Multiple Negative Pressure Wound Therapy Systems

Abstract

Existing NPWT systems can only treat one wound at a time, resulting in inaccurate treatment when used to treat more than one wound. Further improvements in NPWT are needed to fully realize the benefits of treatment. A negative pressure therapy device includes a negative pressure source that provides negative pressure to a plurality of wound dressings via each fluid flow path, a pressure sensor configured to measure the combined pressure in the plurality of fluid flow paths, and a controller for operating the negative pressure source. The controller is configured to determine that the plurality of fluid flow paths includes a fluid flow path associated with an occlusion based on a determination that first pressure data received from the pressure sensor satisfies a first occlusion threshold, and to identify at least one fluid flow path among the plurality of fluid flow paths associated with the occlusion based on second pressure data received from the pressure sensor. The second pressure data is measured when at least one of a first valve for the first flow path and a second valve for the second flow path is closed.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority to U.S. Provisional Application No. 62 / 464,988, entitled "MULTIPLE DRESSING NEGATIVE PRESSURE WOUND THERAPY SYSTEM", filed on February 28, 2017; U.S. Provisional Application No. 62 / 464,992, entitled "MULTIPLE DRESSING NEGATIVE PRESSURE WOUND THERAPY SYSTEM", filed on February 28, 2017; and U.S. Provisional Application No. 62 / 465,011, entitled "MULTIPLE DRESSING NEGATIVE PRESSURE WOUND THERAPY SYSTEM", filed on February 28, 2017, each of which is hereby incorporated by reference in its entirety.

Background Art

[0002] The embodiments described herein relate to devices, systems, and methods for treating wounds using, for example, multiple wound dressings in combination with negative pressure wound therapy.

[0003] Negative pressure wound therapy (NPWT) promotes the formation of granulation tissue at the wound site and aids in the normal inflammatory process of the human body while simultaneously removing excess fluid that may contain harmful cytokines and / or bacteria, thereby promoting wound healing.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

[0005] Existing NPWT systems are typically limited, as they can only treat one wound at a time. When existing NPWT systems are used to treat two or more wounds, this results in ineffective and inaccurate treatment. However, further improvements to NPWT are needed to fully realize the therapeutic benefits. [Means for solving the problem]

[0006] In some embodiments, the negative pressure wound therapy device includes a negative pressure source, a plurality of pressure sensors, and a controller. The negative pressure source includes a plurality of inlets configured to connect to a plurality of wound dressings via a plurality of fluid channels and to provide negative pressure to the plurality of wound dressings. The plurality of fluid channels include a first fluid channel configured to fluidly connect a first wound dressing to the first inlet of the plurality of inlets, and a second fluid channel configured to fluidly connect a second wound dressing to the second inlet of the plurality of inlets. The plurality of pressure sensors are configured to measure the pressure in the fluid channels. The plurality of pressure sensors include a first pressure sensor configured to measure the pressure in the first fluid channel, and a second pressure sensor configured to measure the pressure in the second fluid channel. The controller is configured to operate the negative pressure source and to provide an indication of at least one operating state associated with at least one of the first or second fluid channels based on the pressure measured by at least one of the first or second pressure sensors.

[0007] The apparatus described in the preceding paragraph may also include any combination of the following features described in this paragraph, in particular, within the scope of this specification: At least one operating state may include blockage, leakage, overpressure, or full dressing state. The apparatus may further include a housing configured to support a negative pressure source and first and second inlets. The first fluid channel may include a first identifier configured to indicate to the user the fluid connection between the first wound dressing and the negative pressure source. The second fluid channel may include a second identifier configured to indicate to the user the fluid connection between the second wound dressing and the negative pressure source. The first and second identifiers may include at least one of printed pictograms, printed icons, embossed pictograms, embossed icons, Braille characters, or color codes. The first and second identifiers may be located in close proximity to the inlet manifold branch mounting. The controller may further be configured to provide a first indicator associated with the operating state in the first fluid channel and a second indicator associated with the operating state in the second fluid channel. The first and second indicators may be one or more visual or audible indicators.

[0008] In some embodiments, the negative pressure wound therapy device may include a negative pressure source, a pressure sensor, and a controller. The negative pressure source may include a plurality of inlets configured to connect to a plurality of wound dressings via a plurality of fluid channels and to provide negative pressure to the plurality of wound dressings. The plurality of fluid channels may include a first fluid channel configured to fluidly connect a first wound dressing to the first inlet of the plurality of inlets, and a second fluid channel configured to fluidly connect a second wound dressing to the second inlet of the plurality of inlets. The first fluid channel may include a flow limiter or flow expander and a pressure sensor configured to measure the pressure in at least one of the plurality of fluid channels. The controller may be configured to operate the negative pressure source and provide an indication of at least one operating state related to at least one of the first or second fluid channels based on the pressure measured by the pressure sensor.

[0009] The apparatus described in the preceding paragraph may also include any combination of the following features described in this paragraph, in particular, within the scope of this specification: At least one operating state may include one or more of the following conditions: blockage, leakage, overpressure, or full dressing. The controller may be configured to provide an indication of at least one operating state based on pressure changes over time. Pressure changes over time in the first fluid passage may differ from pressure changes over time in the second fluid passage. The controller may be further configured to detect blockage in the first or second fluid passage based on the difference in pressure changes over time in the first and second fluid passages. The apparatus may further include a housing configured to support a negative pressure source and first and second inlets. The first fluid passage may include a first identifier configured to indicate to the user the fluid connection between the first wound dressing and the negative pressure source. The second fluid passage may include a second identifier configured to indicate to the user the fluid connection between the second wound dressing and the negative pressure source. The first and second identifiers may include at least one of printed emojis, printed icons, embossed emojis, embossed icons, Braille characters, or color codes. The controller may be further configured to provide a first indicator associated with the operating state in the first fluid channel, and a second indicator associated with the operating state in the second fluid channel. The first and second indicators may be one or more visual or audible indicators.

[0010] In some embodiments, the negative pressure therapy device may include a negative pressure source, pressure sensors, and a controller. The negative pressure source may be configured to connect to multiple wound dressings via multiple fluid channels and to provide negative pressure to the multiple wound dressings. The multiple fluid channels may include a first fluid channel and a second fluid channel. The first fluid channel may be configured to fluidly connect a first wound dressing to the negative pressure source. The first fluid channel may have a first valve configured to prevent the passage of fluid into the first fluid channel. The second fluid channel may be configured to fluidly connect a second wound dressing to the negative pressure source. The second fluid channel may have a second valve configured to prevent the passage of fluid into the second fluid channel. Multiple pressure sensors may be configured to measure the pressure in the multiple fluid channels. The controller may be configured to operate the negative pressure source and detect an operating state associated with at least one of the first or second fluid paths based on the measured pressure.

[0011] The apparatus described in the preceding paragraph may also include any combination of the following features described in this paragraph, in particular, as described herein: The controller may be configured to detect the operating state in the first fluid passage when the first valve is open, allowing the passage of fluid in the first fluid passage, and when the second valve is closed, preventing the passage of fluid in the second fluid passage. The operating state in the first fluid passage may include an obstruction in the first fluid passage. The fluid passages may further include a third fluid passage configured to fluidly connect a third wound dressing to a negative pressure source. The third fluid passage may include a third valve configured to prevent the passage of fluid in the third fluid passage. The controller may be configured to detect the operating state in the first fluid passage when the first valve is open, allowing the passage of fluid in the first fluid passage, when the second valve is closed, preventing the passage of fluid in the second fluid passage, and when the third valve is closed, preventing the passage of fluid in the third fluid passage.

[0012] Any apparatus described in either of the preceding two paragraphs may also include any combination of the following features described in this paragraph, in particular within the description herein: The controller may be configured to close a first valve to prevent the passage of fluid through a first fluid passage, close a second valve to prevent the passage of fluid through a second fluid passage, open a third valve to allow the passage of fluid through a third fluid passage, determine the presence of an obstruction in the third fluid passage based on comparing the measured pressure with a first threshold, and provide an indication of the obstruction to the user in response to the determination that an obstruction is present in the third fluid passage. The controller may be further configured to open a first valve to allow fluid to pass through the first fluid passage, open a second valve to allow fluid to pass through the second fluid passage, close a third valve to block fluid from passing through the third fluid passage, determine the presence of an obstruction in one or more of the first and second fluid passages based on comparing the measured pressure with a second threshold, and provide an indication to replace the third wound dressing in response to determining that no obstruction exists in the first and second fluid passages. The controller may be further configured to provide an indication of obstruction to the user in response to determining that an obstruction exists in at least one of the first or second fluid passages.

[0013] In some embodiments, a method for operating a negative pressure wound therapy device includes closing a first valve associated with a first fluid channel. The first fluid channel may be configured to provide a fluid connection between a negative pressure source and a first wound dressing. Closing the first valve can prevent the flow of fluid in the first fluid channel. The method may further include opening a second valve associated with a second fluid channel. The second fluid channel may be configured to provide a fluid connection between a negative pressure source and a second wound dressing. Opening the second valve may enable the flow of fluid in the second fluid channel. The method may further include determining an operating state associated with the second fluid channel, at least in part on a measured pressure in the second fluid channel. The method may further include providing an indication of the operating state.

[0014] The methods described in the preceding paragraph may also include any combination of the following features or steps described in this paragraph, in particular within the description herein: An operating state associated with the second fluid channel may include an obstruction in the second fluid channel. The method may further include closing a second valve and opening a first valve in response to determining an obstruction in the second fluid channel, and providing an indication for replacing the second dressing. The method may further include determining an operating state associated with the first fluid channel. The method may further include a third fluid channel configured to provide a fluid connection between a negative pressure source and a third wound dressing. The third fluid channel may include a third valve configured to provide a fluid connection between the negative pressure source and the third wound dressing. Closing the third valve prevents the flow of fluid in the third fluid channel.

[0015] In some embodiments, a method for operating a negative pressure wound therapy device includes opening a first valve associated with a first fluid channel. The first fluid channel may be configured to provide a fluid connection between a negative pressure source and a first wound dressing. Closing the first valve block prevents the flow of fluid in the first fluid channel. The method may further include closing a second valve associated with a second fluid channel. The second fluid channel may be configured to provide a fluid connection between a negative pressure source and a second wound dressing. Opening the second valve allows the flow of fluid in the second fluid channel. The method may further include closing a third valve associated with a third fluid channel. The third fluid channel may be configured to provide a fluid connection from a negative pressure source to a third wound dressing. Closing the third valve block prevents the flow of fluid in the third fluid channel. The method may further include determining the presence of an obstruction in the first fluid channel, at least in part, based on a measured pressure in the first fluid channel. The method may further include, upon determining an obstruction in the first fluid passage, closing a first valve, opening second and third valves (for example, closing the first valve prevents the flow of fluid in the first fluid passage), determining the presence of an obstruction in at least one of the second or third fluid passages (for example, opening the second and third valves allows the flow of fluid in the second and third fluid passages), providing an indication to the user to replace the first wound dressing in response to determining that there is no obstruction in the second and third fluid passages, and providing an indication to the user in response to determining that there is an obstruction in at least one of the second or third fluid passages.

[0016] Any of the devices of the preceding paragraphs may also include, among other things described herein, any combination of the following features described in this paragraph. The device may further include an indicator configured to warn the user to check at least one of a plurality of wound dressings, a processor configured to periodically activate the indicator, and a button configured to allow the user to reset the warning in order for the user to check at least one of the plurality of wound dressings.

[0017] Any of the pump embodiments disclosed below, and any of the negative pressure wound therapy embodiments, are included but not limited to these. Any feature, component, or detail of any of the arrangements or embodiments disclosed in this application may be combined with any other feature, component, or detail of any of the arrangements or embodiments disclosed herein to form new arrangements and embodiments.

Brief Description of the Drawings

[0018] [Figure 1] A negative pressure therapy system including a TNP device and a remote data processing system according to some embodiments is shown. [Figure 2] A negative pressure therapy system including the TNP device of FIG. 1, as well as an inlet manifold branch fitting, a pressure sensor, and a plurality of fluid flow paths, and a wound dressing disposed on a wound according to some embodiments are illustrated. [Figure 3] Some embodiments of the negative pressure therapy system 200 of FIG. 2 are illustrated. [[ID=二十]] [Figure 4A] Some embodiments according to illustrate the inlet manifold branch fitting of FIG. 3. [Figure 4B] Some embodiments according to illustrate the inlet manifold branch fitting of FIG. 3. [Figure 4C] Some embodiments according to illustrate the inlet manifold branch fitting of FIG. 3. [Figure 5] A diagram of a negative pressure wound therapy system according to some embodiments is shown. [Figure 6] Shows a diagram of a negative pressure wound therapy system according to some embodiments. [Figure 7] Shows a diagram of a negative pressure wound therapy system according to some embodiments. [Figure 8A] Shows a diagram of a TNP device according to some embodiments. [Figure 8B] Shows a diagram of a TNP device according to some embodiments. [Figure 9] Shows a diagnostic process performed by a negative pressure wound therapy system according to some embodiments. [Figure 10] Shows a diagnostic process performed by a negative pressure wound therapy system according to some embodiments. [Figure 11] Shows a diagnostic process performed by a negative pressure wound therapy system according to some embodiments. [Figure 12A] Illustrates a portable negative pressure device according to some embodiments. [Figure 12B] Illustrates a portable negative pressure device according to some embodiments. [Figure 12C] Illustrates a portable negative pressure device according to some embodiments. [Figure 12D-G] Illustrates a user interface of a portable negative pressure device according to some embodiments. [Figure 13] Illustrates a wound dressing according to some embodiments. [Figure 14] Illustrates a cross-section of one embodiment of a fluid connector connected to a wound dressing. <op [Figure 15A] Illustrates an embodiment of a wound dressing incorporating a negative pressure indicator according to some embodiments. [Figure 15B-C] Illustrates an embodiment of a wound dressing incorporating a negative pressure indicator according to some embodiments. [Figure 15D] Illustrates an embodiment of a wound dressing incorporating a negative pressure indicator according to some embodiments.

