Fluid connector for negative pressure wound therapy

Abstract

Disclosed herein are negative pressure appliances and methods of operating negative pressure appliances in treating a wound with negative pressure. Also disclosed are improved fluid connectors or suction adapters for connecting a source of negative pressure to a wound, having an air leak channel separate from a suction channel.

Description

[0001] background Technical Field

[0002] Embodiments of this disclosure relate to methods and apparatus for dressing and treating wounds using decompression therapy or local negative pressure (TNP) therapy. Specifically, but not in a limiting sense, the embodiments disclosed herein relate to negative pressure therapy devices, methods for controlling the operation of a TNP system, and methods for using a TNP system. Background Technology

[0003] Many different types of wound dressings are known for aiding the healing process in humans or animals. These different types of wound dressings include many different types of materials and layers, such as gauze, padding, foam pads, or multilayer wound dressings. Local negative pressure (TNP) therapy, sometimes also called vacuum-assisted closure, negative pressure wound therapy (NPWT), or decompression wound therapy, is widely recognized as a beneficial mechanism for improving wound healing rates. This type of treatment is suitable for a wide range of wounds, such as incisions, open wounds, and abdominal wounds.

[0004] TNP treatment helps close and heal wounds by reducing tissue edema, promoting blood flow, stimulating granulation tissue formation, and removing excess exudate. It also reduces bacterial load and thus wound infection. Furthermore, TNP treatment allows for less external disturbance to the wound and promotes faster healing. Summary of the Invention

[0005] The embodiments disclosed herein relate to devices, systems, apparatuses, and methods for negative pressure wound therapy.

[0006] A fluid connector for negative pressure wound therapy may include a top layer, a bottom layer, and an intermediate layer. Each layer may be made of a flexible, liquid-impermeable material. Each layer may include a proximal end and a distal end. The connector may include an upper fluid passage at least partially defined between the top and intermediate layers. The upper fluid passage may include a proximal end and a distal end. The upper fluid passage may include an upper channel spacer material positioned between the upper and intermediate layers. The upper fluid passage may be configured to provide gas from an opening in the top layer located at or near the proximal end of the upper fluid passage. The connector may include a lower fluid passage at least partially defined between the intermediate and bottom layers. The lower fluid passage may be configured to be in fluid communication with a negative pressure source. The lower fluid passage may include a lower channel spacer material positioned between the intermediate and bottom layers. The connector may include an opening in the distal end of the bottom layer. The opening in the bottom layer may be configured to be positioned above an opening in a dressing configured to be positioned above a wound. The opening in the bottom layer may be fluidly connected to the lower fluid passage. The connector may include an opening in the distal end of the intermediate layer. The opening in the intermediate layer may be fluidly connected to the upper fluid passage. The opening in the intermediate layer may be positioned above an opening in the bottom layer. The distal end of the upper channel spacer material may extend further than the distal end of the lower channel spacer material. The lower fluid passage may include a portion at its distal end that does not contain the lower channel spacer material. This portion of the lower fluid passage may include an opening in the underlayer. When negative pressure from a negative pressure source is applied to the lower fluid passage, the portion in the lower fluid passage may collapse, thereby blocking fluid flow through this portion of the lower fluid passage between the lower and upper channel spacers, while allowing fluid flow through the openings in the dressing, the underlayer, and the intermediate layer between the lower and upper channel spacers.

[0007] The fluid connector in any of the preceding paragraphs and / or any of the fluid connectors disclosed herein may include one or more of the following features: A portion of the lower channel spacer material at its distal end may overlap with an opening in the underlayer. The fluid connector may include an applicator attached to the underlayer at its distal end, the applicator including an adhesive configured to adhere to the dressing. The applicator may include an opening positioned directly below the opening in the underlayer and configured to be positioned above the opening in the dressing. At least a portion of the opening in the intermediate layer may overlap with the opening in the applicator. The opening in the underlayer may be wider than the opening in the intermediate layer. The center of the opening in the intermediate layer may be positioned more distally than the center of the opening in the underlayer. The upper channel spacer material may include foam. The lower channel spacer material may be a 3D knitted or 3D fabric material. Each of the top and bottom layers may have an enlarged distal end. The enlarged ends of the top and bottom layers may be rectangular or teardrop-shaped. The bottom layer is configured to attach to the dressing. The opening in the top layer may include a filter. The fluid connector may include a connector in fluid communication with the proximal end of the lower channel spacer material, the connector being configured to be fluidly connected to a negative pressure source.

[0008] A fluid connector for negative pressure wound therapy may include an upper fluid passage. The upper fluid passage may be configured to provide gas from an opening located proximal to or near the upper fluid passage toward its distal end. The fluid connector may include a lower fluid passage. The lower fluid passage may be configured to be in fluid communication with a negative pressure source and allow fluid to flow toward the negative pressure source through the lower fluid passage. The fluid connector may include an intermediate layer between the upper and lower fluid passages. The intermediate layer may include a fluid-impermeable material. The fluid connector may include a first opening at the distal end of the lower fluid passage. The first opening may be configured to be positioned above an opening in a dressing configured to be positioned above a wound. The fluid connector may include a second opening at the distal end of the intermediate layer, positioned above the first opening in the sublayer, and the second opening is fluidly connected to the upper fluid passage. The upper fluid passage may extend more distally than the lower fluid passage, and the lower fluid passage may include the vacant portion where the first opening is located. When negative pressure is applied from a negative pressure source to the lower fluid passage, the empty portion can collapse, thereby blocking the fluid flow through the empty portion between the upper and lower fluid passages, while allowing fluid flow through the dressing and filler positioned in the wound between the upper and lower fluid passages.

[0009] The fluid connector described in any of the preceding paragraphs and / or any of the fluid connectors disclosed herein may include one or more of the following features: The lower fluid passage may include material. A portion of the material at the distal end of the lower fluid passage may overlap with the first opening. The fluid connector may include an applicator attached at the distal end to the bottom surface of the fluid connector. The applicator may include an adhesive configured to adhere to a dressing. The applicator may include an opening directly below the first opening. The applicator may be configured to be positioned above an opening in the dressing. At least a portion of a second opening may overlap with an opening in the applicator. The first opening may be wider than the second opening. The center of the second opening may be positioned further away from the center of the first opening. The gas may include air.

[0010] A method of operating a fluid connector described in any of the preceding paragraphs and / or any of the fluid connectors described herein is disclosed. A method of operating a negative pressure wound therapy system is also disclosed, the negative pressure wound therapy system including a fluid connector described in any of the preceding paragraphs and / or any of the fluid connectors described herein. A method of operating a negative pressure wound therapy system may include providing a suction adapter. The suction adapter may include an upper fluid passage configured to provide gas from an opening located proximal to or near the upper fluid passage toward a distal end of the upper fluid passage. The suction adapter may include a lower fluid passage configured to be in fluid communication with a negative pressure source and to allow fluid to flow toward the negative pressure source through the lower fluid passage. The suction adapter may include an intermediate layer between the upper and lower fluid passages. The intermediate layer may include a fluid-impermeable material. The suction adapter may include a first opening at the distal end of the lower fluid passage. The first opening may be configured to be positioned above an opening in a dressing configured to be positioned above a wound. The suction adapter may include a second opening at the distal end of the intermediate layer. The second opening may be positioned above the first opening in a sublayer. The second opening may be fluidly connected to the upper fluid passage. The upper fluid passage may extend further than the lower fluid passage. The lower fluid passage may include the empty portion where the first opening is located. The method may include: when the suction adapter is attached to the dressing and the first opening is positioned in fluid communication with an opening in the dressing, applying negative pressure from a negative pressure source to the wound through the lower fluid passage of the suction adapter, and causing the empty portion to collapse and block fluid flow through the empty portion between the upper and lower fluid passages, while allowing at least some gas flow from the upper fluid passage through the dressing and the wound packing positioned in the wound and to be suctioned through the lower fluid passage.

[0011] A fluid connector for negative pressure wound therapy may include a top layer, a bottom layer, and an intermediate layer. Each layer may be made of a flexible, liquid-impermeable material. Each layer may include a proximal end and a distal end. The connector may include an upper fluid passage at least partially defined between the top and intermediate layers. The upper fluid passage may include a proximal end and a distal end. The upper fluid passage may include an upper channel spacer material positioned between the upper and intermediate layers. The upper fluid passage may be configured to provide gas from an opening in the top layer located at or near the proximal end of the upper fluid passage. The connector may include a lower fluid passage at least partially defined between the intermediate and bottom layers. The lower fluid passage may be configured to be in fluid communication with a negative pressure source. The lower fluid passage may include a lower channel spacer material positioned between the intermediate and bottom layers. The connector may include one or more openings in the distal end of the bottom layer. One or more openings in the bottom layer may be configured to be positioned above an opening in a dressing configured to be positioned above a wound. At least one of the one or more openings in the bottom layer may be fluidly connected to the lower fluid passage. The connector may include an opening in the distal end of the intermediate layer. An opening in the intermediate layer may be fluidly connected to the upper fluid passage. An opening in the intermediate layer may be positioned above at least one of one or more openings in the bottom layer. The distal end of the upper channel spacer material may extend more distally than at least a portion of the distal end of the lower channel spacer material, such that the lower fluid passage may include a portion excluding the lower channel spacer material at its distal end. A portion of the lower fluid passage may include one or more openings in the bottom layer.

[0012] The fluid connector described in any of the preceding paragraphs and / or any of the fluid connectors disclosed herein may include one or more of the following features: When negative pressure from a negative pressure source is applied to the lower fluid passage, a portion of the lower fluid passage may collapse, thereby blocking fluid flow through that portion of the lower fluid passage between the lower channel spacer material and the upper channel spacer material, while allowing fluid flow between the lower channel spacer material and the upper channel spacer material through an opening in the dressing, one or more openings in the underlayer, and an opening in the intermediate layer. A portion of the lower channel spacer material at the distal end may overlap with one of the one or more openings in the underlayer. The fluid connector may include an applicator attached to the underlayer at the distal end, the applicator including an adhesive configured to adhere to the dressing. The applicator may include an opening positioned directly below one or more openings in the underlayer and configured to be positioned above an opening in the dressing. At least a portion of the opening in the intermediate layer may overlap with the opening in the applicator. One or more openings in the underlayer may be wider than the openings in the intermediate layer. The center of the opening in the intermediate layer may be located more distally than the center of each of the one or more openings in the underlayer. The upper channel spacer material may include foam. The lower channel spacer material can be a 3D knitted or 3D fabric material. Each of the top and bottom layers can have an enlarged distal end. The enlarged ends of the top and bottom layers can be rectangular or teardrop-shaped. The bottom layer is configured to attach to the dressing. Openings in the top layer can include filters. A fluid connector can include a connector in fluid communication with the proximal end of the lower channel spacer material, configured to be fluidly connected to a negative pressure source. The lower fluid passage can include a welded portion where a portion of the bottom layer is welded to an intermediate layer. When negative pressure from a negative pressure source is applied to the lower fluid passage, the welded portion in the lower fluid passage can block fluid flow through that portion of the lower fluid passage between the lower and upper channel spacers, while allowing fluid flow through openings in the dressing, one or more openings in the bottom layer, and openings in the intermediate layer between the lower and upper channel spacers. This portion of the lower fluid passage can include a distal portion and a proximal portion separated from the distal portion by the welded portion of the lower fluid passage. One or more openings in the bottom layer can include two openings. The welded portion of the bottom layer can be located between the two openings. At least one of the two openings may be semi-circular in shape. The distal end of the lower channel spacer material may include a bifurcated shape comprising a base portion between the two side portions. The two side portions may extend distally from the base portion, one or more openings in the bottom layer, and an opening in the intermediate layer. The base portion may be adjacent to one or more openings in the bottom layer and an opening in the intermediate layer. The lower fluid passage may be located between the two side portions of the lower channel spacer material and distal to the base portion of the lower channel spacer material.

[0013] A fluid connector for negative pressure wound therapy may include an upper fluid passage. The upper fluid passage may be configured to provide gas from an opening located proximal to or near the upper fluid passage toward its distal end. The fluid connector may include a lower fluid passage. The lower fluid passage may be configured to be in fluid communication with a negative pressure source and allow fluid to flow toward the negative pressure source through the lower fluid passage. The fluid connector may include an intermediate layer between the upper and lower fluid passages. The intermediate layer may include a fluid-impermeable material. The fluid connector may include one or more first openings at the distal end of the lower fluid passage. The one or more first openings may be configured to be positioned above an opening in a dressing configured to be positioned above a wound. The fluid connector may include a second opening at the distal end of the intermediate layer. The second opening may be positioned above at least one of the one or more first openings in the underlying layer. The second opening may be fluidly connected to the upper fluid passage. The upper fluid passage may extend more distally than the lower fluid passage, and the lower fluid passage may include an empty portion where one or more first openings may be located. When negative pressure is applied from a negative pressure source to the lower fluid passage, it can block the fluid flow through the empty portion between the upper and lower fluid passages, while allowing fluid flow through dressings and fillers positioned in the wound between the upper and lower fluid passages.

[0014] The fluid connector described in any of the preceding paragraphs and / or any of the fluid connectors disclosed herein may include one or more of the following features: A void portion may collapse in response to negative pressure applied to the lower fluid passage, thereby blocking fluid flow through the void portion between the upper and lower fluid passages. The void portion may include a welded portion, at which a portion of the underlayer may be welded to an intermediate layer. When negative pressure is applied to the lower fluid passage, the welded portion may be adapted to block fluid flow through the void portion between the upper and lower fluid passages. The void portion of the lower fluid passage may include a distal portion and a proximal portion separated from the distal portion by the welded portion of the lower fluid passage. One or more openings in the underlayer may include two openings. The welded portion of the underlayer may be located between the two openings. At least one of the two openings may be semi-circular in shape. The lower fluid passage may include a lower channel spacer material. A portion of the lower channel spacer material at the distal end of the lower fluid passage may overlap with one of the one or more first openings. A portion of the lower channel spacer material at the distal end of the lower fluid passage may abut the distal edge of one of the one or more first openings. A portion of the lower channel spacer material at the distal end of the lower fluid passage may include a bifurcated shape, the bifurcated shape including a base portion between two side portions. The two side portions may extend distally from the base portion, one or more first openings in the underlayer, and an opening in the intermediate layer. The base portion may be adjacent to one or more first openings in the underlayer and an opening in the intermediate layer. A portion of the lower fluid passage may be positioned between the two side portions of the lower channel spacer material and distal to the base portion of the lower channel spacer material. The fluid connector may include an applicator attached at the distal end to the bottom surface of the fluid connector. The applicator may include an adhesive configured to adhere to a dressing. The applicator may include an opening directly below one or more first openings. The applicator may be configured to be positioned above an opening in the dressing. At least a portion of a second opening may overlap with an opening in the applicator. One or more first openings may be wider than the second opening. The center of the second opening may be positioned distally away from the center of each of the one or more first openings. The gas may include air.

[0015] A method of operating a negative pressure wound therapy system may include providing a suction adapter. The suction adapter may include an upper fluid passage configured to provide gas from an opening located proximal to or near the upper fluid passage toward its distal end. The suction adapter may include a lower fluid passage configured to be in fluid communication with a negative pressure source and to allow fluid to flow toward the negative pressure source through the lower fluid passage. The suction adapter may include an intermediate layer between the upper and lower fluid passages. The intermediate layer may include a fluid-impermeable material. The suction adapter may include one or more first openings at the distal end of the lower fluid passage. The one or more first openings may be configured to be positioned above an opening in a dressing configured to be positioned above a wound. The suction adapter may include a second opening at the distal end of the intermediate layer. The second opening may be positioned above at least one of the one or more first openings in the underlying layer. The second opening may be fluidly connected to the upper fluid passage. The upper fluid passage may extend more distally than the lower fluid passage. The lower fluid passage may include an empty portion containing one or more first openings. The method may include: when the suction adapter is attached to a dressing and one or more first openings are positioned in fluid communication with an opening in the dressing, applying negative pressure from a negative pressure source to the wound through a lower fluid passage of the suction adapter, and causing an empty portion to block fluid flow through the empty portion between the upper and lower fluid passages, while allowing at least some gas flow from the upper fluid passage through the dressing and the wound packing positioned in the wound and to be suctioned through the lower fluid passage.

[0016] The methods described in any of the preceding paragraphs and / or any of the methods disclosed herein may include one or more of the following features. Applying negative pressure from a negative pressure source to the wound via the lower fluid passage of the suction adapter causes the vacant portion to collapse, thereby selectively blocking fluid flow. The vacant portion may include a welded portion, where the bottom layer may be welded to the intermediate layer, such that the welded portion selectively blocks fluid flow while negative pressure from the negative pressure source is applied to the wound via the lower fluid passage of the suction adapter.

[0017] Other embodiments of devices, apparatuses, and related methods for use with negative pressure are described below. Attached Figure Description

[0018] Figure 1 A decompression wound treatment system according to some embodiments is shown.

[0019] Figure 2 A pump assembly and tank according to some embodiments are shown.

[0020] Figure 3 A schematic diagram of the electrical components of a pump assembly according to some embodiments is shown.

[0021] Figure 4AAn embodiment of a negative pressure wound treatment system including a pump is shown, and a flexible suction adapter applied to the wound is also shown.

[0022] Figure 4B It shows Figure 4A In one embodiment, a flexible suction adapter is placed above the wound.

[0023] Figure 5A An isometric view is shown of a flexible suction adapter that can be used in a negative pressure wound therapy system.

[0024] Figure 5B It shows Figure 5A Exploded view of the flexible suction adapter.

[0025] Figure 5C It shows Figure 5B A close-up view of the proximal end of the flexible suction adapter.

[0026] Figure 5D It shows Figure 5A Myopic cross-sectional view of the proximal end of the flexible suction adapter.

[0027] Figure 5E It shows Figure 5A Top view of the flexible suction adapter.

[0028] Figure 5F It shows Figure 5A Side view of the flexible suction adapter.

[0029] Figure 5G It shows Figure 5A Bottom view of the flexible suction adapter.

[0030] Figure 6 An exploded view of the alternative flexible suction adapter is shown.

[0031] Figure 7A A top view of a 3D fabric that can be used in a negative pressure wound therapy device is shown.

[0032] Figure 7B It shows Figure 7A A bottom view of the 3D fabric.

[0033] Figure 7C It shows Figure 7A A 3D side cross-sectional view of the fabric.

[0034] Figure 8A -B indicates a structure with two or more protrusions that can be connected to... Figure 5A An embodiment of the connector for the suction adapter shown.

[0035] Figure 9AAn exploded view of a flexible suction adapter that can be used in a negative pressure wound therapy system is shown.

[0036] Figure 9B It shows Figure 9A Top view of the flexible suction adapter.

[0037] Figure 9C It shows Figure 9A Cross-sectional view of the flexible suction adapter.

[0038] Figure 10 A diagram of a system for applying negative pressure according to some embodiments is shown.

[0039] Figure 11A A negative pressure wound treatment system including a negative pressure device is shown according to some embodiments, and a pair of flexible suction adapters applied to the wound are shown.

[0040] Figure 11B It shows Figure 11A In one embodiment, a flexible suction adapter is placed above the wound.

[0041] Figure 12 A diagram of a system for applying negative pressure according to some embodiments is shown.

[0042] Figure 13 A flowchart is shown, according to some embodiments, of a process for determining and indicating one or more operational states.

[0043] Figure 14 A flowchart is shown, according to some embodiments, of a process for determining and indicating one or more operational states.

[0044] Figure 15 A cross-sectional view is shown of a flexible suction adapter that can be used in a negative pressure wound therapy system.

[0045] Figure 16 It shows Figure 15 An exploded view of a portion of the flexible suction adapter.

[0046] Figure 17 It shows Figure 15 An exploded view of a portion of the flexible suction adapter.

[0047] Figure 18 It shows Figure 15 Bottom view of the flexible suction adapter.

[0048] Figure 19-21 This shows the application of the wound dressing to the area under negative pressure. Figure 15 Flexible suction adapter.

[0049] Figure 22-23 A bottom view of different embodiments of the flexible suction adapter is shown.

[0050] Figure 24A -B shows the middle layer of the flexible suction adapter ( Figure 24A ) and bottom layer ( Figure 24B The bottom view of an embodiment of ).

[0051] Figure 25A -B shows the middle layer of the flexible suction adapter ( Figure 25A ) and bottom layer ( Figure 25B The bottom view of an embodiment of ).

[0052] Figure 26A -B shows the middle layer of the flexible suction adapter ( Figure 26A ) and bottom layer ( Figure 26B The bottom view of an embodiment of ).

[0053] Figure 27 A cross-sectional view is shown of an embodiment of a flexible suction adapter that can be used in a negative pressure wound therapy system.

[0054] Figure 28A -B shows the middle layer of the flexible suction adapter ( Figure 28A ) and bottom layer ( Figure 28B The bottom view of an embodiment of ).

