Fluid removal management and control for wound closure in wound treatment

Abstract

To provide a method and a device for covering a wound and providing a treatment to the wound.SOLUTION: Embodiments of a negative pressure wound therapy system and a method for operating the system are disclosed. In one embodiment, a negative pressure wound therapy apparatus can include a wound dressing, a negative pressure source, and a controller. The negative pressure source can provide negative pressure to the wound dressing via a fluid flow path. The controller can monitor a rate of fluid removal from the wound, wirelessly communicate the rate of fluid removal to a remote device, and output an indication when the rate of fluid removal meets a threshold.SELECTED DRAWING: Figure 4A

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Application No. 62 / 519,787, filed on June 14, 2017, and U.S. Provisional Application No. 62 / 519,781, filed on June 14, 2017, the disclosures of both of which are hereby incorporated by reference in their entireties.

Background Art

[0002] Embodiments of the present disclosure relate to methods and devices for covering a wound and providing treatment to the wound. Specifically, but not limited to, the embodiments disclosed herein relate to a negative pressure therapy device, a method for controlling the operation of a topical negative pressure (TNP) system, and a method of using a TNP system.

Summary of the Invention

[0003] In some embodiments, a wound therapy device is disclosed. The wound therapy device includes a wound dressing that includes a stabilization structure configured to be inserted into a wound, a negative pressure source configured to provide negative pressure to the wound dressing via a fluid flow path, and a controller. The controller is configured to monitor the amount of fluid removed from the wound, wirelessly communicate the amount of fluid removed to a remote device, and output a display when the amount of fluid removed meets a threshold.

[0004] The wound therapy device described in the above paragraph may include one or more of the following features. The controller is further configured to adjust the negative pressure level supplied by the negative pressure source to the wound dressing when the fluid removal amount meets a threshold. The controller is further configured to monitor the fluid removal amount from the weight of the fluid aspirated from the wound. The controller is further configured to monitor the weight of the fluid aspirated from the wound and the weight of the fluid stored in the canister. The wound therapy device can further include a pressure sensor configured to monitor one or more characteristics of the pressure in the fluid flow path, and the controller is further configured to monitor the fluid removal amount using one or more characteristics of the pressure. The wound therapy device can further include a canister configured to store the fluid removed from the wound, and the controller is further configured to monitor the fluid removal amount from the fluid level in the canister. The controller is further configured to monitor the fluid level in the canister using one or more characteristics of the pressure in the fluid flow path. The controller is further configured to monitor the fluid level in the canister from the operating level of the negative pressure source. The negative pressure source includes a vacuum pump, and the operating level of the negative pressure source corresponds to the speed of the vacuum pump. One or more characteristics of the pressure include the magnitude of the pressure signal, and the magnitude of the pressure signal increases as the fluid level in the canister increases. The controller is further configured to wirelessly communicate the fluid removal amount to a remote device and cause the remote device to store the fluid removal amount in an electronic medical record associated with the patient.

[0005] In some embodiments, a method of operating a negative pressure wound therapy device comprising a controller and a negative pressure source is disclosed. The negative pressure source applies a negative pressure to a wound dressing via a fluid flow path, and the wound dressing comprises a stabilization structure inserted into the wound. The method includes monitoring the fluid removal amount from the wound, wirelessly communicating the fluid removal amount to a remote device, and outputting a display when the fluid removal amount meets a threshold. The method is implemented by the controller.

[0006] The method described in the above paragraph may include one or more of the following features. The method further includes adjusting the negative pressure level applied to the wound dressing by the negative pressure source when the fluid removal amount meets a threshold. Monitoring the fluid removal amount includes monitoring the fluid removal amount from the weight of the fluid aspirated from the wound. Monitoring the fluid removal amount includes monitoring the weight of the fluid absorbed from the wound and the weight of the fluid absorbed by the wound dressing or stored in the canister. The method further includes monitoring one or more characteristics of the pressure in the fluid flow path, and monitoring the fluid removal amount includes monitoring the fluid removal amount using one or more characteristics of the pressure. Monitoring the fluid removal amount includes monitoring the fluid removal amount from the fluid level in the canister that stores the fluid removed from the wound. Monitoring the fluid removal amount includes monitoring the fluid level in the canister using one or more characteristics of the pressure in the fluid flow path. Monitoring the fluid removal amount includes monitoring the fluid level in the canister from the operating level of the negative pressure source. The negative pressure source includes a vacuum pump, and the operating level of the negative pressure source corresponds to the speed of the vacuum pump. One or more characteristics of the pressure include the magnitude of the pressure signal, and the magnitude of the pressure signal increases as the fluid level in the canister increases. Wirelessly communicating the fluid removal amount includes wirelessly communicating the fluid removal amount to a remote device and causing the remote device to record the fluid removal amount in the electronic medical record associated with the patient.

[0007] In some embodiments, a wound therapy device is disclosed. The wound therapy device is a negative pressure source configured to apply negative pressure to a wound dressing having a stabilization structure via a fluid flow path, the stabilization structure being inserted into the wound and configured to fold when negative pressure is applied to the wound when the stabilization structure is positioned within the wound, a sensor configured to detect the pressure in the fluid flow path, and a controller. The controller is configured to determine a folding measurement amount of the stabilization structure from the pressure in the fluid flow path and output a display corresponding to the folding measurement amount while the negative pressure source maintains the magnitude of the pressure in the fluid flow path within a negative pressure range.

[0008] The wound treatment device described in the above paragraph may include one or more of the following features. The controller is configured to determine a folding measurement amount from a change in the magnitude of the pressure in the fluid flow path over time. The controller is further configured to determine the folding measurement amount by comparing the magnitude of the pressure in the fluid flow path over time with a pressure change pattern. The pressure change pattern indicates one or more of (i) the magnitude of the pressure in the fluid flow path when the stabilization structure is fully folded, (ii) the magnitude of the pressure in the fluid flow path when the stabilization structure is partially folded, or (iii) the magnitude of the pressure in the fluid flow path when the stabilization structure is not folded. The folding measurement amount includes the amount of folding of the stabilization structure. The controller is further configured to detect rupture or damage of the suture when the suture is close to the wound dressing, and the controller is configured to (i) activate or deactivate the negative pressure source, (ii) activate or deactivate an alarm, (iii) increase or decrease the target negative pressure provided by the negative pressure source, or (iv) output a display for releasing the negative pressure source in the fluid flow path. The controller is configured to output a display for controlling the activation and deactivation of the negative pressure source to adjust the magnitude of the pressure in the fluid flow path according to a target level of folding of the stabilization structure for a certain period of time, rather than aiming for a predetermined negative pressure threshold. The time is at least 1 minute, 5 minutes, 10 minutes, 30 minutes, 1 hour, or 5 hours. The controller is configured to output a display for presentation to the user or for storage in a memory device. The controller is further configured to store device usage data associated with the display in the memory device, and the device usage data includes one or more of a pressure level, an alarm, an exudate level, an event log, and an operating time. The controller is further configured to determine whether the wound dressing includes a stabilization structure from the pressure in the fluid flow path. The sensor is configured to detect the pressure in the fluid flow path in the wound dressing, in one or more lumens of the fluid flow path, or at the inlet of the negative pressure source. The negative pressure source is configured to perform negative pressure therapy when the magnitude of the pressure in the fluid flow path is maintained within a negative pressure range.

[0009] In some embodiments, a method of operating a wound therapy device comprising a controller and a negative pressure source is disclosed. The negative pressure source is configured to apply a negative pressure to a wound dressing via a fluid flow path, the wound dressing includes a stabilization structure, the stabilization structure is configured such that the wound dressing is inserted into the wound, and the stabilization structure is configured to further fold when the negative pressure is applied to the wound when the stabilization structure is positioned within the wound. The method includes monitoring a pressure within the fluid flow path, determining a measure of folding of the stabilization structure from the pressure within the fluid flow path while the negative pressure source maintains the magnitude of the pressure within the fluid flow path within a negative pressure range, and outputting a display corresponding to the measure of folding. The method is implemented by a controller.

[0010] The method described in the above paragraph may include one or more of the following features. Determining the folding measurement includes determining the folding measurement from a change in the magnitude of the pressure in the fluid flow path over time. Determining the folding measurement includes determining the folding measurement by comparing the magnitude of the pressure in the fluid flow path over time with a pressure change pattern. The pressure change pattern indicates one or more of (i) the magnitude of the pressure in the fluid flow path when the stabilization structure is fully folded, (ii) the magnitude of the pressure in the fluid flow path when the stabilization structure is partially folded, or (iii) the magnitude of the pressure in the fluid flow path when the stabilization structure is not folded. The folding measurement includes the amount of folding of the stabilization structure. Outputting the display includes outputting a display for (i) activating or deactivating a negative pressure source, (ii) activating or deactivating an alarm, (iii) increasing or decreasing the target negative pressure provided by the negative pressure source, or (iv) releasing the negative pressure source in the fluid flow path. Outputting the display includes outputting a display for controlling the activation and deactivation of the negative pressure source to adjust the magnitude of the pressure and aim for a predetermined negative pressure threshold, but rather for controlling the activation and deactivation of the negative pressure source for a certain period of time according to a target level of folding of the stabilization structure. The time is at least 1 minute, 5 minutes, 10 minutes, 30 minutes, 1 hour, or 5 hours. Outputting the display includes outputting a display for presentation to the user or for storage in a memory device. The method further includes storing device usage data associated with the display in a memory device, and the device usage data includes one or more of a pressure level, an alarm, an exudate level, an event log, and an operating usage time. The method may further include determining whether the wound dressing includes a stabilization structure from the pressure in the fluid flow path. Monitoring the pressure in the fluid flow path includes monitoring the pressure in the fluid flow path in the wound dressing, in one or more lumens of the fluid flow path, or at the inlet of the negative pressure source. The negative pressure source is configured to perform negative pressure therapy when the magnitude of the pressure in the fluid flow path is maintained within a negative pressure range.

Brief Description of the Drawings

[0011] The features and advantages of the present disclosure will become apparent from the following detailed description taken in conjunction with the accompanying drawings.

