Pressure-reducing therapy devices

Abstract

A pump assembly (104, 1000) for reduced pressure wound therapy, comprising: an accommodation (120, 1020); a pump (232, 1090), supported within or by the housing, such that the pump comprises: an engine (1092); one input (250) and one output (252); a first valve, configured to control the flow of a fluid through the inlet; and a second valve, configured to control the flow of a fluid through the outlet; a flow path through the pump assembly; and characterized by A one-way flow valve (246, 1030) is in fluid communication with the pump and is supported inside a manifold (240) arranged within the housing and coupled to the pump inlet, such that the one-way flow valve is configured to substantially impede the flow of a gas through the flow path, in a flow direction away from the pump, so that the pump assembly has been sterilized in such a way that at least one inside and one outside of the housing, the flow path, the first and second valves, and the pump have been sterilized.

Description

Reduced pressure therapy apparatus Field of the invention The embodiments disclosed herein relate to methods and apparatus for bandaging and treating a wound with topical negative pressure (TNP) therapy. For example, but not limitation, some embodiments disclosed herein relate to treating a wound with reduced pressure delivered from a pump set. Although not required, some embodiments of the pump set may be sterile. As another non-limiting example, some embodiments disclosed herein refer to apparatus and methods for controlling the operation of a NPT system. Description of Related Art Many different types of wound dressings are known to aid the healing process of a person or animal. These different types of wound dressings include many different types of materials and layers, for example gauze, silk, compresses, foam compresses or multi-layered wound dressings. Topical negative pressure (TNP) therapy, sometimes referred to as vacuum-assisted closure negative pressure wound therapy, or reduced pressure wound therapy, has been widely recognized as a beneficial mechanism for improving speed of healing a wound. Such therapy is applicable to a wide range of wounds, such as incisional wounds, open wounds, and abdominal wounds or the like. Some examples of such systems are known from US 2009 / 125004, US 4,643,641 and WO 2010 / 126444. PNT therapy aids wound closure and healing by reducing tissue edema, promoting blood flow, stimulating granulation tissue formation, removing excess exudative material, and may reduce bacterial load and thus therefore, infection of the wound. On the other hand, NPT therapy allows less disturbance of the wound from the outside and favors faster healing. Compendium of some achievements Some embodiments disclosed herein relate to a reduced pressure wound therapy pump assembly, comprising a housing, a pump supported within or by the housing, a flow path through the pump assembly, and a valve. One-way flow, or non-return, in fluid communication with the pump and supported by the housing. Some embodiments of the one-way flow valve may have been configured to substantially prevent the flow of gas through the flow path in a flow direction away from the pump. The pump may have a motor, an inlet and an outlet, a first valve, supported by the pump and configured to control the flow of a fluid through the inlet, and a second valve, supported by the pump. support the pump and that it has been configured to control the flow of fluid through the outlet. Some embodiments disclosed herein relate to a reduced-pressure wound therapy pump assembly, comprising a housing, a pump supported within or by the housing, a one-way flow, or non-return, valve in fluid communication with the pump, and a flow path through the pump assembly. The one-way flow valve may be configured to substantially prevent the flow of a gas through the flow path, in a flow direction away from the pump. The pump may comprise a motor, an inlet and an outlet. In any of the pump embodiments disclosed herein, although it is not necessary, the pump may also have a first valve configured to control the flow of a fluid through the inlet, and a second valve configured to control the flow of a fluid through the outlet. Some pump embodiments disclosed herein may use orifices or other features or components to control a flow or flow rate of fluid through the pump. Some embodiments disclosed herein relate to a negative pressure therapy kit for reduced pressure wound therapy, which comprises a pump assembly comprising a housing, a pump supported within the housing, and a controller supported within the housing. or by the housing, and at least one switch or button, supported by the housing. As used throughout this specification, the term "some embodiments" or "in some embodiments" is used to refer to any embodiment described, illustrated, incorporated by reference, or otherwise disclosed in this specification. The at least one switch or button may be in communication with the controller and may be accessible to a user in order to allow the user to control one or more modes of operation of the pump. In some embodiments, although not required, the negative pressure therapy set may comprise a bandage, configured to form a substantially fluid-tight seal over a wound, a conduit, engageable with the bandage and the pump assembly, and configured to provide a substantially or completely closed fluid flow path, from the pump assembly to the bandage, and a first packaging element, for packaging the pump assembly, the one or more batteries, the bandage, and the conduit. In some embodiments, the controller may have been configured to control the operation of the pump and the valve. Some realizations of the game for Negative Pressure Therapy may have been configured in such a way that the Negative Pressure Therapy Set is sterile. The set for negative pressure therapy may have been sterilized in such a way that at least the interior and exterior of the housing, the at least one valve, the pump, the controller and the at least one switch or button have been sterilized. In some embodiments, the pump may have a pump motor, an inlet and an outlet, at least one valve, configured to control fluid flow through at least one of the inlet and outlet, and a flow path. through at least the inlet, the outlet and the at least one valve. Some embodiments disclosed herein relate to reduced pressure treatment of wounds with a reduced pressure pump. The pump embodiments disclosed herein need not have been sterilized. However, the practice of sterilizing the reduced-pressure pump prior to use and providing the pump and / or dressing or pump set components in a sterile state may make it possible to use the pump in an operating room (to which also referred to as the operating room) or in any other location where sterility of devices is necessary. For example, and without limitation, some embodiments are directed to a sterile pump set comprising a sterile pump, sterile bandage, and sterile tubing, connectable to the bandage and pump, and usable in an operating room. Some embodiments disclosed herein relate to a negative pressure therapy kit for reduced pressure wound therapy, comprising a pump having a flow rate of approximately 350 milliliters per minute or less, and a bandage comprising a cover layer. The dressing may have a wound-contacting surface, which is covered with a silicon-based material adhesive. Some embodiments disclosed herein relate to catheterless pumps for reduced pressure wound therapy, comprising a housing, a flow path through the pump, one or more valves in communication with the flow path, and a pump , supported within or by the housing, in such a way that the pump does not have a cartridge. Some embodiments disclosed herein relate to a cartridgeless pump assembly for reduced pressure wound therapy, which comprises a housing and a pump, supported within or by the housing. The pump may have a motor, an inlet and an outlet, a first valve, supported by the pump and configured to control the flow of a fluid through the inlet, and a second valve, supported by the pump and configured to control the flow of a fluid through the inlet. flow of a fluid through the outlet. The pump or pump assembly may be without a cartridge. Furthermore, although not necessary for all embodiments disclosed herein, the first and second valves may each have a leak rate of between about 0.1 ml / min and about 10 ml / min. min at nominal working pressures and / or during nominal sterilization pressures, or between 0.1 l / min or less and 5 ml / min or more, or between 1 ml / min or less and 3 ml / min or more, or between any two values ​​in any of the above ranges, at rated working pressures. In some embodiments, the leakage rate can be from about 0.4 ml / min to 0.7 ml / min at nominal working pressures and / or over the course of nominal sterilization pressures. Some embodiments of the pump assembly may have a piezoelectric pump, such as, without limitation, the piezoelectric pump disclosed in US 7,550,034 and / or US 2011 / 186765. Some piezoelectric pumps may have ports to carry out the functions of a valve, such that, when the pump is idle, the flow rate through the pump may be as high as 200 ml / min. Therefore, in some embodiments, in the event that the flow rate of the pump may be as high as approximately 300 ml / min or 320 ml / min, or otherwise, the first and second valves (which may consist of orifices ) can each have a leakage rate of up to approximately 200 ml / min. Some embodiments disclosed herein relate to a sterile pump set comprising any of the pump embodiments disclosed herein, a bandage, a conduit, engageable with the bandage and the sterile pump and configured to provide a path of delivery. reduced pressure fluid to the bandage, one or more batteries, and a first packaging element and a second packaging element, configured to be removably engaged with the first packaging element. In some embodiments, at least one of the first and second packaging elements may have recesses for receiving the sterile pump, a bandage, a conduit engageable with the bandage and the sterile pump, and configured to provide a pressure fluid path. reduced to bandage. The sterile pump set may be sterilized once the pump, bandage, tubing, and one or more batteries have been arranged to be supported within at least one of the first packaging element and the second packaging element. Some embodiments disclosed herein relate to a method of initiating wound treatment in an operating room, comprising applying a sterile dressing over a wound to create a substantially fluid-tight closure over the wound, attaching a sterile pump to the bandage through a sterile line, and reduce the amount of pressure between the bandage and the wound in an operating room by activating the existing pump in the operating room. Some of the embodiments disclosed herein relate to apparatus and methods for controlling the operation of a negative pressure wound therapy system. in particular, but without Limitation, embodiments disclosed herein relate to negative pressure therapy apparatus and bandages, as well as methods and algorithms for operating such negative pressure therapy systems. In some embodiments, although it is not necessary, an apparatus may comprise a bandage configured to be placed over a wound and create a substantially fluid-impermeable closure over the wound. An apparatus may comprise a source of negative pressure delivery configured to be attached to the bandage. The apparatus may further comprise a controller, configured to activate the negative pressure supply source, monitor a duty cycle of the negative pressure supply source, and determine if the duty cycle exceeds a duty cycle threshold. worked. In some embodiments, the controller may be configured to monitor a plurality of duty cycles of the negative pressure supply source over a plurality of equal and consecutive duration times, and determine if a duty cycle of the plurality of duty cycles exceeds a duty cycle threshold. The duty cycle may reflect the amount of time the negative pressure supply source is on for a certain period of time or for one of the plurality of consecutive and equal duration times. In some embodiments, the controller may have been configured to determine if a certain number of duty cycles exceed the duty cycle threshold and if that number exceeds an overload threshold. In some embodiments, the controller may be configured to determine if a set of duty cycles among the plurality of duty cycles exceeds a duty cycle threshold, and to determine if the number of duty cycles in the set exceeds a threshold of duty cycles. overload. The controller may have been configured to determine if the number of duty cycles that exceed the duty cycle threshold are consecutive. In some embodiments, the overload threshold may comprise 30 duty cycles, the time period or duration may comprise one minute, and / or the duty cycle threshold may comprise 9%. In some embodiments, the controller may be configured to continuously monitor the duty cycle or a plurality of duty cycles. Some embodiments of the apparatus comprise a switch, configured to stop the negative pressure supply source for a certain period of time, and the controller may be configured to restart the negative pressure supply source on expiration of the time period. The time period can be variable. In some embodiments, the apparatus may be enclosed in a housing comprising an outer surface, and the switch comprises a button located on the outer surface of the housing. Some embodiments of the apparatus comprise a controller configured to provide an indication of a state of operation. The operating state may comprise determining that the duty cycle exceeds the duty cycle threshold, and the indication may comprise turning off the negative pressure supply source to indicate a leak in the seal. In some embodiments, the operating state includes the possibility of the negative pressure supply source being temporarily stopped, and the controller may be configured to provide a first indication when the negative pressure supply source is active, and a second indication when the negative pressure supply source is temporarily stopped, such that the second indication is different from the first indication. In some embodiments, the controller may be configured to activate the pressure input source to attempt to generate a desired magnitude of negative pressure under the bandage and, if upon expiration of a first time interval, a magnitude of pressure under the bandage. the bandage has not reached the desired amount of negative pressure, the controller can turn off the source of negative pressure supply for a second time interval. Upon expiration of the second time interval, the controller may activate the negative pressure delivery source in order to try to generate the desired amount of negative pressure under the bandage. The controller may have been configured to vary the second time interval based on the number of times the amount of pressure under the bandage has not reached the desired amount of negative pressure. For example, the controller may have been configured to double the second time interval as long as a resulting value does not exceed a second interval threshold. The apparatus may comprise a sensor configured to detect pressure under the bandage and to communicate the detected pressure to the controller. In some embodiments, the controller may be configured to turn off the negative pressure supply source once the amount of pressure under the bandage has reached the desired amount of negative pressure, and turn on the negative pressure supply source once the amount of negative pressure has been reached. amount of pressure under the bandage rises above a negative pressure threshold, such that the desired amount of negative pressure corresponds to a pressure that is more negative than the negative pressure threshold. In some embodiments, the negative pressure delivery source can be operated by placing a bandage over a wound to create a substantially fluid-impermeable closure over the wound, delivering negative pressure to the bandage from the negative pressure delivery source. negative pressure, monitoring a duty cycle of the negative pressure supply source, and providing an indication if the duty cycle is determined to exceed a duty cycle threshold. The duty cycle may reflect an amount of time that the negative pressure supply source is active for a certain period of time, such as once per minute. Some embodiments of the apparatus may have been configured to monitor a total time elapsed since an initial activation, and disable activation of the negative pressure source when the total time elapsed reaches a certain threshold of useful life. The shelf life threshold may comprise, for example, 7 days. In some embodiments, the apparatus for applying negative pressure to a wound comprises a bandage, configured to be placed over a wound to create a substantially fluid-impermeable closure over the wound, a source of negative pressure delivery, configured to be coupled to the bandage, and a controller, configured to activate the negative pressure supply source, monitor a duty cycle of the negative pressure supply source, and provide an indication if the duty cycle exceeds a certain duty cycle threshold. worked. In some embodiments, the apparatus comprises a bandage, configured to be placed over a wound to create a substantially fluid-tight seal over a wound, and a pump configured to be coupled to the bandage, a switch, configured to stop the pump for a certain period of time, and a controller, configured to restart the pump at the expiration of the period of time. The time period can be variable. Some embodiments of the apparatus comprise a miniature diaphragm pump driven by a motor, or a miniature diaphragm pump driven by a piezoelectric transducer. In some embodiments, the pump may comprise a miniature piston pump and a miniature diaphragm pump. Some embodiments disclose a method of operating a source of negative pressure delivery (eg, a negative pressure pump), such that the method comprises placing a bandage over a wound to create a substantially fluid-impermeable seal over the wound. the wound, supplying a negative pressure to the bandage from the pump, stopping the pump for a certain period of time, and restarting the pump at the expiration of the period of time. The time period can be variable. In some embodiments, a negative pressure pump may be operated by placing a bandage over a wound in order to create a substantially fluid-impermeable seal over the wound, aspirating fluid from the bandage using the negative pressure pump, measuring a magnitude or degree of activity of the pump, comparing the degree of activity of the pump with a certain threshold, and providing an indication if the degree of activity exceeds the threshold. Measurement of the degree of activity may comprise determining a duty cycle of the pump, determining a flow rate of the fluid aspirated from the wound (eg, by use of a fluid meter, or flowmeter), measuring the rate of change of pressure under the bandage using a pressure sensor, etc., or any combination of these practices. Some embodiments disclose a method of operating a negative pressure pump, which comprises placing a bandage over a wound to create a substantially fluid-impermeable seal over the wound, supplying a negative pressure to the bandage from the pump to draw pressure under the bandage, in the direction of a first negative pressure set point, activate the pump to draw pressure under the bandage, in the direction of the first set point, if the magnitude of the negative pressure under the bandage rises