[0055] Figure 29A -B shows the middle layer of the flexible suction adapter ( Figure 29A ) and bottom layer ( Figure 29B The bottom view of an embodiment of ).

[0056] Figure 30A -B shows the middle layer of the flexible suction adapter ( Figure 30A ) and bottom layer ( Figure 30B The bottom view of an embodiment of ). Detailed Implementation

[0057] Overview

[0058] The embodiments disclosed herein relate to devices, systems, apparatus, and methods for treating wounds with decompression. As used herein, a decompression level or negative pressure level (e.g., -X mmHg) represents a pressure level relative to normal ambient atmospheric pressure, which may correspond to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Therefore, a negative pressure value of -X mmHg reflects an absolute pressure X mmHg lower than 760 mmHg, or in other words, an absolute pressure of (760-X) mmHg. Additionally, a negative pressure "less" or "smaller" than X mmHg corresponds to a pressure closer to atmospheric pressure (e.g., -40 mmHg is smaller than -60 mmHg). A negative pressure "more" or "larger" than -X mmHg corresponds to a pressure further away from atmospheric pressure (e.g., -80 mmHg is larger than -60 mmHg). In some embodiments, the local ambient atmospheric pressure is used as a reference point, and this local atmospheric pressure need not be, for example, 760 mmHg.

[0059] The embodiments of this disclosure are generally applicable to local negative pressure (TNP) or decompression therapy systems. In short, negative pressure wound therapy helps close and heal many forms of "difficult-to-heal" wounds by reducing tissue edema, promoting blood flow and granulation tissue formation, or removing excess exudate, and can reduce bacterial load (and thus reduce the risk of infection). Additionally, this treatment allows for less disturbance to the wound, resulting in faster healing. TNP therapy systems can also assist in the healing of surgically closed wounds by removing fluid. In some embodiments, TNP therapy helps stabilize tissue at adjacent closure sites. Another beneficial use of TNP therapy can be found in grafts and flaps, where removing excess fluid is important and close proximity of the graft to the tissue is necessary to ensure tissue viability.

[0060] negative pressure system

[0061] Figure 1 An embodiment of a negative pressure or decompression wound treatment (or TNP) system 100 is shown, comprising a wound packing 130 disposed within a wound cavity 110, the wound cavity being sealed by a wound covering 120. The wound packing 130, combined with the wound covering 120, may be referred to as a wound dressing. A flow path 140 of a tube or conduit, such as a single-lumen or multi-lumen tube, is connected to the wound covering 120 having a negative pressure wound treatment device configured to provide decompression, for example, a pump assembly 150. The wound covering 120 may be in fluid communication with the wound cavity 110. In any system embodiment disclosed herein, such as Figure 1In the embodiments shown, the pump assembly may be a tankless pump assembly (meaning exudate is collected in the wound dressing or delivered via tube 140 for collection at another location). However, any pump assembly embodiment disclosed herein may be configured to include or support a tank. Additionally, in any system embodiment disclosed herein, any pump assembly embodiment may be mounted to or supported by the dressing, or adjacent to the dressing. The wound packing 130 may be of any suitable type, such as hydrophilic or hydrophobic foam, gauze, an inflatable bag, etc. The wound packing 130 may conform to the wound cavity 110 such that it substantially fills the cavity. The wound covering 120 may provide a substantially fluid-impermeable seal over the wound cavity 110. The wound covering 120 may have a top side and a bottom side, and the bottom side may adhesively (or in any other suitable manner) seal the wound cavity 110. The conduit 140 or lumen disclosed herein, or any other conduit or lumen, may be formed of polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.

[0062] Some embodiments of the wound dressing 120 may have a port (not shown) configured to receive the end of a conduit 140. In other embodiments, the conduit 140 may otherwise pass through or be beneath the wound dressing 120 to supply depressurization to the wound cavity 110 in order to maintain a desired level of depressurization in the wound cavity. The conduit 140 may be any suitable article configured to provide at least substantially sealed fluid flow path between the pump assembly 150 and the wound dressing 120 to supply depressurization provided by the pump assembly 150 to the wound cavity 110. The wound dressing 120 and the wound packing 130 may be provided as a single article or as an integral single unit. In some embodiments, the wound packing is not provided, and the wound dressing itself may be considered as a wound dressing. The wound dressing may then be connected via the conduit 140 to a negative pressure source, such as the pump assembly 150. The pump assembly 150 may be miniaturized or portable, but larger conventional pumps may also be used.

[0063] Wound covering 120 may be positioned over the wound site to be treated. Wound covering 120 may form a substantially sealed cavity or enclosure over the wound site. In some embodiments, wound covering 120 may be configured to have a membrane with high water vapor permeability to allow excess fluid to evaporate, and may have a superabsorbent material contained therein to safely absorb wound exudate. It should be understood that the term wound is used throughout this specification. In this sense, the term wound should be understood to be interpreted broadly and to encompass both open and closed wounds where the skin is torn, cut, or punctured, or where trauma has caused contusion, or any other surface or other condition or defect on the patient's skin, or those wounds that have otherwise benefited from decompression treatment. Thus, a wound is broadly defined as any area of ​​damaged tissue where fluid may or may not be produced. Examples of such wounds include, but are not limited to, acute wounds, chronic wounds, surgical and other incisions, subacute and dehiscence wounds, lacerations, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, open wounds, and venous ulcers. The components of the TNP system described herein are particularly suitable for incisions that discharge small amounts of wound exudate.

[0064] Some embodiments of the system are designed to operate without the use of an exudate tank. Some embodiments may be configured to support an exudate tank. In some embodiments, configuring the pump assembly 150 and tubing 140 such that tubing 140 can be quickly and easily removed from the pump assembly 150 facilitates or improves the dressing or pump change process, if necessary. Any pump embodiment disclosed herein may be configured to have any suitable connection between the tubing and the pump.

[0065] In some embodiments, the pump assembly 150 may be configured to deliver a negative pressure of about -80 mmHg, or between about -20 mmHg and -200 mmHg. It should be noted that these pressures are relative to normal ambient atmospheric pressure; therefore, -200 mmHg would actually be approximately 560 mmHg. The pressure range may be between about -40 mmHg and -150 mmHg. Alternatively, pressure ranges up to -75 mmHg, up to -80 mmHg, or exceeding -80 mmHg may be used. Additionally, pressure ranges below -75 mmHg may be suitable. Alternatively, the pump assembly 150 may supply a pressure range exceeding about -100 mmHg or even 150 mmHg. In some embodiments, the pump assembly 150 is configured to provide continuous or intermittent negative pressure therapy. Continuous treatment can be administered at pressures above -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, and -200 mmHg, or below -200 mmHg. Intermittent treatment can be administered between low and high negative pressure setpoints. The low setpoint can be set to above 0 mmHg, 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, or below -180 mmHg. The high setpoint can be set to above -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -200 mmHg. During intermittent treatment, negative pressure at a low setpoint may be delivered for a first duration, and after the first duration expires, negative pressure at a high setpoint may be delivered for a second duration. After the second duration expires, negative pressure at a low setpoint may be delivered. The first and second durations may be the same or different values. The first and second durations may be selected from the following ranges: less than 2 minutes, 2 minutes, 3 minutes, 4 minutes, 6 minutes, 8 minutes, 10 minutes, or greater than 10 minutes. In some embodiments, switching between low and high setpoints and switching between high and low setpoints may be performed according to a stepped waveform, a square waveform, a sine waveform, etc.

[0066] In some embodiments, the TNP system 100 may include multiple wound dressings connected to the pump assembly 150. The performance and wound healing capabilities (such as fluid management) of a TNP system with multiple wound dressings having the pump assembly 150 may be equal to or greater than the performance and wound healing capabilities of a standard single wound dressing with a single pump setup.

[0067] In operation, a wound packing 130 is inserted into the wound cavity 110, and a wound covering 120 is placed to seal the wound cavity 110. A pump assembly 150 provides a negative pressure source to the wound covering 120, which is transmitted to the wound cavity 110 via the wound packing 130. Fluid (e.g., wound exudate) is drawn through a conduit 140 and can be stored in a container. In some embodiments, the fluid is absorbed by the wound packing 130 or one or more absorbent layers (not shown).

[0068] Wound dressings that can be used with the pump assembly of this application and other embodiments include those available from Smith & Nephew, such as Renasy-F, Renasy-G, Renasy AB, and Pico Dressings. Any dressing described herein can be used with Smith & Nephew's Renasy soft-port connector or as an interface between the dressing and the pump assembly. For example, a Renasy soft-port connector can be positioned in flow path 140 and used as a port for the wound dressing. In other embodiments, other suitable wound dressings may be used.

[0069] Pump assembly and tank

[0070] Figure 2A front view 200 of a pump assembly 230 and a tank 220 according to some embodiments is shown. As shown, the pump assembly 230 and the tank are connected, thereby forming a TNP device or system. The pump assembly 230 includes one or more indicators, such as a visual indicator 202 configured to indicate an alarm, and a visual indicator 204 configured to indicate the status of the TNP system. Indicators 202 and 204 may be configured to alert a user (such as a patient or healthcare provider) to various operational or fault states of the system, including indicating a normal or correct operating state, pump malfunction, power supply to the pump or power failure, detection of leakage in wound coverings or flow paths, suction blockage, no flow state, tank full state, or any other similar or suitable state or combinations thereof. The pump assembly 230 may include additional indicators. The pump assembly may use a single indicator or multiple indicators. Any suitable indicator may be used, such as visual, audio, tactile indicators, etc. Indicator 202 can be configured to emit alarm status signals, such as full tank, low power, disconnected tubing 140, or broken seal in wound seal 120. Indicator 202 can be configured to display a flashing red light to attract the user's attention. Indicator 204 can be configured to emit status signals for the TNP system, such as normal treatment delivery or leak detected. Indicator 204 can be configured to display one or more different colored lights, such as green or yellow. For example, a green light can be emitted when the TNP system is operating correctly, and a yellow light can be emitted to indicate a warning.

[0071] Pump assembly 230 includes a display or screen 206 mounted in a recess 208 formed in the housing of the pump assembly. Display 206 may be a touchscreen display. Display 206 may support playback of audiovisual (AV) content, such as instructional videos. As explained herein, display 206 may be configured to present multiple screens or a graphical user interface (GUI) for configuring, controlling, and monitoring the operation of the TNP system. Pump assembly 230 includes a gripping portion 210 formed in the housing of the pump assembly. Gripping portion 210 may be configured to assist a user in holding pump assembly 230, such as during the removal of tank 220. Tank 220 may be replaced by another tank, such as when tank 220 is filled with fluid.

[0072] Pump assembly 230 includes one or more keys or buttons 212 configured to allow a user to operate and monitor the operation of the TNP system. As shown, three buttons 212a, 212b, and 212c are included. Button 212a may be configured as a power button to turn pump assembly 230 on / off. Button 212b may be configured as a play / pause button for delivering negative pressure therapy. For example, pressing button 212b starts the treatment, and pressing button 212b subsequently pauses or ends the treatment. Button 212c may be configured to lock display 206 or button 212. For example, button 212c may be pressed so that the user does not inadvertently change the delivery of the treatment. Button 212c may be pressed to unlock the controls. In other embodiments, additional buttons may be suitable, or one or more of the shown buttons 212a, 212b, or 212c may be omitted. Multiple button presses or a sequence of button presses can be used to operate pump assembly 230.

[0073] Pump assembly 230 includes one or more latch recesses 222 formed in the cap. In the illustrated embodiment, two latch recesses 222 may be formed on the side of pump assembly 230. The latch recesses 222 may be configured to allow canister 220 to be attached and detached using one or more canister latches 221. Pump assembly 230 includes an air outlet 224 for allowing air removed from wound cavity 110 to escape. Air entering the pump assembly may pass through one or more suitable filters, such as antimicrobial filters. This maintains the reusability of the pump assembly. Pump assembly 230 includes one or more strap mounts 226 for attaching a carrying strap to pump assembly 230 or for attaching a support. In the illustrated embodiment, two strap mounts 226 may be formed on the side of pump assembly 230. In some embodiments, various features are omitted, or various additional features are added to pump assembly 230.

[0074] Canister 220 is configured to retain fluid (e.g., exudate) removed from wound cavity 110. Canister 220 includes one or more latches 221 for attaching the canister to pump assembly 230. In the illustrated embodiment, canister 220 includes two latches 221 on the side of the canister. The exterior of canister 220 may be formed of frosted plastic so that the canister is substantially opaque and the contents of the canister are substantially hidden from view in plan view. Canister 220 includes a gripping portion 214 formed in the canister shell. The gripping portion 214 may be configured to allow a user to hold pump assembly 220, such as during removal of the canister from device 230. Canister 220 includes a substantially transparent window 216, which may also include volume scales. For example, the illustrated 300 mL canister 220 includes scales of 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, and 300 mL. Other embodiments of the canister may retain different volumes of fluid and may include different scales. For example, the canister may be an 800 mL canister. Can 220 includes a conduit channel 218 for connection to conduit 140. In some embodiments, one or more of these features, such as gripping portion 214, or various additional features added to can 220, are omitted. Any disclosed can may include or omit a curing agent.

[0075] Electronic devices and software

[0076] Figure 3 A schematic diagram 300 of the electrical components of a pump assembly (such as pump assembly 230) according to some embodiments is shown. The electrical components are operable to accept user input, provide output to the user, operate the pump system and TNP system, provide network connectivity, etc. The electrical components may be mounted on one or more printed circuit boards (PCBs). As shown, the pump assembly may include multiple processors. Utilizing multiple processors to allocate or assign various tasks to different processors may be advantageous. A first processor may be responsible for user activities, and a second processor may be responsible for controlling the pump. In this way, pump activities that may require a higher level of response (corresponding to a higher level of risk) can be offloaded to a dedicated processor and thus not interrupted by user interface tasks, which may take longer to complete user interaction.

[0077] The pump assembly may include a user interface processor or controller 310 configured to operate one or more components to accept user input and provide output to the user, such as a display 206, buttons 212, etc. Input to and output from the pump assembly may be controlled by an input / output (I / O) module 320. For example, the I / O module may receive data from one or more ports, such as serial, parallel, or mixed ports. The processor 310 also receives data from one or more expansion modules 360, such as one or more USB ports, SD ports, optical disc (CD) drives, DVD drives, FireWire ports, Thunderbolt ports, PCI Express ports, etc. The processor 310, along with other controllers or processors, stores data in one or more memory modules 350, which may be internal and / or external to the processor 310. Any suitable type of memory may be used, including volatile or non-volatile memory, such as RAM, ROM, magnetic storage, solid-state memory, magnetoresistive random access memory (MRAM), etc.

[0078] In some embodiments, processor 310 may be a general-purpose processor, such as a low-power processor. In other embodiments, processor 310 may be a dedicated processor. Processor 310 may be configured as a “central” processor in the electronic architecture of the pump assembly, and processor 310 may coordinate the activities of other processors, such as pump control processor 370, communication processor 330, and one or more additional processors 380 (e.g., a processor for controlling display 206, a processor for controlling button 212, etc.). Processor 310 may run a suitable operating system, such as Linux, Windows CE, VxWorks, etc.

[0079] Pump control processor 370 can be configured to control the operation of a negative pressure source or pump 390. Pump 390 may be a suitable pump, such as a diaphragm pump, peristaltic pump, rotary pump, rotary vane pump, vortex pump, screw pump, liquid ring pump, pump operated by a piezoelectric transducer (e.g., diaphragm pump), voice coil pump, etc. Pump control processor 370 can use data received from one or more pressure sensors to measure the pressure in the fluid flow path, calculate the fluid flow rate, and control the pump. Pump control processor 370 can control actuators such as pump motors to achieve a desired negative pressure level in the wound cavity 110. The desired negative pressure level may be a pressure set or selected by the user. In various embodiments, pump control processor 370 uses pulse width modulation (PWM) to control the pump actuator (e.g., pump motor). The control signal used to drive the pump actuator may be a PWM signal with a duty cycle of 0-100%. Pump control processor 370 can perform flow rate calculations and detect various conditions in the flow path. Pump control processor 370 can transmit information to processor 310. The pump control processor 370 may include internal memory or available memory 350. The pump control processor 370 may be a low-power processor.

[0080] The communication processor 330 can be configured to provide wired or wireless connectivity. The communication processor 330 can utilize one or more antennas 340 to send and receive data. The communication processor 330 can provide one or more of the following types of connectivity: Global Positioning System (GPS) technology, cellular connectivity (e.g., 2G, 3G, LTE, 4G), WiFi connectivity, Internet connectivity, etc. The connectivity can be used for various activities such as pump component location tracking, asset tracking, compliance monitoring, remote selection, log uploading, alarms and other operational data, as well as adjustments to treatment settings, software or firmware upgrades, etc. The communication processor 330 can provide dual GPS / cellular functionality. The cellular functionality can be, for example, 3G functionality. In this case, if the GPS module cannot establish a satellite connection due to various factors including atmospheric conditions, building or terrain interference, satellite geometry, etc., a 3G network connection can be used to determine the device location, such as through unit identification, triangulation, forward link timing, etc. The pump component may include a SIM card and can obtain SIM-based location information.

[0081] The communication processor 330 can transmit information to the processor 310. The communication processor 330 may include internal memory or available memory 350. The communication processor 330 may be a low-power processor.

[0082] In some embodiments, the pump assembly may track and store one or more of various data, such as positioning data, treatment parameters, logs, device data, etc. The pump assembly may track and record treatment and other operational data. The data may, for example, be stored in memory 350.

[0083] In some embodiments, using the connection provided by the communication processor 330, the device can upload any data stored, maintained, and / or tracked by the pump assembly. For example, the following information can be uploaded to a remote computer or server: activity logs, including treatment delivery information such as treatment time; alarm logs, including alarm type and occurrence time; error logs, including internal error messages, transmission errors, etc.; treatment duration information, which can be calculated hourly, daily, etc.; total treatment time, including the treatment duration from the first application of a specific treatment procedure or multiple procedures; lifetime treatment information; device information, such as serial number, software version, battery level, etc.; device location information; patient information; etc. The device can also download various operational data, such as treatment selections and parameters, firmware and software patches and upgrades, etc. The pump assembly can provide internet browsing functionality using one or more browser programs, email programs, application software (e.g., applications), etc.

[0084] In some embodiments, the communication processor 330 may use the antenna 340 to transmit the location of the pump assembly, such as the location of the pump assembly housing, to other devices in the vicinity of the pump assembly (e.g., within 10, 20, or 50 meters). The communication processor 330 may perform one-way or two-way communication with other devices, depending on the implementation. Communication transmitted by the communication processor 330 may include identification information to uniquely identify the pump assembly relative to one or more other pump assemblies also nearby. For example, the identification information may include a serial number or a value derived from a serial number. The signal strength of communication transmitted via the communication processor 330 may be controlled (e.g., maintained at a constant or substantially constant level) to enable another device to determine the distance to the pump assembly, such as the distance between the device and the pump assembly.

[0085] In some embodiments, the communication processor 330 may communicate with other devices near the pump assembly, enabling the communication processor 330 itself to determine the distance from the pump assembly to the other devices. In such embodiments, the communication processor 330 may track and store indications of the distance from the pump assembly to the other devices, or of distance changes over time, and may later provide this information to the other devices. For example, the communication processor 330 may determine the duration for which the pump assembly has been removed from the coverage area of ​​the device, and subsequently report that time to the device upon its return to the coverage area.

[0086] Flexible suction adapter

[0087] Figure 4A-6 It shows something similar to Figure 1An embodiment of the negative pressure wound therapy system 5501 shown is described. Here, system 5501 may include a flexible suction adapter 5500 (sometimes referred to as a fluid connector) having a bridging portion 5502 with a proximal end 5503 and a distal end 5505, and an applicator 5520 at the distal end 5505 forming the bridging portion 5502 of the flexible suction adapter 5500. Figure 4B As shown, connector 5504 is preferably located at the proximal end 5503 of bridging portion 5502 for connection to at least one of channels 5512 and / or 5516. Cap 5536 may be provided with system 5501 (and in some cases may be attached to connection 5504 as shown). Cap 5536 serves to prevent fluid leakage from proximal end 5503. System 5501 may include a negative pressure source, such as a pump or negative pressure unit 5534 capable of supplying negative pressure. The pump also preferably includes a canister or other container for storing wound exudate and other fluids that can be removed from the wound. In some embodiments, the pump 5534 may be a reference... Figure 2 The pump 200 is described above. In some embodiments, this pump 5534 may be a RENASYS GO pump, such as that sold by Smith & Nephew. The pump 5534 may be connected to the connector 5504 via a tube 5540. In use, the applicator 5520 is placed over an opening 5535 formed in a cover 5531, which is placed over a properly prepared wound 5530, in some cases, the wound may be filled with wound-filling material such as foam or gauze. Subsequently, with the pump 5534 connected to the connector 5504 via the tube 5540, the pump is activated, thereby supplying negative pressure to the wound. Negative pressure may be applied until the desired level of healing of the wound 5530 is achieved.

