about 70 mmHg, less than about 80 mmHg, less than about 90 mmHg, less than about 100 mmHg, less than about 110 mmHg, less than about 120 mmHg, less than about 125 mmHg, less than about 130 mmHg, less than about 135 mmHg, less than about 140 mmHg, less than about 145 mmHg, or less than about 150 mmHg. In some embodiments, the pump 410 includes a status indicator 490 that indicates whether the negative pressure is less than about 40 mmHg or greater than about 200 mmHg. In some embodiments, the pump 410 includes a status indicator 490 that indicates whether the negative pressure is less than about 100 mmHg or greater than about 150 mmHg, e.g., 125 mmHg. In some embodiments, the pump 410 includes a status indicator 490 that indicates whether the pressure is outside of a set range. In some embodiments, the set range is between about 40 mmHg and about 200 mmHg, between about 40 mmHg and about 150 mmHg, between about 40 mmHg and about 125 mmHg, between about 100 mmHg and about 150 mmHg, e.g., 125 mmHg.

[0063] In some embodiments, the connection between the pump unit 410 and the wound dressing 420 allows the user to properly install the wound exudate management system 400 (e.g., by connecting the wound dressing 420 to the pump 410). In some embodiments, a one-way check valve 234 housed within the cartridge 230 of the in-line filter 200 maintains negative pressure within the wound dressing 300 / 420 when the pump 410 is temporarily disconnected or not operating.

[0064] In some embodiments, the wound exudate management systems provided herein include a wound dressing for covering and protecting the wound. In some embodiments, the wound dressing 300 / 420 covers and protects the wound. In some embodiments, the wound dressing 300 / 420 includes an absorbent material to absorb wound exudate and promote wound healing. In some embodiments, the wound dressing 300 / 420 includes an adhesive layer for adhering the wound dressing adjacent to the wound.

[0065] In some embodiments, the wound dressing 420 of the wound management system 400 includes a wound contact layer for contacting the wound. For example, the wound dressing 420 can be provided in the form of the wound dressing 300 including the wound contact layer 330 as described above. In some embodiments, the wound dressing of the wound management system optionally includes a pressure distribution layer, such as the pressure distribution layer 340 described above. In some embodiments, the wound dressing 420 of the wound management system 400 includes a plurality of absorbent material layers 350 disposed between the wound contact layer 330 and the pressure distribution layer 340. In some cases, the wound dressing 300 further includes a backing layer 310 having a first surface 311 and a second surface 312, the first surface 311 of the backing layer 310 being adjacent to and in contact with the pressure distribution layer 340 and the adhesive layer 320. In some embodiments, the wound exudate management system described herein includes a wound dressing having an envelope structure 374 formed by bonding peripheral portions of the pressure distribution layer 340 and the wound contact layer 330.

[0066] In some embodiments, the wound exudate management system provided herein includes a wound dressing for covering and protecting a wound, the wound dressing for covering and protecting a wound includes an adhesive layer 320 for adhering the wound dressing adjacent to the wound, a wound contact layer 330 for contacting the wound, a pressure distribution layer 340, a plurality of absorbent material layers 350 disposed between the wound contact layer 330 and the pressure distribution layer 340, and a backing layer 310 having a first surface 311 and a second surface 312, the first surface 311 of the backing layer 310 being adjacent to and in contact with the pressure distribution layer 340 and the adhesive layer 320.

[0067] In some embodiments, the wound exudate management system described herein includes a wound dressing having an envelope structure formed by joined peripheral portions of a pressure distribution layer and a wound contact layer, the envelope structure defining a cavity. In some cases, the wound exudate management system includes a wound dressing 300, the wound dressing 300 including a thermoplastic spunlace layer 370 connected to a pressure distribution layer 340 and a nonwoven spunlace layer 372 connected to a wound contact layer 330. The envelope structure 374 is formed by joining peripheral portions 373 of the thermoplastic spunlace layer 370 and the nonwoven spunlace layer 372 such that a plurality of absorbent material layers 350 are substantially disposed within an interior cavity 375 of the envelope structure 374. In some embodiments, the wound exudate management system disclosed herein includes a wound dressing comprising an absorbent material disposed within a cavity 375 of an envelope structure 374, the envelope structure 374 being formed by joining peripheral portions 373 of a thermoplastic spunlace layer 370 and a nonwoven spunlace layer 372.

[0068] In some cases, the wound exudate management system disclosed herein includes a wound dressing, the wound dressing includes an absorbent material including carboxymethyl cellulose fibers. In some embodiments, the wound contact layer 330 of the wound dressing of the wound exudate management system disclosed herein includes carboxymethyl cellulose fibers and has reinforced nylon stitching 332. In some cases, the wound exudate management system disclosed herein includes a wound dressing, the wound dressing includes a pressure dispersion layer 340 including reticulated foam. In some cases, the wound exudate management system disclosed herein further includes fenestrations 351 in one or more of the multiple absorbent material layers 350 in the wound dressing 300 and a pressure transmission member 462 disposed in a flexible connector 460 connected to a second surface of the backing layer 310 of the wound dressing 300.

