Wound treatment tube set system for wound volume estimation

Abstract

The present invention provides a tubing set module that includes one or more components of a negative pressure wound therapy (“NPWT”) system, such as valves, fractional leakage devices, pressure sensors, etc. The tubing set module can communicate with a controller of the NPWT system via a communication interface provided by the tubing set module. Communication between the tubing set module and the controller can be used to fully automate one or more processes related to the operation of components included in the tubing set module that are part of the NPWT system, thereby allowing the NPWT system to, for example, estimate wound site volume, estimate fluid volume to be instilled, monitor wound healing progress, etc., without any user interaction or involvement. The tubing set module can be defined by one or more housing elements. The tubing set module can be incorporated into any of a tube, a fluid reservoir, a wound dressing, and / or a treatment device that houses components of the NPWT system.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit of the priority of U.S. Provisional Application No. 62 / 755,035, filed on Nov. 2, 2018, which is hereby incorporated by reference in its entirety. Background of the Invention

[0003] The present disclosure generally relates to a wound treatment system and, more particularly, to a wound treatment system configured to estimate a volume relative to a wound site.

[0004] Negative pressure wound therapy (NPWT) is a class of wound treatment that involves applying negative pressure to a treatment site to promote wound healing. Recent advancements in wound healing using NPWT involve applying topical fluids to the wound to function in combination with NPWT. However, it may be difficult to determine the appropriate volume of the instilled fluid delivered to the wound. Additionally, it may be difficult to accurately monitor and track the wound healing process over time. Accordingly, it is advantageous to provide a system and method that allows for an accurate and reliable estimation of the available space at the wound site into which the instilled fluid can be delivered and an estimation of the wound healing process over time. Advantageously, such a system and method will additionally allow for such volume determination to be automatically performed by a controller that is not only configured to automatically process and calculate the volume determination, but the controller is also configured to automatically actuate any desired components of the NPWT system as needed to obtain the necessary data points required for such calculations. Additionally, such methods and systems can advantageously be performed at any stage during NPWT treatment and can account for changes in the type or size of the fluid removal canister used during the NPWT treatment process. Summary of the Invention

[0005] In one particular embodiment of the present disclosure, a wound treatment system includes a treatment device, a tube, and a tube set module. The treatment device includes: a canister configured to collect wound exudate from a wound; a pump fluidly coupled to the canister and configured to draw a negative pressure within the canister. The tube is attached to and fluidly coupled to the canister. The tube and the canister define a negative pressure circuit. The tube set module is in fluid communication with the canister and the tube. The tube set module includes a valve, a graduated leak device, and a communication interface. The valve is configured to selectively permit flow within the tube when in an open configuration and to selectively block flow when in a closed configuration. The graduated leak device is configured to provide fluid communication between the negative pressure circuit defined by the tube and the canister and ambient atmosphere. The communication interface is configured to receive communications from a controller. The valve is configured to actuate to the closed configuration in response to a first communication received by the tube set module via the communication interface.

[0006] In some embodiments, the valve is configured to be actuated to an open configuration in response to a second communication received by the tubing module. The communication interface is configured to wirelessly receive communications from the controller.

[0007] In some embodiments, the graduated leak device is configured to selectively provide fluid communication between the negative pressure circuit and the ambient atmosphere in a first configuration and block fluid communication between the negative pressure circuit and the ambient atmosphere in a second configuration. The graduated leak device is configured to be actuated to the first configuration in response to a third communication received by the tubing module.

[0008] In some embodiments, the tubing module further includes a pressure sensor configured to detect the pressure within the negative pressure circuit. The communication interface is configured to transmit information related to the pressure detected by the pressure sensor to the controller. The system may further include a controller. In response to the controller receiving information related to the pressure detected by the pressure sensor from the communication interface, a first communication is transmitted by the controller.

[0009] In some embodiments, the tubing module is provided with a tubing string. In some embodiments, the tubing module is integrated into a fluid tank. The tubing module is integrated into a treatment device housing to which a fluid tank is attached. In some embodiments, the tubing module is defined by a single housing element. Each of the valve, the graduated leak device, and the communication interface is housed within the housing element. The tubing module is defined by a plurality of housing elements. Each of the valve and the graduated leak device is housed within a separate and different housing element.

[0010] In a specific implementation of the present disclosure, a method of operating a wound treatment device is provided. A first end of a fluid tube is operatively connected to a fluid tank and a pump of the treatment device. A second end of the fluid tube is operatively connected to a wound dressing. A tubing module including a valve, a graduated leak device, and a communication interface is operatively connected to a negative pressure circuit defined by the fluid tube and the fluid tank. In response to a first communication received by the communication interface from a controller computer component, the valve is actuated from an open configuration, in which fluid communication is provided between the wound dressing and the fluid tank, to a closed configuration, in which fluid communication between the wound dressing and the fluid tank is blocked.

[0011] In some embodiments, the actuation of the valve is achieved by an actuator element housed within a housing element of the tubing module. The actuation of the valve is achieved in response to a signal being transmitted from the communication interface to a control input provided on the valve.

[0012] In some embodiments, the tube set module further includes a pressure sensor. In some embodiments, the pressure within the negative pressure circuit is detected by the pressure sensor. Information related to the detected pressure is transmitted to the controller computer component using a communication interface. In response to the controller computer component receiving information related to the detected pressure from the tube set module, an instruction is transmitted by the controller computer component to the pump to initiate the application of negative pressure to the negative pressure circuit.

[0013] In some embodiments, the graduated fluid leak device is actuated from a closed configuration in which fluid communication between the negative pressure circuit and ambient atmosphere is blocked to an open configuration in which fluid communication between the negative pressure circuit and ambient atmosphere is provided in response to the tube set module receiving an instruction from the computer controller component.

[0014] In a specific implementation of the present disclosure, a tube set assembly for a wound treatment system includes a tube set module and a controller. The tube set module is configured to be operably connected to a fluid reservoir and a fluid tube of the wound treatment system. The tube set module includes a housing, a communication interface, a valve, and a power source. The housing has a body extending between a first outlet formed at a first end of the housing and a second outlet formed at a second end of the housing. The communication interface is configured to allow information to be received wirelessly by the tube set module. The valve defines a first configuration and a second configuration, in the first configuration, the first outlet and the second outlet are in fluid communication with each other, and in the second configuration, fluid communication between the first outlet and the second outlet is blocked. The controller is configured to transmit a first instruction and a second instruction to the tube set module via the communication interface. In response to receiving the first instruction from the controller, the valve is configured to be actuated to the first configuration. In response to receiving the second instruction from the controller, the valve is configured to be actuated to the second configuration.

[0015] In some embodiments, the tube set module assembly further includes a first tube adapter attached to the first outlet of the housing and a second tube adapter attached to the second outlet of the housing. The first adapter and the second adapter are configured to provide a fluid-tight attachment to the fluid tube of the wound treatment device. The tube set module assembly further includes a graduated leak device that provides fluid communication between at least one of the first end and the second end of the housing and ambient atmosphere through an opening extending through the housing body.

[0016] In some embodiments, the tube set module assembly further includes a third outlet disposed at the first end of the housing and a fourth outlet disposed at the second end of the housing. The tube set module assembly further includes an adapter attached to each of the first outlet, the second outlet, the third outlet, and the fourth outlet of the housing. The adapter is configured to provide a fluid-tight attachment to the fluid tube of the wound treatment device.

[0017] In some embodiments, in a first valve configuration, the third outlet and the fourth outlet are in fluid communication. In the first valve configuration, fluid communication is blocked between the first outlet and the third outlet, between the first outlet and the fourth outlet, between the second outlet and the third outlet, and between the second outlet and the fourth outlet. In a second valve configuration, fluid communication is provided between the first outlet and the third outlet.

[0018] In some embodiments, in the second valve configuration, fluid communication between the first outlet and the fourth outlet is blocked. In the second valve configuration, fluid communication between the third outlet and the fourth outlet is blocked. The valve can be a rotatable valve.

[0019] Those skilled in the art will understand that the summary is merely exemplary and is not intended to be limiting in any way. As defined solely by the claims, other aspects, inventive features, and advantages of the devices and / or processes described herein will become apparent in the detailed description set forth herein and in connection with the drawings. Brief Description of the Drawings

[0020] FIG. 1 is a partial block diagram of a negative pressure wound therapy system according to an exemplary embodiment, the negative pressure wound therapy system including a therapy device coupled to a wound dressing via a tube.

[0021] FIG. 2 is a more detailed block diagram illustrating the negative pressure wound therapy system of FIG. 1 according to an exemplary embodiment.

[0022] Figure 3 is a more detailed block diagram illustrating the negative pressure circuit, the removed fluid tank circuit, and the wound site circuit of the negative pressure wound therapy system of FIG. 1 according to an exemplary embodiment.

[0023] Figure 4 is a block diagram showing a negative pressure wound therapy system according to an exemplary embodiment.

[0024] Figure 5 is a flowchart of a method of using a negative pressure wound therapy system according to an exemplary embodiment.

[0025] Figure 6A is a flowchart of a method of using a negative pressure wound therapy system to infuse an initial fluid volume into a wound site according to an exemplary embodiment.

[0026] Figure 6B illustrates a negative pressure wound therapy system applied to a desired wound site to be treated prior to infusing an initial fluid volume into the wound site according to an exemplary embodiment.

[0027] Figure 6C illustrates, according to an exemplary embodiment, after applying a first negative pressure to the negative pressure wound therapy system Figure 6BNegative pressure wound therapy system.

[0028] Figure 6D Illustrates, according to an exemplary embodiment, during the exhaust of a negative pressure wound therapy system after applying a first negative pressure as shown in Figure 6C the negative pressure wound therapy system. Figure 6C Negative pressure wound therapy system.

[0029] Figure 6E Illustrates, according to an exemplary embodiment, after applying a second negative pressure to a negative pressure wound therapy system Figure 6B the negative pressure wound therapy system.

[0030] Figure 6F Illustrates, according to an exemplary embodiment, during the exhaust of a negative pressure wound therapy system after applying a second negative pressure as shown in Figure 6E the negative pressure wound therapy system. Figure 6E Negative pressure wound therapy system.

[0031] Figure 6G Illustrates, according to an exemplary embodiment, using Figure 6B a wound therapy system to infuse fluid to a wound site.

[0032] Figure 7 Illustrates, according to an exemplary embodiment, a negative pressure wound therapy system applied to a wound site after initially infusing fluid to the wound site.

[0033] Figure 8A Is a flowchart of a method for using Figure 7 a negative pressure wound therapy system to infuse an additional amount of fluid to a wound site according to an exemplary embodiment.

[0034] Figure 8B Illustrates, according to an exemplary embodiment, after applying a first negative pressure to a negative pressure wound therapy system Figure 7 the negative pressure wound therapy system.

[0035] Figure 8C Illustrates, according to an exemplary embodiment, during the exhaust of a negative pressure wound therapy system after applying a first negative pressure as shown in Figure 8B the negative pressure wound therapy system. Figure 8B Negative pressure wound therapy system.

[0036] Figure 8D Illustrates, according to an exemplary embodiment, after applying a second negative pressure to a negative pressure wound therapy system Figure 7 the negative pressure wound therapy system.

[0037] Figure 8E Illustrates, according to an exemplary embodiment, during the exhaust of a negative pressure wound therapy system after applying a second negative pressure as shown in Figure 8DAfter the application of the first negative pressure as shown, during the exhaust of the negative pressure wound therapy system Figure 8D negative pressure wound therapy system.

[0038] Figure 9A is a negative pressure wound therapy system according to an exemplary embodiment for use Figure 7 Flowchart of a method for instilling an additional fluid volume into a wound site using a negative pressure wound therapy system.

[0039] Figure 9B Illustrates a negative pressure wound therapy system after the application of a first negative pressure according to an exemplary embodiment Figure 7 negative pressure wound therapy system.

[0040] Figure 9C Illustrates, according to an exemplary embodiment, during the exhaust of the negative pressure wound therapy system after the application of a first negative pressure as shown in Figure 9B negative pressure wound therapy system. Figure 9B negative pressure wound therapy system.

[0041] Figure 9D Illustrates a negative pressure wound therapy system after the application of a second negative pressure to the negative pressure wound therapy system according to an exemplary embodiment Figure 7 negative pressure wound therapy system.

[0042] Figure 9E Illustrates, according to an exemplary embodiment, during the exhaust of the negative pressure wound therapy system after the application of a first negative pressure as shown in Figure 9D negative pressure wound therapy system. Figure 9D negative pressure wound therapy system.

[0043] Figure 10A Flowchart of a method for determining whether there is sufficient dead space in a negative pressure wound therapy system according to an exemplary embodiment.