[0088] In some embodiments, the bridging portion 5502 may include an upper channel material or layer 5512 positioned between the upper layer 5510 and the intermediate layer 5514, wherein a lower channel material or layer 5516 is positioned between the intermediate layer 5514 and the bottom layer 5518. Preferably, layers 5510, 5514, and 5518 have elongated portions extending between proximal and distal ends and may be made of a fluid-impermeable material, such as a polymer, like polyurethane. It should be appreciated that layers 5510, 5514, and 5518 may each freely comprise different material compositions including a semi-permeable material. In some embodiments, one or more of layers 5510, 5514, and 5518 may be at least partially transparent. Figure 5BAs shown, the upper layer 5510 and the lower layer 5518 may be bent, rounded, or convex outwards over most of their length. During assembly, for example, layers 5510, 5514, and 5518 may be clamped together to weld or adhere the layers together. In doing so, the proximal ends of channels 5512 and 5516 may be sandwiched between these layers, thus partially compressing the proximal ends of channels 5512 and 5516 and stretching layers 5510, 5514, and 5518 over these aforementioned proximal ends. Of course, the proximal ends of the material used in the bridging portion 5502 may not necessarily be rounded or bent; as... Figure 6 As shown, they can remain essentially square and straight.

[0089] The upper channel layer 5512 and the lower channel layer 5516 are preferably elongated layers extending from the proximal end 5503 to the distal end 5505, and may each preferably comprise a porous material, including, for example, open-cell foam, such as polyethylene or polyurethane. In some embodiments, one or more of the upper channel layer 5512 and the lower channel layer 5516 may be composed of fabric (e.g., knitted or woven spacer fabrics such as knitted polyester 3D fabric, Baltex 7970.RTM, or Gehring 879.RTM)) or nonwoven materials. Suitable materials may also include terry-knitted or terry-woven materials. The fibers may not necessarily be woven and may include felted and flocked (including materials such as Flotex.RTM) fiber materials. The selected materials are preferably adapted to guide wound exudate away from the wound through the channels and to deliver negative pressure and / or exhaust air to the wound site, and may also impart a degree of resistance to kinking or occlusion to the channel layers 5512 and 5516, as described below. In one embodiment, the upper channel layer 5512 may include an open-cell foam, such as polyurethane, and the lower channel layer may include a fabric as described herein. In another embodiment, the upper channel layer is optional, and the system may be modified to have an open upper channel. Figure 5B In the embodiments shown, the upper channel layer 5512 may have a curved, circular, or upwardly convex upper surface and a substantially flat lower surface, and the lower channel layer 5516 may have a curved, circular, or downwardly convex lower surface and a substantially flat upper surface.

[0090] In some embodiments, the fabric may have a three-dimensional (3D) structure, wherein one or more types of fibers form a structure in which the fibers extend in all three dimensions. In some cases, such a fabric may aid in wicking, fluid transport, and / or negative pressure transport. To prevent channels 5512 and / or 5516 from shifting or twisting while encapsulated in system 5501 (which could impair the performance of the respective channels under negative pressure), in some embodiments it may be preferable to adhere or otherwise secure channels 5512 and / or 5516 to one or more layers 5510, 5514, and 5518. In some embodiments, these materials remain open and are capable of delivering negative pressure to the wound area at typical pressures used in negative pressure therapy (e.g., between 40 and 150 mmHg, but higher and lower values ​​are also possible). In some embodiments, the fabric may comprise several layers of material stacked or laminated on top of each other, which may be used in some cases to prevent channels 5516 from collapsing under the application of negative pressure. In other embodiments, the fabric used in channel 5516 may be between 1.5 mm and 6 mm thick; more preferably, the fabric may be between 3 mm and 6 mm thick and may comprise one or more separate layers of fabric. In other embodiments, channel 5512 may be 1.2-3 mm thick, and preferably thicker than 1.5 mm. Furthermore, and as mentioned above, the material used in system 5501 is preferably conformal and soft, which helps to avoid pressure sores and other complications that may arise from the wound care system pressing on the patient's skin. Other examples of 3D fabrics are... Figure 7A -C will be described below.

[0091] Preferably, the distal ends of layers 5510, 5514, and 5518, as well as channel layers 5512 and 5516, are enlarged at their distal ends (to be positioned above the wound site) and may be formed into a "teardrop" or other enlarged shape. At least the distal ends of layers 5512, 5514, 5516, and 5518 may also be provided with at least one through-hole. This hole can be used not only to drain wound exudate and apply negative pressure to the wound, but also during the manufacture of the device, as these holes can be used to properly align these respective layers.

[0092] For further reference Figure 5B -C and 6, Channel connector 5506 is located at the proximal end 5503 of bridging portion 5502. Channel connector 5506 is preferably configured to embed in the lower channel layer 5516 to create a robust fluid connection. In some embodiments, channel connector 5506 may be inserted into a pre-formed cavity formed in channel 5516; such as Figure 6 As shown, this cavity can be cut or may be in the form of a tongue-and-groove connector. In some embodiments, the channel connector 5506 may be as follows: Figure 8AOne of the connectors described in -B. With one end of the channel connector 5506 embedded in the lower channel layer 5516, the other end of the channel connector 5506 can be connected to or communicate with the connector tube 5507; however, in some embodiments, the channel connector 5506 can be directly connected to the connector 5504, or additionally directly connected to the tube 5540 connected to the negative pressure source. When using the connector tube 5507, the resulting assembly allows the connector 5504 to be attached to the connector tube. A cap 5536, which can be secured to the suction adapter, for example via a cap cord 5527, secured by a loop provided on the outer surface of the connector tube 5507. The cap 5536 can be used to cover the end of the suction adapter, for example at the connector 5504, to prevent leakage of exudate and other wound fluids. The connector 5504 is preferably configured to connect to the tube 5540 connected to the negative pressure source. Connector 5504 may include, for example, a lip or other such structure to help secure connector 5504 to tube 5540 and / or cap 5536, but it should be understood that other connector types are possible, including quick-disconnect connectors, Luer locks, Christmas trees and other such connectors.

[0093] The upper layer 5510 may include additional material extending downward, preferably at least the thickness of the bridging portion 5502; this material can then be used to bond or weld other layers to form a fluid-impermeable seal. More specifically, during assembly, the upper layer 5510 may be attached to the lower layer 5518, for example, by melting, welding, or adhesive, to form a fluid-impermeable seal (except for orifices at the distal and proximal ends). Preferably, an intermediate layer 5514 is attached to the top layer 5510 and the bottom layer 5518. In some embodiments, it may be preferred to attach or bond connectors 5504 and / or 5506 and tube 5507 to at least one of layers 5510, 5514, and 5518 to create a fluid-impermeable connection. To provide a more robust connection, some embodiments may also include a weld 5532 formed on the lower layer 5518. The lower channel 5516 may have a hole or orifice formed therethrough, which can be used to weld it to the lower layer 5518 via the weld 5532. The lower channel 5516 is welded to the lower layer 5518 via a weld 5532 created through the through hole 5533, which helps to prevent displacement or shifting of the various layers and channels. Obviously, it should be understood that other fixing devices, such as adhesives, can be used, and such arrangements can also be used in the upper channel 5512.

[0094] In some embodiments, such as Figure 5A-6As shown, a controlled gas leak 5524 (sometimes referred to as a gas leak, air leak, or controlled air leak) may be provided on the bridging portion 5502, for example, at its proximal end. This air leak 5524 may include an opening or channel extending through the upper layer 5510, such that the air leak 5524 is in fluid communication with the upper channel 5512. When suction is applied to the suction adapter 5500, gas (such as air) can enter through the gas leak 5524 and move along the upper channel 5512 from the proximal end 5503 to the distal end 5505. The gas is then drawn into the lower channel 5516 through an orifice passing through the distal ends of the penetrating layers 5512, 5514, 5516, and 5518. The air leak 5524 preferably includes a filter 5525. Preferably, the air vent 5524 is located near the bridging portion 5502 to minimize the possibility of wound exudate or other fluids coming into contact with and potentially clogging or interfering with the air vent 5524 or its filter 5525. In some embodiments, the filter 5525 is a microporous membrane capable of excluding microorganisms and bacteria, and may be capable of filtering out particles larger than 45 micrometers. Preferably, the filter 5525 can exclude particles larger than 1.0 micrometer, and more preferably, particles larger than 0.2 micrometers. Advantageously, some embodiments provide a filter 5525 that is at least partially chemically resistant to, for example, water, common household liquids such as shampoo, and other surfactants. In some embodiments, reapplying a vacuum to the suction adapter 5500 and / or wiping the exposed external portions of the filter 5525 may be sufficient to remove any foreign matter clogging the filter 5525. The filter 5525 may be made of a suitably resistant polymer such as acrylic, polyethersulfone, or polytetrafluoroethylene, and may be oleophobic and / or hydrophobic. In some embodiments, filter 5525 may further include a support backing layer, such as a nonwoven polyester support. Preferably, gas vent 5524 supplies a relatively constant airflow that does not increase significantly with the application of additional negative pressure to system 5501. In embodiments of suction adapter 5500, as additional negative pressure is applied, the airflow through gas vent 5524 increases; preferably, this increase in airflow is minimized and does not increase proportionally to the negative pressure applied thereto.

[0095] In some embodiments, a filter 5525 disposed in a controlled air leak 5524 may be used in system 5501 for use with more dynamic and active patients. For example, a chemically resistant filter may allow the patient to shower or bathe without impairing the filter's function when reconnected to a negative pressure source. Any blockages or fluid obstructing the air leak 5524 can then be cleared, for example, by wiping the filter 5525 or by reapplying negative pressure to the suction adapter 5500. This system will also have the advantage that if the patient needs to be disconnected from the negative pressure source (e.g., with showering), system 5501 and any combined wound dressing material (if present) do not need to be removed and then reapplied. This will provide significant advantages in terms of improving the cost-effectiveness and ease of use of this treatment system.

[0096] The suction adapter 5500 is preferably configured to provide a consistent fluid flow even when the suction adapter 5500 is kinked or compressed. For example, when used on a patient, the bridging portion 5502 may become folded over itself, or the patient may be flipped over, thus placing his or her weight over at least a portion of the suction adapter 5500. Typically, prior art dressings and fluid connectors become obstructed or inefficient in such situations, and in some cases may lead to complications such as pressure sores. However, here, certain embodiments provide improved anti-obstruction properties when kinked or compressed. Preferably, by employing channel layers 5512 and 5516 as described above, and more preferably by employing foam channel layer 5512 and fabric channel layer 5516, the suction adapter 5500 is able to maintain a flow rate of at least 0.08 L / min, and preferably 0.12 L / min, through the air leak 5524 when negative pressure is applied by a negative pressure source. Other embodiments also provide a suction adapter 5500 capable of handling at least 10 L / day or 6.9 ml / min of fluid exudate flowing from the wound site through the lower channel 5516. Some embodiments provide a suction adapter 5500 to maintain these flow rates by a weight, such as 12 kg, applied downwards to the bridging portion by a rod of 1 inch diameter. In some embodiments, these flow rates are also maintained when the bridging portion 5502 is kinked to itself with the same weight or, for example, 4.75 kg, placed directly on the folded area. Preferably, the suction adapter 5500 is capable of withstanding folding or kinking over extended periods (e.g., more than 40 hours) without exhibiting any degradation in performance (e.g., flow rate) compared to its performance before folding or kinking. Preferably, embodiments of the suction adapter 5500 are also capable of delivering and maintaining negative pressure at the wound site at levels close to those of a negative pressure source. For example, an acceptable pressure level maintained at the wound site can be within ±0.25 mmHg of the negative pressure set at the negative pressure source, wherein this pressure is preferably maintained at this level for 95% of the time the suction adapter 5500 applies negative pressure thereto. Acceptable pressure levels may include a pressure range between 40 and 120 mmHg, but a level of 200 mmHg has been successfully used.

[0097] For further reference Figure 4A-5BIn addition to the above, the suction adapter 5500 also includes an applicator 5520 designed for placement over a wound site. Preferably, the applicator 5520 includes a flexible layer 5550, such as polyethylene or polyurethane, having an adhesive layer on its underside (wound-facing) side. Optionally, a protective release layer 5529 may be placed on the adhesive layer, which is removable prior to use. In some embodiments, due to the flexibility of layer 5550, a more rigid removable backing layer 5552 may be provided on the upper side of the applicator 5520 to facilitate handling of the applicator 5520. The applicator 5520 preferably includes an attachment point for a bridging element 5502 at its distal end 5505, for example, using a section of double-sided adhesive tape 5528. The double-sided adhesive tape 5528 may be protected by an additional protective release layer that is removed before the bridging element 5502 is adhered to the applicator 5520. It should be understood that different attachment methods, such as heat sealing, welding, or suitable adhesives, are also contemplated. Some embodiments may also allow the bridging element 5502 and the applicator 5520 to be manufactured as a single unit that does not require a separate attachment device. The applicator 5520 preferably includes at least one orifice 5526 that passes through itself and is designed to be positioned above the wound site, and it can be used to connect the wound site fluid to a negative pressure source and an air leak, while also serving as a conduit for extracting wound exudate from the wound site.

[0098] In use and reference Figure 4A -B, System 5501 can be used in a similar manner to other embodiments previously disclosed herein, as referenced Figure 1 The system 100 is described above. The wound site 5530 is preferably cleaned and prepared in a suitable manner, and wound filling material (if desired) is placed in the wound site, followed by a cover 5531. An orifice 5535 is then created through the cover 5531 to the wound site, although some embodiments may have a pre-formed orifice 5535. The operator can then position an applicator portion 5520 over the orifice 5535. After removing the backing layer 5529 (if present) from the adhesive layer on the underside of the applicator portion 5520, the applicator is sealed to the cover 5531, and the backing layer 5552 (if present) is also removed from the applicator portion 5520. A fluid conduit, such as a tube 5540, can then be connected to a connector 5504. The tube 5540 may also be connected to the connector 5504 before the applicator is applied to the wound site. The fluid conduit is connected to a negative pressure source 5534, preferably with a container for receiving wound exudate inserted between the fluid conduit and the negative pressure source. Then, negative pressure can be applied to the wound site 5530 until the wound site progresses to the desired healing level.

[0099] During use of system 5501, wound exudate from wound site 5530 is drawn in by negative pressure through lower channel layer 5516. Gas vent 5524 allows gas (such as air) to enter through upper channel layer 5512 into an orifice at the distal end of penetrating layers 5512, 5514, 5516, and 5518. Negative pressure draws the gas through the upper channel layer backward toward a negative pressure source or pump into lower channel layer 5516. In some embodiments, controlled gas vent 5524 provides a constant airflow through suction adapter 5500, which can then be used to determine if a blockage or leak is present. Causes of blockage may include, for example, a situation where lower channel 5516 becomes clogged with wound debris. Causes of leak may include, for example, an improper seal of a drape over the wound site, or physical damage to suction adapter 5500, resulting in excessive gas leakage into the system. In some embodiments, a blockage or leak can be determined by measuring the pump speed while the pump is operating to maintain a constant negative pressure. Pump speed can also be measured indirectly by measuring the amount of voltage or signal sent to the pump.

[0100] Figure 7A -C shows a view of the 3D fabric that can be used in the various embodiments described herein, for example Figure 4A-6 The bridging portion 5502 of the suction adapter shown herein. Although other porous materials (such as foam) may be used in the embodiments described herein, for example in... Figure 5B In the upper channel 5512 and / or lower channel 5516 shown in -C, however, the use of 3D fabrics may be advantageous in some cases. Certain 3D fabrics have been found to perform well, even when compressed, in delivering negative pressure to and from the fluid aspiration adapter (e.g., when the patient's weight is directly on the aspiration adapter, or when negative pressure is applied and / or when the fluid aspiration adapter is kinked or folded). Some 3D fabrics found to have acceptable properties include knitted polyester 3D fabrics, Baltex 7970.RTM., Gehring 879.RTM., or Coolmax.RTM. Of course, other fiber and fabric types can be used in part or in whole to manufacture 3D fabrics, and include, but are not limited to, polyamides such as nylon, viscose, cotton, and other synthetic microfibers. 3D fabrics may also be constructed at least in part from fibers such as Nomex.RTM. and Kevlar.RTM. Other types of fabrics and materials disclosed elsewhere herein may also be used.

[0101] In one embodiment, such as Figure 7A As shown in -C, the 3D fabric may include a bottom side 5603, a top side 5605, and an opening center region 5607. Figure 7AThe bottom (wound-facing) side 5603 of the 3D fabric is shown, which can be woven to create elongated or oval openings 5611 extending longitudinally on the fabric. In one embodiment, the elongated or oval openings 5611 represent or provide an opening area between 10% and 45% (or about 10% to about 45%) of the bottom surface area, more preferably 10% to 30% (or about 10% to about 30%). Here, the fibers are knitted (e.g., by warp knitting) to also include these larger openings or pores, which, in addition to wound fluid being transported along the fibers by capillary action, allow for a large-scale delivery of wound fluid. Pores (such as those formed at the distal end of the 3D fabric) may also be present. Figure 5B and 6 (As shown in the image) It can also help to expel large amounts of wound debris and fluid.

[0102] Figure 7B A top side 5605 of a 3D fabric that can be used as described herein is shown. In one embodiment, this top side 5605 does not have the large oval opening 5611 of the bottom side 5603, but may instead have openings 5613 defined by fibers that extend longitudinally and generally laterally or at an angle across the width of the fabric. As shown, these openings are generally rhomboid. In one embodiment, these openings 5613 may represent or provide an opening area larger than that of the bottom layer, for example, between 30% and 50% (or about 30% and about 50%). Of course, it should be understood that the fabric shown herein is a non-limiting example, and different fabric constructions and orientations are possible, for example, where the top side 5605 is positioned downwards to face the wound, and the bottom side 5603 faces upwards.

[0103] Figure 7C A cross-section of the 3D fabric is shown (the spherical protrusions on the vertical fibers in the fabric are artificial products of the cutting process). Vertically extending fibers 5609 are woven to extend through the intermediate opening region 5607, while also connecting to the bottom layer 5603 and the top layer 5605. Preferably, the fibers 5609 present in the intermediate layer 5607 of the opening will have sufficient stiffness to help prevent compression of the fabric. As shown in the figure, and not wanting to be bound by theory, it has been found that well-performing 3D fabrics typically include a larger opening region 5607 in the intermediate portion, which allows exudates and other fluids to be effectively transported away from the wound site when negative pressure is applied, while the denser outer layers 5603, 5605 help provide additional tensile strength and capillary wicking. For example, the intermediate layer may include more than 50% (or more than about 50%) of the opening volume. Obviously, the resulting fabric cannot be too thick or made of overly stiff fibers, as the resulting suction adapter and system must remain sufficiently flexible for comfortable use by the patient.

[0104] It is often advantageous to tailor the performance characteristics of 3D fabrics to account for the various requirements of suction adapters during use. Specifically, for example, the flow rate of exudate through the fabric under compression can be simplified by taking into account the fabric's porosity. In such cases, and again, without wanting to be bound by theory, the porosity of the fabric, and therefore the space available for fluid travel, can be determined in part by the knitting pattern of the fibers used to manufacture the 3D fabric, the thickness of the fibers used, and their respective stiffness and hardness (especially under compression). The fibers can also be modified by surface properties (the fibers may be flat or textured) and the number of fibers or filaments used in the resulting fabric. Compression resistance can be influenced by the choice of fibers or monofilaments used along the vertical axis of the fabric, and generally stiffer materials will improve compression resistance along that axis. Other material properties such as hydrophobicity can also play a role. In some cases, it may be beneficial to treat the fabric to be hydrophilic, for example, with a hydrophilic polymer to improve fluid wicking. Preferred embodiments of 3D fabrics used with certain suction adapters have been found to work well when Baltex.RTM. fabrics are treated in this manner. Other possible treatments may include lipophilic coatings to prevent proteins from adhering and accumulating during use, which could lead to blockage and pressure loss at the wound site.

[0105] The flow velocity through the 3D fabric under negative pressure can be estimated by treating each opening as a separate orifice plate constrained by Bernoulli's principle under laminar flow conditions. To simplify calculations, the opening area can be used for a given area of ​​the 3D fabric. Thus, the 3D fabric can be optimized to achieve a good balance between factors such as the desired compressive resistance and the resulting flow velocity under negative pressure. Further optimization will occur in cases where the stiffness and flow velocity of the 3D fabric are tailored for application according to the embodiments described herein. Optimization of the properties and dimensions of the 3D fabric will also preferably take into account the balance between the desired flow velocity and stiffness and the fabric's conformability, as an overly stiff fabric may not be able to bend properly and may also be uncomfortable for the patient. The 3D fabric should preferably be designed to flex against tissue compression, thereby preventing tissue compression (e.g., for bony prominences in a patient) and potential subsequent discomfort and injury, such as pressure sores. For example, the fabric dimensions can be tailored to the end use of a suction adapter, which is smaller in the case of distal limbs such as fingers and larger for the abdomen and burn wounds. Stiff fabrics can also cause pressure sores and other such complications, although they may be functionally acceptable in larger sizes.