[0069] In an embodiment, the pressure transmission member 462 is disposed within the flexible connector 460. The pressure transmission member allows the flexible connector 460 to transmit the flow rate and / or pressure of the fluid within the flexible connector and prevents collapse of the flexible connector when the flexible connector is made of a thin-walled flexible material. This allows the wound dressing to experience or exhibit negative pressure created by the pump. The pressure transmission member 462 can include a variety of materials, including, but not limited to, nylon. Additionally, the pressure transmission member 462 may be configured with a lattice structure. The shape, material, and arrangement of the pressure transmission member allow for continuous fluid flow along the flexible connector 460. Otherwise, the shape, flexibility, material, or arrangement of the flexible connector may prevent continuous fluid flow in light of the negative pressure created by the pump 410 and in light of the use and positioning of a typical wound exudate management system.

[0070] In some embodiments, the wound exudate management system disclosed herein comprises an absorbent indicator 470, such as a disk 368, and an adhesive member 480, such as an adhesive ring 366. The adhesive member 480 adheres a flexible connector, such as the flexible connector 460, and the absorbent indicator 470 to the backing layer 310 of the wound dressing 300. In some embodiments, the wound exudate management system disclosed herein comprises an absorbent indicator 368, which is disposed in a path located between the absorbent layer 450 and the flexible connector 460 of the wound dressing, and the absorbent indicator 368 / 470 is capable of absorbing exudate to indicate the presence of exudate on the side of the absorbent layer 350 furthest from the wound 80. In some embodiments, the absorbent indicator 368 / 470 visually indicates the presence of exudate on the side of the absorbent layer furthest from the wound. In some embodiments, the signal generated by the absorbent indicator absorbing the exudate may be visual, audible, vibratory, or the like.

[0071] (wound dressing) In some embodiments, the wound dressings disclosed herein include wound dressings configured to function in combination with an in-line filter and configured to function in a reduced pressure closed wound therapy (NPWT) system. In some embodiments, the wound dressings disclosed herein limit the transmission of fluid to a pressure tube that includes any portion of a wound exudate management system between a medical disc and a pump unit. In some embodiments, the wound dressings disclosed herein can be disconnected from the pump at least once a day for seven days without affecting the system's ability to transmit pressure and process fluids (including without causing leakage).

[0072] In some embodiments, the wound dressings disclosed herein include a backing layer, such as backing layer 310. In some embodiments, the wound dressings disclosed herein include at least one absorbent layer, such as absorbent layer 350. In some embodiments, the wound dressings disclosed herein have a perforated hydrophobic layer including at least a first edge opposite a second edge and a release liner. In some embodiments, the wound dressings optionally include an outer cover layer that completely covers the other layers of the wound dressing. In some embodiments, below the cover layer is an absorbent pad that forms a central raised island below the cover layer. In some embodiments, the absorbent pad includes multiple absorbent material layers 350. The absorbent layer is capable of absorbing exudate from the wound. In some embodiments, the outer cover layer covers the side of the absorbent layer that is furthest from the wound. In some embodiments, the cover layer, also referred to as the backing layer, is adapted to allow negative pressure to be applied to the wound and has ports 314 for fluid flow between the absorbent layer 350. A conduit, or tube, allows for fluid flow between the port and the negative pressure source, and the conduit is connected to the outer layer by an adhesive ring 366 .

[0073] An indicator means, or absorbent indicator 368, is disposed between the wound dressing 420 and the second pressure tube 450. In some embodiments, the signal generated by the absorbent indicator 368 absorbing the exudate may be, for example, visual, audible, vibratory, etc. In one embodiment, the indicator means comprises a layer of gel-forming fibers. Alternatively, the indicator means may be provided within the port but on the cover layer. In some embodiments, the wound dressing further comprises a wound contact layer 330 adhered to the absorbent layer 320 by a heat-sealable lace layer made of a polyamide lace layer. The wound dressing may further comprise an exudate and pressure distribution layer. The exudate and pressure distribution layer, also referred to as a pressure distribution layer 370, is preferably a polyester foam that helps to spread the exudate across the absorbent layer 350 and lubricate the application of negative pressure across the wound dressing. A further heat-sealable lace layer may be provided between the distribution layer and the cover layer. The heat-sealable layer helps to adhere the layers together. In some embodiments, the absorbent layer 350, the wound contact layer 330, and the indicator means 368 comprise gel forming fibers in the form of one or more layers of a carboxymethyl cellulose fabric.

[0074] In some embodiments, the wound dressings configured to function in combination with the in-line filters disclosed herein include materials suitable for use in bandages. Materials suitable for bandages are non-irritating, durable, and flexible, including, by way of non-limiting example, natural fiber woven fabrics (e.g., cotton, linen, hemp), synthetic fiber woven fabrics (e.g., nylon, polyester, aramid, olefin, and acrylic), and plastics (e.g., polyvinyl chloride, low density polyethylene, and polypropylene). In some embodiments, the wound dressings disclosed herein include a wound dressing package and a release liner system. Materials suitable for the wound dressing package and release liner system are easily torn, including, by way of non-limiting example, paper and wax paper. In some embodiments, the wound dressings disclosed herein are sized to fit different parts of the body, for example, a human finger, or a human knee. In some embodiments, the wound dressings disclosed herein are sized in standard sizes including, for example, 5x5cm, 6x7cm, 10x12cm, 10x20cm, 15x20cm, 30x20cm, 40x20cm, 50x20cm, 20x20cm, 25x25cm, 30x30cm, 35x35cm, 40x40cm, 45x45cm, 50x50cm, or any size between these exemplary sizes. In some embodiments, the wound dressings disclosed herein are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, or more millimeters in length or width (including increments therein).In some embodiments, the wound dressings disclosed herein are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, or more centimeters in length or width (including increments therein). In some embodiments, suitable shapes for the wound dressings disclosed herein include square, rectangular, oval, circular, and butterfly wound dressings. In some embodiments, the wound dressings disclosed herein include wound dressings having multiple sites for the location of the absorbent layer and multiple sites for the location of the perforated hydrophobic layer.