above a second negative pressure set point, monitoring the amount of time the pump has been running, and providing an indication if the amount of time exceeds a predetermined amount of time. The method may further comprise determining the amount of time that the pump has been running over a certain time period, and providing the indication if the amount of time exceeds 9% of the time period. In some embodiments, providing the indication further comprises determining the amount of time the pump has been running, over a certain period of time. In some embodiments, providing the indication further comprises activating an alarm. In some embodiments, the apparatus may be configured to activate a negative pressure delivery source to aspirate a pressure under a negative pressure wound therapy dressing until a desired negative pressure value is obtained, such as a value between a first point set point and a second set point, or approximately equal to the value of the second set point. The magnitude of the pressure under the bandage can be measured. The apparatus may have been configured to activate the negative pressure supply source to draw the subbandage pressure toward a second desired negative pressure magnitude (for example, the second set point value) if the subbandage pressure decreases above a certain threshold (for example, decreases to the value of the first set point). The amount of time that the negative pressure supply source has been operated, eg continuously, can be monitored. The operation of the negative pressure supply may be temporarily stopped or discontinued if the negative pressure supply has been operated for a predetermined amount of time without approximately the desired second magnitude of negative pressure being established under the dressing (for example, the value of the second set point). Some embodiments disclose a method of operating a negative pressure delivery source, which comprises placing a bandage over a wound to create a substantially fluid-impermeable seal over the wound, and delivering negative pressure to the bandage from the delivery source. negative pressure. Delivering negative pressure to the bandage from the negative pressure delivery source comprises activating the negative pressure delivery source to attempt to generate a desired amount of negative pressure under the bandage, and updating a first count of activations; if, at the expiration of a first time interval, the negative pressure under the bandage has not reached the desired negative pressure magnitude, deactivate the negative pressure supply source for a second time interval, as long as the first activation count is less than a first retry threshold; if the first activation count is not less than the first retry threshold, deactivate the negative pressure supply source for a third time interval, reset the first activation count, and at the expiration of the third time interval, activate the source supply of negative pressure to try to generate the magnitude of negative pressure desired under the bandage; activating the negative pressure supply source at the expiration of the second time interval, in order to try to generate the desired amount of negative pressure under the bandage, and updating the first activation count; deactivating the negative pressure supply source when the negative pressure under the bandage has reached the desired negative pressure magnitude, resetting the first activation count, and monitoring the negative pressure under the bandage; when the negative pressure under the bandage 10 rises above a negative pressure threshold, activating the negative pressure supply source and updating a second count of activations such that the desired negative pressure magnitude corresponds to a pressure that it is more negative than the negative pressure threshold; if, before the expiration of a fourth time interval, the negative pressure under the bandage has reached the desired negative pressure magnitude, turn off the negative pressure supply source, monitor the negative pressure under the bandage, and restore the 15 second activation count; if, by the expiration of the fourth time interval, the negative pressure under the dressing has not reached the desired negative pressure magnitude, turn off the negative pressure supply source for the second time interval, provided the second activation count is less than a second retry threshold; if the second activation count is not less than the second retry threshold, turn off the negative pressure supply source for the third time interval, reset the second activation count, and at the expiration of the third time interval, activate the second activation count. negative pressure input source to try to generate the desired amount of negative pressure under the bandage and update the first activation count; continuously monitor a duty cycle of the negative pressure supply source; keep track of the number of duty cycles that exceed a certain duty cycle threshold; and deactivating the negative pressure supply source in the time that the third time interval lasts, when the number of work cycles that exceed the duty cycle threshold exceeds a certain overload threshold. Brief description of the drawings Embodiments of the present invention will be described hereinafter by way of example only, with reference to the accompanying drawings, in which: Figure 1 illustrates one embodiment of a reduced pressure wound therapy apparatus, comprising a pump, a bandage, and a conduit. Figures 2A-2F are various views of the embodiment of the pump illustrated in Figure 1. Figure 3A illustrates an embodiment of a wound dressing kit comprising a dressing, a pump, a conduit, two batteries and one or more sealing strips, carried within a first packaging element. Figure 3B is an isometric view from below of the bandage kit embodiment of Figure 3A. Figure 3C is an exploded view of the wound dressing kit embodiment of Figure 3A. Figure 4A is a first exploded view of one embodiment of the pump of Figure 1. Figure 4B is a second exploded view of the embodiment of the pump of Figure 1. Figures 5A and 5B are first and second views of the first housing member. Figures 6A and 6B are first and second views of the second housing member. Figures 7A-7D illustrate the use of one embodiment of a TNP wound management system being used to treat a wound site on a patient. Figures 8A-20H are, respectively, top isometric, bottom isometric, top plan, bottom plan, front elevational, rear elevational, first side, and second side views of embodiments of packaging elements. which can be used with any of the embodiments of wound dressing devices disclosed herein, including a variety of differently dimensioned wound dressing devices. Figure 21 illustrates a pump assembly in accordance with some embodiments. Figure 22 illustrates a cross-sectional view showing the interior of a pump assembly according to some embodiments. Figure 23 illustrates a system schematic of a pump assembly in accordance with some embodiments. Figure 24 illustrates a schematic of electrical components of a pump assembly in accordance with some realizations. Figure 25 illustrates a top level state diagram of the operation of a pump set according to some embodiments. Figure 26 illustrates a status diagram of the operation of a pump assembly in accordance with some embodiments. Figure 27 illustrates another state diagram of pump assembly operation in accordance with some embodiments. Figure 28 illustrates a graph representing a duty cycle determination for a pump assembly in accordance with some embodiments. Figure 29 illustrates the operation of a pump set in the presence of a small leak, according to some embodiments. Figure 30 illustrates the operation of a pump set in the presence of a large leak, according to some embodiments. Figure 31 illustrates the operation of a pump set in the presence of a very large leak, according to some embodiments. Figure 32 illustrates the operation of a pump set in the presence of an extremely large leak, in accordance with some embodiments. In the drawings, like reference numerals refer to like parts. Detailed Description of the Preferred Embodiments The embodiments disclosed herein relate to apparatus and methods of treating a wound with reduced pressure. As used herein, magnitudes of reduced or negative pressure, such as -X mm Hg [millimeters of mercury ], represent magnitudes of pressure that are below standard atmospheric pressure, which corresponds to 760 mm Hg (or 1 atm, 29.93 inHg [inches of mercury column], 101, 325 kPa, 14, 696 psi [ pounds per square inch], etc.). Accordingly, a negative pressure value of -X mm Hg reflects the absolute pressure, which is X mm Hg below 760 mm Hg, or, in other words, an absolute pressure of (760 - X) mm Hg. . In addition to that, negative pressure that is "less" or "smaller" than X mm Hg corresponds to a pressure that is closer to atmospheric pressure (for example, -40 mm Hg is less than -60 mm Hg). . Negative pressure that is "greater" or "greater" than -X mm Hg corresponds to a pressure that is further from atmospheric pressure (for example, -80 mm Hg is greater than 30 -60 mm Hg). Some of the embodiments comprise a pump and / or a pump and bandage kit. Some embodiments are directed to a pump and / or pump and dressing set that have been sterilized prior to delivery to the hospital, operating room, or operating room, or to the medical professional using such devices, in such a manner that the sterile pump and / or sterile pump / bandage set may be applied immediately following surgical or operative procedures. An advantage of this is that the surgeon can discharge the patient from the operating room knowing that the reduced pressure pump is working and that the reduced pressure therapy has been started at the earliest possible time point. An additional advantage of applying the dressing kit immediately following a surgical or other procedure is that by doing so, the possibility of infection may be reduced by eliminating a subsequent dressing change that might otherwise be involved. be required in the room. In other words, for patients who have a bandage applied (but not a pump) in the operating room, and then find a problem such as a leak or other problem with the bandage, should it be need to remove the bandage to be reapplied, replaced, or otherwise treated once the patient has been discharged from the operating room, the patient's wound may be at risk of infection when the bandage is reapplied, replaced, or otherwise treated way, out of the 45 operating room. However, with the embodiments disclosed herein, if the pump is applied and tested while the patient is in the operating room, any issues with the bandage that may require the bandage to be removed, repositioned, or treated otherwise, they can be performed in the sterile environment of the operating room, significantly reducing or eliminating the risk of exposure to pathogens, bacteria, or other contaminants. On the other hand, it is not generally possible for a hospital to sterilize a conventional pump once it has been received by the hospital, and therefore the hospital may resort to packing the pumps in sterile bags, but there is a risk of compromising the sterile field of the operating room with this solution, particularly once the device has been turned on and any pathogens, bacteria, or other contaminants that may be within the pump have been released as a result of pump operation. In some embodiments, the pump may have been configured to be amenable to gas sterilization, such that it has properties, components and other characteristics that make the pump susceptible to complete exposure and penetration of the sterilizing gas throughout all components of the pump. For example, and without limitation, one or more valves in the pump have been selected or configured to allow a sufficient flow of sterilizing gas through such that the entire fluid path within the pump can be exposed. to sterilization gas. As will be explained in more detail below, in some embodiments, the pump may have other components, such as, without limitation, strategically placed one-way flow valves, to complement the other valves within the pump, which may enhance the efficiency of the pump by reducing leakage through the flow path within the pump assembly. Additionally, if provided, the sterile pump / bandage set may also have been designed and configured to be amenable to gas sterilization. As described below, the sterile pump / bandage set may have been configured in such a way that all components comprising the sterile pump / bandage set are packaged together in at least a first packaging element prior to use, allowing all components to be sterilized together. Furthermore, as will be described, the components comprising the sterile pump / bandage set may have been arranged in the packaging in such a way that at least some of the components may be removed in a predefined order, making it easier for the surgeon or practitioner to doctor assemble and apply bandage to patient. There are a number of benefits to having the ability to initiate treatment of a wound in the operating room, including, without limitation, providing a substantially watertight barrier over the wound while the wound is in a healthy state. sterile and in an environment that will inhibit or prevent bacteria and other contaminants from reaching the wound. Additionally, initiation of reduced pressure treatment at the earliest possible stage is also advantageous for wound healing. Additionally, embodiments disclosed or incorporated by reference herein, such as those disclosed in US Patent Application No. 13 / 092,042, UK Patent Application Nos. 1015656.0, 1006986.2, 1006983.9, 1006985.4, 1006988.8 and 1008347.5 comprise improved wound dressing components. All embodiments, components, features, and other details of these disclosures are hereby incorporated by reference herein as if they formed part of this disclosure, and may be used instead of, or in combination with, any of the components, features and other details of the embodiments that are disclosed herein. For example, in some embodiments, the wound dressing may have been configured to act as an intermediate cushioning element to help prevent compression or shear forces being exerted on the wound dressing, for example, due to patient movement. for damage to a healing wound. Embodiments of the wound dressing can act as a waste cartridge for collecting and storing exudate material removed from the wound site, and also in a manner related to managing the accumulation of solids within a wound dressing covering the wound site. a wound while NPT therapy is being applied. Furthermore, embodiments disclosed herein relate to a method and a suction port for applying negative pressure to a wound dressing, as well as a method for manufacturing a suction port and a wound dressing. Furthermore, some embodiments disclosed herein are directed to systems including negative pressure therapy bandages and apparatus, as well as methods and algorithms for operating such negative pressure therapy apparatus for use with negative pressure therapy bandages. negative pressure. In some embodiments, a negative pressure therapy apparatus comprises a pump assembly configured, among other things, to provide negative pressure to a wound. Some embodiments of pump sets disclosed herein comprise new and inventive control logic configured to control the operation of the pump set. For example, some embodiments comprise new and inventive control logic configured to control the operation of a pump set in response to monitoring and detection of various operating states, such as the presence and / or severity of a leak(s). in the system, the flow rate of fluid (eg, air, liquid and / or solid exudate material, etc.) drawn from a wound, and the like. In some embodiments, control logic may have been configured to detect a leak or leaks in a system (for example, a leak or leaks in the dressing that is in fluid communication with the pump, a leak or leaks in the seal created by the bandage on the wound, etc.), as well as to control the operation of the pump set when such a leak or leaks is detected. In some embodiments, the pump set may have been configured to distinguish between at least a normal or small leak (eg, a leak that has a relatively low flow rate), a large leak (eg, a leak that has a relatively low flow rate). relatively large flow rate) and a very large leak (for example, a leak having a relatively very large flow rate), some embodiments may have additionally been configured to also distinguish between the aforementioned leaks and an extremely large leak . In some embodiments, the pump assembly may comprise a negative pressure source, such as a disposable miniature pump, powered by a power input source, such as a battery source. The pump set may have been set to provide therapy for a predetermined period of time, such as approximately 1 day, 2-10 days, etc. In some embodiments, the pump set may be required to provide therapy uninterrupted for such a period of time. In some embodiments, the pump set may be configured to turn itself off for a predetermined period of time (eg, 7 days), after an initial activation. The algorithm or logic that is disclosed in this memory can help the pump set to run more efficiently and save power, such as, but not limited to, battery power. In some embodiments, the pump set may have been configured to monitor the duty cycle of the negative pressure supply source (eg, a pump). As used herein, "duty cycle" reflects the amount of time the negative pressure supply source is active or running over a period of time. In other words, the duty cycle reflects the time that the negative pressure supply source is in an active state, as a fraction of the total time under consideration. This can be represented mathematically as: DC = t / T, (1) where DC is the duty cycle, t is the duration that the negative pressure supply source is active, and T is the total time under consideration. The duty cycle can be measured as an absolute value (for example, X seconds), as a ratio (for example, 1 / X), as a percentage (for example, X%), etc. For example, if over a period of 1 minute, the negative pressure supply source has been on (or running) for 6 seconds and off (or not running) for 54 seconds, the duty cycle can be represented as 6 seconds, 1 / 10, 10%, etc. In some embodiments, the pump assembly may include a controller, configured to monitor the duty cycle of the negative pressure supply source. Duty cycle measurements may reflect a degree of activity of the negative pressure supply source. For example, the duty cycle may indicate that the negative pressure supply is operating normally, working hard, working extremely hard, etc. Furthermore, duty cycle measurements, such as periodic duty cycle measurements, can reflect various operating states, such as the presence and / or severity of leaks in the system, the fluid flow rate (for example, air, liquid and / or solid exudative material, etc.) aspirated from a wound, and similar conditions. Based on the duty cycle measurements, such as by comparing the measured duty cycle to a set of thresholds (eg, determined in calibration), the controller can take effect, and / or be programmed to take effect. , algorithms, or logic that control the operation of the system according to various system requirements. For example, duty cycle measurements may indicate the presence of a large leak in the system, and the controller may have been programmed to indicate this condition to the user (eg, patient, nursing staff, medical professional, etc.) and / or or suspend or temporarily stop the operation of the negative pressure supply source in order to save energy. In