[0106] In practice, and as previously described herein, embodiments of the suction adapter using 3D fabric exhibit a flow rate of at least 0.08 L / min, preferably up to 10 L / min, during the application of negative pressure, and should be able to handle at least 10 L / day of fluid exudate discharge. Some embodiments of the suction adapter can be configured to treat much larger wounds, including abdominal wounds, and in some cases, can exudate at least 0.5 L / h or 12 L / day. In more extreme cases, the pump used (e.g., RENASYS EZ) may be able to evacuate up to 16 L / min, thereby evacuating large wounds to a negative pressure level of 120 mmHg in less than a minute. The calculated pressure drop should be minimized due to the 3D fabric, and the negative pressure level measured at the wound site is preferably within 25 mmHg of the pressure level measured at the negative pressure source. Although the pressure drop increases with increasing applied negative pressure (thus making the 25 mmHg target more difficult to achieve), embodiments of the wound treatment system are preferably able to maintain this target pressure at a negative pressure of at least 200 mmHg. The suction adapter and system are preferably capable of operating within the pressure range required for negative pressure, estimated to be from about 40 mmHg to 200 mmHg. Pressure ranges greater than 200 mmHg are possible, but may cause patient discomfort in some cases. The device may also operate at lower pressure ranges (e.g., 20 mmHg), but at such low pressure levels, the therapeutic effect of the negative pressure may be reduced, with the device acting more as a drainage device. Preferably, embodiments of the negative pressure treatment system are capable of maintaining these target pressures at the wound site for 95% of the time negative pressure is applied to the wound. In some embodiments, the fabric may comprise several layers of material stacked or laminated on top of each other, which may be used in some cases to prevent the channel 5516 from collapsing under the application of negative pressure. In other embodiments, the fabric used in the channel 5516 may be between 1.5 mm and 6 mm thick; more preferably, the fabric may be between 3 mm and 6 mm thick and may comprise one or more separate layers of fabric. In other embodiments, the channel 5512 may be 1.2-3 mm thick, and preferably thicker than 1.5 mm. Preferably, the 3D fabric is capable of withstanding a load of at least 5.3 psi with compression not exceeding 10% of its original thickness. Furthermore, the 3D fabric is also capable of resisting compression to less than half its original thickness when subjected to a load of 15 psi.

[0107] In a preferred embodiment, the 3D fabric can be woven from 100% polyester using 150 and 225 denier yarns to produce a fabric weighing approximately 23 to 25 ounces per square yard. In these cases, the fabric may be approximately 5.8-6.8 mm thick. The bottom portion of the fabric may also have... Figure 7AThe similar openings or apertures 5611 shown may be elongated, rectangular, or oval, and oriented longitudinally along their long axis along the fabric. The openings 5611 may be arranged in multiple rows extending longitudinally across the fabric, for example, 2 to 5 rows, or more preferably 3 rows, as shown below. Figure 7A As shown in the diagram. Openings 5611 may be equidistant from each other in each row and may form an alternating pattern from one row to another. In one embodiment, each row may have approximately 6-10 openings per 2 inches (or approximately 50 mm), more preferably 8 openings. Along a given width or transverse dimension of the fabric, the transverse rows formed by the openings may have approximately 6-10 openings per 2 1 / 8 inches (or approximately 54 mm), more preferably 8 openings. In one embodiment, the opening may have a length between approximately 1 / 16'' and approximately 1'' in the longitudinal direction, and a width between approximately 1 / 32'' and 1 / 2'' in the width direction. In one example, the measured longitudinal length of the opening is approximately 1 / 8'' (or approximately 3.2 mm), and the transverse width is 1 / 32'' (or approximately 0.79 mm). In one embodiment, the 3D fabric may have a length between approximately 50 mm and 100 mm, more preferably approximately 60 mm, a width between approximately 5 mm and 15 mm, more preferably approximately 9 mm, and a thickness of approximately 6 mm.

[0108] Embodiments of the system described herein have been tested and found to perform satisfactorily. Such tests were performed by constructing a suction adapter from the embodiments described herein. The distal end of the suction adapter was then placed over an opening fabricated onto a cover, which was positioned over a simulated wound cavity equipped with a controllable and variable-rate wound fluid source. In some cases, the simulated wound cavity was also filled with foam or other wound-filling materials. In some tests, the simulated wound fluid was a 5:1 water-glycerol mixture, while in others, filtered horse serum (available from Oxoid in the UK) was used. The proximal end of the suction adapter was then connected to a negative pressure source, in this case, a pump. Flow rate tests and other measurements were then performed at various negative pressure ranges and at simulated exudate flow rates and air leakage rates.

[0109] Figure 8AAn embodiment of connector 5704 is shown, which is similar to the previously described connector 5506 and can be used to securely connect a negative pressure source to a channel 5716 of a suction adapter, as described herein. For example, the channel 5716 may be an upper channel 5512, or more preferably, a lower channel 5516 as shown in Figures 55-56. Generally, such connectors 5704 can be used to provide a more secure connection from a negative pressure source to a negative pressure treatment system. The use of these connectors 5704 is optional and may not be necessary in all embodiments described herein. In use, the tube 5740 connected to connector 5704 may be pulled out, or other external forces may somehow detach connector 5704 from its attached channel 5716. In such cases, negative pressure applied to the wound may be reduced or stopped. As described above, other means of securing connector 5704 to the rest of the system may include bonding or attaching other layers of the treatment system, if present, to connector 5704. Connector 5704 may be designed to form a robust connection with the fabric or material used in the channel; when using 3D fabric or 3D knitted material, some embodiments of connector 5704 are configured to engage or attach to a portion of the material or a material fiber to create a more robust connection. Preferably, embodiments of connector 5704 are capable of withstanding tensile forces up to 20 kg before connector disconnection and / or failure occur, preferably causing the connector to disengage from the channel to which it is connected. It should be understood that other embodiments may be configured to withstand lower tensile forces and may be tailored for release to prevent injury to the patient (e.g., contraction of the suction adapter and / or drainage tube around the limb).

[0110] Figure 8B An embodiment of connector 5704a is shown, comprising two or more protrusions 5752 extending longitudinally distally from a preferred cylindrical body of connector 5704a. The body also includes a central channel 5755 extending longitudinally through the body of connector 5704a. The protrusions 5752 may additionally include one or more barbs 5754 attached thereto. Preferably, these barbs 5754 are angled proximally to act as anchors when pushed or inserted into channel 5716. When channel 5716 is a 3D fabric or knitted material, the barbs 5754 are configured to engage fibers therein for a stronger connection. At the proximal end of connector 5704a, a lip 5756 may also be provided for connection to tube 5740; the lip may be provided in a truncated conical form. Tube 5740 may be connected to connector 5704a (and other connectors described herein) for example by press fit, but other connection methods are possible. Tube 5740 may be coupled with… Figure 6The tube 5507 is the same as, or may be, any other tube used to provide fluid communication with a negative pressure source. It will also be appreciated that features of these connectors, particularly at the distal end, can be incorporated into the ends of tubes used to deliver negative pressure, allowing these tubes to be directly connected to a suction adapter system. Examples of such applications in which additional disclosures relating to the foregoing description of connectors can be found include U.S. Patent No. 9,050,398, entitled “APPARATUSES ANDMETHODS FORNEGATIVE PRESSURE WOUND THERAPY,” published June 9, 2015, the entire contents of which are incorporated herein by reference.

[0111] Flexible suction adapter with individual air leak vent

[0112] Figure 9A -C illustrates an embodiment of a flexible suction adapter 900, which is similar to the reference adapter. Figure 4A-8B An embodiment of the flexible suction adapter 5500 shown and described. Figure 9A An exploded view of the suction adapter 900 is shown, and Figure 9B A top view of the suction adapter 900 is shown. Additionally, Figure 9C A cross-sectional view of a suction adapter 900 is shown. The suction adapter 900 may include a bridging portion 902 having a proximal end 903 and a distal end 905, and an applicator 920 at the distal end 905 of the bridging portion 902 to form a flexible suction adapter 900. Preferably, the flexible suction adapter is constructed in a manner similar to that of the flexible suction adapter 5500, and the bridging portion 902 may be constructed from a similar two-layer arrangement as previously described. For example, in some embodiments, the bridging portion 902 may include an upper channel layer 912 positioned between an upper layer 910 and an intermediate layer 914, wherein a lower channel layer 916 is positioned between the intermediate layer 914 and a bottom layer 918.

[0113] In some embodiments, such as Figure 9A As shown in -C, a controlled gas leak 924 (sometimes referred to as a gas leak, air leak, or controlled air leak) may be provided on the bridging portion 902, for example, adjacent to its proximal end. This air leak 924 may include an opening or channel extending through the upper layer 910, such that the air leak 924 is in fluid communication with the upper channel 912. The air leak 924 may include a filter 925.

[0114] The applicator 920 preferably includes an attachment point at the bridging portion 902 at the distal end 905, for example, using a section of double-sided adhesive tape 928. It should be understood that different attachment methods, such as heat sealing, welding, or suitable adhesives, are also conceivable.

[0115] Connector 904 may be located at the proximal end 903 of bridging portion 902 for connection to at least one of channels 912 and / or 916. Cap 936 may be provided with suction adapter 900 (and in some cases may be attached to connector 904 as shown). Figure 9A As shown, a channel connector 906 may be located at the proximal end 903 of the bridging portion 902. The channel connector 906 is preferably configured to embed in the lower channel layer 916 to create a robust fluid connection. With one end of the channel connector 906 embedded in the lower channel layer 916, the other end of the channel connector 906 may be connected to or communicate with the connector tube 907. However, in some embodiments, the channel connector 906 may be directly connected to the connector 904 or directly connected to a tube connected to a negative pressure source.

[0116] Each component of the suction adapter 900 may be similar to each corresponding component of the suction adapter 5500, and therefore, except as described below, the previous description of each corresponding component of the suction adapter 5500 also applies to each component of the suction adapter 900.

[0117] Similar to the suction adapter 5500, the upper fluid passage may be defined by an upper layer 910 and an intermediate layer 914, and lies between the upper and intermediate layers. In some embodiments, such as Figure 9C As shown, the upper layer 910 and the lower layer 918 extend further at the distal end 905 than the intermediate layer 914, such that the upper fluid passage can also be partially defined between the upper layer 910 and the lower layer 918. The upper fluid passage may include an upper channel spacer material or layer 912. The lower fluid passage may include a lower channel spacer material or layer 916. In some embodiments where the upper layer 910 extends further at the distal end 905 than the intermediate layer 914, the upper channel spacer layer 912 may also extend further at the distal end 912 than the intermediate layer 914 and the lower channel spacer layer 916 to support the upper layer 910. Figure 9A As shown in -C, in some embodiments, the distal ends of layers 910, 914, and 918, as well as channel layers 912 and 916, are enlarged at their distal ends (to be positioned above the wound site) and may form a "teardrop" or other enlarged shape. At least the distal ends of layers 912 and 916 may also have at least one through-hole. This orifice can be used not only to drain wound exudate and apply negative pressure to the wound, but also during device fabrication, as these orifices can be used to properly align these respective layers. In another embodiment, the upper fluid channel may further include an auxiliary spacer layer 970 positioned below the distal end of the upper channel spacer layer 912 and distal to the distal end of the lower channel spacer layer 916, such that the auxiliary spacer layer 970 supports the distal end of the upper channel spacer layer 912. Figure 9A and 9CAs shown, the auxiliary spacer layer 970 may include one or more orifices that can be aligned with one or more orifices at the distal end of the spacer layer 912.

[0118] In some embodiments, such as Figure 9A and 9C As shown, the suction adapter 900 includes two orifices at a lower layer 918: an air leak channel orifice 952 and a suction orifice 954, both formed at the lower layer 918, for example, at an enlarged distal end of the lower layer 918. In some embodiments, the air leak channel orifice 952 and / or the suction orifice 954 may be formed as a plurality of smaller orifices. As shown, orifices 952 and 954 may be spaced apart, with orifice 954 located proximal to orifice 952. These orifices may all be located on the central longitudinal axis of the lower layer 918, or one or both orifices may not be located on the central longitudinal axis. The applicator 920 may have two openings 962 and 926 configured to align with the air leak channel orifice 952 and the suction orifice 954.

[0119] like Figure 9C As shown, the air leakage channel orifice 952 is fluidly connected to an upper fluid channel having an upper channel spacer layer 912, thereby forming an air leakage flow extending distally from the air leakage port 924 to the air leakage channel orifice 952. Figure 9C As shown, this air leakage flow extends through the auxiliary spacer 970. Additionally, the suction port 954 is fluidly connected to a lower fluid channel having a lower channel spacer 916, thereby forming a suction flow extending distally from the connector 904 and / or the negative pressure source.

[0120] In some embodiments, the upper layer 910 may form a fluid tight seal with the intermediate layer 914 and / or the lower layer 918, and the intermediate layer 914 may form a fluid tight seal with the lower layer 918, such that the upper fluid passage extending distally from the air leak port 924 to the air leak channel orifice 952 can be fluidly separated from the lower fluid passage extending distally from the connector 904 to the suction orifice 954. Figure 9C As shown, in some embodiments, the distal end of the intermediate layer 914 may extend between the auxiliary spacer layer 970 and the lower channel spacer layer 916 and be sealed to the lower layer 918, thereby separating the upper fluid channel and the lower fluid channel. The upper layer 910, intermediate layer 914 and lower layer 918 may be attached to each other using any of the means previously described herein, such as by melting, welding or sealing with an adhesive.

[0121] The air leak orifice 952 and the suction orifice 954 may be sufficiently spaced apart from each other so that wound exudate drawn into the suction orifice 954 does not enter the air leak orifice 952. In some embodiments, the upper fluid channel may include a filter (not shown) near the air leak orifice 952 to prevent wound exudate from entering the upper fluid channel and clogging it. The filter may be permeable to gas (such as air) to allow gas from the gas leak orifice to be delivered to the wound dressing, but may be impermeable to liquids or bacteria. The filter located at the air leak orifice 952 may be similar to the filter 5525 previously described herein.

[0122] In some embodiments, the lower fluid passage may include a filter (not shown) near the suction orifice 954. The filter is configured to substantially prevent wound exudate from entering the lower fluid passage. Preferably, the filter is impermeable to liquids but permeable to gases and serves as a liquid barrier, ensuring that no liquid can escape from the wound dressing, thereby eliminating the need for a canister for collecting wound fluid between the suction adapter and the negative pressure source. The filter may be hydrophobic. The filter may be attached or sealed above the wound dressing to the suction adapter and / or the covering membrane. For example, the filter may be molded into the suction adapter 900, or may be adhered to the lower layer 918 of the suction adapter 900 using an adhesive (such as, but not limited to, UV-curable adhesives).

[0123] The auxiliary spacer 970 may be constructed of any flexible material suitable for conveying gas (such as air) from the controlled air leak. The auxiliary spacer 970 may be constructed of any material suitable for the upper channel spacers 912, 5512 and lower channel spacers 916, 5516 as previously described above, such as open-cell foams like polyethylene or polyurethane, or fabrics like knitted or woven spacer fabrics (such as knitted polyester 3D fabric, Baltex 7970.RTM, or Gehring 879.RTM) or nonwoven materials.

[0124] exist Figure 9A and 9C In the illustrated embodiment 900, double-sided adhesive tape 928 is adhered around suction orifices 926 and 954, thereby securing the applicator 920 to the lower layer 918. However, in some embodiments, the size and shape of the double-sided adhesive tape 928 may be configured to adhere around air leak orifices 952 and 962, or both orifices 962 / 952 and 926 / 954. In some embodiments, the suction adapter 900 may include additional double-sided adhesive tape (not shown), similar to adhesive tape 928, to adhere around air leak orifices 952 and 962. In some embodiments, additionally or alternatively, the applicator may be attached to the lower layer 918 with adhesive and / or solder for the double-sided adhesive tape.

[0125] During operation, Figure 9AThe embodiment described in -C provides an air leakage path extending into the wound dressing, which is fluidly separated from the suction flow path extending from the wound dressing to the negative pressure source. This embodiment is similar to... Figure 5A-6 The air leakage path in this embodiment differs from the fluid connection between the suction flow path above the wound dressing and the embodiment in which the air leakage path is fluidly connected. Figure 5A-6 In some embodiments, if orifice 5526 is blocked, for example, if the suction adapter is not properly positioned above an opening formed in a wound dressing placed above the wound, or if orifice 5526 is blocked by wound exudate, the negative pressure source can continue to operate by drawing fluid (such as air) from an air leak and drawing gas from the suction adapter. This can make it difficult to detect blockage of the suction adapter or misalignment of the suction adapter at the opening in the wound dressing. By having an air leak path fluidly separate from the suction flow path as described herein, if suction orifice 926 is blocked, the negative pressure source can stop drawing fluid (such as air) from the suction adapter because the air leak will only flow through the wound. Therefore, this makes it possible to detect blockage of the suction adapter. Furthermore, by having a separate, controlled air leak path, it will be easier to measure the flow or pressure through the suction flow path without interference from the air leak.

[0126] although Figure 9A -C illustrates an example of a flexible suction adapter 900 having fluid-separated or isolated air leak channels (upper fluid channel) and suction channels (lower fluid channel), but other arrangements of the flexible suction adapter 900 that fluidly separate the isolated air leak channels and suction channels are possible. For example, the air leak channels and suction channels may be arranged side by side, rather than placing one channel on top of the other. In some embodiments, two physically separate hoses may be connected to the wound bed, one hose serving solely as a means of allowing delivery from a negative pressure source, and the other hose serving solely as an air leak channel to allow air from a controlled air leak port to flow into the wound.

[0127] Figure 10 A diagram is shown of a system 1000 for applying negative pressure, according to some embodiments, such as using a suction adapter 900 or any suction adapter having a separate air leakage path. As shown, system 1000 includes a negative pressure source 1022 fluidly connected to a wound dressing 1006 via a fluid flow path 1040 to supply negative pressure to one or more wound sites. The fluid flow path 1040 includes a suction adapter 1020 and a tube 1042 connected by a connector 1052. The suction adapter 1020 also includes a gas leak port 1012 (sometimes referred to as an air leak port) configured to introduce gas (such as air) into the suction adapter 1020.

[0128] like Figure 10As shown, the suction adapter 1020 includes a calibrated leak path 1026 and a suction path 1024. Suction path 1024 is fluidly connected to fluid flow path 1040 via connector 1052 to supply negative pressure to the wound site through wound dressing 1006. Calibrated leak path 1026 is fluidly connected to air leak 1012 to supply gas (such as air) from the air leak into the wound through wound dressing 1006. Figure 10 As shown, the calibrated leak path 1026 and suction path 1024 can be referenced as previously stated herein. Figure 9A -C is connected to each other only through the wound fluid, as described. In some embodiments, the air leak 1012 may be located at any suitable location in the fluid flow path. For example, the air leak 1012 may be incorporated into the connector 1052. In some embodiments, the air leaks may be electronically or electromechanically adjusted by the system's controller to close or amplify the leak. For example, the controller may communicate with the air leaks to open or close each air leak individually or as a unit. For example, the air leak may be a solenoid valve. Communication between the air leak and the controller may be wired or wireless.

[0129] In some embodiments, the suction adapter 1020 is capable of maintaining a constant leakage rate through the air leak port 1012 while applying negative pressure through a negative pressure source. Some embodiments can support air leaks of 1, 2, 3, 4, 5, 6, 7, 8, 9 mL / min or greater (+ / - 0.5 mL / min or another suitable deviation). Some embodiments can support air leaks of 10, 20, 30, 40, 50, 60, 70, 80, 90 mL / min or greater (+ / - a few mL / min or another suitable deviation). Some embodiments can support air leaks of 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9 L / min or greater (+ / - a few liters / min or another suitable deviation). In some cases, the leakage rate can be discussed according to a controlled leak path (CLP), where CLP is a suitable constant. For example, air leaks can have leakage rates of 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or greater. For instance, assuming a leakage rate of 0.1 L / min, 1 CLP corresponds to 0.1 L / min, 5 CLP corresponds to 0.5 L / min, and so on. The negative pressure source must work harder under conditions of higher air leakage intensity, thus depleting its power supply more quickly. Therefore, in some embodiments, relatively low leakage rates are chosen.