MODE FOR CARRYING OUT THE INVENTION

[0019] Embodiments disclosed herein relate to apparatus and methods for treating multiple wounds by decompression, including a negative pressure source and wound dressing components and apparatus. Apparatus and components including materials to be placed over and packed onto wounds may be collectively referred to herein as wound dressings.

[0020] Some embodiments disclosed herein relate to wound therapy for the human or animal body. Therefore, any reference to wound herein may refer to a wound on the human or animal body, and any reference to body herein may refer to the human or animal body. The term “wound” as used herein, in addition to its broad, ordinary meaning, includes any part of a patient’s body that may be treated using negative pressure. It should be understood that the term wound is broadly interpreted to include open and closed wounds where the skin is torn, incised, or punctured, or where trauma causes a contusion, or any other surface or condition or defect on the patient’s skin, or anything else that may benefit from decompression therapy. Thus, a wound is broadly defined as any damaged area of ​​tissue where fluid may or may not be generated. Examples of such wounds include, but are not limited to, abdominal wounds, or other large or incisional wounds, dehiscences, acute wounds, chronic wounds, subacute wounds and dehiscences resulting from surgery, trauma, sternotomy, fasciotomy, or any other condition, as well as flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, traumatic ulcers and venous ulcers.

[0021] Treatment of such wounds can be carried out using negative pressure wound therapy, in which decompression or negative pressure may be applied to the wound to facilitate and promote wound healing. It will also be understood that the wound dressings and methods disclosed herein may be applied to other parts of the body and are not necessarily limited to the treatment of wounds.

[0022] Embodiments of this disclosure will be understood to be generally applicable to use in topical negative pressure (TNP) therapy systems. Briefly, negative pressure wound therapy may help close and heal many forms of “difficult-to-heal” wounds by reducing tissue edema, promoting blood flow and granular tissue formation, and removing excess exudate, thereby reducing bacterial load (and therefore risk of infection). In addition, the treatment may reduce wound anxiety, leading to earlier healing. TNP therapy systems may also assist in the healing of surgically closed wounds by helping to remove fluid and stabilize tissue in a parallel position of closure. Further beneficial uses of TNP therapy can be found in grafts and flaps where removing excess fluid is important and it is required that the graft be in close proximity to the tissue to ensure tissue viability.

[0023] As used herein, a reduced pressure or negative pressure level, such as -X mmHg, represents a pressure level relative to normal ambient pressure, which may correspond to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Thus, a negative pressure value of -X mmHg reflects a pressure that is, for example, X mmHg below 760 mmHg, i.e., a pressure of (760-X) mmHg. In addition, negative pressures "lower" or "smaller" than X mmHg correspond to pressures closer to atmospheric pressure (e.g., -40 mmHg is lower than -60 mmHg). Negative pressures "higher" or "larger" than -X mmHg correspond to pressures further away from atmospheric pressure (e.g., -80 mmHg is higher than -60 mmHg). In some embodiments, a local ambient pressure is used as a reference point, and such a local pressure does not necessarily have to be, for example, 760 mmHg.

[0024] The negative pressure range in some embodiments of this disclosure may be about -80 mmHg, or between about -20 mmHg and -200 mmHg. It should be noted that these pressures are relative to normal ambient pressure, which may be 760 mmHg. Therefore, -200 mmHg would substantially be about 560 mmHg. In some embodiments, the pressure range may be between about -40 mmHg and -150 mmHg. Alternatively, pressure ranges of -75 mmHg or less, -80 mmHg or less, or above 80 mmHg may be used. In other embodiments, pressure ranges below -75 mmHg may be used. As an alternative, pressure ranges of approximately -100 mmHg or even above -150 mmHg may be supplied by the negative pressure device.

[0025] In some embodiments of the wound closure devices described herein, increased wound contraction may lead to increased tissue expansion in the surrounding wound tissue. This effect may be amplified, in some cases, by changing the force applied to the tissue, for example, by changing the negative pressure applied to the wound over time, in conjunction with an increase in the tensile force applied to the wound by the embodiment of the wound closure device. In some embodiments, the negative pressure may be changed over time, for example, using a sine wave, a square wave, and / or in synchronization with one or more physiological indicators of the patient (such as heart rate).

[0026] Figure 1 shows a negative pressure therapy system 100 including a TNP device 102 and a remote data processing system 122 according to several embodiments. The TNP device 102 may be used to treat a wound using a wound dressing that is in fluid communication with the TNP device 102 via a fluid channel. The TNP device 102 may include a controller 104, a memory device 106, a negative pressure source 108, a user interface 110, a power supply 112, a pressure sensor 114, and a transceiver 116, all configured to communicate electrically with each other. The power supply 112 can supply power to one or more components of the TNP device 102.

[0027] The controller 104 can control the operation of one or more other components of the TNP device 102 according to instructions stored in at least the memory device 106. For example, the controller 104 can control the operation of the negative pressure source 108 and the supply of negative pressure therefrom. The negative pressure source 108 may include, but is not limited to, a rotary diaphragm pump or other diaphragm pump, piezoelectric pump, peristaltic pump, piston pump, rotary vane pump, liquid-sealed pump, scroll pump, diaphragm pump operated by a piezoelectric transducer, or any other suitable pump or micropump, or any combination of the above. The user interface 110 may include one or more elements that receive user input or provide user output to the patient or caregiver. One or more elements that receive user input may include buttons, switches, dials, or touchscreens.

[0028] The pressure sensor 114 can be used to monitor pressure under a wound dressing, such as (i) the pressure in the fluid passages connecting the TNP device 102 and the wound dressing, (ii) the pressure in the wound dressing, or (iii) the pressure in or within the TNP device 102. In some implementations, the pressure sensor 114 may include at least two pressure sensors positioned to measure the pressure in multiple fluid passages, such as multiple passages connecting the TNP device 102 to multiple wound dressings. In other implementations, the pressure sensor 114 may include at least two pressure sensors positioned in or fluid-connected to the fluid passages to enable pressure difference measurements. For example, a first pressure sensor may be positioned upstream of the wound (e.g., at or near the inlet of the TNP device 102), and a second pressure sensor may be positioned to detect pressure in or near the wound, or in or near the canister or dressing.

[0029] The transceiver 116 may be used to communicate with the data processing system 122 via the network 120. The transceiver 116 can transmit device usage data to the data processing system 122, such as alarms for a therapy program managed by the TNP device 102, measured pressure, or changes. In some embodiments, the transceiver 116 communicates with one or more shut-off valves in the negative pressure therapy system. The network 120 can be a communication network, such as a wired or wireless communication network, such as a cellular communication network. The memory device 106 may be used to store the device usage data that can be transmitted by the transceiver 116. In some embodiments, the data processing system 122 can transmit data, such as operating parameters, to the TNP device 102.

[0030] Figure 2 shows negative pressure therapy systems 200 according to several embodiments. The system 200 includes the TNP device 102 of Figure 1, a first fluid channel 208, a first wound dressing 202 configured to be placed on a first wound 220, a second fluid channel 210, a second wound dressing 204 configured to be placed on a second wound 222, an inlet manifold branching attachment 206, and a third fluid channel 212. The TNP device 102 can be used to treat a first wound 220 using the first wound dressing 202 which is in fluid communication with the TNP device 102 via the first fluid channel 208, the inlet manifold branching attachment 206, and the third fluid channel 212. The TNP device 102 can also be used to treat a second wound 222 using a second wound dressing 204 that is in fluid communication with the TNP device 102 via a second fluid passage 210, an inlet manifold branch attachment 206, and a third fluid passage 212.

[0031] The inlet manifold branching connector 206 is installed between the TNP device 102 and the first and second wound dressings, thereby advantageously allowing the TNP device 102 to simultaneously generate and maintain negative pressure in or beneath both wound dressings. In this example, the inlet manifold is not integrated into the TNP device. Instead, an inlet manifold branching connector 206, such as a Y-connector, is used to connect the first and second fluid passages 208-B to the third fluid passage 212. In other embodiments, the inlet manifold can be integrated into the TNP device 102 so that the first and second fluid passages connect directly to the TNP device via an integrated inlet manifold (as shown in Figures 12A-12C).

[0032] To measure the pressure in the third fluid channel 212, a pressure sensor 114 is positioned in the third fluid channel 212, for example, at or near the inlet of the TNP device 102. The controller of the TNP device 102 can monitor the pressure measured by the pressure sensor 114 and determine whether an operating condition (e.g., blockage, leakage, overpressure, or full coverage) has occurred within the negative pressure therapy system 200.

[0033] In some embodiments, a controller can determine the existence of an operational condition by comparing the measured pressure to the expected measured pressure (or flow). The “expected” pressure (or flow) can be the pressure measured by a pressure sensor in a negative pressure system operating under normal conditions. The expected pressure may be equal to or approximately equal to the pressure supplied by the negative pressure source (or pressure selected by the user) (e.g., within 1, 2, 3, 4, 5, 10, 15, or 20 Mmhg). In contrast, the “unexpected” pressure (or flow) can be any measured pressure other than the expected pressure (or flow). For example, in some embodiments, a wound dressing experiencing blockage, overpressure, or a dressing full condition may cause the pressure sensor to measure a lower pressure (e.g., a more positive pressure) than the expected pressure. In other embodiments, a wound dressing experiencing a leak condition may cause the pressure sensor to measure a lower pressure than the expected pressure. In some embodiments, an operational condition can alter the measured pressure (e.g., a spike, dip, increase, or decrease in the measured pressure). In some embodiments, the measured pressure is compared to one or more thresholds to determine whether it is expected or unexpected.

[0034] In some embodiments, the TNP device 102 functions only when two or more wound dressings are connected (e.g., to provide negative pressure). Furthermore, to avoid confusing the user, some indicators or functions of the TNP device that are available when only a single wound dressing is connected may be disabled. For example, in some embodiments, the dressing full indicator is unavailable in TNP systems with two or more connected wound dressings. For this reason, the dressing full indicator may be disabled or removed from the front panel to avoid confusing the user with an unavailable function.

[0035] Figure 3 shows several embodiments of the negative pressure therapy system 200. The system 200 includes a TNP device 102, a first fluid channel 208, a first wound dressing 202, a second fluid channel 210, a second wound dressing 204, and a plurality of integrated inlet manifolds or connectors 302, 304. The plurality of integrated inlet manifolds 302, 304 are integrated with the TNP device 102 and are fluidly connected to the first wound dressing 202 via the first fluid channel 208 and to the second wound dressing 204 via the second fluid channel 210.

[0036] In some applications, the fluid channel 208 may be located far from the TNP device 102. Therefore, it may be desirable for the fluid channel to include one or more indicators 306, 308, which would help the user identify which fluid channel 208 is connected to a particular inlet of one of the multiple integrated inlet manifolds 302, 304.

[0037] As shown, the first fluid channel 208 includes a plurality of first identifiers (stars) 306, and the second fluid channel 208 includes a plurality of second identifiers (triangles) 308. In both examples, at least one identifier 302, 304 is located close to the inlet manifolds 302, 304, and at least one identifier is located close to the wound dressing. In some embodiments, the fluid channel may include three or more identifiers 306, 308. For example, identifiers 306, 308 may be located along the length of the fluid channel. Alternatively, identifiers 306, 308 may include printed pictograms, printed icons, embossed pictograms, embossed icons, Braille characters, or color codes. In some embodiments, an electronically controlled display (LEDs, indicators, etc. on a display device) is associated with each fluid channel. This makes it easier for the TNP device 102 to indicate any possible operating conditions occurring in the associated dressing.

[0038] In some embodiments, at least one pressure sensor may be placed with the inlet manifold (either an integrated manifold or an attachment manifold) to measure the combined pressure of the first and second fluid passages. The controller of the TNP device 102 monitors the pressure measured by the pressure sensor and determines whether an operating condition has occurred in either of the fluid passages. In some embodiments, the controller may be configured to provide a first indicator related to the operating condition in the first fluid passage 208 and a second indicator related to the operating condition in the second fluid passage 210.

[0039] In some embodiments, the negative pressure therapy system includes three or more wound dressings. Therefore, the number of fluid channels and inlets can correspond to the number of wound dressings. For example, a negative pressure therapy system with four wound dressings may have at least four fluid channels and at least four inlet manifolds. In some embodiments, a single wound dressing may be configured to communicate with a TNP device via two or more fluid channels. In some embodiments, the negative pressure therapy system may include more inlet manifolds than fluid channels and / or wound dressings. In these examples, additional inlets can be ignored or plugged in.