some embodiments, the system may have been configured to monitor flow rate by any other suitable means. The pump set may have been configured to use flow meters (eg, mechanical, pressure-based, optical, mass, thermal mass, electromagnetic, sonic, ultrasonic, laser Doppler, etc.), anemometers, pressure transducers or sensors, electromagnetic sensors (for example, sensors configured to measure the speed of the pump, such as Hall effect sensors), electromagnetic measurements (for example, that measure the current and / or power consumption of the pump , which measure the current and / or power draw from the power input source, which measure the remaining capacity of the power input source, etc.), or any combination thereof. Based on the monitored flow rate, such as by comparing the flow rate to a set of thresholds (eg, determined in calibration), the controller can perform, and / or be programmed to perform, algorithms or logic that controls the operation of the system according to various system requirements. For example, the controller may have been configured to get periodic measurements from a pressure sensor or get periodic feedback from a pump motor. The pressure sensor can measure the pressure under the bandage. The controller can determine the flow rate, for example, by determining a pressure gradient, the rate of change of pressure, and / or the rate of pressure decay. For example, a positive pressure gradient (for example, one that is increasing) may reflect an increasing flow rate (for example, a leak) relative to a threshold, and the controller may have been programmed to indicate this state when Username. In some embodiments, the system may be provided for the treatment of a wound. The dressing may create a substantially sealed or closed space around the wound (for example, under the dressing), and the pump assembly may have a sensor that is capable of periodically or continuously measuring or monitoring a magnitude of pressure within the wound. of this space. The pump set, or a controller thereof, may be configured to control the amount of pressure within the space (eg, under the bandage), between a first negative pressure set point limit and at least one second. negative pressure set point limit. In some embodiments, the first set point limit may be about -70 mm Hg, or from about -60 mm Hg or less to about -80 mm Hg or more. In some embodiments, the second set point limit may be about -90 mm Hg, or from about -80 mm Hg or less to about -100 mm Hg or more. In some embodiments, the system may have been configured to include a "retry" functionality and / or logic. The pump set may have been configured to monitor a magnitude of negative pressure under the dressing (which may correspond to the magnitude of negative pressure within the cavity of the wound), comparing the monitored magnitude to a desired negative pressure magnitude (eg, a first set point, second set point, etc.), and suspending or temporarily stopping therapy if the desired negative pressure magnitude is not reached during a certain interval of time. Following suspension or temporary stopping of therapy, the pump set may have been set to restart therapy (for example, restart the source of negative pressure delivery) and try again to generate the desired amount of negative pressure under the bandage. . The retry functionality can, for example, save battery power and allow transient and / or non-transient leaks to be resolved without user intervention, or allow the user to fix the leak (for example, reinforce the bandage, fix sealing, check the connection or connections, etc.). In some embodiments, a controller may implement, and / or be programmed to implement, functional capability and / or retry logic. In some embodiments, the system may have been configured to provide "play / pause" functionality and / or logic via a switch, button, etc., located outside the pump set housing or elsewhere. appropriate in which it can be accessed by the user. The play / pause functionality may allow the user to suspend and / or restart therapy (eg, temporarily stop and / or restart the pump). The pump set may have been configured to automatically restart therapy thereafter at a certain predetermined or variable pause interval. The pump set may have been configured to automatically restart therapy at the expiration of such an interval and / or upon prompting the user of the expiration of such an interval. In some embodiments, the system may have been configured to provide an indication, alarms, etc. to the user that reflect the operating states. The system may include visual, audible, tactile, and other indicators and / or alarms configured to alert the user to various states of operation. Such states include system on / off, standby stop, pause, normal operation, dressing problem, leak, error, and the like. Indicators and / or alarms may include speakers, displays, light sources, etc., and / or combinations thereof. For example, it can provide an indication by turning the negative pressure supply source on or off, reducing the amount of negative pressure generated by the negative pressure supply source, reducing the amount of power used by the source negative pressure supply, etc., or any combination of these. Figure 1 illustrates one embodiment of a reduced pressure wound treatment apparatus 100, comprising a wound dressing 102, in combination with a pump assembly 104. In any of the apparatus embodiments disclosed herein, such as In the embodiment illustrated in Figure 1, the pump set may be a non-cartridge pump set (meaning that the pump set does not have a cartridge for collection of exudate material or liquid). However, any of the pump embodiments disclosed herein can be configured to include or support a cartridge. Additionally, in any of the apparatus embodiments disclosed herein, any of the pump assembly embodiments may be mounted to or supported by the bandage, or be adjacent to the bandage. The bandage 102 may be placed over a wound (not shown), as described in more detail in US Patent Application No. 13 / 092,042, the disclosure of which is hereby incorporated by reference so as to form part of this disclosure, and a conduit 106 may then be connected to bandage 102. Bandage 102 or any other bandage disclosed herein may have any of the materials, sizes, components, or other details of any of the bandage embodiments disclosed herein. US Patent Application No. 13 / 092,042, and such embodiments and illustrations thereof are hereby incorporated by reference in their entirety, as if forming a part of this disclosure. Conduit 106 or any other conduit disclosed herein may be made of polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material. Some embodiments of bandage 102 may have a port 108, configured to receive one end of conduit 106 (eg, first end 106a of conduit 106), although such a port 108 is not required. In some embodiments, the conduit may otherwise pass through and / or under the bandage 108 to provide a source of reduced pressure delivery to a space between the bandage 102 and the wound to maintain a desired amount of reduced pressure in said space. Some embodiments of apparatus 100 may have been configured such that first end 106a of conduit 106a is pre-attached to port 108. Conduit 106 may consist of any suitable article configured to provide at least one substantially fluid flow path. sealed between pump assembly 104 and bandage 102, in order to deliver the reduced pressure provided by pump assembly 104 to bandage 102. Bandage 102 may be provided as a single item, with all wound dressing elements (including port 108) pre-attached and integrated into a single unit. Wound dressing 102 can then be connected, via conduit 106, to a source of negative pressure delivery, such as pump set 104. In some embodiments, although it is not necessary, pump set 104 can be miniaturized. and portable, although larger conventional pumps, such as the EZ CARE(TM) pump, can also be used with the bandage. It will be understood that embodiments of the present invention are generally applicable to use in topical negative pressure (TNP) therapy systems. Briefly, pressure wound therapy Negative aids in the closure and healing of many forms of "difficult to heal" wounds by reducing tissue edema, promoting blood flow and granular tissue formation, and / or removing excess exudative material, and may reduce the bacterial load (and therefore the risk of infection). In addition to this, the therapy enables less disturbance to a wound, which leads to faster healing. PNT therapy systems can also aid the healing of surgically closed wounds, by removing fluid and helping to stabilize tissue at the closure apposition site. An additional beneficial use of PNT therapy can be found in grafts and flaps where removal of excess fluid is important and close graft-to-tissue proximity is required in order to ensure tissue viability. The wound dressing 102 may be placed over the site of a wound to be treated. The bandage 102 may form a cavity or enclosure that substantially forms a seal over the wound site. It will be appreciated that, throughout this specification, reference is made to a wound. In this sense, it is to be understood that the term "wound" should be interpreted broadly, so as to encompass open and closed wounds in which the skin is torn, cut or punctured, or in which trauma causes a bruise, or any other superficial or other conditions or blemishes on a patient's skin, or otherwise benefiting from reduced pressure treatment. A wound is therefore defined, in a broad sense, as any damaged region of tissue, in which fluid may or may not be produced. Examples of such wounds include acute wounds, chronic wounds, surgical incisions and other incisions, subacute and dehiscent wounds, traumatic wounds, skin flaps and grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stoma, surgical wounds. , traumatisms and venous ulcers, or other similar, although they are not limited by these. In some embodiments, the components of the PNT system described herein may be particularly suitable for incised wounds that exude a small amount of exudative wound material. Some embodiments of the apparatus have been designed to function without the use of a cartridge of exudation material. The bandage 102 may be configured to have a film that has a high water vapor permeability to allow excess fluid to evaporate, and may have a superabsorbent material contained within it to safely absorb moisture. exudate material from the wound. Some embodiments of the apparatus have been designed for single use therapy and can be disposed of in an environmentally friendly manner after a maximum use of approximately seven to eleven days. The pump may have been programmed to automatically end therapy after a desired number of days; for example, after seven days, no further operation of the pump will be possible. Some embodiments have been designed for longer or repeated use and may be configured to support a cartridge of exudate material. The apparatus 100 can be made in a wide variety of different models or versions, such that the size of the bandage 100 can be varied to accommodate a wide range of wound sizes. For example, appliances 100 can be made that have the following sizes of bandages 102 and wound pads (ie, absorbents, not illustrated in Figure 1). Bandage Approximate Size Wound Pad Approximate Size 4in x 11.75in (cm x 30cm) cm x 20 cm (2 in x 8 in) cm x 15 cm (6 in x 6 in) cm x 10 cm (4 in x 4 in) cm x 20 cm (6 in x 8 in) cm x 15 cm (4 in x 6 in) cm x 20 cm (4 in x 8 in) cm x 10 cm (2 in x 4 in) cm x 20 cm (8 in x 8 in) cm x 15 cm (6 in x 6 in) Some embodiments of the overlay or bandage may be substantially impervious to airflow and the flow of bacteria or other contaminants through the overlay, while being permeable to vapor transmission. In some embodiments, it may be preferable that the wound site be partially or completely filled with a wound packing material. This wound packing material is optional, but may be desirable in certain wounds, eg, deeper wounds. The wound packing material may be used in addition to the wound dressing 102. The wound packing material can generally comprise a porous and conformable or malleable material, for example, foam (including reticulated foams) and gauze. Preferably, the wound packing material has been sized or shaped to fit within the wound site, so as to fill any void spaces. The wound dressing 102 can then be placed over the wound site and the wound packing material overlying the wound site. When using a wound packing material, once the wound dressing 102 has been applied to form a seal over the wound site, it is transmitted TNP from a pump, through the wound dressing 102 and through the wound packing material, to the wound site. This negative pressure draws exudate material from the wound and other fluids or secretions away from the wound site. In some embodiments, tube 106 may have a connector 112 located at a second end 106b of tube 106. Connector 112 may be configured to mate with a short length of conduit 114 protruding from pump assembly 104, with a mating connector 114a. in communication with the short length of the 114, and with a connector supported by the pump housing (as described in more detail below), or otherwise. The length of the tube 114, in some embodiments, can be about 14 mm (0.55 in), or from about 1.27 cm (0.5 in) to about 12.7 cm (5 inches). The short length of conduit or tubing 114 can reduce discomfort caused to a patient while lying or otherwise resting on the pump and connector 112. Configuring the pump assembly 104 and tubing 106 such that the tubing 106 can be quickly and easily removed from the pump assembly 104, it can facilitate or enhance the dressing procedure or changes to the pump, if necessary. Any of the pump embodiments disclosed herein may be configured to have any of the connection configurations disclosed herein between the tubing and the pump. In some embodiments, such as the illustrated embodiment, the pump assembly 104 may be of a sufficiently small and portable size to be carried on a user's body or within a user's clothing. For example, the pump assembly 104 may have been sized to be affixed, using medical grade adhesive tape or otherwise, to a person's skin in a comfortable position, adjacent to or over the bandage 102, or another way. Alternatively, the pump assembly 104 may be sized to fit inside a person's pants or shirt pocket, or it may be attached to a person's body using a lanyard, pouch, or other device or item. suitable. In some embodiments, the pump assembly 104 may be powered by one or more batteries (eg, two batteries) and may weigh approximately 84 grams, or less than 90 grams, including the weight of the batteries. In some embodiments, pump assembly 104 can have any desired number of batteries and can weigh between about 80 grams and about 90 grams, or between about 75 grams and about 100 grams, or anywhere within the above ranges. For example, the weight and / or size of the pump assembly 104 can be reduced by reducing the size and / or weight of the batteries (to, for example, AAA size batteries, or smaller), or the size and / or or the weight of the bomb. On the other hand, some embodiments of the pump assembly 104 may be sized to have a total volume defined by an external surface area of ​​the pump of approximately 92.5 cubic centimeters (approximately 5.6 cubic inches) or less, or between 75 cubic centimeters or less and 115 cubic centimeters or more, or between 85 cubic centimeters and 100 cubic centimeters. Additionally, the pump assembly 104 can be further miniaturized using techniques known to one of ordinary skill in the art, to sizes on the order of about 40 cubic centimeters, or 40 cubic centimeters or less, or between 30 cubic centimeters or less. less and 60 cubic centimeters or more. Some embodiments of the pump assembly 104 may be sized to have a total volume of between 32.77 cubic centimeters (2 cubic inches) or less and 106.52 cubic centimeters (6.5 cubic inches) or more, or between about 65.55 cubic centimeters (4 cubic inches) and approximately 98.32 cubic centimeters (6 cubic inches), or between any values ​​within the above ranges. The pump assembly 104 may have an overall external size that is about 7.2 cm x about 6.4 cm x about 2.1 cm (or 7.2 cm x 6.4 cm x 2.1 cm), or a maximum of about 8.5 cm x about 8.5 cm x about 3 cm. Additionally, the pump assembly 104 may have an overall exterior size that is about 5.5 cm x about 4.8 cm x about 1.5 cm (or 5.5 cm x 4.8 cm x 1.5 cm ). As mentioned, the size and weight of the pump assembly 104 can be optimized, as they are in the embodiments disclosed herein, to make it more comfortable for the user to wear or carry, thus achieving greater mobility. increased. The negative pressure range for some embodiments of the present invention may be approximately -80 mm Hg, or between approximately -20 mm Hg and -200 mm Hg. Note that these pressures are relative to normal ambient atmospheric pressure; that is, -200 mm Hg will be approximately 560 mm Hg in practical terms. Alternatively, a pressure range down to -70 mm Hg, down to -80 mm Hg, or above -80 mm Hg can be used. Also, in other embodiments, it is possible to use a range of pressures below -75 mm Hg. Alternatively, a pressure range of above about -100 mm Hg, or even 150 mm Hg, may be provided by the apparatus 100. Other details regarding the operation of the pump assembly 104 are set forth in US Patent Application No. 13 / 092,042, and such embodiments, configurations, details, and illustrations thereof are hereby incorporated by reference in its whole, as if they were part of this disclosure. Figures 2A-2F are various views of the embodiment of the pump assembly 103 illustrated in Figure 1. Figure 3A illustrates one embodiment of a wound dressing 100 kit comprising a bandage 102 (which may be any of the dressing embodiments disclosed or incorporated by reference herein), a pump assembly 104, a conduit 140, one or more batteries 142 (two of which are shown), and one or more sealing strips 148, supported within a first packaging element 150. Figure 3B is an isometric view from below of the wound dressing kit 100 embodiment of Figure 3A. Figure 3C is an exploded view of the wound dressing kit 100 embodiment of Figure 3A. Referring to Figures 2A-3C, pump assembly 104 may have a housing 120 comprising a first housing member 120a and a second housing member 120b, a control button 122 (which may also be a switch or other component). the like), a battery cover 124, a connector 128 and one or more lights, which may be LED lights. In some embodiments, the pump assembly 104 may have more than one button 122 and may have three or more lights 132. The lights 132 may be configured to alert a user of a variety of operating and / or failure states of the assembly. 