[0012]

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DETAILED DESCRIPTION OF THE INVENTION

[0013] First The present disclosure relates to methods and devices for covering and treating wounds using, for example, negative pressure therapy or topical negative pressure (TNP) therapy, and positive pressure wound therapy or wound therapy not assisted by applied pressure. Specifically, but not limited to, embodiments of the present disclosure relate to negative pressure therapy devices, methods for controlling the operation of a TNP system, and methods of using a TNP system. The methods and devices can incorporate or implement any combination of the features described below.

[0014] Devices and components that overlay and pack a wound, if any, may be collectively referred to herein as a wound dressing.

[0015] Throughout this specification, it will be understood that reference is made to wounds. The term "wound" is broadly construed and includes open and closed wounds where the skin is lacerated, incised, or punctured, or bruised by trauma, or any other surface or other condition or defect in the patient's skin, or any other that may benefit from negative pressure therapy. Thus, a wound is broadly defined as any damaged area of tissue, which may or may not produce fluid. Examples of such wounds include, but are not limited to, abdominal wounds, or other large or incisional wounds as a result of any of surgery, trauma, sternotomy, fasciotomy, or other conditions, dehisced wounds, acute wounds, chronic wounds, subacute wounds and dehisced wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, electrical burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, traumatic ulcers, and venous ulcers.

[0016] When used in this section or elsewhere in this specification, a reduced pressure or negative pressure level such as -X mmHg typically represents a pressure level lower than the atmospheric pressure corresponding to 760 mmHg (or 1 atmosphere, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Thus, a negative pressure value of -X mmHg represents a pressure that is X mmHg lower than the atmospheric pressure, such as (760 - X) mmHg. Further, a negative pressure that is "lower" or "smaller" than -X mmHg corresponds to a pressure closer to the atmospheric pressure (e.g., -40 mmHg is lower than -60 mmHg). A negative pressure that is "higher" or "greater" than -X mmHg corresponds to a pressure further from the atmospheric pressure (e.g., -80 mmHg is higher than -60 mmHg).

[0017] The negative pressure range for some embodiments of the present disclosure can be between about -80 mmHg, or about -10 mmHg to -200 mmHg. It should be noted that these pressures are relative to normal ambient atmospheric pressure. Thus, -200 mmHg would be approximately 560 mmHg in actuality. In some embodiments, the pressure range can be between about -40 mmHg and -150 mmHg. Alternatively, pressure ranges of -75 mmHg or less, -80 mmHg or less, or greater than -80 mmHg can be used. Also, in other embodiments, a pressure range below -75 mmHg can be used. As an alternative, a pressure range of approximately -100 mmHg or even above -150 mmHg can be supplied by the negative pressure device. In some embodiments, the negative pressure range can be as small as about -20 mmHg or about -25 mmHg, which can be useful for reducing fistulas. In some embodiments of the wound closure device described herein, an increase in wound contraction can lead to an increase in tissue expansion in the surrounding wound tissue. This effect may, in some cases, be increased by changing the force applied to the tissue in conjunction with an increase in the tensile force applied to the wound by an embodiment of the wound closure device, for example, by changing the negative pressure applied to the wound over time. In some embodiments, the negative pressure can be changed over time, for example, using a sine wave, a square wave, or in synchronization with one or more physiological indicators of the patient (e.g., heart rate).

[0018] Examples of such applications, where further disclosure regarding the foregoing description can be found, include U.S. Patent No. 8,235,955, titled "Wound treatment apparatus and method," issued on August 7, 2012, and U.S. Patent No. 7,753,894, titled "Wound cleansing apparatus with stress," issued on July 13, 2010. Both applications are hereby incorporated by reference in their entirety. Other applications that may include teachings relevant to the combination with the embodiments described in this section or elsewhere in this specification include Application No. 12 / 886,088, titled "Systems And Methods For Using Negative Pressure Wound Therapy To Manage Open Abdominal Wounds," filed on September 20, 2010, published as U.S. Patent Application Publication No. 2011 / 0213287; Application No. 13 / 092,042, titled "Wound Dressing And Method Of Use," filed on April 21, 2011, published as U.S. Patent Application Publication No. 2011 / 0282309; and Application No. 13 / 365,615, titled "Negative Pressure Wound Closure Device," filed on February 3, 2012, published as U.S. Patent Application Publication No. 2012 / 0209227, each of which is hereby incorporated by reference in its entirety.Additional applications that may contain teachings related to the combination use with the embodiments described in this specification include the patent application number 13 / 942,493, filed on July 15, 2013, titled "Negative Pressure Wound Closure Device", published as US Patent No. 2014 / 0180225; the PCT application number PCT / US2013 / 050619, filed on July 16, 2013, titled "Negative Pressure Wound Closure Device", published as International Patent No. 2014 / 014871A1; the PCT application number PCT / US2013 / 050698, filed on July 16, 2013, titled "Negative Pressure Wound Closure Device", published as International Patent No. 2014 / 014922A1; the PCT application number PCT / IB2013 / 01555, filed on May 5, 2013, titled "Devices and Methods for Treating and Closing Wounds with Negative Pressure", published as International Patent No. 2013 / 175309A1; the PCT application number PCT / US2014 / 025059, filed on March 12, 2014, titled "Negative Pressure Wound Closure Device and Systems and Methods of Use in Treating Wounds with Negative Pressure", published as International Patent No. 2014 / 165275A1; the PCT application number PCT / GB2014 / 050746, filed on March 13, 2014, titled "Compressible Wound Fillers and Systems and Methods of Use In Treating Wounds With Negative Pressure", published as International Patent No. 2014 / 140578A1; and the "Negative Pressure Wound Closure Device" filed on October 21, 2014, published as PCT Application Publication No. PCT / US2014 / 061627.The entire foregoing application is hereby incorporated by reference into this specification and should be considered a part of this specification.

[0019] Throughout this specification, it will be understood that in some embodiments, reference is made to elongated, elongated-shaped, or longitudinally-extended strips. These terms are to be construed broadly and in some embodiments refer to an elongated material having two parallel or substantially parallel surfaces, and in cross-section, the thickness of the material measured perpendicular to the surfaces is understood to be relatively small compared to the height of the material measured parallel to the surfaces. In some embodiments, a strip may be composed of individual material lengths, while in other embodiments, a strip may simply refer to an elongated portion of an overall structure having two parallel or substantially parallel surfaces. In some embodiments, the strip has a rectangular or substantially rectangular-shaped surface, and the length of the surface is longer than the height of the surface. In some embodiments, the length of the surface may be greater than twice, four times, six times, eight times, ten times, twelve times, or greater than the height of the surface.

[0020] When used in this section or elsewhere in this specification, when referring to a wound, the term "horizontal direction" refers to a direction or plane that is substantially parallel to the skin surrounding the wound. The term "vertical direction" generally refers to a direction that extends perpendicular to the horizontal plane when referring to a wound. The term "longitudinal axis direction" refers to a direction in the horizontal plane along the direction in which the wound is longest when referring to a wound. The term "transverse direction" generally refers to a direction in the horizontal plane that is perpendicular to the longitudinal axis direction when referring to a wound. The terms "horizontal direction", "vertical direction", "longitudinal direction", and "transverse direction" may also be used throughout this specification to describe the stabilization structures and wound closure devices described herein. When describing these structures or devices, these terms should not be construed to mean that the structures or devices must be placed within the wound in a particular orientation, although in certain embodiments it may be preferred to do so.

[0021] One or more of the features described herein may be considered in relation to negative pressure wound therapy, although one or more of the features may be applicable to other situations such as positive pressure wound therapy or conventional wound therapy without applying pressure.

[0022] Summary While treating a patient's wound using a TNP device, the TNP device can remove fluid, including wound exudate, from the wound. The TNP device may include a controller that automatically monitors or tracks the fluid removal accumulation or amount from the wound, such as the total volume of fluid removal, the instantaneous fluid removal amount, or the fluid removal amount per unit time (e.g., over the last 5 hours, or the last 1 hour, etc.), so that the fluid removal from the wound helps to remain well within the implementation tolerance limits of the TNP device and within the limits regarding the patient's health or comfort. The controller can use one or more sensors to monitor the volume or amount of fluid removal, communicate the data to another device, control the operation of the TNP device, or provide a display to the user of the TNP device corresponding to the volume or amount of fluid removal.

[0023] One or more sensors used by a controller to monitor the volume or amount of fluid removal can include, for example, a scale, a level sensor, a pressure sensor, or an activation sensor. The scale can measure the weight of fluid removed from a wound, for example, by weighing a canister or wound dressing (which may be any of the wound closure devices described herein or may include any of them) that collects and stores fluid removed from the wound. Since the weight of the removed fluid can generally be proportional to the volume of fluid removal, the controller can use the weight to monitor the volume or amount of fluid removal. A fluid level sensor can measure the level of flow in a canister (or wound dressing) that collects and stores fluid removed from the wound. Since the level of flow in the canister (or wound dressing) can generally be proportional to the volume of the removed fluid, it can thus be used by the controller to monitor the volume or amount of fluid removal. A pressure sensor can measure the pressure in a fluid flow path where the TNP device applies negative pressure to the wound. In such an implementation, the controller can analyze one or more characteristics of the pressure in the fluid flow path, such as the magnitude of the pressure pulse, to determine and monitor the volume or amount of fluid removal. An activation sensor can measure the operating level of the TNP device, such as the speed of the negative pressure source actuator (monitor, etc.) of the TNP device, and the controller can use that operating level to determine and monitor the volume or amount of fluid removal.

[0024] The controller can store in the memory device one or more values indicating the volume or amount of fluid removal over time for further processing. In one example, the controller may further transmit one or more values to a remote device manually or automatically in response to user input, using the transmitter of the TNP device. The controller may, for example, transmit one or more values in a message via a wireless communication network, and when the remote device receives them, cause the remote device to store the one or more values in an electronic medical record associated with the user of the TNP device or an individual defined to use the TNP device. In another example, the controller can provide a notification (such as an alarm output) when the volume or amount of fluid removal meets a threshold indicating excessive fluid removal or a sudden increase or decrease in fluid removal. In yet another example, the controller can automatically increase or decrease one or more operating parameters, such as the negative pressure applied to the wound by the TNP device, according to the volume or amount of fluid removal.