[0075] In some embodiments, the wound dressing configured to function in combination with the in-line filters disclosed herein includes a backing. In some embodiments, the backing is made from polyurethane (PU). In some embodiments, the backing is made from a film. In some embodiments, the backing is made from a polyurethane film laminated to a polyurethane foam. In some embodiments, the polyurethane has a thickness between 0.02 mm and 0.04 mm. In some embodiments, the backing is transparent. In some embodiments, the backing has a high moisture vapor transmission rate (MVTR), allowing moisture to permeate the wound dressing and evaporate from the wound. In some embodiments, the backing has a weight of at least 2500 g / m 2 / day. In some embodiments, the backing has an MVTR of 1,000 g / m 2 / day, 30,000g / m 2 / day, or 9,000g / m 2 / day, 27,000g / m 2 / day. In some embodiments, the MVTR is measured using the ISO standard for the liquid in contact. In some embodiments, the backing is made of a backing film or strikethrough film.

[0076] In some embodiments, the wound dressing configured to function in combination with the in-line filters disclosed herein comprises an absorbent layer that is substantially insoluble in water. In some embodiments, the absorbent layer is a non-adhesive layer. In some embodiments, the absorbent layer comprises fibers selected from the group consisting of sodium carboxymethyl cellulose fibers, alginate fibers, chitosan or chitosan derivative fibers, acrylic fibers, non-gelling fibers, superabsorbent fibers, and combinations thereof. In some embodiments, the absorbent layer comprises antimicrobial fibers, such as antimicrobial fibers that include silver ions or metal ions. In some embodiments, the wound dressing comprises one or more agents selected from the group consisting of antibiotics, anesthetics, anti-inflammatory agents, skin protectants, and odor absorbing agents. In some embodiments, the fibers comprise chemically modified cellulose. In some embodiments, the fibers are carboxymethyl cellulose fibers having a degree of substitution between 0.1 and 0.5 carboxymethyl groups per cellulose unit. In some embodiments, the fibers are acrylic fibers that incorporate comonomers to provide pigment sites within the fibers. In some embodiments, the comonomer is selected from the group consisting of itaconic acid and 2-acrylamido methyl propane sulphonic acid. When the fiber is an alginate fiber, it may be a calcium alginate fiber or a mixed metal alginate fiber, such as a calcium alginate / sodium alginate fiber. The alginate polymer may have high mannuoronate or high guluronate. In some embodiments, the wound dressing includes an absorbent layer comprising chemically modified cellulose. In some embodiments, the wound dressing includes an absorbent layer comprising, for example, carboxymethylcellulose, carboxyethylcellulose, or other chemically modified cellulose. In some embodiments, the carboxymethylcellulose is sodium carboxymethylcellulose.In some embodiments, the absorbent layer comprises HYDROFIBER® (ConvaTec, UK).

[0077] In some embodiments, the wound dressings described herein provide several benefits to wound healing, including trapping exudate and trapping bacteria (including benefits such as protecting the skin around the wound, reducing maceration, and minimizing cross-infection during wound dressing removal), micro-contouring the wound bed (including benefits such as minimizing "dead space" where bacteria can grow and maintain moisture balance in the wound bed), and forming a cohesive gel in response to wound fluid levels (including benefits such as when the wound dressings come into contact with exudate, providing rapid and sustained antimicrobial activity on demand).

[0078] In some embodiments, a wound dressing configured to function in combination with an in-line filter disclosed herein absorbs exudate from a wound. In some embodiments, the wound dressing described herein comprises an absorbent layer having a minimum level of absorbency. In some embodiments, the absorbency of the wound dressing described herein can be measured by the free swell absorbency method. In some embodiments, the absorbency of the wound dressing described herein is at least 0.30 g / cm 2 , or at least 0.40 g / cm 2 , or at least 0.50 g / cm 2 In some embodiments, the wound dressing is capable of delivering 1.1 mL / cm2 of exudate without the need for a canister to collect exudate (such as in moderately exuding wounds). 2 / day of fluid for three days. In some embodiments, the wound dressing is configured to deliver up to 0.6 mL / cm without the need for a canister to collect exudate (such as for low-exuding wounds). 2 / day of fluid for 7 days. In some embodiments, the wound dressings described herein comprise gelling fibers, absorbent fibers, or hydrophilic foams.

[0079] In some embodiments, the wound dressings disclosed herein include an absorbent core comprising a material selected from the group consisting of foams, polyurethane foams, absorbent textiles, hydrogels, superabsorbent fibers, superabsorbent powder fiber blends, and mixtures thereof. In some embodiments, the absorbent core comprises a gelling blend of materials selected from the group consisting of foams, polyurethane foams, absorbent textiles, hydrogels, superabsorbent fibers, superabsorbent powder fiber blends, and mixtures thereof. In some embodiments, the absorbent core comprises a non-gelling blend of materials selected from the group consisting of foams, polyurethane foams, absorbent textiles, hydrogels, superabsorbent fibers, superabsorbent powder fiber blends, and mixtures thereof. In some embodiments, the wound dressings disclosed herein include an absorbent hydrophilic layer comprising a material selected from the group consisting of HYDROFIBER® (ConvaTec, UK), gelling fibers, gelling fiber blends, gelling fiber-synthetic fiber blends, superabsorbent fibers, superabsorbent powder fiber blends, and mixtures thereof.