104, including alerting the user to normal or proper operating states, pump failure, power supplied to the pump or power supply failure, battery voltage status or degree, detection of a leak within the bandage or flow path, suction blockage, or any other similar or suitable conditions, or combinations thereof. The housing 120 may have been configured such that a sterilizing gas, such as ethylene dioxide, can permeate the housing such that internal components of the pump assembly 104 are exposed to the sterilizing gas during the normal sterilization procedure. sterilization. Ordinarily, the pump will be exposed to the sterilizing gas within a chamber from which air or any other gas has been substantially evacuated, such that the sterilizing gas is drawn into the pump housing 120 and to the pump. interior of other spaces and chambers located within pump assembly 104. For example, some embodiments of pump housing 120 may have an unsealed gap surrounding connector 128 through which sterilizing gas may pass. Also, in some embodiments, the first housing member 120a can be attached to the second housing member 120b without having to use a plug in between. For the sterilization procedure, in some embodiments, the components to be sterilized may be subjected to the following steps, among others, in any order. The components can be placed in a chamber or vessel that is evacuated to about 70 mbar A (or between 67 mbar A and 80 mbar A) for between about 15 minutes and 1 hour and 15 minutes. Components may also be subjected to inert dilution, vapor pressure or conditioning, or nitrogen cycling, which may be followed by additional evacuation cycles. Ethylene oxide or any other suitable sterilizing gas may be introduced into the chamber or container, with a pressure set point of approximately 482 mbar A (or from approximately 467 mbar A to approximately 500 mbar A). Components can be exposed to sterilization gas at a temperature of about 46 degrees Celsius (or between about 42 degrees Celsius and 49 degrees Celsius), or up to 60 degrees Celsius. Components can be exposed to sterilizing gas for approximately 10 minutes (short cycle), or approximately 1 hour (long cycle), or approximately 9 minutes to approximately 11 minutes (short cycle), or approximately 59 minutes to approximately 1 hour. (long cycle), or longer. The components or chamber can be flushed by circulation with nitrogen and / or with air, and / or degassed thereafter. Pump assembly 104 may be powered by one or more batteries 142. Batteries 142 may be lithium chloride or any other suitable batteries that are suitable for exposure to ethylene dioxide and / or other sterilization gases. Batteries 142 may be supported outside of pump housing 120 in order to minimize or eliminate the possibility of an electrical spark that could cause an explosion in the presence of the sterilization gas, or a gas that is explosive, during the sterilization procedure. , if they are supported within the packaging element or elements. Additionally, in the event that there are a plurality of batteries 142, the batteries may be separated from one another or otherwise spaced within the package, so as to prevent any loss of energy or spark formation in the batteries during sterilization procedure, or otherwise prior to use. Referring to Figure 3A, the batteries 142 and sealing strip(s) 148 may be positioned below the bandage 102 in such a way that the bandage 102 is to be removed from the first packaging element 150 prior to removing the batteries. 142, thereby suggesting an order in which the components of the dressing kit 100 are removed from the packaging 150 and / or applied to the patient or assembled to the other components comprising the apparatus 100. In some embodiments, conduit 140 may be positioned within packaging 150 in such a way that both ends of conduit 140 are free or otherwise disconnected from the other components of apparatus 100 to improve exposure of the internal surfaces of the package. conduit 140 to ensure complete exposure of the tubing to the sterilizing gas. The ends of the conduit 140 can be supported within recesses formed in the first packing element 150. The first packaging element 150 may have one or more recesses configured to receive and support the components of the apparatus 100, including a recess 190 to receive the pump assembly 104, a recess 192 to receive the bandage 102, a recess 194 to receive the one or more sealing strips 148 and / or conduit 140, a recess 196 to receive conduit 114 and / or connector 114a, if present, and recesses 200a and 200b separated from each other, for batteries 142. Separate arrangement of batteries from each other can reduce or eliminate the risk of explosion during sterilization procedures, due to the potentially flammable nature of ethylene oxide. In some embodiments, the first packaging element 150 may be made of a material or combination of materials that is rigid and / or strong enough to hold the batteries, pump, and / or other components in place during treatment or transportation. of the dressing game. For example, some embodiments of the first bandage element 150 may have been configured to provide a compression or interference fit, or interposition, of components, such as batteries, pump, or other components, sufficient to withstand accelerations between about 15 g and about 25 g, or between 1 g and 40 g, or between 1 g and 20 g, or between 25 g and 40 g. Some embodiments of the first packaging element 150 may have been configured to closely hold the pump, batteries, tubing (with pinch elements or tubing recesses), and other components sufficiently to prevent movement or loosening of the components that could lead to shorting or melting / abrasion of the packaging, resulting in damage to the packaging or ingress of bacteria, while not impeding the user's ability to remove such components from the packaging as necessary. Additionally, as illustrated, the first packaging element 150 may have grooves or recesses 193 sized and configured to facilitate the surgeon's or user's access to and removal of the various components of the apparatus 100, both with the gloved hand as without it. Alternatively, lugs or protrusions 195 may have been formed on the first packaging element 150 to provide additional support and protection for the packaging and kit components. The first packaging element 150 may be made of any suitable material that can be sterilized, including a recyclable virgin medical grade material, pEtG Blue tinted 0.80 Eastman 6763, supplied by Nelipak Custom Thermoformed Products. The packaging element 150 may be extruded and thermoformed from EASTAR(TM) copolyester resin from EASTAR Chemical Product. For example, the raw material, which may be extruded sheet or film, may be thermoformed, or heat-formed, using a vacuum and pressing on a die-cutting tool, at elevated temperatures. Other suitable materials for the first packaging element 150 include polycarbonate, PVC [poly(vinyl chloride)] or any other suitable resin or plastic material. In some embodiments, the first packaging element may be made of a material (including a plate, sheet, film, or other form) having a thickness of 0.8 mm (or about 0.8), or a thickness of 0.8 mm or less, or 1.0 mm or less, or between about 0.7 mm and 1.2 mm. A gas permeable cover 151 (also referred to herein as a second packaging element) may be placed over the first packaging element 150 so as to form a seal therewith, in order to provide the contents of the bandage kit 100 a barrier against bacteria and contaminants. For example, a layer or film or foil form of TYVEK(TM), paper, or any other suitable material may be arranged to form a seal with a lip portion of the first packaging element 150. The cover 151 may be made of any material. suitable material, including TYVEK, which is permeable to sterilization gas but provides a barrier to bacteria and other contaminants. The cover 151 can be opaque, transparent or translucent. The cover 151 can be engaged sealingly with the first packaging element 150, once all the components of the bandage kit have been assembled therein. Thereafter, the first packaging element 150, cover 151, and dressing kit components can be placed inside a hermetically sealed, impervious bag having a patch of TYVEk or other sterilization gas-permeable material, over a opening formed in the bag to allow sterilizing gas to enter the bag and sterilize the components of the dressing kit. Figures 4A and 4B are first and second exploded views of the embodiment of the pump assembly 104 of Figure 1, showing the first housing member 120a separated from the second housing member 120b. Figures 5A and 5B are first and second views of the first housing member 120b. Figures 6A and 6B are first and second views of the second housing member 120b. Referring to Figures 4A-6B, some embodiments of pump assembly 104 may have a battery compartment 220 supported or formed within housing 120. One or more battery contacts 222 may be supported within battery compartment 220. One or more electrical cables 224 may connect battery contacts 222 to a pump 232 and / or control board 230. The pump assembly 104 may be assembled in a clean room to reduce the risk of contamination or bioburden. to which the pump is exposed or may pick up during assembly. In some embodiments, pump 232 may comprise a motor, an inlet port or connector 250, and an outlet port 252. Pump 232 may have one or more valves within it. For example, a first valve may be located within pump 232, adjacent to inlet port 250. Additionally, a second valve may be located within pump 232, adjacent to inlet port 250. outlet port 252. Pump 232 may define a flow path through inlet port 250, through the first and second valves, and out of outlet port 252. In some embodiments, battery contacts 222 may also be configured to have polarity protection. For example, similar to the one or more projections 124d adjacent to the battery contact 125, the one or more battery contacts 222 may have plastic or other projections (not shown) adjacent the contacts to prevent the contact between the battery contact 222 and the wrong side of a battery that is inserted into the battery compartment in the wrong orientation. For example, the one or more protrusions may have been sized and configured to prevent the negative side of a standard cylindrical battery from contacting the battery contact 222 adjacent to the one or more protrusions, while allowing the positive side of said battery comes into contact with contact 222 for battery. Generally, with this configuration, the battery can only generally make contact with contact 222 if the battery is inserted into battery compartment 220 in the correct orientation, thereby providing polarity protection for pump assembly 104. protrusions will preferably be made of a non-conductive material. Alternatively or additionally, control board 230 may be configured to have polarity protection features or components. Additionally, control board 230 may have one or more fuses to protect against excessive power conditions or power surge conditions. The pump assembly 104 may have a flow manifold 240 and a one-way flow valve 246, in fluid communication with a fluid flow path located within the pump assembly 104. The one-way flow valve 246 (to which (also referred to as a non-return valve) may be a diaphragm valve made of silicone or any other suitable elastomeric or soft material, including, without limitation, polyurethane, viton, nitrile rubber, neoprene, teflon and other suitable materials. Other suitable valves as a one-way flow valve are, for example, and without limitation, umbrella valves, ball valves, spool valves, and duckbill valves. In some embodiments, the leakage rate of the one-way flow valve 246 may be approximately 0.05 ml / minute. In some embodiments, one-way flow valve 246 may be located within pump 232 or in place of one of the valves located within pump 232. Manifold 240 and / or one-way flow valve 246 or 246 may be in communication with connector 128. In some embodiments, one-way flow valve 246 may be supported within manifold 240, and manifold 240 may be mated substantially to form a seal with inlet port or connector 250 existing on pump 232, or otherwise supported within housing 120, so as to be in fluid communication with inlet port or connector 250. For example, referring to the Figures 4A and 4B, manifold 240 can be assembled with pump 232 such that inlet connector 250 is received within opening 261 formed in manifold 240. Air and / or other gas can escape from the pump. 232 through inlet port or connector 252. During sterilization, pump 232 may have been configured in such a way that sterilization gas can penetrate internal spaces or c chambers of the 232 pump in order to ensure that the entire 232 pump (both internally and externally) has been sterilized. One or more valves (which may be umbrella valves or any other suitable valve) may have been located within the pump 232. For example, without limitation, one or more valves may be supported within the pump 232 such that it is positioned one adjacent to each of inlet port 250 and outlet port 252. For optimal sterilization, in some embodiments, the sterilization gas may be introduced slowly in order to optimize the flow of the sterilization gas through the valves and to prevent the pressure caused by the sterilization gas from completely closing the valves. As mentioned, the valves (such as the first and second valves) may have been configured to have some leakage, thereby allowing the sterilization gas flow to proceed past the valves to sterilize the internal components of the valve. the pump 232. For example, the valves may allow a fluid leakage flow rate through them (i.e., the flow rate through the valve when the valve is in the closed position) of a magnitude between 0, 1 ml / min and 10 ml / min or more, at nominal or typical working pressures (that is, at nominal working pressures of the fluid within the conduit) or at nominal or typical sterilizing pressures. In some configurations, the portion of the flow path between the two valves, or between the valves and the one-way valve, may be the portion of the flow path or pump assembly 104 that presents the most difficulty to sterilize. Some embodiments of the pump assembly may have a piezoelectric pump. Some piezo or other pumps disclosed herein may have, or may be configured to have, orifices to perform the functions of a valve, such that when the pump is at rest, the flow rate through the pump can be as high as 200 ml / min. Therefore, in some embodiments where the flow rate may be as high as approximately 300 ml / min or 320 ml / min, or other values, the first and second valves (which may consist of ports) may each have one of them, a leakage rate of up to approx. 200 ml / min. Pump 232 may be of any suitable type, such as, without limitation, a rotary diaphragm pump or other diaphragm pump, piezoelectric pump, peristaltic pump, piston pump, rotary vane pump, liquid ring pump, double scroll pump, piezoelectric transducer driven diaphragm pump, or any other pump or suitable micropump, or any combination of the above. Pump 232 can be, for example, a conventional commercially available vacuum pump, such as the KPV8A-3A pump from Koge Electronics. Pump 232 may also be a KNF diaphragm pump or any suitable KNF pump. Some embodiments of the pump can be as light as about 10 grams, or between about 6 grams and 15 grams, or anywhere within the above range. Pump 232 may have a pumping capacity of approximately 500 ml per minute, or between approximately 300 ml per minute or less and approximately 600 ml per minute or greater, or between approximately 400 ml per minute and approximately 500 ml per minute, or between any values ​​within the above ranges. In some embodiments, pump assembly 104 may comprise two or more pumps 232. For example, pump assembly 104 may have a first pump having a high flow rate configured to provide rapid contraction of the space between the layer wound overlay and the wound itself, and a second, smaller capacity pump configured to maintain the reduced amount of pressure in the space between the wound overlay layer and the wound itself, after initial contraction. In some embodiments, the pump flow rate may be approximately 20 times the leak alarm flow rate, which may be set to approximately 15 milliliters per minute. As mentioned, connector 128 can be a threaded connector (as illustrated) that can threadly receive a mating threaded connector, mated with the end of tube 106. Threaded connector 128 can be a non-standard size, in compared to other medical connectors, in order to prevent a medical professional from inadvertently attaching a standard Luer connector (such as a connector from an IV line) to it. Alternatively, not illustrated, the connector 128 may be a standard tube connector (such as a push-through connector), configured to seally receive the tube above it, such that it is possible to omit a Separate mating connector at the end of the tube 106. Manifold 240 may have a separate port 260 that may be configured to receive a conduit or connector 262 from a pressure monitoring device. The pressure monitoring device may be supported by control board 230 and may be configured to monitor the magnitude of pressure within the fluid flow path. The pressure monitoring device may have been configured to protect motor 232 from pressure exceeding a predefined threshold. In some embodiments, the pressure monitoring device may have been calibrated so that it does not exceed 175 + 50 mm Hg. In some embodiments, the pressure monitoring device may have been calibrated so that it does not exceed 235 mm Hg. The pressure monitoring device may have been configured to cut power to the motor when the pressure reading reaches a predetermined value, and may have been configured to resume power when the magnitude of the pressure falls below the predetermined value or a second value default that can be higher or lower than the first default value. Additionally, the pump assembly 104 may have been programmed to prevent such over-pressurization. The pump assembly 104 may have been configured such that the software provides the primary mechanism for preventing over-pressurization, and the pressure monitoring device may provide back-up protection against over-pressurization. The pump 232 may have a layer of open foam or other material disposed around an outer surface of the pump 232, enclosing it at least partially, in order to reduce noise and vibration produced by the pump 232. All of these components may be supported within the first and second pump housing members 120a, 120b, which may be secured to each other by any suitable fasteners 270 (eg a pair of screws). One or more labels 270 may be affixed to an exterior surface of housing 120. Additionally, in some embodiments, pump 232 may have one or more weights, padding, foam padding (such as memory foam), plastic (such as ABS , polyurethane, urethane, or other plastic) or other materials, panels, sheets, or segments supported by the pump 232 or located adjacent to the one or more external surfaces of the pump. Some embodiments may have mass-based or compliant damping materials. Such components or materials (not shown) can dampen vibration and / or attenuate noise produced by the pump. For example, one or more weights (made of steel, metal, or any other suitable material) may be supported or attached to an external surface of the pump 232 or any other pump embodiment disclosed herein. Steel weights can weigh approximately 1.8 grams, 3.8 grams, or 5.8 grams, or between 1 gram and 10 grams or more, or between 1.5 grams and 6 grams. Two or more weights may be supported or affixed to an external surface of the pump 232 or any other pump embodiment disclosed herein. Attached to an external surface of the pump 232 are two steel weights, each weighing approximately 1.8 grams, 3.8 grams, or 5.8 grams, or between 1 gram and 10 grams or more, or between 1.5 grams and 6 grams. Each of the two plates may be placed on opposite sides of the motor 232, or otherwise. In some embodiments, four steel weights may be attached to an external surface of the pump 232, each of which weigh approximately 1.8 grams, 3.8 grams or 5.8 grams, or between 1 gram and 10 grams, or between 1.5 grams and 6 grams. The plates can be arranged such that two plates are placed, one on each of two opposite sides of the motor 232, or otherwise. In some embodiments, the weights may be arranged adjacent to three or more sides of the pump 232, including, for example, and without limitation, the sides and top surfaces of the pump 232. Referring to Figure 4A, battery