[0025] The controller can further use information about the patient, such as the volume or amount of fluid removed, the patient's metabolism or physiological functions, or data from other treatments of the patient, to communicate data to another device, control the operation of the TNP device, or provide a display to the user of the TNP device. In one example, the controller can receive information about the volume or amount of fluid (which can include infusion fluid, medication, or pain reliever) that can be provided to the patient, and use the volume or amount of fluid that can be provided to the patient to adjust a threshold used to cause activation by the TNP device. During the first few days of treating a wound, it may be particularly important to ensure that more fluid is given to the patient than is removed from the wound. Thus, for example, the controller can compare the volume of fluid given to the patient to the volume of fluid removed from the wound and provide a notification (such as activating an alarm) as to whether the volume of fluid removed meets or exceeds the volume of fluid provided to the patient. Additionally or alternatively, the controller can automatically adjust one or more operating parameters, such as the level of negative pressure provided by the TNP device, to attempt to reduce the amount of fluid removed from the wound. In another example, the controller can receive information about the patient's metabolism or physiological functions and adjust a threshold used to cause activation by the TNP device corresponding to the volume or amount of fluid removed. As a result, the controller can be more sensitive to the volume or amount of fluid removed for a particular individual compared to other individuals (e.g., a smaller individual compared to a larger individual), or at a particular time compared to other times (e.g., when the patient is in a critical condition compared to when the patient is in a stable condition).

[0026] A wound dressing used in negative pressure wound therapy may include a wound matrix or a stabilization structure configured to be folded when negative pressure is applied to a wound in which the stabilization structure is disposed or positioned, and when the wound closes and heals. The stabilization structure may be rigid or substantially rigid. However, once the stabilization structure is placed within the wound, it can be difficult to monitor the folding of the stabilization structure because it is difficult to see the stabilization structure through the wound or through a drape, foam, or other wound dressing component disposed over the stabilization structure.

[0027] The TNP device may include a controller that monitors the pressure within a fluid flow path connecting a negative pressure source to a wound dressing that includes a stabilization structure. Advantageously, in certain embodiments, the controller can monitor the folded state of the stabilization structure based on the pressure within the fluid flow path. The stabilization structure can vary the power of the negative pressure wound therapy, such as during continuous or intermittent modes of operation of the TNP device, and the folded state of the stabilization structure can cause pressure changes, noise, or artifacts due to non-uniform compression or decompression of the stabilization structure, etc. Such pressure artifacts can be detected and analyzed to determine the folded state of the stabilization structure. For example, unlike a foam that becomes substantially planar when sufficient negative pressure is applied (such as -80 mmHg) and does not fold further when the negative pressure is increased, the stabilization structure can be folded over a wider range of negative pressures. Folding of the stabilization structure can cause fluctuations in pressure levels, such as pressure artifacts. This is caused by removing air from the cells of the stabilization structure, thereby causing its folding.

[0028] The controller can, for example, determine the folding measurement amount of the stabilization structure from the pressure change in the fluid flow path and output a display corresponding to the folding measurement amount. The pressure change can be detected using one or more pressure sensors in the fluid flow path. The folding measurement amount can be determined using, for example, among other methods, one or more of the magnitude between the peaks of the pressure change, a statistical pressure algorithm, pressure pattern matching, pressure micro-changes such as envelope changes in the pressure signal, or pressure frequency changes. In some examples, the folding measurement amount can be the degree or amount of folding of the stabilization structure and can indicate the degree or amount of wound closure.

[0029] As the wound closes and heals, the controller can monitor the healing of the wound from the folding measurement amount. When the wound heals or closes, there may be a possibility of folding of the stabilization structure more than can be predicted when a specific negative pressure level is applied to the wound incorporating the stabilization structure. As a result, the controller may determine that the degree or amount of folding in the excessive degree or amount of folding due to the application of negative pressure can be due to the healing or closure of the wound. The display output by the controller can be output for presentation to the user and indicates that, because the wound is partially healed or closed, the stabilization structure can be replaced with a smaller stabilization structure that may be more suitable for the wound.

[0030] The controller can control the amount of pain received based on the provision of wound treatment, the degree or amount of folding of the stabilization structure, the size of the wound, the amount of fluid removed from the wound, or the measured folding amount. For example, the controller can activate or deactivate the negative pressure source according to the measured folding amount for at least a certain period of time (30 seconds, 1 minute, 2 minutes, 3 minutes, 5 minutes, or 10 minutes, etc.) or during a number of compression or decompression cycles (2, 3, 5, 10, 20, or 50 compression-decompression cycles). Further, in addition to or instead of controlling the negative pressure source to target a specific negative pressure level or range, the controller can activate or deactivate the negative pressure source according to the measured folding amount. In certain embodiments, advantageously, such control can enable adjustment of the provision of therapy to a specific wound, environment, or patient (non-linear, etc.), thereby enabling a faster, less painful, more effective, or more responsive therapy. Further, for example, such control can enable the controller to better respond to or prevent blockages in the fluid flow path since a more adjusted and customized negative pressure therapy can be applied based on the measured fluid removal from the wound. For example, a more appropriate level of negative pressure can be continuously selected based on the measured fluid removal, which can reduce the risk of blockage since the negative pressure is applied adjusted to the fluid removal flow rate.

[0031] Before starting or resuming the provision of therapy, the controller can determine one or more characteristics of the wound dressing from the pressure in the fluid flow path. The one or more characteristics can include the size of the wound dressing, the type of wound dressing, or whether the wound dressing includes a stabilization structure. In one example, corresponding to determining that the wound dressing includes a stabilization structure, the controller can determine to control the application of negative pressure based on the measured folding amount, and corresponding to determining that the wound dressing does not include a stabilization structure, the controller can determine to control the application of negative pressure instead of the pressure set value.

[0032] The controller can detect or characterize patient movement from pressure fluctuations in the fluid flow path due to the transition of the stabilization structure of the wound dressing. Patient movement can include, for example, the patient moving a leg or arm, or breathing (e.g., when the stabilization structure is placed within an abdominal wound).

[0033] The controller can determine whether a suture has ruptured or broken from pressure fluctuations in the fluid flow path. Sutures can be used to hold tissues near the wound dressing together. In one example, the controller monitors the pressure fluctuation cycle, such as the peak-to-peak pressure signal, and can detect a pressure increase that may indicate a change in the wound volume due to a ruptured or broken suture.

[0034] Negative pressure therapy system FIG. 1 illustrates an embodiment of a negative pressure therapy system 100 including a wound packer 102 inserted into a wound 101. The wound packer 102 may include a porous material such as a foam, and in some embodiments may include one or more embodiments of a wound closure device described in more detail elsewhere in this section or this specification. In some embodiments, the periphery or top of any wound closure device inserted into the wound 101 may also be covered with a foam or other porous material. A single drape 104 or multiple drapes may be placed over the wound 101 and are preferably adhered or sealed to the skin at the periphery of the wound 101 to create a fluid tight seal. An aperture 106 may be created through the drape 104 to provide a fluid connection from the wound 101 to a negative pressure source such as a TNP device 110 including a pump, which may be created manually or pre-formed within the drape 104. The fluid connection between the aperture 106 and the pump of the TNP device 110 is preferably created via a conduit 108. In some embodiments, the conduit 108 may comprise a RENASYS® Soft Port™ manufactured by Smith & Nephew. Of course, in some embodiments, the drape 104 need not necessarily include an aperture 106 and the fluid connection to the pump of the TNP device 110 may be made by placing the conduit 108 under the drape. In some wounds, particularly larger wounds, multiple conduits 108 may be used and fluidly connected via one or more apertures 106.

[0035] In some embodiments, the drape 104 may be provided with one or more corrugated shapes or folds. The corrugated shape is preferably aligned along the longitudinal axis of the wound, such that by preferentially folding in a direction perpendicular to the longitudinal axis of the wound, it may assist in closing the wound. Such corrugated shapes may assist in applying a contractile force parallel to the wound surface and in the direction of wound closure. An example of such a drape can be found in Application No. 12 / 922,118, titled "Vacuum Closure Device", filed on November 17, 2010 (U.S. Patent Application Publication No. 2011 / 0054365), which is hereby incorporated by reference in its entirety.

[0036] In use, the wound 101 is prepared and cleaned. In some cases, such as abdominal wounds, a non-adherent or minimally adherent organ protection layer (not shown) may be applied over any exposed viscera. The wound packer 102 is then inserted into the wound and covered with the drape 104 so as to form a fluid-tight seal. Next, the first end of the conduit 108 is positioned to be in fluid communication with the wound, for example, via the aperture 106. The second end of the conduit 108 is connected to the TNP device 110. Next, the pump of the TNP device 110 can be actuated to supply a negative pressure to the wound 101 and withdraw wound exudate from the wound 101. The negative pressure may also assist in promoting closure of the wound 101, for example, by approximating the opposing wound edges, as will be described in more detail below in connection with embodiments of the aforementioned wound closure device.

[0037] Any structure or component disclosed in this section of the specification or elsewhere in the specification may include a radiopaque substance. Advantageously, the radiopaque substance enables a clinician to more easily detect fragments of the wound closure device that may become dislodged from the structure and lost within the wound. Some examples of radiopaque substances include barium sulfate, bismuth trioxide, bismuth subcarbonate, bismuth oxychloride, and tungsten.

[0038] Figure 2 shows a negative pressure therapy system 10A according to some embodiments. The system 10A includes a TNP device 11 (which may be similar to the TNP device in the TNP device 110 and overview section) and a remote data processing system 13. The TNP device 11 can be used to treat a wound using a wound dressing that is in fluid communication with the TNP device 11 via a fluid flow path. The TNP device 11 may include a controller 12A (which may be similar to the controller in the overview section), a memory device 12B, a negative pressure source 12C, a user interface 12D, a power supply 12E, a pressure sensor 12F, a transceiver 12G, and an additional sensor 12H configured to communicate electrically with each other. The TNP device 11 may include a canister 12I for collecting fluid including wound exudate. In some embodiments, the wound exudate can be further or alternatively absorbed by the wound dressing, and further, the canister 12I may or may not be used.