[0044] Figure 10B Illustrates a negative pressure wound therapy system after the application of a first negative pressure to the negative pressure wound therapy system according to an exemplary embodiment Figure 7 negative pressure wound therapy system.

[0045] Figure 10C Illustrates, according to an exemplary embodiment, during the exhaust of the negative pressure wound therapy system after the application of a first negative pressure as shown in Figure 10B negative pressure wound therapy system. Figure 10B negative pressure wound therapy system.

[0046] Figure 11 Flowchart of a process for monitoring the healing process of a wound site over time according to an exemplary embodiment.

[0047] Figure 12A flowchart of a method for instilling an initial fluid volume to a wound site using a negative pressure wound therapy system according to an exemplary embodiment.

[0048] Figure 13 An example of a negative pressure wound therapy system including a tubing set module according to an exemplary embodiment is illustrated.

[0049] Figure 14 An example of a negative pressure wound therapy system including a tubing set module according to an exemplary embodiment is illustrated.

[0050] Figure 15 An example of a negative pressure wound therapy system including a tubing set module according to an exemplary embodiment is illustrated.

[0051] Figure 16A A block diagram of a negative pressure wound therapy system including a tubing set module according to an exemplary embodiment.

[0052] Figure 16B An example according to an exemplary embodiment includes Figure 16A a negative pressure wound therapy system with a tubing set module.

[0053] Figure 17 A flowchart of a fully automatic method for operating a tubing set module according to an exemplary embodiment. Detailed Description

[0054] Overview

[0055] Referring generally to the drawings, a wound therapy system according to various exemplary embodiments is shown. The wound therapy system can include a therapy device and a wound dressing. The therapy device can include an instillation fluid tank, a removal fluid tank, valves, a pneumatic pump, an instillation pump, a tubing set module, and a controller. The wound dressing can be applied to the skin around a patient's wound. The therapy device can be configured to deliver instillation fluid to the wound and provide negative pressure wound therapy (NPWT) by maintaining the wound under negative pressure. The components of the wound therapy device, the wound dressing, and the wound site form a negative pressure circuit.

[0056] The controller can be configured to operate the pneumatic pump, the instillation pump, the tubing set module, and / or other controllable components of the therapy device. In some embodiments, based on a comparison of the observed dynamic pressure responses of the negative pressure applied to the entire negative pressure circuit and the negative pressure applied to a selected portion of the negative pressure circuit, the controller estimates the wound volume. Based on the comparison of the observed dynamic responses, the controller can be configured to determine the amount of instillation fluid to be delivered to the wound site.

[0057] The tubing set module includes one or more elements that can be actuated, controlled, or otherwise engaged by a controller, wherein selective communication of the controller with the tubing set module is configured to allow the controller, among other functions, to implement and monitor various dynamic pressure responses in all and / or part of the negative pressure circuit as needed to estimate wound volume, determine the amount of instillation fluid to be delivered to the wound site, and / or perform any other number of functions related to the use of the NPWT system 100.

[0058] According to some embodiments, the volume relative to the wound site determined by the controller may be related to the dead space at the wound site (i.e., the available space within the applied drape layer surrounding the wound site into which instillation fluid can be delivered). In some such embodiments, the controller may be configured to determine the amount of instillation fluid to be delivered to the wound site based on a predetermined percentage (e.g., 20%, 50%, 80%, etc.) of the calculated dead space volume at the wound site. The controller may then operate the tubing set module and the instillation pump to deliver the determined volume of instillation fluid to the wound. By making the amount of instillation fluid to be delivered to the wound site based on the calculated dead space volume at the wound site, the negative pressure system can be configured to provide a more efficient and precise delivery of instillation fluid, which can reduce the risk of leakage caused by over-delivery of instillation fluid and the risk of ineffective wound site treatment caused by under-delivery of instillation fluid.

[0059] In some embodiments, during wound treatment, the controller may additionally or alternatively measure and monitor the volume relative to the wound site multiple times, wherein the controller determines the healing progress of the wound site based on changes in the measured volume relative to the wound site during NPWT treatment. By monitoring the healing progress of the wound site, the controller can be configured to alert the user if the wound site is not healing as expected or desired. These and other features of the wound treatment system are described in detail below.

[0060] Wound treatment system

[0061] Now referring to FIG. 1, there is shown a negative pressure wound therapy (NPWT) system 100 according to an exemplary embodiment. The NPWT system 100 is shown as including a treatment device 102 fluidly connected to a wound dressing 112 via tubes 108 and 110. As will be described in more detail below, according to various embodiments, the tubing set module 300 can be operably connected to tube 108 and / or 110.

[0062] According to various embodiments, the wound dressing 112 may be placed on or within the wound site 114 and adhered or sealed to the skin 116 surrounding the patient's wound site 114 using a sterile drape layer 117. Several examples of wound dressings 112 that may be used in combination with the NPWT system 100 are also described in detail in U.S. Patent 7,651,484, issued on January 26, 2010, U.S. Patent 8,394,081, issued on March 12, 2013, and U.S. Patent Application 14 / 087,418, filed on November 22, 2013. The entire disclosure of each of these patents and patent applications is incorporated herein by reference.

[0063] As illustrated in the block diagram of FIG. 2, generally, the treatment device 102 includes a pneumatic pump 120, an infusion pump 122, a filter 128, and a controller 118. The pneumatic pump 120 may be fluidly coupled to the removal fluid tank 106 (e.g., via a conduit 136) and may be configured to evacuate the removal fluid tank 106 by pumping air out of the removal fluid tank 106. In some embodiments, the pneumatic pump 120 is configured to operate in both a forward direction and a reverse direction. For example, the pneumatic pump 120 may operate in the forward direction to pump air out of the removal fluid tank 106 and reduce the pressure within the removal fluid tank 106. The pneumatic pump 120 may operate in the reverse direction to pump air into the removal fluid tank 106 and increase the pressure within the removal fluid tank 106. The pneumatic pump 120 may be controlled by the controller 118, which will be described in more detail below.

[0064] The treatment device 102 may be configured to provide negative pressure wound therapy by reducing the pressure at the wound site 114. The treatment device 102 may create a vacuum (relative to atmospheric pressure) at the wound site 114 by removing wound exudate, air, and other fluids from the wound site 114. Wound exudate may include fluids filtered from the patient's circulatory system into the site of lesion or inflammation. For example, wound exudate may include water and dissolved solutes such as blood, plasma proteins, white blood cells, platelets, and red blood cells. Other fluids 121 removed from the wound site 114 may include infusion fluid 105 previously delivered to the wound site 114. The infusion fluid 105 may include, for example, a cleansing fluid, a prescription fluid, a drug-laden fluid, an antibiotic fluid, or any other type of fluid that may be delivered to the wound site 114 during wound treatment. The infusion fluid 105 may be held in the infusion fluid tank 104 and controllably dispensed to the wound site 114 via a tube 108. In some embodiments, the infusion fluid tank 104 is capable of being detached from the treatment device 102 to allow for reloading and replacement of the removal fluid tank 106 as needed.

[0065] The drip pump 122 can be fluidly coupled to the drip fluid reservoir 104 via an upstream drip tube 108a and fluidly coupled to the wound dressing 112 via a downstream drip tube 108b. The drip pump 122 is operable to deliver the drip fluid 105 to the wound dressing 112 and the wound site 114 by pumping the drip fluid 105 through the upstream drip tube 108a and the downstream drip tube 108b. The drip pump 122 can be controlled by a controller 118, which will be described in more detail below. According to some embodiments, the drip tube valve 109 is configured to allow flow only in the direction from the drip fluid reservoir 104 to the wound site 114 (e.g., via a one-way valve or via a valve configured to be selectively switched to a closed position by the user and / or the controller 118 before applying negative pressure to the wound site 114), and the drip tube valve can generally be disposed at a location along a portion of the downstream drip tube 108b. As will be described in more detail below, according to various embodiments, the drip tube valve 109 can be provided as part of a tubing set module 300.

[0066] The filter 128 can be positioned between the removal fluid reservoir 106 and the pneumatic pump 120 (e.g., along the conduit 136) such that air pumped out of the removal fluid reservoir 106 passes through the filter 128. The filter 128 can be configured to prevent liquid or solid particles from entering the conduit 136 and reaching the pneumatic pump 120. The filter 128 can include, for example, a hydrophobic and / or lipophilic bacterial filter such that aqueous and / or oily liquids will bead on the surface of the filter 128. The pneumatic pump 120 can be configured to provide sufficient air flow through the filter 128 such that the pressure drop across the filter 128 is not significant (e.g., such that the pressure drop will not substantially impede the application of negative pressure from the treatment device 102 to the wound site 114).

[0067] The removal fluid reservoir 106 can be a component of the treatment device 102 that is configured to collect wound exudate and other fluids 121 removed from the wound site 114. In some embodiments, the removal fluid reservoir 106 is removable from the treatment device 102 to allow the removal fluid reservoir 106 to be emptied and replaced as needed. The lower portion of the removal fluid reservoir 106 can be filled with wound exudate and other fluids 107 removed from the wound site 114, while the upper portion of the removal fluid reservoir 106 can be filled with air. The treatment device 102 can be configured to evacuate the removal fluid reservoir 106 by pumping air out of the removal fluid reservoir 106. The reduced pressure within the removal fluid reservoir 106 can be transferred via the tube 110 to the wound dressing 112 and the wound site 114.

[0068] As shown in FIG. 1, a tube valve 111 is disposed along a tube 110 at a location between a fluid removal canister 106 and a wound site 114, and the tube valve is configured to selectively permit and prevent fluid flow between the fluid removal canister 106 and the wound site 114. The tube valve 111 can be defined by any number of different configurations (such as a spring-biased configuration, a duckbill configuration, a clamping configuration, a check valve configuration, etc.), which are configured to allow selective control of fluid through the tube 110 and can include being configured to be selectively opened and / or closed by a user in response to a sensed stimulus (such as a predetermined threshold pressure) or by a controller 118. As will be described in more detail below, according to various embodiments, the tube valve 111 can be provided as part of a tube set module 300.

[0069] See Figure 3 the block diagram of, when the tube valve 111 is in an open flow configuration, the fluid removal canister 106, the tube 110 (i.e., both the upstream tube portion 110a and the downstream tube portion 110b), the conduit 136 extending between the pneumatic pump 120 and the fluid removal canister 106, the portion of the downstream drip tube 108b extending between the sterile drape layer 117 and the drip tube valve 109, and the wound site 114 are fluidly connected to define a negative pressure circuit 200. Also see Figure 3 , when the tube valve 111 is in a closed non-flow configuration, the fluid removal canister 106, the conduit 136, and the upstream tube portion 110a of the tube 110 extending between the fluid removal canister 106 and the tube valve 111 define a fluid removal canister circuit 202, which is fluidly isolated from a wound site circuit 204, and the wound site circuit is defined by the wound site 114, the downstream tube portion 110b of the tube 110 extending between the tube valve 111, the portion of the downstream drip tube 108b extending between the sterile drape layer 117 and the drip tube valve 109, and the wound site 114. As will be discussed in more detail below, the volume of the tube 110, the volume of the conduit 136, and the volume of the portion of the downstream drip tube 108b extending between the sterile drape layer 117 and the drip tube valve 109 define a known volume, which can be easily subtracted from or otherwise accounted for in the volume calculation results relative to the volume of the wound site 114.

[0070] Referring again to FIG. 1, according to some embodiments, at a position upstream of the tube valve 111 and downstream of the removal fluid tank 106, a graduated leak device 113 is additionally provided along the tube 110 and is operatively fluidly connected to the tube. The graduated leak device is defined by an exhaust hole 113a formed through the outer wall of the tube 110, and the exhaust hole 113a can be selectively closed by an exhaust valve 113b. A portion of the graduated leak device 113 may additionally be a flow detector 113c, which is configured to measure the air flow through the exhaust hole 113a. As will be described in more detail below, the graduated leak device 113 is configured to selectively control and measure the air flow between the tube 110 and the surrounding environment around the treatment device 102. According to various embodiments, the graduated leak device 113 can be selectively opened to allow air to enter the tube 110 at a known predetermined rate. As will be described in more detail below, according to various embodiments, the graduated leak device 113 can be provided as part of the tube set module 300.