[0040] Figures 4A to 4C illustrate inlet manifold branch mounting sections 206 according to several embodiments. In some embodiments, the inlet manifold branch mounting section 206 may be used in place of the integrated inlet manifold in Figure 3. As shown, the Y-shaped inlet manifold branch mounting section 206 may include three conduit mounting sections 302, 304, and 410. The pump conduit mounting section 410 can be used to connect to a conduit or tube extending from a pump or TNP device, or to connect to the pump itself. The pump conduit mounting section 410 may include a male non-Luer connector at the proximal end of the Y-shaped inlet manifold branch mounting section. The male connector can be attached to a female connector on the conduit or pump. The pump conduit mounting section 410 has a shaft 408 extending from the mounting section and forming the Y-shaped bottom portion of the inlet manifold branch mounting section 206.

[0041] The Y-shaped inlet manifold branching attachment also includes two covering conduit attachments 302, 304. The covering conduit attachments 302, 304 may be used to connect to couplings of fluid passages extending from the wound dressing. In some embodiments, conduits or tubes may be used to connect the wound dressing to the Y-shaped inlet manifold branching attachment 206. The conduits or tubes may be flexible bridges, rigid tubes, or any other devices that may serve to transport fluid. The conduits or tubes may include couplings at their proximal and distal ends. The conduits or tubes may be connected to the couplings of the inlet manifold branching attachment at their distal ends and to the conduit attachments of the Y-shaped inlet manifold branching attachment at their proximal ends.

[0042] The covering material conduit mounting portions 302 and 304 may include a female non-Luer connector at the distal end of the Y-shaped inlet manifold branch mounting portion. The female connector can be attached to the male connector of the coupling of the inlet manifold branch mounting portion or to the coupling of the conduit.

[0043] In some embodiments, the inlet manifold branch attachment 206 or conduit may include an incorporated valve, clamp, cap, and / or other closing mechanism. Thus, the flow or passage of fluid to and from one wound dressing can be blocked while another wound dressing continues to apply negative pressure. In some embodiments, the closing mechanism may be a valve (e.g., a back valve).

[0044] In some embodiments, the valve incorporated in the Y-shaped inlet manifold branch attachment 206 is a manual shut-off valve. For example, the user can manually close the valve associated with the conduit attachment 302, thereby shutting off the flow of fluid to and from the first wound dressing 202. Similarly, the user can manually close the valve associated with the conduit attachment 304, thereby shutting off the flow of fluid to and from the second wound dressing 204. In some embodiments, the valve is located within the conduit attachment 410, where closing the aforementioned valve shuts off the flow of fluid to and from the first and second wound dressings 202 and 204.

[0045] In some embodiments, the valves incorporated into the Y-shaped inlet manifold branching attachment 206 are electromechanical valves. For example, a controller (e.g., the controller of the TNP device described in Figure 1) can communicate with the valves to open and close each valve individually or as a unit. Communication between the valves and the TNP device 102 can be wired or wireless. For example, a wireless transceiver of the TNP device 102 (e.g., see Figure 1) can communicate with a wireless transceiver of the valve. The wireless transceiver of the valve may be located within or in close proximity to the inlet manifold branching attachment 206.

[0046] The covering conduit mounting portions 302 and 304 each include shafts 404 and 402, respectively, and form the upper Y-shaped portion of the connector. The proximal ends of shafts 404 and 402 and the distal end of shaft 408 meet at joint 406. In some embodiments, joint 406 may include a hinge that allows rotation of shafts 404, 402, and 408 around joint 406. In some embodiments, only the shafts 404 and 402 of the covering conduit mounting portion can move relative to joint 406, while the shaft 408 of the pump conduit mounting portion is fixed. In some embodiments, the entire Y-shaped inlet manifold branch mounting portion consists of two parts that allow 360° rotation. Figure 4C illustrates an embodiment of a Y-shaped inlet manifold branch mounting portion formed by two freely rotating parts that allow rotation of each part relative to the other. The rotation of the Y-shaped inlet manifold branch attachment allows the user to twist the pump while the wound dressing extending from the wound dressing and the conduit remain stationary.

[0047] In some embodiments, the male and female non-Luer connectors may be made of rigid plastic. In some embodiments, the shafts 408, 404, and 402 may be made of flexible plastic tubing. In some embodiments, the Y-shaped inlet manifold branching attachment may be wrapped in a soft silicone sleeve to enhance patient comfort and prevent the Y-shaped inlet manifold branching attachment from becoming a pressure point.

[0048] Using the Y-shaped inlet manifold branching attachment 206 illustrated in Figures 4A to 4C, the TNP device 102 can draw pressure simultaneously in two wound dressings to attach a single pump to two wound dressings. The performance and fluid management of the multi-site dressing and Y-connector are equivalent to the control tests of a standard single wound dressing with a single pump setup. Although the attachment 206 is illustrated as Y-shaped, the attachment 206 can be any suitable shape or combination of shapes in some implementations. In some embodiments, Luer, quick-release, or other types of connectors can be used as one or more connectors of the attachment 206, the TNP device 102, and one or more of the fluid passages 208, 210.

[0049] In some embodiments, the negative pressure therapy system may include three or more wound dressings and associated fluid channels that communicate fluidly with an inlet manifold branching attachment. Thus, in some embodiments, the inlet manifold branching attachment is attached to two or more TNP devices and / or three or more fluid channels (e.g., one pressure source and three wound dressings ("1:3", 1:4, 1:5, 2:1, 2:2, 2:3, 2:4, 2:5)). The inlet manifold branching attachment may be a separate attachment, such as a Y-connector that can connect to a third fluid channel, or the inlet manifold may be incorporated into the TNP device 102. The total number of inlet manifolds included in the inlet manifold branching attachment (e.g., the number of "splits" performed by the inlet manifold branching attachment) may be equal to the number of dressings connected. In some examples, one or more inlet manifolds are connected to a single wound dressing.

[0050] Figure 5 illustrates a negative pressure therapy system 500 having pressure sensors 502, 504, and 506 positioned to measure the pressure in each fluid passage related to the wound dressing. Specifically, the first pressure sensor 502 measures the pressure in the first fluid passage 208. The second pressure sensor 504 measures the pressure in the second fluid passage 210. The third pressure sensor 506 measures the pressure in the third fluid passage 212.

[0051] By placing sensors within each fluid channel, the controller can monitor the pressure in each fluid channel to determine whether an operational state has occurred in the negative pressure therapy system 500. Furthermore, since the sensors measure the pressure in each fluid channel, once an operational state is determined, the controller can determine, in particular, which channel / wound dressing combination is experiencing the operational state. The negative pressure therapy system 500 provides the ability to monitor the function of individual wound dressings, thereby enabling the same characteristics and functions provided by a negative pressure therapy system utilizing a single wound dressing.

[0052] Pressure sensors 502, 504, and 506 can be positioned anywhere in the fluid flow path, such as between the wound dressing and the inlet manifold branching attachment 206, or near the wound dressing. In some embodiments, to reduce costs, the number of pressure sensors is less than the number of wound dressings. For example, if the number of wound dressings is N, only N1 pressure sensors are used in a negative pressure therapy system. For example, in these examples, the controller can perform a process to determine whether a dressing without an associated pressure sensor is experiencing an operating condition. In some embodiments, one or more pressure sensors are connected to the inlet manifold branching attachment 206, as described above with respect to Figures 4A to 4C.

[0053] Multiple shut-off valves 512, 514, 516 (for example, as shown in Figure 12C) may be positioned within the negative pressure therapy system 500 such that the closure of the valves prevents the passage of fluid to and from the associated wound dressing. The shut-off valves 512, 514, 516 may be positioned anywhere in the fluid flow path, such as between the outlet of the inlet manifold branching attachment 206 and the corresponding dressing inlet. In some embodiments, one or more shut-off valves are incorporated into the inlet manifold branching attachment 206, as described above with respect to Figures 4A-4C.

[0054] In some embodiments, valves 512, 514, and 516 are manually shut-off valves. For example, a user can manually close the first valve 512, thereby shutting off the flow of fluid to and from the first wound dressing 202. In other embodiments, the valves are electromechanical valves. For example, the TNP device 102 can communicate with the valves to open and close each valve individually or as a unit. Communication between the valves and the TNP device 102 can be wired or wireless. For example, a wireless transceiver in the TNP device 102 (see, for example, Figure 1) can communicate with a wireless transceiver in the valve. In some cases, the wireless transceiver in the valve may be located within or near the inlet manifold branching attachment 206.

[0055] In the TNP system 500, the controller can efficiently determine which fluid channel / wound dressing combination is experiencing an operating state, and in some embodiments, the associated valves can be closed to improve the overall efficiency of the TNP device. For example, during normal operation when the wound dressing is not experiencing an operating state, pressure sensors 502, 504, and 506 may measure approximately the same pressure. When a fluid channel / wound dressing experiences an operating state, the measured pressure associated with the fluid channel / wound dressing changes so that the controller can determine: (1) which particular fluid channel / wound dressing is experiencing an operating state and / or (2) which particular type of operating state is being experienced. For example, if pressure is measured downstream of an obstruction occurring in the first fluid channel / wound dressing, the measured pressure in the first fluid channel may increase (e.g., become more negative) because the obstruction restricts the fluid flow, resulting in a decrease in the volume through which the fluid flows. As another example, if the pressure is measured upstream of an obstruction in the first fluid channel / wound dressing, the measured pressure in the first fluid channel may decrease (e.g., become more positive) because the obstruction severely restricts or blocks the fluid flow in the portion of the fluid channel where the pressure is measured. This pressure change allows the controller to determine that an operating condition (obstruction) has occurred on the first fluid channel / wound dressing. In some embodiments, the operating condition causes one or more spikes in the measured pressure. In other embodiments, the operating condition results in an increase or decrease in the measured pressure. The controller can make these determinations regarding obstruction, overpressure, pressure leak, dressing full state, etc.

[0056] In some embodiments, electronically controllable valves are used to stop treatment for specific wound dressings, preventing pressure loss and improving the overall efficiency of the TNP device. This can be effective in negative pressure therapy systems with multiple wound dressings.

[0057] Figure 6 shows negative pressure therapy systems 600 according to several embodiments. The illustrated systems differ from negative pressure therapy systems 200 in that they include flow reducers or limiters 209 in a first fluid passage 208, and multiple integrated inlet manifolds 602, 604 replace the inlet manifold branching attachment 206. In some embodiments, the inlet manifolds 602, 604 can be replaced by a single inlet and branching attachment 206, and the flow limiter 209 can be incorporated into one of the passages or branches of the attachment 206. The addition of the flow limiter 209 allows the controller to determine which wound dressing is experiencing an operational state, despite utilizing a single pressure sensor 114.

[0058] A flow limiter 209 (such as a small volumetric container or small orifice) restricts the flow through the first fluid flow path 208 so that the difference in flow between the first fluid flow path 208 and the second fluid flow path 210 can be perceived by the controller. For example, the TNP device 102 can draw pressure in two wound dressings simultaneously. The flow limiter 209 restricts the pressure in the first fluid flow path 208. In some embodiments, during normal operation, the flow detected by the system 600 (e.g., the controller) is a combination of flows through fluid flow paths 208 and 210, each of which can be known in advance (calculated based on the characteristics of each fluid flow path, calculated via calibration, etc.). When an operating condition such as blockage occurs, the detected flow in the first fluid flow path 208 decreases to a flow equal to or approximately equal to the flow through flow path 210. Thus, the system 600 not only detects the change in flow but also, based on the measured flow, detects that fluid is flowing through fluid flow path 210 and that fluid flow path 208 is experiencing blockage. Similarly, the system 600 can detect and indicate operating conditions, such as blockages in the fluid channel 210. Indication of operating conditions may be carried out using any of the methods described herein, such as audio-visual indication using LEDs, display devices, and similar devices. For example, each of the fluid channels 208 and 210 may be associated with a specific color or symbol, and such color or symbol may be displayed and / or announced. In some embodiments, the measured flow is compared to one or more thresholds.

[0059] In some embodiments, the flow (or flow rate) can be directly monitored or measured using a flow meter. In some implementations, the flow can be indirectly monitored or measured. For example, the flow can be determined by monitoring changes in pressure measured by a pressure sensor 114. The controller can determine the flow rate, for example, by determining the pressure gradient, the rate of pressure change, or the rate of pressure decay. As another example, in a system having a negative pressure source that generates a variable flow rate, the flow rate can be determined based on the pressure and velocity of the negative pressure source (e.g., a pump motor). For example, the flow rate can be determined according to Equation 1 below: Flow rate=C1*F*P+C2 (formula 1) In the formula, F is the pump speed (frequency of the tachometer signal measuring the pump motor rotation), P is the measured pressure, and C1 and C2 are appropriate constants. Further details are described in U.S. Patent No. 8,905,985 and U.S. Patent Application Publication No. 2012 / 0001762, which are incorporated herein by reference in their entirety.

[0060] In some embodiments, the flow limiter 209 may be replaced with a flow expander configured to increase the flow. In such cases, the detection of the operating state is the same as described above, except that the flow in the channel 208 associated with the wound 220 is increased by the flow limiter.