[0130] Figure 15 It shows something similar to the reference. Figure 9A -C shows and describes an embodiment of the flexible suction adapter 900, specifically the flexible suction adapter 1500. Figure 15A cross-sectional view of a suction adapter 1500 is shown. The suction adapter 1500 may include a bridging portion 1502 having a proximal end 1503 and a distal end 1505, and an applicator 1520 at the distal end 1505 of the bridging portion 1502 to form a flexible suction adapter 1500. The flexible suction adapter may be constructed in a manner similar to the flexible suction adapter 5500, suction adapter 900, or any other suction adapter disclosed herein, and the bridging portion 1502 may be constructed from a similar two-layer arrangement as previously described. For example, the bridging portion 1502 may include an upper channel spacer layer or material 1512 positioned between an upper layer 1510 and an intermediate layer 1514, wherein a lower channel spacer layer or material 1516 is positioned between the intermediate layer 1514 and a bottom layer 1518.

[0131] In some cases, such as Figure 15 As shown, a controlled gas leak 1524 (sometimes referred to as a gas leak, air leak, or controlled air leak) may be provided on the bridging portion 1502, for example, adjacent to its proximal end. This gas leak 1524 may include an opening or channel extending through the upper layer 1510, such that the gas leak 1524 is in fluid communication with the upper channel 1512. The gas leak 1524 may include a filter, as shown in the reference. Figure 9A -C shows and describes the filter 925 of the flexible suction adapter 900.

[0132] The applicator 1520 may include an attachment point at the bridging portion 1502 at the distal end 1505, for example, using a section of double-sided adhesive tape. It should be understood that different attachment methods may also be conceived, such as heat sealing, welding, or suitable adhesives.

[0133] Connector 1504 may be disposed at the proximal end 1503 of bridging portion 1502 for connection to at least one of channels 1512 or 1516. Figure 15 As shown, channel connector 1506 may be located at the proximal end 1503 of bridging portion 1502. Channel connector 1506 may be configured to be embedded in lower channel layer 1516 to form a secure fluid connection. With one end of channel connector 1506 embedded in lower channel layer 1516, the other end of channel connector 1506 may be connected or communicated with connector 1504, or directly connected or communicated with a tube or cavity connected to a negative pressure source.

[0134] Each component of suction adapter 1500 may be similar to each corresponding component of suction adapter 5500 or suction adapter 900, and therefore, in addition to what is described herein, the previous descriptions of each corresponding component of suction adapter 1500 also apply to each component of suction adapter 5500 or suction adapter 900.

[0135] Similar to suction adapters 5500 and 900, the upper fluid passage may be defined by and between the upper layer 1510 and the intermediate layer 1514, and the lower fluid passage may be defined by and between the intermediate layer 1514 and the lower layer 1518. In some cases, such as Figures 15 to 18 As shown, the upper layer 1510 and the lower layer 1518 extend further than the middle layer 1514 at the distal end 1505, such that the upper layer 1510 and the lower layer 1518 can be directly connected (e.g., sealed) to each other at the distal end 1505. The upper fluid passage may include an upper channel spacer layer 1512. The lower fluid passage may include a lower channel spacer layer 1516.

[0136] In some cases, such as Figure 15-17 As shown, the upper channel spacer 1512 may extend further than the lower channel spacer 1516 at its distal end 1505 to support the upper layer 1510. Figure 15-17 As shown, in some cases, the distal ends of layers 1510, 1514, and 1518, as well as channel spacers 1512 and 1516, may be enlarged at their distal ends (to be positioned above the wound site) and may form a "teardrop" or other enlarged shape. The lower fluid passage may further include an empty portion or hollow space 1570 below the distal end of the upper channel spacer 1512. The hollow space 1570 may be located further distally than the distal end of the lower channel spacer 1516. As described in further detail elsewhere in this specification, the hollow space 1570 may collapse under negative pressure. The hollow space 1570 may not contain the lower channel spacer material 1516. The hollow space 1570 may be empty or include voids.

[0137] In some cases, such as Figure 15 and 16 As shown, the suction adapter 1500 may include at least one opening 1552 in the lower layer 1518, for example, in the enlarged distal end of the lower layer 1518. The opening 1552 may be formed as a single hole or a plurality of smaller holes. As shown, the opening 1552 may be located on the central longitudinal axis of the lower layer 1518, or the opening 1552 may not be located on the central longitudinal axis. The applicator 1520 may have an opening 1562 configured to align with the opening 1552. Figure 15 and 17 As shown, the intermediate layer 1514 may include, for example, an opening 1517 at its distal end. The opening 1517 provides fluid communication between the upper and lower fluid channels. The opening 1517 may be in fluid communication with the hollow space 1570, such as being positioned above the hollow space 1570. The opening 1517 may be positioned distally away from the distal end of the lower channel spacer 1516. The lower channel spacer 1516 may terminate distally away from the opening in the intermediate layer 1517. The distal end of the lower channel spacer 1516 may not overlap with the opening 1517 in the intermediate layer 1514.

[0138] In some embodiments, the upper channel spacer 1512 may be disposed on and extend along the central longitudinal axis of the suction adapter 1500. The upper channel spacer 1512 may extend more distally than any portion of the lower channel spacer 1516 on the central longitudinal axis. Thus, a portion may exist above at least one opening 1552 in the lower layer 1518, wherein the upper channel spacer 1512 may be visible and distal to the lower channel spacer 1516.

[0139] like Figure 15 As shown, opening 1552 can be positioned within hollow space 1570. Therefore, opening 1552 can be fluidly connected to an upper fluid channel having an upper channel spacer 1512, thereby forming a gas leakage flow (such as an air leakage flow) extending distally from air leak 1524 toward the wound through opening 1517, hollow space 1570, and opening 1552. Opening 1552 can be fluidly connected via hollow space 1570 to a lower fluid channel having a lower channel spacer 1516, thereby forming a suction flow extending distally from connector 1504 and / or negative pressure source.

[0140] In some cases, the upper layer 1510 may form a fluid-tight seal with the intermediate layer 1514 and / or the lower layer 1518, and the intermediate layer 1514 may form a fluid-tight seal with the upper layer 1510 and the lower layer 1518, such that, except at the distal end 1505, the upper fluid passage extending distally from the air leak 1524 to the opening 1552 may be fluidly separated from the lower fluid passage extending distally from the connector 1504 to the opening 1552. The upper layer 1510, the intermediate layer 1514, and the lower layer 1518 may be sealed to each other using any of the means previously described herein, such as by melting, welding, or sealing with adhesive.

[0141] In some cases, the lower fluid channel may include a filter (not shown) adjacent to the opening 1552. The filter is configured to substantially prevent wound exudate from entering the lower fluid channel. The filter may be impermeable to liquids but permeable to gases, and serves as a liquid barrier, ensuring that no liquid can escape from the wound dressing, thereby eliminating the need for a canister for collecting wound fluid between the suction adapter and the negative pressure source. The filter may be hydrophobic. The filter may be attached or sealed above the wound dressing to the suction adapter and / or the covering membrane. For example, the filter may be molded into the suction adapter 1500, or may be adhered to the lower layer 1518 of the suction adapter 1500 using an adhesive (such as, but not limited to, UV-curing adhesives).

[0142] Figure 18 A bottom view of the distal end 1505 of the suction adapter 1500 is shown. (As shown) Figure 18As shown, when viewed from the bottom, the lower channel layer 1516 and / or the intermediate layer 1514 may be exposed or visible at least partially through the opening 1552 and the opening 1562 in the applicator 1520. The opening 1552 may at least partially overlap with the opening 1562 in the applicator 1520.

[0143] In some cases, openings 1517 and 1552 are aligned such that opening 1517 of the intermediate layer 1514 is at least partially exposed or visible through openings 1552 and 1562. Opening 1517 may at least partially overlap with openings 1552 and 1562. A portion of the upper channel layer 1512 above opening 1517 may be exposed to or overlap with openings 1552 and 1556. Openings 1552 and 1562 may have similar or larger dimensions than opening 1517. The entire opening 1517 may be above openings 1552 and / or 1562, such that opening 1517 completely overlaps with or is exposed through openings 1552 and / or 1562. In some cases, opening 1517 may only partially overlap with or be exposed through openings 1552 and / or 1562. The center of opening 1517 may be located distally from the center of opening 1552.

[0144] When negative pressure is applied to the suction adapter 1500, for example, via connector 1504 and lower channel layer 1516, the hollow space 1570 can collapse. This collapse terminates or prevents fluid communication between the lower fluid passage (e.g., lower channel layer 1516) and the upper fluid passage (e.g., upper channel layer 1512) through the hollow space 1570. Thus, airflow (e.g., airflow) through the upper fluid passage may not be directly delivered to the lower fluid passage. Instead, when the suction adapter 1500 is positioned above an opening in a wound dressing located above a wound and negative pressure is applied to the suction adapter 1500 via connector 1504, airflow can be delivered to the lower fluid passage through openings 1517 and 1552, openings in the wound dressing, and wound packing positioned in the wound. Airflow can be delivered to the lower fluid passage because the lower channel layer portion 1564 at the distal end of the lower channel spacer material 1516 communicates with one or more of the dressing or wound filled with wound packing. As described herein, such an arrangement can advantageously provide more accurate identification of obstruction (e.g., when the suction adapter is not properly positioned above the wound) because the fluid flow path between the gas delivered through the upper fluid passage and the suction delivered through the lower fluid passage can only be provided through openings in the wound dressing and wound packing, not through the hollow space 1570.

[0145] As described herein, the hollow space 1570 can collapse due to the application of negative pressure. Other components of the suction adapter 1500 allow the upper spacer 1512 and lower spacer 1516 to collapse to a certain extent, but the hollow space 1570 may collapse more significantly because there is no internal structure within the hollow space 1570 to resist collapse. When the hollow space 1570 collapses, the distal end of the intermediate layer 1514 above the hollow space 1570 can be drawn towards the opening 1552 of the lower layer 1518, causing the distal end of the intermediate layer 1514 to block the fluid flow between the upper and lower fluid passages. Therefore, as described herein, when the hollow space 1570 collapses, airflow can only be achieved through the opening in the wound dressing between the upper and lower fluid passages. Figure 19-21 A suction adapter 1500 is shown attached to a wound dressing 1900 positioned above a wound filled with wound filler. (See diagram.) Figure 19-21 As shown, when negative pressure is applied, the distal end of the suction adapter 1500 collapses.

[0146] The distal end of the lower channel spacer 1516 and the opening 1517 of the intermediate layer 1514 are sufficiently spaced apart from each other, such that the opening 1517 is aligned with the opening 1552, allowing airflow (such as airflow) from the upper fluid passage to the wound when the intermediate layer 1514 is drawn into the opening 1552. For example, the distance between the distal end of the lower channel spacer 1516 and the center of the opening 1517 may be greater than or less than 5 mm, greater than or less than 1 cm, greater than or less than 2 cm, greater than or less than 3 cm, greater than or less than 5 cm, etc. In some cases, when the intermediate layer 1514 is drawn towards the opening 1552 due to the collapse of the hollow space 1570, the entire opening 1517 is positioned above the opening 1552 or the opening 1562, such that the entire opening 1517 is in fluid communication with the opening of the wound dressing.

[0147] like Figure 18 As shown, a portion of the lower fluid channel layer 1516 may be exposed at the opening 1552 of the lower layer 1518 or the opening 1556 of the applicator 1520. This portion may be the lower channel layer portion 1564. As described herein, when a negative pressure is applied and the distal end of the middle layer 1514 is aspirated to the opening 1552, fluid flow between the wound and the lower fluid channel can be maintained through the exposed portion of the lower fluid channel layer 1516.

[0148] During operation, the suction adapter 1500 provides a gas (e.g., air) leakage path extending into the wound dressing (e.g., via an upper fluid passage), which is fluidly separated from the suction flow path extending from the wound dressing to a negative pressure source (e.g., via a lower fluid passage). As described herein, by separating the gas leakage path from the suction flow path fluidly as described herein, if the opening 1552 is blocked, the negative pressure source can stop the suction of gas (e.g., air) supplied by the suction adapter, because the gas leak will only flow through the wound. This makes it possible to detect blockages in the suction adapter (e.g., the suction adapter is not properly positioned above an opening formed in the wound dressing, which is positioned above the wound) or blockages caused by wound exudate. Additionally or alternatively, by having separate, controlled air leakage paths, it is easier to measure the flow or pressure through the suction flow path without interfering with the air leakage.

[0149] Figure 22-23 Bottom views of different embodiments of the distal ends 1605, 1705 of the suction adapters 1600, 1700, are shown, which are similar to reference... Figure 9A Embodiments of the flexible suction adapters 900 and 1500 shown and described in -C and 15-18. Some of the different layers are shown as partially transparent to show the orientation of the different layers. Reference numerals for the same or substantially the same features may share the same last two digits. For example... Figure 22-23 As shown, when viewed from the bottom, the intermediate layers 1614, 1714 may be at least partially exposed or visible through openings 1652, 1752. At least one opening 1652, 1752 of the suction adapters 1600, 1700 may at least partially overlap with openings 1662, 1762 of the applicators 1620, 1720.

[0150] like Figure 22 As shown, the distal end of the lower channel spacer layer 1616 may have a forked shape, the forked shape including a base portion 1616a and two forked or side portions 1616b, 1616c extending from the base portion 1616a. The two side portions 1616b, 1616c may extend from opposite sides of the base portion 1616a such that the two side portions 1616b, 1616c are spaced apart. This configuration may provide additional support to the suction adapter 1600 and prevent at least some wrinkling of the different layers (e.g., the bottom layer 1618). In some embodiments, various openings 1617, 1652, 1662 may be positioned between the two side portions 1616b, 1616c, and the two side portions 1616b, 1616c may extend distally beyond the openings 1617, 1652, 1662. In some embodiments, various openings 1617, 1652, 1662 may be located on the distal side of the base portion 1616a.

[0151] Figure 23 Different embodiments of a suction adapter 1700 having a lower channel spacer 1716 with varying shapes are shown. In the illustrated configuration, the lower channel spacer 1716 includes an enlarged distal end 1716a. The enlarged distal end 1716a may have a straight distal edge that can be positioned adjacent to a proximal portion of the opening 1752 of the suction adapter 1700, such that the enlarged distal end 1716a of the lower channel spacer 1716 does not overlap with the opening 1752. In some configurations, the enlarged distal end 1716a of the lower channel spacer 1716 may at least partially overlap with the opening 1752.

[0152] Figure 24A-26B Bottom views of different embodiments of the distal ends of intermediate layers 2014, 2114, 2214 and bottom layers 2018, 2118, 2218, which can be used with any of the suction adapters described herein, are shown. The intermediate layers 2014, 2114, 2214 and bottom layers 2018, 2118, 2218 can be similar to those described in the reference diagram. Figure 9A -C and the embodiments shown and described in 15-18. Reference numerals for the same or substantially the same features may share the same last three digits.

[0153] Figure 24A -B illustrates an embodiment of the intermediate layer 2014 and the bottom layer 2018. (As...) Figure 24A As shown, the distal end of the intermediate layer 2014 may have a rectangular shape, wherein a first length L1 is measured from the distal edge 2015 of the intermediate layer 2014 and along the longitudinal axis of the intermediate layer 2014. An opening 2017 may be located at or near the center of the distal end of the intermediate layer 2014. For example, the center of the opening 2017 may be located at a distance of a second length L2 from the distal edge 2015 and aligned with the longitudinal centerline of the intermediate layer 2014. The second length L2 may be approximately half the first length L1. The opening 2017 may have an elliptical shape, including a third length L3 and a width W1. In some embodiments, the third length L3 may be between approximately 5 mm and approximately 20 mm, between approximately 10 mm and approximately 15 mm, or approximately 10 mm. In some embodiments, the width W3 may be between approximately 2 mm and approximately 10 mm, between approximately 5 mm and approximately 7 mm, or approximately 4 mm.

[0154] like Figure 24BAs shown, the distal end of the base layer 2018 may have a rectangular shape, wherein a first length L4 is measured from the distal edge 2019 of the base layer 2018 and along the longitudinal axis of the base layer 2018. An opening 2052 may be located at or near the center of the distal end of the base layer 2018. For example, the center of the opening 2052 may be located at a distance of a second length L5 from the distal edge 2019 and aligned with the longitudinal centerline of the base layer 2018. The second length L5 may be approximately half the first length L4. The opening 2052 may have a circular shape including a diameter D1. In some embodiments, the diameter D1 may be between approximately 10 mm and approximately 40 mm, between approximately 20 mm and approximately 30 mm, or approximately 16 mm.

[0155] Figure 25A -B illustrates an embodiment of the intermediate layer 2114 and the bottom layer 2118. (As shown...) Figure 25A As shown, the distal end of the intermediate layer 2114 may have a rectangular shape, wherein a first length L6 is measured from the distal edge 2115 of the intermediate layer 2114 and along the longitudinal axis of the intermediate layer 2114. An opening 2117 may be located at or near the center of the distal end of the intermediate layer 2114. For example, the center of the opening 2117 may be located at a distance of a second length L7 from the distal edge 2115 and aligned with the longitudinal centerline of the intermediate layer 2114. The second length L7 may be approximately half the first length L6. The opening 2117 may have an elliptical shape, comprising a third length L8 and a width W2. In some embodiments, the third length L8 may be between approximately 5 mm and approximately 20 mm, between approximately 10 mm and approximately 15 mm, or approximately 10 mm. In some embodiments, the width W2 may be between approximately 2 mm and approximately 10 mm, between approximately 5 mm and approximately 7 mm, or approximately 4 mm.

[0156] like Figure 25B As shown, the distal end of the base layer 2118 may have a rectangular shape, wherein a first length L9 is measured from the distal edge 2119 of the base layer 2118 and along the longitudinal axis of the base layer 2118. An opening 2152 may be located at or near the center of the distal end of the base layer 2118. For example, the center of the opening 2152 may be located at a distance of a second length L from the distal edge 2119. 10 And aligned with the longitudinal centerline of the bottom layer 2118. The second length L5 may be about half the length of the first length L4. The opening 2152 may have a circular shape including a diameter D2. In some embodiments, the diameter D2 may be between about 10 mm and about 40 mm, between about 20 mm and about 30 mm, or about 20 mm.

[0157] Figure 26A -B illustrates an embodiment of the intermediate layer 2214 and the bottom layer 2218. (As shown...) Figure 26A As shown, the distal end of the intermediate layer 2214 may have a rectangular shape, wherein the first length L 11Measured from the distal edge 2215 of the intermediate layer 2214 and along the longitudinal axis of the intermediate layer 2214. The opening 2217 may be located at or near the center of the distal end of the intermediate layer 2214. For example, the center of the opening 2217 may be located at a distance L from the distal edge 2215. 12 And aligned with the longitudinal centerline of the intermediate layer 2214. Second length L 12 It can be the first length L 11 Approximately half of. Opening 2217 may have an elliptical shape, which includes a third length L. 13 and width W3. In some embodiments, the third length L 13 It can be between about 1 mm and about 5 mm, between about 2 mm and about 4 mm, or about 2 mm. In some embodiments, the width W3 can be between about 2 mm and about 10 mm, between about 5 mm and about 7 mm, or about 4 mm.

[0158] like Figure 26B As shown, the far end of the bottom layer 2218 may have a rectangular shape, wherein the first length L 14 Measured from the distal edge 2219 of the base layer 2218 and along the longitudinal axis of the base layer 2218. The opening 2252 may be located at or near the center of the distal end of the base layer 2218. For example, the center of the opening 2252 may be located at a distance L from the distal edge 2219. 15 And aligned with the longitudinal centerline of the bottom layer 2218. Second length L 15 It can be the first length L 14 Approximately half of the diameter. The opening 2252 may have a circular shape including a diameter D3. In some embodiments, the diameter D3 may be between approximately 10 mm and approximately 50 mm, between approximately 20 mm and approximately 40 mm, or approximately 30 mm.

[0159] Figure 27 An embodiment of a flexible suction adapter 2300 is shown, which is similar to the reference adapter. Figure 9A Embodiments of the flexible suction adapters 900 and 1500 shown and described in -C and 15-18. Reference numerals for the same or substantially the same features may share the same last two digits. For example... Figure 27 As shown, the distal end 2305 of the suction adapter 2300 may include a solder portion 2319, at which a portion of the bottom layer 2318 may be soldered to the intermediate layer 2314. The solder portion 2319 may be positioned in at least one opening of the suction adapter 2300 such that the at least one opening includes a proximal opening 2352a spaced apart from the distal opening 2352b.