[0039] The controller 12A can control the operation of one or more other components of the TNP device 11 according to at least instructions stored in the memory device 12B. For example, the controller 12A can control the operation and supply of negative pressure by the negative pressure source 12C. The negative pressure source 12C can include, but is not limited to, a rotary diaphragm pump or other diaphragm pump, a piezoelectric pump, a peristaltic pump, a piston pump, a rotary vane pump, a liquid-sealed pump, a scroll pump, a diaphragm pump operated by a piezoelectric transducer, a voice coil pump, or any other suitable pump or micropump, or any combination of the above. The user interface 12D can include one or more elements for receiving user input or providing user output to a patient or caregiver. The one or more elements for receiving user input can include buttons, switches, dials, touchscreens, microphones, etc. The one or more elements for providing user output can include light, displays, speakers, etc.

[0040] The pressure sensor 12F can be used to monitor the pressure under the wound dressing, such as by monitoring (i) the pressure in the fluid flow path connecting the negative pressure source 12C and the wound dressing as shown in FIG. 3, (ii) the pressure in or within the wound dressing, or (iii) the pressure in or within the negative pressure source 12C. In some implementations, the pressure sensor 12F may include at least two pressure sensors, which are positioned within the fluid flow path or fluidly connected to the fluid flow path to enable measurement of pressure differences, such as measuring the difference between the pressure at the wound or near the wound and the pressure at or near the TNP device 11. For example, a first pressure sensor may be positioned upstream of the wound (e.g., at or near the inlet of the negative pressure source 12C), and a second pressure sensor may be positioned to detect the pressure at or near the wound or at or near the cannister. This configuration includes one or more lumens forming a first fluid flow path connecting the negative pressure source 12C to the wound, and one or more lumens connecting the TNP device 11 to the wound, and can be achieved by incorporating a second fluid flow path through which the second pressure sensor can monitor the pressure at or near the wound or at or near the cannister. The first and second fluid flow paths can be fluidly separated from each other.

[0041] FIG. 3 shows a negative pressure therapy system 10B according to some embodiments. The system 10B includes a TNP device 11, a fluid flow path 15, a wound dressing 16, and a wound 17. The TNP device 11 can be used to treat the wound 17 using the wound dressing 16 that is in fluid communication with a negative pressure source 12C via the fluid flow path 15. To measure the pressure within the fluid flow path 15, a pressure sensor 12F is shown in FIG. 3 positioned within the fluid flow path 15, for example, at or near the inlet of the TNP device 11. The wound dressing 16 can embody any of the wound dressings or wound closure devices described herein. In some implementations, the canister 12I is not used and instead, wound exudate may be collected by the wound dressing 16, which can be absorbent. In other implementations, both the canister 12I and the wound dressing 16 can be used and the wound dressing 16 may be absorbent.

[0042] Returning to FIG. 2, the transceiver 12G can be used to communicate with the data processing system 13 via the network 14. The transceiver 12G can transmit device usage data, such as, for example, an alarm, a fluid removal amount, a measured pressure, or a change to a therapy program executed by the TNP device 11, to the data processing system 13. The network 14 can be a communication network, such as a wireless communication network like a cellular communication network, or a wired communication network. The memory device 12B can be used to store device usage data that can be transmitted by the transceiver 12G. In some implementations, the data processing system 13 can automatically store data received from the transceiver 12G into an electronic medical file associated with a patient who has used, or is scheduled to use, the TNP device 11. In some examples, the transceiver 12G can include a transmitter for transmitting data separate from a receiver used to receive data.

[0043] The additional sensor 12H can include, for example, a level sensor that detects the fluid level within the canister 12I, or a scale that measures one or more components of the negative pressure therapy systems 10A and 10B such as the canister 12I or the wound dressing 16. The controller 12A can use the additional sensor 12H to monitor the amount of fluid removed from a wound such as the wound 17.

[0044] Pressure therapy method FIG. 4A illustrates a fluid removal management process 20 executable by a device, such as the controller 12A of the TNP device 11 or the controller of the TNP device 110. For convenience, the fluid removal management process 20 is described in connection with the TNP device 11 of FIGS. 2 and 3, but alternatively may be implemented by other systems described herein or other computing systems not shown. In certain embodiments, advantageously, the fluid removal management process 20 enables the TNP device 11 to monitor the amount of fluid removed from the wound 17, automatically wirelessly communicate the amount of fluid removed to another device, and output a display if the amount of fluid removed is excessive.

[0045] In block 21, the fluid removal management process 20 can monitor the amount of fluid removed from the wound 17. For example, the fluid removal management process 20 can monitor the amount of fluid removed using measurements provided by one or more sensors such as the pressure sensor 12F or the additional sensor 12H.

[0046] In block 22, the fluid removal management process 20 can wirelessly communicate the amount of fluid removed to the data processing system 13. The fluid removal management process 20 can communicate the amount of fluid removed to the data processing system 13 via the network 14 using, for example, the transceiver 12G. In some implementations, the fluid removal management process 20 can communicate on a wired interface instead of or in addition to wireless communication.

[0047] In block 23, the fluid removal management process 20 can determine whether the fluid removal amount meets a threshold value. The threshold value may be a quantity threshold value, and the magnitude of the quantity threshold value indicates that the fluid quantity increases or decreases excessively during the delivery of the negative pressure therapy using the TNP device 11.

[0048] If the fluid removal amount meets the threshold value, in block 24, the fluid removal management process 20 can output an indication that the flow rate of the fluid removal amount has increased or decreased excessively during the delivery of the negative pressure therapy using the TNP device 11. The indication can include, for example, the activation of a visible or audible alarm of the user interface 12D, or the display of a warning message in text on the display of the user interface 12D.

[0049] On the other hand, if the fluid removal amount does not meet the threshold value, the fluid removal management process 20 may end.

[0050] FIG. 4B illustrates a folding monitoring process 30 that can be executed by a device such as the controller 12A of the TNP device 11 or the controller of the TNP device 110. For convenience, the folding monitoring process 30 is described in connection with the TNP device 11 of FIGS. 2 and 3, but alternatively, it may be executed by other systems described herein or by other computing systems not shown. In certain embodiments, advantageously, the folding monitoring process 30 can monitor the TNP device 11 folding the stabilization structure of the wound dressing 16 disposed within the wound 17 from the pressure in the fluid flow path 15 and appropriately control the operation of the TNP device 11.

[0051] In block 31, the folding monitoring process 30 can monitor the pressure within the fluid flow path. For example, the controller 12A can monitor the pressure using the pressure sensor 12F or an additional sensor 12H positioned to detect the pressure in the fluid flow path 15.

[0052] In block 32, the folding monitoring process 30 can determine the folding measurement amount of the stabilization structure of the wound dressing. For example, the controller 12A can determine the folding measurement amount of the stabilization structure of the wound dressing 16 from the pressure in the fluid flow path 15 detected by the pressure sensor 12F or the additional sensor 12H. The folding measurement amount can be determined, for example, from the change in the magnitude or frequency of the pressure in the fluid flow path over time, as described herein. In one example, the controller compares the magnitude over time to one or more pressure patterns indicating (i) the magnitude of the pressure in the fluid flow path when the stabilization structure is fully folded, (ii) the magnitude of the pressure in the fluid flow path when the stabilization structure is partially folded, and (iii) the magnitude of the pressure in the fluid flow path when the stabilization structure is not folded, and the controller can determine the folding measurement amount to one or more of the pressure patterns from a certain degree of similarity in the magnitude over time. In another example, the folding measurement amount may be or be related to the degree or amount of folding of the stabilization structure.

[0053] In block 33, the folding monitoring process 30 can output a display corresponding to the folding measurement amount. For example, the controller 12A can output a display according to the folding measurement amount. In some implementations, instead of controlling the operation and deactivation of the negative pressure source to adjust the magnitude of the pressure and aim for a predetermined negative pressure threshold, the folding monitoring process 30 can output a display that controls the operation and deactivation of the negative pressure source for a certain period of time (such as 1 minute, 5 minutes, 10 minutes, 30 minutes, 1 hour, or 5 hours) according to the folding measurement amount. In some implementations, the controller can output a display for presentation to the user (such as via a visual, audible, or tactile alarm of the user interface 12D, or the display of a warning message in text on the display of the user interface 12D), or for storage in a memory device, such as storage associated with device usage data, such as pressure level, alarm, effluent level, event log, and operating usage time. In some embodiments, in block 33, the folding monitoring process 30 can adjust one or more parameters of the negative pressure treatment, such as the negative pressure level, mode (e.g., continuous or intermittent). The control of the negative pressure treatment can be associated with achieving or maintaining the target level of folding of the stabilization structure (e.g., 10% at the start of treatment, 30% after the application of treatment over some time, etc.). Further, or alternatively, the folding monitoring process 30 can activate or deactivate the negative pressure source, increase or decrease the target negative pressure provided by the negative pressure source, or release the negative pressure in the fluid flow path.

[0054] Fluid detection The presence or absence of exudate within the fluid flow path can be detected by processing data from one or more pressure sensors, such as pressure sensor 12F. This detection can be improved by changing one or more settings of the negative pressure source, such as increasing the delivered vacuum level, decreasing the vacuum level, temporarily stopping or stopping the negative pressure source, changing the speed of an actuator (pump motor, etc.), or changing the cadence of the actuator. In some embodiments, as the negative pressure source operates, it generates pressure pulses or signals that propagate through the fluid flow path. According to some embodiments, the pressure signal is illustrated in the pressure curve 402 of FIG. 5. As illustrated in region 404, the pressure within the fluid flow path varies or fluctuates about a specific pressure setting or setpoint 408 (e.g., selected by the user) during normal operation of the system. Region 406 illustrates the pressure pulse within the flow path in the event of an occlusion distal to the negative pressure source, such as the cannister (or dressing) being full or the cannister filter being blocked or clogged. As illustrated, the distal occlusion results in a volume decrease upstream of the cannister (or dressing) and an increase in the amplitude of the pressure pulse. In some embodiments, the frequency of the pressure signal decelerates or decreases. In certain embodiments, such changes or "bounces" in the magnitude (or frequency) of the pressure pulse signal can be amplified or improved by changing the cadence of the actuator, such as by changing the speed of the actuator or adjusting pulse width modulation (PWM) control parameters, etc. Such adjustments to the negative pressure source operation are not essential, but can be performed in a short period and with little change so that the operation of the system is relatively unaffected. In some embodiments, the cannister filter may be hydrophobic such that liquid flow is substantially blocked while air flow is permitted. Further details of flow rate detection are described in U.S. Patent No. 8,843,327, which is incorporated by reference in its entirety.