[0061] In some embodiments, the flow limiter 209 is a permanent limiter, such as an orifice, having a diameter smaller than one or more of the conduits in the fluid channel 208. In some embodiments, the flow limiter 209 is a temporary limiter, such as an adjustable valve, that temporarily restricts the fluid flow when determining whether an operating condition exists. In some embodiments, a controller can control the temporary flow limiter. In certain embodiments, multiple flow reducers and / or enhancers may be used in systems including three or more wound dressings and associated fluid channels. For example, a system with three wound dressings may include a flow limiter in the first fluid channel and a flow enhancer in the second fluid channel. Similarly, a system with three wound dressings may include a flow limiter in the first fluid channel and a stronger (or narrower) flow limiter in the second fluid channel. In any of these embodiments, the difference in flow rates between the multiple fluid channels may allow the TNP device to determine which fluid channel / wound dressing is experiencing an operating condition.

[0062] In some embodiments, a canister may be connected between the TNP device 102 and / or a plurality of integrated inlet manifolds 602, 604. The canister can collect exudate removed from wounds 220, 222. Alternatively, the canister may be connected between each wound dressing and the inlet manifold branch attachment.

[0063] Figure 7 shows negative pressure therapy systems 700 according to several embodiments. System 700 differs from negative pressure therapy system 200 in that it includes a third wound dressing 510, a third wound 512, a fourth fluid channel 508, and a number of shut-off valves 512, 514, 516. In addition to the treatment of wound 220-B as described in system 200, system 700 can be used to treat a third wound 518 using the third wound dressing 510 which is in fluid communication with the TNP device 102 via the fourth fluid channel 508, the inlet manifold branch attachment 206, and the third fluid channel 212.

[0064] Multiple shut-off valves 512, 514, and 516 are positioned within the fluid passage such that closing the corresponding valve shuts off the flow of fluid to and from the connecting fluid passage / covering material. The shut-off valve 21 can be positioned at any location from the outlet of the inlet manifold branch mounting section 206 to the corresponding covering material inlet. As shown in the figure, the first valve 512 is positioned on the first fluid passage 208, the second valve 514 is positioned on the second fluid passage 210, and the third valve 516 is positioned on the fourth fluid passage 508.

[0065] In some embodiments, the multiple valves 512, 514, 516 are manual shut-off valves. For example, a user can manually close the first valve 512, thereby shutting off the flow of fluid to and from the first wound dressing 202. In other embodiments, each of the multiple valves is an electromechanical valve. For example, the TNP device can communicate with the valves to open and close each valve individually or as a unit. Communication between the valves and the TNP device 102 can be wired or wireless. For example, a wireless transceiver of the TNP device 102 (see, for example, Figure 1) can communicate with a wireless transceiver of a valve. The wireless transceiver of a valve may be located within or near the inlet manifold branching attachment 206.

[0066] Figure 8A shows a negative pressure therapy system 800A according to several embodiments. In this example, the TNP device 102 includes at least a controller 104, a negative pressure source 108, a plurality of pressure sensors 502, 504, and a plurality of integrated inlet manifolds 602, 604.

[0067] The integrated inlet manifolds 602, 604 can be combined into a single unit (for example, as shown in Figures 3 and 12), with a single negative pressure passage connected to the negative pressure source 108. Alternatively, each of the multiple integrated inlet manifolds 602, 604 can be connected directly to the negative pressure source without first combining it with another inlet manifold.

[0068] Multiple pressure sensors 502, 504 are positioned such that the first pressure sensor 502 measures the pressure in the first fluid passage 208 connected to the first inlet manifold 302, and the second pressure sensor 504 measures the pressure in the second fluid passage 210 connected to the second inlet manifold 304. In some embodiments, the pressure sensors 502, 504 may be located within the inlet manifold. In other embodiments, the pressure sensors are located in the housing of the TNP device 102.

[0069] Figure 8B shows negative pressure therapy system 800B according to several embodiments. In this example, system 800B includes an inlet manifold branching attachment 206. As described herein, the inlet manifold may include an inlet manifold branching attachment 206 (as shown in Figures 4A-4B) and / or one or more integrated inlet manifolds (as shown in Figures 12A-12C).

[0070] The inlet manifold branch mounting section 206 includes a pressure sensor 504 on a first branch 304 fluidly connected to a first covering material 202 via a fluid passage 208, and a wireless transceiver or receiver 802 that communicates with a wireless receiver 804 that communicates with a controller 104 of a TNP device 102. The pressure sensor 504 measures the pressure in the fluid passage 208, while the pressure sensor 502 measures the combined pressure in the fluid passages 208 and 210. Operating conditions, such as blockage in one or more of the fluid passages 208 or 210, can be determined based on the pressures measured by sensors 502 and 504 using any of the methods described herein. In some embodiments, the inlet manifold branch mounting section 206 can communicate with the TNP device 102, for example, to provide pressure data. The communication can be wired or wireless (e.g., over Bluetooth®). In some embodiments, detection of covering fullness and / or other operating conditions can be used to provide a display to the user.

[0071] Figure 9 shows a diagnostic process 900 performed by a negative pressure wound healing system 500 (see, for example, Figure 5) according to several embodiments. The process 900 may be performed by the controller of the negative pressure wound healing system. As described above, operating conditions may include occlusion, leakage, overpressure, full dressing, etc. The process can detect one of the aforementioned operating conditions by analyzing the pressure measured by pressure sensors 502, 504, and 506.

[0072] In block 902, the process monitors pressure sensors 502, 504, and 506 to measure the pressure in various fluid passages 208, 210, and 508. In some embodiments, the controller continuously monitors pressure sensors 502, 504, and 506 at predetermined intervals (such as 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, or 60 minutes) and / or in response to user input.

[0073] In block 904, the process determines that an operational condition has occurred, at least in part, based on a change in pressure measured by one of several pressure sensors. For example, the occurrence of an occlusion in one of the wound dressings may result in a momentary or prolonged spike or dip in the measured pressure. As another example, the process may determine the flow based on the measured pressure (or directly, if one or more flow meters are used). As illustrated in relation to Figure 5, by arranging pressure sensors to monitor the condition in each of the fluid channels associated with the wound dressing, the process 900 can monitor pressure sensors 502, 504, and 506 and determine in particular which fluid channel / wound dressing is experiencing an operational condition. Thus, the negative pressure therapy system 500 provides the ability to monitor the function of individual wound dressings, thereby enabling the same set of features provided by a negative pressure therapy system utilizing a single wound dressing.

[0074] In block 906, process 900 provides an indication of a channel / covering (or channel / covering) that has been determined to be experiencing an operational state. In some embodiments, one or more LEDs or other indicators can be used to indicate to the user or caregiver that an operational state has been detected. For example, each wound dressing may have a corresponding LED that turns on when an operational state is not detected in the associated wound dressing and turns off when an operational state is detected in the associated wound dressing. In some embodiments, other indicators may be associated with the wound dressing experiencing an operational state, such as an audible, wireless message, display notification and / or other signal that can get the attention of the user or caregiver. In some embodiments, the TNP device may, in addition or alternatively, provide indication by closing a valve associated with the wound dressing experiencing an operational state.

[0075] Figure 10 shows a diagnostic process 1000 performed by a negative pressure wound healing system 700 (see, for example, Figure 7) in several embodiments. Process 1000 may be performed by the controller of the negative pressure wound healing system. As described above, operating conditions may include occlusion, leakage, overpressure, full dressing, etc. The process can detect one of the aforementioned operating conditions by analyzing the pressure measured by the pressure sensor 502. Once the process determines that an operating condition has occurred, it can initiate a diagnosis to determine which channel / dressing is experiencing the operating condition. In some embodiments, the process is implemented in firmware or software that includes a diagnostic mode for determining which channel / wound dressing is experiencing the operating condition. In some embodiments, the operator can switch between operating modes through the interface of the TNP device (touchscreen interface or dedicated buttons or switches).

[0076] In block 1002, process 1000 monitors a pressure sensor 502 that measures the pressure of the TNP device 102. In some embodiments, process 1000 continuously monitors the pressure sensor 502. In other embodiments, process 1000 monitors the pressure sensor 502 at predetermined intervals (1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, or 60 minutes). In other embodiments, the process can monitor the pressure sensor in response to user input.

[0077] In block 1004, the process determines that an operational condition has occurred (or may have occurred) and initiates a diagnostic mode to determine which fluid channel / wound dressing is experiencing the operational condition. During the diagnostic mode, the process can determine that an operational condition has occurred, at least partially based on changes in pressure, flow, etc., measured by the pressure sensor 502. For example, the occurrence of an operational condition in one of the fluid channels / wound dressings may result in a momentary or prolonged spike or dip in the pressure measured by the pressure sensor 502.

[0078] In block 1006, a fluid channel / wound dressing is selected for testing. In some embodiments, the user and / or the process can make this selection. For example, the user can make the selection by providing input to the process. The section can be any one based on the user's suspicion or any one based on the process's suggestion. In some embodiments, the process can make the selection. The process's selection can be random, for example, based on user input or based on data in the controller.

[0079] The valve associated with the selected fluid channel / covering material is opened, and the valve associated with the unselected covering material is closed, thereby connecting the negative pressure therapy system to a negative pressure system with a single wound covering fluid-connected to a negative pressure source. The valves can be opened and closed manually by the user or controller. In some embodiments, the controller can control the shut-off valves electronically (via wired or wireless connection). For example, a wireless transmitter or transceiver of the TNP device can communicate with a wireless transceiver or receiver of the valve. In such embodiments, the wireless transceiver can communicate with each valve and control each valve individually or as a unit.

[0080] In block 1008, the process monitors the pressure sensor 502 to determine whether the selected wound dressing is experiencing an operational condition. This analysis may be similar to a determination made by a process in a negative pressure system having a single wound dressing fluidly connected to a negative pressure source. For example, a pressure lower than expected (or higher than expected flow) may indicate that the wound dressing is experiencing leakage, while a pressure higher than expected (or lower than expected flow) may indicate that the wound dressing is experiencing blockage, overpressure, or a full dressing condition.

[0081] If the process determines that the selected wound dressing has not experienced an operational state (for example, if the pressure measured by the pressure sensor 502 is generally equivalent to the expected pressure), a different fluid channel / wound dressing is selected for testing. In other words, process 1000 returns to block 1006. The newly selected fluid channel / wound dressing is a wound dressing that has not been tested in the current diagnostic mode.

[0082] In block 1010, the process determines that a previously selected wound dressing is experiencing an operational state. The valve associated with the selected wound dressing is closed when the fluid channel previously determined to be experiencing an operational state and the valve associated with the wound dressing are closed. All other valves are open. As described above, the valves may be opened and closed manually by the user or automatically by the controller.

[0083] In block 1012, the process monitors a pressure sensor to determine whether either the fluid channel / wound dressing associated with the opening valve is experiencing an operational state. For example, the pressure sensor may sense an expected pressure (or flow) if no operational state is present, or an unexpected pressure (or flow) if an operational state is present. If the process determines that an operational state is present among the wound dressings associated with the opening valve, a new wound dressing is selected (block 1006). As described above, the newly selected wound dressing is a wound dressing that has not been tested during the current diagnostic mode.

[0084] In block 1014, the process determined which of the multiple wound dressings was experiencing an operational condition. The process can provide appropriate indications as described herein, which facilitate addressing and correcting operational conditions. For example, if a full operational condition of a wound dressing is detected, the wound dressing can be replaced. In some embodiments, the user is required to manually replace the wound dressing. In some embodiments, the wound dressing is replaced without the user's assistance. In block 1014, all valves are open, and the diagnostic mode is complete. As described above, the valves can be opened manually or electromechanically.

[0085] Figure 11 shows a diagnostic process 1100 performed by a negative pressure wound healing system 700 (see Figure 7) in several embodiments. The process 1100 may be performed by a controller of the negative pressure wound healing system. The process can monitor the measured pressure and determine whether either the fluid flow path or the wound dressing in the negative pressure system is experiencing an operational state.

[0086] In block 1102, the process determined that no operational state exists within the negative pressure system. In some embodiments, one or more LEDs or other indicators can be used to indicate to the user or caregiver that no operational state exists. For example, each wound dressing may have a corresponding LED that turns on when no operational state is detected in the associated wound dressing and turns off (or vice versa) when an operational state is detected in the associated wound dressing. In some embodiments, all associated LEDs are on when no operational state is detected in the negative pressure system. In some embodiments, other indicators may be associated with the non-fault state (the state in which no operational state is detected), such as sound, wireless message, display notification and / or other signals that can attract the attention of the user or caregiver. In some embodiments, the TNP device may not provide an indication that no operational state has been detected.

[0087] In some embodiments, the process continuously monitors measured pressure to determine whether either the fluid channel or wound dressing in the negative pressure system is experiencing an operational state. In other embodiments, the process monitors measured pressure at predetermined intervals (1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, or 60 minutes). In some embodiments, the process monitors a pressure sensor in response to user input.

[0088] In block 1104, the process determines that an operating condition has occurred. As described above, operating conditions may include blockage, leakage, overpressure, full coating, etc. The process can detect one of the aforementioned operating condition conditions by analyzing the pressure measured by the pressure sensor 502. For example, an operating condition may be determined based on the measured pressure (spikes, dips, increases, or decreases in the measured pressure) or changes in flow rate.