[0080] In some embodiments, a wound dressing configured to function in combination with an in-line filter disclosed herein includes a perforated adhesive layer, such as adhesive layer 320. In some embodiments, the perforated adhesive layer includes a perforated hydrophobic layer. In some embodiments, the perforated adhesive layer is not hydrophobic, for example, when the perforated adhesive layer includes a hydrogel adhesive. In some embodiments, the wound dressing described herein includes an adhesive or hydrophobic layer that includes cuts, an adhesive or hydrophobic layer that includes slits, an adhesive or hydrophobic layer that includes holes, an adhesive or hydrophobic layer that includes openings, an adhesive or hydrophobic layer that includes discontinuities, and an adhesive or hydrophobic layer that includes bevels. In some embodiments, the perforated adhesive layer or the perforated hydrophobic layer is selected from the group consisting of silicone adhesives, hydrocolloid adhesives, polyurethane adhesives, rubber-based adhesives, acrylic adhesives, coated woven materials, hydrogel adhesives, and combinations thereof. In some embodiments, the distribution and spacing of the perforations are regularly spaced at intervals substantially greater than their area. In some embodiments, the perforations are a shape selected from a circle, a square, a rectangle, a triangle, an oval, a pentagon, a hexagon, and a rounded rectangle. In some embodiments, the perforations are circular and between 0.1 mm and 5 mm, or between 0.5 mm and 2 mm. In some embodiments, the spacing between the perforations is between 0.2 mm and 10 mm. In some embodiments, the number of perforations per unit area is between 1 and 100, or between 1 and 50, or between 1 and 20 perforations / cm. 2 In some embodiments, the wound dressing disclosed herein comprises an open structure hydrophobic layer comprising a material selected from the group consisting of a silicone adhesive, a hydrocolloid adhesive, a polyurethane adhesive, a hydrogel, an acrylic adhesive, a coated woven material, and mixtures thereof.

[0081] In some embodiments, a wound dressing configured to function in combination with an in-line filter disclosed herein includes an adhesive surrounding an absorbent layer that adheres the wound dressing to the wound. In some embodiments, the absorbent layer is a non-adhesive layer. The adhesive can hold the absorbent member in direct contact with the wound and seal the wound dressing to the skin surrounding the wound. The adhesive is preferably a silicone adhesive, more preferably a pressure-sensitive silicone adhesive, such as, for example, Dow Corning MD7-4502, M67-9900 (DowDuPont, USA), or Wacker Chemie AG SILPURAN® 2114 (Wacker Chemie, Germany). The adhesive can also be a hydrocolloid, polyurethane, rubber-based adhesive, or an acrylic adhesive.

[0082] In some embodiments, the wound dressing configured to function in combination with the in-line filter disclosed herein includes a foam layer. The foam layer may be an open-cell foam layer. The foam layer may be a hydrophilic foam layer. In some embodiments, the hydrophilic foam layer is a polyurethane foam, such as a hydrophilic open-cell foam. The foam typically has a thickness of 0.25 mm to 5 mm, preferably 1 mm to 4.0 mm, and most preferably 1.5 mm to 3 mm. The foam layer preferably has an absorbency of 10 to 20 g / g, as measured by the free swell absorbent capacity method. In some embodiments, the foam layer includes a metal-based antimicrobial agent that is sustained-released when the binder layer contacts moisture. In some embodiments, the foam layer includes an inorganic antimicrobial agent. In some embodiments, the foam layer does not include an inorganic antimicrobial agent.

[0083] The foam layer may be bonded to the wound contact layer, preferably by a polymer-based melt layer, by adhesive, by flame lamination, by ultrasound, or by curing directly on the foam layer. The foam layer may be bonded directly to the wound contact layer to form a laminate structure extending together and separated by a bond line. Alternatively, the foam layer may form islands on the top surface of the components surrounded by the wound contact layer. By forming islands of foam in this way on the top surface of the absorbent member, the foam may tend to spread exudate in the foam layer laterally, physically limiting rewetting of the wound contact layer.

[0084] The fabric layer may be disposed between the wound contact layer and the foam layer to limit distortion of the components that may occur when the foam layer expands upon absorbing exudate. The fabric layer may be made from absorbent fibers such as polyester, nylon, or cotton, preferably including a highly absorbent component such as cross-linked sodium polyacrylate, or may be made from highly absorbent fibers such as polyacrylic acid.

[0085] In some embodiments, a one-way wicking layer is disposed between the wound contact layer and the foam layer to help prevent rewetting of the wound contact layer outside the wound area by exudate migrating down from the foam toward the wound. The one-way wicking layer has properties that resist the passage of exudate in one direction. The one-way wicking layer may be, for example, an embossed perforated film made from ethylene-methyl acrylate / ethylene vinyl acetate.

[0086] (How to use an in-line filter) In some embodiments, the present disclosure discloses a method of using an in-line filter to maintain a negative pressure in a wound dressing and protect a wound exudate management system from wound exudate. In some embodiments, wound exudate is absorbed by an in-line filter disclosed herein, and the wound exudate is prevented from entering a pump by a filter membrane in the in-line filter. In some embodiments, a method of protecting a wound exudate management system disclosed herein includes obtaining an in-line filter 200 including an inlet opening 210, an outlet opening 220, a one-way check valve 234, and at least one filter membrane 236, and connecting the outlet opening 220 to a first pressure tube 440, the first pressure tube 440 being connected to a pump 410 of the wound exudate management system 400 at an end opposite the end connected to the outlet opening 220 of the in-line filter 200. The method includes connecting the opening 220 to a first pressure tube 440, connecting the inlet opening 210 to a second pressure tube 450, the second pressure tube 450 being connected to the wound dressing 300 at an end opposite the end connected to the inlet opening 210 of the inline filter 200, and generating negative pressure within the wound dressing 300 by operating a pump 410 of the wound exudate management system 400 to draw air from the wound dressing 300.

