Wound therapy tubing set system for wound volume estimation

Abstract

The invention relates to a wound therapy tubing set system for wound volume estimation. A tubing stack module is provided that includes one or more elements of a negative pressure wound therapy ("NPWT") system, such as valves, indexing leakage devices, pressure sensors, etc. The bank module may communicate with a controller of the NPWT system via a communication interface provided by the bank module. Communication between the tubule module and the controller may be used to fully automate one or more processes involving operation of components included in the tubule module of the NPWT system, thereby allowing the NPWT system to, for example, estimate a volume of a wound site, estimate a volume of fluid to be dropped, monitor a progress of wound healing, etc. without any user interaction or participation. The tube stack module may be defined by one or more housing elements. The tube stack module may be incorporated into any of a tube, a fluid canister, a wound dressing, and / or a therapeutic device housing components of the NPWT system.

Description

[0001] This application is a divisional application of an application filed on March 26, 2019, with application number 201980073641.0 and invention name “Wound therapy tube set system for wound volume estimation”. CROSS-REFERENCE TO RELATED APPLICATIONS

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

[0003] The present disclosure relates generally 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 type of wound treatment that involves applying negative pressure to a treatment site to promote wound healing. Recent advances in utilizing NPWT for wound healing involve applying topical fluids to the wound in combination with NPWT. However, determining the appropriate volume of instillation fluid to deliver to the wound can be difficult. Furthermore, accurately monitoring and tracking the wound's healing progress over time can be challenging. Therefore, it would be advantageous to provide a system and method that allows for accurate and reliable estimation of the available space at a wound site into which instillation fluid can be delivered, as well as estimation of the wound site's healing progress over time. Advantageously, such a system and method would also allow such volume determinations to be automatically performed by a controller, wherein the controller is not only configured to automatically process and calculate the volume determinations, but also to automatically activate any required components of the NPWT system as needed to obtain the necessary data points required for such calculations. Furthermore, such a method and system can advantageously be performed at any stage during NPWT treatment and can account for changes in the type or size of removal fluid canisters used during NPWT treatment. Summary of the Invention

[0005] In one 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 tank configured to collect wound exudate from a wound; a pump fluidly connected to the tank and configured to draw negative pressure within the tank. The tube is attached to and fluidly connected to the tank. The tube and the tank define a negative pressure circuit. The tube set module is in fluid communication with the tank and the tube. The tube set module includes a valve, a graduated leakage device, and a communication interface. The valve is configured to selectively allow flow within the tube when in an open configuration and selectively block flow when in a closed configuration. The graduated leakage device is configured to provide fluid communication between the negative pressure circuit defined by the tube and the tank and the ambient atmosphere. The communication interface is configured to receive communications from a controller. The valve is configured to actuate to a 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 actuate to the 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 actuate to the first configuration in response to a third communication received by the tubeset module.

[0008] In some embodiments, the tubing module further comprises a pressure sensor configured to detect 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 comprise a controller. In response to the controller receiving information related to the pressure detected by the pressure sensor from the communication interface, the controller transmits a first communication.

[0009] In some embodiments, the tubing module is provided in series with the tubing. In some embodiments, the tubing module is integrated into the fluid tank. The tubing module is integrated into the therapeutic device housing to which the fluid tank is attached. In some embodiments, the tubing module is defined by a single housing element. Each of the valve, the graduated leakage device, and the communication interface is housed within the housing element. The tubing module is defined by multiple housing elements. Each of the valve and the graduated leakage device is housed within a separate, distinct housing element.

[0010] In one embodiment of the present disclosure, a method for operating a wound therapy device is provided. A first end of a fluid tube is operably connected to a fluid tank and a pump of the therapy device. A second end of the fluid tube is operably connected to a wound dressing. A tubing module comprising a valve, a graduated leakage device, and a communication interface is operably 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 assembly, the valve is actuated from an open configuration to a closed configuration. In the open configuration, fluid communication is provided between the wound dressing and the fluid tank. In the closed configuration, fluid communication between the wound dressing and the fluid tank is blocked.

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

[0012] In some embodiments, the tubing 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 assembly using a communication interface. In response to the controller computer assembly receiving the information related to the detected pressure from the tubing module, the controller computer assembly transmits an instruction to the pump to initiate application of negative pressure to the negative pressure circuit.

[0013] In some embodiments, the method further comprises actuating the graduated leak device from a closed configuration in response to the tubing module receiving an instruction from the computer controller assembly to an open configuration in which fluid communication between the negative pressure circuit and the ambient atmosphere is blocked, and in which fluid communication is provided between the negative pressure circuit and the ambient atmosphere.

[0014] In some embodiments, the graduated fluid leakage device is actuated from a closed configuration, in which fluid communication between the negative pressure circuit and the ambient atmosphere is blocked, to an open configuration, in which fluid communication between the negative pressure circuit and the ambient atmosphere is provided in response to the tube set module receiving instructions from the computer controller assembly.

[0015] In one embodiment of the present disclosure, a tubing assembly for a wound therapy system includes a tubing module and a controller. The tubing module is configured to be operably connected to a fluid tank and fluid tube of the wound therapy system. The tubing module includes a housing, a communication interface, a valve, and a power source. The housing has a body extending between a first outlet formed on a first end of the housing and a second outlet formed on a second end of the housing. The communication interface is configured to allow information to be received wirelessly by the tubing module. The valve defines a first configuration and a second configuration, in which, in the first configuration, the first outlet and the second outlet are in fluid communication with each other, and in the second configuration, the 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 tubing module via the communication interface. In response to receiving the first instruction from the controller, the valve is configured to actuate to the first configuration. In response to receiving the second instruction from the controller, the valve is configured to actuate to the second configuration.

[0016] In some embodiments, the tubing module assembly further comprises a first tubing adapter attached to the first outlet of the housing and a second tubing 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 tubing of the wound therapy device. The tubing module assembly further comprises a graduated seepage device that provides fluid communication between at least one of the first end portion of the housing and the second end portion of the housing and ambient atmosphere via an opening extending through the housing body.

[0017] In some embodiments, the tubing module assembly further comprises a third outlet disposed on the first end of the housing and a fourth outlet disposed on the second end of the housing. The tubing module assembly further comprises 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 tubing of the wound therapy device.

[0018] 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.

[0019] 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 may be a rotatable valve.

[0020] Those skilled in the art will appreciate that the present disclosure is illustrative only and is not intended to be limiting in any way. Other aspects, inventive features, and advantages of the devices and / or processes described herein, as limited only by the claims, will become apparent from the detailed description set forth herein and in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a partial block diagram of a negative pressure wound therapy system including a therapy device coupled to a wound dressing via tubing, according to an exemplary embodiment.

[0022] Figure 2 is a more detailed illustration of the exemplary embodiment according to Figure 1 Block diagram of a negative pressure wound therapy system.

[0023] Figure 3 is a more detailed illustration of the exemplary embodiment according to Figure 1 Block diagram of the negative pressure circuit, fluid removal tank circuit, and wound site circuit of a negative pressure wound therapy system.

[0024] Figure 4 is a block diagram illustrating a negative pressure wound therapy system according to an exemplary embodiment.

[0025] Figure 5 is a flow chart of a method of using a negative pressure wound therapy system according to an exemplary embodiment.

[0026] Figure 6A is a flow chart of a method of instilling an initial amount of fluid into a wound site using a negative pressure wound therapy system according to an exemplary embodiment.

[0027] Figure 6B Illustrated is a negative pressure wound therapy system applied to a desired wound site to be treated prior to instilling an initial volume of fluid into the wound site, according to an exemplary embodiment.

[0028] Figure 6C Illustrated is a diagram of a negative pressure wound therapy system after applying a first negative pressure according to an exemplary embodiment. Figure 6B Negative pressure wound therapy system.

[0029] Figure 6D Illustrated in accordance with exemplary embodiments Figure 6C After applying the first negative pressure as shown in FIG, during exhaust of the negative pressure wound therapy system Figure 6C Negative pressure wound therapy system.

[0030] Figure 6E Illustrated is a diagram illustrating a process of applying a second negative pressure to a negative pressure wound therapy system according to an exemplary embodiment. Figure 6BNegative pressure wound therapy system.

[0031] Figure 6F Illustrated in accordance with exemplary embodiments Figure 6E After applying the second negative pressure as shown in FIG, during exhaust of the negative pressure wound therapy system Figure 6E Negative pressure wound therapy system.

[0032] Figure 6G Illustrate the use according to the exemplary embodiment Figure 6B The wound treatment system delivers fluid to the wound site.

[0033] Figure 7 Illustrated is a negative pressure wound therapy system applied to a wound site after initial instillation of fluid into the wound site, according to an exemplary embodiment.

[0034] Figure 8A is used according to an exemplary embodiment Figure 7 Flowchart of a method for a negative pressure wound therapy system to instill an additional amount of fluid into a wound site.

[0035] Figure 8B Illustrated is a diagram of a negative pressure wound therapy system after applying a first negative pressure according to an exemplary embodiment. Figure 7 Negative pressure wound therapy system.

[0036] Figure 8C Illustrated in accordance with exemplary embodiments Figure 8B After applying the first negative pressure as shown in FIG, during exhaust of the negative pressure wound therapy system Figure 8B Negative pressure wound therapy system.

[0037] Figure 8D Illustrated is a diagram illustrating a process of applying a second negative pressure to a negative pressure wound therapy system according to an exemplary embodiment. Figure 7 Negative pressure wound therapy system.

[0038] Figure 8E Illustrated in accordance with exemplary embodiments Figure 8D After applying the first negative pressure as shown in FIG, during exhaust of the negative pressure wound therapy system Figure 8D Negative pressure wound therapy system.

[0039] Figure 9A is used according to an exemplary embodiment Figure 7 Flowchart of a method for a negative pressure wound therapy system to instill an additional amount of fluid into a wound site.

[0040] Figure 9B Illustrated is a diagram of a negative pressure wound therapy system after applying a first negative pressure according to an exemplary embodiment. Figure 7Negative pressure wound therapy system.

[0041] Figure 9C Illustrated in accordance with exemplary embodiments Figure 9B After applying the first negative pressure as shown in FIG, during exhaust of the negative pressure wound therapy system Figure 9B Negative pressure wound therapy system.