[0071] As will be described in more detail below, when both the exhaust valve 113b and the tube valve 111 are closed, the operation of the pneumatic pump 120 can be configured to evacuate only the removal fluid tank circuit 202 portion of the negative pressure circuit 200 (such as, for example Figure 6E illustrated). When the exhaust valve 113b is closed and the tube valve 111 is open, the operation of the pneumatic pump 120 can be configured to evacuate the entire negative pressure circuit 200 (such as, for example Figure 6C illustrated). When the exhaust valve 113b is open and the tube valve 111 is closed, air flow from the surrounding environment of the treatment device 102 can enter through the exhaust hole 113a of the graduated leak device 113 and fill the vacuum within the removal fluid tank circuit 202 (such as, for example Figure 6F illustrated). As, for example Figure 6D shown, when both the exhaust valve 113b and the tube valve 111 are open, air flow from the surrounding environment of the treatment device 102 can enter through the exhaust hole 113a of the graduated leak device 113 and fill the vacuum within the entire negative pressure circuit 200. It should be understood that, according to various embodiments, the opening and / or closing of the exhaust valve 113b and / or the tube valve 111 can be achieved manually or automatically, for example, using the tube set module 300.

[0072] Although the disclosed graduated leak device 113 is positioned in series with the portion of the tube 110 that extends between the wound site 114 and the removal fluid tank 106, according to some embodiments, such as, for example Figure 4 illustrated, the graduated leak device 113 can also be formed in series with the conduit 136. Figure 4 The operation of the graduated leak device 113 of the embodiments of Figure 4The indexing leak device 113 is configured to provide a path through which air from the surrounding environment can flow into and fill part or all of the negative pressure circuit 200 after a vacuum is formed in part or all of the negative pressure circuit 200. It should be understood that, according to various embodiments, any method or system illustrated or disclosed herein that incorporates the indexing leak device 113 embodiment illustrated in FIG. 1 can be modified using the indexing leak device 113 embodiment as Figure 4 shown.

[0073] As illustrated in the block diagram of FIG. 2, according to various embodiments, the controller 118 can be configured to operate various components of the treatment device 102. Specifically, as will be described in more detail below, according to various embodiments, the controller 118 can be configured to control various components of the NPWT system 100 to perform one or more volume determination processes, through which, for example, the amount of instillation fluid 105 to be delivered to the wound site 114 can be determined, the healing process of the wound site 114 can be tracked, etc. According to various embodiments, the controller 118 can be configured to perform these processes with minimal user intervention and / or input.

[0074] According to various embodiments, the treatment device 102 can include a variety of sensors. For example, in some embodiments, the treatment device 102 can include pressure sensors 115a and / or 115b, which are serially positioned in the upstream tube section 110a and / or the downstream tube section 110b and are configured to measure the pressure at the fluid removal tank 106 and / or the wound site 114. The pressure measurements recorded by the pressure sensors 115a and / or 115b can be transmitted to the controller 118. According to various embodiments, the controller 118 can use the pressure measurements from the pressure sensors 115a and / or 115b as inputs for various pressure test operations and control operations performed by the controller 118. As will be described in more detail below, according to various embodiments, the pressure sensors 115a and / or 115b can be provided as part of the tube set module 300.

[0075] In some embodiments, the treatment device 102 includes a user interface 126. The user interface 126 can include one or more buttons, dials, sliders, keys, or other input devices configured to receive input from the user. The user interface 126 can also include one or more display devices (e.g., LEDs, LCD displays, etc.), speakers, haptic feedback devices, or other output devices configured to provide information to the user. The user interface 126 can also display alerts generated by the controller 118. For example, in the case where the fluid removal tank 106 is not detected, the controller 118 can generate a "no tank" alert.

[0076] In some embodiments, the treatment device 102 includes a data communication interface 124 (e.g., a USB port, a wireless transceiver, etc.) configured to receive and transmit data. The communication interface 124 may include a wired or wireless communication interface (e.g., a jack, an antenna, a transmitter, a receiver, a transceiver, a wire terminal, etc.) for data communication with an external system or device. In various embodiments, the communication may be direct (e.g., local wired or wireless communication) or via a communication network (e.g., a WAN, the Internet, a cellular network, etc.). For example, the communication interface 124 may include a USB port or an Ethernet network card and ports for sending and receiving data via an Ethernet-based communication link or network. In another example, the communication interface 124 may include a Wi-Fi transceiver or a cellular or mobile phone communication transceiver for communicating via a wireless communication network.

[0077] Usage method

[0078] See Figure 5 , which shows a flowchart of a method 500 of using an NPWT system 100 according to an exemplary embodiment. As will be discussed in more detail with reference to Figures 6A to 6G The initial setup of the NPWT system 100 and the delivery of an initial amount of instillation fluid 105 to the wound site 114 being treated by the NPWT system 100 occur at step 502.

[0079] As shown at step 504, according to various embodiments, it may be desirable to deliver additional instillation fluid 105 to the wound site 114 after the initial amount of instillation fluid 105 has been instilled into the wound site 114. It should be understood that determining when and whether to deliver additional instillation fluid 105 to the wound site 114 at step 504 may be based on any number of various factors, including, for example, the elapsed time since the last instillation, the type of the wound site 114, the process required for treating the wound site 114, the sensed conditions associated with the wound site 114, etc., and may be automatically determined by the controller 118 or may be based on user input.

[0080] If it is determined at step 504 that additional fluid is to be delivered, then at step 506, the dead space 119 at the wound site 114 is determined according to any of the methods described hereinafter. According to various embodiments (described in more detail hereinafter), at step 506, the controller 118 may be configured to determine the dead space 103 at the wound site 114 prior to delivery of such additional instilled fluid 105, regardless of: whether the amount of instilled fluid 105 previously instilled into the wound site 114 is known; whether there is unabsorbed instilled fluid 105 and / or wound exudate in the space defined between the wound site 114 and the drape layer 117; whether the volume of any contents 107 removed from the fluid reservoir 106, the volume of the fluid reservoir 106 itself, and / or the volume of any contents 107 previously emptied from the fluid reservoir 106 is known; whether the fluid reservoir 106 has been replaced with a different sized fluid reservoir 106 during the NPWT treatment; changes in the shape / size / volume of the wound site 114; and so on.

[0081] At step 508, the amount of additional instilled fluid 105 to be delivered to the wound site 114 is calculated. According to various embodiments, the amount of additional instilled fluid 105 delivered to the wound site 114 may be based on the dead space volume determined at step 506. For example, in some embodiments, the controller 118 may calculate the volume of instilled fluid 105 to be delivered to the wound site 114 by multiplying the dead space volume determined at step 506 by a fluid instillation factor. The fluid instillation factor may be equal to or less than one (i.e., between zero and one), such that the volume of instilled fluid 105 delivered to the wound site 114 does not exceed the available space (i.e., the dead space) within the drape layer 117, thereby minimizing the risk of accidental leakage from the wound dressing 112 / drape layer 117. In some embodiments, the fluid instillation factor is between approximately 0.2 and approximately 0.8.

[0082] In addition to being used to calculate the volume of instilled fluid 105, in some embodiments, the NPWT system 100 may be used in addition or alternatively to monitor and track the healing progress of the wound site 114 over time. Thus, in some embodiments, method 500 may optionally include step 510 of estimating the volume of the wound site 114 and using the estimated volume to track the healing progress of the wound site 114, as discussed in more detail hereinafter with reference to Figure 11 More detailed discussion.

[0083] In some embodiments, it may be desirable to remove, at some time after delivery of the instillation fluid 105 to the wound site 114, the instillation fluid 105 previously instilled into the wound site 114. Thus, it may be advantageous to confirm, prior to instilling the instillation fluid 105 into the wound site 114, that the void space in the removal fluid canister 106 will be sufficient to receive the instillation fluid 105 removed from the wound site 114 and / or any additional fluid 121 (e.g., wound exudate), before delivering additional instillation fluid 105 to the wound site 114. Accordingly, method 500 may optionally include step 512, at which the volume of additional instillation fluid 105 calculated at step 508 is compared to the void space of the removal fluid canister 106 (e.g., the void space measured during determination of the void space at the wound site 114 at step 506), wherein if the instillation fluid 105 to be delivered exceeds the void space of the removal fluid canister 106, an alert is issued to the user at step 514. If the instillation fluid 105 to be delivered does not exceed the void space of the removal fluid canister 106 (or if step 512 is not included as part of method 500), the calculated instillation fluid 105 is delivered to the wound site 114, where some or all of steps 504, 506, 508, 510, 512, 514, 516 are repeated any number of additional times during the NPWT treatment.

[0084] See Figure 6A , which shows a flow chart detailing the steps of method 600 according to one embodiment, the method for initial setup of the NPWT system 100 and for delivering an initial amount of instillation fluid 105 to Figure 5 the wound site 114 as required in step 502 of method 500. At step 602, the NPWT system 100 (such as, for example, illustrated in FIG. 1) is provided, where the sterile drape layer 117 and the wound dressing 112 are positioned at the desired wound site 114 to be treated, as, for example, Figure 6B shown.

[0085] Once the setup of the NPWT system 100 is complete at step 502, determination of the available void space 119 at the wound site 114 into which the instillation fluid 105 can be delivered can be initiated at step 604, where the controller 118 operates the pneumatic pump 120 to establish a first desired negative pressure throughout the negative pressure circuit 200, such as, for example, Figure 6C illustrated.

[0086] In an embodiment where the tube valve 111 includes a normally closed pressure - sensitive valve that can open in response to a predetermined threshold negative pressure being applied, the first desired negative pressure generated by the controller 118 at step 604 may be equal to or greater than the predetermined threshold pressure required to open the tube valve 111, so as to ensure that the vacuum applied by the pneumatic pump 120 is applied to the entire negative - pressure circuit 200. In some embodiments, the threshold pressure required to open the tube valve 111 may be a pressure of about - 125 mmHg, where the controller 118 is configured to apply a first negative pressure equal to or greater than - 125 mmHg at step 604.

[0087] Alternatively, in an embodiment where the opening / closing of the tube valve 111 is controlled manually or directly in response to a signal from the controller 118 (using, for example, the tube - set module 300 described below), the negative pressure delivered at step 604 may generally include any desired range of negative pressures, where step 604 includes verifying by the user and / or the controller that the tube valve 111 is in an open - flow orientation before the pneumatic pump 120 applies the negative pressure. As, for example Figure 6C illustrated, according to various embodiments, the drip - tube valve 109 and the exhaust valve 113b may be configured to be set in a closed configuration during the application of negative pressure to the negative - pressure circuit 200.

[0088] As Figure 6D illustrated, at step 606, after the first desired negative pressure is reached within the negative - pressure circuit 200 (such as the negative pressure measured by the pressure sensor 115a and / or the pressure sensor 115b and reported to the controller 118), the operation of the pneumatic pump 120 is stopped, and the exhaust valve 113b is opened to allow air from the ambient environment surrounding the treatment device 102 to flow through the exhaust hole 113a and into the negative - pressure circuit 200. According to various embodiments, the opening of the exhaust valve 113b at step 606 may be achieved manually by the user or in response to an instruction from the controller 118 transmitted to the tube - set module 300. In other embodiments, the graduated leak device 113 may be formed without the exhaust valve 113b (i.e., the exhaust hole 113a defines a constant leakage amount within the tube 110), such that air from the ambient environment surrounding the treatment device 102 will flow into the negative - pressure circuit 200 without any intervention by the user and / or the controller 118.

[0089] As air from the surrounding environment flows into the negative pressure circuit 200, parameters associated with the air flow entering the negative pressure circuit 200 through the exhaust hole 113a (e.g., via the flow detector 113c, the pressure sensors 115a, 115b, etc.) are monitored, and the measured parameters are then used by the controller 118 at step 612 to determine the volume of the negative pressure circuit 200. According to various embodiments, the parameters associated with the air flow entering the negative pressure circuit 200 may include, for example: the rate of the air flow entering the negative pressure circuit 200 (as measured by the flow detector 113c, for example); the duration required to increase the pressure within the negative pressure circuit 200 to a predetermined pressure (ambient pressure) after the exhaust hole 113a is opened and / or after the operation of the pump 120 is stopped; the changing pressure within the negative pressure circuit 200 as the pressure increases from the negative pressure applied at step 604 to the predetermined pressure (as measured by the pressure sensor 115a and / or the pressure sensor 115b, for example), and so on.

[0090] Once the pressure within the negative pressure circuit 200 has increased to the desired pressure and the controller 118 has completed measuring the results of the desired parameters, the controller 118 may be configured to operate the pneumatic pump 120 to establish a second desired negative pressure within the fluid removal tank circuit 202 portion of the negative pressure circuit 200 at step 608, such as, for example Figure 6E as illustrated. In embodiments where the tube valve 111 includes a normally closed pressure-sensitive valve that can open in response to a predetermined threshold negative pressure applied, the second desired negative pressure generated by the controller 118 at step 608 may be less than the predetermined threshold pressure required to open the tube valve 111, so as to ensure that the vacuum applied by the pneumatic pump 120 at step 608 is applied only to the fluid removal tank circuit 202 portion of the negative pressure circuit 200. For example, in some embodiments, the threshold negative pressure required to open the tube valve 111 may be approximately -125 mmHg, where the controller 118 is configured to apply a negative pressure less than -125 mmHg at step 608, such as a pressure of approximately -50 mmHg.