[0087] In some cases, the pump 410 maintains a negative pressure of between 60 mmHg and 125 mmHg at the wound dressing 300 / 420. In some embodiments, the one-way check valve 234 housed within the cartridge 230 of the in-line filter can maintain a negative pressure of 80±20 mmHg across the entire wound dressing pad area when the wound dressing 300 / 420 is disconnected from the pump 410. In some embodiments, the one-way check valve 234 housed within the cartridge 230 of the in-line filter 200 can maintain a negative pressure of 80±20 mmHg across the entire wound dressing pad area when the wound dressing 300 / 420 is disconnected from the pump 410 for at least 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours, 48 ​​hours, or 72 hours. In some embodiments, the pump 410 further comprises a status indicator 490 that provides a visual cue to indicate when the pump 410 is off, on, and / or on but malfunctioning. In some embodiments, a malfunction of the pump 410 is caused by the pump 410 sensing a negative pressure at the wound dressing 300 / 420 outside of a negative pressure range between 40 mmHg and 200 mmHg. In some embodiments, a malfunction of the pump 410 is caused by the pump 410 sensing a negative pressure outside of a negative pressure range between 100 mmHg and 150 mmHg, e.g., outside 125 mmHg.

[0088] (Method of Treating a Wound) In some embodiments, the present disclosure provides a method of treating a wound by applying negative pressure to a wound dressing covering the wound. In some embodiments, the method disclosed herein is suitable for treating a wound with moderate exudation. In some embodiments, the method disclosed herein is suitable for treating a wound with low exudation. In some embodiments, the level of wound exudate is determined by weighing the soiled wound dressing before and after application to the wound. In some embodiments, the level of wound exudate is determined by measuring the contents of a wound drainage bag or canister. In some embodiments, the level of wound exudate is determined based on saturation of the wound dressing at predetermined intervals, for example, every 24 hours or 48 hours. In some embodiments, the level of wound exudate is determined based on the appearance of the wound bed. For example, if the wound is highly exuding, the skin surrounding the wound will be macerated and will be recognized by a whitish, plump, or sticky appearance, and the skin surrounding the wound may be easily broken down, increasing the overall size of the wound. Alternatively, non-exuding to low exuding wounds can be determined by checking that the wound dressing is dry and slightly attached to the wound bed. In that case, the wound dressing needs to be hydrated with liquid (e.g., saline) to allow it to be removed without causing discomfort to the patient.

[0089] In some embodiments, a method of treating a wound includes applying and maintaining a negative pressure to a wound dressing 420 / 300 in contact with a wound 80 using a wound exudate management system 400. In some embodiments, the wound exudate management system 400 includes an absorption indicator 368 / 470 disposed between the wound dressing 300 / 420 and a second pressure tube 450. The absorption indicator signals exudate being absorbed beyond the capacity of the wound dressing 300 / 420. In some embodiments, the signal generated by the absorption indicator absorbing exudate may be visual, audible, vibratory, etc.

[0090] In some embodiments, the method of treating a wound disclosed herein includes monitoring whether wound exudate reaches and is absorbed into the in-line filter, causing a partial blockage of the lumen 401 connecting the wound dressing 300 / 420 to the pump 410. In some embodiments, the method of treating a wound includes monitoring a status indicator 490 of the pump 410. Partial blockage of the in-line filter 200 / 430 by exudate causes the negative pressure to drop below a predetermined negative pressure range.

[0091] (Example 1) An example of treating a wound using a wound exudate management system will now be described. A healthcare provider obtained a wound dressing 300 for use with a reduced pressure occlusive wound therapy system 400. The wound dressing 300 included a silicone adhesive border 310 with a centrally located absorbent pad 450 covered with a polyurethane film 410 and included an integral flexible airway located over a Medicel™ disk 368, which was in direct contact with the absorbent pad 350 and attached via an adhesive ring 366. The opposite end of the airway was fitted with a luer fitting 364 with an in-line filter 200, which attached the wound dressing 300 to a pump tubing attached to a pump unit 410. The healthcare provider covered the patient's wound 80 with the wound dressing 300. Activation of the pump 410 applied negative pressure to the wound dressing 300 / 420. At the same time, the wound dressing became highly saturated with exudate. Exudate entered the tubing 450 connecting the wound dressing 300 to the pump 410, but was prevented from reaching the pump by the in-line filter 200 / 430. Blockage of the in-line filter 200 / 430 by exudate impeded airflow and caused a drop in negative pressure in the wound dressing 300 / 420. When absorbent capacity was lost in the wound dressing 300 / 420, the wound dressing 300 / 420 no longer conformed closely to the wound and / or peri-wound area. This provided a visual indication to the healthcare provider that the in-line filter 200 / 430 needed to be replaced. The healthcare provider replaced the wound dressing 300 containing the blocked in-line filter 200 with a new wound dressing 300 / 420 containing an in-line filter, and reconnected the tubing located between the wound dressing, the in-line filter, and the pump.