[0042] Figure 9D Illustrated is a diagram illustrating a process of applying a second negative pressure to a negative pressure wound therapy system according to an exemplary embodiment. Figure 7 Negative pressure wound therapy system.

[0043] Figure 9E Illustrated in accordance with exemplary embodiments Figure 9D After applying the first negative pressure as shown in FIG, during exhaust of the negative pressure wound therapy system Figure 9D Negative pressure wound therapy system.

[0044] Figure 10A is a flow chart of a method of determining whether sufficient dead space exists in a negative pressure wound therapy system according to an exemplary embodiment.

[0045] Figure 10B Illustrated is a diagram of a negative pressure wound therapy system after applying a first negative pressure according to an exemplary embodiment. Figure 7 Negative pressure wound therapy system.

[0046] Figure 10C Illustrated in accordance with exemplary embodiments Figure 10B After applying the first negative pressure as shown in FIG, during exhaust of the negative pressure wound therapy system Figure 10B Negative pressure wound therapy system.

[0047] Figure 11 is a flow chart of a process for monitoring the healing progress of a wound site over time, according to an exemplary embodiment.

[0048] Figure 12 is a flow chart of a method of instilling an initial amount of fluid into a wound site using a negative pressure wound therapy system according to an exemplary embodiment.

[0049] Figure 13 A negative pressure wound therapy system including a tube set module according to an exemplary embodiment is illustrated.

[0050] Figure 14 A negative pressure wound therapy system including a tube set module according to an exemplary embodiment is illustrated.

[0051] Figure 15 A negative pressure wound therapy system including a tube set module according to an exemplary embodiment is illustrated.

[0052] Figure 16A is a block diagram of a negative pressure wound therapy system including a tubing module according to an exemplary embodiment.

[0053] Figure 16B Illustrated according to an exemplary embodiment includes Figure 16A Negative pressure wound therapy system with a tube set module.

[0054] Figure 17 is a flow chart of a fully automated method of operating a tube stack module according to an exemplary embodiment. DETAILED DESCRIPTION

[0055] Overview Referring generally to the accompanying drawings, a wound treatment system according to various exemplary embodiments is shown. The wound treatment system may include a treatment device and a wound dressing. The treatment device may include an instillation fluid tank, a removal fluid tank, a valve, a pneumatic pump, an instillation pump, a tubing module, and a controller. The wound dressing may be applied to the skin surrounding a wound of a patient. The treatment device may be configured to deliver the instillation fluid to the wound and provide negative pressure wound therapy (NPWT) by maintaining the wound under negative pressure. The components of the wound treatment 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 module, and / or other controllable components of the treatment device. In some embodiments, the controller estimates the wound volume based on a comparison of the observed dynamic pressure response 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. Based on the comparison of the observed dynamic response, the controller can be configured to determine an amount of instillation fluid to be delivered to the wound site.

[0057] The tube set module includes one or more elements that can be actuatable, controllable, or otherwise engaged by a controller, wherein selective communication between the controller and the tube set module is configured to allow the controller to implement and monitor various dynamic pressure responses in all and / or part of the negative pressure circuit as needed to, among other functions, estimate wound volume, determine the amount of instillation fluid to be delivered to the wound site, and / or perform any other number of functions that may be associated with 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 surrounding the wound site within the applied drape layer into which the 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 module and the instillation pump to deliver the determined volume of instillation fluid to the wound. By basing the amount of instillation fluid to be delivered to the wound site on the calculated dead space volume at the wound site, the negative pressure system can be configured to provide more efficient and accurate delivery of the 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 a volume relative to the wound site multiple times, wherein the controller determines the progress of healing at the wound site based on changes in the measured volume relative to the wound site during NPWT treatment. By monitoring the progress of healing at the wound site, the controller may be configured to alert a user if healing at the wound site is not proceeding as expected or desired. These and other features of the wound treatment system are described in detail below.

[0060] Wound treatment system Now see Figure 1 , shows 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, a tube set module 300 can be operably connected to tubes 108 and / or 110.

[0061] According to various embodiments, a wound dressing 112 can be placed over or within a wound site 114 and adhered or sealed to the patient's skin 116 surrounding the wound site 114 using a drape layer 117. Several examples of wound dressings 112 that can 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.

[0062] like Figure 2, generally speaking, the treatment device 102 includes a pneumatic pump 120, an infusion pump 122, a filter 128, and a controller 118. The pneumatic pump 120 can be fluidly coupled to the removal fluid tank 106 (e.g., via a conduit 136) and can be configured to draw a vacuum within 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 can operate in a 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 can operate in a 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 can be controlled by the controller 118, which will be described in more detail below.

[0063] The treatment device 102 can be configured to provide negative pressure wound therapy by reducing the pressure at the wound site 114. The treatment device 102 can draw 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 can include fluid that has filtered from the patient's circulatory system into the lesion or inflamed area. For example, wound exudate can 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 can include the instillation fluid 105 previously delivered to the wound site 114. The instillation fluid 105 can include, for example, a cleaning fluid, a prescription fluid, a drug-loaded fluid, an antibiotic fluid, or any other type of fluid that can be delivered to the wound site 114 during wound treatment. The instillation fluid 105 can be held in the instillation fluid tank 104 and controllably distributed to the wound site 114 via the tube 108. In some embodiments, the drip fluid tank 104 is detachable from the therapeutic device 102 to allow for refilling and replacement of the drip fluid tank 106 as needed.

[0064] The drip pump 122 can be fluidly coupled to the drip fluid tank 104 via the upstream drip tube 108a and to the wound dressing 112 via the downstream drip tube 108b. The drip pump 122 can be operated 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 the controller 118, which will be described in more detail below. According to some embodiments, the drip valve 109 is configured to allow flow only in the direction from the drip fluid tank 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 a user and / or the controller 118 before applying negative pressure to the wound site 114), which drip valve can generally be located along a portion of the downstream drip tube 108b. As will be described in greater detail below, according to various embodiments, a dripper valve 109 may be provided as part of a tubing set module 300 .

[0065] The filter 128 can be positioned between the removal fluid tank 106 and the pneumatic pump 120 (e.g., along the conduit 136) such that air pumped from the removal fluid tank 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 up on the surface of the filter 128. The pneumatic pump 120 can be configured to provide sufficient airflow through the filter 128 such that a pressure drop across the filter 128 is not significant (e.g., such that the pressure drop will not substantially prevent the application of negative pressure from the treatment device 102 to the wound site 114).

[0066] The removal fluid tank 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 tank 106 can be detachable from the treatment device 102 to allow the removal fluid tank 106 to be emptied and replaced as needed. The lower portion of the removal fluid tank 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 tank 106 can be filled with air. The treatment device 102 can be configured to draw a vacuum within the removal fluid tank 106 by pumping air out of the removal fluid tank 106. The reduced pressure within the removal fluid tank 106 can be transferred to the wound dressing 112 and the wound site 114 via the tube 110.

[0067] like Figure 1As shown in FIG, a tube valve 111 is disposed along the tube 110 at a location between the removal fluid tank 106 and the wound site 114, the tube valve being configured to selectively permit and prevent the flow of fluid between the removal fluid tank 106 and the wound site 114. The tube valve 111 can be defined by any number of different structures (e.g., a spring-biased structure, a duckbill structure, a clamping structure, a check valve structure, etc.) configured to selectively control the flow of fluid through the tube 110, and can include a valve configured to be selectively opened and / or closed by a user in response to a sensed stimulus (e.g., 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 the tube set module 300.

[0068] See also Figure 3 , when tube valve 111 is in the open flow configuration, removal fluid tank 106, tube 110 (i.e., both upstream tube portion 110a and downstream tube portion 110b), conduit 136 extending between pneumatic pump 120 and removal fluid tank 106, the portion of downstream drip tube 108b extending between drape layer 117 and drip tube valve 109, and wound site 114 are fluidly connected to define negative pressure circuit 200. See also Figure 3 When tube valve 111 is in the closed, non-flow configuration, removal fluid tank 106, conduit 136, and upstream tube portion 110a of tube 110 extending between removal fluid tank 106 and tube valve 111 define a removal fluid tank circuit 202 that is fluidly isolated from a wound site circuit 204 defined by wound site 114, downstream tube portion 110b of tube 110 extending between tube valve 111, the portion of downstream drip tube 108b extending between drape layer 117 and drip tube valve 109, and wound site 114. As will be discussed in greater detail below, the volume of tube 110, the volume of conduit 136, and the volume of the portion of downstream drip tube 108b extending between drape layer 117 and drip tube valve 109 define known volumes that can be readily subtracted from or otherwise accounted for in volume calculations relative to wound site 114.

[0069] See again Figure 1According to some embodiments, a graduated leak device 113 is additionally positioned along tube 110 at a location upstream of tube valve 111 and downstream of removal of fluid tank 106 and operatively fluidically connected to the tube. The graduated leak device is defined by a vent 113a formed through the outer wall of tube 110, which is selectively closable by a vent valve 113b. Also forming part of graduated leak device 113 may be a flow detector 113c configured to measure airflow through vent 113a. As will be described in more detail below, graduated leak device 113 is configured to selectively control and measure airflow between tube 110 and the ambient environment surrounding treatment device 102. According to various embodiments, graduated leak device 113 can be selectively opened to allow airflow into tube 110 at a known, predetermined rate. As will be described in more detail below, according to various embodiments, graduated leak device 113 may be provided as part of tube set module 300.

[0070] 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 draw a vacuum only on the removal fluid tank circuit 202 portion of the negative pressure circuit 200 (such as, for example, Figure 6E 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 draw a vacuum in the entire negative pressure circuit 200 (such as, for example, Figure 6C When the vent valve 113b is open and the tube valve 111 is closed, airflow from the surroundings of the treatment device 102 can enter through the vent 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 As exemplified). Figure 6D As shown, when both the exhaust valve 113b and the tube valve 111 are open, airflow from the environment surrounding the treatment device 102 can enter through the exhaust hole 113a of the graduated leakage device 113 and fill the vacuum in 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.