[0091] Alternatively, in embodiments where the opening / closing of the tube valve 111 is controlled manually or directly in response to a signal from the controller 118, the negative pressure delivered at step 608 may generally include any desired range of negative pressures, where step 608 includes verifying by the user and / or the controller that the tube valve 111 is in a closed non-flow orientation before the pneumatic pump 120 applies the negative pressure. It should be understood that in such embodiments, the second negative pressure applied by the controller 118 to the fluid removal tank circuit 202 at step 608 may include a pressure equal to or different from the negative pressure applied by the controller 118 to the negative pressure circuit 200 at step 604. Such as, for example Figure 6EAs illustrated, according to various embodiments, the drip tube valve 109 and the exhaust valve 113b can be configured to be set in a closed configuration (manually or automatically, e.g., using the tube set module 300) during the application of a negative pressure to the fluid removal tank circuit 202 at step 608.

[0092] As Figure 6F As illustrated, at step 610, after a second desired negative pressure is reached within the fluid removal tank circuit 202 (such as the negative pressure measured by, for example, pressure sensor 115a and / or pressure sensor 115b and reported to the controller 118), the operation of the pneumatic pump 120 is stopped and air from the surrounding environment around the treatment device 102 is allowed to flow through the exhaust hole 113a and into the fluid removal tank circuit 202. As air from the surrounding environment flows into the fluid removal tank circuit 202, the parameters associated with the air flow through the exhaust hole 113a and into the fluid removal tank circuit 202 are monitored, whereupon the controller 118 then uses the measured parameters to calculate the volume of the fluid removal tank circuit 202 at step 612. According to various embodiments, the parameters associated with the air flow into the fluid removal tank circuit 202 can include, for example: the rate of air flow into the fluid removal tank circuit 202 (as measured by, for example, the flow detector 113c); the duration required for the pressure within the fluid removal tank circuit 202 to increase to a predetermined pressure (e.g., ambient pressure) after the exhaust hole 113a is opened and / or the operation of the pump 120 is stopped at step 610; the pressure within the fluid removal tank circuit 202 (as measured by, for example, pressure sensor 115a and / or pressure sensor 115b) as the pressure increases from the negative pressure applied at step 608 to the predetermined pressure, and so on.

[0093] At step 612, the controller 118 may be configured to determine the volumes of the fluid removal canister circuit 202 and the negative pressure circuit 200 based on the parameters measured at steps 606 and 610. According to some embodiments, the controller 118 may cause these volume calculations to be based on the relationships between various measured parameter values stored and the corresponding volumes. These relationships between the measured parameter measurements and the corresponding volumes stored by the controller 118 may include various functions, models, look-up tables, etc., and may be based on the information already input and stored by the controller 118, or on information obtained and processed by the controller 118 during an optional initial training process performed by the controller 118 prior to using the NPWT system 100 to treat the wound site 114 (e.g., prior to initiation of method 500; as part of the initial setup and initial infusion of the infusion fluid in step 502, etc.). A non-limiting example of an embodiment of a training process available to the controller 118 to generate such relationships is outlined in the related co-pending U.S. Provisional Application No. 62 / 650,132, filed Apr. 17, 2018, entitled "WOUND THERAPY SYSTEM WITH WOUND VOLUME ESTIMATION", the entire disclosure of which is incorporated herein by reference.

[0094] Using the determined volumes of the fluid removal canister circuit 202 and the negative pressure circuit 200, the controller 118 may determine the volume of the dead space 119 at the wound site 114 (i.e., the portion of the internal space defined between the wound site 114 and the lower surface of the drape layer 117 that is not occupied by the wound dressing 112 and / or any infusion fluid 105 / other fluid) by subtracting the volume of the fluid removal canister circuit 202 from the volume of the negative pressure circuit 200. According to various embodiments, determining the volume of the dead space 119 at the wound site 114 at step 614 may also include subtracting or otherwise adjusting the calculated difference between the volume of the fluid removal canister circuit 202 and the volume of the negative pressure circuit 200 to account for the known volume of the downstream tube portion 110b and the known volume of the portion of the downstream infusion tube 108b that extends between the drape layer 117 and the infusion tube valve 109 in the determination of the volume of the dead space 119 at the wound site 114.

[0095] At step 614, an initial amount of the instillation fluid 105 to be delivered to the wound site 114 is calculated. According to various embodiments, the calculated initial amount of the instillation fluid 105 delivered to the wound site 114 can be based on the volume of the dead space 119 calculated by the controller 118 at step 612. For example, in some embodiments, by multiplying the volume of the dead space 119 calculated at step 612 by a fluid instillation factor, the controller 118 can calculate the initial volume of the instillation fluid 105 to be delivered to the wound site 114. The fluid instillation factor can be equal to or less than one (i.e., between zero and one), such that the volume of the instillation fluid 105 delivered to the wound site 114 does not exceed the available space within the drape layer 117, thereby reducing accidental leakage from the wound dressing 112 / drape layer 117. In some embodiments, the fluid instillation factor is between approximately 0.2 and approximately 0.8. However, it is contemplated that in various alternative embodiments, the fluid instillation factor can have any value.

[0096] As previously described with reference to step 510, in addition to calculating the amount of the instillation fluid 105 to be delivered during any treatment phase of using the NPWT system 100 and under any number of different conditions (e.g., allowing the calculation of additional instillation fluid 105 at step 516 even if the removal fluid canister 106 has been emptied or has been entirely replaced with a removal fluid canister 106 of a different size during the course of treatment), in some embodiments, the NPWT system 100 can additionally or alternatively be used to monitor and track the healing progress of the wound site 114 over time. Thus, in some embodiments, at step 616, an initial baseline volume estimate of the wound site 114 can optionally be determined (via, for example, the method described below with reference to Figure 11 and stored, and this estimate can be used as a reference point to which future volume estimates of the wound site 114 can be compared to track the healing process of the wound site 114.

[0097] For reasons related to those referenced in Figure 5For similar reasons as described in step 512 of method 500, according to some embodiments, at step 618, the amount of the initial infusion fluid 105 to be delivered, calculated at step 614, may be compared with the determined dead space 103 of the removal fluid canister 106 to determine whether the dead space within the removal fluid canister 106 will be sufficient to collect any fluid 121 (including unabsorbed infusion fluid 105) from the wound site 114 after delivering the infusion fluid 105 at step 516. It should be understood that in embodiments where the NPWT system 100 has not been operated prior to using the NPWT system 100 at step 602, the volume of the removal fluid canister 106 should be empty, such that the dead space 103 of the removal fluid container 106 should be equal to the volume of the removal fluid canister 106. If the volume of the removal fluid canister 106 is unknown at step 602 and / or if removal fluid 107 is present in the removal fluid canister 106, the dead space 103 of the removal fluid container can be calculated by subtracting the known volumes of the catheter 136 and the upstream tube portion 110a from the volume of the removal fluid canister loop 202 determined at step 614. Similar to step 514, at step 620, if the initial volume of the infusion fluid 105 to be delivered, calculated at step 614, exceeds the dead space 103 of the removal fluid canister 106, an alert may be issued to the user. Otherwise, if the volume of the initial infusion fluid 105 to be delivered does not exceed the dead space 103 of the removal fluid canister 106, the calculated infusion fluid 105 is delivered to the wound site 114 at step 622, as shown, for example Figure 6F as shown in

[0098] See Figure 7 , which shows the NPWT system 100 according to one embodiment at a time point after deciding to infuse additional infusion fluid 105 into the wound site 114 at step 504 of method 500, but before determining the wound dead space at the wound site at step 506. As shown in Figure 5 at a time immediately before determining the dead space at the wound site 114 at step 506, an amount of fluid 121 (e.g., unabsorbed infusion fluid 105 from a previous infusion, wound exudate, etc.) may be present in the space between the sterile drape layer 117 and the wound site 114, where the remaining space between the sterile drape layer 117 and the wound site 114 defines the initial dead space 119a. Also as shown in Figure 7 Figure 7 Figure 7As shown, according to some embodiments, at the time immediately before the start of step 506, an initial amount of removal fluid 107 may be present in the removal fluid tank 106, where the remaining volume of the removal fluid tank 106 is defined by the initial dead space 103a. It should be understood that according to some embodiments, at the time immediately before step 506, there may be no fluid at the wound site 114 and / or in the removal fluid tank 106. In these embodiments, the amount of fluid 121 in the wound space and the removal fluid 107 in the removal fluid tank 106 will each be equal to zero.

[0099] As described above, immediately before the initiation of step 506, an amount of fluid 121 may be present at the wound site 114. According to some embodiments, before Figure 5 delivering additional instillation fluid 105 to the wound site 114 at step 516 of method 500, it may not be desirable and / or necessary to remove the fluid 121 (e.g., unabsorbed instillation fluid 105 from a previous instillation, wound exudate, etc.) in the wound site. Thus, in some embodiments of method 500, the additional instillation fluid 105 instilled at step 516 may be delivered to the wound site 114 regardless of any fluid 121 that may be present at the wound site 114.

[0100] See Figures 8A to 8E , which illustrates one embodiment of method 800 for determining the amount of dead space at the wound site 114. At Figure 5 step 506 of method 500, this method can be used in embodiments where fluid 121 in the wound site 114 is not removed from the wound site 114 before instilling additional instillation fluid 105. Specifically, according to Figures 8A to 8E method 800, since no fluid 121 is drained from the wound site 114 during method 800 (i.e., step 506), the final dead space into which the additional instillation fluid 121 will drip will be the same initial dead space 119a that was present at the wound site immediately before the initiation of step 506 (i.e., Figure 7 the dead space 119a shown in

[0101] As Figure 8A shown in the flowchart of Figures 6A to 6G , method 800 for determining dead space is substantially the same as method 600 for calculating dead space 119 after initially instilling instillation fluid 105 at step 502 into the wound site 114 (which is discussed in more detail with reference to Figure 8A ). Specifically, similar to steps 604 and 606, Figure 8B method 800 of Figure 8Cshown), during these steps, a negative pressure is applied to the negative pressure circuit 200 and removed from the negative pressure circuit. Similar to Figure 6A steps 608 and 610 of method 600 of Figure 8A method 800 of Figure 8D and Figure 8E shown), during these steps, a negative pressure is applied to the removed fluid tank circuit 202 and removed from the removed fluid tank circuit. Also similar to Figure 6A method 600 of Figures 8A to 8E in method 800 of

[0102] As described above, Figures 8A to 8E method 800 of Figure 6A can be performed in substantially the same manner as method 600 described above with reference to Figures 6A to 6E However, as described with reference to the method of

[0103] After completing step 808, the controller 118 can be configured to, at step 508 of Figure 5 method 500 of Figures 6A to 6G calculate the volume of the dead space 119a at the wound site 114 (which corresponds to the maximum volume of additional instilled fluid 105 that can be delivered to the wound site 114). More specifically, at step 508, after calculating the volumes of the removed fluid tank circuit 202 and the negative pressure circuit 200 based on the parameters measured at steps 804 and 808 (in a manner similar to that described in step 612 of method 600 with reference to Figures 8A to 8EThe volume of the fluid removal canister circuit 202 of method 800 is defined by the dead space 103a of the fluid removal canister 106, the conduit 136, and the upstream tube portion 110a; and the volume of the negative pressure circuit 200 is defined by the volume of the fluid removal canister circuit 202 (i.e., the dead space 103a of the fluid removal canister 106, the conduit 136, and the upstream tube portion 110a), the downstream tube portion 110b, the dead space 119a of the wound site 114, and the portion of the downstream drip tube 108b that extends between the sterile drape layer 117 and the drip tube valve 109.

[0104] According to various embodiments, in an embodiment of method 500, wherein the determination of the volume of the dead space 119a at the wound site 114 at step 508 is based on measurement parameters related to the fluid removal canister circuit 202 and the negative pressure circuit 200 obtained using Figures 8A to 8E method 800, step 508 may also include subtracting or otherwise adjusting the calculated difference between the volume of the fluid removal canister circuit 202 and the volume of the negative pressure circuit 200 to account for the known volume of the downstream tube portion 110b and the known volume of the portion of the downstream drip tube 108b that extends between the sterile drape layer 117 and the drip tube valve 109 in the determination of the volume of the dead space 119a at the wound site 114.