[0092] (Example 2) Another example involves testing of a given reduced pressure closed wound therapy system to evaluate the effectiveness of the systems and methods described herein. As an initial baseline, the reduced pressure closed wound therapy system was initially tested without the use of an in-line filter. More specifically, the initial baseline evaluation used conventional luer lock fittings to connect the wound dressing to the pump to provide negative pressure. Each luer lock fitting was provided with a check valve to prevent air from escaping within the wound dressing, but no filter was provided. In the absence of a filter, exudate passed through the luer lock and entered the pump. After a three-day trial period, 100% of the baseline systems had exudate in the pump, often causing damage to the pump.

[0093] In a second baseline test, the Luer lock fitting was provided with a first filter formed of PTFE having an average pore size of about 0.2 microns. To facilitate rapid testing of the filter, a new test method was employed which involved contacting the wound dressing directly with the test solution. Filters evaluated at this stage of testing demonstrated a pass rate of about 88%. This was an improvement over the 0% pass rate of the conventional fitting without a filter, but there remained a need for improvement.

[0094] The third study used glass silicone membranes with an average pore size of approximately 0.2 microns. The first group of these filters was tested prior to sterilization, and the second group was evaluated after sterilization by ethylene oxide (EO) sterilization. In this study, it was unexpectedly discovered that while the non-sterilized filters performed well with a 100% pass rate, performance decreased once the filters were sterilized. More specifically, filters sterilized by the EO sterilization method were found to have only a 60% pass rate. While an improvement over the 0% pass rate of the conventional fitting, the sterilized group performed poorly compared to the second baseline study. Thus, there remained a need for further improvement.

[0095] The fourth test evaluated filters according to embodiments of the present application. The filters evaluated in this test were made of PESU and were chosen to have a larger average pore size of about 3 microns. Again, both sterile and non-sterile filters were evaluated. In this case, a 100% pass rate was found for both non-sterile and EO sterilized filters. Thus, contrary to expectations, the filters with the larger average pore size were found to have improved exudate blocking properties compared to the filters evaluated in the second and third tests, which had smaller average pore sizes, respectively.

[0096] (More examples) Certain embodiments of the present application relate to a wound dressing comprising: an adhesive layer for adhering the wound dressing adjacent to the wound, a wound contact layer for contacting the wound, a pressure distribution layer, a plurality of absorbent material layers disposed between the wound contact layer and the pressure distribution layer, the plurality of absorbent material layers including a first absorbent material layer facing the wound contact layer and a second absorbent material layer facing the pressure distribution layer, a backing layer having a first surface and a second surface, the first surface of the backing layer adjacent to and in contact with the pressure distribution layer and the adhesive layer, a port defined in the backing layer, and an absorbency indicator aligned with the port, the absorbency indicator configured to absorb exudate to indicate the presence of exudate in the second absorbent material layer.

[0097] In some embodiments, the wound dressing further comprises an envelope structure defining a cavity, the plurality of absorbent layers being received within the cavity, in some embodiments, the envelope structure is at least partially defined by the pressure distribution layer and the wound contact layer, and the peripheries of the pressure distribution layer and the wound contact layer are joined to at least partially define the envelope structure.

[0098] In some embodiments, the wound dressing further comprises a flexible connector attached adjacent to the port and a tube having a first end connected to the flexible connector and a second end opposite the first end. In some embodiments, the wound dressing further comprises an in-line filter coupled to the second end of the tube. In some embodiments, the absorption indicator is visible through the flexible connector. In some embodiments, the wound dressing further comprises a pressure transfer member coupled to the flexible connector.

[0099] In some embodiments, the wound dressing further comprises a nonwoven spunlace layer disposed between the wound contact layer and the first absorbent layer, and a thermoplastic spunlace layer disposed between the pressure dispersing layer and the second absorbent layer, In some embodiments, the nonwoven spunlace layer and the thermoplastic spunlace layer are peripherally bonded to define an envelope structure in which the multiple absorbent layers are disposed.

[0100] An embodiment of the present application relates to a wound exudate management system, the wound exudate management system comprising: a pump for generating negative pressure, a wound dressing for covering and protecting a wound, a first pressure tube having a first lumen, a second pressure tube having a second lumen, an in-line filter disposed between the first pressure tube and the second pressure tube, and a flexible connector, the first pressure tube being disposed between the pump and the in-line filter, the second pressure tube being disposed between the in-line filter and the flexible connector, and the flexible connector being disposed between the second pressure tube and the wound dressing such that the pump and the wound dressing are in fluid communication through the lumen and the in-line filter.

[0101] In some embodiments, the wound dressing includes an adhesive layer for adhering the wound dressing adjacent to the wound. In some embodiments, the wound dressing includes a wound contact layer for contacting the wound, a pressure distribution layer, a plurality of absorbent material layers disposed between the wound contact layer and the pressure distribution layer, and a backing layer having a first surface and a second surface, the first surface of the backing layer being adjacent to and in contact with the pressure distribution layer and the adhesive layer. In some embodiments, the wound dressing further includes a thermoplastic spunlace layer connected to the pressure distribution layer and a nonwoven spunlace layer connected to the wound contact layer, and the envelope structure is formed by joining peripheral portions of the thermoplastic spunlace layer and the nonwoven spunlace layer such that the plurality of absorbent material layers are disposed substantially within the interior cavity of the envelope structure. In some embodiments, the absorbent material is disposed within the interior cavity of the envelope structure. In some embodiments, the absorbent material and / or the wound contact layer comprises carboxymethyl cellulose fibers. In some embodiments, the wound contact layer comprises a reinforced nylon stitch. In some embodiments, the wound dressing further comprises fenestrations in one or more of the multiple absorbent material layers.