[0071] While the disclosed graduated leakage device 113 is positioned in tandem with the portion of the tube 110 extending between the wound site 114 and the removal fluid canister 106, according to some embodiments, such as e.g. Figure 4 As illustrated, the indexed leakage device 113 may also be formed in series with the conduit 136 . Figure 4 The operation of the graduated leakage device 113 of the embodiment is similar to Figure 1 The operation of the illustrated graduated leakage device 113, wherein Figure 4The graduated leakage 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, the invention described herein may be combined with the invention. Figure 1 Any of the methods or systems of the illustrated embodiments of the graduated leakage device 113 may be used as Figure 4 The illustrated embodiment of the graduated leakage device 113 is modified.

[0072] like Figure 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 greater 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, via which, for example, the amount of instillation fluid 105 to be delivered to the wound site 114 can be determined, the healing progress of the wound site 114 can be tracked, etc. According to various embodiments, the controller 118 can be configured such that these processes can be performed with minimal user intervention and / or input.

[0073] According to various embodiments, the therapeutic device 102 can include a variety of sensors. For example, in some embodiments, the therapeutic device 102 can include pressure sensors 115a and / or 115b positioned inline within the upstream tubing portion 110a and / or the downstream tubing portion 110b and configured to measure the pressure at the removal fluid 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 input to various pressure testing 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 tubing set module 300.

[0074] In some embodiments, the therapeutic device 102 includes a user interface 126. The user interface 126 may include one or more buttons, dials, sliders, keys, or other input devices configured to receive input from a user. The user interface 126 may also include one or more display devices (e.g., LEDs, LCD displays, etc.), speakers, tactile feedback devices, or other output devices configured to provide information to the user. The user interface 126 may also display alerts generated by the controller 118. For example, if the removal of the fluid tank 106 is not detected, the controller 118 may generate a "no tank" alert.

[0075] In some embodiments, the therapeutic 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 wired terminal, etc.) for communicating data with an external system or device. In various embodiments, 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 card and a port 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.

[0076] How to use See also Figure 5 , a flow chart showing a method 500 of using the NPWT system 100 according to an exemplary embodiment is shown. Figures 6A to 6G As will be discussed in greater detail, initial setup of the NPWT system 100 and delivery of an initial amount of instillation fluid 105 to the wound site 114 being treated by the NPWT system 100 occurs at step 502 .

[0077] 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 instilling an initial amount of instillation fluid 105 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 wound site 114, the desired course of treatment of the wound site 114, sensed conditions associated with the wound site 114, etc., and may be determined automatically by the controller 118 or may be based on user input.

[0078] 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 below. According to various embodiments (described in greater detail below), at step 506, the controller 118 can be configured to determine the dead space 103 at the wound site 114 prior to delivery of such additional instillation fluid 105, regardless of whether the amount of instillation fluid 105 previously instilled into the wound site 114 is known; whether there is unabsorbed instillation 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 in the removal fluid canister 106, the volume of the removal fluid canister 106 itself, and / or the volume of any contents 107 previously emptied from the removal fluid canister 106 is known; whether the removal fluid canister 106 has been replaced with a different sized removal fluid canister 106 during the NPWT treatment; changes in the shape / size / volume of the wound site 114; and the like.

[0079] At step 508, the amount of additional instillation fluid 105 to be delivered to the wound site 114 is calculated. According to various embodiments, the amount of additional instillation fluid 105 delivered to the wound site 114 can be based on the dead space volume determined at step 506. For example, in some embodiments, the controller 118 can calculate the volume of instillation 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 can be equal to or less than one (i.e., between zero and one) so that the volume of instillation 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 about 0.2 and about 0.8.

[0080] In addition to being used to calculate the volume of the instilled fluid 105, 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, the method 500 may optionally include a 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 described below with reference to Figure 11 Discuss in more detail.

[0081] In some embodiments, it may be desirable to remove the instillation fluid 105 previously instilled into the wound site 114 from the wound site 114 at some time after the instillation fluid 105 is delivered to the wound site 114. Thus, it may be advantageous to confirm, before instilling the instillation fluid 105 into the wound site 114, that the dead space in the removal fluid tank 106 will be sufficient to accommodate the instillation fluid 105 removed from the wound site 114 and / or any additional fluid 121 (e.g., wound exudate) before delivering the additional instillation fluid 105 to the wound site 114. Thus, the method 500 may optionally include a step 512 at which the volume of additional instillation fluid 105 calculated at step 508 is compared to the dead space of the removal fluid tank 106 (e.g., the dead space measured during the determination of the dead space at the wound site 114 at step 506), wherein if the instillation fluid 105 to be delivered exceeds the dead space of the removal fluid tank 106, an alert is issued to the user at step 514. If the instillation fluid 105 to be delivered does not exceed the dead space of the removed fluid tank 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, wherein some or all of steps 504, 506, 508, 510, 512, 514, 516 are repeated any number of additional times during the NPWT treatment.

[0082] See also Figure 6A , shows a flow chart detailing the steps of a method 600 for initial setup of the NPWT system 100 and for delivering an initial amount of instillation fluid 105 to the Figure 5 The wound site 114 required in step 502 of the method 500 is provided. At step 602, the NPWT system 100 (such as, for example, Figure 1 exemplified), wherein the drape layer 117 and wound dressing 112 are positioned at the desired wound site 114 to be treated, such as, for example Figure 6B shown.

[0083] Once the setup of the NPWT system 100 is completed at step 502 , determining the dead space 119 available at the wound site 114 to which the instillation fluid 105 can be delivered can begin at step 604 , where the controller 118 operates the pneumatic pump 120 to establish a first desired negative pressure within the entire negative pressure circuit 200 , such as, for example Figure 6C exemplified.

[0084] In embodiments where the tube valve 111 comprises a normally closed pressure-sensitive valve capable of opening in response to an applied predetermined threshold negative pressure, 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 in order 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 approximately negative 125 mmHg, wherein the controller 118 is configured to apply a first negative pressure equal to or greater than negative 125 mmHg at step 604.

[0085] 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 (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. For example, Figure 6C As illustrated, according to various embodiments, the drip tube valve 109 and the exhaust valve 113b can be configured to be disposed in a closed configuration during application of negative pressure to the negative pressure circuit 200 .

[0086] like Figure 6D As illustrated, at step 606, after a first desired negative pressure is reached within the negative pressure circuit 200 (e.g., as measured by pressure sensor 115a and / or pressure sensor 115b and reported to controller 118), the pneumatic pump 120 is deactivated and the vent valve 113b is opened to allow air from the environment surrounding the therapeutic device 102 to flow through the vent 113a and into the negative pressure circuit 200. According to various embodiments, the opening of the vent valve 113b at step 606 may be manually performed by a user or in response to a command from the controller 118 transmitted to the tubing module 300. In other embodiments, the graduated leak arrangement 113 may be formed without the vent valve 113b (i.e., the vent 113a defines a constant leak within the tubing 110), such that air from the environment surrounding the therapeutic device 102 will flow into the negative pressure circuit 200 without requiring any intervention from the user and / or controller 118.

[0087] As air from the surrounding environment flows into the negative pressure circuit 200, parameters related to the flow of air entering the negative pressure circuit 200 through the vent 113a are monitored (e.g., via the flow detector 113c, the pressure sensor 115a, the pressure sensor 115b, etc.), wherein the measured parameters are then used by the controller 118 to determine the volume of the negative pressure circuit 200 at step 612. According to various embodiments, the parameters related to the flow of air entering the negative pressure circuit 200 may include, for example: the rate of air flow entering the negative pressure circuit 200 (as measured, for example, by the flow detector 113c); the duration required for the pressure within the negative pressure circuit 200 to increase to a predetermined pressure (ambient pressure) after the vent 113a is opened and / or after 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, for example, by the pressure sensor 115a and / or the pressure sensor 115b), etc.

[0088] Once the pressure within the negative pressure circuit 200 increases to the desired pressure and the controller 118 has completed the measurement of the desired parameter, the controller 118 may be configured to operate the pneumatic pump 120 to establish a second desired negative pressure within the removed fluid tank circuit 202 portion of the negative pressure circuit 200 at step 608, such as, for example Figure 6E In embodiments where the tube valve 111 comprises a normally closed pressure-sensitive valve that is capable of opening in response to an applied predetermined threshold negative pressure, 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 in order to ensure that the vacuum applied by the pneumatic pump 120 at step 608 is applied only to the removal fluid 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 negative 125 mmHg, wherein the controller 118 is configured to apply a negative pressure less than negative 125 mmHg, such as, for example, approximately negative 50 mmHg, at step 608.

[0089] Alternatively, in embodiments where the opening / closing of the tube valve 111 is controlled manually or in direct response to a signal from the controller 118, the negative pressure delivered at step 608 may generally include any desired range of negative pressures, wherein step 608 includes verifying by the user and / or the controller that the tube valve 111 is in a closed, no-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 removal fluid tank circuit 202 at step 608 may include a pressure that is equal to or different from the negative pressure applied by the controller 118 to the negative pressure circuit 200 at step 604. For example, Figure 6EAs illustrated, according to various embodiments, drip valve 109 and vent valve 113b can be configured to be placed in a closed configuration (manually or automatically, such as using tubing set module 300 ) during application of negative pressure to removal fluid canister circuit 202 at step 608 .

[0090] like Figure 6F As illustrated, at step 610, after a second desired negative pressure is reached within the removal fluid tank circuit 202 (such as the negative pressure measured by, for example, pressure sensor 115a and / or pressure sensor 115b and reported to controller 118), operation of the pneumatic pump 120 is stopped, and air from the ambient environment surrounding the therapeutic device 102 is allowed to flow through the vent 113a and into the removal fluid tank circuit 202. As air from the ambient environment flows into the removal fluid tank circuit 202, parameters associated with the flow of air through the vent 113a and into the removal fluid tank circuit 202 are monitored, wherein the measured parameters are subsequently used by the controller 118 to calculate the volume of the removal fluid tank circuit 202 at step 612. According to various embodiments, parameters related to the air flow into the removal fluid tank circuit 202 may include, for example: the rate of air flow into the removal fluid tank circuit 202 (as measured, for example, by flow detector 113 c); the duration required for the pressure within the removal fluid tank circuit 202 to increase to a predetermined pressure (e.g., ambient pressure) after the vent 113 a is opened and / or the pump 120 is stopped at step 610; the pressure within the removal fluid tank circuit 202 as the pressure increases from the negative pressure applied at step 608 to the predetermined pressure (as measured, for example, by pressure sensor 115 a and / or pressure sensor 115 b), and the like.