[0055] A canisterless system can use an absorbent dressing for exudate removed from a wound. Such a dressing can include an absorbent or superabsorbent material for collecting or retaining exudate so that the exudate is not drawn to a negative pressure source. Similar to a canister filter, a dressing filter (which may be hydrophobic) can be used to prevent exudate from reaching the negative pressure source. In such a system, detection of a full dressing condition or an occluded dressing filter (which may occur) may be equivalent to detection of a full canister condition.

[0056] Changes in the characteristics of the pressure signal can be used to determine folding of the stabilization structure, fluid removal volume, distal occlusion, the level of exudate within the canister (or dressing), canister (or dressing) full condition, etc. Characteristics can include the magnitude, frequency, shape (e.g., envelope shape), etc. of the signal. In some embodiments, the fluid removal volume can be detected by monitoring changes in the magnitude of the pressure pulse over time. For example, as the canister (or dressing) becomes filled with wound exudate, the magnitude of the pressure pulse can increase as shown in region 406. Further details regarding monitoring the fluid removal volume are disclosed in U.S. Patent No. 2016 / 0184496, which is incorporated by reference in its entirety.

[0057] Stabilization Structure and Wound Closure Device FIG. 6A is a diagram of an embodiment of a stabilization structure 6000 that includes a plurality of elongated strips 6006 arranged in parallel or quasi-parallel, the longitudinal length of which can be aligned with the longitudinal axis of the wound. In embodiments, the elongated strips 6006 may also be arranged in a non-parallel fashion. The various cells within this stabilization structure 6000 may have various shapes and sizes. As will be described in more detail below, the lengths and shapes of the elongated strips 6006, intervening members 6010, and cells 6004 can be designed to facilitate greater closure of the stabilization structure. In certain embodiments, the junction 6900 between the elongated strip and the intervening member is thinner and can facilitate rotation and closure of the stabilization structure. In some embodiments, the stabilization structure may be tearable such that the structure can be shaped to the shape of the wound. As described elsewhere in this specification, tearing can occur at the intersection between the intervening member and the elongated strip, or at any suitable location along the elongated strip or intervening member.

[0058] All of the stabilization structures described in this section of the specification or elsewhere in the specification may be made to accommodate any size of wound. However, to better accommodate the needs of the clinical environment, in certain embodiments, the stabilization structures described herein may be provided in a pack that includes two sizes, such as one smaller stabilization structure and one larger stabilization structure that is approximately 1.25 times larger, approximately 1.5 times larger, approximately 1.75 times larger, approximately 2 times larger, approximately 2.5 times larger, approximately 3 times larger, approximately 4 times larger, approximately 5 times larger, or greater than approximately 5 times larger. In some embodiments, the pack may include more than two sizes, such as three sizes, four sizes, five sizes, or more than five sizes. The stabilization structures within the pack can be various sizes relative to each other, such as in the ratios described above.

[0059] In certain embodiments, the stabilization structure 6000 can be folded with or without applying negative pressure in any of the ways described in this section or elsewhere in this specification. For example, the stabilization structure can be folded significantly more in one plane than in another plane when negative pressure is applied. In some embodiments, the stabilization structure is configured to be folded more in a horizontal plane parallel to the length and width of the stabilization structure than in a vertical plane perpendicular to the horizontal plane. In embodiments, a particular row can be folded in a first direction and another row can be folded in the same or opposite direction. In certain embodiments, the stabilization structure can be folded along the width of the stabilization structure while being relatively rigid along the length of the stabilization structure and in the vertical direction.

[0060] The stabilization structure may be composed of any of the materials described in this section or elsewhere in this specification, including flexible plastics such as silicon and polyurethane, rigid plastics such as polyvinyl chloride, semi-rigid plastics, semi-flexible plastics, and biocompatible materials, composite materials, metals, foams. In certain embodiments, the stabilization structure may include a radiopaque material, which allows a clinician to more easily locate fragments of the stabilization structure within the wound.

[0061] Returning to FIG. 6A, the stabilization structure 6000 may have an outer perimeter that at least partially defines an elliptical shape. As described above, the stabilization structure 6000 may include a plurality of cells 6004 provided side by side, each cell being defined by one or more walls, each cell having an upper end and a lower end, and an opening extending through its upper and lower ends. Similar to other stabilization structures described in this section of the present specification or elsewhere in the present specification, the stabilization structure 6000 is configured to be folded by folding one or more cells 6004. In some embodiments, all of the cells are of the same approximate shape and size, while in other embodiments, the cells are of different shapes and sizes. In some embodiments, the stabilization structure described in this section of the present specification or elsewhere in the present specification may be dome-shaped, such that the central portion of the stabilization structure bulges upward. For example, the lower portion of the stabilization structure may be concave, while the upper portion of the stabilization structure is convex.

[0062] The elongate piece 6006 may be made of a single material, as described elsewhere in the present specification, or the elongate piece may be made of a plurality of materials. For example, the elongate piece 6006 may include a section of a more rigid material and a section of a more flexible material. The elongate piece 6006 may be curved along its length to facilitate the curved outer perimeter of the stabilization structure 6000. The elongate piece may be curved along an outward length direction from the center of the stabilization structure 6000. The arc of the curve of the elongate piece 6006 may vary considerably, with some portions of the piece 6006 being highly curved while others are minimally curved or rather straight.

[0063] Similarly, the stabilization structure 6000 may further include a plurality of intervening members 6010 connected to the elongate piece 6006. The intervening members 6010 may all be of similar shape and size, or may be of various shapes and sizes. The intervening members may be composed of any of the materials disclosed in this section of the present specification or elsewhere in the present specification. Further, the intervening members may be composed of a plurality of materials.

[0064] Advantageously, due to the elliptical shape of the stabilization structure 6000, the structure can conform to the shape of the wound. Since most wounds are rounded in shape, the elliptical stabilization structure 6000 can fit better to the wound.

[0065] In an embodiment, the outer perimeter 6002 may have a reduced edge 6012 to facilitate folding of the stabilization structure. By removing the mass of the stabilization structure over the reduced edge 6012, the stabilization structure can be folded more freely at the edge 6012, thus allowing for a better fit within the wound. Further, by reducing the mass over the reduced edge 6012, pinching of the surrounding tissue can be reduced during and after folding of the stabilization structure 6000.

[0066] All of the stabilization structures 6000 and stabilization structures and wound closure devices described in this section or elsewhere in this specification can be folded in a dynamic manner over various time scales. In certain embodiments, most of the folding can occur within the first few minutes after negative pressure is applied. However, after the initial folding, the stabilization structure or wound closure device can continue to fold at a slower rate, applying a longitudinal tension increase over time to draw the edges of the wound closer together. By slowly drawing the edges of the wound closer together over time, the stabilization structure or wound closure device allows the surrounding healing tissue to be reformed synergistically with the closure of the device or stabilization structure. Since the folding structure or device slowly draws the edges of the wound together without rapidly applying pressure to newly formed or weakened tissue, slow dynamic wound closure can allow for accelerated healing of the surrounding tissue.

[0067] In some embodiments, the stabilization structure described in this section or elsewhere in this specification is placed within the wound over a period of time and may further be removed or replaced with another stabilization structure. For example, the stabilization structure can be inserted into the wound for a period of time to promote wound closure by drawing the edges closer together. After a period of time has elapsed, the stabilization structure can be replaced by a stabilization structure having a different size or foldability, such as a stabilization structure with a smaller size or a reduced density. This process can be repeated multiple times, thereby continuously drawing the wound edges closer over time and allowing for continued repair and remodeling of the surrounding tissue. In certain embodiments, the stabilization structure is configured to remain within the wound for at least less than about 1 hour, at least about 1 hour, at least about 2 hours, at least about 4 hours, at least about 6 hours, at least about 8 hours, at least about 12 hours, at least about 24 hours, at least about 2 days, at least about 4 days, at least about 6 days, at least about 1 week, at least about 2 weeks, at least about 3 weeks, or longer than 3 weeks.

[0068] In certain embodiments, up to 90% of the collapse of the stabilization structure or wound closure device can occur within the first few minutes after negative pressure is applied, and the remaining 10% of the collapse can occur slowly over a period of minutes, hours, days, weeks, or months. In other embodiments, up to about 80%, up to about 70%, up to about 60%, up to about 50%, up to about 40%, up to about 30%, up to about 20%, up to about 10%, or about 0% of the collapse occurs immediately within the first few minutes after negative pressure is applied, and the remaining collapse occurs at a slower rate, etc., over a period of minutes, hours, days, weeks, or months. In other embodiments, the stabilization structure can be collapsed at a variable rate. In some embodiments, the entire collapse occurs at a slow rate, while in other embodiments, the entire collapse occurs almost immediately within the first few minutes. In further embodiments, the collapse can occur at any rate, and the rate can vary over time. In certain embodiments, the amount of collapse can be varied in a variable manner by adding or removing a portion of the structure, or by controlling the application of negative pressure and the perfusion fluid.

[0069] Returning to FIG. 6A, in some embodiments, the pattern of the stabilization structure 6000 is designed to facilitate maximum closure of the stabilization structure. The maximum closure is preferably in a direction perpendicular to the length direction of the elongated member and within a horizontal plane. As will be described in more detail below, greater closure can be achieved by varying the length of the elongated piece 6006, the length of the intervening member 6010, and the shape of the cell 6004. The shape of the cell 6004 can include any of the shapes described in this section of the present specification or elsewhere in the present specification. For example, as shown in FIG. 6A, the cell 6004 can be a diamond shape or a parallelepiped in which a smaller diamond shape 6020 is located within a larger diamond 6022. Such a structure can provide greater overall closure of the stabilization device 6000 to provide maximum closure of the wound. Further, the smaller diamond shape 6020 located within the larger diamond 6022 can spread the load over a larger area to reduce the possibility of damaging the tissue structure under the matrix. This structure can also reduce the possibility that the foam or drape is pulled into the matrix and prevents closure of the wound.