[0089] For example, in a negative pressure system operating under normal conditions (e.g., when the fluid channel / wound dressing is not experiencing an operational condition), the pressure sensor measures a “expected pressure,” i.e., a pressure equal to (or approximately equal to) the selected pressure supplied by the negative pressure source. In contrast, when the negative pressure system is operating under conditions other than normal (e.g., one or more fluid channels / wound dressings are experiencing an operational condition), the pressure sensor measures a pressure different from the expected pressure. In some embodiments, fluid channels / wound dressings experiencing blockage, overpressure, or a full dressing condition can cause the pressure sensor to measure a pressure higher than the expected pressure. In other examples, fluid channels / wound dressings experiencing a leak condition can cause the pressure sensor to measure a pressure lower than the expected pressure. As described herein, in some embodiments, the flow rate can be used to determine the presence of an operational condition.

[0090] In block 1106, if the process determines that a wound dressing in the negative pressure system is experiencing an operational state, it can provide an indication of the detected operational state. For example, each wound dressing may have a corresponding LED. In response to the detection of an operational state, the process may cause each LED to flash. In other embodiments, other indicators may be used instead of or in conjunction with the LEDs. For example, voice, wireless messages, display notifications, and / or other signals may be used to indicate that the negative pressure system is experiencing an operational state. In some embodiments, the process may turn off the negative pressure therapy system at least momentarily to indicate that the system is experiencing an operational state.

[0091] In block 1108, the process may stop or wait to begin troubleshooting until it receives input from the user. For example, the process may detect that the system is experiencing an operational state and provide instructions to the user or caregiver, and wait until it receives an acknowledgment. In some embodiments, the process may begin troubleshooting immediately without waiting for user input, or it may begin troubleshooting after a delay.

[0092] In block 1110, the user perceives that a fluid channel / wound dressing in the negative pressure system is experiencing an operational condition and provides input to the process to initiate troubleshooting. In some examples, the user can initiate the troubleshooting process by pressing a button. In other examples, the process automatically initiates the troubleshooting process immediately after or after a predetermined interval in which no input is received from the user.

[0093] The user proceeds by selecting a fluid channel / wound dressing for troubleshooting (e.g., testing the operational status). In some embodiments, the user and / or the process may make this selection. The selection of the fluid channel / wound dressing may be based on various factors, including the user's suspicion, suggestions by the process and similar matters, or the fluid channel / wound dressing may be selected arbitrarily or based on an algorithm.

[0094] In block 1112, after a fluid channel / wound dressing has been selected for testing, the valve associated with the selected channel / wound dressing is opened and the valves associated with the unselected channels / wound dressings are closed, thereby connecting the negative pressure therapy system to a negative pressure system having a single wound dressing with a single negative pressure source. In some embodiments, the valves can be opened and closed manually. In other embodiments, the valves can be operated by a controller. For example, the controller can wirelessly control the shut-off valves using a wireless transmitter or transceiver configured to communicate with the wireless transceiver or receiver of the valve. In some embodiments, the wireless transceiver can communicate with each valve and control each valve individually or as a unit.

[0095] In block 1114, the user can indicate to the process that all valves associated with unselected flow paths / cladding materials are closed. In some embodiments, the process can communicate with the valves to determine their status without user input. In some embodiments, such as when the valves are wirelessly controlled by a controller, the process does not wait for user input to open or close the valves.

[0096] In blocks 1116-1118, the process invokes an operational state detection scheme to determine whether the selected fluid channel / wound dressing is experiencing an operational state. This analysis is similar to the determination made by the process in a negative pressure system with a single wound dressing and a single negative pressure source. For example, a negative pressure lower than expected (or higher than expected flow) may indicate that the fluid channel / wound dressing is experiencing leakage, while a negative pressure higher than expected (or lower than expected flow) may indicate that the fluid channel / wound dressing is experiencing blockage, overpressure, or a full dressing state. If the process determines that no operational state exists, the process moves to block 1130. If the process determines that an operational state exists, the process moves to block 1120.

[0097] In block 1120, in response to a determination that the selected fluid channel / wound dressing is experiencing an operational state, the process can provide a display to the user. For example, the process can turn on or off an LED associated with the selected wound dressing.

[0098] In block 1122, the valve associated with the selected fluid channel / wound dressing (and valves associated with other fluid channels / wound dressings previously determined to be experiencing an operational state) is closed, and all other valves are open. As described above, the valves can be opened and closed manually by the user or controller. During this step, all known fluid channels / wound dressings experiencing an operational state can be shut off from the negative pressure source, and only untested fluid channels / wound dressings can remain in fluid communication with the negative pressure source.

[0099] In block 1124, the process again activates the operational state detection scheme to determine whether either the fluid channel or the wound dressing, which is in fluid communication with the negative pressure source, is experiencing an operational state. For example, the process determines whether the measured pressure substantially matches the expected pressure (or substantially matches the substantially assumed flow).

[0100] If no operational status is detected in step 1126, the process proceeds to step 1134. If operational status is detected, the process proceeds to step 1128.

[0101] In step 1128, if the process determines that at least one of the fluid channels / wound dressings not selected or untested in step 1110 is experiencing an operational state, the process can provide instructions to the user. For example, each wound dressing may have a corresponding LED. Upon detection of an operational state, the process can flash each LED associated with the untested wound dressing. Furthermore, the process can turn off each of the LEDs associated with the wound dressing determined to be experiencing an operational state, and each of the LEDs associated with the wound dressing determined not to be experiencing an operational state. The process then returns to step 1108.

[0102] In step 1130, the process determined that the selected fluid channel / wound dressing was not experiencing an operational state. The process can indicate that the selected channel / wound dressing is not experiencing an operational state, for example, by turning on (or turning green) the LED associated with the process. However, in some embodiments, one of the remaining fluid channels / wound dressings is experiencing an operational state.

[0103] In step 1132, a new fluid channel / wound dressing is selected for testing, and the process returns to step 1112. The newly selected fluid channel / wound dressing has not been tested during the current troubleshooting process (e.g., not selected in block 1110). As described above, wound dressing selection can be made by the user and / or by the process.

[0104] In step 1134, no operational state is detected on the fluid channel / wound dressing associated with the open valve. Therefore, the fluid channel / wound dressing associated with the closed valve is determined to be experiencing an operational state. In some embodiments, if the operational state is a full dressing state, the wound dressing experiencing the operational state is replaced and the associated valve is opened. In some embodiments, the user may manually replace the wound dressing. In some embodiments, the user will know which wound dressing needs to be replaced based on process indications (e.g., any off LEDs). In some examples, the user will determine which wound dressing should be replaced by visual inspection to see which wound dressing is associated with a closed valve. In some embodiments, the wound dressing is replaced without user assistance.

[0105] In step 1136, the diagnostic mode ends. The process can then proceed to step 1102 and continue monitoring the measured pressure.

[0106] In some cases, to assist in the troubleshooting process, fluid pathways can be blocked, for example, by closing valves or tightening fluid pathways. These pathways can be blocked manually by the user or automatically by the negative pressure wound healing system. By closing fluid pathways, the diagnostic process performed by the negative pressure wound healing system can be simplified, for example, by reducing the number of dressings to troubleshoot. Additionally, or alternatively, by closing fluid pathways, the user can change dressings without turning off the negative pressure wound healing system, or alternatively, without stopping the delivery of negative pressure to other wound dressings.

[0107] Figures 12A to 12C illustrate portable negative pressure devices according to several embodiments. As shown, the TNP device 102 may include an outer housing 1210 for housing and / or supporting the components of the TNP device 102.

[0108] The outer housing 1210 may include an indicator 1212 that can be designed to provide the user with information (e.g., information regarding the operating status of the TNP device 102). In some embodiments, the indicator 1212 may include one or more indicators, such as icon 1222 (indicating normal operation), 1224 (indicating the presence of one or more leaks preventing the device from providing negative pressure wound therapy), 1226 (checking the dressing), and 1228 (low power holding), which can warn the user of one or more operating and / or fault conditions of the TNP device 102. For example, the indicators may include icons that warn the user of normal or proper operating conditions, pump failure, power failure, battery status or voltage level, wound dressing status or capacity, leak detection in the dressing or fluid passage between the dressing and the pump assembly, suction blockage, or other similar or appropriate conditions or combinations thereof.

[0109] For example, the display unit 1212 may include a dressing check indicator 1226 that can provide the user with an alert prompting them to check the wound dressing. In some cases, the alert ensures that the full or substantially full dressing is replaced in a timely manner. For example, a timer or reminder, which can be controlled by the processor of the TNP device, can activate the dressing check indicator 1226 after a predetermined time. For example, the dressing check indicator may be configured to activate once a day, such as every 24 hours, or at other appropriate times. In some cases, the daily reminder may be more frequent to minimize the risk of wound maceration, but not so frequent as to be inconvenient for the user. In some cases, the dressing check indicator 1226 may be activated at a time convenient for the user. For example, the indicator may be activated at a time that fits into the user's daily life, such as when the user is getting dressed or showering. In some cases, the covering check indicator 1226 (or other indicators 1222, 1224, or 1228) can be reset by a single or double press of button 1216, or by other operation of button 1216. For example, the checking covering indicator can be stopped by first pressing button 1216, which pauses the TNP device 102. This press of button 1216 can signal user confirmation of the checking covering warning. The TNP device 102 can then resume providing negative pressure with a second press of button 1216.

[0110] In the illustrated embodiment, one or more icons 1222, 1224, 1226, and 1228 may be printed directly on the indicator 1212 of the outer housing 1210. In some embodiments, one or more icons 1222, 1224, 1226, and 1228 may be provided on a label attached to a portion of the outer housing 1210. One or more icons 1222, 1224, 1226, and 1228 may be illuminated when a state corresponding to that icon exists in the system.

[0111] The TNP device 102 may include one or more user input functions, such as a button 1216, designed to receive input from a user to control the operation of the TNP device 102. In the illustrated embodiment, there is a single button that can be used to activate and deactivate the TNP device 102, or to control other operating parameters of the TNP device 102. For example, in some embodiments, button 1216 can be used to activate the TNP device 102, deactivate the TNP device 102, clear an indicator such as one of icons 1222, 1224, 1226, or 1228, and / or for any other suitable purpose to control the operation of the TNP device 102 (e.g., by sequentially pressing button 1216). The button may be a push button that can be located on the front outside of the housing 1210. In some embodiments, multiple input functions (e.g., multiple buttons) may be provided on the TNP device 102.

[0112] In some embodiments, the TNP device 102 may include a connector 1202 for connecting a tube or conduit (inlet manifold branch attachment 206 or integrated inlet manifold) to the TNP device 102. As shown in Figure 12B, the connector 1202 may include two conduits 602 and 604 for fluid connection of the system to two separate wounds. In some embodiments, three or more wounds can be connected to the TNP device 102 via the conduits, conduits 602 and 604 or one or more additional conduits.

[0113] Embodiments of the pump systems described herein can be compact and small in size. In some embodiments disclosed herein, the pump assembly of the system may have a diameter (e.g., equivalent diameter) or lateral dimension between 15 mm and 35 mm, less than 15 mm, less than 25 mm, less than 35 mm, or less than 50 mm. For example, in some embodiments, the diameter or lateral dimension of the system may be 10 mm, 23 mm, or 40 mm, or the diameter or lateral dimension may be in the range of approximately 26 mm to approximately 27 mm, approximately 22 mm or less, or approximately 28 mm. In some embodiments disclosed herein, the thickness or height of the system may be approximately 8 mm, between approximately 6 mm and approximately 10 mm, or less than 20 mm. For example, in some embodiments, the thickness or height of the system may be 5 mm, 12 mm, or 20 mm.

[0114] In some embodiments, the TNP device 102 may include a negative pressure source configured to apply pressure for a maximum of 7, 10, or 30 days. The negative pressure source may include a motor, a sound coil actuator, a piezoelectric actuator, and similar devices. In some embodiments, the TNP device 102 may be battery-powered (for example, powered by two AA batteries).

[0115] In some embodiments, in addition to or instead of one or more indicators of the display unit 1212, the device may provide one or more auditory, tactile, sensory, or similar warnings.

[0116] Figure 12C illustrates a portable negative pressure device 1210 incorporating shut-off valves 1242, 1244 (sometimes called taps) in each fluid flow path according to several embodiments. As described herein in relation to Figures 4A-4C, 5 or 7, a plurality of shut-off valves 1242, 1244 may be positioned within a negative pressure therapy system such that the closure of the valves shuts off the provision of negative pressure to the associated wound dressing. The shut-off valves 1242, 1244 may be positioned anywhere within the fluid flow path, such as between the outlets of the inlet manifold branching attachments (e.g., conduits 602 and 604) and the corresponding dressing inlets, or in some cases, on or within the dressing. In some embodiments, one or more shut-off valves 1242, 1244 may be incorporated into the inlet manifold branching attachment, as described herein in relation to Figures 4A-4C.

[0117] In some cases, one or more of valves 1242, 1244 are manually shut-off valves. For example, a user can manually close valve 1242, thereby shutting off the provision of negative pressure to the associated wound dressing. In other cases, one or more valves may be operated by a system. For example, the valves may be electromechanical valves. For example, a TNP device may communicate with the valves to open and close each valve individually or as a unit. Communication between the valves and the TNP device may be wired or wireless. For example, a wireless transceiver in the TNP device may communicate with a wireless transceiver in the valve.

[0118] Figures 12A to 12G illustrate user interface indicators 1212 of portable negative pressure devices according to several embodiments. The indicator 1212 may have one or more combinations of indicators 1222, 1224, 1226, and 1228 shown in Figures 12A to 12G, however fewer, more, or different indicators are intended. For example, in some cases, the portable negative pressure device may not include an indicator, and / or the indicator may not include any buttons or indicators.