[0091] At step 612, the controller 118 can be configured to determine the volumes of the removed fluid tank 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 can base these volume calculations on stored relationships between various measured parameter values ​​and corresponding volumes. These relationships between the measured parameter measurements and corresponding volumes stored by the controller 118 can include various functions, models, lookup tables, etc., and can be based on existing information input and stored by the controller 118, or based on information obtained and processed by the controller 118 during an optional initial training process performed by the controller 118 before the NPWT system 100 is used to treat the wound site 114 (e.g., before the method 500 is started; as part of the initial setup and initial instillation of the instillation fluid at step 502, etc.). One non-limiting example of an embodiment of a training process that may be used by the controller 118 to generate such a relationship is outlined in related co-pending U.S. provisional application 62 / 650,132, filed on April 17, 2018, entitled “WOUND THERAPY SYSTEM WITH WOUND VOLUME ESTIMATION,” the entire disclosure of which is incorporated herein by reference.

[0092] Using the determined volumes of the removal fluid tank circuit 202 and the negative pressure circuit 200, the controller 118 can determine the volume of the dead space 119 at the wound site 114 (i.e., the portion of the interior 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 instillation fluid 105 / other fluid) by subtracting the volume of the removal fluid tank 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 can also include subtracting or otherwise adjusting the calculated difference between the volume of the removal fluid tank 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 extending between the drape layer 117 and the drip tube valve 109 in determining the volume of the dead space 119 at the wound site 114.

[0093] 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 to be delivered to the wound site 114 may be based on the volume of the dead space 119 calculated by the controller 118 at step 612. For example, in some embodiments, the controller 118 may calculate the initial volume of the instillation fluid 105 to be delivered to the wound site 114 by multiplying the volume of the dead space 119 calculated at step 612 by a fluid drip factor. The fluid drip factor may be equal to or less than one (i.e., between zero and one) so 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 unintended leakage from the wound dressing 112 / drape layer 117. In some embodiments, the fluid drip factor is between approximately 0.2 and approximately 0.8. However, it is contemplated that in various alternative embodiments, the fluid drip factor may have any value.

[0094] As previously described with reference to step 510, in addition to being used to calculate the amount of instillation fluid 105 to be delivered during any treatment phase using the NPWT system 100 and under any number of different conditions (e.g., allowing calculation of additional instillation fluid 105 to be delivered at step 516 even if the removal fluid canister 106 has been emptied or entirely replaced with a different sized removal fluid canister 106 during 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 616, an initial baseline wound site 114 volume estimate may optionally be determined by the controller 118 (via, for example, the method described below with reference to FIG. Figure 11 The estimated value can be used as a reference point, and the volume estimate of the future wound site 114 can be compared with the reference point to track the healing progress of the wound site 114.

[0095] For reference Figure 5For reasons similar to those described above with respect to step 512 of method 500, according to some embodiments, at step 618, the amount of initial instillation fluid 105 to be delivered calculated at step 614 may be compared to the determined dead space 103 of the removed fluid tank 106 to determine whether the dead space within the removed fluid tank 106 will be sufficient to collect any fluid 121 (including unabsorbed instillation fluid 105) from the wound site 114 after the instillation fluid 105 is delivered at step 516. It should be understood that in embodiments where the NPWT system 100 has not been operated prior to its use at step 602, the volume of the removed fluid tank 106 should be empty such that the dead space 103 of the removed fluid tank 106 should be equal to the volume of the removed fluid tank 106. If the volume of the removal fluid tank 106 is unknown at step 602 and / or if removal fluid 107 is present in the removal fluid tank 106, the dead space 103 of the removal fluid container can be calculated by subtracting the known volume of the conduit 136 and the upstream tubing portion 110a from the volume of the removal fluid tank circuit 202 determined at step 614. Similar to step 514, at step 620, an alert can be issued to the user if the initial volume of the instillation fluid 105 to be delivered calculated at step 614 exceeds the dead space 103 of the removal fluid tank 106. Otherwise, if the volume of the initial instillation fluid 105 to be delivered does not exceed the dead space 103 of the removal fluid tank 106, the calculated instillation fluid 105 is delivered to the wound site 114 at step 622, such as, for example. Figure 6F As shown in .

[0096] See also Figure 7 , showing the NPWT system 100 according to one embodiment in determining Figure 5 The method 500 of claim 500 is performed at a time point after instilling the additional instillation fluid 105 into the wound site 114 at step 504, but before determining the wound void space at the wound site at step 506. Figure 7 As shown in , at a time immediately prior to determining the dead space at the wound site 114 at step 506, a certain amount of fluid 121 (e.g., unabsorbed instillation fluid 105 from a previous instillation, wound exudate, etc.) may be present in the space between the drape layer 117 and the wound site 114, wherein the remaining space between the drape layer 117 and the wound site 114 defines an initial dead space 119a. Also as shown in Figure 7, according to some embodiments, at a time immediately prior to the start of step 506, an initial amount of removal fluid 107 may be present in removal fluid tank 106, wherein the remaining volume of removal fluid tank 106 is defined by initial dead space 103a. It should be understood that according to some embodiments, at a time immediately prior to step 506, there may be no fluid at wound site 114 and / or in removal fluid tank 106, in which embodiments, the amount of each of fluid 121 in the wound space and removal fluid 107 in removal fluid tank 106 will be equal to zero.

[0097] As described above, immediately prior to initiation of step 506, a quantity of fluid 121 may be present at the wound site 114. According to some embodiments, Figure 5 In some embodiments of the method 500, it may be undesirable and / or unnecessary to remove fluid 121 in the wound site (e.g., unabsorbed instillation fluid 105 from a previous instillation, wound exudate, etc.) before delivering additional instillation fluid 105 to the wound site 114 at step 516 of the method 500. Thus, in some embodiments of the method 500, the additional instillation fluid 105 instilled into the wound site at step 516 may be delivered to the wound site 114 without regard to any fluid 121 that may be present at the wound site 114.

[0098] See also Figures 8A to 8E , illustrates one embodiment of a method 800 for determining the amount of dead space at a wound site 114, wherein Figure 5 At step 506 of method 500, the method may be used in embodiments where the fluid 121 in the wound site 114 is not removed from the wound site 114 prior to instilling additional instillation fluid 105. Specifically, according to Figures 8A to 8E Since no fluid 121 is expelled from the wound site 114 during the 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 at the wound site that existed immediately prior to initiation of step 506 (i.e., Figure 7 The dead space 119a shown in FIG.

[0099] like Figure 8A As shown in the flowchart in FIG, the method 800 for determining dead space is similar to the method 600 for calculating the dead space 119 after the instillation fluid 105 is initially instilled into the wound site 114 at step 502 (which refers to FIG. Figures 6A to 6G Specifically, similar to steps 604 and 606, Figure 8A The method 800 also includes steps 802 and 804 (e.g., respectively). Figure 8B and Figure 8C), during these steps, negative pressure is applied to and removed from the negative pressure circuit 200. Figure 6A Steps 608 and 610 of method 600, Figure 8A The method 800 also includes steps 806 and 808 (e.g., respectively). Figure 8D and Figure 8E ), during these steps, negative pressure is applied to and removed from the removal fluid tank circuit 202. Figure 6A Method 600, in Figures 8A to 8E In the method 800 , step 802 of applying negative pressure to the negative pressure circuit 200 and then step 804 of removing the negative pressure may be performed before or after step 806 of applying negative pressure to the fluid tank circuit 202 and then step 808 of removing the negative pressure.

[0100] As mentioned above, Figures 8A to 8E The method 800 can be compared with the method described above. Figure 6A The method 600 is performed in substantially the same manner as described above. Figures 6A to 6E As described in the method, according to various embodiments, any range of negative pressure may generally be applied to the negative pressure circuit 200 at step 604 of method 600, but the negative pressure applied to the negative pressure circuit 200 at step 802 of method 800 must be limited to a negative pressure that will not cause the fluid 121 at the wound site 114 to be discharged into the removal fluid tank 106.

[0101] After completing step 808, the controller 118 may be configured to Figure 5 At step 508 of method 500, the volume of the dead space 119a at the wound site 114 is calculated (which corresponds to the maximum volume of additional instillation fluid 105 that can be delivered to the wound site 114). More specifically, at step 508, the volume of the removal fluid tank circuit 202 and the negative pressure circuit 200 is calculated based on the parameters measured at steps 804 and 808 (in a manner similar to that described with reference to FIG. Figures 6A to 6G 6 (as described in step 612 of method 600), the dead space 119a at the wound site 114 can be calculated based on subtracting the measured volume of the removed fluid tank circuit 202 from the measured volume of the negative pressure circuit 200, where Figures 8A to 8EThe volume of the removed fluid tank circuit 202 of method 800 is defined by the following items: the dead space 103a of the removed fluid tank 106, the conduit 136 and the upstream tube portion 110a; and the volume of the negative pressure circuit 200 is defined by the following items: the volume of the removed fluid tank circuit 202 (i.e., the dead space 103a of the removed fluid tank 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 extending between the disinfection cloth layer 117 and the drip tube valve 109.

[0102] According to various embodiments, in embodiments of method 500, where the volume of dead space 119a at wound site 114 is determined at step 508, the volume of dead space 119a at wound site 114 is determined based on the volume of dead space 119a at wound site 114 using a method of Figures 8A to 8E With reference to the measured parameters associated with the removal fluid tank circuit 202 and the negative pressure circuit 200 obtained by method 800, step 508 may also include subtracting or otherwise adjusting the calculated difference between the volume of the removal fluid tank 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 extending between the drape layer 117 and the drip tube valve 109 in determining the volume of the dead space 119a at the wound site 114.

[0103] Although, as described above, in some embodiments of method 500, additional instillation fluid 105 may 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 instillation fluid 105.