[0160] In some embodiments, the welded portion 2319 may terminate or prevent fluid communication between the lower fluid passage (e.g., lower channel layer 2316) and the upper fluid passage (e.g., upper channel layer 2312) via the hollow space 2370. Thus, airflow (e.g., airflow) through the upper fluid passage may not be directly delivered to the lower fluid passage. Instead, when the suction adapter 2300 is positioned above an opening in a wound dressing located above the wound 2330 and negative pressure is applied to the suction adapter 2300 via connector 2304, airflow can be delivered to the lower fluid passage through openings 2317, 2352a, and 2352b, openings in the wound dressing, and wound packing located in the wound 2330. Airflow can be delivered to the lower fluid passage because the lower channel layer portion 2364 at the distal end of the lower channel spacer material 2316 is in communication with one or more of the dressing or the wound 2330 filled with wound packing. As described herein, such an arrangement can advantageously provide more accurate identification of obstruction (e.g., when the suction adapter 2300 is not properly positioned above the wound 2330) because the fluid flow path between the gas delivered through the upper fluid passage and the suction delivered through the lower fluid passage can only be provided through openings in the wound dressing and wound packing, and not through the hollow space 2370.

[0161] Figure 28A-30B Bottom views of different embodiments of the distal ends of intermediate layers 2414, 2514, 2614 and bottom layers 2418, 2518, 2618, which can be used with the suction adapter 2300 described above or any suction adapter described herein, are shown. The intermediate layers 2414, 2514, 2614 and bottom layers 2418, 2518, 2618 can be similar to those described in the reference document. Figure 9A The embodiments shown and described in -C, 15-18, and 27. Reference numerals for the same or substantially the same features may share the same last three digits.

[0162] Figure 28A -B illustrates an embodiment of the intermediate layer 2414 and the bottom layer 2418. (As shown...) Figure 28A As shown, the distal end of the intermediate layer 2414 may have a rectangular shape, wherein the first length L 16 Measured from the distal edge 2415 of the intermediate layer 2414 and along the longitudinal axis of the intermediate layer 2414. The opening 2417 may be located at or near the center of the distal end of the intermediate layer 2414. For example, the center of the opening 2417 may be located at a distance L from the distal edge 2415. 17 And aligned with the longitudinal centerline of the intermediate layer 2414. Second length L 17 It can be the first length L 16 Approximately half. Opening 2417 may have an elliptical shape, which includes a third length L. 18and width W4. In some embodiments, the third length L 18 It can be between about 1 mm and about 5 mm, between about 2 mm and about 4 mm, or about 2 mm. In some embodiments, the width W4 can be between about 2 mm and about 10 mm, between about 5 mm and about 7 mm, or about 4 mm.

[0163] like Figure 28B As shown, the far end of the bottom layer 2418 may have a rectangular shape, wherein the first length L 19 Measured from the distal edge 2419 of the substrate 2418 and along the longitudinal axis of the substrate 2418. The proximal opening 2452a and the distal opening 2452b may be located at or near the center of the distal end of the substrate 2418. For example, the weld portion 2419 may be positioned at its center between the two openings 2452a, 2452b with a second length L from the distal edge 2419. 20 And aligned with the longitudinal centerline of the bottom layer 2418. Second length L 20 It can be the first length L 19 Approximately half of the openings 2452a and 2452b. The welded portion 2419 may have a width W5 separating the two openings 2452a and 2452b. The width W5 may be between approximately 1 mm and approximately 10 mm, between approximately 3 mm and approximately 8 mm, or approximately 6 mm. The openings 2452a and 2452b may each have a semi-circular shape, said semi-circular shape including a diameter D4 measured from the edge of the proximal opening 2452a through the welded portion 2419 to the edge of the distal opening 2452b. In some embodiments, the diameter D4 may be between approximately 10 mm and approximately 50 mm, between approximately 20 mm and approximately 40 mm, or approximately 30 mm.

[0164] Figure 29A -B illustrates an embodiment of the intermediate layer 2514 and the bottom layer 2518. (As shown...) Figure 29A As shown in -B, the intermediate layer 2514 and the bottom layer 2518 are as described above. Figure 28A -B The intermediate layer 2414 and the bottom layer 2518 described are the same or similar. For example... Figure 29B As shown, the weld portion 2519 may have a width W6 separating the two openings 2552a, 2552b. The width W6 may be between about 1 mm and about 10 mm, between about 3 mm and about 8 mm, or about 4 mm. The openings 2552a and 2552b may each have a semi-circular shape, the semi-circular shape including a diameter D5 measured from the edge of the proximal opening 2552a through the weld portion 2519 to the edge of the distal opening 2552b. In some embodiments, the diameter D5 may be between about 10 mm and about 50 mm, between about 20 mm and about 40 mm, or about 20 mm.

[0165] Figure 30A-B illustrates an embodiment of the intermediate layer 2614 and the bottom layer 2618. (As follows) Figure 30A As shown in -B, the intermediate layer 2614 and the bottom layer 2618 are as described above. Figure 28A -B The intermediate layer 2414 and the bottom layer 2518 described are the same or similar. For example... Figure 30B As shown, the proximal opening 2652a and the distal opening 2652b can be located at or near the center of the distal end of the substrate 2618. For example, the center of the weld portion 2619 between the two openings 2652a and 2652b can be aligned with the longitudinal centerline of the substrate 2618. Additionally, the center of the weld portion 2619 can be positioned at a distance L from the distal edge 2619. 20 The distal center of the bottom layer 2618 is offset. The welded portion 2619 may have a width W7 separating the two openings 2652a, 2652b. The width W7 may be between about 5 mm and about 20 mm, between about 10 mm and about 15 mm, or about 10 mm.

[0166] Multiple dressing negative pressure wound therapy

[0167] Figure 11A-11B A negative pressure wound treatment system 400 according to some embodiments is illustrated. Systems 400a, 400b (collectively referred to as 400) may include a pump assembly or negative pressure unit 434 capable of supplying negative pressure. In some embodiments, the negative pressure unit 434 and Figure 2 The same as shown. The negative pressure unit 434 may be fluidly connected to one or more wound dressings 406a, 406b (collectively referred to as 406) to supply negative pressure to one or more wounds. In some embodiments, the fluid connection between the wound dressing 406 and the negative pressure unit 434 is referred to as a fluid flow path (e.g., a path through which fluid is aspirated from a wound via negative pressure flow). For example, a first fluid flow path may include components providing a fluid connection from the negative pressure unit 434 to a first wound dressing 406a. As a non-limiting example, the first fluid flow path may include a path from the wound dressing 406a to the negative pressure unit 434 or a path from the first wound dressing 406a to an inlet of a branch attachment 444 fluidly connected to the negative pressure unit 434. As shown, the system 400 may include multiple suction adapters (as referenced) Figure 9A -C describes the suction adapter 900 and / or refers to Figure 10The suction adapter 1020 is fluidly connected to a plurality of wound dressings (and corresponding fluid flow paths) and a negative pressure unit 434. Therefore, the description of suction adapters 900 and 1020 and their components herein can also be applied to suction adapters and their components in systems 400a and 400b. For example, suction adapters for systems 400a and 400b may include controlled leakage channels separate from the fluid suction channels. Each wound dressing and fluid flow path may include various features or elements that match or resemble the features or elements of another wound dressing or fluid flow path within the system. For ease of reference, one or more corresponding features or elements may be commonly referred to using reference numerals without corresponding letters. For example, bridging element 402a and bridging element 402b may be collectively referred to as bridging element 402. However, it should be noted that in some embodiments, the elements that have been commonly mentioned are not the same and may have different features or properties.

[0168] refer to Figure 11A System 400a may include a suction adapter, such as suction adapter 900 or 1020, which includes a bridging member 402 having a proximal end 403 and a distal end 405, and an applicator 420 forming a flexible suction interface or adapter at the distal end 405 of the bridging member 402. Negative pressure unit 434 may include a canister or other container for storing wound exudate and other fluids that can be removed from the wound. Negative pressure unit 434 may be a reference... Figure 2 The negative pressure unit 5534 is described above. Alternatively or additionally, the wound dressing 406 may collect wound exudate and other fluids, and the canister may not be present. In some embodiments, multiple canisters are provided, for example, one canister per wound dressing. In some embodiments, the negative pressure unit 434 may be a Renasys Touch device manufactured by Smith & Nephew. In some embodiments, a connector other than the Renasys soft port or a device other than Renasys Touch may be used.

[0169] Figure 11B It shows Figure 11A In some embodiments, a flexible suction adapter is positioned over the wound. In some embodiments, the applicator 420 is positioned over an opening 435 formed in a cover 431, which is disposed over a suitably prepared wound 430, in some cases where the wound may be filled with wound-filling material such as foam or gauze. Subsequently, when the negative pressure unit 434 is connected to the connector 404 via a tube 440 or an inlet manifold branch accessory or connector 444, the negative pressure unit 434 is activated, thereby supplying negative pressure to the wound via a fluid flow path. Negative pressure can be applied until the desired level of wound healing is achieved. Although in Figure 11A-11BTwo wounds and wound dressings are shown. In some embodiments, the negative pressure unit 434 can treat more than two wounds. In some embodiments, negative pressure wound therapy can be provided to a single wound.

[0170] appendix

[0171] The negative pressure unit 434 can be fluidly connected to the wound dressing 406 via one or more tubes 440, 442, one or more bridging elements 402, or via an inlet manifold branch attachment 444. For example, the negative pressure unit 434 can be fluidly connected to multiple wound dressings 406 via tube 440, inlet manifold branch attachment 444, tube 442, and bridging element 402. As another example, the manifold branch attachment 444 can be directly connected to the negative pressure unit 434 without using tube 440. Figure 11A-11B As shown, the inlet manifold branch attachment 444 can be configured to connect the negative pressure unit 434 to multiple fluid flow paths via multiple dressing catheter attachments 445a, 445b. The inlet manifold branch attachment 444 may include any number of dressing catheter attachments 445 configured to be fluidly connected to the negative pressure attachment 446 via a connector. For example, the inlet manifold branch attachment may include two dressing catheter attachments 445a, 445b, three dressing catheter attachments, or more than three dressing catheter attachments.

[0172] Multiple dressing catheter attachment portions 445 may include a first dressing catheter attachment portion 445a and a second dressing catheter attachment portion 445b. However, it should be understood that more or fewer dressing catheter attachment portions may be included in the inlet manifold branch attachment 444. Each of the dressing catheter attachment portions 445 includes an axis extending remotely from the connector and including an inlet distal to the connector. The inlet is configured to fluidly connect at least a portion of the fluid flow path to the negative pressure unit 434.

[0173] The inlet manifold branch fitting 444 may also include one or more negative pressure attachment portions 446. Each of the negative pressure attachment portions 446 may include an axis extending away from the connector and an inlet on the distal side of the connector. The inlet may be configured for fluid connection to the negative pressure unit 434. For example, the inlet may include a male or female non-Luer connector for attachment to a corresponding male or female connector of a conduit or pump. In some embodiments, the negative pressure attachment portion 446 is attached to the negative pressure unit 434 via a conduit 440 or other conduit. The negative pressure attachment portion 446 may also be directly attached to (or integrated with) the housing of the negative pressure unit 434.

[0174] The inlet manifold branch accessory 444 or conduit may include one or more valves, clamps, caps, air vents, or other flow regulator mechanisms configured to introduce fluid into a fluid flow path, or alternatively to block or restrict the flow or passage of fluid through a fluid flow path. In some embodiments, the valves, air vents, or other flow regulator mechanisms in the inlet manifold branch accessory 444 may be opened or closed electronically. For example, the controller of the negative pressure unit 434 may communicate with the valves, air vents, etc., to open or close each individually or as a unit. This communication may be wired or wireless.

[0175] The dressing catheter attachment portion 445 may include a shaft forming a top portion that is Y-shaped (for two wounds), W-shaped (for three wounds), or another shape for an inlet manifold branch attachment. The proximal end of the dressing catheter shaft and the distal end of the pump catheter shaft may meet at a connector. In some embodiments, the connector may include a hinge that allows the shaft to rotate about the connector. In some embodiments, the inlet manifold branch attachment may be a W-shaped connector (such as...). Figure 6 (as shown in the illustration). In embodiments such as these, the inlet manifold branch attachment may include three or more dressing catheter attachment portions and a negative pressure attachment portion.

[0176] The inlet manifold branch fitting may include rigid or flexible plastic tubing and may or alternatively be encased in a soft silicone sleeve to increase patient comfort and prevent the inlet manifold branch fitting 444 from becoming a pressure point.

[0177] In some embodiments, a negative pressure unit is attached to multiple wound dressings 406 using an inlet manifold branch attachment, allowing the negative pressure unit to simultaneously draw fluid from multiple wounds 430. The performance and wound healing capabilities (such as fluid management) of this system can be equal to or exceed the performance and wound healing capabilities of a standard single wound dressing with a single pump setup.

[0178] In some embodiments, an integrated inlet manifold (not shown) may be used in place of inlet manifold branch attachment 444. In examples such as these, the inlet manifold may be incorporated (e.g., directly attached) into the negative pressure unit 434 or the pump housing, such that one or more fluid flow paths can be fluidly connected to the pump via one or more inlets of the integrated inlet manifold. The integrated inlet manifold may include a branch attachment (similar to the Y-shaped or W-shaped branch attachments described herein), or may include one or more separate integrated inlets fluidly connected to the pump.

[0179] Determine the operation status

[0180] In some embodiments, system 400 may apply negative pressure to one or more wounds. The negative pressure level at one or more wounds (e.g., under one or more wound dressings) may be sufficiently close to the negative pressure level at the negative pressure source. For example, an acceptable pressure level maintained at the wound may be within ±1 mmHg, ±5 mmHg, ±10 mmHg, ±25 mmHg, etc., of the negative pressure setpoint. In some embodiments, this pressure may be maintained at this level for 95% (or another suitable percentage) of the time that system 400 applies negative pressure to it. In some embodiments, acceptable pressure levels may include a pressure range between -40 and -120 mmHg. However, other pressure levels may be used as described herein.

[0181] As described in more detail herein, one or more air leaks in one or more fluid flow paths, such as air leaks 424, 5524, 924, or 1012, can be used to determine one or more operating states within the system. For example, an air leak may be a controlled air leak that introduces a relatively constant flow of air, gas, or other fluid into the fluid flow path. In some embodiments, as an additional negative pressure is applied to the system, the flow entering the fluid flow path from the air leak does not increase significantly. However, when a steady state has been reached (e.g., when a negative pressure setpoint has been reached), the presence of an air leak in the system can maintain a substantially constant baseline flow through the system. Conversely, the presence of an air leak may require the negative pressure source to work harder to maintain the desired negative pressure level at the leak site. Therefore, the system can determine the presence of one or more operating states (such as blockage, leak, full tank, misalignment of the suction adapter, etc.) by monitoring the flow through the fluid flow path, which can be measured directly or indirectly based on, for example, monitoring the activity of the negative pressure source.

[0182] In some embodiments, each fluid flow path may include an air leak (e.g., Figure 11A-11B (as shown in the diagram), and each air leak in the corresponding fluid flow path can introduce air, gas, or other fluids at different velocities into the system. In other words, each air leak in the system can have a different leakage rate. For example, the leakage rate of an air leak can be based at least in part on the size or shape of the air leak, whether the air leak includes a filter, the size or porosity level of the filter, the occlusion level of the air leak or filter, and so on. The fluid introduced into the fluid flow path increases the velocity of that fluid flow path.

[0183] Therefore, each fluid flow path in system 400 may have a different flow rate. The total flow rate (TFR) of system 400 (e.g., the aggregate of flows to each wound dressing) can be monitored, calculated, or determined, and then used to determine the operating state of system 400. Operating states may include, for example, a "no flow" state (e.g., all flow paths are blocked), a blocked state of one or more flow paths (e.g., a blocked state in a first fluid flow path, a blocked state in a second fluid flow path, etc.), a full state, normal operation (e.g., no blockage in any fluid flow path), and so on.

[0184] In some embodiments, system 400 is capable of providing indications, such as alarms, to inform a patient or caregiver of the operational status of system 400 based on a comparison of a determined total flow rate and one or more flow thresholds. In some embodiments, the flow thresholds corresponding to the operational status of system 400 are predetermined. In some embodiments, the flow thresholds are based at least in part on dynamic measurements or calculations, such as flow rate or pressure, of system 400 during a specific mode of the system (e.g., calibration mode).

[0185] Figure 12 A diagram of a system for applying negative pressure according to some embodiments is shown. As shown, system 500 includes a negative pressure source 522 fluidly connected to wound dressings 506a, 506b via fluid flow path 540d, inlet manifold branch accessory 544, and fluid flow paths 540a, 540b, to supply negative pressure to one or more wound sites via suction paths 528a and 528b, respectively connected to fluid flow paths 540a and 540b. Suction path 528a may be connected to flow channel 540a via connector 530, and suction path 528b may be connected to flow channel 540b via connector 530. Each of the first fluid flow path 540a and the second fluid flow path 540b includes air leaks 512, 514 configured to introduce fluid into controlled air leak paths 526a and 526b, respectively. Controlled air leak paths 526a and 526b can be fluidly separated from suction channels 528a and 528b, such that the controlled air leak paths and suction paths are connected only through the wound bed fluid.

[0186] In some embodiments, air leak vents can be electronically or electromechanically adjusted by the system's controller to close or widen the leak. For example, the controller can communicate with the air leak vents to open or close each air leak vent individually or as a unit. For example, an air leak vent can be a solenoid valve. Communication between the air leak vent and the controller can be wired or wireless.

[0187] In some embodiments, system 500 or 1000 is capable of maintaining a constant leakage rate through the air leak outlet while applying negative pressure via a negative pressure source. Some embodiments can support air leaks of 1, 2, 3, 4, 5, 6, 7, 8, 9 mL / min or greater (+ / - 0.5 mL / min or another suitable deviation). Some embodiments can support air leaks of 10, 20, 30, 40, 50, 60, 70, 80, 90 mL / min or greater (+ / - a few mL / min or another suitable deviation). Some embodiments can support air leaks of 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9 L / min or greater (+ / - a few liters / min or another suitable deviation). In some cases, the leakage rate can be discussed according to a controlled leak path (CLP), where CLP is a suitable constant. For example, air leaks can have leakage rates of 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or greater. For instance, assuming a leakage rate of 0.1 L / min, 1 CLP corresponds to 0.1 L / min, 5 CLP corresponds to 0.5 L / min, and so on. The negative pressure source must work harder under conditions of higher air leakage intensity, thus depleting its power supply more quickly. Therefore, in some embodiments, relatively low leakage rates are chosen.

[0188] In some embodiments, the first air leak 512 has a different leakage rate than the second air leak 514. For example, the first air leak may have a leakage rate of 1 CLP, and the second air leak may have a leakage rate of 2 CLP. Alternatively, the first air leak may have a leakage rate of 0.5 CLP, and the second air leak may have a leakage rate of 1 CLP. However, it should be noted that the leakage rate of the system can be any suitable flow rate. Due to the different leakage rates, the first fluid flow path 520a and the second fluid flow path 520b may have different flow rates. Alternatively, the first air leak 512 and the second air leak 514 may be equal or substantially equal (e.g., + / - 0.1 L / min or another suitable deviation). For example, the first air leak 512 and the second air leak 514 may each have a leakage rate of 1 CLP. However, it should be noted that the leakage rate of the system can be any suitable flow rate. Due to the equal leakage rates, the first fluid flow path 520a and the second fluid flow path 520b may have similar flow rates. In some embodiments, the total flow rate (TFR) of the system is the aggregate of flows from one or more wound dressings in the system. Therefore, in some cases, the TFR may be equal to the flow rate along the fluid flow path 520d.

[0189] Flow rate monitoring

[0190] System 500 or 1000 can monitor or determine the TFR in the system based, for example, by monitoring the activity of negative pressure sources 522 or 1022. In some embodiments, flow rate monitoring may be performed by a pump control processor (e.g., Figure 3 The pump control processor 370) alone or in conjunction with a processor (such as Figure 3 The user interface processor 310) is used in conjunction with the flow rate monitoring to ensure that treatment is properly delivered to one or more wounds, to detect blockages, full conditions, no flow conditions or leaks in one or more fluid flow paths, high pressure, to ensure that the flow rate is not unsafe (e.g., highly dangerous), etc.

[0191] In some embodiments, the system performs flow monitoring directly by using one or more flow meters positioned, for example, in the fluid flow path. In some embodiments, the system performs flow rate monitoring indirectly by measuring or monitoring the activity of a negative pressure source, such as by monitoring the activity of an actuator. For example, the system may monitor the activity of a vacuum pump motor, including monitoring the speed of the vacuum pump motor using a tachometer, monitoring the current or voltage supplied to the pump (e.g., the current or voltage of a PWM signal), etc. The system may continuously monitor one or more of these characteristics to determine the activity of the negative pressure source.