[0105] Although as described above, in some embodiments of method 500, additional drip fluid 105 can be delivered at step 516 without first removing any remaining fluid 121 at the wound site 114, according to other embodiments, it may be desirable to remove the fluid 121 in the wound site 114 before delivering the additional drip fluid 105.

[0106] See Figures 9A to 9E , which shows an embodiment of method 900 for determining the amount of dead space at the wound site 114, at Figure 5 step 506 of method 500, which can be used in embodiments where it is desired to remove the fluid 121 in the wound site 114 before dripping the additional drip fluid 105. Specifically, according to Figures 9A to 9E method 900, during method 900 (i.e., step 506), any fluid 121 that was present at the wound site 114 immediately prior to step 506 (e.g., as shown in Figure 7 ) is drained from the wound site 114 such that the final dead space 119b into which the additional drip fluid 121 will drip will be larger than the initial dead space 119a at the wound site that existed immediately prior to the initiation of step 506 by an amount that roughly corresponds to the volume of the fluid 121 that was drained from the wound site 114 into the fluid removal canister 106 during method 900.

[0107] AsFigure 9A As shown in the flowchart of, the method 900 for determining the dead space is substantially the same as the method 600 for calculating the dead space 119 after initially dripping the dripping fluid 105 into the wound site 114 at step 502 (refer to Figures 6A to 6G discussed in more detail). Specifically, similar to steps 604 and 606, Figure 9A the method 900 also includes steps 902 and 904 (shown in Figure 9B and Figure 9C respectively), during which negative pressure is applied to the negative pressure circuit 200 and removed from the negative pressure circuit. Similar to Figure 6A steps 608 and 610 of the method 600, Figure 9A the method 900 also includes steps 906 and 908 (shown in Figure 9D and Figure 9E respectively), during which negative pressure is applied to the removed fluid tank circuit 202 and removed from the removed fluid tank circuit.

[0108] However, different from Figure 6A the method 600, in which the step 604 of applying negative pressure to the negative pressure circuit 200 and the subsequent step 608 of removing negative pressure can be performed before or after the step 610 of applying negative pressure to the removed fluid tank circuit 202 and the subsequent step 612 of removing negative pressure, while in Figure 9A the method 900, the step 902 of applying negative pressure to the negative pressure circuit 200 and the subsequent step 904 of removing negative pressure are performed before the step 906 of applying negative pressure to the removed fluid tank circuit 202 and the subsequent step 908 of removing negative pressure. Additionally, although as described above with reference to Figures 6A to 6E the method, according to various embodiments, any range of negative pressure can generally be applied to the negative pressure circuit 200 at step 604 of the method 600, but the negative pressure applied to the negative pressure circuit 200 at step 902 of Figure 9A the method 900 must be sufficient to cause the fluid 121 to drain from the wound site 114 into the removed fluid tank 106.

[0109] After completing step 908, the controller 118 can be configured to calculate the volume of the final dead space 119b at the wound site 114 (which corresponds to the maximum volume of additional dripping fluid 105 that can be delivered to the wound site 114) at step 508 of Figure 5 the method 500. More specifically, at step 508, the volumes of the removed fluid tank circuit 202 and the negative pressure circuit 200 are calculated based on the parameters measured at steps 904 and 908 (in a manner similar to that referred to Figures 6A to 6GAfterwards, in the manner described in step 612 of method 600, based on subtracting the measured volume of the fluid removal canister circuit 202 from the measured volume of the negative pressure circuit 200, the final dead space 119b at the wound site 114 can be calculated, where Figures 9A to 9E The volume of the fluid removal canister circuit 202 in method 800 is defined by: the final dead space 103b of the fluid removal canister 106 (wherein at step 802, the final dead space 103b of the fluid removal canister 106 is approximately equal to the difference between the initial dead space 103a within the fluid removal canister 106 and the volume of the fluid 121 drained from the wound site 114 into the fluid removal canister 106, as for example Figure 9B shown), the catheter 136, and the upstream tube section 110a; and the volume of the negative pressure circuit 200 is defined by: the volume of the fluid removal canister circuit 202 (i.e., the final dead space 103b of the fluid removal canister 106, the catheter 136, and the upstream tube section 110a), the downstream tube section 110b, the final dead space 119b of the wound site 114, and the portion of the downstream drip tube 108b that extends between the sterile drape layer 117 and the drip tube valve 109.

[0110] According to various embodiments, in an embodiment of method 500, wherein the volume of the dead space 119 at the wound site 114 is determined at step 508 based on measurement parameters related to the fluid removal canister circuit 202 and the negative pressure circuit 200 obtained using Figures 9A to 9E method 900, step 508 may also include subtracting or otherwise adjusting the calculated difference between the volume of the fluid removal canister circuit 202 and the volume of the negative pressure circuit 200 to account for the known volume of the downstream tube section 110b and the known volume of the portion of the downstream drip tube 108b that extends between the sterile drape layer 117 and the drip tube valve 109 in the determination of the volume of the dead space 119a at the wound site 114.

[0111] In Figure 5 some embodiments of method 500, wherein the fluid 121 in the wound site 114 is removed prior to dripping the additional drip fluid 105 at step 516, it may be desirable to ensure that the initial dead space 103a in the fluid removal canister 106 is sufficient to hold the fluid 121 that will be drained from the wound site 114 into the fluid removal canister during step 506, immediately before the step of determining the dead space at the wound site begins at step 506, so as to avoid the risk of overflow of the fluid removal canister 106.

[0112] Thus, in some embodiments of method 500, wherein the fluid 121 in the wound site 114 is removed prior to dripping any additional drip fluid 105 at step 516, the method of step 506 for determining the dead space at the wound site 114 (such as for example with reference toFigures 9A to 9E The method 900 (as described) may include determining whether there is sufficient dead space at the fluid removal canister 106 to contain fluid 121 that is from the wound site 114 and can be drained into the fluid removal canister 106, as part of a method for determining the dead space at the wound site 114.

[0113] Figures 10A to 10C An embodiment of such a method is illustrated that can be used to minimize the risk of overflow of the fluid removal canister 106 during step 506 of determining the dead space at the wound site 114 (e.g., via method 900 as described). At steps 1002 and 1004 (as shown in and respectively), negative pressure is applied to and removed from the fluid removal canister circuit 202 to determine the initial dead space 103a in the fluid removal canister 106 (e.g., as shown) before starting step 506. Generally speaking, Figures 9A to 9E steps 1002 and 1004 of method 1000 can be performed in a manner that is substantially similar to steps 608 and 610 of method 600. At step 1006, the volume of the fluid removal canister circuit 202 is calculated based on the parameters measured at step 1004 (in a manner similar to that described with reference to step 612 of method 600). Once the volume of the fluid removal canister circuit 202 is calculated, the known volumes of the catheter 136 and the upstream tube portion 110a can be subtracted from the calculated volume of the fluid removal canister circuit 202 to determine the volume of the initial dead space 103a in the fluid removal canister 106 (i.e., the maximum volume of fluid 121 that can be drained from the wound site 114 and contained by the fluid removal canister 106). Figure 10B and Figure 10C shown), negative pressure is applied to and removed from the fluid removal canister circuit 202 to determine the initial dead space 103a in the fluid removal canister 106 (e.g., as shown) before starting step 506. Generally speaking, Figure 7 shown). Generally speaking, Figures 10A to 10C steps 1002 and 1004 of method 1000 can be performed in a manner that is substantially similar to steps 608 and 610 of method 600. At step 1006, the volume of the fluid removal canister circuit 202 is calculated based on the parameters measured at step 1004 (in a manner similar to that described with reference to step 612 of method 600). Once the volume of the fluid removal canister circuit 202 is calculated, the known volumes of the catheter 136 and the upstream tube portion 110a can be subtracted from the calculated volume of the fluid removal canister circuit 202 to determine the volume of the initial dead space 103a in the fluid removal canister 106 (i.e., the maximum volume of fluid 121 that can be drained from the wound site 114 and contained by the fluid removal canister 106). Figures 6A to 6G steps 1002 and 1004 of method 1000 can be performed in a manner that is substantially similar to steps 608 and 610 of method 600. At step 1006, the volume of the fluid removal canister circuit 202 is calculated based on the parameters measured at step 1004 (in a manner similar to that described with reference to step 612 of method 600). Once the volume of the fluid removal canister circuit 202 is calculated, the known volumes of the catheter 136 and the upstream tube portion 110a can be subtracted from the calculated volume of the fluid removal canister circuit 202 to determine the volume of the initial dead space 103a in the fluid removal canister 106 (i.e., the maximum volume of fluid 121 that can be drained from the wound site 114 and contained by the fluid removal canister 106). Figures 6A to 6G steps 1002 and 1004 of method 1000 can be performed in a manner that is substantially similar to steps 608 and 610 of method 600. At step 1006, the volume of the fluid removal canister circuit 202 is calculated based on the parameters measured at step 1004 (in a manner similar to that described with reference to step 612 of method 600). Once the volume of the fluid removal canister circuit 202 is calculated, the known volumes of the catheter 136 and the upstream tube portion 110a can be subtracted from the calculated volume of the fluid removal canister circuit 202 to determine the volume of the initial dead space 103a in the fluid removal canister 106 (i.e., the maximum volume of fluid 121 that can be drained from the wound site 114 and contained by the fluid removal canister 106).

[0114] Once the volume of the initial dead space 103a is calculated at step 1006, at step 1008, the controller 118 can be configured to estimate the volume of the fluid 121 at the wound site 114 at a time immediately prior to determining the dead space at the wound site 114 at step 506. The volume of the fluid 121 at the wound site 114 can be based on any number of different factors and variables, such as, for example, stored values of the amount of instilled fluid 105 previously delivered to the wound site 114, stored values of the fluid 121 previously removed from the wound site, elapsed time (e.g., elapsed time since the previous instillation, elapsed time since the previous removal of the fluid 121, etc.), and so on, where at step 1008, the controller 118 is also configured to compare this estimated volume of the fluid 121 with the initial dead space 103a calculated at step 1006, and if the controller 118 determines that the estimated volume of the fluid 121 exceeds the calculated initial dead space 103a, then at step 1010, the user is alerted to empty the fluid removal canister 106. If the calculated initial dead space 103a is sufficient to contain the estimated volume of fluid 121 from the wound site 114, then at step 1012, the controller 118 can be configured to, for example, begin step 506 of determining the dead space at the wound site 114 according to the method 900 as described with reference to Figures 9A to 9E the method 900, begin step 506 of determining the dead space at the wound site 114.

[0115] As described above, according to some embodiments of the method 500, it may be advantageous to monitor the volume change of the wound site 114 at optional step 510 to track the healing progress of the wound site 114.

[0116] Generally speaking, the volume of the wound site 114 is defined by the entire interior that extends between the wound site 114 and the sterile drape layer 117 attached to the skin 116 surrounding the wound site 114. At various points during the treatment using the NPWT system 100, any one and any combination of the wound dressing 112, the fluid 121, and / or the dead space 119 can be located within and define the volume of the wound site. It should be understood that unless the wound dressing 112 is replaced during the treatment, the volume of the wound site 114 occupied by the wound dressing 112 will generally remain constant during the treatment process, while the portions of the volume of the wound site 114 occupied by the fluid 121 and / or the dead space 119 can vary over time.

[0117] See Figure 11 , which shows a block diagram that illustrates what can be done in Figure 5An embodiment of a method 1100 for tracking the healing process of a wound site 114 used at step 510 of method 500. At step 1102, at a time point prior to the initial infusion of the infusion fluid 105 into the wound site 114, the controller 118 estimates and records the initial volume of the wound site 114, and this initial volume can be used as a baseline to be compared with subsequent volume estimates of the wound site 114 to track the healing process. According to various embodiments, the estimation of the initial volume of the wound site 114 at step 1102 can be performed according to (or as) step 616 of the method 600 as described Figures 6A to 6G to proceed.

[0118] At step 1104, after estimating the initial volume of the wound site 114 at step 1102, at one or more additional times during the treatment (e.g., once a day), the estimated volume of the wound site 114 is determined and recorded, where the time for estimating the volume of such one or more wound sites 114 and the determined volume values of the wound site 114 are stored as data points in the memory of the treatment device 102 and / or presented to the user as an output of the treatment device 102 (e.g., via the communication interface 124 or the user interface 126). In some embodiments, the estimated wound volume can be plotted as a function of time.