[0070] FIGS. 6B and 6C show different views of an embodiment of the stabilization structure of FIG. 6A. As described above in connection with FIG. 6A, the stabilization structure includes the cell 6004, the intervening member 6010, and the elongated piece 6006, but here also includes a simulated shape 6910 of the wound for comparison.

[0071] Any of the stabilization structures described in this section of the specification or elsewhere in the specification may be composed of any suitable means. For example, the stabilization structure may be formed through molding or may be directly printed using 3D printing technology. In certain embodiments, the stabilization structures of FIGS. 6A-6C may be composed of a single polymer via 3D printing. In some embodiments, the stabilization structure may be composed of one polymer, two polymers, three polymers, or four or more polymers. The stabilization structure may be composed of any of the materials disclosed in this section of the specification or elsewhere in the specification. The stabilization structure may be made by cutting out the structure from a solid block of material. Methods used for cutting may include, for example, water jet cutting, laser cutting, or die cutting. The stabilization structure may be cut to a size along the wall of the cell 6004. For example, the intervening member along the outer surface of the elongate piece 6006 may be cut to appropriately size the stabilization structure. The stabilization structure may be cut along the wall, along any portion of the elongate piece, or along any portion of the intervening member.

[0072] In some embodiments, the stabilization structure 6000 of FIGS. 6A-6C may be configured to include perforations or detachable sections that allow a portion of the device to be separated from the remainder of the device. For example, perforations may be incorporated at the junctions 6900 between the various cells 6004 included within the stabilization structure 6000, and individual rows or cells may be removed to change the shape of the stabilization structure 6000.

[0073] Applicable to all of the stabilization structures or wound closure devices described in this section of the specification or elsewhere in the specification, the stabilization structure or wound closure device can be torn such that the stabilization structure can be shaped to the shape of the wound. In some embodiments, the stabilization structure may be torn at the intersection between the intervening member and the elongate piece, and in further embodiments, the elongate piece or the intervening member may be torn at any suitable location.

[0074] Wound Closure and Treatment Methods The stabilization structures or wound closure devices described in this section or elsewhere in this specification may be used in combination with a method or system for wound closure. In some embodiments of the methods used for wound closure, one or more of any of the stabilization structures or wound closure devices of any of the embodiments described in this section or elsewhere in this specification are placed within the wound. In some embodiments, an organ protection layer may be provided within the wound prior to placement of the stabilization structure. In certain embodiments, a foam or other porous material may be placed within the wound with, under, over, or around the stabilization structure or wound closure device. The foam or other porous material may surround the outer perimeter of the stabilization structure or wound closure device. The stabilization structure or wound closure device may be configured to be folded in any of the ways described in this section or elsewhere in this specification, such as by having a particular size and shape, or by including a particular volume of foam or other porous material within the cells of the structure. The stabilization structure or wound closure device may further be altered in any of the ways described in this section or elsewhere in this specification to better conform to the shape of the wound. After placement in the wound, the stabilization structure or wound closure device can be sealed with a fluid-tight drape. The fluid-tight drape can include ports configured for application of negative pressure. Next, a negative pressure source may be connected to the ports and negative pressure may be applied to the wound. The stabilization structure or wound closure device can be replaced over time with stabilization structures or wound closure devices of various shapes and sizes that are desirable to best promote wound healing.

[0075] Figures 7-15E illustrate embodiments of a method of treating a wound using a wound closure device that includes a stabilization structure, as described in this section of the specification and elsewhere in the specification. To better illustrate non-limiting embodiments of the method, numbers have been added to the steps of FIG. 13 to enable a reader to more readily follow such steps of the method. However, the steps may be performed in any order and any numbering system is for clarity only. Further, in some embodiments, various steps of these methods may be excluded. In other embodiments, additional steps may be added to the methods based on the methods described in this section of the specification and elsewhere in the specification. The porous layers and structures described in this section may be any material or structure described elsewhere in the specification, such as a foam.

[0076] FIG. 7, which is described in more detail below, shows an embodiment of an open wound 5100 prior to treatment using a wound closure device. The open wound of FIG. 7 is similar to the wounds described elsewhere in the specification, particularly in relation to FIG. 1. In some examples, such wounds may be created via a surgical incision or other means, as described elsewhere in the specification.

[0077] FIG. 8 shows an embodiment of an initial step of a method of treating an open wound 5100 using a wound closure device. Prior to treatment, the wound is washed using a pad 5180 and the skin 5190 is prepared for application of the wound closure device, as described in relation to FIGS. 6A-6C.

[0078] FIG. 9 shows an embodiment of an early step of a method for treating an open wound 5100. In some embodiments, a tissue protection layer 5170 may be placed over the wound to protect underlying tissue from problems associated with negative pressure wound therapy or other potential hazards. Thus, in certain embodiments, a tissue protection layer 5170 is provided that can be sized and cut to be placed over the wound site 5100. The tissue protection layer 5170 may be a material that does not adhere closely to the wound site or exposed viscera. Such a tissue protection layer may be composed of any suitable material, such as a biocompatible polymer. For example, an organ protection layer manufactured by Smith & Nephew and sold under the brand RENASYS® acts as a tissue protection layer and is placed over the abdominal cavity or wound bed 5100 and pushed into the peritoneal recess. In a further example, these materials are generally non-adhesive and are used within surgical grafts, so materials such as the fluoropolymer polytetrafluoroethylene (PTFE) are applicable. In one embodiment, the tissue protection layer is permeable. For example, the tissue protection layer 5170 may be provided with openings such as holes, slits, or channels to allow fluid removal from the wound site 5100 or the transmission of negative pressure to the wound site 5100. In a further embodiment, the tissue protection layer may be used over non-abdominal wounds in other areas of the body, such as the leg, arm, shoulder, or back. In certain embodiments, the tissue protection layer may include a sensor configured to measure the pressure within and around the wound. For example, the sensor may be used to measure the level of negative pressure applied to the wound or the pressure on an organ underlying an abdominal wound.

[0079] Figures 10A - 10C illustrate embodiments of possible initial steps in a method for treating an open wound. However, as described above, the steps need not be performed in this order and may be performed in any order. In Figure 10A, two - piece porous materials such as a foam, a bottom piece 5102, and a top piece 5116 are selected to approximate the size of the wound 5100. In some embodiments, the top piece and the bottom piece are of the same thickness. However, in certain embodiments, the top piece 5116 may be at least twice as thick, at least four times as thick, at least ten times as thick, or more than ten times as thick as the bottom piece 5102, or vice versa. Figure 10B illustrates an embodiment of a further step in the method for treating an open wound. The bottom piece 5102 is shaped to the shape of the wound by cutting or other suitable means and may then be placed within the wound 5100 as further shown below in Figures 10C and 11A.

[0080] Figures 11A and 11B show a foam layer 5102 (e.g., a 15 - mm layer of foam) that is placed within the wound bed 5100 after shaping. In Figures 12A - 12C, a stabilization structure 5104 similar to the stabilization structures disclosed in Figures 6A - 6C, or any other stabilization structure described elsewhere in this specification, is of the shape of the wound. The stabilization structure may be shaped to the shape of the wound by cutting or other suitable means, or the stabilization structure may first be of a size that is easily accommodated by the wound. As shown in Figure 12B, the stabilization structure 5104 may be placed within the wound. To assist in inserting the device into the wound bed, the device may be deformed slightly inwardly or horizontally so as to facilitate entry into the wound site. In some embodiments, the device may be slightly compressed during insertion and released upon contact with the walls of the wound. In certain embodiments, the wound closure device 5104 may be arranged such that the longitudinal sides of the matrix are aligned with the longitudinal axis of the wound 5100. Following Figure 12B, another foam layer 5116 (e.g., a 10 - mm foam layer) is placed on top of the wound closure device 5104.

[0081] FIG. 12C illustrates the stabilization structure of FIGS. 12A and 12B and the application of port 5122 to the foam. The bridge portion of the foam 5118 can be disposed in close contact with the foam layer 5116 at the edge of the wound. The bridge portion of the foam 5118 may extend over the uninjured skin, with a piece of drape 5120 disposed therebetween and the uninjured skin. Further, the suction port 5122 can be connected to the bridge portion 5118 with a section of the drape 5120 therebetween. In an alternative embodiment, the bridge portion 5118 and the suction port 5122 can be disposed over the wound during the various steps illustrated in FIGS. 11A-12B.

[0082] In FIG. 13, as shown in steps 1-4, the device can be covered by one or more drapes 5120. A hole may be made in the drape covering the bridge portion of the foam, and the suction port 5122 may be disposed over the hole. The protective layer 5124 on the upper surface of the one or more drapes can be removed after the drape 5120 is applied. Once the drape 5120 is applied and the port is in place, negative pressure can be applied from the vacuum source through the drape to the wound. Due to the negative pressure, the stabilization structure can be folded horizontally as described in other parts of this specification. The tissue anchors adhered to the stabilization structure through the porous layer can engage the tissue of the wound and promote closure of the wound.

[0083] Figures 14A - 14C provide further views of the upper foam layer 5116 disposed on the wound, followed by placement of the bridge portion 5118 and one or more drapes or wound covers 5120. Figures 14D - 14G illustrate embodiments of some steps of a method for treating and closing a wound. As shown in Figure 14D, the suction port 5122 is separated from the release liner 5126 and then applied to the wound as shown in Figures 11A - 13. Figure 14E illustrates the canister 5128 inserted into the negative pressure wound therapy device 5130 for collection preparation of wound exudate. Figure 14F illustrates a snap connection between the tube connected to the suction port and the tube connected to the negative pressure wound therapy device 5130. Once the connection is made, negative pressure wound treatment can be initiated as shown in Figure 14G.

[0084] Figures 15A - 15E illustrate an alternative method of closing a wound that is somewhat similar to the method of Figures 7 - 14G. Here, the foam is placed under the muscle and fascia, and then the foam extends vertically from the wound and is folded. Such a method can result in improved closure of the dermis rather than, to the extent possible, at the fascial level. In an alternative embodiment, such a configuration may be combined with a stabilization structure as disclosed elsewhere in this section of the specification or elsewhere in the specification by providing a folded foam layer 5116 protruding from the wound. Figure 15E is a cross - sectional view of the alternative method.