[0119] Figure 13 shows a perspective view of an embodiment of the wound dressing 1300 in conjunction with a fluid connector 1310. The illustrated wound dressing can be used with any embodiment of the negative pressure system described herein. As illustrated, the wound dressing 1300 has an elliptical absorbent layer 1320 having a plurality of lobes 1322. In some embodiments, the absorbent layer 1320 may have six lobes. In some embodiments, two or more lobes 1322 (e.g., six lobes) are provided on the wound dressing 1300. The lobes 1322, and in particular the gaps between the lobes 1322, help the wound dressing 1300 to conform to non-planar wounds. For example, it may be advantageous to use the dressing 1300 to conform around joints such as elbows and knees. The covering material 1300 may have a rectangular or square-shaped backing layer 1324, and in some embodiments, the covering material 1300 as a whole may be 190 mm × 230 mm or 145.5 mm × 4100 mm.

[0120] In some embodiments, the covering material 1300 may also have a circular notch 1328 in the central body portion, which may be located along the centerline of the covering material 1300 that transverses the longitudinal axis of the covering material 1300. In some embodiments, such a notch 1328 may have a diameter of 10 mm or about 10 mm, or may be in the range of 5 mm to 25 mm, or about 5 mm to about 25 mm. As illustrated, the circular notch 1328 may be symmetrically positioned on both sides of the centerline in the longitudinal direction of the covering material 1300, and may form an arc greater than 180 degrees, and in some cases may form an arc of 180 to 270 degrees (or about 180 to 270 degrees).

[0121] In the figure, the fluid connector 1310 may include an elongated conduit, a bridge 1320 having a proximal end 1330 and a distal end 1340, and an applicator 1380 at the distal end 1340 of the bridge 1320. In some embodiments, the bridge 1320 provides a soft fluid connection between the tube 1390 and the wound dressing 1300, and advantageously, can separate the tube 1390 from the wound dressing 1300, reducing the possibility of pressure points caused by the tube 1390. In some embodiments, the length of the bridge 1320 may be 20, 30, 45, 60, or 70 centimeters (± a few centimeters). An optional coupling 1360 may be located at the proximal end 1330 of the bridge 1320. In some embodiments, a cap (not shown) may be attached to the coupling 1360, which may be useful in preventing fluid from leaking out of the proximal end 1330.

[0122] The negative pressure system (shown in Figures 12A to 12C) may be connected to the coupling 1360 via tube 1390 (by connecting tube 1390 to one of connectors 602 or 604), or the system may be connected directly to the coupling 1360, or directly to the bridge 1320. During use, the dressing 1300 is placed over a suitably prepared wound, which in some cases may be filled with wound packing material such as foam or gauze. The applicator 1380 of the fluid connector 1310 has a sealing surface that is placed over the gap of the dressing 1300 and seals to the uppermost surface of the dressing 1300. Either before, during, or after the connection of the fluid connector 1310 to the dressing 1300, the system is connected to the coupling 1360 via tube 1390, or directly to the coupling 1360 or the bridge 1320. The pump is then activated, thereby supplying negative pressure to the wound. The application of negative pressure may be continued until the desired level of wound healing is achieved. In some embodiments, the system can be miniaturized and portable, but a larger conventional pump may be used with the dressing 1300. In some embodiments, the system may be mounted or attached to the dressing 1300, or adjacent to the dressing 1300.

[0123] In some embodiments, some or all other components of the TNP system, such as a negative pressure source (e.g., a pump) and power supplies, sensors, connectors, and user interface components (e.g., buttons, switches, speakers, screens), may be integrated with the wound dressing 1300. The wound dressing 1300 may include a cover layer for placement on top of the wound dressing layer. The cover layer may be the outermost layer of the dressing. In some embodiments, the wound dressing 1300 may include a second positioning cover layer on top of either the wound dressing layer or the integrated components. The second cover layer may be the outermost layer of the dressing or may be a separate outer shell surrounding the integrated components of the local negative pressure system.

[0124] As shown in the embodiment of Figure 13, the fluid connector 1310 includes an enlarged distal end or head 1340 that fluid-communicates with the covering material 1300, as will be described in more detail below. In one embodiment, the enlarged distal end has a round or circular shape. The head 1340 is shown in the figure as being located near the edge of the covering material 1300, but may be located anywhere on the covering material. For example, in some embodiments, it may be provided in the center or off-center, not on or near the edge or corner of the covering material 1300. In some embodiments, the covering material 1300 may include two or more fluid connectors 1310, each including one or more heads 1340 that fluid-communicate. In one embodiment, the head 1340 may be 30 mm along the widest edge. The head 1340 forms at least part of the applicator 1380, which is configured to seal to the uppermost surface of the wound dressing as described above.

[0125] Figure 14 shows a cross-section of a wound dressing 1400 similar to the wound dressing 1300 shown in Figure 13, along a fluid connector 1410. Alternatively, the wound dressing 1400 may be placed over a wound site to be treated, and may be any embodiment of the wound dressings disclosed herein, or any combination of features of any number of the embodiments of the wound dressings disclosed herein. The dressing 1400 may be used in conjunction with any negative pressure system embodiment described herein. The dressing 1400 may be installed to form a sealed cavity over the wound site. In one embodiment, the dressing 1400 includes a top layer or cover layer, or a backing layer 1420 attached to any wound contact layer 1422, which are described in more detail below. These two layers 1420, 1422 may be joined or sealed together to define an internal space or chamber. This internal space or chamber may include additional structures that may be adapted to distribute or transmit negative pressure and to store wound exudate and other fluids removed from the wound, and other functions which will be described in more detail below. Examples of such structures described below include a permeable layer 1426 and an absorbent layer 1421.

[0126] As used herein, the top layer or upper layer refers to the layer furthest from the surface of the skin or wound while the dressing is in use and positioned over the wound. Therefore, the bottom layer, lower layer, lowest layer or lower layer refers to the layer closest to the surface of the skin or wound while the dressing is in use and positioned over the wound.

[0127] As illustrated in Figure 14, the wound contact layer 1422 may be a polyurethane layer, a polyethylene layer, or other flexible layer perforated by, for example, a hot-pinning process, a laser ablation process, or an ultrasonic process, or by several other methods, or otherwise made permeable to liquids and gases. The wound contact layer 1422 has a bottom surface 1424 and an top surface 1423. Perforations 1425 may provide through-holes in the wound contact layer 1422, allowing fluid to flow through the layer 1422. The wound contact layer 1422 helps prevent tissue infiltration into other materials of the wound dressing. The perforations are preferably small enough to satisfy this requirement while allowing fluid to flow through them. For example, perforations formed as slits or holes with dimensions ranging from 0.025 mm to 1.2 mm are considered small enough to help prevent tissue infiltration into the wound dressing while allowing wound exudate to flow into the dressing. In some configurations, the wound contact layer 1422 can help maintain the overall integrity of the dressing 1400 by sealing in air around the absorbent pad to maintain negative pressure in the wound.

[0128] Some embodiments of the wound contact layer 1422 may also act as carriers for optional upper and lower adhesive layers (not shown). For example, a lower pressure-sensitive adhesive may be provided on the lower surface 1424 of the wound dressing 1400, while an upper pressure-sensitive adhesive layer may be provided on the upper surface 1423 of the wound contact layer. The pressure-sensitive adhesive, which may be a silicone, hot-melt, hydrophilic colloid, or acrylic-based adhesive, or other such adhesives, may be formed on both sides of the wound contact layer, on one of optionally selected sides, or not on either side of the wound contact layer. Utilizing the lower pressure-sensitive adhesive layer may help to adhere the wound dressing 1400 to the skin around the wound site. In some embodiments, the wound contact layer may include a perforated polyurethane film. The lower surface of the film may be provided with a silicone pressure-sensitive adhesive, and the upper surface may be provided with an acrylic pressure-sensitive adhesive, thereby helping the dressing maintain its integrity. In some embodiments, adhesive layers may be provided on both the upper and lower surfaces of the polyurethane film layer, and all three layers may be perforated.

[0129] A layer 1426 of porous material may be placed above the wound contact layer 1422. This porous or permeable layer 1426 allows fluids, including liquids and gases, to permeate away from the wound site into the upper layer of the wound dressing. In particular, the permeable layer 1426 ensures that the outside air channels can be maintained to transmit negative pressure throughout the wound area, even when the absorbent layer has absorbed a considerable amount of exudate. The layer 1426 should preferably remain open under the normal pressure that will be applied during negative pressure wound therapy, as described above, so that the entire wound site receives equal negative pressure. The layer 1426 may be formed from a material having a three-dimensional structure. For example, knitted or woven spacer cloth (e.g., Baltex 7970 weft-knit polyester) or nonwoven fabric may be used.

[0130] In some embodiments, the permeable layer 1426 includes a 3D polyester spacer fabric layer comprising an uppermost layer (i.e., the layer distal to the wound bed during use) which is 84 / 144 woven polyester, a lowermost layer (i.e., the layer placed close to the wound bed during use) which is 10-denier flat polyester, and a third layer formed sandwiched between these two layers, which is an area defined by woven polyester viscose, cellulose, or similar monofilament fibers. Other materials and fibers of other linear mass densities may, of course, also be used.

[0131] Throughout this disclosure, while references are made to monofilament fibers, it will be understood that, of course, multifilament alternatives may be used. Therefore, the uppermost spacer fabric has more filaments in a single thread used to form it than the number of filaments that make up the thread used to form the lowermost spacer fabric layer.

[0132] This difference in the number of filaments in the spaced layers helps to control the flow of moisture across the permeable layers. Specifically, by increasing the number of filaments in the top layer, that is, by making the top layer from a thread with more filaments than the thread used in the bottom layer, the fluid tends to be absorbed more along the top layer than along the bottom layer. During use, this difference causes the fluid to be drawn away from the wound bed and into the central region of the dressing, where the absorbent layer 1421 helps to contain the fluid or draws it forward on its own towards the cover layer that can release the fluid.

[0133] To improve the flow of liquid across the permeable layer 1426 (i.e., perpendicular to the channel region formed between the uppermost and lowermost spacer layers), the 3D fabric may be treated with a dry cleaning agent (but not limited to perchloroethylene) to help remove any industrial products, such as previously used mineral oils, greases, and / or waxes, that may interfere with the hydrophilic ability of the permeable layer. In some embodiments, the process may then proceed to an additional manufacturing step in which the 3D spacer fabric is washed with a hydrophilic agent (but not limited to 30 g / l of Feran Ice, commercially available from Rudolph Group). This process step helps ensure that the surface tension of the material is low enough that liquids such as water can penetrate the fabric as soon as they come into contact with the 3D fabric. This step also helps to control the flow of any liquid insult component of any exudates.

[0134] The absorbent layer 1421 is provided on top of the permeable layer 1426. The absorbent, which comprises a foam or nonwoven natural or synthetic material and optionally a superabsorbent material, forms a reservoir for the fluid, specifically the liquid to be removed from the wound site. In some embodiments, the layer 1421 may also help to draw the fluid toward the backing layer 1420.

[0135] The material of the absorbent layer 1421 may also prevent the fluid collected in the wound dressing 1400 from flowing freely within the dressing, and may act to contain any fluid collected within the dressing. The absorbent layer 1421 also helps distribute the fluid throughout the layer by suction, drawing the fluid away from the wound site and storing it throughout the absorbent layer. This helps prevent aggregation in areas of the absorbent layer. The volume of the absorbent material must be sufficient to control the rate at which wound exudate flows when negative pressure is applied. Since the absorbent layer experiences negative pressure during use, the material of the absorbent layer is selected to absorb fluid under such conditions. There are several materials that can absorb fluid under negative pressure, such as superabsorbent materials. The absorbent layer 1421 may typically be manufactured from ALLEVYN foam Freudenberg 114-224-4 and / or Chem-Posite 11C-450. In some embodiments, the absorbent layer 1421 may include a composite material comprising superabsorbent powder, fibrous material such as cellulose, and binding fibers. In one embodiment, the composite material is a thermally bonded composite material of airlaid.

[0136] In some embodiments, the absorbent layer 1421 is a layer of nonwoven cellulose fibers having a superabsorbent material in the form of dry particles dispersed throughout the layer. The use of cellulose fibers introduces a high-speed suction element that helps to quickly and evenly distribute the liquid absorbed by the coating material. The parallel arrangement of numerous twisted fibers leads to a strong capillary action of the fiber pad that helps to distribute the liquid. In this way, the liquid is efficiently supplied to the superabsorbent material. The suction action also helps to bring the liquid into contact with the upper cover layer, which helps to increase the evaporation rate of the coating material.

[0137] A gap, hole, or orifice 1427 is provided in the backing layer 1420 so that negative pressure can be applied to the dressing 1400. The fluid connector 1410 is mounted or sealed to the top of the backing layer 1420 over the orifice 1427 created in the dressing 1400, and transmits negative pressure through the orifice 1427. A long tube may be connected at a first end to the fluid connector 1410 and at a second end to a negative pressure system (not shown) so that fluid can be removed from the dressing. If the fluid connector is bonded to the top layer of the wound dressing, the long tube may be connected at the first end of the fluid connector such that the tube or conduit extends away from the fluid connector parallel to it or substantially to the top surface of the dressing. The fluid connector 1410 may be bonded and sealed to the backing layer 1420 using an adhesive such as acrylic, cyanoacrylate, epoxy, UV-curable, or hot-melt adhesive. The fluid connector 1410 may be formed from a soft polymer having a hardness of 30 to 90 on the Shore A scale, such as polyethylene, polyvinyl chloride, silicone, or polyurethane. In some embodiments, the fluid connector 1410 may be made from a soft material or a compatible material.