[0104] See also Figures 9A to 9E , shows one embodiment of a method 900 for determining the amount of dead space at a wound site 114, where Figure 5 At step 506 of method 500, the method may be used in embodiments where it is desired to remove the fluid 121 in the wound site 114 before instilling additional instillation fluid 105. Specifically, according to Figures 9A to 9E During method 900 (ie, step 506), any fluid 121 (eg, Figure 7 ) is discharged from the wound site 114 so that the final dead space 119b into which the additional instillation fluid 121 will drip will be larger than the initial dead space 119a at the wound site immediately prior to initiation of step 506 by an amount that roughly corresponds to the volume of fluid 121 discharged from the wound site 114 into the removal fluid tank 106 during method 900.

[0105] like Figure 9A As shown in the flowchart in FIG, the method 900 for determining dead space is similar to the method 600 for calculating the dead space 119 after the instillation fluid 105 is initially instilled into the wound site 114 at step 502 (see FIG. Figures 6A to 6G Specifically, similar to steps 604 and 606, Figure 9A The method 900 also includes steps 902 and 904 (e.g., respectively). Figure 9B and Figure 9C ), during these steps, negative pressure is applied to and removed from the negative pressure circuit 200. Figure 6A Steps 608 and 610 of method 600, Figure 9A The method 900 also includes steps 906 and 908 (e.g., respectively). Figure 9D and Figure 9E ), during these steps, negative pressure is applied to and removed from the removal fluid tank circuit 202.

[0106] However, with Figure 6A Unlike the method 600 of FIG. 5 , in this method, the step 604 of applying negative pressure to the negative pressure circuit 200 and the step 608 of subsequently removing the negative pressure may be performed before or after the step 610 of applying negative pressure to the fluid tank circuit 202 and the step 612 of subsequently removing the negative pressure. Figure 9A In the method 900, the step 902 of applying negative pressure to the negative pressure circuit 200 and the step 904 of subsequently removing the negative pressure are performed before the step 906 of applying negative pressure to the fluid tank circuit 202 and the step 908 of subsequently removing the negative pressure. Figures 6A to 6E As described in the method of FIG. 6 , according to various embodiments, any range of negative pressure may generally be applied to the negative pressure circuit 200 at step 604 of the method 600, but in Figure 9A The negative pressure applied to the negative pressure circuit 200 at step 902 of method 900 must be sufficient to cause the fluid 121 to be discharged from the wound site 114 into the removal fluid tank 106.

[0107] After completing step 908, the controller 118 may be configured to Figure 5 At step 508 of method 500, the volume of the final dead space 119b at the wound site 114 is calculated (which corresponds to the maximum volume of additional instillation fluid 105 that can be delivered to the wound site 114). More specifically, at step 508, the volume of the removal fluid tank circuit 202 and the negative pressure circuit 200 is calculated based on the parameters measured at steps 904 and 908 (in a manner similar to that described with reference to FIG. Figures 6A to 6G612 of method 600), a final dead space 119b at the wound site 114 may be calculated based on subtracting the measured volume of the removed fluid tank circuit 202 from the measured volume of the negative pressure circuit 200, where Figures 9A to 9E The volume of the removal fluid tank circuit 202 in the method 800 is defined by the final dead space 103b of the removal fluid tank 106 (wherein, at step 802, the final dead space 103b of the removal fluid tank 106 is substantially equal to the difference between the initial dead space 103a within the removal fluid tank 106 and the volume of the fluid 121 drained from the wound site 114 into the removal fluid tank 106, as e.g., Figure 9B ), conduit 136, and upstream tube portion 110a; and the volume of negative pressure circuit 200 is defined by the volume of the fluid tank circuit 202 removed (i.e., the volume of the final dead space 103b removing the fluid tank 106, conduit 136, and upstream tube portion 110a), downstream tube portion 110b, the final dead space 119b of the wound site 114, and the portion of the downstream drip tube 108b extending between the sterile cloth layer 117 and the drip tube valve 109.

[0108] According to various embodiments, in embodiments of method 500, where the volume of dead space 119 at wound site 114 is determined at step 508, the volume of dead space 119 at wound site 114 is determined based on the volume of dead space 119 at wound site 114 using a method of Figures 9A to 9E With reference to the measured parameters associated with the removal fluid tank circuit 202 and the negative pressure circuit 200 obtained by method 900, step 508 may also include subtracting or otherwise adjusting the calculated difference between the volume of the removal fluid tank 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 extending between the drape layer 117 and the drip tube valve 109 in determining the volume of the dead space 119a at the wound site 114.

[0109] exist Figure 5 In some embodiments of method 500, in which fluid 121 in the wound site 114 is removed prior to instilling additional instillation fluid 105 at step 516, it may be desirable to ensure that the initial dead space 103a in the removal fluid tank 106 is sufficient to hold the fluid 121 that will be discharged from the wound site 114 into the removal fluid tank during step 506, prior to initiating the step of determining the dead space at the wound site at step 506, so as to avoid the risk of overflowing the removal fluid tank 106.

[0110] Thus, in some embodiments of method 500, wherein fluid 121 in the wound site 114 is removed prior to instilling any additional instillation fluid 105 at step 516, the method of step 506 of determining dead space at the wound site 114 (e.g., such as with reference to Figures 9A to 9E ) may include determining whether there is sufficient dead space at the removal fluid tank 106 to hold fluid 121 from the wound site 114 that can be drained into the removal fluid tank 106 as part of a method of determining dead space at the wound site 114.

[0111] 10A to 10C One embodiment of such a method is illustrated, which may be used in step 506 of determining the dead space at the wound site 114 (e.g., via Figures 9A to 9E The risk of spillage from the fluid tank 106 is minimized during the method 900 described above. Figure 10B and Figure 10C ), applying negative pressure to and removing the negative pressure from the removal fluid tank circuit 202 to determine the initial dead space 103a in the removal fluid tank 106 before starting step 506 (e.g., as shown in FIG. Figure 7 Generally speaking, 10A to 10C Steps 1002 and 1004 of method 1000 may be Figures 6A to 6G Steps 608 and 610 of method 600 are performed in a substantially similar manner. At step 1006, the volume of the removed fluid tank circuit 202 is calculated based on the parameters measured at step 1004 (in a manner similar to that of reference 1). Figures 6A to 6G Once the volume of the removal fluid tank circuit 202 is calculated, the known volumes of the conduit 136 and the upstream tubing portion 110 a can be subtracted from the calculated volume of the removal fluid tank circuit 202 to determine the volume of the initial dead space 103 a in the removal fluid tank 106 (i.e., the maximum volume of fluid 121 drained from the wound site 114 that the removal fluid tank 106 can hold).

[0112] Once the volume of the initial dead space 103a is calculated at step 1006, the controller 118 may 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, at step 1008. The volume of the fluid 121 at the wound site 114 may be based on any number of different factors and variables, such as, for example, a stored value of the amount of instilled fluid 105 previously delivered to the wound site 114, a stored value of fluid 121 previously removed from the wound site, elapsed time (e.g., elapsed time since the last instillation, elapsed time since the last removal of the fluid 121, etc.), etc., wherein at step 1008, the controller 118 is further configured to compare this estimated volume of the fluid 121 to 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, alert the user to empty the removal fluid tank 106, at step 1010. If the calculated initial dead space 103a is sufficient to hold the estimated volume of fluid 121 from the wound site 114, then at step 1012, the controller 118 may be configured to, for example, Figures 9A to 9E The method 900 begins with step 506 of determining the void space at the wound site 114 .

[0113] As described above, according to some embodiments of method 500 , it may be advantageous to monitor changes in the volume of wound site 114 at optional step 510 to track the progress of healing of wound site 114 .

[0114] Generally speaking, the volume of the wound site 114 is defined by the entire interior that extends between the wound site 114 and the drape layer 117 attached to the skin 116 around the wound site 114. At various points during treatment using the NPWT system 100, located within and defining the volume of the wound site may be any one or any combination of the wound dressing 112, the fluid 121, and / or the dead space 119. It should be understood that unless the wound dressing 112 is replaced during treatment, the volume of the wound site 114 occupied by the wound dressing 112 will generally remain constant during treatment, while the portion of the volume of the wound site 114 occupied by the fluid 121 and / or the dead space 119 may change over time.

[0115] See also Figure 11 , shows a block diagram illustrating that Figure 5An embodiment of a method 1100 for tracking the healing progress of a wound site 114 as used at step 510 of method 500 is provided. At step 1102, an initial volume of the wound site 114 is estimated and recorded by the controller 118 at a point in time prior to the initial instillation of the instillation fluid 105 into the wound site 114, and this initial volume can be used as a baseline to compare with subsequent volume estimates of the wound site 114 to track the healing progress. According to various embodiments, the estimate of the initial volume of the wound site 114 made at step 1102 can be based on (or as a reference to) Figures 6A to 6G Step 616 of method 600 is performed.

[0116] At step 1104, after estimating the initial volume of the wound site 114 at step 1102, at one or more additional times during treatment (e.g., once daily), an estimated volume of the wound site 114 is determined and recorded, wherein the time at which the volume of such one or more wound sites 114 is estimated and the determined volume value of the wound site 114 are stored as data points within a memory of the treatment device 102 and / or presented to a 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 may be plotted as a function of time.

[0117] At step 1104, additional wound site 114 volume estimates determined at one or more additional times during treatment may be estimated according to any number of different processes. For example, according to some embodiments, the wound site 114 volume estimate recorded at step 1104 may be based on a final void space volume at the wound site 114, such as by reference to, for example, Figure 5 508 of method 500 to calculate, and / or using reference such as Figures 9A to 9E The method 900 is used for calculation.

[0118] like Figure 5 Step 510 and Figure 6A As shown in step 616 of , according to some embodiments, the volume estimation of the wound site 114 at steps 1102 and / or 1104 may be performed in conjunction with a method of delivering the instillation 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 estimation values ​​for the wound site 114 at steps 1102 and / or 1104 may be performed independently of any delivery of the instillation fluid 105 to the wound site 114.