cover 124 may have a latching or lug member 124a that may be configured to mate with a mating feature of housing 120 to prevent battery cover 124 from inadvertently opening when is in the closed position. Additionally, guides or projections 124b may have been formed on the battery cover 124 in order to make it easier for the battery cover 124 to be opened and closed. Guides 124b may mate with mating guides or channels 120c formed in housing 120. Battery cover 124 may be configured to have a gripping surface for single finger use. For example, and without limitation, a plurality of depressions 124c may have been formed in a surface of battery cover 124 to improve grip between a user's finger or other object and battery cover 124, in order to facilitate handling. opening and closing the battery cover 124. Referring to Figure 4B, battery cover 124 may support one or more battery contacts or terminals 125 thereon configured to provide a connection between the two batteries. Battery cover 124 may additionally support one or more projections 124d adjacent battery contact 125. The one or more protrusions 124d may be sized and configured to prevent the negative side of a standard cylindrical battery from contacting the battery contact 125 adjacent the one or more protrusions 124d, while allowing a positive side of said battery comes into contact with contact 125 for battery. With this configuration, the battery can generally only make contact with contact 125 if the battery is inserted into battery compartment 230 in the correct orientation, thereby providing correct polarity protection for pump assembly 104. Referring to Figures 4A and 4B, the housing 120 may have one or more lugs 121 and depressions or channels 123, configured to receive the lugs 121 in order to improve the connection between the two housing members 120, 120b. The lugs 121 and the depressions 123 can hold the edges of the housing 120 together better, in order to improve the strength of the housing 120 and to make the joint between the two members 120a, 120b of the housing stronger. Control board 230 can be assembled to housing 12 with similar features. As described in US Patent Application No. 13 / 092,042, the disclosure of which is hereby incorporated by reference, as if fully disclosed herein, a lower surface of any of the Embodiments of the wound dressing 102 disclosed herein may have an optional wound contact layer. Any of the dressing embodiments disclosed herein can be made without the wound contact layer. The wound contact layer can be a polyurethane layer or a polyethylene layer, or another flexible layer that can be made porous or perforated, for example, through a hot-tip procedure, a laser ablation procedure, an ultrasonic or other procedure, or otherwise become permeable to liquid and gas. The perforations may allow fluid and / or gas to flow through the layer. The wound contact layer can help prevent tissue ingrowth into the other wound dressing material. The perforations may have been dimensioned small enough to satisfy this requirement, but still allow fluid to pass through. For example, perforations formed as slits or holes ranging in size from 0.025mm to 1.2mm are considered small enough to help prevent tissue ingrowth into the wound dressing while that allow exudate material from the wound to flow into the dressing. The wound contact layer helps hold the entire wound dressing together and helps create an airtight seal around the absorbent pad to maintain negative pressure in the wound. The wound contact layer also acts as a carrier for an optional upper and lower adhesive layer (not shown). For example, a lower pressure sensitive adhesive may be provided on the underside surface 101 of the wound dressing, while an upper pressure sensitive adhesive layer may be provided on the upper surface 103 of the wound contact layer. the wound. The pressure sensitive adhesive, which may be hydrocolloid or acrylic based adhesive, hot melt, silicone or other similar adhesives, may be formed on both sides or, optionally, on one or more selected sides. of the wound contact layer. When a lower pressure sensitive adhesive layer is used, it helps to adhere the wound dressing to the skin around a wound site. As mentioned, any bandage embodiments for use in the bandage kits disclosed or incorporated by reference herein may have an adhesive-coated bottom surface (eg, for wound contact). In some embodiments, as mentioned, the adhesive can be a silicone adhesive including, for example, polysiloxanes or polyorganosiloxanes, or other silicone polymeric pressure sensitive adhesives. For example, polydimethylsiloxane or other similar material can be used. The adhesive formulation can be a mixture of alkyl-linked siloxanes, which can be spread and cast as a two-part mixture with a catalyst, such that a final polymerization step occurs following casting or spreading. In some embodiments, a dressing layer may have a liner of non-perforated silicone adhesive (liner weight: 130 gsm nominal) and a fully spread acrylic adhesive (between 27 gsm and 37 gsm), coated on opposite sides of a bandage. transparent extruded EU30 polyurethane film (between 27 gsm and 37 gsm). The moisture vapor permeability of some embodiments of such an arrangement may be between about 367 gm-2 / 24 hours and about 405 gm-2 / 24 hours, or an average moisture vapor permeability of 382 gm-2 / 24 hours. Some embodiments or arrangements of a silicone adhesive layer suitable for the bandage embodiments disclosed herein may have a moisture vapor transmission rate of between about 350 gm-2 / 24 hours and about 410 gm-2. 2 / 24 hours. Suitably, the average moisture vapor permeability of some silicone adhesive layer embodiments or arrangements suitable for the bandage embodiments disclosed herein may be about 380 gm-2 / 24 hours. Some of the bandage embodiments disclosed herein may have Wacker Silres PSA 45 pressure sensitive adhesive coated thereon. Additionally, any of the bandage embodiments disclosed herein may have an antimicrobial agent or substance incorporated within the bandage or coated on one or more surfaces of the bandage. For example, and without limitation, a wound contact layer of any of the dressing embodiments disclosed herein may have nanocrystalline silver agents, silver salts, copper salts, or gold salts such as, without limitation, the which are disclosed in US Pat. No. 11 / 922,894 (entitled ANTIMICROBIAL BIGUANIDE METAL COMPLEXES -"ANTIMICROBIAL BIGUANIDE METAL COMPLEXES"-), filed on May 21, 2008, Application that is incorporated by reference herein as if it were part of this disclosure, PHMB, chlorohexadine , peroxide, hypochloride or other bleaches, incorporated within it or on it. On the other hand, an absorbent layer of any bandage embodiments disclosed herein may have, incorporated within or on it, silver sulfide diazine or any of the previously mentioned active substances or agents. These can be used separately or together. These can, respectively, kill microorganisms within the wound and microorganisms within the absorption matrix. As yet another option, other active components, eg, pain suppressants such as ibuprofen, or healing agents, may be incorporated within the bandage. Agents that enhance cell activity, such as growth factors, or that inhibit enzymes, such as matrix metalloproteinase inhibitors, such as tissue inhibitors of metalloproteinase (TIMPS) may also be incorporated into the bandage. or zinc chelators. Odor-capturing elements such as activated carbon, cyclodextrin, zeolite, or the like may also be included within the absorbent layer or other portions or components of the dressing, or on top of the filter layer. A layer of porous material may be placed on top of the wound contact layer. This porous layer, or transmission layer, allows the transmission of fluid, including liquid and gas, away from a wound site, into upper layers of the wound dressing. In particular, the transmission layer can ensure that it is possible to maintain a channel with free air to communicate negative pressure over the wound area, even when the absorbent layer has absorbed substantial amounts of exudative materials. The layer should remain open under the typical pressures that will be applied during negative pressure wound therapy as described above, such that the entire wound site sees equalized negative pressure. The layer may have been formed from a material that has a three-dimensional structure. For example, a knitted or woven spacer fabric (eg Baltex® 7970 weft knit polyester), or a non-woven fabric can be used. Other materials may be used, and examples of such materials are described in US Patent Application No. 13 / 092,042, which is hereby incorporated by reference as a part of this disclosure. In some embodiments, the transmission layer may have a 3D polyester spacer fabric layer. This layer may have a top layer (i.e., a layer distal to the wound bed during use) that is a textured 84 / 144 polyester, and an under layer (i.e., a layer that extends proximal to, or closer to, the wound bed during use) which may be a flat 100 denier polyester, as well as a third layer, formed sandwiched between these two layers, which is a region defined by a knitted monofilament fiber of polyester viscose, cellulose or the like. Other materials and other suitable linear mass densities for the fiber may be used. This differential between the filament counts in the separate layers helps to control the flow of moisture through the transmission layer. In particular, having a higher filament count in the top layer, that is, the top layer being made of a yarn that has more filaments than the yarn used in the layer below, the liquid tends to be absorbed by capillarity along the layer above rather than along the layer below. During use, this differential tends to either draw fluid away from the wound bed and into a central region of the dressing, where the absorbent layer helps to contain the fluid away, or else it draws fluid into the wound by wicking itself. direction of its advance, towards the cover layer, in which it can be transpired. Preferably, in order to improve the flow of liquid through the transmission layer (or perpendicular to the channel region formed between the upper and lower spacer layers), the 3D fabric is treated with an agent dry cleaning agents (such as, but not limited to, perchlorethylene) in order to remove any manufacturing products, such as previously used mineral oils, greases and / or waxes, which could interfere with the hydrophilic capabilities of the transmission layer In some embodiments, an additional manufacturing step may be subsequently carried out in which the 3D spacer fabric is washed in a hydrophilic agent (such as Feran Ice at 30 g / l, available at, but not limited to, the Rudolph Group.) This process step helps to ensure that the surface tension on the materials is so low that liquid, such as water, can enter the fabric t even as soon as it comes into contact with the 3D knitted fabric. This also helps to control the flow of the liquid component of any oozing materials. Again, as described in more detail in US Patent Application No. 13 / 092,042, a layer of absorbent material may be provided on top of the transmission layer. The absorbent material, which may be a foam or a natural or synthetic non-woven material, and which may optionally include or consist of a superabsorbent material, forms a reservoir for a fluid, particularly a liquid, withdrawn from the wound site, and drag those fluids onto a cover layer. The material of the absorbent layer can prevent the fluid collected in the wound dressing from flowing in a suppurative manner. The absorbent layer can also help distribute fluid throughout the length and width of the layer through capillary wicking action, so that fluid is drawn from the wound site and stored throughout the length and width of the layer. the absorbent layer. This helps to avoid clumping in areas of the absorbent layer. The capacity of the absorbent material must be sufficient to handle the flow rate of exudative materials from a wound when negative pressure is applied. Since the absorbent layer experiences negative pressures during use, the absorbent layer material is chosen to absorb liquid under such circumstances. There are various materials that are capable of absorbing liquid when under negative pressure, for example, superabsorbent materials. The absorbent layer can be made of ALLEVYN foam, Freudenberg 114-224-4 and / or Chem-PositeTM11C-450, or any other suitable material. In some embodiments, the absorbent layer may be a layer of nonwoven cellulose fibers having superabsorbent material in the form of dry particles dispersed throughout the length and width thereof. The use of cellulose fibers introduces rapid capillary absorption elements that help to quickly and evenly distribute the liquid captured by the bandage. The juxtaposition of multiple strand-like fibers leads to strong capillary action in the fibrous pad, which helps distribute fluid. In this way, the superabsorbent material is efficiently supplied with liquid. Also, all regions of the absorbent layer are supplied with liquid. The wicking action also helps to bring liquid into contact with the top cover layer to help increase sweat rates from the bandage. The wicking action also helps to deliver fluid downward toward the wound bed when exudation slows or stops. This delivery process helps keep the transmission layer and the lower region of the wound bed in a moist state, which helps prevent crusting within the dressing (which could lead to obstruction) and helps maintain an environment optimized for wound healing. In some embodiments, the absorbent layer may be an embossed, or air-foamed material. Optionally, heat meltable fibers can be used to help hold the napkin structure together. It will be appreciated that, instead of using superabsorbent particles, or in addition to such use, superabsorbent fibers may be used in accordance with some embodiments of the present invention. An example of a suitable material is the product Chem-Posite™ 11 C, available from Emerging Technologies Inc. (ETi), USA. Optionally, the absorbent layer can include stable synthetic fibers and / or stable bicomponent fibers, and / or stable natural fibers and / or superabsorbent fibers. The fibers of the absorbent layer can be secured to each other by latex bonding or thermal bonding, or by hydrogen bonding, or a combination of any bonding technique or other securing mechanism. In some embodiments, the absorbent layer is formed by fibers that function to lock superabsorbent particles within the absorbent layer. This helps to ensure that superabsorbent particles do not move out of the absorbent layer and into an underlying wound bed. This is particularly useful because, when negative pressure is applied, there is a tendency for the absorbent pad to collapse downward, and this action will push particulate superabsorbent material toward the wound bed, if the particulates had not already been applied. contained or held away by the fibrous structure of the absorbent layer. The absorbent layer may comprise a layer of multiple fibers. Preferably, the fibers are in the form of strands and are made of cellulose, polyester, viscose, or a similar material. Preferably, dry absorbent particles are distributed over the entire length and width of the absorbent layer, when it is ready for use. In some embodiments, the absorbent layer comprises a pad of cellulose fibers and a plurality of superabsorbent particles. In further embodiments, the absorbent layer is a nonwoven layer of randomly oriented cellulose fibers. The superabsorbent particles / fibers can be, for example, sodium polyacrylate or carbomethoxycellulose materials, or the like, or any material that is capable of absorbing many times its own weight in liquid. In some embodiments, the material can absorb more than five times its own weight in 0.9% W / W [weight ratio] saline, etc. In some embodiments, the material can absorb more than 15 times its own weight in 0.9% W / W saline, etc. In some embodiments, the material is capable of absorbing more than 20 times its own weight in 0.9% W / W saline, etc. Preferably, the material is capable of absorbing more than 30 times its own weight in 0.9% W / W saline, etc. The absorbent layer may have one or more through-holes located such that they underlie the suction port. The dressing 102 may have a gas impermeable but moisture vapor permeable cover layer which extends across the width of the wound dressing. The cover layer, which can be, for example, a polyurethane film (for example Elastollan SP9109) or any other suitable material having a pressure sensitive adhesive disposed on one of its faces, is substantially gas impermeable, thereby creating a substantially sealed enclosure over the wound. In this way, an effective chamber is produced between the cover layer and a wound site, in which a negative pressure can be established. The cover layer can be arranged to form a seal with the wound contact layer in a boundary region around the perimeter of the bandage, ensuring that no air is drawn in through the perimeter area, for example , by techniques using adhesive or welding. The cover layer can protect the wound from external bacterial contamination (bacterial barrier) and allows fluid from wound exudation to be transferred through the layer and evaporated from the outer surface of the film. The cover layer may have a polyurethane film and an adhesive pattern spread on the film. The polyurethane film is permeable to moisture vapor and can be made from a material that has increased water transmission rate when wet. A hole may be provided in the cover film to allow negative pressure to be applied to the bandage 102. As mentioned, in some embodiments, a suction port 108 may be provided to form a seal with the top of the cover film over the hole, which can communicate negative pressure through the hole. The port may be adhered and sealed to the cover film using an adhesive such as acrylic, cyanoacrylate, epoxy, UV-curable or heat meltable adhesive. Port 108 may be made of a soft polymer, for example, a polyethylene, polyvinyl chloride, silicone, or polyurethane having a hardness of between 30 and 90 on the Shore A scale. The dressing 102 may have a filter element that is impermeable to liquids, but permeable to gases. The filter element can act as a liquid barrier to prevent or substantially prevent liquids from escaping from the wound dressing, as well as an odor barrier. The filter element can also function as a barrier against bacteria. In some embodiments, the pore size of the filter element may be approximately 0.2 pm. Suitable materials for the filter material of the filter element include 0.2 micron Gore™ expanded PTFE [polytetrafluoroethylene] from the MMT range, PALL Versapore 200R, and Donaldson TX6628. The filter element therefore allows the gas to be evacuated through the orifice. Liquid, particulate material, and pathogens, however, remain contained in the dressing. Other details regarding the filter are set forth in US Patent Application Ser. No. 13 / 092,042 and are incorporated herein by reference. The wound dressing 102 and its methods of manufacture and use as described herein may also incorporate features, configurations, and materials described in the following Patents and Patent Applications, each of which is incorporated herein by reference. in their entirety, as if formed a part of this disclosure: US Patent Nos. 7,524,315, 7,708,724, and 7,909,805; US Patent Application Publication Nos. 2005 / 0261642, 2007 / 0167926, 2009 / 0012483, 2009 / 0254054, 2010 / 0160879, 2010 / 0160880, 2010 / 0174251, 2010 / 0274207,3208107 / 0009838, 2011 / 0028918, 