[0119] At step 1104, the additional wound site 114 volume estimates determined at one or more additional times during the treatment process can be estimated according to any number of different processes. For example, according to some embodiments, the volume estimate of the wound site 114 recorded at step 1104 can be based on the final void space volume at the wound site 114, which volume is calculated, for example, with reference to step 508 of method 500 as described Figure 5 and / or calculated using the method 900 as described Figures 9A to 9E to proceed.

[0120] As Figure 5 step 510 and Figure 6A step 616 show, according to some embodiments, the volume estimation of the wound site 114 at step 1102 and / or step 1104 can be performed in combination with the method of delivering the infusion fluid 105 to the wound site 114. However, it should be understood that according to other embodiments, the determination and recording of some, all, or none of the volume estimates of the wound site 114 at step 1102 and / or step 1104 can be performed independently of any delivery of the infusion fluid 105 to the wound site 114.

[0121] Since an additional wound site 114 volume estimate is obtained at step 1104, at step 1106, the change in the estimated wound site 114 volume over time can be used to determine the healing progress of the wound site 114. For example, step 1106 can include comparing the wound site 114 volume estimate obtained at step 1104 with one or more previous estimates of the wound site 114 volume (estimates obtained at step 1104 or step 1102) to identify a change in the wound site 114 volume. In some embodiments, step 1006 can also include determining the rate of healing of the wound site 114 based on the change in the estimated wound site 114 volume over time. In some embodiments, step 1106 can include extrapolating or predicting the time at which the wound site 114 will be fully healed based on a series of wound site 114 volume estimates stored by the controller 118. For example, step 1106 can include predicting the time at which the estimated wound site 114 volume will reach zero (or another threshold) based on the initial wound site 114 volume estimate obtained at step 1002 and a series of additional wound site 114 volume estimates obtained at step 1004.

[0122] According to some embodiments, instead of providing or in addition to the metered leak device 113 located upstream of the tube valve 111, the NPWT system 100 can include a metered leak device 113 located downstream of the tube valve 111. Generally speaking, such embodiments in which the metered leak device 113 is located downstream of the tube valve 111 can operate in a manner that is substantially similar to the various methods described with reference to FIGS. 1 to Figure 11 However, contrary to the steps of monitoring the pressure decay within the fluid removal canister loop 202, determining the volume of the fluid removal canister loop 202 based on the monitored pressure decay, and subsequently using the determined volume of the fluid removal canister loop 202 to calculate the volume of the wound site 114, in Figure 12 method 1200, the pressure decay is monitored within the wound site loop 204, and the determined volume of the wound site loop 204 is subsequently used to calculate the dead space 103 within the fluid removal canister 106.

[0123] For example, refer to Figure 12 , which shows a flowchart detailing the steps of method 1200 according to one embodiment, the method for the initial setup of the NPWT system 100 and delivering an initial amount of instillation fluid 105 to the wound site 114, where the metered leak device 113 of the NPWT system 100 is positioned downstream of the tube valve 111. Generally speaking, Figure 12 steps 1202, 1204, and 1206 of the embodiment of method 1200 can be performed in a manner that is substantially similar to that described for steps 602, 604, and 606 of method 600 with reference to Figure 6A .

[0124] At step 1208, the controller 118 is configured to initiate operation of the pump 120 to apply a second negative pressure (which may be equal to or different from the negative pressure applied by the controller 118 at step 1204) to the negative pressure circuit 200. According to various embodiments, the drip tube valve 109 and the exhaust valve 113b may be configured to be set in a closed configuration during the application of the negative pressure to the negative pressure circuit 200 at step 1208. In embodiments where the tube set module 300 is controlled using the controller 118, the controller 118 may be configured to instruct the tube set module 300 to effect closure of the perfusion tube valve 109 and / or the exhaust valve 113b.

[0125] At step 1210, after a second desired negative pressure is reached within the negative pressure circuit 200 (such as, for example, the negative pressure measured by the pressure sensor 115a and / or the pressure sensor 115b and reported to the controller 118), the tube valve 111 is closed to define the wound site circuit 204, the operation of the pneumatic pump 120 is stopped, and air from the ambient environment surrounding the treatment device 102 is allowed to flow through the vent hole 113a and into the wound site circuit 204. As air from the ambient environment flows into the wound site circuit 204, parameters associated with the air flow through the vent hole 113a and into the wound site circuit 204 are monitored, where the measured parameters are subsequently used by the controller 118 to calculate the volume of the wound site circuit 204 at step 1212. According to various embodiments, the parameters associated with the air flow into the wound site circuit 204 may include, for example: the rate of air flow into the wound site circuit 204 (such as, for example, measured by the flow detector 113c); the duration required for the pressure within the wound site circuit 204 to increase to a predetermined pressure (e.g., ambient pressure) after the vent hole 113a is opened and / or the operation of the pump 120 is stopped at step 1210; the pressure within the wound site circuit 204 (such as, for example, measured by the pressure sensor 115b) as the pressure increases from the negative pressure applied at step 1208 to the predetermined pressure, and so on.

[0126] At step 1212, the controller 118 may be configured to determine the volume of the wound site circuit 204 based on the parameters measured during step 1208. According to some embodiments, the controller 118 may cause the volume calculation of the wound site circuit 204 to be based on the relationships between various measured parameter values stored and the corresponding volumes. These relationships between the measured parameter measurements and the corresponding volumes stored by the controller 118 may include various functions, models, look-up tables, etc., and may be based on the information already input and stored by the controller 118, or on information obtained and processed by the controller 118 during an optional initial training process performed by the controller 118 prior to treating the wound site 114 with the NPWT system 100 (e.g., prior to the initiation of method 500; as part of the initial setup of the instilled fluid and the initial instillation at step 502, etc.). A non-limiting example of an embodiment of a training process that may be used by the controller 118 to generate such relationships is outlined in the related co-pending U.S. Provisional Application No. 62 / 650,132, filed Apr. 17, 2018, entitled “WOUND THERAPY SYSTEM WITH WOUND VOLUME ESTIMATION”, the entire disclosure of which is incorporated herein by reference.

[0127] Using the determined volume of the wound site circuit 204, the controller 118 may determine the volume of the dead space 119 at the wound site 114 by subtracting or otherwise adjusting the calculated volume of the wound site circuit 204 to account for the known volume of the downstream tube portion 110b and the portion of the downstream drip tube 108b that extends between the drape layer 117 and the drip tube valve 109 in the determination of the volume of the dead space 119a at the wound site 114, thereby determining the volume of the dead space 119 (i.e., the portion of the internal space defined between the wound site 114 and the lower surface of the drape layer 117 that is not occupied by the wound dressing 112 and / or any instilled fluid 105 / other fluid).

[0128] At step 1214, an initial amount of the instillation fluid 105 to be delivered to the wound site 114 is calculated. According to various embodiments, the calculated initial amount of the instillation fluid 105 delivered to the wound site 114 may be based on the volume of the dead space 119 calculated by the controller 118 at step 1212. For example, in some embodiments, by multiplying the volume of the dead space 119 calculated at step 1212 by a fluid instillation factor, the controller 118 may calculate the initial volume of the instillation fluid 105 to be delivered to the wound site 114. The fluid instillation factor may be equal to or less than one (i.e., between zero and one), such that the volume of the instillation fluid 105 delivered to the wound site 114 does not exceed the available space within the drape layer 117, thereby reducing accidental leakage from the wound dressing 112 / drape layer 117. In some embodiments, the fluid instillation factor is between approximately 0.2 and approximately 0.8. However, it is contemplated that in various alternative embodiments, the fluid instillation factor may have any value.

[0129] As described previously with reference to step 510, in addition to calculating the amount of the instillation fluid 105 to be delivered during any treatment phase of using the NPWT system 100 and under any number of different conditions (e.g., allowing the calculation of additional instillation fluid 105 to be delivered at step 516 even if the removal fluid canister 106 has been emptied or has been entirely replaced with a removal fluid canister 106 of a different size during the course of treatment), in some embodiments, the NPWT system 100 may additionally or alternatively be used to monitor and track the healing progress of the wound site 114 over time. Thus, in some embodiments, at step 1216, an initial baseline volume estimate of the wound site 114 may optionally be determined (via, for example, the method described with reference to Figure 11 and stored, and this estimate may be used as a reference point against which future volume estimates of the wound site 114 may be compared to track the healing process of the wound site 114.

[0130] At step 1218, the dead space 103 of the removal fluid canister 106 may be calculated to determine whether the dead space within the removal fluid canister 106 will be sufficient to collect any fluid 121 (including unabsorbed instillation fluid 105) from the wound site 114 after delivering the instillation fluid 105 at step 516. It should be understood that in embodiments where the NPWT system 100 has not been run prior to using the NPWT system 100 at step 1202, the volume of the removal fluid canister 106 should be empty, such that the dead space 103 of the removal fluid container 106 should be equal to the volume of the removal fluid canister 106.

[0131] The dead space 103 of the fluid removal container can be calculated by subtracting the known volumes of the conduit 136 and the upstream tube portion 110a from the volume of the fluid removal canister circuit 202. The volume of the fluid removal canister circuit is determined by subtracting the volume of the wound site 204 calculated at step 1212 from the determined volume of the negative pressure circuit 200. It should be understood that the volume of the negative pressure circuit 200 can be determined in a manner similar to the method for determining the volume of the wound site circuit 204 at step 1212.

[0132] Similar to step 514, at step 1220, if the initial volume of the infusion fluid 105 to be delivered calculated at step 1214 exceeds the dead space 103 of the fluid removal canister 106, an alert can be issued to the user. Otherwise, if the volume of the initial infusion fluid 105 to be delivered does not exceed the dead space 103 of the fluid removal canister 106, the calculated infusion fluid 105 is delivered to the wound site 114 at step 1222.

[0133] It should be understood that in some embodiments of the NPWT system 100 in which the graduated leak device 113 is provided both upstream and downstream of the tube valve 111, it can be operated according to a method the same as or similar to the Figure 6A method 600 or a method the same as or similar to the Figure 12 method 1200 to estimate the volume of the wound site 114 and / or estimate the dead space 103 at the fluid removal canister 106.

[0134] In other embodiments of the NPWT system 100 in which both an upstream graduated leak device and a downstream graduated leak device 113 are provided, it can be operated according to a method the same as or similar to the Figure 6A method 600 and a method the same as or similar to the Figure 12 method 1200 to estimate the volume of the wound site 114 and / or estimate the dead space 103 at the fluid removal canister 106. For example, according to some embodiments, a modified method of operating the NPWT system 100 having both an upstream graduated leak device and a downstream graduated leak device 113 may include the following steps: monitoring the pressure decay within the negative pressure circuit 200 (such as, for example, as described in step 606 of the Figure 6A method 600 and / or Figure 12 step 1206 of the Figure 6A method 1200); monitoring the pressure decay within the fluid removal canister circuit 202 (such as, for example, as described in step 610 of the Figure 12 method 600); and monitoring the pressure decay within the wound site circuit 204 (such as, for example, as described in step 1210 of the

[0135] In such embodiments, the volume of the wound site 114 determined based on direct measurement (e.g., using method 1200 of Figure 12 ) can be compared with the volume of the wound site 114 calculated based on indirect measurement results (e.g., using method 600 of Figure 6A ), and the determination of the dead space 103 at the fluid removal canister 106 based on direct measurement results (e.g., using method 600 of Figure 6A ) can be compared with the volume of the dead space 103 calculated based on indirect measurement results (e.g., using method 1200 of Figure 12 ). In such embodiments, the controller 118 can be configured to generate an alert or warning in response to a difference between the direct and indirect measurement results of the volume of the wound site 114 and / or the dead space 103 at the fluid removal canister 106. By providing such redundancy to the calculation of the volume of the wound site 114 and / or the dead space 103 of the fluid removal canister 106, such embodiments can be configured to allow the NPWT system 100 to provide more accurate and reliable results.

[0136] It should be understood that, according to various embodiments, the controller 118 can be programmed to allow the NPWT system 100 to determine the volume relative to the wound site 114 by any or all of the methods described herein. Thus, while in some embodiments the controller 118 can optionally be pre-programmed to automatically determine the volume of the instilled fluid 105 to be delivered according to a specific method (e.g., an embodiment of method 900 as shown in Figures 9A to 9E ), the controller 118 can also optionally allow the user to: select any mode in other modes of calculating the volume relative to the wound site 114 based on whether the user desires to remove the fluid 121 in the wound site 114, for example, before instilling additional instilled fluid 105; verify whether the dead space 103a in the fluid removal canister 106 is sufficient before determining the dead space at the wound site 114; verify whether the dead space 103b in the fluid removal canister 106 is sufficient before instilling the calculated amount of additional instilled fluid 105 to be delivered to the wound site 114; monitor changes in the volume of the wound site 114 to track the healing process; and so on.