[0102] In some embodiments, the system further includes an absorbency indicator and an adhesive member, the adhesive member adhering the flexible connector and the absorbency indicator to the wound dressing. In some embodiments, the absorbency indicator is disposed in a pathway located between the absorbent layer and the flexible connector, and the absorbency indicator is capable of absorbing exudate to indicate the presence of exudate on the side of the absorbent layer furthest from the wound. In some embodiments, the wound exudate management system further includes a status indicator, the status indicator providing a visual cue to indicate when the pump is off, on, and / or on but malfunctioning.

[0103] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will occur to those skilled in the art without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be used in practicing the present invention. The following claims define the scope of the present invention, and it is intended that methods and structures within the scope of the claims and their equivalents be covered thereby.

[0104] While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be understood as being illustrative and not restrictive in nature, and only the preferred embodiments have been shown and described, it being understood that changes and modifications which are within the spirit of the invention are protected.

[0105] Certain embodiments of the present application relate to a wound dressing for use in a reduced pressure closed wound therapy system, the wound dressing comprising an adhesive layer for adhering the wound dressing adjacent to the wound, a wound contact layer for contacting the wound, a backing layer including a port, a tube having a first end connected to the port and an opposite second end, a first fitting connected to the second end of the tube, the first fitting configured to connect to a second fitting of the reduced pressure closed wound therapy system for applying negative pressure via the port, and a filter disposed within the first fitting, the filter being constructed of a hydrophilic material and having an average pore size of at least 2 microns, and the wound dressing being sterile.

[0106] In some embodiments, the average pore size is about 3 microns. In some embodiments, the hydrophilic material comprises polyethersulfone (PESU). In some embodiments, the wound dressing is sterilized by ethylene oxide (EO) sterilization. In some embodiments, the wound dressing further comprises a check valve mounted within the first fitting. In some embodiments, the wound dressing further comprises a pressure dispersion layer, the backing layer being adjacent to and in contact with the adhesive layer and the pressure dispersion layer. In some embodiments, the wound dressing further comprises a plurality of absorbent material layers disposed between the wound contact layer and the pressure dispersion layer, the plurality of absorbent material layers comprising a first absorbent material layer facing the wound contact layer and a second absorbent material layer facing the pressure dispersion layer. In some embodiments, the wound dressing further comprises an absorption indicator aligned with the port, the absorption indicator configured to absorb exudate to indicate the presence of exudate in the second absorbent material layer.

[0107] Certain embodiments of the present application relate to a fitting configured for use with a wound dressing, the fitting comprising a first end configured to mate with a tube, a second end configured to mate with a mating fitting, and a filter disposed within a chamber disposed between the first and second ends, the filter being formed of a hydrophilic material and having an average pore size of at least 2 microns, and the fitting being sterile.

[0108] In some embodiments, the average pore size is about 3 microns. In some embodiments, the hydrophilic material comprises polyethersulfone (PESU). In some embodiments, the fitting further comprises a check valve mounted within the chamber. In some embodiments, the fitting is sterilized by ethylene oxide (EO) sterilization.

[0109] Certain embodiments of the present application relate to an apparatus that includes an attachment, the apparatus further comprising a wound dressing for attachment to a wound and a tube connecting the wound dressing to the attachment.

[0110] Certain embodiments of the present application relate to a system including an apparatus, the apparatus further comprising a mating fitting, the fitting engaging the mating fitting, a second tube connected to the mating fitting, and a pump connected to the second tube such that the pump is operable to provide negative pressure to the wound dressing.

[0111] Certain embodiments of the present application relate to a wound dressing for use in a reduced pressure closed wound therapy system, the wound dressing comprising an adhesive layer for adhering the wound dressing adjacent to the wound, a wound contact layer for contacting the wound, a backing layer including a port, a tube having a first end connected to the port and an opposite second end, a first fitting connected to the second end of the tube, the first fitting configured to connect to a second fitting of a reduced pressure closed wound therapy system for applying negative pressure via the port, and a filter disposed within the first fitting, the filter being constructed of polyethersulfone (PESU) and having an average pore size of at least 2 microns.

[0112] In some embodiments, the average pore size is about 3 microns. In some embodiments, the wound dressing is sterile. In some embodiments, the wound dressing is sterilized by ethylene oxide (EO) sterilization. In some embodiments, the wound dressing further comprises a check valve mounted within the first fitting.

[0113] In some embodiments, the wound dressing further comprises a pressure dispersion layer. The backing layer is adjacent to and in contact with the adhesive layer and the pressure dispersion layer. In some embodiments, the wound dressing further comprises a plurality of absorbent material layers disposed between the wound contact layer and the pressure dispersion layer. The plurality of absorbent material layers includes a first absorbent material layer facing the wound contact layer and a second absorbent material layer facing the pressure dispersion layer. In some embodiments, the wound dressing further comprises an absorption indicator aligned with the port, the absorption indicator configured to absorb exudate to indicate the presence of exudate in the second absorbent material layer.

[0114] One embodiment relates to a fitting configured for use with a wound dressing, the fitting comprising a first end configured to mate with a tube, a second end configured to mate with a mating fitting, and a filter disposed within a chamber disposed between the first and second ends, the filter being formed of polyethersulfone (PESU) and having an average pore size of at least 2 microns, and the fitting being sterilized by ethylene oxide sterilization.