2011 / 0054421 and 2011 / 0054423; as well as US Application Serial Nos. 12 / 941,390, filed November 8, 2010, 29 / 389,782, filed April 15, 2011, and 29 / 389,783, filed April 15, 2011 Based on these Patents and Patent Applications incorporated by reference, characteristics, configurations, materials and methods of manufacture and / or use referring to components similar to those described in the Application may be substituted, added or implemented in embodiments of this Application. present disclosure. In operation, the wound dressing 102 is arranged to form a seal over a wound site, forming a wound cavity. Pump assembly 104 provides a source of negative pressure to dressing 102. Fluid is drawn into the orifice through the wound dressing, from a wound site, under the wound contact layer. The fluid travels to the orifice through the transmission layer. As fluid is drawn through the transmission layer, exudate material from the wound is absorbed into the absorbent layer. The general shape of the wound dressing may be square, oval, rectangular, or otherwise. The bandage may have rounded corner regions. It will be appreciated that wound dressings in accordance with other embodiments of the present invention may be shaped differently, such as square, circular or elliptical, or other similar. The desired size for the wound dressing 102 can be selected based on the size and type of the wound on which it is to be used. In some embodiments, the wound dressing 102 may measure between 20 and 40 cm in its major axis, and between c10 and 25 cm in its minor axis. For example, bandages may be provided in the sizes of approximately 10 cm x 20 cm, 10 cm x 30 cm, 10 cm x 40 cm, 15 cm x 20 cm and 15 cm x 30 cm, as described above. In some embodiments, the wound dressing 102 may be a square-shaped dressing, with sides measuring between 15 cm and 25 cm (eg, 15 cm x 15 cm, 20 cm x 20 cm, and 25 cm x 25 cm). The absorbent layer may have a smaller area than the total bandage and, in some embodiments, may have a length and width that are both between about 3 cm and 10 cm shorter, more preferably about 5 cm. shorter than those of the total bandage 102. In some rectangular shaped embodiments, the absorbent layer may measure between approximately 10 cm and 35 cm on its major axis, and between 5 cm and 10 cm on its minor axis. For example, absorbent layers may be provided in sizes 5.6 cm x 15 cm or 5 cm x 10 cm (for 10 cm x 20 cm bandages), 5.6 cm x 25 cm or 5 cm x 20 cm (for 10 cm x 30 cm bandages), 5.6 cm x 35 cm or 5 cm x 30 cm (for 10 cm x 40 cm bandages), 10 cm x 15 cm (for 15 cm x 20 cm bandages), and 10 cm x 25 cm (for 15 cm x 30 cm bandages). In some embodiments, of a square shape, the absorbent layer may have sides that are between 10 cm and 20 cm in length (eg, 10 cm x 1 cm for a 15 cm x 15 cm bandage, 15 cm x 15 cm for a 20 cm x 20 cm bandage, or 20 cm x 20 cm for a 25 cm x 25 cm bandage). The transmission layer may be smaller in size than the absorber layer and, in some embodiments, may have a length and width that are both about 0.5 cm to 2 cm shorter, more preferably, about 1 cm shorter than those of the absorbent layer. In some triangular shaped embodiments, the transmission layer may measure between 9 cm and 34 cm on its major axis and between 3 cm and 5 cm on its minor axis. For example, transmission layers can be provided in sizes 4.6 cm x 14 cm or 4 cm x 9 cm (for 10 cm x 20 cm bandages), 4.6 cm x 24 cm or 4 cm x 19 cm ( for 10 cm x 30 m bandages), 4.6 cm x 34 cm or 4 cm x 29 cm (for 10 cm x 40 cm bandages), 9 cm x 14 cm (for 15 cm x 20 cm bandages) and 9 cm x 24 cm (for 15 cm x 30 cm bandages). In some square-shaped embodiments, the transmission layer may have sides that are between 9 cm and 19 cm in length (for example, 9 cm x 9 cm for a 15 cm x 15 cm bandage, 14 cm x 14 cm for a 20 cm x 20 cm bandage, or 19 cm x 19 cm for a 25 cm x 25 cm bandage). The dressing may contain antimicrobial agents, eg, nanocrystalline silver, on the wound contact layer, and / or silver sulfide diazine within the absorbent layer. These can be used separately or together. These, respectively, kill microorganisms within the wound and microorganisms in the adsorption matrix. As yet another option, other active components may be included, eg pain suppressants such as ibuprofen. Also, agents that enhance cell activity, such as growth factors, or that inhibit enzymes, such as matrix metalloproteinase inhibitors, such as tissue inhibitors of metalloproteinase (TIMPS) could be used. or zinc chelators. As yet another option, odor-capturing elements such as activated carbon, cyclodextrin, zeolite, or similar materials may be included within the absorbent layer, or as yet another layer above the filter layer. . While some embodiments of the present invention have been described thus far in which the transmission layer has been formed as a 3D knit layer, for example two layers separated from each other by a monofilament layer, it will be appreciated that some embodiments of the present invention present invention are not limited to the use of such material. In some embodiments, as an alternative to such a 3D knit material, it is possible to use one or more layers of a wide variety of materials. In each case, in accordance with embodiments of the present invention, the openings presented by layers of the transmission layer become increasingly wider as one moves away from the side of the bandage that in use will be located proximal to the wound. . In some embodiments, the transmission layer may be provided with multiple layers of open cell foam. In some embodiments, the foam is a crosslinked open cell foam. The foam can be hydrophilic or capable of absorbing water-based fluids by capillary action. The pore size of each layer is selected such that in the foam layer closest to the wound side during use, the pore size is smaller. If only a single additional foam layer is used that includes pore sizes that are larger than the pore sizes of the first layer. This helps prevent solid particles from being trapped in the bottom layer, thus helping to keep the bottom layer in an open configuration whereby it is therefore capable of transmitting air across the length and width of the bandage. In some embodiments, two, three, four, or more layers of foam may be included. The foam layers may have been integrally formed, for example, by selecting a foam having a large pore size and then repeatedly immersing this, to a lesser and lesser extent, in a material that will clog the pores; or, alternatively, the transmission layer formed by the multiple foam layers can be provided by layering different types of foam in a layer arrangement, or by securing such foam layers in place in a known manner. Figures 7A-7D illustrate the use of one embodiment of a TNP wound management system that is used to treat a patient's wound site. Figure 7A shows a wound site W as it is cleaned and prepared for treatment. Here, the healthy skin surrounding the wound site W is preferably cleaned and the 5 excess hair is removed or shaved. The wound site W can also be irrigated with sterile saline, if necessary. Optionally, a skin protectant may be applied to the skin surrounding the wound site W. If necessary, a wound packing material, such as foam or gauze, can be placed at the W site of the wound. This may be preferable if the wound site W corresponds to a deeper wound. Once the skin surrounding the wound site W has been prepared, the cover 151 can be removed from the first packaging element 150 in order to provide access to the components. The bandage 102 can be removed from the packaging 150 and, as illustrated in Figure 7B, can be placed and positioned over the wound site W. The wound dressing 102 can be placed with the wound contact layer belonging to the dressing 102 above and / or in contact with the wound site W. In some embodiments, an adhesive layer may be provided on a lower surface of the wound contact layer, which may, in some cases, be protected by an optional release layer that is to be removed prior to dressing 102 placement. of wound on the place W of the wound. Bandage 102 may be positioned such that port 108 is elevated relative to the remainder of bandage 102 to prevent fluid from pooling around port 108. In some embodiments, bandage 102 it is positioned such that the port 108 does not directly overlap the wound, and is located level with or higher than the wound. To help ensure a proper seal for the PNT, the edges of the bandage 102 may be smoothed on its surface to prevent wrinkles or folds. The bandage and the adhesive formed thereon can be configured in such a way that the bandage can be lifted off the skin or wound and repositioned to remove wrinkles and folds, or simply to reposition the bandage on the wound, or by other reasons, without sacrificing adhesive performance. Tube 106 can be connected to bandage 102, either before or after placement of bandage 102 on the wound. Thereafter, pump assembly 104 can be removed from packaging 150 and connected to tubing 106, as illustrated in Figure 7C. Batteries 142 can be removed from packaging 150 and installed in pump assembly 104 either before the pump is attached to conduit 106 or after. Pump assembly 104 may be configured to apply negative pressure to the wound site via bandage 102 and typically through tubing or conduit 106. In some embodiments, a connector may be used to join conduit 106 to bandage 102 and pump assembly 104. By applying negative pressure with pump assembly 104, bandage 102 may, in some embodiments, partially collapse and present a wrinkled appearance as a result of evacuation of some or all of the air located under the bandage 102. In some embodiments, the pump assembly 104 may have been configured to detect if any leakage is present in the bandage 102, such as at the interface, or interface, between the bandage 102 and the skin that surrounds the W site of the wound. In the event a leak is found, the leak is preferably remedied before further treatment. Leakage can be addressed by repositioning the bandage 102, smoothing out any wrinkles or folds in the bandage, or by applying fixation strips 148 around the periphery of the bandage 102. Referring to Figure 7D, as mentioned, fixation straps 148 may be attached around the peripheral edges of bandage 102, or otherwise. Such fixation straps 148 may be advantageous in some situations in order to provide an additional seal against the patient's skin surrounding the wound site W. For example, sealing or fixation strips 148 can provide an additional seal for when the patient is more mobile. In some cases, the fixation straps 148 may be used prior to activation of the pump set 104, particularly if the bandage 102 is positioned over a hard-to-reach or contoured area. In some embodiments, the bandage kit 100 can be provided with up to five sealing strips. Treatment of the wound site W is preferably continued until the wound has reached a desired degree of healing. In some embodiments, it may be desirable to replace the bandage 102 after a certain period of time has elapsed, or if the bandage is filled with wound fluids. During such changes, the pump assembly 105 can be maintained, so that only the dressing 102 is changed. Figures 8A-20H are, respectively, top isometric, bottom isometric, top plan, bottom plan, front elevational, rear elevational, first side, and second side views of packaging element embodiments. which can be used with any of the embodiments of wound dressing devices disclosed herein, including a variety of differently sized wound dressing devices. Any of the embodiments of the packaging elements illustrated in Figures 8A-20H or otherwise disclosed in this Application may have any of the same features, materials or other details as any of the other packaging elements disclosed in this specification. , including the first packaging element 150 previously discussed. The packaging element 300 illustrated in Figures 8A-8H has been configured to support a bandage having a size of approximately 10 cm x 20 cm, and / or one or more of the other components of any of the NPT therapy kits. disclosed in this report. The packaging element 310 illustrated in Figures 9A-9H is configured to support a bandage that is approximately 10 cm x 20 cm in size, and / or one or more of the other components of any of the therapy kits. of NPT disclosed in this report. The packaging element 320 illustrated in Figures 10A-10H has been configured to give support to a bandage having a size of approximately 10 cm x 30 cm, and / or to one or more of the other components of any of the NPT therapy kits disclosed herein. The packaging element 330 illustrated in Figures 11A-11H has been configured to support a bandage that is approximately 10 cm x 30 cm in size, and / or one or more of the other components of any of the therapy kits. of NPT that are disclosed in the present memory. The packaging element 300 illustrated in Figures 12A-12H has been configured to support a bandage that is approximately 10 cm x 40 cm in size, and / or one or more of the other components of any of the therapy kits. of TNP that are disclosed in this memory. The packaging element 350 illustrated in Figures 13A-13H has been configured to support a bandage that is approximately 10 cm x 40 cm in size, and / or one or more of the other components of any of the therapy kits. of NPT that are disclosed in the present memory. The packaging element 360 illustrated in Figures 14A-14H has been configured to support a bandage that is approximately 15 cm x 15 cm in size, and / or one or more of the other components of any of the kits. for NPT therapy disclosed herein. The packaging element 365 illustrated in Figures 14I-10P has been configured to support a bandage that is approximately 15 cm x 15 cm in size, and / or one or more of the other components of any of the therapy kits. of NPT that are disclosed in the present memory. The packaging element 370 illustrated in Figures 15A-15H is configured to support a bandage that is approximately 15 cm x 15 cm in size, and / or one or more of the other components of any of the therapy kits. of TNP that are disclosed in this memory. The packaging element 380 illustrated in Figures 16A-16H has been configured to support a bandage that is approximately 15 cm x 20 cm in size, and / or one or more of the other components of any of the kits. for NPT therapy disclosed herein. The packaging element 390 illustrated in Figures 17a-17H has been configured to support a bandage that is approximately 20 cm x 20 cm in size, and / or one or more of the other components of any of the therapy kits. of TNP that are disclosed in this report. The packaging element 395 illustrated in Figures 17I-17P has been configured to support a bandage that is approximately 20 cm x 20 cm in size, and / or one or more of the other components from any of the kits. for NPT therapy disclosed herein. The packaging element 400 illustrated in Figures 18A-18H has been configured to support a bandage that is approximately 15 cm x 30 cm in size, and / or one or more of the other components of any of the therapy kits. of TNP that are disclosed in this report. The packaging element 405 illustrated in Figures 18I-18P has been configured to support a bandage that is approximately 15 cm x 30 cm in size, and / or one or more of the other components of any of the therapy kits. of TNP that are disclosed in this report. The packaging element 410 illustrated in Figures 19A-19H is configured to support a bandage that is approximately 25 cm x 25 cm in size, and / or one or more of the other components of any of the therapy kits. of NPT that are disclosed in the present memory. The packaging element 420 illustrated in Figures 20A-20H has been configured to support a bandage that is approximately 25 cm x 25 cm in size, and / or one or more of the other components of any of the therapy kits. of TNP that are disclosed in this memory. Figure 21 illustrates a pump assembly 1000 in accordance with some embodiments. Any of the embodiments of the pump assembly 1000 disclosed herein may have any of the same or similar components, features, materials, sizes, configurations, and other details of any other of the embodiments of the pump assembly disclosed herein. or incorporated by reference therein, including the embodiment of pump assembly 104 described above. Preferably, the pump assembly 1000 can be miniaturized and portable, although larger conventional portable or non-portable (eg, wall suction) pumps can also be used. Pump set 1000 may include a switch or button 1002, which is illustrated as a play / pause button located on the exterior of the pump set housing. As explained below, button 1002 may have been configured to stop, temporarily stop, and / or restart therapy. Although illustrated as a push button 1002, other types of switches or buttons may be included, such as a touch pad, touch screen, keyboard, and more. The pump assembly may additionally include a connector 1050 (for connecting a conduit, for example, conduit 106) and three LED indicators 1062, 1064, and 1066. As illustrated, the LED indicator 1062 (for example, an 'OK' flag) may have been set to indicate normal / abnormal system operation. For example, an active (eg, illuminated) indicator 1062 may represent normal operation. LED indicator 1064 (eg, bandage indicator) may have been configured to indicate a leak in the system. For example, an active (eg, illuminated) indicator 1064 may represent a leak. The LED indicator 1066 (eg, battery indicator) may have been configured to indicate the remaining capacity or useful life of a power source (eg, batteries). For example, an active indicator 1066 (eg, illuminated) may represent low capacity. In some embodiments, the flags 1062, 1064, and 1066 may each be a different color, two different colors (eg, two flags may share the same color), or the same color. Although the pump assembly preferably includes three LED indicators and a play / pause button, other configurations, positions and types of indicators, alarms and switches may alternatively be used. In some embodiments, the 5 Pump assembly 1000 may include visual, audible, tactile, and other indicators or alarms configured to alert the user to various states of operation. Such states include system on / off, standby stop, temporary stop, normal operation, a dressing problem, leak, error, and the like. Indicators may include speakers, displays, light sources, etc., and / or combinations thereof. Figure 22 illustrates a cross-sectional view showing the interior of pump assembly 1000 according to some embodiments. As illustrated, a housing 1020 may enclose the pump assembly. A one-way flow valve 1030 may have been configured to maintain a certain amount of negative pressure when the source of negative pressure supply is not active (for example, to prevent leakage), and to prevent aspirated fluids and / or exudate material from entering. or removed from the wound enter the pump assembly through connector 1050. A control board 1040, such as a printed circuit board assembly (PCBA), may be configured to mechanically support and electrically connecting various electrical / electronic components described below. The PCBA can be single-sided or double-sided. A source of negative pressure delivery 1090, such as a pump, can aspirate fluid and / or exudate material from a wound. In any of the embodiments disclosed herein, the negative pressure supply source 1090 may have any of the same components, features, limitations, or other details as any of the other negative pressure supply source embodiments disclosed. herein, including, without limitation, the previously disclosed pump 232. Various pumps can be used for the source of negative pressure supply, including peristaltic pumps, piston pumps, rotary vane pumps, liquid ring pumps, double scroll pumps, diaphragm pumps, piezoelectric pumps (for example, a diaphragm pump driven by a piezoelectric transducer), etc., or a combination thereof. While the pump assembly preferably includes a low power, low noise, miniature pump, any suitable pump may alternatively be used. The pump assembly 1000 includes indicators 1060 (eg, LEDs), a pressure sensor 1070 for monitoring pressure in the system, such as pressure under the bandage, and a battery cover 1080, configured to provide access to a battery compartment. 