[0137] Tube set module

[0138] Although in some arrangements, some or all of the graduated leak device 113, the tube valve 111, and / or the drip tube valve 109 or other components of the NPWT system 100 may be configured to be manually operated / actuated / utilized by a user, as described above, according to various embodiments, some or all of these components may alternatively be configured to be operated / actuated / utilized by the controller 118 without any user assistance. In this way, the implementation of the system / method for determining the volume of the drip fluid to be delivered to the wound site, estimating the volume of the wound, monitoring the healing process of the wound, and / or other uses of the NPWT system 100 can be fully automated using the controller 118, thereby allowing for easier use of the NPWT system 100.

[0139] By providing an automated means for the NPWT system 100, the controller 118 can control one or more of the graduated leak device 113, the tube valve 111, the drip tube valve 109, and / or other components of the NPWT system 100 or otherwise interact with them via this automated means, and the tube set module 300 can increase the accuracy of the NPWT system 100. For example, in view of the ability of the controller 118 to independently actuate (i.e., without user intervention) the operation of the graduated leak device 113, the tube valve 111, and / or the drip tube valve 109 elements using the tube set module 300, the controller 118 can be configured to increase the rate of collecting data related to the drip fluid volume estimation, wound site volume estimation, wound site 114 healing process monitoring, and / or other functions of the NPWT system 100. By increasing the data points for providing such information, the reliability of the information provided by the controller 118 can thus be increased. Similarly, avoiding or minimizing user involvement provided by the tube set module 300 can facilitate (and thus increase) the likelihood of using the arrangement of the double graduated leak device 113 as described above Figure 12 and thus also increase the reliability of the NPWT system 100.

[0140] Generally speaking, the tube set module 300 includes a housing element 304 that houses a power supply 301, a communication interface 302, and one or more actuatable elements 303 configured to be controlled by the controller 118. In some embodiments, the tube set module 300 may also optionally include one or more additional non-actuatable elements 305, such as, for example, the pressure sensor 115a and / or the pressure sensor 115b. According to an embodiment in which the graduated leak device 113 is not defined by the exhaust valve 113b and only includes the non-actuatable exhaust hole 113a, the non-actuatable element 305 may include such a graduated leak device 113 formed without the exhaust valve 113b.

[0141] It should be understood that, according to some embodiments, some or all of the actuatable elements 303 may be configured to be self-actuating. In some such embodiments, the actuatable elements 303 may include an internal actuator operably connected (via wired, wireless, or any other type of connection) to the power source 301 and / or the communication interface 302 of the cannula module 300, via which the instructions and / or power received from the controller 118 are relayed to the actuators of the actuatable elements 303. In other such embodiments, such self-actuating actuatable elements 303 may separately include one or both of a power source and / or a communication interface (in addition to the power source 301 and / or the communication interface 302 of the cannula module). In such embodiments, the instructions from the controller 118 may be received directly by the communication interface of the actuatable element 303 from the controller, or may be received indirectly by the communication interface of the actuatable element 303 from the communication interface 302 of the cannula module 300. In other embodiments, some or all of the actuatable elements 303 may be configured to be actuated by any number of different types of known actuators or combinations of known actuators housed by the housing element 303, wherein the actuators of the housing element 303 are configured to effect the actuation of one or more of the actuatable elements 303 in response to instructions received from the controller 118.

[0142] The power source 301 may include any number of energy sources and combinations of energy sources configured to supply sufficient energy to the communication interface 302, the actuatable elements 303, and / or the non-actuatable elements 305 housed by the housing element 304 according to the needs of the operation of the NPWT system 100. In some embodiments in which some or all of the cannula modules 300 are integrated into the treatment device 102, the power supplied by the power source 301 of the housing element 304 may include the power source of the treatment device 102.

[0143] The communication interface 302 may include any number of wired and / or wireless connections and combinations of wired and / or wireless connections, via which the cannula module 300 may receive communications (such as, for example, actuation signals) from the controller 118. According to some embodiments, the communication interface 302 may also optionally be configured to send information to and / or receive information from the controller 118, other cannula modules 300, the housing element 304, and / or other sources (such as, for example, information regarding the status of one or more of the actuatable elements 303 and / or the non-actuatable elements 305 of the cannula module 300). In some embodiments in which some or all of the cannula modules 300 are integrated into the treatment device 102, the communication interface 302 of the housing element 304 may be defined by a portion of the communication interface of the treatment device 102.

[0144] According to some arrangements, the tubing set module 300 may be defined by a single housing element 304, where each of the actuatable elements 303 (such as upstream and / or downstream fractional leakage devices 113, tubing valves 111, and / or drip tubing valves 109, etc.) and / or non-actuatable elements 305 will be controlled / utilized by the controller 118 so as to form part of a single integrated housing element 304. In other embodiments, the tubing set module 300 may be defined by a plurality of separate and distinct housing elements 304, where each housing element 304 is formed together with one or more of the various actuatable elements 303 and / or non-actuatable elements 305 that will be controlled / utilized by the controller 118.

[0145] According to various arrangements, one or more housing elements 304 that define the tubing set module 300 may be provided as separate, discrete, single components of the NPWT system 100, which may subsequently be attached to or otherwise incorporated into one or more other components of a new or existing NPWT system 100. In other arrangements, some or all of the one or more housing elements 304 that define the tubing set module 300 may be provided as an integrated part of one or more of the other components of the NPWT system 100.

[0146] For example, in some arrangements, some or all of the tubing set module 300 may be integrated into the wound dressing 112, where the portion of the tubing set module 300 that is provided with the wound dressing 112 is configured to be removed from the NPWT system 100 as the wound dressing 112 is removed. When removing the integrated wound dressing 112 / tubing set module 300, the entire wound dressing 112 / tubing set module 300 may be discarded. Alternatively, the tubing set module 300 may be removed from the wound dressing 112 and then the wound dressing 112 may be discarded, and the tubing set module may optionally be reused with another wound dressing 112 and / or other components of the NPWT system 100.

[0147] In other arrangements, some or all of the tubing set module 300 may be integrated into the fluid removal canister 106, where the portion of the tubing set module 300 that is provided with the fluid removal canister 106 is removed from the NPWT system 100 as the fluid removal canister 106 is removed from the NPWT system 100. In some such embodiments, the tubing set module 300 may be formed integrally with the fluid removal canister 106, while in other embodiments, the tubing set module 300 may be formed non-integrally with the fluid removal canister 106.

[0148] According to another arrangement, the tubing set module 300 may be configured to be integrally coupled in series with one or both of the tubes 108 and / or 110. In such embodiments, an attachment adapter 400 may be provided on the tubing set module 300 and / or one or both of the tubes 108 and / or 110 to facilitate a fluid-tight attachment of the tubing set module 300 to the tube 108 and / or 110. According to some embodiments, the attachment adapter 400 may be provided on the tubing set module 300, wherein the attachment adapter 400 is configured to be able to directly form a fluid-tight attachment with one or both of the tubes 108 and / or 110, thereby allowing the formation of the NPWT system without the tubing set module 300 and / or the fractional leakage device 113, and the tubing valve 111 and / or the drip tubing valve 109 is / are equipped with the tubing set module 300 to provide the NPWT system 100 as disclosed herein.

[0149] In some arrangements, some or all of the tubing set module 300 may be integrated into the housing of the treatment device 102. In such embodiments, the efficiency of using the NPWT system 100 may be increased, such as by incorporating the tubing set module 300 including some or all of the fractional leakage device 113, the tubing valve 111, and / or the drip tubing valve 109 into the housing of the treatment device 102, and the time to set up the NPWT system 100 may be reduced compared to the time that would otherwise be required to set up the NPWT system 100 where some or all of the fractional leakage device 113, the tubing valve 111, and / or the drip tubing valve 109 are provided as separate and discrete components of the NPWT system 100. Additionally, by incorporating the tubing set module 300 into the housing of the treatment device 102, the NPWT system 100 as described herein may be provided regardless of the particular tube, fluid removal canister, wound dressing, or other components provided to define the NPWT system 100 for treating the wound site 114.

[0150] See Figures 13 to 16B , various embodiments of the tubing set module 300 configured to allow partial or full automatic control of the NPWT system 100 using the controller 118 are shown. It should be understood that although reference has been made to the controller 118 provided as part of the treatment device 102, it should be understood that according to various arrangements, the controller 118 may be provided independently and remotely from the treatment device 102 and / or the NPWT system 100 (e.g., by a telemedicine provider). In such embodiments, the remotely provided controller 118 may be configured to communicate directly with the tubing set module 300 and / or indirectly with the tubing set module 300 through a communication interface provided by the treatment device 102.

[0151] As Figure 13Exemplified by an embodiment of the NPWT system 100, in some arrangements, the tubing set module 300 is provided as a single integrated housing element 304 that houses actuatable elements 303 including a graduated leak device 113, a tubing valve 111, and an optional irrigation tubing valve 109. According to some embodiments, one or both of the tubing valve 111 and the optionally provided irrigation tubing valve 109 may include the same or different clamps. As Figure 13 shown, a power supply 301 is also housed within the housing element 304 and is configured to actuate the actuatable elements 303 in response to instructions received from the controller 118 via the communication interface 302.

[0152] Although in Figure 13 the exemplified embodiment, the single integrated tubing set module 300 is shown in series with both the tubing 108 and the tubing 110, it should be understood that according to other arrangements (not shown), a first housing element 304 including the graduated leak device 113 and the tubing valve 111 may be provided in series with the tubing 110, and an optional second housing element 304 including the drip tubing valve 109 may be provided in series with the tubing 110.

[0153] As Figure 13 exemplified by the NPWT system 100, in some embodiments, the tubing set module 300 may be integrally formed with an upstream tubing portion 110a and / or an upstream irrigation tubing 108a. According to some such embodiments, the upstream tubing portion 110a and / or the upstream irrigation tubing 108a integrally formed with the tubing set module 300 may in turn be integrally formed with the treatment device 102. In such embodiments, the tubing set module 300 is configured to be removably attached to a downstream tubing portion 110b and / or a downstream drip tubing 108b integrally formed with the wound dressing 112, such that after using the NPWT system 100 with a first wound dressing 112, the treatment device 102 having the integrated upstream tubing portion 110a and / or upstream irrigation tubing 108a and the tubing set module 300 can be reused with a new second wound dressing 112. In other embodiments, such as for example exemplified by Figure 14 the NPWT system 100, some or all of the tubing set modules 300 may alternatively be integrally formed with the wound dressing 112, where the tubing set module 300 is configured to be removed from the NPWT system 100 as the wound dressing 112 is removed.

[0154] Referring to Figure 15 the NPWT system 100, according to some embodiments, the tubing set module 300 may include a first housing element 304 that houses the graduated leak device 113 and an optional irrigation tubing valve 109, a pressure sensor 115a and / or a pressure sensor 119 positioned in series with the tubing 108 and / or 110. A second housing element 304 including the tubing valve 111 may be spaced apart from the first housing element 304. AsFigure 14 As shown, according to some arrangements, the second housing element 304 may be integrated into the fluid removal canister 106. In other embodiments, the second housing element 304 may alternatively be incorporated into the treatment device 102, or may be disposed at a second location in series with the tube 110.

[0155] See Figure 16A , a block diagram of an NPWT system 100 according to one embodiment is shown. As Figure 16A exemplified by the NPWT system 100, according to some embodiments, fluid communication between some or all of the negative pressure circuit 200 and the surrounding environment may be provided by a bleed valve system 450 provided along the irrigation tube 108, which serves as an alternative or supplement to the graduated leak device 113. According to various embodiments, the bleed valve system 450 may include a structure similar to the graduated leak device 113 (including any combination of components of the graduated leak device 113 embodiments, which include the vent hole 113a, the exhaust valve 113b, and / or the flow detector 113c).

[0156] Also as Figure 16A exemplified, in such NPWT system 100 embodiments, the tube valve 111 and / or the drip tube valve 109 may be replaced by a valve assembly 460 that is fluidly attached to the tube 110 at the junction between the upstream tube portion 110a and the downstream tube portion 110b, and is attached to the drip tube assembly at the junction between the upstream tube 108a and the downstream tube 108b, and the valve assembly may be actuated to multiple positions. In a first position, the valve assembly 460 may permit fluid to flow from the pneumatic pump 120 via the tube 110 to the wound site 114, and from the drip pump 104 via the drip tube 108 to the wound site 114. In a second position, the valve assembly 460 may permit fluid to flow from the pneumatic pump 120 via the tube 110 to the wound site 114 while blocking the flow of fluid from the drip pump 104 via the drip tube 108 to the wound site 114. In a third position, the valve assembly 460 may block the flow of fluid from the pneumatic pump 120 via the tube 110 to the wound site 114 while permitting fluid to flow from the drip pump 104 via the drip tube 108 to the wound site 114. In a fourth position, the valve assembly 460 may fluidly connect the upstream tube portion 110a to the upstream drip tube 108a, thereby isolating the downstream tube portion 110b, the downstream tube 108, and the wound dressing 112 from the remainder of the treatment device 102.