[0138] The absorption layer 1421 may include at least one through-hole 1428 positioned beneath the fluid connector 1410. In some embodiments, the through-hole 1428 may be the same size as, or larger than, the opening 1427 in the backing layer. As illustrated in Figure 14, a single through-hole may be used to provide an opening beneath the fluid connector 1410. It will be understood that multiple openings may be used as alternatives. In addition, if two or more ports are to be utilized according to a particular embodiment of the present disclosure, one or more openings may be made in the absorption layer and the obscuration layer, aligned with each fluid connector. Although not essential to the particular embodiment of the present disclosure, the use of through-holes in the superabsorbent layer may provide unobstructed fluid channels, particularly when the absorption layer is near saturation.

[0139] The gap or through-hole 1428 may be provided in the absorbent layer 1421 below the orifice 1427, as shown in Figure 14, so that the orifice connects directly to the permeable layer 1426. This allows the negative pressure applied to the fluid connector 1410 to be transmitted to the permeable layer 1426 without passing through the absorbent layer 1421. This ensures that the negative pressure applied to the wound site is not obstructed by the absorbent layer when the absorbent layer absorbs wound exudate. In other embodiments, the gap may not be provided in the absorbent layer 1421, or alternatively, multiple gaps may be provided below the orifice 1427. In further alternative embodiments, additional layers may be provided above the absorbent layer 1421 and below the backing layer 1420.

[0140] The backing layer 1420 is impermeable to gases but permeable to water vapor and may extend across the width of the wound dressing 1400. For example, the backing layer 1420 may be a polyurethane film (e.g., Elastollan SP9109) having a pressure-sensitive adhesive on one side. The backing layer 1420 is impermeable to gases and therefore acts to cover the wound and seal the wound cavity on which the wound dressing is placed. In this way, an effective chamber is created between the backing layer 1420 and the wound site, where negative pressure can be established. The backing layer 1420 can be sealed to the wound contact layer 1422 in the boundary region around the outer periphery of the dressing, ensuring that air is drawn through the boundary area, for example by adhesive or welding techniques. The backing layer 1420 protects the wound from external bacterial contamination (bacterial barrier) and allows fluid from the wound exudate to move through the layer and evaporate from the outer surface of the film. The backing layer 1420 may comprise two layers: a polyurethane film and an adhesive pattern spread over the film. The polyurethane film may be permeable to moisture and may be made from a material whose water permeation rate increases when wet. In some embodiments, the permeability of the backing layer increases when it is wet. The permeability of a wet backing layer may be up to about 10 times that of a dry backing layer.

[0141] The absorbent layer 1421 may have a larger area than the permeable layer 1426 so that the absorbent layer overlaps with the edge of the permeable layer 1426, thereby ensuring that the permeable layer does not come into contact with the backing layer 1420. This provides an outer channel of the absorbent layer 1421 that is in direct contact with the wound contact layer 1422, which helps in the more rapid absorption of exudate into the absorbent layer. Furthermore, this outer channel ensures that fluid does not accumulate around the periphery of the wound cavity, which may lead to leakage by seeping out from the sealing around the dressing. As shown in Figure 14, the absorbent layer 1421 may define a periphery smaller than the periphery of the backing layer 1420 so that the boundary or boundary region is defined between the edge of the absorbent layer 1421 and the edge of the backing layer 1420.

[0142] As shown in Figure 14, one embodiment of the wound dressing 1400 includes a gap 1428 in the absorbent layer 1421 placed beneath the fluid connector 1410. During use, for example, when negative pressure is applied to the dressing 1400, the portion of the fluid connector facing the wound may come into contact with the permeable layer 1426, and thus can help transmit negative pressure to the wound site even when the absorbent layer 1421 is filled with wound fluid. In some embodiments, a backing layer 1420 may be at least partially adhered to the permeable layer 1426. In some embodiments, the gap 1428 is at least 1 to 2 mm larger than the diameter of the portion of the fluid connector 1410 facing the wound or the orifice 1427.

[0143] In particular, in some embodiments involving a single fluid connector 1410 and a through-hole, it may be preferable for the fluid connector 1410 and the through-hole to be positioned off-center, as shown in Figure 13. In such a location, it may be possible to position the dressing 1400 on the patient so that the fluid connector 1410 is elevated relative to the rest of the dressing 1400. Such positioning may reduce the likelihood of the fluid connector 1410 and filter 1414 coming into contact with wound fluid that could prematurely occlude the filter 1414 in order to reduce the transmission of negative pressure to the wound site.

[0144] Turning to the fluid connector 1410, some embodiments include a sealing surface 1416, a bridge 1411 (corresponding to bridge 1320 in Figure 13) with a proximal end 1330 and a distal end 1340, and a filter 1414. The sealing surface 1416 may form the previously described applicator, which seals to the uppermost surface of the wound dressing. In some embodiments, the bottom layer of the fluid connector 1410 may comprise the sealing surface 1416. The fluid connector 1410 may further, in some embodiments, have a top surface defined by a separate upper layer of the fluid connector, spaced perpendicularly from the sealing surface 1416. In other embodiments, the top and bottom surfaces may be formed from the same piece of material. In some embodiments, the sealing surface 1416 may include at least one gap 1429 within it to communicate with the wound dressing. In some embodiments, the filter 1414 may be positioned across the opening 1429 of the sealing surface, or it may extend across the entire opening 1429. The sealing surface 1416 may be configured to seal the fluid connector to the cover layer of the wound dressing and may include an adhesive or joint. In some embodiments, the sealing surface 1416 may be located on an orifice in the cover layer. In other embodiments, the sealing surface 1416 may be located on the gap between the orifice in the cover layer and the absorbent layer 1420, allowing the fluid connector 1410 to provide airflow through the permeable layer 1426. In some embodiments, the bridge 1411 may include a first fluid passage 1412 communicating with a negative pressure source, the first fluid passage 1412 comprising a porous material, which may be the same as or different from the porous layer 1426 described earlier, such as a 3D knitted material. The bridge 1411 may be enclosed by at least one flexible film layer 1408, 1410 having a proximal and distal end and configured to surround the first fluid passage 1412, the distal end of the flexible film connecting to the sealing surface 1416. The filter 1414 is configured to substantially prevent wound exudate from entering the bridge.

[0145] Some embodiments may further include an optional second fluid passage positioned above the first fluid passage 1412. For example, some embodiments may provide an air leak located at the proximal end of the uppermost layer 1408, which is configured to provide an air path to the first fluid passage 1412 and the covering material 1400.

[0146] The fluid passage 1412 is constructed from a flexible, standardized material that allows fluid to pass through even if the spacer twists or folds. Suitable materials for the fluid passage 1412 include, but are not limited to, foams including open-cell foams such as polyethylene or polyurethane foam, meshes, 3D knits, nonwoven materials, and fluid channels. In some embodiments, the fluid passage 1412 may be constructed from materials similar to those described above with respect to the permeable layer 1426. Advantageously, such materials used for the fluid passage 1412 may not only allow for greater patient comfort but may also provide greater torsional resistance, allowing the fluid passage 1412 to still move fluid from the wound towards the negative pressure source even while twisting or bending.

[0147] In some embodiments, the fluid passage 1412 may consist of a wicking fabric, such as a knitted or woven spacer cloth (a 3D woven fabric made of polyester, such as Baltex 7970® or Gehring 879®), or a nonwoven fabric. These selected materials can preferably be used to guide wound exudate away from the wound, to transmit negative pressure and / or discharged air to the wound site, and may also provide some torsional or occluding resistance to the fluid passage 1412. In some embodiments, the wicking fabric may have a three-dimensional structure that, in some cases, may help in the suction of fluid or the transmission of negative pressure. In certain embodiments, in embodiments including a wicking fabric, these materials can remain open and still transmit negative pressure to the wound area under normal pressures, for example, between 40 and 150 mmHg, as used in negative pressure therapy. In some embodiments, the wicking fabric may include several layers of material stacked or laminated on top of each other, which may be useful in some cases to prevent the fluid passage 1412 from collapsing under negative pressure conditions. In other embodiments, the wicking fabric used for the fluid passage 1412 may be between 1.5 mm and 6 mm thick, for example, the wicking fabric may be between 3 mm and 6 mm thick, and may consist of either one or several individual wicking fabric layers. In other embodiments, the fluid passage 1412 may be between 1.2 and 3 mm thick, such as thicker than 1.5 mm. In some embodiments, for example, a suction adapter used with a dressing that holds fluids such as wound exudate may use a hydrophobic layer in the fluid passage 1412, so that only gases move through the fluid passage 1412. In addition, as previously described, the materials used in the system can be conforming and soft, which may help to avoid pressure ulcers and other complications that may result from wound treatment systems that apply pressure to the patient's skin.

[0148] The filter element 1414 is provided to be impermeable to liquids but permeable to gases, acting as a liquid barrier to ensure that the liquid cannot leak out of the wound dressing 1400. The filter element 1414 may also function as a bacterial barrier. Typically, the pore size is 0.2 μm. Suitable materials for the filter material of the filter element 1414 include 0.2 micron Gore® extended PTFE, PALL Versapore® 200R, and Donaldson® TX6628 from the MMT range. Larger pore sizes may also be used, but these may require a secondary filter layer to ensure complete containment of biological contamination. Since wound fluids contain lipids, it is preferable to use an oleophobic filter membrane, for example, 1.0 micron MMT-332 before 0.2 micron MMT-323. This prevents lipids from blocking the hydrophobic filter. The filter element may be attached to or sealed in a port and / or covering film above the orifice. For example, the filter element 1414 may be molded onto the fluid connector 1410, or, but is not limited to, it may be bonded to either or both the top of the cover layer and the bottom of the suction adapter 1410 using an adhesive such as a UV-curing adhesive.

[0149] It will be understood that other types of materials may be used for the filter element 1414. More broadly, a microporous membrane, which is a thin, flat polymer material, can be used, containing billions of microscopic pores. Depending on the membrane chosen, these pores can range in size from 0.01 micrometers to larger than 10 micrometers. Microporous membranes are available in both hydrophilic (water filtering) and hydrophobic (water-repellent) forms. In some embodiments, the filter element 1414 includes a support layer and an acrylic copolymer membrane formed on the support layer. A wound dressing 1400 according to a particular embodiment of this disclosure uses a microporous hydrophobic membrane (MHM). The MHM may be formed using a number of polymers. For example, the MHM may be formed from one or more of PTFE, polypropylene, PVDF, and acrylic copolymers. All of these arbitrary polymers may be treated to obtain specific surface properties, which may be both hydrophobic and oleophobic. These will repel liquids with low surface tension, such as multivitamin infusions, lipids, surfactants, oils, and organic solvents.

[0150] MHMs block liquids while allowing air to flow through the membrane. MHMs are also highly efficient air filters that eliminate potentially infectious aerosols and particles. Single MHM pieces are well-known as an alternative to mechanical valves or vents. Therefore, incorporating MHMs can reduce product assembly costs and improve profits and the cost / benefit ratio to patients.

[0151] The filter element 1414 may also include an odor absorbent, such as activated carbon, carbon fiber cloth, or Vitec Carbotec-RT Q2003073 foam, or similar materials. For example, the odor absorbent may form a layer of the filter element 1414 or be sandwiched between hydrophobic microporous membranes within the filter element. Thus, the filter element 1414 allows gases to be discharged through the orifice. However, liquids, particulate matter, and pathogens are contained within the covering material.

[0152] Similar to the embodiments of wound dressings described above, some wound dressings include a perforated wound contact layer with a silicone adhesive on the skin contact surface and an acrylic adhesive on the back surface. Above this bordered layer is a permeable layer or a 3D spacer cloth pad. Above the permeable layer is an absorbent layer. The absorbent layer may include a superabsorbent nonwoven (NW) pad. The absorbent layer may be in contact with the permeable layer for approximately 5 mm beyond its periphery. The absorbent layer may have a gap or through-hole toward one end. The gap may be approximately 10 mm in diameter. Above the permeable and absorbent layers is a backing layer. The backing layer may be a high water vapor permeability (MVTR) film, which is a pattern coated with acrylic adhesive. The high MVTR film and wound contact layer enclose the permeable and absorbent layers, creating a periphery boundary of approximately 20 mm. The backing layer may have a 10 mm gap that overlaps the gap in the absorbent layer. A fluid connector may be connected above the hole, comprising a liquid-impermeable, gas-permeable semi-permeable membrane (SPM) or filter that overlaps the aforementioned gap.

[0153] Figures 15A to 15D illustrate embodiments of wound dressings incorporating negative pressure indicators according to several embodiments. Figure 15A shows a negative pressure indicator 1591 on or inside the wound dressing 1500 to indicate the point in time when negative pressure is established beneath the dressing. The negative pressure indicator 1591 may be a mechanical indicator. In some embodiments, the negative pressure indicator 1591 may be an indicator that does not require direct line of sight from the patient. For example, the negative pressure indicator 1591 may be an indicator that can be touched or felt by the patient or user. The negative pressure indicator 1591 may be one or more gaps or cutouts within the absorbent material of the dressing. In some cases, when negative pressure is applied beneath the cover layer, the dressing tightens and the cover layer can be compressed as it is drawn into one or more gaps or cutouts within the absorbent material.