1100 for drums. While the pump set is preferably powered by two standard, disposable alkaline batteries (eg, 2 aA batteries), any type of power source may alternatively be used, including rechargeable batteries as well as external power supply. . Figure 23 illustrates a system schematic of pump assembly 1000 in accordance with some embodiments. The pump assembly includes a push button 1002, a control board 1040, and indicators 1060. The pump assembly 1000 may be powered by a battery cell 1130. The pump assembly also includes a pump 1090, such as a pump for diaphragm, driven by an electric motor 1092, as well as a pressure sensor 1070. An inlet 1120 may be configured to connect pump assembly 1000 to a bandage, for example, through conduit. The inlet 1120 may be connected to a one-way valve 1030, which may have been configured to help maintain a certain amount of negative pressure when the negative pressure supply source is not active, prevent leakage, and prevent fluids and / or material from entering. of exudate aspirated or extracted from the wound enter pump assembly 1000. Pump 1090 may also be connected to outlet 1110. In some embodiments, outlet 1110 may be configured to vent air to atmosphere. In some embodiments, a filter (not shown) may be interposed between the outlet and the atmosphere. The filter can be a bacterial filter, odor filter, etc., or any combination thereof. Figure 24 illustrates an electrical component schematic of pump assembly 1000 in accordance with some embodiments. The 1140 module, which may be a control board (for example, a PCBA [Printed Circuit Board Assembly]), may include an input / output (I / O) module -"I / O [input / output]"-) 1150, a controller 1160, and a memory 1170. In some embodiments, the module 1140 may include additional electrical / electronic components, for example, a fuse or fuses. Controller 1160 may be a microcontroller, processor, microprocessor, etc., or any combination thereof. For example, controller 1160 may be of the STM8L MCU family type from ST Microelectronics, such as the STM8L 151G4U6, or of the MC9S08QE4 / 8 series type from Freescale, such as the MC9S08QE4CWJ. Preferably, controller 1160 is a low power or ultra low power device, but other types of devices may alternatively be used. Memory 1170 may include one or more volatile and / or non-volatile memory modules, such as one or more of a Read-Only Memory (ROM), a write-once memory, and a read-multiple memory. (WORM -"Write Once Read Many"-), a random access memory (for example, SRAM, DRAM, SDRAM, DDR, etc.), a solid state memory, a flash type memory, or pulse access , a magnetic storage device, etc., or any combination thereof. Memory 1170 may have been configured to store program code or instructions (executed by the controller), system parameters, operational data, user data, etc., or any combination thereof. The 1150 I / O module may have been configured to function as an interface between the 1160 controller and other system components that provide and / or are sensitive to electromagnetic signals. In other words, I / O module 1150 may have been configured to allow controller 1160 to monitor system operation and to control other system components. In some embodiments, as illustrated, I / O module 1150 may be in electromagnetic communication with a button 1002, with indicators 1060, with a pressure sensor 1070, with a power supply 1130 and with a negative pressure supply supply 1090. The I / O module may comprise one interface or multiple interfaces configured to communicate with the various components. The interface may include standard and non-standard ports, such as serial ports, parallel ports, bus interfaces, etc., or any combination thereof. In some embodiments, the pump set 1000 may have been configured to control the operation of the system. For example, the pump set 1000 may have been configured to provide an appropriate balance between the uninterrupted delivery of therapy and / or the avoidance of discomfort caused to the user by, for example, frequent or unnecessary temporary stopping or discontinuation of therapy. , and the desire to save energy, limit the noise and vibration generated by the negative pressure supply source, etc. Figure 25 illustrates a top level state diagram 1200 of pump set operation according to some embodiments. In some embodiments, controller 1140 may be configured to implement state diagram 1200 flow. As illustrated in Figure 25, pump set operation may, in some embodiments, be grouped into four general state categories: idle / initialization (states 1206 and 1202), active 1210, operational 1250, and end of life (state 1214). As illustrated in Figures 25 and 26, state categories 1210 and 1250 each comprise multiple states and transitions between states. In some embodiments, as long as the power source is not connected, has been removed (as illustrated by transition 1204), or the pump set has not been activated (eg, by pulling an activation strip, pressing the switch or similar action), the pump set remains in state 1206. While in this state, the pump set may remain inactive. When the power source is connected and / or the pump set is first activated, the pump set transitions to state 1202, in which a self-test(s) may be performed. power on and initialization (POST - "Power On Self Test (s) "-). The power-on and initialization self-test(s) may (are) include performing various checks to ensure proper system functionality, such as testing the 1170 memory (for example, performing a check, such as such as a cyclic redundancy check, program code integrity check, random access memory test, etc.), reading from the 1070 pressure sensor to determine if the pressure values ​​are within proper limits, Reading the remaining capacity or useful life of the power source (for example, battery voltage, current, etc.), to determine if it is within proper limits, Testing the input source negative pressure, and the like. As illustrated, the indicators 1060 (eg, LEDs) may have been configured to indicate to the user (eg, by blinking, or flashing once) that the pump set is undergoing POST test(s). In some embodiments, if one or more of the POST test(s) fails, the pump set may transition to an unrecoverable error state 1214. While in this state, the pump set may deactivate therapy, and flags 1060 may have been configured to indicate to the user that an error has been encountered. In some embodiments, all indicators may be configured to stay on. Based on the severity of the error, in some embodiments, the pump set may have been configured to recover from the error and continue operation (or transition to the unrecoverable error state 1214). As illustrated, the pump set may transition to state 1214 upon encountering a fatal error during operation. Fatal errors can include program memory errors, program code errors (for example, when an invalid variable value is encountered), controller malfunctions (for example, when the watchdog timer expires without being reset). by controller 1160), component failure (eg, negative pressure supply source inoperative, pressure sensor 1070 inoperative, etc.), and any combination thereof. Upon passing the POST test(s), in some embodiments, the pump set may transition to a manual temporary stop state 1216. As illustrated, this transition may be indicated to the user by deactivation of one of the indicators 1060 (for example, the battery indicator 1066). When the pump set transitions to and remains in the manual temporary stop state 1216, an indication of this may be given to the user, such as by turning off flags 1062 ('OK' flag) and 1064 (bandage flag). In some embodiments, therapy may be suspended while the pump set remains in the manual temporary stop state 1216. For example, the negative pressure supply source (eg, pump 1090) may be deactivated (or turned off). In some embodiments, an indication may be provided by turning off the negative pressure supply source. In some embodiments, the pump set may have been configured to transition 1224 from the manual temporary stop state 1216 to the category of operating states 1250 (in which the pump set has been configured to deliver therapy), in response to the reception of a signal from the switch. For example, the user can press a button to start, suspend, and / or restart therapy. In some embodiments, the pump set may have been configured to monitor the length of time the pump set remains in the 1216 manual temporary stop state. This may be accomplished, for example, by maintaining a timer (in firmware [default installed programming]). permanent in hardware], software, hardware, or any combination thereof), which can be reset and started when the pump set transitions to the 1216 manual temporary stop state. The pump set it may have been configured to automatically transition 1224 from the manual temporary halt state 1216 to the category of operating states 1250 when the duration time exceeds a certain threshold. In some embodiments, such a threshold may be a preset value, such as between 1 minute or less and 1 hour or more. In some embodiments, the threshold can be set or changed by the user. In some embodiments, the threshold can be varied based on various operating states or any combination thereof. For example, as the pump set approaches the end of its useful life (as explained below), the threshold may be lowered. In some embodiments, the user can temporarily stop the therapy by activating the switch (eg, pressing the button), thereby causing the pump set to transition 1222 from the category of operating states 1250 to the manual temporary stop state 1216 In some embodiments, the pump set may have been configured such that the user can only temporarily stop the therapy, while disconnection from the power source (eg, by removing the batteries) is required to stop the therapy. In some embodiments, the pump set may have been configured to include a temporarily stopped state 1218. When the pump set transitions to and remains in the temporarily stopped state 1218, an indication thereof may be given to the user. For example, the pump set may have been configured to turn off the 'OK' indicator 1062 and cause the bandage indicator 1064 to flash or blink. In some embodiments, therapy may be suspended while the pump set remains in the manual temporary stop state 1216. For example, the negative pressure supply source (eg, pumps 1090) may be deactivated (or turned off), which which provides indication to the user that the pump set is in the temporarily stopped state 1218. As explained below, in some embodiments, the pump set may have been configured to transition from the category of operating states 1250 to the temporarily stopped state 1218 when the number of retry cycles exceeds a certain retry limit (transition 1228) or when the duty cycle is determined to exceed a certain duty cycle limit (transition 1230). In some embodiments, transitions 1228 and 1230 may reflect the presence of a leak in the system. In some embodiments, the pump set may have been configured to transition 1226 from the temporarily stopped state 1218 to the category of operating states 1250 (if the pump set has been configured to activate the pump in order to deliver therapy) in response to receiving a signal from the switch (for example, the user presses a button to restart therapy). In some embodiments, the pump set may have been configured to monitor the length of time the pump set remains in the temporarily stopped state 1218. For example, this may be accomplished by maintaining a timer (in firmware, software, hardware, or in any combination thereof) that can be reset and started when the pump set transitions to the temporarily stopped state 1218. The pump set may have been configured to automatically transition 1226 from the temporarily stopped state 1218 to the category of operating states 1250 when the time duration exceeds a certain threshold. The threshold may be the same as, or different from, the threshold of the manual temporary stop state 1216 described above. In some embodiments, the threshold may be a preset value, such as between 1 minute or less and 1 hour or more. In some embodiments, the threshold can be set or changed by the user. In some embodiments, the threshold can be varied based on various operating conditions or any combination thereof. For example, as the pump set approaches the end of its useful life (as explained below), the threshold may be lowered. In some embodiments, the pump set includes both manual stop state 1216 and stop state 1218, in order to differentiate between various causes for temporarily stopping therapy. Such differentiation capability may enable the pump set to provide the user with an indication of a particular cause for temporarily stopping therapy (eg, the manual temporary stopped state 1216 and the temporarily stopped state 1218 may provide different indications). For example, therapy may be temporarily stopped as a result of the user manually pressing the button, in which case the pump set may transition 1222 from the category of operating states 1250 to the manual temporary stop state 1216. As another For example, therapy may be stopped as a result of leak detection, in which case the pump set may transition 1228 and / or 1230 from operating state category 1250 to the temporarily stopped state 1218. In some embodiments, the The pump set may have been configured to include a single state indicating a temporary suspension or pause in therapy delivery, or more than two such states. In some embodiments, the pump set may have been configured to monitor the remaining capacity or life of the power source (for example, by periodically reading or sampling battery voltage, current, etc.) . The pump set may have been configured to indicate the remaining capacity to the user. For example, if the power source is determined to have normal remaining capacity (for example, as a result of comparison with a threshold, such as 2.7 V, 2.6 V, 2.5 V, etc.), the battery indicator 1066 can be disabled. If the power source is determined to have low remaining capacity, the pump set may have been configured to provide an indication to the user, for example, by causing the battery indicator 1066 to blink or flash, as illustrated by the figure below. transition 1230. In some embodiments, the battery indicator 1066 may have been configured to be made to blink or flash intermittently or continuously, regardless of the state of the pump set or only in specific states. In some embodiments, when the remaining capacity of the power supply is determined to be at or near a critical magnitude (for example, as a result of comparison to a threshold, such as 2.4 V, 2.3 V, 2, 2 V, etc.), the pump set may have been configured to transition to a battery critical state 1212. In some embodiments, the pump set may be configured to remain in this state until the capacity of the power source is increased, such as by power source replacement or recharging. The pump set may have been configured to turn therapy off while in critical battery state 1212. In addition, as illustrated, the pump set may have been configured to indicate to the user that the power source is at or near the critical magnitude, for example, by turning off all indicators. In some embodiments, the pump set may be set to deliver therapy for a predetermined period of time, such as approximately 1 day, 2 to 4 days, following a first activation. In some embodiments, such a period of time may be a preset value, may be modified by the user and / or varied based on various operating conditions, and / or a combination of these situations. The pump set can be discarded after the expiration of said period of time. In some embodiments, the first activation may be reflected by a transition to the active state category 1210, pulling the activation strip (eg, transition to state 1202), etc. Once the pump set has been activated, the pump set may have been configured to monitor the amount of time it has been active. In some embodiments, the pump set may have been configured to monitor the cumulative amount of time spent in the active state category 1210. This may be accomplished, for example, by maintaining a timer (in firmware, software, hardware, or whatever). combination thereof) that reflects such a period of time. When the duration reaches or exceeds a threshold (for example, 7 days), the pump set may have been configured to transition to an end of life (EOL) state 1240. The The pump set may have been configured to deactivate therapy while in state 1240 and to indicate to the user that the end of life of the pump set has been reached. For example, the pump assembly may have been configured to disable all indicators and / or disable the button. In some embodiments, when the pump assembly is expendable, the transition to end-of-life state 1240 means that the pump assembly may be expendable. The pump set may have been configured to disable reactivation of the pump set once it has reached end of life. For example, the pump set may have been configured to not allow reactivation, even if the power source is disconnected and reconnected later, which may be done by storing an indication, value, flag, etc. in read-only memory. Figure 26 illustrates the operational flow in state category 1250 of pump set 1000 according to some embodiments. The pump set may have been configured to deliver therapy, monitor system leaks, provide an indication(s) to the user, and the like. As explained below, in some embodiments, the pump set may have been configured to deliver therapy by initially attempting to establish a first magnitude of desired negative pressure (for example, a negative pressure between -5 mm Hg or less and -200 mm Hg or less). Hg or greater, such as -100 mm Hg) under bandage 1010. In some embodiments, the first desired negative pressure magnitude may be a preset value, may be set or modified by the user, and / or varied based on various operating conditions or any combination thereof. Once the desired first magnitude of negative pressure under the bandage 1010 has been established, the pump assembly may have been configured to turn off the source of negative pressure input (eg, the pump). When the negative pressure under the bandage 1010 is reduced (i.e., gravitates toward normal atmospheric pressure) as a result of leaks in the system, the pump assembly may have been configured to restore a negative pressure under the bandage by activating the pump to establish a second desired amount of negative pressure under the bandage (eg, a negative pressure between -5 mm Hg or less and -200 mm Hg or more, such as -100 mm Hg). In some embodiments, the second desired negative pressure magnitude may be a preset value, set or changed by the user, and / or varied based on various operating conditions or any combination thereof. In some embodiments, the first and second desired negative pressure magnitudes may be the same. In some embodiments, the first and second desired negative pressure magnitudes may be different, ie, the second negative pressure magnitude may be less than the first negative pressure magnitude, or vice versa. In some embodiments, the pump assembly may transition