[0119] Because additional wound site 114 volume estimates were obtained at step 1104, the estimated change in wound site 114 volume over time may be used at step 1106 to determine the healing progress of the wound site 114. For example, step 1106 may 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 changes in the wound site 114 volume. In some embodiments, step 1106 may also include determining a rate of wound site 114 healing based on the estimated change in wound site 114 volume over time. In some embodiments, step 1106 may include extrapolating or predicting when 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 may include predicting when 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 the series of additional wound site 114 volume estimates obtained at step 1004 .

[0120] According to some embodiments, instead of or in addition to providing an indexed leak device 113 located upstream of the pipe valve 111, the NPWT system 100 may include an indexed leak device 113 located downstream of the pipe valve 111. Generally speaking, such embodiments in which the indexed leak device 113 is located downstream of the pipe valve 111 may be substantially similar to the embodiments described with reference to FIG. Figures 1 to 11 However, in contrast to the steps of monitoring the pressure decay within the removal fluid tank circuit 202, determining the volume of the removal fluid tank circuit 202 based on the monitored pressure decay, and then using the determined volume of the removal fluid tank circuit 202 to calculate the volume of the wound site 114, in Figure 12 In the method 1200 , the pressure decay is monitored within the wound site circuit 204 , and the determined volume of the wound site circuit 204 is then used to calculate the dead space 103 in the removal fluid tank 106 .

[0121] For example, see Figure 12 , shows a flow chart detailing the steps of a method 1200 for initial setup of an NPWT system 100 and delivery of an initial amount of instillation fluid 105 to a wound site 114, wherein the graduated leak device 113 of the NPWT system 100 is positioned downstream of the tube valve 111, according to one embodiment. In general, Figure 12 Steps 1202, 1204, and 1206 of the embodiment of method 1200 may be compared to those of reference Figure 6A Steps 602, 604, and 606 of method 600 are performed in a substantially similar manner as described above.

[0122] 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 vent valve 113b may be configured to be set to a closed configuration during the application of negative pressure to the negative pressure circuit 200 at step 1208. In embodiments in which a tubing set module 300 controlled by the controller 118 is used, the controller 118 may be configured to instruct the tubing set module 300 to effectuate closure of the priming tube valve 109 and / or the vent valve 113b.

[0123] At step 1210, after a second desired negative pressure is reached within the negative pressure circuit 200 (such as the negative pressure measured by, for example, pressure sensor 115a and / or pressure sensor 115b and reported to the controller 118), the tube valve 111 is closed to define the wound site circuit 204, the pneumatic pump 120 is stopped, and air from the ambient environment surrounding the treatment device 102 is allowed to flow through the vent 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 113a and into the wound site circuit 204 are monitored, with the measured parameters subsequently used by the controller 118 to calculate the volume of the wound site circuit 204 at step 1212. According to various embodiments, parameters related to the flow of air into the wound site circuit 204 may include, for example: the rate of air flow into the wound site circuit 204 (as measured, for example, by 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 exhaust hole 113a is opened and / or the pump 120 is stopped at step 1210; the pressure within the wound site circuit 204 as the pressure increases from the negative pressure applied at step 1208 to the predetermined pressure (as measured, for example, by pressure sensor 115b), and the like.

[0124] At step 1212, the controller 118 can 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 can base the volume calculation of the wound site circuit 204 on stored relationships between various measured parameter values ​​and corresponding volumes. These relationships between measured parameter measurements and corresponding volumes stored by the controller 118 can include various functions, models, lookup tables, etc., and can be based on existing information input and stored by the controller 118, or based on information obtained and processed by the controller 118 during an optional initial training process performed by the controller 118 before the wound site 114 is treated using the NPWT system 100 (e.g., before initiation of the method 500; as part of the initial setup and initial instillation of the instillation fluid at step 502, etc.). One non-limiting example of an embodiment of a training process that may be used by the controller 118 to generate such a relationship is outlined in related co-pending U.S. provisional application 62 / 650,132, filed on April 17, 2018, entitled “WOUND THERAPY SYSTEM WITH WOUND VOLUME ESTIMATION,” the entire disclosure of which is incorporated herein by reference.

[0125] Using the determined volume of the wound site circuit 204, the controller 118 may determine the volume of the dead space 119 (i.e., the portion of the interior 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 instillation fluid 105 / other fluid) at the wound site 114 by subtracting or otherwise adjusting the calculated volume of the wound site circuit 204 to account for / account for the known volume of the downstream tube portion 110b and the portion of the downstream drip tube 108b extending between the drape layer 117 and the drip tube valve 109 in determining the volume of the dead space 119a at the wound site 114.

[0126] 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 to be 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, the controller 118 may calculate the initial volume of the instillation fluid 105 to be delivered to the wound site 114 by multiplying the volume of the dead space 119 calculated at step 1212 by a fluid drip factor. The fluid drip factor may be equal to or less than one (i.e., between zero and one) so 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 unintended leakage from the wound dressing 112 / drape layer 117. In some embodiments, the fluid drip factor is between approximately 0.2 and approximately 0.8. However, it is contemplated that in various alternative embodiments, the fluid drip factor may have any value.

[0127] As previously described with reference to step 510, in addition to being used to calculate the amount of instillation fluid 105 to be delivered during any treatment phase using the NPWT system 100 and under any number of different conditions (e.g., allowing calculation of additional instillation fluid 105 to be delivered at step 516 even if the removal fluid canister 106 has been emptied or entirely replaced with a different sized removal fluid canister 106 during 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 wound site 114 volume estimate may optionally be determined by the controller 118 (via, for example, reference to Figure 11 The estimated value can be used as a reference point, and the volume estimate of the future wound site 114 can be compared with the reference point to track the healing progress of the wound site 114.

[0128] At step 1218, the dead space 103 of the removed fluid tank 106 may be calculated to determine whether the dead space within the removed fluid tank 106 will be sufficient to collect any fluid 121 (including unabsorbed instillation fluid 105) from the wound site 114 after the instillation fluid 105 is delivered at step 516. It should be understood that in embodiments where the NPWT system 100 has not been operated prior to its use at step 1202, the volume of the removed fluid tank 106 should be empty such that the dead space 103 of the removed fluid container 106 should be equal to the volume of the removed fluid tank 106.

[0129] The dead space 103 of the removed fluid container can be calculated by subtracting the known volume of the conduit 136 and the upstream tube portion 110a from the volume of the removed fluid tank circuit 202, which 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 used to determine the volume of the wound site circuit 204 at step 1212.

[0130] Similar to step 514, at step 1220, if the initial volume of the instillation fluid 105 to be delivered calculated at step 1214 exceeds the dead space 103 of the removed fluid tank 106, an alert may be issued to the user. Otherwise, if the volume of the initial instillation fluid 105 to be delivered does not exceed the dead space 103 of the removed fluid tank 106, the calculated instillation fluid 105 is delivered to the wound site 114 at step 1222.

[0131] It should be understood that in some NPWT system 100 embodiments where the graduated leak device 113 is positioned upstream and downstream of the pipe valve 111, the graduated leak device 113 may be positioned upstream and downstream of the pipe valve 111 according to the embodiment of the present invention. Figure 6A The method 600 is the same as or similar to the method Figure 12 The NPWT system 100 may be operated in the same or similar manner as the method 1200 to estimate the volume of the wound site 114 and / or estimate the dead space 103 at which the fluid tank 106 is removed.

[0132] In other embodiments of the NPWT system 100 where both an upstream indexed leak device and a downstream indexed leak device 113 are provided, the Figure 6A The method 600 is the same as or similar to the method and Figure 12 1200 to estimate the volume of the wound site 114 and / or estimate the dead space 103 at the removal of the fluid tank 106. For example, according to some embodiments, a modified method of operating the NPWT system 100 having both an upstream indexed leak device and a downstream indexed leak device 113 may include the following steps: monitoring the pressure decay within the negative pressure circuit 200 (such as, for example, a reference pressure decay). Figure 6A Step 606 of method 600 and / or Figure 12 monitoring the pressure decay within the removal fluid tank circuit 202 (such as, for example, reference to Figure 6A and monitoring the pressure decay within the wound site circuit 204 (such as, for example, reference Figure 12 1200 as described in step 1210 of method 1200).

[0133] In such embodiments, based on direct measurement (e.g., using Figure 12 The method 1200) determines the volume of the wound site 114 can be compared to the volume of the wound site 114 based on indirect measurements (e.g., using Figure 6A 600) and based on direct measurements (e.g., using Figure 6A The method 600) determines that the dead space 103 at which the fluid tank 106 is removed can be compared to the method 600 based on indirect measurements (e.g., using Figure 12 In one embodiment, the controller 118 can be configured to compare the dead space 103 volume calculated by the method 1200 of FIG. 12 to the dead space 103 volume calculated by the method 1200 of FIG. 12 . In such embodiments, the controller 118 can be configured to generate an alarm or alert in response to a discrepancy between the direct and indirect measurements of the volume of the wound site 114 and / or the dead space 103 at the removal of the fluid tank 106. By providing such redundancy to the dead space 103 calculations for the wound site 114 and / or the removal of the fluid tank 106, such embodiments can be configured to allow the NPWT system 100 to provide more accurate and reliable results.

[0134] 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 determine the volume relative to the wound site 114 according to a particular method (e.g., Figures 9A to 9E ), automatically determining the volume of the instillation fluid 105 to be delivered, the controller 118 may also optionally allow the user to: select any of the other modes of calculating the volume relative to the wound site 114 based on whether the user wishes to, for example, remove fluid 121 from the wound site 114 before instilling additional instillation fluid 105; verify whether sufficient dead space 103a in the fluid tank 106 has been removed before determining the dead space at the wound site 114; verify whether sufficient dead space 103b in the fluid tank 106 has been removed before instilling the calculated amount of additional instillation 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.

[0135] Pipe group module Although in some arrangements, some or all of the graduated leak device 113, tube valve 111, and / or drip tube valve 109, or other NPWT system 100 components 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, implementations of systems / methods for determining the volume of instillation fluid to be delivered to a wound site, estimating the volume of a wound, monitoring the healing progress of a wound, and / or other uses of the NPWT system 100 may be fully automated using the controller 118, thereby allowing for easier use of the NPWT system 100.