[0085] Further details regarding wound closure devices, stabilization structures, related devices, and methods of use that can be combined with or incorporated into any of the embodiments described herein are described elsewhere in this specification and in International Patent Application No. PCT / US2013 / 050698, filed July 16, 2013, published as International Patent Application Publication No. 2014 / 014922A1, which is hereby incorporated by reference in its entirety.

[0086] Other variations The values such as threshold values, limit values, periods, etc. provided in this specification are not intended to be absolute and thus may be approximate. Further, any threshold values, limit values, periods, etc. provided in this specification may be fixed or changed automatically or by the user. Further, as used in this specification, terms indicating relative degrees such as exceeding, greater than, less than, etc. in relation to a reference value are intended to include the case where they are equal to the reference value. For example, exceeding a positive reference value can include being greater than or equal to the reference value. Moreover, as used in this specification, terms indicating relative degrees such as exceeding, greater than, less than, etc. in relation to a reference value are intended to include the opposite of the disclosed relationships such as below, less than, greater than, etc. in relation to the reference value. Also, although the blocks of various processes may be described with respect to determining whether a value reaches or does not reach a specific threshold value, the blocks can be similarly interpreted, for example, with respect to whether a value is (i) less than or greater than the threshold value, or (ii) satisfies or does not satisfy the threshold value.

[0087] It should be understood that the properties, substances, features, or groups described in connection with a particular aspect, embodiment, or example are applicable to any other aspect, embodiment, or example described in this specification, unless they are incompatible therewith. All of the features disclosed in this specification (including any appended claims, abstract, and drawings), or likewise all of the steps of any method or process disclosed, may be combined in any combination, except combinations where at least some of such features or steps are mutually exclusive. The subject matter of the present invention is not limited to the details of any of the foregoing embodiments. The subject matter extends to any novel one, or any novel combination, of the features disclosed in this specification (including any appended claims, abstract, and drawings), or likewise to any novel one, or any novel combination, of the steps of any method or process disclosed.

[0088] While specific embodiments have been described, these embodiments are presented by way of example only and are not intended to limit the scope of protection. In fact, the novel methods and systems described herein may be embodied in various other forms. Furthermore, various omissions, substitutions, and modifications may be made in the forms of the methods and systems described herein. Those skilled in the art will recognize that, depending on the embodiment, the actual steps performed in the illustrated or disclosed process may differ from the steps shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, and others may be added. For example, the actual steps or the order of steps performed in the disclosed process may differ from that shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, and others may be added. For example, the various components shown in the figures may be implemented as software or firmware on a processor, controller, ASIC, FPGA, or dedicated hardware. The hardware components such as processors, ASICs, FPGAs, etc. may include logic circuits. Furthermore, the features and characteristics of the specific embodiments disclosed above can be combined in various ways to form additional embodiments, all of which will fall within the scope of the present disclosure.

[0089] The user interface screens illustrated and described herein may include additional or alternative components. These components may include menus, lists, buttons, text boxes, labels, radio buttons, scroll bars, sliders, check boxes, combo boxes, status bars, dialog boxes, windows, etc. The user interface screens may include additional or alternative information. The components may be arranged, grouped, and labeled in any suitable order.

[0090] This disclosure includes certain embodiments, examples, and applications, but the disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments or uses and their obvious modifications and their equivalents, and includes embodiments that do not necessarily provide all of the features and advantages described herein. Accordingly, it will be understood by those skilled in the art that the scope of this disclosure is not intended to be limited by the specific disclosure of the preferred embodiments herein, but may be defined by the claims presented herein or presented hereafter.

[0091] Conditional language such as "can," "could," "might," or "may" is ordinarily intended to convey that a particular embodiment includes, while other embodiments do not include, a particular feature, element, or step, unless specifically stated otherwise or otherwise interpreted within the context in which it is used. Thus, such conditional language is not necessarily intended to imply that a feature, element, or step is necessarily included in one or more embodiments, or that logic for determining whether such a feature, element, or step is included in a particular embodiment, or should be implemented in a particular embodiment, is necessarily included in one or more embodiments, whether or not user input or instructions are present. The terms "comprising," "including," and "having" are synonymous and are used in an inclusive non-limiting fashion and do not exclude additional elements, features, acts, and operations, etc. Also, the term "or" is used in an inclusive sense (and not an exclusive sense) such that, for example, when used to connect a list of elements, it means one, some, or all of the listed elements. Further, the term "each," as used herein, in addition to having its ordinary meaning, may also mean any subset of a series of elements to which the term "each" applies.

[0092] Conjunctive phrases such as the phrase "at least one of X, Y, and Z" are to be construed separately, together with the context in which they are commonly used to convey that an item, term, etc. can be either X, Y, or Z, unless specifically stated otherwise. Thus, such conjunctive phrases do not necessarily imply that a particular embodiment requires inclusion of at least one of X, at least one of Y, and at least one of Z.

[0093] Phrases indicating the degree used herein, such as the terms "about", "approximately", "generally", and "substantially" used herein, represent a value, amount, or property that is close to a predetermined value, amount, or property that still performs the desired function or yields the desired result. For example, the terms "about", "approximately", "generally", and "substantially" can mean an amount within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of a predetermined amount. As another example, in certain embodiments, the terms "generally parallel" and "substantially parallel" mean a value, amount, or property that deviates from a perfectly parallel state by 15 degrees or less, 10 degrees or less, 5 degrees or less, 3 degrees or less, 1 degree or less, or 0.1 degree or less.