[0192] In some embodiments, a tachometer (such as a Hall effect sensor) can be used to measure the activity level of a pump motor. The tachometer can be read periodically, such as every 100 ms or another suitable time interval, and the periodic readings can be combined (e.g., averaged) over a duration (e.g., 32 seconds or another suitable duration). The combined tachometer readings can be used to determine the flow rate, which can then be used for leak detection, blockage detection, limiting maximum flow rates, etc. The combined tachometer readings (e.g., in terms of number of times or pulses) can be converted to a flow rate (e.g., in mL / min) using one or more conversion equations or tables, such that the TFR of the system (e.g., the collection of flows in each fluid flow path associated with a wound dressing) is determined. In some embodiments, the TFR is determined according to the following equation:

[0193] TFR=C1*F*P+C2

[0194] Where TFR is the total flow rate, F is the frequency of the pump tachometer signal, P is the pressure generated by the pump (e.g., negative pressure setpoint), and C1 and C2 are suitable constants (determined for a given negative pressure source). The determined flow rate can be compared with various flow rate thresholds (such as one or more blockage thresholds) to determine the presence of a specific condition (such as blockage, leakage, full tank, etc.).

[0195] In some embodiments, the total flow rate of the system can be determined. The total flow rate (TFR) can correspond to the sum of the leakage rates observed from the negative pressure source. For example, one or more conversion equations or conversion tables can be used to determine the expected TFR, for example, in calibration mode. If there are no air leaks, the expected TFR can correspond to the TFR of the system in steady-state operation (e.g., when the negative pressure setpoint has been reached). The system can then monitor the TFR and compare it to one or more leakage or flow rate thresholds to determine the presence of a specific condition, such as blockage, no flow, normal operation, full tank, etc. In some embodiments, the expected TFR can be determined under non-steady-state conditions. In some cases, more than one expected TFR can be used.

[0196] In some embodiments, a blockage is detected when the determined flow rate fails to meet one or more flow thresholds. For example, a blockage alarm can be enabled if the blockage persists for a period of time, such as 30 seconds or another suitable period. This approach allows for hysteresis, preventing transient events from causing the system to falsely report the presence of one or more operational states. In embodiments where the system includes more than one wound dressing, a different blockage alarm can be enabled for each wound dressing. The blockage alarm can be disabled when the determined flow rate exceeds one or more flow thresholds. In some embodiments, the system can distinguish between a blockage and a full state in one or more fluid flow paths.

[0197] In some embodiments, blockage and presence of fluid in one or more fluid flow paths are detected by processing data from one or more pressure sensors (not shown), which may be located at any suitable location in the flow path. In some embodiments, the pressure sensors are located at or near the inlet of a negative pressure source. This detection can be enhanced by changing one or more settings of the pump, such as increasing the pressure level delivered by the pump, decreasing the pressure level, stopping the pump, changing the pump speed, changing the pump rhythm, etc.

[0198] In some embodiments, the flow rate can be estimated as the volume of air, gas, or other fluid moving per unit time in the fluid flow path, normalized to standard temperature and standard pressure (e.g., 1 atm). The flow rate can be calculated periodically according to the following formula, such as every 250 milliseconds or any other suitable time value:

[0199] TFR = Slope * Tachometer reading + Intercept

[0200] The tachometer is a short tachometer average (e.g., the average of the most recent tachometer readings, measured in Hz over a period of 2.5 seconds or another suitable timeframe), and the slope and intercept are constants based on the negative pressure setpoint. For a given negative pressure source, the values ​​of the slope and intercept can be determined for possible pressure setpoints (e.g., -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg). Flow rate as a function of pump speed may not be the best fit as a single line, as pumps can be designed to be more efficient at lower flow rates. Therefore, slope and intercept values ​​can be pre-calculated for various setpoints and various pumps. As described in this article, a given flow rate can be compared with various flow thresholds to determine the existence of a specific operating state (e.g., blocked state, no flow state, full state, abnormal state, normal state, etc.).

[0201] Additionally, the system may use one or more sensors to determine and monitor pressure in the fluid flow path. For example, the fluid flow path may include pressure sensors at or near wound dressing 406, at or near inlet manifold branch attachment 444, or anywhere else along the fluid flow path. In some embodiments, the pump assembly includes a pressure sensor in or near the pump assembly inlet (or canister connection). This pressure sensor measures the pressure in or near the canister (or in the dressing in a canisterless system). The pump assembly may continuously measure the pressure in the canister, such as every millisecond or any other suitable duration. A suitable number of the most recent pressure sensor readings may be averaged to mitigate the effects of one or more erroneous readings.

[0202] Based on the determined total flow rate, the pump assembly can monitor and detect various operating states as described herein. One or more of these states can be detected through, for example... Figure 13 and 14 Detection is performed using flowcharts 700 or 800 shown. Blockages in one or more fluid flow paths can be determined by comparing the total flow rate to one or more flow thresholds. The comparison can be performed with a hysteresis, such as continuously or substantially continuously over a period of time, like 2 minutes or any other suitable duration. One or more flow thresholds can be selected or determined based on a specific pressure setpoint, as the TFR is also expected to depend on the setpoint. That is, to detect blockages, the pump assembly can utilize multiple flow thresholds corresponding to a specific pressure setpoint. Alternatively or additionally, flow thresholds can be selected or determined based on the leakage rate of one or more air leaks. As explained herein, flow rate can be determined indirectly by detecting and monitoring pump speed.

[0203] If one or more flow thresholds are met or not met (e.g., over a period of time), the system determines that a blockage exists in at least one of the fluid flow paths and provides an indication, which may include activating an alarm (e.g., visual, audio, or tactile), suspending negative pressure operation, etc. For example, to determine the presence of a blockage, the pump assembly may determine whether the total flow rate meets, exceeds, or falls below a flow threshold during a 2-minute time period or any other suitable time period. Because the total flow rate can be updated at periodic time intervals due to periodic sampling of the tachometer, the pump assembly may compare the total flow rate as it updates to the flow threshold within the 2-minute time period. A blockage can be detected as long as each total flow rate determined during the 2-minute interval meets, exceeds, or falls below the flow threshold. Alternatively or additionally, a blockage can be detected if a majority of the calculated total flow rates (e.g., 9 out of 10 or any other suitable number) meet, exceeds, or falls below the flow threshold. When the total flow rate falls below (or exceeds) one or more flow thresholds over a period of time (e.g., 5 seconds or any other suitable duration), the detected blockage may be cleared.

[0204] The threshold can be any suitable flow threshold, such as a value selected or determined based on the negative pressure setpoint and expected flow rate in the fluid path, which can be determined as described herein.

[0205] In some embodiments, one or more flow sensors or flow meters may be used to directly measure fluid flow. In some embodiments, a pump assembly may utilize one or more of the techniques described herein in parallel to control the pump and detect various conditions. The pump assembly may be configured to appropriately arbitrate between parameters determined using different techniques. For example, the pump assembly may arbitrate between determining the flow rate indirectly (e.g., based on the pump speed measured by a tachometer) and determining the flow rate directly (e.g., by using a flow meter). In some embodiments, the pump assembly may determine the flow rate indirectly and directly when necessary, such as when the indirectly determined flow rate is considered inaccurate or unreliable.

[0206] In some embodiments, selecting or activating a Y-connector or W-connector feature for treating multiple wounds can alter or modify the detection of one or more operational states, such as blockage, leakage, fullness, etc. Activating a Y-connector or W-connector feature can adjust one or more of the various thresholds described herein. In some embodiments, the system automatically detects the presence of a Y-connector or W-connector. For example, if a single wound dressing with a leakage rate of 1 CLP is connected, the system can automatically detect the presence of a Y-connector by detecting a leak exceeding the expected 1 CLP leakage rate. For example, the system can prompt the user to confirm the presence of another flow path, for example, with a leakage rate of 2 CLP. Once the user confirms, the system will know that a blockage has been detected and can determine the flow threshold at least in part based on the determination of the leakage rate. A similar determination can be used for a W-connector with three flow paths. For example, continuing with the foregoing example, if the system detects a leak exceeding the expected 3 CLP leakage rate, the system can detect the presence of a W-connector and can prompt the user to confirm the presence of another flow path with a leakage rate of, for example, 4 CLP. In some embodiments, a similar approach can be used when treating more than three wounds.

[0207] Figure 13 A flowchart of a process 700 for determining and indicating one or more operational states, according to some embodiments, is shown. In some embodiments, process 700 is implemented by a decompression wound treatment system 500, such as by one or more controllers of the system.

[0208] At block 702, process 700 determines one or more operating parameters. For example, process 700 may determine the number of attached wound dressings, whether the fluid flow path corresponding to the attached wound dressings includes an air leak, the leakage rate of one or more air leaks, the expected total flow rate (TFR) of the system, the expected flow rate for each fluid flow path, one or more flow thresholds, the activity level of the negative pressure source, etc. In some embodiments, process 700 may perform one or more of these determinations in a calibration mode. Alternatively, some or all of these determinations may be automatically detected or received by the process upon each wound dressing attachment. In some embodiments, a user may input some or all of the operating parameters, or the process may perform internal calculations, or may utilize conversion equations or conversion tables.

[0209] As described herein, in some embodiments, process 700 can detect the presence of one or more attached wound dressings by detecting a leakage rate higher than expected. For example, the process can automatically detect the presence of a Y-connector by detecting a leak at a leakage rate higher than expected and prompt the user to confirm the presence of an alternative flow path. Once the user confirms, the process determines how to detect the blockage. In other embodiments, the process can detect when a wound dressing is attached and will determine the specifications of the air leak vent based on the attached wound dressing.

[0210] Process 700 may also determine the expected flow rate for each of the fluid flow paths corresponding to each of the attached wound dressings. As described herein, each of the fluid flow paths may include one or more air leaks configured to introduce fluid into the fluid flow path containing the air leak. Additionally, each of the air leaks may have a different leakage rate (e.g., the rate at which fluid is introduced into the fluid flow path). Therefore, each fluid flow path may have a different expected flow rate.

[0211] Process 700 may determine multiple flow thresholds based at least in part on the quantity of wound dressings or the leakage rate of one or more air leaks. For example, the process may have two wound dressings, each with a different flow rate. The process may determine a first flow threshold corresponding to a flow rate equal to the combined expected flow rate of a first fluid flow path and the expected flow rate of a second fluid flow path. A second flow threshold corresponds to the expected flow rate of the second fluid flow path. A third flow threshold corresponds to the expected flow rate of the first fluid flow path. Therefore, if the monitored TFR meets the first flow threshold, the system operates normally. If the monitored TFR meets the second flow threshold but not the third flow threshold, the process may determine that the first fluid flow path is blocked. The process can make this determination because when the flow rate is equal to the expected flow rate of the second fluid flow path, the process only detects flow in the second fluid flow path. Therefore, the process does not detect any flow from the first fluid flow path, and thus the process can determine that the first fluid flow path is blocked. In some embodiments, one or more of the thresholds may be higher or lower than the expected flow rate to allow variation, for example, during operation.

[0212] In some embodiments, the flow thresholds may correspond to the leakage rate of the system. For example, the system may have two wound dressings. Each wound dressing may have an associated fluid flow path. A first fluid flow path associated with a first wound dressing includes an air leakage of 1 CLP. A second fluid flow path associated with a second wound dressing includes an air leakage of 2 CLP. Process 700 may determine that the first flow threshold corresponds to a leakage rate of 3 CLP, the second flow threshold corresponds to a leakage rate of 2 CLP, and a third flow threshold corresponds to 1 CLP. Therefore, if the process detects a TFR of 1 CLP (e.g., meeting the third threshold but not the second or third threshold), the process may determine that the second fluid flow path is blocked. The process can make this determination because when the TFR is equal to 1 CLP, the system only detects flow in the first fluid flow path. Therefore, the process does not detect flow from the second fluid flow path, and thus the process may determine that the second fluid flow path is blocked. Similarly, if the process detects a TFR of 2 CLP (e.g., the TFR meets the second threshold but not the third threshold), the process may determine that the first fluid flow path is blocked. Similarly, if the process detects a TFR of 3CLP (e.g., the TFR meets the third threshold), it can determine that neither the first nor the second fluid flow path is blocked, and the system is operating normally. Conversely, if the process detects no flow, it can determine that the system is blocked due to, for example, all fluid flow paths being blocked or the tank being full. This is summarized in the table below:

[0213] <![CDATA[ Flow rate ]]> <![CDATA[ Sure ]]> 3CLP Normal operation 2CLP The first fluid flow path is blocked. 1CLP The second fluid flow path is blocked. 0CLP The system is blocked

[0214] Table 1: CLP is 1 and 2.

[0215] In some embodiments, one or more of the thresholds may be higher or lower to address inaccuracies. For example, although the first air leak is equal to 1 CLP, the first flow threshold provides a small buffer (e.g., 0.03, 0.05, 0.1, 0.15, 0.2, or 0.25 CLP) such that the threshold is slightly below or slightly above 1 CLP. Similar buffers can be used for other flow thresholds. For example, the first and second thresholds may be 0.5 and 1 CLP, respectively, and the process may involve determining the following:

[0216] <![CDATA[ Flow rate ]]> <![CDATA[ Sure ]]> 1.5CLP Normal operation 1CLP The first fluid flow path is blocked. 0.5CLP The second fluid flow path is blocked. 0CLP The system is blocked

[0217] Table 2: CLP values ​​are 0.5 and 1.

[0218] At block 704, process 700 uses one or more flow rate monitoring techniques described herein to monitor total flow rate (TFR). If one or more such techniques are performed in parallel, the process can appropriately arbitrate between flow rates determined using multiple flow rate monitoring techniques. In some embodiments, the process may perform one of the techniques, such as flow rate determination based on pump speed, and utilize one or more other techniques as needed. In various embodiments, the process may utilize one or more other techniques if the determined flow rate is considered inaccurate or unreliable. In some embodiments, the total flow rate corresponds to the collection of flows in each flow path during the process. For example, the total flow rate may correspond to the collection of flows in a first fluid flow path and flows in a second fluid flow path.

[0219] In some embodiments, the monitored TFR can be compared with the expected TFR to determine whether the system is operating normally. Therefore, by comparing the monitored TFR with the expected TFR (e.g., by subtracting the expected TFR from the monitored TFR), process 700 can determine the deviation between the current flow rate and the expected flow rate. This deviation may be due to the presence of one or more operating states.

[0220] At box 706, process 700 determines whether the monitored TFR meets (e.g., substantially equal to or exceeds) a first flow threshold corresponding to the expected TFR. If the first flow threshold is met, then at box 708, the system may indicate that the system is operating normally. The indications in box 708 or any other box of process 700 may be performed using any of the methods described herein.

[0221] If the monitored TFR does not meet the first threshold, process 700 transitions to block 710, where the process determines whether the monitored TFR meets a second flow threshold. If the second flow threshold is met (e.g., the TFR is substantially equal to or higher than the second flow threshold), then at block 712, process 700 may indicate a blockage present in the first fluid flow path. This determination is made because, based on the determination that the TFR meets the second threshold (and does not meet the first flow threshold), the process can determine that it has only detected flow from the second fluid flow path.

[0222] If the monitored TFR does not meet the second threshold, process 700 transitions to block 714, where it determines whether the monitored TFR meets a third flow threshold. If the third flow threshold is met (e.g., the TFR is substantially equal to or higher than the third threshold), then at block 716, the process can indicate a blockage in the second fluid flow path. This determination is made because, based on the determination that the TFR meets the third threshold (and does not meet the first and second thresholds), the process can determine that it has only detected flow from the first fluid flow path.

[0223] If the monitored TFR does not meet the third threshold, process 700 transitions to box 718, where it determines and indicates that the system is blocked.

[0224] Although the examples provided in the combination process 700 generally relate to systems with a first wound dressing and a second wound dressing, it should be noted that similar techniques can be performed for systems with any number of wound dressings.

[0225] Furthermore, it should be understood that fewer, more, or different boxes may be used as part of process 700. For example, process 700 may include fewer boxes if, for example, one or more leakage rates are equal or approximately equal (e.g., + / - 0.1 L / min or another suitable deviation). As described above, the system may have two wound dressings, and each wound dressing may have an associated fluid flow path. For example, a first fluid flow path associated with a first wound dressing may include an air leak of 1 CLP, and a second fluid flow path associated with a second wound dressing may also include an air leak of 1 CLP. Therefore, process 700 may utilize two flow thresholds: a first flow threshold corresponding to a leakage rate of 2 CLP, and a second flow threshold corresponding to a leakage rate of 1 CLP. If process 700 detects a TFR of 1 CLP (e.g., meeting the first threshold but not the second threshold), the process may determine that either the first or second fluid flow path is blocked. Process 700 can make this determination because when the TFR is equal to 1 CLP, the process detects flow from only one of the fluid flow paths. In some cases, the process can identify or indicate which fluid flow path is blocked, while in others, it can identify or indicate that a blockage has occurred somewhere within one of the fluid flow paths. If the process 700 detects a TFR of 2CLP (e.g., the TFR meets a third threshold), it can determine that neither the first nor the second fluid flow path is blocked and the system is operating normally. Additionally, if the process detects no flow, it can determine that the system is blocked due to, for example, all fluid flow paths being blocked or the tank being full. This is summarized in the table below:

[0226] <![CDATA[ Flow rate ]]> <![CDATA[ Sure ]]> <![CDATA[ 2CLP ]]> <![CDATA[ Normal operation ]]> <![CDATA[ 1CLP ]]> <![CDATA[ A blockage occurs somewhere in the fluid flow path. ]]> <![CDATA[ 0CLP ]]> <![CDATA[ The system is blocked ]]>

[0227] Table 3: CLP is 1 and 1.

[0228] Figure 14 A flowchart of a process 800 for determining and indicating one or more operational states, according to some embodiments, is shown. In some embodiments, process 800 is implemented by a decompression wound treatment system 600, such as by one or more controllers of the system.

[0229] At block 802, similar to block 702 of FIG. 7, process 800 determines one or more operating parameters. For example, the process may determine the number of attached wound dressings, whether the fluid flow path corresponding to the attached wound dressings includes air leaks, the leakage rate of one or more air leaks, the total leakage rate, the expected total flow rate (TFR) of the system, the expected flow rate for each fluid flow path, one or more flow thresholds, the pump activity level, etc. In some embodiments, the process may perform some or all of these determinations in a calibration mode. Alternatively, some or all of these operating parameters may be automatically detected or received by the process at each wound dressing attachment. In some embodiments, a user may input some or all of the operating parameters, or the process may perform internal calculations, or may utilize transformation equations or transformation tables.

[0230] As described herein, process 800 can detect the presence of one or more attached wound dressings by detecting a leakage rate higher than expected. For example, the process can automatically detect the presence of a W-connector by detecting a leak at a rate higher than expected and prompt the user to confirm the existence of an alternative flow path. Once the user confirms, the process will know how to detect blockages. In other embodiments, the process can detect when a wound dressing is attached and will determine the specifications of the air leak vent based on the attached wound dressing.

[0231] Process 800 can determine multiple flow thresholds. In this example, the process can determine at least seven flow thresholds. However, it should be noted that more or fewer flow thresholds can be determined. As described with reference to box 702 of Figure 7, the flow thresholds may correspond to the TFR of the system in one or more operating states.

[0232] In some embodiments, a first flow threshold corresponds to the flow rate equal to the combined flow rate of a first fluid flow path (expected first flow rate), a second fluid flow path (expected second flow rate), and a third fluid flow path (expected third flow rate). A second flow threshold corresponds to the combined flow rate of the expected second and third flow rates. A third flow threshold corresponds to the combined flow rate of the expected first and third flow rates. A fourth flow threshold corresponds to the combined flow rate of the expected first and second flow rates. A fifth flow threshold corresponds to the flow rate equal to the expected third flow rate. A sixth flow threshold corresponds to the flow rate equal to the expected second flow rate. A seventh flow threshold corresponds to the flow rate equal to the expected first flow rate.

[0233] For example, a first fluid flow path may have a leakage rate of 1 CLP, a second fluid flow path may have a leakage rate of 3 CLP, and a third fluid flow path may have a leakage rate of 5 CLP. A first flow threshold corresponds to a leakage rate equal to 9 CLP (e.g., the aggregate of all leakage rates). A second flow threshold corresponds to a leakage rate equal to 8 CLP. A third flow threshold corresponds to a leakage rate equal to 6 CLP. A fourth flow threshold corresponds to a leakage rate equal to 5 CLP. A fifth flow threshold corresponds to a leakage rate equal to 4 CLP. A sixth flow threshold corresponds to a leakage rate equal to 3 CLP. A seventh flow threshold corresponds to a leakage rate equal to 1 CLP. In summary:

[0234] Flow rate Sure 9CLP Normal operation 8CLP The first fluid flow path is blocked. 7CLP N / A or unexpected flow rate 6CLP The second fluid flow path is blocked. 5CLP The first fluid flow path and the second fluid flow path are blocked. 4CLP The third fluid flow path is blocked. 3CLP The first and third fluid flow paths are blocked. 2CLP N / A or unexpected flow rate 1CLP The second and third fluid flow paths are blocked. 0CLP The system is blocked

[0235] Table 4: CLP values ​​are 1, 3, and 5.