[0115] In some embodiments, the average pore size is about 3 microns.In some embodiments, the fixture further comprises a check valve mounted within the chamber.

[0116] Some embodiments of the present application include the fitting and further include a wound dressing for attachment to the wound and a tube connecting the wound dressing to the fitting.

[0117] One embodiment of the present application relates to a system comprising an apparatus, further comprising a mating fitting, the fitting engaging with the mating fitting, a second tube connected to the mating fitting, and a pump connected to the second tube such that the pump is operable to provide negative pressure to the wound dressing.

[0118] One embodiment of the present application relates to a reduced pressure closure wound therapy system comprising a wound dressing for adhering adjacent to a wound, a tube connected to the wound dressing, a pump connected to the tube and configured to provide negative pressure to the wound dressing via the tube, and an in-line filter disposed within the tube, the filter being formed of polyethersulfone (PESU) and having an average pore size of at least 2 microns and configured to prevent passage of exudate from the wound dressing to the pump.

[0119] In some embodiments, the average pore size is about 3 microns. In some embodiments, the tube comprises a first tube having a first tube first end and an opposite first tube second end, the first tube first end being connected to a wound dressing and the first tube second end including a first fitting, and a second tube having a second tube first end and an opposite second tube second end, the second tube first end including a second fitting mated with the first fitting, wherein fluid flows between the second tube second end and the pump, and an in-line filter is disposed within one of the first fitting or the second fitting. In some embodiments, the in-line filter is disposed within the first fitting. In some embodiments, the first fitting further comprises a check valve configured to permit fluid flow through the first fitting away from the wound dressing and to prevent fluid flow through the first fitting towards the wound dressing. In some embodiments, the wound dressing and the in-line filter are sterilized by ethylene oxide sterilization. In some embodiments, the wound dressing further comprises an absorbent indicator configured to absorb exudate to indicate the presence of exudate within the wound dressing.

[0120] In the above description, the use of words such as preferred, preferably, preferred or more preferred indicates that the feature so described may be more desirable, but it is to be understood that it may not be necessary nonetheless. It is to be understood that embodiments lacking the same are within the scope of the invention as defined by the following claims. In reading the claims, when phrases such as "a," "an," "at least one," or "at least a portion" are used, it is intended that there is no intention to limit the claim to only one item, unless the claim specifically states to the contrary. When the words "at least a portion" and / or "a portion" are used, an item can include a portion and / or the entire item, unless specifically stated otherwise.

Claims

1. 1. A wound dressing for use in a reduced pressure occlusive wound therapy system, comprising: an adhesive layer for adhering the wound dressing adjacent to a wound; a wound contact layer for contacting the wound; a backing layer having a port; a tube having a first end connected to the port and a second end opposite the first end; a first fitting connected to the second end of the tube, the first fitting configured to connect with a second fitting of the reduced pressure closure wound therapy system to apply negative pressure through the port; and an in-line filter disposed within the first fitting; Including, the in-line filter comprising an inlet opening having a first connector, an outlet opening having a second connector, and a removable cartridge disposed between the inlet opening and the outlet opening; the cartridge comprising a cavity, a one-way check valve, and at least one filter membrane, the filter membrane comprising a material having an average pore size of at least 0.2 microns; The wound dressing is sterile. Wound dressings.

2. 10. The wound dressing of claim 1, wherein the average pore size is 3 microns.

3. 3. The wound dressing of claim 1 or 2, wherein the material of the filter membrane comprises polyethersulfone (PESU).

4. 4. The wound dressing of claim 1, wherein the wound dressing is sterilized by ethylene oxide (EO) sterilization.

5. Further comprising a pressure dispersion layer, the backing layer is adjacent to and in contact with the adhesive layer and the pressure distribution layer; A wound dressing according to any one of claims 1 to 4.

6. a plurality of absorbent layers disposed between the wound contact layer and the pressure dispersing layer; The plurality of absorbent material layers includes a first absorbent material layer facing the wound contact layer and a second absorbent material layer facing the pressure dispersion layer.

6. The wound dressing of claim 5.

7. and an absorption indicator aligned with the port. the absorbency indicator is configured to absorb exudate to indicate the presence of exudate in the second absorbent material layer.

7. The wound dressing of claim 6.

8. 1. An attachment configured for use with a wound dressing, comprising: a first end configured to couple to a tube; a second end configured to mate with a mating fitting; an in-line filter disposed within a chamber disposed between the first end and the second end; Equipped with the in-line filter comprising an inlet opening having a first connector, an outlet opening having a second connector, and a removable cartridge disposed between the inlet opening and the outlet opening; the cartridge comprising a cavity, a one-way check valve, and at least one filter membrane, the filter membrane comprising a material having an average pore size of at least 0.2 microns; The fitting is sterile. Mounting fixture.

9. 9. The fixture of claim 8, wherein the average pore size is 3 microns.

10. 10. The fitting of claim 8 or 9, wherein the material of the filter membrane comprises polyethersulfone (PESU).

11. 11. The fitting of any one of claims 8 to 10, wherein the fitting is sterilized by ethylene oxide sterilization.

12. 12. An apparatus comprising the fixture of any one of claims 8 to 11, a wound dressing for adhering to the wound; a tube connecting the wound dressing to the fitting; Further comprising: Device.

13. A system comprising the device of claim 12, a mating fitting, said fitting engaging with said mating fitting; a second tube connected to the mating fitting; a pump connected to the second tube so as to be operable to provide a negative pressure to the wound dressing; Further comprising: system.

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