[0094] The scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere in this specification, but can be defined by what is presented in this section or elsewhere in this specification or by the claims presented hereinafter. The language of the claims should be interpreted in a broad sense based on the language used in the claims and is not limited to the examples described in this specification or during the procedure of this application, and those examples should be construed as non-exclusive. [Appended Claim 1] A wound dressing comprising a stabilization structure configured to be inserted into a wound, A negative pressure source configured to apply negative pressure to the wound dressing via a fluid flow path, A controller, monitoring the fluid removal amount from the wound and wirelessly communicating the fluid removal amount to a remote device, and a controller that outputs a display when the fluid removal amount satisfies a threshold value. A wound therapy device comprising the same. [Additional Item 2] The wound therapy device according to Additional Item 1, wherein the controller is further configured to adjust a negative pressure level supplied from the negative pressure source to the wound dressing when the fluid removal amount satisfies the threshold value. [Additional Item 3] The wound therapy device according to one or more of Additional Items 1 and 2, wherein the controller is further configured to monitor the fluid removal amount from the weight of the fluid sucked from the wound. [Additional Item 4] The wound therapy device according to Additional Item 3, wherein the controller is further configured to monitor the weight of the fluid sucked from the wound and the weight of the fluid stored in the canister. [Additional Item 5] The wound therapy device according to any one or more of Additional Items 1 to 4, further comprising a pressure sensor configured to monitor one or more characteristics of the pressure in the fluid flow path, and the controller is further configured to monitor the fluid removal amount using the one or more pressure characteristics. [Additional Item 6] The wound therapy device according to any one or more of Additional Items 1 to 5, further comprising a canister configured to store the fluid removed from the wound, and the controller is further configured to monitor the fluid removal amount from the fluid level in the canister. [Additional Item 7] The wound therapy device according to Additional Item 6, wherein the controller is further configured to monitor the fluid level in the canister using one or more characteristics of the pressure in the fluid flow path. [Additional Item 8] The wound therapy device according to Additional Item 7, wherein the controller is further configured to monitor the fluid level in the canister from the operating level of the negative pressure source. [Additional Item 9] The wound treatment device according to claim 8, wherein the negative pressure source includes a vacuum pump, and the operating level of the negative pressure source corresponds to the speed of the vacuum pump. [Additional Item 10] The wound treatment device according to any one or more of claims 3 and 7 to 9, wherein the one or more pressure characteristics include the magnitude of a pressure signal, and the magnitude of the pressure signal increases as the fluid level in the canister increases. [Additional Item 11] The wound treatment device according to any one or more of claims 1 to 10, wherein the controller wirelessly communicates the fluid removal amount to the remote device, and the remote device stores the fluid removal amount in an electronic medical record associated with the patient. [Additional Item 12] A method of operating a negative pressure wound treatment device comprising a controller and a negative pressure source configured to apply negative pressure to a wound dressing via a fluid flow path, the wound dressing comprising a stabilization structure inserted into the wound, the method comprising: monitoring a fluid removal amount from the wound; wirelessly communicating the fluid removal amount to a remote device; outputting a display when the fluid removal amount meets a threshold, and wherein the method is performed by the controller. [Additional Item 13] The method according to claim 12, further comprising adjusting a negative pressure level provided to the wound dressing by the negative pressure source when the fluid removal amount meets the threshold. [Additional Item 14] The method according to any one or more of claims 12 and 13, wherein monitoring the fluid removal amount includes monitoring the fluid removal amount from the weight of the flow rate aspirated from the wound. [Additional Item 15] The method according to claim 14, wherein monitoring the fluid removal amount includes monitoring the weight of the fluid absorbed from the wound and the weight of the fluid absorbed by the wound dressing or stored in the canister. [Additional item 16] Further comprising monitoring one or more characteristics of the pressure in the fluid flow path, wherein said monitoring of the fluid removal amount includes monitoring the fluid removal amount using said one or more pressure characteristics, according to any one or more of claims 12 to 15. [Additional item 17] The method according to any one or more of claims 12 to 16, wherein said monitoring of the fluid removal amount includes monitoring the fluid removal amount from the fluid level in a canister storing the fluid removed from the wound. [Additional item 18] The method according to claim 17, wherein said monitoring of the fluid removal amount includes monitoring the fluid level in the canister using one or more characteristics of the pressure in the fluid flow path. [Additional item 19] The method according to claim 18, wherein said monitoring of the fluid removal amount includes monitoring the fluid level in the canister from the operating level of the negative pressure source. [Additional item 20] The method according to claim 19, wherein the negative pressure source comprises a vacuum pump, and the operating level of the negative pressure source corresponds to the speed of the vacuum pump. [Additional item 21] The method according to any one or more of claims 15 and 18 to 20, wherein said one or more pressure characteristics include the magnitude of a pressure signal, and the magnitude of the pressure signal increases as the fluid level in the canister increases. [Additional item 22] The method according to any one or more of claims 12 to 21, wherein said wireless communication of the fluid removal amount includes wirelessly communicating the fluid removal amount to a remote device and storing the fluid removal amount in an electronic medical record associated with the patient by the remote device. [Additional item 23] A negative pressure source configured to apply negative pressure to a wound dressing material including a stabilization structure via a fluid flow path, wherein the stabilization structure is inserted into the wound and is configured to be folded when negative pressure is applied to the wound when the stabilization structure is positioned within the wound, the negative pressure source, A sensor configured to detect the pressure within the fluid flow path, A controller, wherein the negative pressure source determines a folding measurement amount of the stabilization structure from the pressure within the fluid flow path while maintaining the magnitude of the pressure within the fluid flow path within a negative pressure range, and a controller configured to output a display corresponding to the folding measurement amount, a wound treatment device comprising the same. [Additional item 24] The wound treatment device according to additional item 23, wherein the controller is configured to determine the folding measurement amount from a change in the magnitude of the pressure within the fluid flow path over time. [Additional item 25] The wound treatment device according to any one or more of additional items 23 and 24, wherein the controller is further configured to determine the folding measurement amount from a comparison with a pressure change pattern of the magnitude of the pressure within the fluid flow path over time. [Additional item 26] The wound treatment device according to additional item 25, wherein the pressure change pattern indicates one or more of (i) the magnitude of the pressure within the fluid flow path when the stabilization structure is completely folded, (ii) the magnitude of the pressure within the fluid flow path when the stabilization structure is partially folded, and (iii) the magnitude of the pressure within the fluid flow path when the stabilization structure is not folded. [Additional item 27] The wound treatment device according to any one or more of additional items 23 to 26, wherein the folding measurement amount includes the folding amount of the stabilization structure. [Additional item 28] The wound treatment device according to any one or more of claims 23 to 27, wherein the controller is further configured to detect that the suture has ruptured or broken from the pressure in the fluid flow path when the suture is close to the wound dressing material. [Claim 29] The controller is configured to (i) activate or deactivate the negative pressure source, (ii) activate or deactivate an alarm, (iii) increase or decrease the target negative pressure provided by the negative pressure source, or (iv) output the display for releasing the negative pressure in the fluid flow path. The wound treatment device according to any one or more of claims 23 to 28. [Claim 30] The controller is configured to output a display for controlling the activation and deactivation of the negative pressure source according to the target level of folding of the stabilization structure for a certain period of time, rather than aiming for a predetermined negative pressure threshold by adjusting the magnitude of the pressure in the fluid flow path by controlling the activation and deactivation of the negative pressure source. The wound treatment device according to any one or more of claims 23 to 29. [Claim 31] The wound treatment device according to claim 30, wherein the time is at least 1 minute, 5 minutes, 10 minutes, 30 minutes, 1 hour, or 5 hours. [Claim 32] The controller is configured to output a display for presentation to the user or storage in a memory device. The wound treatment device according to any one or more of claims 23 to 31. [Claim 33] The controller is further configured to store the device usage data associated with the display in a memory device, and the device usage data includes one or more of a pressure level, an alarm, an exudate level, an event log, and an operating time. The wound treatment device according to any one or more of claims 23 to 32. [Claim 34] ​The wound treatment device according to any one or more of claims 23 to 33, further configured such that the controller determines whether the wound dressing includes the stabilization structure from the pressure in the fluid flow path. [Claim 35] The wound treatment device according to any one or more of claims 23 to 34, wherein the sensor is configured to detect the pressure in the fluid flow path in the wound dressing, in one or more lumens of the fluid flow path, or at an inlet of the negative pressure source. [Claim 36] The wound treatment device according to any one or more of claims 23 to 35, wherein the negative pressure source is configured to perform negative pressure therapy when the magnitude of the pressure in the fluid flow path is maintained within the negative pressure range. [Claim 37] A method of operating a wound treatment device including a controller and a negative pressure source configured to apply a negative pressure to a wound dressing via a fluid flow path, wherein the wound dressing includes a stabilization structure, and further configured to be folded when a negative pressure is applied to the wound when the stabilization structure is positioned within the wound, the method comprising: monitoring the pressure in the fluid flow path; determining a folding measurement amount of the stabilization structure from the pressure in the fluid flow path while the negative pressure source maintains the magnitude of the pressure in the fluid flow path within a negative pressure range; outputting a display corresponding to the folding measurement amount; and the method is implemented by the controller. [Claim 38] The method according to claim 37, wherein determining the folding measurement amount includes determining the folding measurement amount from a change in the magnitude of the pressure in the fluid flow path over time. [Claim 39] The method according to any one or more of claims 37 and 38, wherein determining the folding measurement amount includes determining the folding measurement amount by comparing the magnitude of the pressure in the fluid flow path over time with a pressure change pattern. [Appended Item 40] The method according to appended item 39, wherein the pressure change pattern indicates one or more of (i) the magnitude of the pressure in the fluid flow path when the stabilization structure is fully folded, (ii) the magnitude of the pressure in the fluid flow path when the stabilization structure is partially folded, and (iii) the magnitude of the pressure in the fluid flow path when the stabilization structure is not folded. [Appended Item 41] The method according to any one or more of appended items 37 to 40, wherein the folding measurement amount includes the folding amount of the stabilization structure. [Appended Item 42] The method according to any one or more of appended items 37 to 41, wherein outputting the display includes outputting the display for (i) activating or deactivating the negative pressure source, (ii) activating or deactivating an alarm, (iii) increasing or decreasing the target negative pressure provided by the negative pressure source, or (iv) releasing the negative pressure in the fluid flow path. [Appended Item 43] The method according to any one or more of appended items 37 to 42, wherein outputting the display includes outputting the display for controlling the activation and deactivation of the negative pressure source according to a target level of folding of the stabilization structure for a certain period of time, rather than adjusting the magnitude of the pressure to aim for a predetermined negative pressure threshold. [Appended Item 44] The method according to appended item 43, wherein the time is at least 1 minute, 5 minutes, 10 minutes, 30 minutes, 1 hour, or 5 hours. [Appended Item 45] The method according to any one or more of appended items 37 to 44, wherein outputting the display includes outputting the display for presentation to a user or storage in a memory device. [Appended Item 46] Further comprising storing, in a memory device, device usage data associated with the display, the device usage data including one or more of a pressure level, an alarm, an effluent level, an event log, and an operating usage time, the method according to any one or more of appended claims 37 to 45. [Appended Claim 47] Further comprising determining whether the wound dressing includes the stabilization structure from the pressure in the fluid flow path, the method according to any one or more of appended claims 37 to 46. [Appended Claim 48] The monitoring of the pressure in the fluid flow path further includes monitoring the pressure in the wound dressing in one or more lumens of the fluid flow path or at an inlet of the negative pressure source, the method according to any one or more of appended claims 37 to 47. [Appended Claim 49] The negative pressure source is configured to perform negative pressure therapy when the magnitude of the pressure in the fluid flow path is maintained within the negative pressure range, the method according to any one or more of appended claims 37 to 48.

Claims

1. A negative pressure source configured to apply a negative pressure to a wound dressing material including a stabilization structure via a fluid flow path, wherein the stabilization structure is at least partially rigid, the stabilization structure is inserted into the wound, and when the stabilization structure is positioned within the wound, it is configured to be folded when a negative pressure is applied to the wound; a negative pressure source, a sensor configured to detect the pressure within the fluid flow path, a controller, wherein the negative pressure source determines a folding measurement amount of the stabilization structure from the pressure within the fluid flow path while maintaining the magnitude of the pressure within the fluid flow path within a negative pressure range, a controller configured to output a display corresponding to the folding measurement amount; a wound therapy device comprising the same.

2. The wound therapy device according to claim 1, wherein the controller is configured to determine the folding measurement amount from a change in the magnitude of the pressure within the fluid flow path over time.

3. The wound therapy device according to claim 1, wherein the controller is further configured to determine the folding measurement amount from a comparison with a pressure change pattern of the magnitude of the pressure within the fluid flow path over time.

4. The wound therapy device according to claim 3, wherein the pressure change pattern indicates one or more of (i) the magnitude of the pressure within the fluid flow path when the stabilization structure is fully folded, (ii) the magnitude of the pressure within the fluid flow path when the stabilization structure is partially folded, and (iii) the magnitude of the pressure within the fluid flow path when the stabilization structure is not folded.

5. The wound therapy device according to claim 1, wherein the folding measurement amount includes the folding amount of the stabilization structure.

6. The wound therapy device according to claim 1, wherein the controller is further configured to detect from the pressure within the fluid flow path that the suture has ruptured or broken when the suture is close to the wound dressing material.

7. The wound therapy device according to claim 1, wherein the controller is configured to (i) activate or deactivate the negative pressure source, (ii) activate or deactivate an alarm, (iii) increase or decrease a target negative pressure provided by the negative pressure source, or (iv) output the display for releasing the negative pressure within the fluid flow path.

8. The controller controls the operation and deactivation of the negative pressure source to adjust the magnitude of the pressure in the fluid flow path, not aiming for a predetermined negative pressure threshold, but outputs the display for controlling the operation and deactivation of the negative pressure source for a certain period according to the target level of folding of the stabilization structure. The wound therapy device according to claim 1, wherein the wound therapy device is configured to output the display.

9. The wound therapy device according to claim 8, wherein the certain period is at least one minute.

10. The controller of the wound therapy device according to claim 1 is configured to output the display for presentation to the user or for storage in a memory device.

11. The controller is further configured to store device usage data in a memory device, and the device usage data includes one or more of a pressure level, an alarm, an exudate level, an event log, and an operation usage time. The wound therapy device according to claim 1.

12. The controller of the wound therapy device according to claim 1 is further configured to determine whether the wound dressing material includes the stabilization structure from the pressure in the fluid flow path.

13. The sensor of the wound therapy device according to claim 1 is configured to detect the pressure in the fluid flow path in the wound dressing material, in one or more lumens of the fluid flow path, or at the inlet of the negative pressure source.

14. The negative pressure source of the wound therapy device according to claim 1 is configured to perform negative pressure therapy when the magnitude of the pressure in the fluid flow path is maintained within the negative pressure range.

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