[0236] In some embodiments, the order of flow thresholds may be changed based on the leakage rate of the air leak.

[0237] At box 804, similar to box 704 of FIG7, process 800 uses one or more of the flow rate monitoring techniques described herein to monitor TFR.

[0238] At box 806, process 800 determines whether the monitored TFR meets (e.g., substantially equal to or exceeds) a first flow threshold. If the first flow threshold is met, then at box 808, the process may indicate that the system is operating normally. Indications in box 808 or any other box of process 800 may be performed using any of the methods described herein.

[0239] If the monitored TFR does not meet the first flow threshold, the process transitions to box 810, which determines whether the monitored TFR meets (e.g., substantially equal to or exceeds) a second flow threshold. If the second flow threshold is met (and the first flow threshold is not met), then at box 812, the process may indicate a blockage present in the first fluid flow path. The process can make this determination because, based on the thresholds met, the process can determine that it has only detected flow from the second and third fluid flow paths.

[0240] If the monitored TFR does not meet the second flow threshold, the process transitions to box 814, which determines whether the monitored TFR meets (e.g., substantially equal to or exceeds) a third flow threshold. If the third flow threshold is met (and the first and second flow thresholds are not met), then at box 816, the process may indicate a blockage in the second fluid flow path. The process can make this determination because, based on the thresholds met, it can determine that it has detected flow only from the first and third fluid flow paths.

[0241] If the monitored TFR does not meet the third flow threshold, the process transitions to box 818, which determines whether the monitored TFR meets (e.g., substantially equal to or exceeds) a fourth flow threshold. If the fourth flow threshold is met (and the first, second, and third flow thresholds are not met), then at box 820, the process may indicate a blockage present in the first and second fluid flow paths. The process can make this determination because, based on the thresholds met, it can determine that it has only detected flow from the third fluid flow path.

[0242] If the monitored TFR does not meet the fourth flow threshold, the process transitions to box 822, which determines whether the monitored TFR meets (e.g., substantially equal to or exceeds) the fifth flow threshold. If the fifth flow threshold is met (and the first through fourth flow thresholds are not met), then at box 824, the process may indicate a blockage in the third fluid flow path. The process can make this determination because, based on the thresholds met, it can determine that it has only detected flow from the first and second fluid flow paths.

[0243] If the monitored TFR does not meet the fifth flow threshold, the process transitions to box 826, which determines whether the monitored TFR meets (e.g., substantially equal to or exceeds) the sixth flow threshold. If the sixth flow threshold is met (and the first through fifth flow thresholds are not met), then at box 828, the process may indicate that there is a blockage in the first and third fluid flow paths. The process can make this determination because, based on the thresholds met, the process can determine that it has only detected flow from the second fluid flow path.

[0244] If the monitored TFR does not meet the sixth flow threshold, the process transitions to box 830, which determines whether the monitored TFR meets (e.g., substantially equal to or exceeds) the seventh flow threshold. If the seventh flow threshold is met (and the first through sixth flow thresholds are not met), then at box 832, the process can indicate the presence of a blockage in the second and third fluid flow paths. The process can make this determination because, based on the thresholds met, it can determine that it has only detected flow from the first fluid flow path.

[0245] At box 834, process 800 determines that no flow threshold is met and indicates a system blockage.

[0246] Although the examples provided in the combination process 800 relate to systems with a first wound dressing, a second wound dressing, and a third wound dressing, it should be noted that similar techniques can be performed for systems with any number of wound dressings.

[0247] Examples, embodiments, methods, processes, or apparatuses of negative pressure wound therapy systems with calibrated leak paths are further provided in International Application No. PCT / EP2018 / 056494, entitled “MULTIPLE DRESSING NEGATIVE PRESSURE WOUND THERAPY SYSTEM WITHCALIBRATED LEAK PATHS”, filed March 15, 2018, which is incorporated herein by reference in its entirety.

[0248] the term

[0249] Depending on the implementation, certain operations, actions, events, or functions of any process described herein may be performed in a different order, and may be added, combined, or omitted (as not all practices of the process are necessary). Furthermore, in some embodiments, operations, actions, functions, or events may be performed concurrently, such as through multithreaded processing, interrupt handling, or multiple processors or processor cores, or on other parallel architectures, rather than sequentially.

[0250] The processing of the various components of the illustrated system can be distributed across multiple machines, networks, and other computing resources. Furthermore, two or more components of the system can be combined into fewer components. The various components of the illustrated system can be implemented in one or more virtual machines, rather than in dedicated computer hardware systems and / or computing devices. Similarly, the illustrated data repository can represent physical and / or logical data storage, including, for example, storage area networks or other distributed storage systems. Moreover, in some embodiments, the connections between the illustrated components represent possible paths for data flow, rather than actual connections between hardware components. Although some examples of possible connections are shown, any subset of the illustrated components can be connected to any other subset of the components in various embodiments.

[0251] Any patents, applications, and other references mentioned above (including any references that may be listed in the accompanying application documents) are incorporated herein by reference. Where necessary, aspects of this disclosure may be modified to incorporate the systems, functions, and concepts of the various references described herein to provide other implementations.

[0252] The features, materials, characteristics, or sets described in conjunction with a particular aspect, embodiment, or example are to be understood to apply to any other aspect, embodiment, or example described herein, unless incompatible therewith. All features disclosed in this specification (including any appended claims, abstract, and drawings), or all steps of any method or process so disclosed, may be combined in any combination, except for at least some mutually exclusive combinations of such features or steps. Protection is not limited to the details of any of the foregoing embodiments. Protection extends to any novel or any novel combination of features disclosed in this specification (including any appended claims, abstract, and drawings), or any novel or any novel combination of steps of any method or process so disclosed.

[0253] Although certain embodiments have been described, these embodiments are presented by way of example only and are not intended to limit the scope of protection. In fact, the novel methods and systems described herein can be embodied in various other forms. Furthermore, various omissions, substitutions, and changes can be made to the form of the methods and systems described herein. Those skilled in the art will understand that in some embodiments, the actual steps taken in the illustrated or disclosed process may differ from those shown in the accompanying drawings. According to embodiments, some of the above-described steps may be removed, and other steps may be added. For example, the actual steps or the order of steps taken in the disclosed process may differ from those shown in the figures. According to embodiments, some of the above-described steps may be removed, and other steps may be added. For example, the various components shown in the figures may be implemented as software or firmware on a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components such as processors, ASICs, FPGAs, etc., may include logic circuitry. Moreover, the features and attributes of the specific embodiments disclosed above can be combined in different ways to form other embodiments, all of which fall within the scope of this disclosure.

[0254] While this disclosure includes certain embodiments, examples, and applications, those skilled in the art will understand that this disclosure extends beyond the specific disclosed embodiments to other alternative embodiments or uses, as well as obvious modifications and equivalents thereof, including embodiments that do not provide all the features and advantages described herein. Therefore, the scope of this disclosure is not intended to be limited by the described embodiments and may be defined by the claims as presented herein or to be presented in the future.

[0255] Conditional languages, such as “can,” “may,” “possibly,” or “may,” unless explicitly stated otherwise or otherwise understood in the context in which they are used, are generally intended to express that some embodiments include (while others do not) certain functions, elements, or steps. Therefore, such conditional languages ​​are not generally intended to imply that one or more embodiments require features, elements, or steps in any way, or that one or more embodiments must include logic for determining whether such features, elements, or steps are included in or performed in any particular embodiment, with or without user input or prompting. The terms “comprising,” “including,” “having,” etc., are synonymous and used in an open-ended manner, and do not exclude additional elements, features, actions, operations, etc. Additionally, the term “or” is used in its inclusive sense (but not in its proprietary sense) so that, when used, for example, to connect lists of elements, the term “or” indicates one, some, or all of the elements in the list. Similarly, the term “and / or” refers to a list of two or more items, covering all of the following interpretations of the word: any one item in the list, all items in the list, and any combination of items in the list. In addition, besides having its ordinary meaning, the term "each" as used herein may mean any subset of a set of elements to which the term "each" is applied. Furthermore, when used in this application, the words "in this document," "above," "below," and words with similar meanings refer to the application as a whole, and not to any particular part of the application.

[0256] Unless otherwise explicitly stated, union language such as the phrase "at least one of X, Y, and Z" is understood in context as generally used to indicate that an item, term, etc., may be X, Y, or Z. Therefore, such union language generally does not imply that certain embodiments require the presence of at least one X, at least one Y, and at least one Z.

[0257] The degree language used herein, such as the terms “about,” “approximately,” “generally,” and “roughly”, refers to a value, quantity, or characteristic that is close to a specified value, quantity, or characteristic, which still performs the desired function or achieves the desired result. For example, the terms “about,” “approximately,” “generally,” and “roughly” may refer to a quantity that is less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of a specified quantity. As another example, in some embodiments, the terms “generally parallel” and “roughly parallel” refer to a value, quantity, or characteristic that deviates from exact parallelism by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degrees.

[0258] Any of the embodiments described herein may or may not be used with a jar. Any of the dressing embodiments described herein are designed to absorb and retain wound exudate.

[0259] The scope of this disclosure is not intended to be limited by the description of certain embodiments, but is to be defined by the claims. The language of the claims will be interpreted broadly based on the language used in the claims and is not limited to the instances described in this specification or during the examination of the application, which should be interpreted as non-exclusive.

Claims

1. A fluid connector for negative pressure wound therapy, comprising: The structure consists of a top layer, a bottom layer, and a middle layer, each constructed of a flexible, liquid-impermeable material, and each layer includes a proximal end and a distal end. An upper fluid passage, the upper fluid passage being at least partially defined between the top layer and the intermediate layer, the upper fluid passage including a proximal end and a distal end, wherein the upper fluid passage includes an upper channel spacer material positioned between the top layer and the intermediate layer, and wherein the upper fluid passage is configured to provide gas from an opening in the top layer located at or near the proximal end of the upper fluid passage; A lower fluid passage, the lower fluid passage being at least partially defined between the intermediate layer and the bottom layer, the lower fluid passage being configured to be in fluid communication with a negative pressure source, the lower fluid passage including a lower channel spacer material positioned between the intermediate layer and the bottom layer; An opening at the distal end of the sublayer, the opening in the sublayer being configured to be positioned above an opening in the dressing, the dressing being configured to be positioned above a wound, wherein the opening in the sublayer is fluidly connected to the lower fluid passage. An opening at the distal end of the intermediate layer, the opening in the intermediate layer being fluidly connected to the upper fluid passage, the opening in the intermediate layer being positioned above the opening in the bottom layer. The distal end of the upper channel spacer material extends further than the distal end of the lower channel spacer material, and the lower fluid passage includes a portion at its distal end that does not contain the lower channel spacer material. This portion of the lower fluid passage includes an opening in the underlying layer. When negative pressure from the negative pressure source is applied to the lower fluid passage, the portion of the lower fluid passage collapses, thereby blocking the fluid flow between the lower channel spacer material and the upper channel spacer material through the portion of the lower fluid passage, while allowing fluid flow between the lower channel spacer material and the upper channel spacer material through the openings in the dressing, the openings in the bottom layer, and the openings in the intermediate layer.

2. A fluid connector for negative pressure wound therapy, comprising: The structure consists of a top layer, a bottom layer, and a middle layer, each constructed of a flexible, liquid-impermeable material, and each layer includes a proximal end and a distal end. An upper fluid passage, the upper fluid passage being at least partially defined between the top layer and the intermediate layer, the upper fluid passage including a proximal end and a distal end, wherein the upper fluid passage includes an upper channel spacer material positioned between the top layer and the intermediate layer, and wherein the upper fluid passage is configured to provide gas from an opening in the top layer located at or near the proximal end of the upper fluid passage; A lower fluid passage, the lower fluid passage being at least partially defined between the intermediate layer and the bottom layer, the lower fluid passage being configured to be in fluid communication with a negative pressure source, the lower fluid passage including a lower channel spacer material positioned between the intermediate layer and the bottom layer; One or more openings at the distal end of the substrate, the one or more openings in the substrate being configured to be positioned above an opening in the dressing, the dressing being configured to be positioned above a wound, wherein at least one of the one or more openings in the substrate is fluidly connected to the lower fluid passage. An opening at the distal end of the intermediate layer, the opening in the intermediate layer being fluidly connected to the upper fluid passage, the opening in the intermediate layer being positioned above at least one of one or more openings in the bottom layer, and The distal end of the upper channel spacer material extends further than at least a portion of the distal end of the lower channel spacer material, such that the lower fluid passage includes a portion at its distal end that does not contain the lower channel spacer material, the portion of the lower fluid passage including one or more openings in the underlying layer.

3. The fluid connector of claim 2, wherein when negative pressure from the negative pressure source is applied to the lower fluid passage, the portion of the lower fluid passage collapses, thereby blocking fluid flow between the lower channel spacer material and the upper channel spacer material through the portion of the lower fluid passage, while allowing fluid flow between the lower channel spacer material and the upper channel spacer material through openings in the dressing, one or more openings in the bottom layer, and openings in the intermediate layer.

4. The fluid connector of claim 2 or 3, wherein a portion of the lower channel spacer material at the distal end overlaps with an opening in the substrate or one of one or more openings in the substrate.

5. The fluid connector of claim 2 or 3, further comprising an applicator attached to the underlying layer at the distal end, the applicator comprising an adhesive configured to adhere to the dressing.

6. The fluid connector of claim 2 or 3, further comprising an applicator attached to the sublayer at the distal end, wherein the applicator includes an opening located directly below an opening in the sublayer or one or more openings in the sublayer, and configured to be positioned above an opening in the dressing.

7. The fluid connector of claim 2 or 3, further comprising an applicator attached to the underlying layer at the distal end, wherein the applicator includes an opening, wherein at least a portion of the opening in the intermediate layer overlaps with the opening in the applicator.

8. The fluid connector according to claim 2 or 3, wherein the opening in the bottom layer or one or more openings in the bottom layer are wider than the opening in the intermediate layer.

9. The fluid connector of claim 2 or 3, wherein the center of the opening in the intermediate layer is located further away than the center of the opening in the bottom layer or the center of each of one or more openings in the bottom layer.

10. The fluid connector according to claim 2 or 3, wherein the upper channel spacer material comprises foam.

11. The fluid connector according to claim 2 or 3, wherein the lower channel spacer material comprises a 3D knitted or 3D fabric material.

12. The fluid connector of claim 2 or 3, wherein each of the top layer and the bottom layer has an enlarged distal end.

13. The fluid connector of claim 12, wherein the enlarged ends of the top layer and the bottom layer are rectangular.

14. The fluid connector of claim 12, wherein the enlarged ends of the top layer and the bottom layer form a teardrop shape.

15. The fluid connector of claim 2 or 3, wherein the underlying layer is configured to attach to the dressing.

16. The fluid connector of claim 2 or 3, wherein the opening in the top layer comprises a filter.

17. The fluid connector of claim 2 or 3, further comprising a connector in proximal fluid communication with the lower channel spacer material, the connector being configured to be fluidly connected to the negative pressure source.

18. The fluid connector of claim 2 or 3, wherein the lower fluid passage includes a welded portion, at which a portion of the bottom layer is welded to the intermediate layer.

19. The fluid connector of claim 18, wherein when negative pressure from the negative pressure source is applied to the lower fluid passage, the welded portion in the lower fluid passage blocks fluid flow through the portion of the lower fluid passage between the lower channel spacer material and the upper channel spacer material, while allowing fluid flow through the opening in the dressing, one or more openings in the bottom layer, and openings in the intermediate layer between the lower channel spacer material and the upper channel spacer material.

20. The fluid connector of claim 18, wherein the lower fluid passage comprises a distal portion and a proximal portion, the distal portion being separated from the proximal portion by a welded portion of the lower fluid passage.

21. The fluid connector of claim 18, wherein one or more openings in the underlying layer comprise two openings.

22. The fluid connector of claim 21, wherein the solder portion of the underlying layer is located between the two openings.

23. The fluid connector of claim 21, wherein at least one of the two openings is semi-circular in shape.

24. The fluid connector of claim 2 or 3, wherein the distal end of the lower channel spacer material includes a bifurcated shape, the bifurcated shape including a base portion between two side portions, wherein the two side portions extend distally from the base portion, one or more openings in the bottom layer and an opening in the intermediate layer, wherein the base portion is adjacent to one or more openings in the bottom layer and an opening in the intermediate layer.

25. The fluid connector of claim 24, wherein the portion of the lower fluid passage is positioned between two side portions of the lower channel spacer material and distal to the base portion of the lower channel spacer material.

26. A fluid connector for negative pressure wound therapy, comprising: An upper fluid passage configured to provide gas toward the distal end of the upper fluid passage from an opening located at or near the proximal end of the upper fluid passage; A lower fluid passage configured to be in fluid communication with a negative pressure source and to allow fluid to flow toward the negative pressure source through the lower fluid passage; An intermediate layer between the upper fluid passage and the lower fluid passage, the intermediate layer comprising a fluid-impermeable material; One or more first openings at the distal end of the lower fluid passage, the one or more first openings being configured to be positioned above an opening in a dressing, the dressing being configured to be positioned above a wound; as well as A second opening at the distal end of the intermediate layer, the second opening being positioned above at least one of one or more first openings in the lower fluid passage, and the second opening being fluidly connected to the upper fluid passage. The upper fluid passage extends further than the lower fluid passage, and the lower fluid passage includes the vacant portion where the one or more first openings are located. When negative pressure is applied from the negative pressure source to the lower fluid passage, it blocks the fluid flow through the empty portion between the upper and lower fluid passages, while allowing the fluid flow of the dressing through the upper and lower fluid passages.

27. The fluid connector of claim 26, wherein the vacant portion collapses in response to negative pressure applied to the lower fluid passage, thereby blocking fluid flow through the vacant portion between the upper fluid passage and the lower fluid passage.

28. The fluid connector of claim 26, wherein the fluid connector further comprises a bottom layer at least partially located below the lower fluid passage, wherein the vacant portion includes a welded portion at which a portion of the bottom layer is welded to the intermediate layer, the welded portion being configured to block fluid flow through the vacant portion between the upper fluid passage and the lower fluid passage when negative pressure is applied to the lower fluid passage.

29. The fluid connector of claim 28, wherein the vacant portion of the lower fluid passage comprises a distal portion and a proximal portion, the distal portion being separated from the proximal portion by a soldered portion of the lower fluid passage.

30. The fluid connector of claim 28 or claim 29, wherein one or more openings in the underlying layer comprise two openings.

31. The fluid connector of claim 30, wherein the solder portion of the underlying layer is located between the two openings.

32. The fluid connector of claim 30, wherein at least one of the two openings is semi-circular in shape.

33. The fluid connector according to any one of claims 26-29, wherein the lower fluid passage includes a lower channel spacer material, and wherein a portion of the lower channel spacer material at a distal end of the lower fluid passage overlaps with one of the one or more first openings.

34. The fluid connector according to any one of claims 26-29, wherein the lower fluid passage includes a lower channel spacer material, and wherein a portion of the lower channel spacer material at the distal end of the lower fluid passage abuts the distal edge of one of the one or more first openings.

35. The fluid connector of any one of claims 26-29, wherein the fluid connector further comprises a bottom layer at least partially located below the lower fluid passage, wherein the lower fluid passage comprises a lower channel spacer material, wherein a portion of the lower channel spacer material at a distal end of the lower fluid passage comprises a bifurcated shape, the bifurcated shape comprising a base portion between two side portions, wherein the two side portions extend distally from the base portion, one or more openings in the bottom layer and an opening in the intermediate layer, wherein the base portion is adjacent to one or more openings in the bottom layer and an opening in the intermediate layer.

36. The fluid connector of claim 35, wherein the portion of the lower fluid passage is positioned between two side portions of the lower channel spacer material and distal to the base portion of the lower channel spacer material.

37. The fluid connector according to any one of claims 26-29, further comprising an applicator attached at the distal end to the bottom surface of the fluid connector, the applicator comprising an adhesive configured to adhere to the dressing.

38. The fluid connector of claim 37, wherein the applicator includes an opening directly below the one or more first openings and configured to be positioned above an opening in the dressing.

39. The fluid connector of claim 37, wherein at least a portion of the second opening overlaps with an opening in the applicator.

40. The fluid connector according to any one of claims 26-29, wherein the one or more first openings are wider than the second opening.

41. The fluid connector according to any one of claims 26-29, wherein the center of the second opening is located further away from the center of each of the one or more first openings.

42. The fluid connector according to any one of claims 26-29, wherein the gas comprises air.

43. The fluid connector according to any one of claims 26-29, wherein when negative pressure is applied from the negative pressure source to the lower fluid passage, fluid flow through the vacant portion between the upper fluid passage and the lower fluid passage is blocked, while fluid flow through the filler positioned in the vacant portion between the upper fluid passage and the lower fluid passage is allowed.

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