[0136] By providing the NPWT system 100 with an automated means by which the controller 118 can control or otherwise interact with 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, the tube set module 300 can increase the accuracy of the NPWT system 100. For example, given the controller 118's ability 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 at which data related to instilled fluid volume estimation, wound site volume estimation, wound site 114 healing progress monitoring, and / or other functions of the NPWT system 100 can be collected. By increasing the number of data points used to provide such information, the reliability of the information provided by the controller 118 can thereby be increased. Similarly, avoiding or minimizing user involvement provided by the tube set module 300 can facilitate (and thereby increase) the use of the aforementioned referenced methods. Figure 12 The described possibility of arranging the dual-indexed leakage device 113 thus also increases the reliability of the NPWT system 100 .

[0137] In general, the tubing module 300 includes a housing element 304 that houses a power source 301, a communication interface 302, and one or more actuatable elements 303 configured to be controlled by the controller 118. In some embodiments, the tubing module 300 may also optionally include one or more additional non-actuatable elements 305, such as, for example, a pressure sensor 115a and / or a pressure sensor 115b. According to embodiments in which the graduated leak device 113 is not defined by a vent valve 113b and includes only a non-actuatable vent hole 113a, the non-actuatable element 305 may include such a graduated leak device 113 formed without a vent valve 113b.

[0138] 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 internal actuators operably connected (via wired, wireless, or any other type of connection) to the power source 301 and / or communication interface 302 of the tubing stack module 300, via which 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 communication interface (in addition to the power source 301 and / or communication interface 302 of the tubing stack module). In such embodiments, instructions from the controller 118 may be received directly from the controller via the communication interface of the actuatable elements 303, or may be received indirectly from the communication interface 302 of the tubing stack module 300 via the communication interface of the actuatable elements 303. 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 actuation of one or more actuatable elements 303 in response to instructions received from the controller 118.

[0139] The power source 301 may include any number and combination of energy sources configured to supply sufficient energy to the communication interface 302, the actuatable element 303, and / or the non-actuatable element 305 housed by the housing element 304, as required for the operation of the NPWT system 100. In some embodiments in which some or all of the tubing set module 300 is integrated into the treatment device 102, the power provided by the power source 301 of the housing element 304 may comprise the power source of the treatment device 102.

[0140] The communication interface 302 can include any number and combination of wired and / or wireless connections via which the tubing set module 300 can receive communications (such as, for example, activation signals) from the controller 118. According to some embodiments, the communication interface 302 can also optionally be configured to send and / or receive information (such as, for example, information regarding the status of one or more actuatable elements 303 and / or non-actuatable elements 305 of the tubing set module 300) to and from the controller 118, other tubing set modules 300, the housing element 304, and / or other sources. In some embodiments in which some or all of the tubing set modules 300 are integrated into the therapeutic device 102, the communication interface 302 of the housing element 304 can be defined as part of the communication interface of the therapeutic device 102.

[0141] According to some arrangements, the tube set module 300 may be defined by a single housing element 304, wherein each of the actuatable elements 303 (e.g., upstream and / or downstream indexing leak devices 113, tube valve 111, and / or drip tube valve 109, etc.) and / or non-actuatable elements 305 to be controlled / utilized by the controller 118 forms part of a single, integrated housing element 304. In other embodiments, the tube set module 300 may be defined by a plurality of separate and distinct housing elements 304, wherein each housing element 304 is formed with one or more of the various actuatable elements 303 and / or non-actuatable elements 305 to be controlled / utilized by the controller 118.

[0142] According to various arrangements, the one or more housing elements 304 defining the tubeset module 300 may be provided as a separate, discrete, unitary component of the NPWT system 100, which may then be attached 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 defining the tubeset module 300 may be provided as an integral part of one or more of the other components of the NPWT system 100.

[0143] For example, in some arrangements, some or all of the tubing set module 300 can be integrated into the wound dressing 112, wherein the portion of the tubing set module 300 provided with the wound dressing 112 is configured to be removed from the NPWT system 100 along with the removal of the wound dressing 112. Upon removal of the integrated wound dressing 112 / tubing set module 300, the entire wound dressing 112 / tubing set module 300 can be discarded. Alternatively, the tubing set module 300 can be removed from the wound dressing 112 before the wound dressing 112 is discarded, and the tubing set module can optionally be reused with another wound dressing 112 and / or other NPWT system 100 components.

[0144] In other arrangements, some or all of the tubeset module 300 may be integrated into the removal fluid tank 106, wherein as the removal fluid tank 106 is removed from the NPWT system 100, the portion of the tubeset module 300 provided with the removal fluid tank 106 is removed from the NPWT system 100. In some such embodiments, the tubeset module 300 may be integrally formed with the removal fluid tank 106, while in other embodiments, the tubeset module 300 may be non-integrally formed with the removal fluid tank 106.

[0145] According to another arrangement, the tube set module 300 can be configured to be integrated in-line with one or both of the tubes 108 and / or 110. In such an embodiment, an attachment adapter 400 can be provided on the tube set module 300 and / or one or both of the tubes 108 and / or 110 to facilitate a fluid-tight attachment of the tube set module 300 to the tubes 108 and / or 110. According to some embodiments, the attachment adapter 400 can be provided on the tube set module 300, wherein the attachment adapter 400 is configured to enable direct fluid-tight attachment to one or both of the tubes 108 and / or 110, thereby allowing the formation of an NPWT system without the tube set module 300 and / or the graduated leak device 113, the tube valve 111 and / or the drip tube valve 109 being added with the tube set module 300 to provide the NPWT system 100 as disclosed herein.

[0146] 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 graduated leak device 113, the tube valve 111, and / or the drip tube valve 109, into the housing of the treatment device 102, the time to set up the NPWT system 100 may be reduced compared to the time that would otherwise be required to set up an NPWT system 100 in which some or all of the graduated leak device 113, the tube valve 111, and / or the drip tube 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 tubing, removal fluid canister, wound dressing, or other components provided to define the NPWT system 100 for treating the wound site 114.

[0147] See also Figures 13 to 16B , various embodiments of a tubing set module 300 configured to allow for partially or fully automated control of the NPWT system 100 using a controller 118 are shown. It should be understood that, while reference has been made to the controller 118 being 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 remote healthcare 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 via a communication interface provided by the treatment device 102.

[0148] like Figure 13As illustrated in the embodiment of the NPWT system 100 of FIG. 1 , in some arrangements, the tube set module 300 is provided as a single integrated housing element 304 that houses an actuatable element 303 including the graduated leak device 113, the tube valve 111, and the optional irrigation tube valve 109. According to some embodiments, one or both of the tube valve 111 and the optional irrigation tube valve 109 may include the same or different clamps. Figure 13 As shown in FIG, the housing element 304 also houses a power source 301 that is configured to actuate the actuatable element 303 in response to instructions received from the controller 118 via the communication interface 302 .

[0149] Despite Figure 13 In the illustrated embodiment, a single integrated tube set module 300 is shown in series with both tube 108 and tube 110, but according to other arrangements (not shown), it will be understood that a first housing element 304 including the graduated leak device 113 and the tube valve 111 can be provided in series with tube 110, while an optional second housing element 304 including the drip tube valve 109 can be provided in series with tube 110.

[0150] like Figure 13 As illustrated in the NPWT system 100 of FIG. 1 , in some embodiments, the tubing module 300 may be integrally formed with the upstream tubing portion 110a and / or the upstream irrigation tube 108a. According to some such embodiments, the upstream tubing portion 110a and / or the upstream irrigation tube 108a integrally formed with the tubing module 300 may in turn be integrally formed with the treatment device 102. In such embodiments, the tubing module 300 is configured to be removably attached to the downstream tubing portion 110b and / or the downstream drip tube 108b integrally formed with the wound dressing 112, such that after use of the NPWT system 100 with a first wound dressing 112, the treatment device 102 with the integrated upstream tubing portion 110a and / or the upstream irrigation tube 108a and tubing module 300 may be reused with a new, second wound dressing 112. In other embodiments, such as, for example, a tubing module 300 may be integrally formed with the treatment device 102. Figure 14 As illustrated in the NPWT system 100 of FIG. 1 , some or all of the tube set modules 300 may alternatively be integrally formed with the wound dressing 112 , wherein the tube set modules 300 are configured to be removed from the NPWT system 100 as the wound dressing 112 is removed.

[0151] See also Figure 15 In the NPWT system 100, according to some embodiments, the tube set module 300 may include a first housing element 304 that houses the graduated leakage device 113 and optionally the irrigation tube valve 109, the pressure sensor 115a and / or the pressure sensor 119 positioned in series with the tubes 108 and / or 110. The second housing element 304 including the tube valve 111 may be spaced apart from the first housing element 304. Figure 14 , according to some arrangements, the second housing element 304 can be integrated into the removal fluid canister 106. In other embodiments, the second housing element 304 can alternatively be incorporated into the treatment device 102, or can be disposed at a second location inline with the tube 110.

[0152] See also Figure 16A , shows a block diagram of a NPWT system 100 according to one embodiment. Figure 16A As exemplified by the NPWT system 100 of FIG. 1 , according to some embodiments, fluid communication between some or all of the negative pressure circuit 200 and the ambient environment can be provided by a purge valve system 450 provided along the irrigation tube 108, either as an alternative to or in addition to the graduated leak device 113. According to various embodiments, the purge valve system 450 can include a structure similar to the graduated leak device 113 (including embodiments of the graduated leak device 113 that include any combination of vent 113a, vent valve 113b, and / or flow detector 113c components).

[0153] Also like Figure 16A As illustrated, in such an embodiment of the NPWT system 100, the tube valve 111 and / or the drip tube valve 109 can 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 attached to the drip tube assembly at the junction between the upstream tube 108a and the downstream tube 108b, and the valve assembly can be actuated to multiple positions. In a first position, the valve assembly 460 can 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 can permit fluid to flow from the pneumatic pump 120 via the tube 110 to the wound site 114, while blocking fluid flow from the drip pump 104 via the drip tube 108 to the wound site 114. In a third position, the valve assembly 460 can 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 can fluidly connect the upstream tube portion 110a with 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 therapeutic device 102.