[0157] When in the first configuration, the valve assembly 460 defines a negative pressure circuit 200 that is defined by tube 136, fluid reservoir 106, tube 110, wound site 114, and the portion of the infusion tube that extends between wound site 114 and the bleed valve 450. When in the fourth configuration, the valve assembly 460 defines a fluid reservoir removal circuit 202 and a wound site circuit 204. The fluid reservoir removal circuit is defined by tube 136, fluid reservoir 106, upstream tube portion 110a, and the portion of upstream tube 108a that extends between the valve assembly 460 and the bleed valve 450. The wound site circuit is defined by downstream tube portion 110b, wound site 114, and downstream tube 108b.

[0158] It should be understood that Figure 16A the valve assembly 460 and the bleed valve 450 of the NPWT system 100 can operate in a manner similar to the operation of the tube valve 111, the fractional leakage device, and / or the drip tube valve 109 as described in any of the methods referenced herein to determine wound site volume, estimate the volume of fluid to be infused, monitor the wound healing process, or perform any other function using the NPWT system 100.

[0159] See Figure 16B , according to one embodiment, a tube set module 300 is shown that is configured for use with the NPWT system 100 in combination with a bleed valve 450 (such as, for example, Figure 16A as shown in). As Figure 16B exemplified, in an embodiment where the bleed valve 450 is provided as a discrete component of the treatment device 112 that can be automatically actuated by the controller 118, the tube set module 300 can include only a single actuatable element 303 defined by the valve assembly 460. It should be understood that in other embodiments (such as, for example, in the case where the bleed valve 450 provided as part of the treatment device cannot be automatically actuated by the controller 118), the bleed valve 450 can be provided as part of the tube set module 300 that is partially or fully integrated into the treatment device 112.

[0160] Although in the Figure 16A exemplified NPWT system 100 embodiment, the bleed valve 450 is illustrated as being provided as part of the treatment device 112, according to other embodiments, the bleed valve 450 can alternatively or additionally be provided as part of the upstream tube 108a. In such embodiments, the bleed valve 450 can thus be provided as the actuatable element 303 of the tube set module 300.

[0161] It should be understood that the controller 118 can be configured to use the NPWT system 100 to implement any number of different operations based on the selective full - automatic actuation / interaction of some or all of the actuable elements 303 and / or non - actuable elements 305 of the cannula module 300 according to any number of different methods and protocols. According to various embodiments, the order and / or combination of instructions transmitted by the controller 118 to the cannula module 300 and / or the information received by the controller 118 from the cannula module 300 can be configured to operate the cannula module 300 in a manner that allows the controller 118 to automatically implement one or more of methods 500, 600, 800, 900, 1000, 1100, 1200, etc.

[0162] Figure 17 What is shown in is a method 1700 by which the controller 118 can utilize the cannula module 300 housing the actuable elements 303 and non - actuable elements 305. The actuable elements include the cannula valve 111, the irrigation cannula valve 109, and the fractional leak device 113, and the non - actuable elements include one or both of the pressure sensors 115a and / or 115b to automatically control the NPWT system 100 according to methods such as, for example, method 500 of reference Figure 5 and method 600 of reference Figure 6A to determine the dead space 119 at the wound site 114.

[0163] At step 1701, in response to the controller 118 being activated to determine the dead space at the wound site 114 (such as, for example, at step 506 of method 500 of reference Figure 5 ), the controller 118 can initiate communication with the cannula module 300 to confirm that the irrigation cannula valve 109 and the exhaust valve 113b of the fractional leak device 113 are closed and the cannula valve 111 is open. If the irrigation cannula valve 109 and / or the exhaust valve 113b is open, the controller 118 can instruct the cannula module 300 to effect actuation of the irrigation cannula valve 109 and / or the exhaust valve 113b to the closed configuration. Similarly, if the cannula valve 111 is detected by the controller 118 as closed, the controller 118 can transmit an instruction via the communication interface 302 to the cannula valve 111 to effect the opening of the cannula valve 111.

[0164] Once the controller 118 receives confirmation via the communication interface 302 that the irrigation cannula valve 109 and the exhaust valve 113b are closed and the cannula valve 111 is open, the controller 118 can be configured to initiate the operation of the pneumatic pump 120 to apply negative pressure to the negative pressure circuit 200 (such as, for example, reference Figure 6Aas described in step 604 of method 600). During operation of the pneumatic pump 120, at step 1703, the controller 118 may be configured to receive pressure readings corresponding to the pressure within the negative pressure circuit 200 from the pressure sensor 115a and / or the pressure sensor 115b. It should be understood that the pressure readings received by the controller 118 at step 1703 may be continuously received at a predetermined interval and / or in response to a specific request for the pressure readings transmitted by the controller 118 to the tube set module 300 via the communication interface 302.

[0165] In response to receiving a pressure reading from the tube set module 300 indicating that the pressure within the negative pressure circuit 200 has reached a threshold pressure, at step 1705, the controller 118 may be configured to stop the operation of the pneumatic pump 120 and transmit an actuation signal to the tube set module 300 configured to cause the exhaust valve 113b to open.

[0166] At step 1707, the controller 118 may be configured to receive pressure readings corresponding to the pressure decay within the negative pressure circuit 200 from the pressure sensor 115a and / or the pressure sensor 115b, such as, for example, as described in Figure 6A step 606. The pressure readings received by the controller 118 at step 1707 may be continuously received at a predetermined interval or in response to a specific request for the pressure readings transmitted by the controller 118 to the tube set module 300 via the communication interface 302.

[0167] Once the controller 118 receives a pressure reading from the tube set module 300 indicating that the pressure within the negative pressure circuit 200 has reached a threshold pressure (such as, for example, ambient pressure), at step 1709, the controller 118 may be configured to use the tube set module 300 to effect actuation of the closure of the tube valve 111 and the exhaust valve 113b, and then apply a negative pressure to the resulting fluid removal tank circuit 202 (such as, for example, during Figure 6A step 608 of method 600).

[0168] At step 1711, the controller 118 may again be configured to receive pressure readings from the tube set module 300. The pressure readings received by the controller 118 at step 1711 may be continuously received at a predetermined interval or in response to a specific request for the pressure readings transmitted by the controller 118 to the tube set module 300 via the communication interface 302. In response to receiving a pressure reading from the tube set module 300 indicating that the pressure within the fluid removal tank circuit 202 has reached a threshold pressure, at step 1713, the controller 118 may be configured to stop the operation of the pneumatic pump 120 and transmit an actuation signal to the tube set module 300 configured to cause the exhaust valve 113b to open.

[0169] At step 1715, the controller 118 may be configured to receive a pressure reading from the pressure sensor 115a corresponding to a pressure decay within the fluid reservoir loop 202, such as, for example, as described in step 610 of reference Figure 6A The pressure reading received by the controller 118 at step 1715 may be continuously received at a predetermined interval or in response to a specific request for the pressure reading transmitted by the controller 118 to the manifold module 300 via the communication interface 302.

[0170] According to some embodiments, after step 1715, at step 1717, the controller 118 may be configured to actuate the opening of the drip tube valve 109 using the manifold module 300, prior to dripping the drip fluid into the wound site 114 (such as, for example, as described in steps 516 of method 500 and / or Figure 5 step 622 of method 600 of reference Figure 6A ).

[0171] Configuration of the exemplary embodiment

[0172] The construction and arrangement of the systems and methods shown in the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, many modifications are possible (e.g., variations in the size, dimensions, structure, shape, and proportions of the various elements, parameter values, installation arrangements, use of materials, colors, orientations, etc.). For example, the positions of the elements may be reversed or otherwise changed, and the nature or number or position of the discrete elements may be altered or changed. Accordingly, all such modifications are intended to be included within the scope of this disclosure. The order or sequence of any process or method steps may be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes, and omissions may be made to the design, operating conditions, and arrangement of the exemplary embodiments without departing from the scope of this disclosure.

[0173] The present disclosure contemplates methods, systems, and program products on any machine-readable medium for implementing various operations. Embodiments of the present disclosure may be implemented using an existing computer processor, or by a special-purpose computer processor of a suitable system incorporated for this or another purpose, or by a hard-wired system. Embodiments within the scope of the present disclosure include a program product that includes a machine-readable medium for carrying or having machine-executable instructions or data structures stored thereon. Such a machine-readable medium can be any available medium that can be accessed by a general-purpose or special-purpose computer or other machine with a processor. By way of example, such machine-readable medium can include RAM, ROM, EPROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to carry or store desired program code in the form of machine-executable instructions or data structures and that can be accessed by a general-purpose or special-purpose computer or other machine with a processor. Combinations of the above are also included within the scope of machine-readable media. Machine-executable instructions include, for example, instructions and data that cause a general-purpose computer, special-purpose computer, or special-purpose processor to perform a particular function or a group of functions.

[0174] Although the figures illustrate a specific order of method steps, the order of the steps may differ from that depicted. Moreover, two or more steps may be performed simultaneously or partially simultaneously. Such variations will depend on the software and hardware systems selected and the designer's choice. All such variations are within the scope of the present disclosure. Similarly, software implementations can be achieved by standard programming techniques with rule-based logic and other logic to implement various connection steps, processing steps, comparison steps, and decision steps.

Claims

1. A wound treatment system, the wound treatment system comprising: A treatment device, the treatment device comprising: A fluid removal canister configured to collect wound exudate from a wound; A pump fluidly coupled to the fluid removal canister and configured to draw a negative pressure within the fluid removal canister; An infusion fluid canister configured to store infusion fluid; and An infusion pump fluidly coupled to the infusion fluid canister and configured to deliver the infusion fluid to the wound; A tube attached to and fluidly coupled to the fluid removal canister, the tube and the fluid removal canister defining a negative pressure circuit; and A tube set module in fluid communication with the fluid removal canister and the tube, the tube set module comprising: A valve configured to selectively permit flow within the tube when in an open configuration and to selectively block flow when in a closed configuration; A graduated leak device configured to provide fluid communication between the negative pressure circuit defined by the tube and the fluid removal canister and ambient atmosphere; and A communication interface configured to receive communication from a controller; Wherein the valve is configured to be actuated to the closed configuration in response to a first communication received by the tube set module via the communication interface; Wherein the controller is configured to Determine the dead space of the wound; Determine a maximum amount of the infusion fluid to be delivered to the wound based on the dead space of the wound; Determine the dead space of the fluid removal canister; Compare the maximum amount of the infusion fluid to be delivered to the wound with the dead space of the fluid removal canister; and Actuate an alarm if the maximum amount of the infusion fluid to be delivered to the wound exceeds the dead space of the fluid removal canister.

2. The system according to claim 1, wherein the valve is configured to be actuated to the open configuration in response to a second communication received by the tube set module.

3. The system according to claim 2, wherein the communication interface is configured to receive communication from the controller wirelessly.

4. The system according to claim 1, wherein the graduated leak device is configured to selectively provide fluid communication between the negative pressure circuit and the ambient atmosphere in a first configuration and to block fluid communication between the negative pressure circuit and the ambient atmosphere in a second configuration.

5. The system according to claim 4, wherein the graduated leak device is configured to be actuated to the first configuration in response to a third communication received by the tube set module.

6. The system according to claim 5, wherein the tube set module further comprises a pressure sensor configured to detect pressure within the negative pressure circuit.

7. The system according to claim 6, wherein the communication interface is configured to transmit information related to the pressure detected by the pressure sensor to the controller.

8. The system according to claim 7, wherein the first communication is transmitted by the controller in response to the controller receiving, from the communication interface, the information related to the pressure detected by the pressure sensor.

9. The system according to claim 1, wherein the tube set module is provided with the tube string.

10. The system according to claim 1, wherein the tube set module is integrated into the fluid removal tank.

11. The system according to claim 1, wherein the tube set module is integrated into the treatment device housing to which the fluid removal tank is attached.

12. The system according to claim 1, wherein the tube set module is defined by a single housing element, and each of the valve, the graduated leakage device, and the communication interface is accommodated within the single housing element.

13. The system according to claim 1, wherein the tube set module is defined by a plurality of housing elements, and each of the valve and the graduated leakage device is accommodated within a separate and different housing element.

Images