[0154] In some embodiments, the negative pressure indicator 1591 may be a small hole arrangement as shown in Figure 15A. In some embodiments, the covering material has three small holes. In some embodiments, as shown in Figure 15A, two sets of three small hole arrangements can be used on both sides of the covering material, extending along the longitudinal axis along the lateral edge of the covering material. In some embodiments, the diameter of the individual negative pressure indicators may be approximately 4 mm to approximately 5 mm.

[0155] Negative pressure indicators can be formed from different types of stepped changes or depressions created in the covering material as a result of cutouts or holes in the absorbent layer. In some embodiments, negative pressure indicators can be formed from holes or cutouts in the absorbent material, with the cover layer covering the holes or cutouts. In some embodiments, the holes or cutouts in the absorbent material can be circular, rectangular, triangular, elliptical, or any other shape. When no vacuum is applied, the area may feel loose, but under negative pressure the area can tighten, and stepped topography or depressions within the cover layer may become apparent. Stepped topography may be visualized and / or felt by the user. Small holes in the absorbent material illustrated in Figure 15A can be used. In other embodiments, large holes in the absorbent material bonded to another film material or rectangular strips in the absorbent material bonded to another film material can be used.

[0156] Small holes cut into the absorbent material can be used in combination with an adhesive-coated top film. The interaction between the two behaves as described above. Under pressure, the absorbent material is compressed, and the film tightens, exposing the holes in the film cover. These holes can be felt when the system is under negative pressure. When the system returns to ambient pressure, the film "loosens" or "stretches" to its original state, and the holes can no longer be easily felt through the top film material. Figures 15B and 15C show cross-sectional views of the holes before (Figure 15B) and during (Figure 15C) the application of negative pressure. The negative pressure indicators of the small holes (4 mm to approximately 5 mm in diameter) allow for a tightened, stepped topography when negative pressure is applied, while concealing the stepped hole areas when the covering material returns to ambient pressure.

[0157] In other embodiments, a large hole with a non-adhesive film can be used as a negative pressure indicator. The large hole may be a gap or cutout as described for the small hole. However, since the cover layer may be covered with an adhesive material, a non-adhesive film 1592 can be used in the large hole of the absorbent material 1522 to prevent the cover layer 1513 from becoming fixed to the lower layer of the covering material after the cover layer 1513 has been compressed into the large hole and then returned to ambient pressure.

[0158] Figure 15D shows a cross-sectional view of an embodiment of a wound dressing having a negative pressure indicator 1591 with large perforations in an absorbent material 1522. When the system is under negative pressure, the cover layer 1513 can adhere to the non-adhesive film material 1592, tightening around the absorbent material 1522 and creating a stepped topography in the dressing defining the negative pressure indicator 1591. When the dressing returns to ambient pressure, the cover layer 1513 can return to its original state. In some embodiments, the large holes can be circular holes with a diameter of 12 mm (approximately 12 mm). In some embodiments, two or more large holes can be used. In some embodiments, an array of large holes can be used. In some embodiments, the holes can be less than 3 mm, 3 mm (approximately 3 mm), 4 mm (approximately 4 mm), 5 mm (approximately 5 mm), 6 mm (approximately 6 mm), 7 mm (approximately 7 mm), or greater than 7 mm in diameter.

[0159] term Depending on the embodiment, any particular operation, action, event, or function of any of the processes described herein may be performed in a different order, and may be added, merged, or excluded as a whole (for example, not all of which are necessary for the practice of the process). Furthermore, in certain embodiments, the actions, actions, functions, or events may be executed concurrently rather than sequentially, for example, through multithreading, interrupt handling, or through multiple processors or processor cores, or on other parallel architectures.

[0160] 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 dedicated computer hardware systems and / or computing devices. Similarly, the illustrated data repository can represent physical and / or logical data storage, including, for example, a storage area network or other distributed storage system. Furthermore, in some embodiments, the connections between the illustrated components represent possible paths of data flow rather than actual connections between hardware. While several embodiments of possible connections are shown, any subset of the illustrated components can communicate with any other subset of components in various implementations.

[0161] The above-mentioned patents, uses, and other references, including those that may be described in the attached application documents, are incorporated herein by reference. The aspects of the disclosure may be modified, if necessary, to provide further implementations using the various systems, functions, and concepts of reference described herein.

[0162] It should be understood that any properties, substances, features, or groups described in relation to a particular aspect, embodiment, or example are applicable to any other aspect, embodiment, or example described herein, provided that they are not incompatible. All of the features disclosed herein (including any of the appended claims, abstract, and drawings), or any of the steps of any method or process disclosed herein, may be combined in any combination, except for any combination in which at least some of such features or steps are mutually exclusive. The protections of the present invention are not limited to the details of any of the embodiments described herein. The protections extend to any novel features or any novel combination of features disclosed herein (including any of the appended claims, abstract, and drawings), or to any novel steps or any novel combination of any method or process steps disclosed herein.

[0163] While specific embodiments have been described, these embodiments are presented merely as examples and are not intended to limit the scope of protection. In fact, the novel methods and systems described herein may be embodied in various other forms. Furthermore, various omissions, substitutions, and modifications may be made in the forms of the methods and systems described herein. Those skilled in the art will recognize that in some embodiments, the actual steps performed in the illustrated or disclosed processes may differ from the steps shown in the figures. In some embodiments, certain steps among the steps described above may be omitted, and others may be added. For example, the actual steps or the order of steps performed in the disclosed processes may differ from those shown in the figures. In some embodiments, certain steps among the steps described above may be omitted, and others 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 may include logic circuits. Furthermore, the features and characteristics of the specific embodiments disclosed above can be combined in various ways to form further embodiments, all of which will fall within the scope of this disclosure.

[0164] This disclosure includes specific embodiments, examples, and uses, but it will be understood by those skilled in the art that the disclosure extends beyond the scope of the specifically disclosed embodiments to other alternative embodiments or uses, as well as obvious modifications thereof and their equivalents, including embodiments that do not necessarily provide all of the features and advantages described herein. Accordingly, the scope of this disclosure is not intended to be limited by the embodiments described, but may be defined by the claims presented herein or thereafter.

[0165] Conditional phrases such as “can,” “could,” “might,” or “may” are typically intended to convey that a particular embodiment includes a particular feature, element, or step, while other embodiments do not, unless otherwise specifically stated or interpreted within the context in which they are used. Therefore, such conditional phrases are not necessarily intended to suggest that the feature, element, or step is required to some extent in one or more embodiments, or that logic for determining whether or not such feature, element, or step is included in any particular embodiment, or should be implemented in such embodiment, is necessarily included in one or more embodiments, with or without user input or instruction. Terms such as “comprising,” “including,” and “having” are synonyms and are used in an inclusive, non-restrictive manner, not excluding additional elements, features, actions, and behaviors. Furthermore, the term "or" is used in an inclusive sense (rather than an exclusive sense), meaning, for example, when used to connect a list of elements, it means one, some, or all of the elements listed. Similarly, the terms "and / or" encompass all of the following interpretations of the word in relation to the enumeration of two or more items: any one item in the enumeration, all items in the enumeration, and any combination of items in the enumeration. In addition, the term "each," as used herein, may mean, in addition to its usual meaning, any subset of the set of elements to which the term "each" applies. Furthermore, as used herein, "herein," "above," "below," and similar terms mean, as used in this application, the entirety of this specification and not any particular part thereof.

[0166] Conjunctions such as "at least one of X, Y, and Z" are to be interpreted differently depending on the context in which they are commonly used to suggest that a certain item or term may be X, Y, or Z, unless otherwise specifically stated. Therefore, such conjunctions are not necessarily intended to suggest that a particular embodiment must include at least one X, at least one Y, and at least one Z.

[0167] As used herein, terms such as “approximately,” “about,” “generally,” and “substantially” describe a degree that is close to a given value, quantity, or characteristic that still performs the desired function or produces the desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may mean quantities that are less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of a given quantity. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” mean a value, quantity, or characteristic that is 15 degrees or less, 10 degrees or less, 5 degrees or less, 3 degrees or less, 1 degree or less, or 0.1 degrees or less from being exactly parallel.

[0168] Any of the embodiments described herein can be used with or without a canister. Any of the dressing embodiments described herein can absorb and retain wound exudate.

[0169] The scope of this disclosure is not intended to be limited by the description of any particular embodiment, and may be defined by the claims. The language of these claims should be interpreted broadly based on the language used herein, and not limited to the examples described herein or during the proceedings of this application, and such examples should be interpreted non-exclusively. [Explanation of Symbols]

[0170] 102 TNP equipment 114 Pressure Sensor 200 Negative Pressure Therapy System 202 First wound dressing 208 First fluid channel 210 Second fluid channel 204 Second wound dressing 206 Inlet manifold branch connection section 212 Third fluid channel

Claims

1. A negative pressure source configured to be connected to multiple wound dressings via multiple fluid channels and to provide negative pressure to multiple wound dressings, wherein the multiple fluid channels are A first fluid channel configured to fluidly connect a first wound dressing to the negative pressure source, having a first valve, wherein when the first valve is open, the fluid allows the fluid to pass through the first fluid channel, and when the first valve is closed, the fluid prevents the fluid from passing through the first fluid channel, and A negative pressure source comprising a second fluid channel configured to fluidly connect a second wound dressing to the negative pressure source, the second fluid channel having a second valve, the second valve allowing fluid to pass through the second fluid channel when open, and preventing fluid from passing through the second fluid channel when closed, A pressure sensor configured to measure the combined pressure in multiple fluid passages, A controller configured to operate the negative pressure source, wherein the controller is further configured to determine that a plurality of fluid passages include a fluid passage associated with a blocked state, based on a determination that first pressure data received from the pressure sensor satisfies a first blockage threshold, and to identify at least one fluid passage in the plurality of fluid passages associated with the blocked state, at least in part, based on second pressure data received from the pressure sensor, the second pressure data being measured when at least one of the first valve or the second valve is closed, Includes, The first pressure data is measured when the first valve and the second valve are open. Negative pressure therapy device.

2. The apparatus according to claim 1, wherein the first blockage threshold corresponds to the expected combined negative pressure of the plurality of fluid passages when at least one of the plurality of fluid passages is associated with the blockage state.

3. The identification of the at least one fluid flow path is performed by the controller, With the first valve remaining open, the second valve is closed, and It is determined that the first fluid passage is associated with the blocked state, at least in part, based on the determination that the second pressure data measured when the first valve is open and the second valve is closed satisfies the second blockage threshold. The apparatus according to claim 1, comprising being configured in such a manner.

4. The apparatus according to claim 3, wherein the second occlusion threshold corresponds to the expected negative pressure of a single fluid channel unrelated to the occlusion state.

5. The aforementioned controller further, Open the second valve, Close the first valve, The apparatus according to claim 3, configured to receive the second pressure data when the second valve is open and the first valve is closed.

6. The aforementioned controller further, The apparatus according to claim 5, which determines that the second fluid passage is associated with the blocked state, at least in part on the determination that the second pressure data measured when the second valve is open and the first valve is closed satisfies a third blockage threshold.

7. The apparatus according to claim 6, wherein the third occlusion threshold corresponds to the expected negative pressure of a single fluid channel unrelated to the occlusion state.

8. The aforementioned controller further, The apparatus according to claim 5, wherein it is determined that the second fluid passage is not associated with the blockage state, at least in part on the determination that the second pressure data measured when the second valve is open and the first valve is closed does not satisfy a third blockage threshold, and the third blockage threshold corresponds to the expected negative pressure of a single fluid passage not associated with the blockage state.

9. The apparatus according to claim 1, wherein the plurality of fluid passages further comprises a third fluid passage configured to fluidly connect a third wound dressing to the negative pressure source, the third fluid passage includes a third valve, the third valve allowing fluid to pass through the third fluid passage when open, and preventing fluid from passing through the third fluid passage when closed.

10. The apparatus according to claim 9, wherein the second pressure data is measured when the first valve is open, the second valve is closed, and the third valve is closed, and the identification of the at least one fluid passage is configured such that the controller determines, at least in part, based on the second pressure data, that the first fluid passage is associated with the occlusion state.

11. The aforementioned controller further, With the first valve remaining open, Close the second valve, Close the third valve, The apparatus according to claim 9, wherein the first fluid passage is configured to determine that it is associated with the blocked state, at least in part on the determination that the second pressure data measured when the first valve is open and the second valve and the third valve are closed satisfies a second blockage threshold, the second blockage threshold corresponding to the expected negative pressure of a single fluid passage.

12. The aforementioned controller further, Close the first valve, Open the second valve and the third valve, The apparatus according to claim 11, configured to determine, at least in part, that at least one of the second fluid passage and the third fluid passage is associated with the blockage, based on third pressure data measured when the first valve is closed and the second valve and the third valve are open.

13. The aforementioned controller further, With the first valve remaining closed and the second valve remaining closed, Open the third valve as described above. The apparatus according to claim 12, which determines that the third fluid passage is associated with the blockage state, based at least in part on fourth pressure data measured when the first valve and the second valve are closed and the third valve is open.

14. The apparatus according to claim 1, wherein the pressure sensor is a single pressure sensor of the apparatus.

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