[0154] When in the first configuration, valve assembly 460 defines a negative pressure circuit 200 defined by tube 136, fluid tank 106, tube 110, wound site 114, and the portion of the irrigation tube extending between wound site 114 and the deflation valve 450. When in the fourth configuration, valve assembly 460 defines a removal fluid tank circuit 202 defined by tube 136, fluid tank 106, upstream tube portion 110a, and the portion of upstream tube 108a extending between valve assembly 460 and deflation valve 450, and a wound site circuit 204 defined by downstream tube portion 110b, wound site 114, and downstream tube 108b.

[0155] It should be understood that Figure 16A The valve assembly 460 and the purge valve 450 of the NPWT system 100 can be operated in a manner similar to the operation of the tube valve 111, graduated leakage device and / or drip tube valve 109 as described in any of the methods described herein to determine wound site volume, estimate the volume of fluid to be instilled, monitor wound healing progress, or perform any other function using the NPWT system 100.

[0156] See also Figure 16B , according to one embodiment, is shown configured for use in conjunction with a purge valve 450 (such as, for example Figure 16A The tube set module 300 is used in conjunction with the NPWT system 100 shown in FIG. Figure 16B In the illustrated embodiment in which the purge valve 450 is provided as a discrete component of the therapeutic device 112 that is capable of being automatically actuated by the controller 118, the tube set module 300 may 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, where the purge valve 450 provided as part of the therapeutic device is not capable of being automatically actuated by the controller 118), the purge valve 450 may be provided as part of the tube set module 300 that is partially or fully integrated into the therapeutic device 112.

[0157] Although Figure 16A In the illustrated embodiment of the NPWT system 100, the purge valve 450 is illustrated as being provided as part of the treatment device 112, but according to other embodiments, the purge valve 450 may alternatively or additionally be provided as part of the upstream tube 108a. In such embodiments, the purge valve 450 may thus be provided as the actuatable element 303 of the tube set module 300.

[0158] It should be understood that the controller 118 can be configured to implement any number of different operations using the NPWT system 100 based on the selective, fully automated actuation / interaction of some or all of the actuatable elements 303 and / or non-actuatable elements 305 of the tubeset module 300 according to any number of different methods and protocols. According to various embodiments, the sequence and / or combination of instructions transmitted by the controller 118 to the tubeset module 300 and / or the information received by the controller 118 from the tubeset module 300 can be configured to automatically operate the tubeset module 300 in a manner that allows the controller 118 to automatically implement one or more of the methods 500, 600, 800, 900, 1000, 1100, 1200, etc.

[0159] Figure 17 17 is a method 1700 by which a controller 118 can utilize a tubing module 300 containing actuatable elements 303 including tubing valve 111, priming tubing valve 109, and graduated leak device 113 and non-actuatable elements 305 including one or both of pressure sensor 115a and / or pressure sensor 115b to determine a desired flow rate based on, for example, a reference flowmeter. Figure 5 Method 500 and Figure 6A The method 600 described herein automatically controls the NPWT system 100 to determine the dead space 119 at the wound site 114 .

[0160] 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 Figure 5 At step 506 of method 500 , controller 118 may initiate communication with tubing set module 300 to confirm that the irrigation tubing valve 109 and the exhaust valve 113 b of the graduated leak device 113 are closed and tubing valve 111 is open. If the irrigation tubing valve 109 and / or the exhaust valve 113 b are open, controller 118 may instruct tubing set module 300 to actuate the irrigation tubing valve 109 and / or the exhaust valve 113 b to a closed configuration. Similarly, if tubing valve 111 is detected as closed by controller 118 , controller 118 may transmit a command to tubing valve 111 via communication interface 302 to actuate the opening of tubing valve 111.

[0161] Once the controller 118 receives confirmation via the communication interface 302 that the irrigation tube valve 109 and the exhaust valve 113b are closed and the tube valve 111 is open, the controller 118 can be configured to initiate operation of the pneumatic pump 120 to apply negative pressure to the negative pressure circuit 200 (such as, for example, reference Figure 6ADuring 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 received continuously, at predetermined intervals, and / or in response to a specific request for pressure readings transmitted by the controller 118 to the tubing set module 300 via the communication interface 302.

[0162] In response to receiving a pressure reading from the tubing 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 operation of the pneumatic pump 120 and transmit an actuation signal to the tubing module 300 configured to cause the exhaust valve 113b to open.

[0163] At step 1707, the controller 118 may be configured to receive a pressure reading corresponding to a pressure decay within the negative pressure circuit 200 from the pressure sensor 115a and / or the pressure sensor 115b, such as, for example, a reference pressure reading. Figure 6A The pressure readings received by the controller 118 at step 1707 may be received continuously at predetermined intervals or in response to a specific request for pressure readings transmitted by the controller 118 to the tube stack module 300 via the communication interface 302 .

[0164] Once the controller 118 receives a pressure reading from the tubing 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 can be configured to actuate the closure of the tubing valve 111 and the vent valve 113b using the tubing module 300, and then apply negative pressure (such as, for example, at 1709) to the resulting removal fluid tank circuit 202. Figure 6A during step 608 of method 600 ).

[0165] At step 1711, the controller 118 may again be configured to receive a pressure reading from the lineset module 300. The pressure readings received by the controller 118 at step 1711 may be received continuously at predetermined intervals or in response to a specific request for a pressure reading transmitted by the controller 118 to the lineset module 300 via the communication interface 302. In response to receiving a pressure reading from the lineset module 300 indicating that the pressure within the removal fluid tank circuit 202 has reached a threshold pressure, at step 1713, the controller 118 may be configured to stop operation of the pneumatic pump 120 and transmit an actuation signal to the lineset module 300 configured to cause the vent valve 113b to open.

[0166] 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 removal fluid tank circuit 202, such as, for example, a reference pressure reading. Figure 6A The pressure readings received by the controller 118 at step 1715 may be received continuously at predetermined intervals or in response to a specific request for pressure readings transmitted by the controller 118 to the tube stack module 300 via the communication interface 302 .

[0167] According to some embodiments, after step 1715, at step 1717, the controller 118 can be configured to actuate the opening of the drip tube valve 109 using the tubing set module 300, and then instill the instillation fluid into the wound site 114 (such as, for example, with reference to FIG. Figure 5 Step 516 of method 500 and / or Figure 6A 622 of method 600).

[0168] Configuration of the exemplary embodiment The construction and arrangement of the systems and methods shown in the various exemplary embodiments are merely illustrative. Although only a few embodiments are described in detail in this disclosure, many modifications are possible (e.g., changes in the size, dimensions, structure, shape, and proportion of the various elements, parameter values, mounting arrangements, use of materials, colors, orientations, etc.). For example, the position of the elements may be reversed or otherwise changed, and the nature, quantity, or position of the discrete elements may be altered or changed. Therefore, 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 changed or reordered according to alternative embodiments. Without departing from the scope of this disclosure, other replacements, modifications, changes, and omissions may be made to the design, operating conditions, and arrangement of the exemplary embodiments.

[0169] The present disclosure contemplates methods, systems, and program products on any machine-readable medium for implementing various operations. The embodiments of the present disclosure can be implemented using existing computer processors, or by a dedicated computer processor of an appropriate system incorporated for this purpose or another purpose, or by a hard-wired system. Embodiments within the scope of the present disclosure include program products that include a machine-readable medium for carrying or having machine-executable instructions or data structures stored thereon. Such machine-readable media 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 media can include RAM, ROM, EPROM, EEPROM, CD-ROM or other optical disk storage devices, magnetic disk storage devices 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 can be accessed by a general-purpose or special-purpose computer or other machine with a processor. The above combinations 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, a special-purpose computer, or a special-purpose processing machine to perform a specific function or group of functions.

[0170] Although the accompanying drawings show a specific order of method steps, the order of steps may vary from that depicted. Furthermore, 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 preferences. All such variations are within the scope of this disclosure. Similarly, software implementations may be implemented using standard programming techniques with rule-based logic and other logic to implement the various connection steps, processing steps, comparison steps, and decision steps.

Claims

1. A tubing assembly for a wound treatment system, the tubing assembly comprising: A tubing module configured to be operably connected to a fluid tank and fluid tubing of the wound treatment system, the tubing module comprising: - a housing having a body extending between a first outlet formed on a first end of the housing and a second outlet formed on a second end of the housing; - a communication interface configured to allow information to be received wirelessly by the tube stack module; and - a valve defining a first configuration in which the first outlet and the second outlet are in fluid communication with each other and a second configuration in which fluid communication between the first outlet and the second outlet is blocked; and - Power supply; and a controller configured to transmit a first instruction and a second instruction to the pipe group module via the communication interface; wherein, in response to receiving the first instruction from the controller, the valve is configured to actuate to the first configuration; and wherein, in response to receiving the second command from the controller, the valve is configured to actuate to the second configuration.

2. The tube set assembly of claim 1 , further comprising 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, wherein the first tube adapter and the second tube adapter are configured to provide a fluid-tight attachment to the fluid tube of the wound therapy device.

3. The tubeset assembly of claim 1 , wherein the tubeset module further comprises a graduated weep providing fluid communication between at least one of the first end of the housing and the second end of the housing and ambient atmosphere through an opening extending through the body of the housing.

4. The tube set assembly of claim 1, wherein the tube set module further comprises a third outlet disposed on the first end of the housing and a fourth outlet disposed on the second end of the housing.

5. The tube set assembly of claim 4, further comprising an adapter attached to each of the first outlet, the second outlet, the third outlet, and the fourth outlet of the housing, the adapter being configured to provide a fluid-tight attachment to a fluid tube of a wound therapy device.

6. The tube set assembly of claim 4, wherein in the first configuration, the third outlet and the fourth outlet are in fluid communication.

7. The tube set assembly of claim 6, wherein in the first 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.

8. The tube set assembly of claim 6, wherein in a second valve configuration, fluid communication is provided between the first outlet and the third outlet.

9. The tube set assembly of claim 8, wherein in the second valve configuration, fluid communication between the first outlet and the fourth outlet is blocked.

10. The tube set assembly of claim 8, wherein in the second valve configuration, fluid communication between the third outlet and the fourth outlet is blocked.

11. The tube set assembly of claim 1 , wherein the valve comprises a rotatable valve.

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