from the manual stop state 1216 and / or the stop state 1218 to the state 1252. As explained above, this transition may be caused by the user pressing the button to start / restart therapy and / or at the expiration of a certain period of time, such as 1 hour. The pump assembly may have been configured to immediately transition to an initial pump down (IDP) state 1260, in which the pump may be activated by establishing the first magnitude of desired negative pressure under the bandage 1010. In some embodiments, the pump may be activated if the amount of pressure under the bandage is above (is less than) the first desired amount of negative pressure. Reference may be made in this report to the activation of the negative pressure supply source to establish the first magnitude of desired negative pressure under bandage 1010 as the "initial pumpdown". The pump set may have been configured to indicate to the user that it is performing initial vacuum pumping, for example, by causing the 'OK' indicator 1062 to blink or flash and turning off the bandage indicator 1064. In some embodiments, the indication may be provided, for example, by activating the negative pressure supply source. The pump assembly may have been configured to measure the magnitude of the pressure under the bandage 1010 by reading or sampling from the sensor 1070. In some embodiments, the pump set may have been configured to monitor how long the pump set remains in the IPD 1260 state. This may be accomplished, for example, by maintaining a timer (in firmware, software, hardware, or in any combination thereof), which can be reset and started when the pump set transitions to the IPD 1260 state. In some embodiments, in order to save power, limit noise and / or vibration generated by the pump, etc., the pump set may have been configured to suspend pump-down operation for a certain period of time and then retry pump-down. This functional capability can, for example, conserve battery power and allow transient and / or non-transient leaks to be fixed without user intervention, or allow the user to fix the leak (for example, straightening the bandage, fixing the clogging, checking the connection or connections, etc.). In some embodiments, when the duration time spent in the IPD state 1260 equals or exceeds a certain threshold (eg, 30 seconds), the pump set may have been configured to transition 1264 to state 1266. In some embodiments, the threshold may be a preset value, such as between 5 seconds and 5 minutes, or higher. In some embodiments, the threshold can be set or changed by the user. In some embodiments, the threshold can be varied based on various operating conditions or any combination thereof. In some embodiments, the pump set may have been configured to deactivate the pump when the 1264 transition occurs. The pump set may have been configured to monitor a certain number of attempts (for example, by maintaining a counter that can be reset in state 1252 and updated in wait state 1270) performed to establish the first desired negative pressure under dressing 1010. In some embodiments, the pump set may have been configured to provide a maximum or limited number of IPD retry attempts with in order to, for example, save energy. Preferably, the pump set may have been configured to provide a limited number of consecutive IPD retry attempts, while the pump set may have been configured to provide a limited number of non-consecutive IPD retry attempts, or a mixture of attempts. of consecutive and non-consecutive IPD retries. The threshold for IPD retry attempts can be 1, 2, 3, 4, 5, and so on. In some embodiments, the threshold may be a preset value. In some embodiments, the threshold can be set or changed by the user. In some embodiments, the threshold can be varied based on various operating conditions or any combination thereof. In some embodiments, the pump set may have been configured to determine, in state 1266, whether the number of IPD retry attempts made equals or exceeds the threshold (eg, 1 retry attempt). In the event that the number of IPD retry attempts made equals or exceeds the threshold, the pump set may have been configured to transition 1228a to the temporarily stopped state 1218, in which therapy is temporarily paused or suspended as has been described above. Otherwise, the pump set may have been configured to transition 1268 to the standby state 1270. In some embodiments, the pump set may have been configured to turn off the negative pressure source in state 1266, which may provide an indication to the user that the pump set has transitioned to state 1266. In some embodiments, the pump set may have been configured to deactivate the pump in standby state 1270, thereby temporarily stopping therapy for a certain period of time (for example, between 1 second or less and 1 minute or more). , such as 15 seconds). This can be accomplished, for example, by maintaining a timer (in firmware, software, hardware, or any combination thereof), which can be reset and started when the pump set transitions to the wait state 1270. This period The time in the wait state 1270 may be preset or variable (eg, automatically or by the user). In some embodiments, the time period can be varied based on various operating conditions or any combination thereof. The amount of time the pump remains in the standby state 1270 may be decreased or increased (eg, multiplied by a factor between 0, 1 or less, and 4, 0 or more, such as 2) at each transition to the state. wait state 1270. The time period may be decreased or increased at each successive transition to the wait state 1270. The time period may be decreased or increased until it equals or exceeds a certain threshold (for example, between 1 second or less and 5 minutes or more, such as 4 minutes). In addition, the time period may be reset to an initial value upon making a transition to a monitoring pressure state 1280, a transition to a manual temporary stop state 1216, a transition to a temporarily stopped state 1218, etc. In some embodiments, the pump set may have been configured to initiate the user that the pump set is in the wait state 1270. For example, the pump set may have been configured to cause the 'OK' indicator 1062 to flash or blink and to turn off the bandage indicator 1064. In some embodiments, turning off the pump can provide an indication that the pump set is in the standby state 1270. Upon expiration of the time period in the wait state, the pump set may have been configured to perform the transition 1272 from the wait state 1270 to the IPD state 1260, in which the pump set may attempt to establish the first desired amount of negative pressure under the bandage 1010. In some embodiments, the pump assembly may be configured to ensure that the amount of negative pressure under the bandage remains above a certain safe amount. For example, the pump assembly may have been configured to maintain the amount of negative pressure under the bandage 1010 above a safe amount between -150 mm Hg or less and -250 mm Hg or more, such as -225 mm Hg. . In some embodiments, once the first magnitude of desired negative pressure under the bandage 1010 has been established, the pump set may have been configured to transition 1276 to a monitoring state 1280. The pump set may have been configured to reset the number of IPD retry attempts when transitioning 1276. The pump set may have been configured to indicate the transition to the 1280 supervisory state to the user, for example, by causing the 'OK' indicator to blink or flash and turn off bandage gauge 1064. While in the 1280 supervisory state, the pump set may have been configured to deactivate the pump (which may provide an indication to the user that the pump set is in the 1280 supervisory state) and periodically or continuously monitor the magnitude of pressure under bandage 1010. The pump set may have been configured to measure the magnitude of pressure under bandage 1010 by reading or sampling from sensor 1070. In some embodiments, the pump assembly may have been configured to determine if, for example, due to leaks in the system, the magnitude of the negative pressure under the bandage 1010 is reduced to and / or exceeds a certain threshold (for example , become smaller than him). The threshold can be selected in the range between -10 mm Hg or less and -100 mm Hg or more, such as -60 mm Hg. In some embodiments, the threshold may be a preset value, may be set or changed by the user, and / or varied based on various operating conditions or any combination thereof. If it is determined that the threshold has been reached or exceeded, the pump set may have been configured to reset the amount of negative pressure under the bandage 1010. In some embodiments, the pump set may have been configured to reset the first amount of negative pressure desired or establish another magnitude of different negative pressure. This may be accomplished by transitioning 1282 to a Maintenance Pump Down (MPD) state 1290. In some embodiments, the pump set may be configured to activate the pump in order to establish the desired amount of negative pressure under the bandage 1010 (eg, the first desired amount) while the pump set remains in the MPD state. 1290. The pump set may have been configured to provide an indication to the user, for example, by causing the 'OK' indicator 1062 to blink or flash and turning off the bandage indicator 1064. In some embodiments, the pump assembly activating the negative pressure source may provide an indication to the user that the pump assembly has transitioned to state 1290. In some embodiments, the pump assembly may have been configured to generate less noise. and vibration when the pump is activated in the MPD 1290 state than when the pump is activated in the IPD 1264 state. For example, the difference in noise level can be between 1 dB or less and 30 dB or more, such like about 7 dB, about 20 dB, etc. As another example, the difference in noise level can be between 30 dB or less and 80 dB or more, such as about 45 dB, about 50 dB, about 65 dB, etc. In some embodiments, the pump set may have been configured to monitor how long it remains in the MPD 1290 state. This may be accomplished, for example, by maintaining a timer (in firmware, software, hardware, or any combination of the themselves) which may be reset and started when the pump set transitions 1282 to the MPD state 1290. In some embodiments, in order to save power, limit noise and / or vibration generated by the pump, etc., the The pump set may have been configured to suspend the pump down maintenance operation for a certain period of time and then retry the initial pump down and / or pump down maintenance at a later time. This functional capability can, for example, conserve battery power and allow transient and / or non-transient leaks to be fixed without user intervention, or allow the user to fix the leak (for example, straighten the bandage, fix the plug , check the connection or connections, etc.). In some embodiments, when the duration time in the MPD 1290 state equals or exceeds a certain threshold (for example, a value between 5 seconds or less and 5 minutes or more, such as 10 seconds) and the magnitude of the pressure under If the dressing 1010 has not reached the desired magnitude of negative pressure, the pump set may have been configured to transition 1292 to state 1294. The threshold may be a preset value, set or changed by the user, and / or modified based on various operating conditions or any combination thereof. In some embodiments, the pump set may have been configured to deactivate the pump at the time of transition 1292, which may provide an indication to the user that the pump set is transitioning. The pump set may have been configured to monitor the number of MPD attempts (for example, by keeping a counter which can be reset to state 1252 and / or when transition 1228b is performed, and updated when transition 1296 is performed) made to establish the desired negative pressure under the bandage 1010. In some embodiments, the pump assembly it may have been configured to provide a limited or maximum number of MPD retry attempts (for example, to save power). Preferably, the pump set may have been configured to provide a limited number of consecutive DPM retry attempts, while the pump set may have been configured to provide a limited number of non-consecutive DPM retry attempts, or a mixture of consecutive and non-consecutive retry attempts. The threshold for MPD retry attempts can be 1, 2, 3, 4, 5, and so on. In some embodiments, the threshold may be a preset value, may be adjusted or modified by the user, and / or may be varied based on various operating conditions or any combination thereof. The pump set may have been configured to set the number of IPD and MPD retry attempts to the same or different values. The pump set may have been configured to determine, in state 1294, whether the number of MPD retry attempts made equals or exceeds the threshold (eg, 3 attempts). In the event that the number of MPD retry attempts made equals or exceeds the threshold, the pump set may have been configured to transition 1228b to the temporarily stopped state 1218, in which therapy is temporarily stopped or suspended. as previously described. Otherwise, the pump set may have been configured to transition 1296 to the wait state 1270, in which therapy is temporarily paused or suspended as described above. Alternatively, the pump set may have been configured to transition to the IPD 1260 state or the MPD 1290 state. In some embodiments, the pump set may have been configured to transition 1284 to the monitoring state 1280 if the magnitude of the pressure under the bandage reaches or exceeds the desired negative pressure magnitude (for example, becomes greater than this). ). The pump set may also have been configured to reset the number of MPD attempts when it makes the 1284 transition. In some embodiments, the pump set may have been configured to monitor the duty cycle of the negative pressure supply source (eg, a pump). The pump set may be configured to monitor the duty cycle periodically and / or continuously. Duty cycle measurements can reflect various system operating conditions, such as the presence and / or severity of leaks, fluid flow rate (e.g., air, liquid and / or solid bleed materials, etc. ) aspirated from the wound, and so on. For example, duty cycle measurements may indicate the presence of a major leak, and the pump set may have been configured to indicate this condition and / or temporarily suspend or stop pump operation to save energy. This functionality can, for example, save battery power and allow transient and / or non-transient leaks to be fixed without user intervention, or allow the user to fix the leak (for example, straighten the bandage , fix the blockage, check the connection or connections, etc.). In some embodiments, the pump set may be configured to periodically monitor the duty cycle, such as once every 10 seconds or less to 5 minutes or more. In some embodiments, the pump set may have been configured to monitor the duty cycle once per minute. This can be accomplished by maintaining a timer (in firmware, software, hardware, or any combination thereof) that can be set to expire every minute (for example, as indicated by a switch or by a query) and can be cleared (for example, by clearing an interrupt). In some embodiments, the time interval required to measure the duty cycle may be a preset value, a value set or changed by the user, and / or a value that is varied based on various operating conditions or any combination of the following. same. In some embodiments, the pump set may have been configured to monitor the duty cycle when the pump set is in the 1250 operating state category (i.e., in any of states 1260, 1266, 1270, 1280, 1290, 1294 and / or on any transitions between any of the states), as the pump set has been configured to activate the pump in this category of states. In some embodiments, the pump set may be configured to monitor the duty cycle when the pump set is in a particular state and / or state transition or subset of states and / or state transitions, from the category of 1250 states. In some embodiments, the pump set may be configured to monitor the duty cycle when the pump set is in a particular state and / or state transition, subset of states and / or state transitions, or in all states and / or state transitions of the active state category 1210, or in any combination of states and / or state transitions disclosed herein. As illustrated in Figure 26, the pump set can transition 1302 from any of states 1260, 1266, 1270, 1280, 1290, 1294 and / or transitions between any of states and state 1300, such that that the pump set determines the duty cycle of the pump for the elapsed minute. The duty cycle can be determined according to the equation: DC = t / T, (2) where DC is the duty cycle, t is the duration that the negative pressure supply source is active, and T is the total time under consideration. In case of duty cycle monitoring once per minute (i.e. T = 60 seconds) , the duty cycle can be expressed (for example, in percentage) as: DC = (Pump running time during the elapsed minute / 60) * 100% (3) In order to determine the duty cycle, the pump set may have been configured to monitor the length of time the pump has been on (eg, pump run time) and / or idle. In some embodiments, the pump set may have been configured to compare the determined duty cycle to a certain duty cycle threshold, which may be selected from the range of 1% or less to 50% or more. The comparison can, for example, indicate the presence of a leak in the system. In other words, if the pump remains on for such a period of time that the duty cycle threshold is reached or exceeded, the pump may be working hard to overcome the leak. In such cases, the pump set may have been set to temporarily suspend or stop delivery of therapy. The pump set may have been configured to provide an indication to the user that the pump is working hard (for example, the duty cycle exceeds the threshold for duty cycle), by turning off, for example, the source of pressure input negative. In some embodiments, the duty cycle threshold may be a preset value, a value set or changed by the user, and / or a varied value based on various operating conditions or any combination thereof. As illustrated in Figure 26, the pump set may have been configured to compare the determined duty cycle to the duty cycle threshold (eg 9%). The pump set may be configured to monitor the number of duty cycles at which the threshold is exceeded, for example by maintaining and updating an overload counter, which may be reset when the pump set transitions from state 1252 to the state of IPD 1260. In some embodiments, the pump set may have been configured to update the overload counter at state 1300. If the determined duty cycle does not exceed the duty cycle threshold, the pump set may decrement the overload counter by one. In some embodiments, the minimum value of the overload counter may be set to zero, ie the overload counter cannot go negative. Conversely, if the determined duty cycle equals or exceeds the duty cycle threshold, the pump set may increment the overload counter by one. In some embodiments, the pump set may have been configured to monitor the total or aggregate number of duty cycles that equal or exceed the duty cycle threshold. This solution can help to smooth or average the variation of the duty cycle in order to, for example, prevent one or more erratic cycles that can be caused by a transient leakage from the interruption of therapy. In some embodiments, the pump set may have been configured to monitor consecutive or non-consecutive duty cycles that exceed the duty cycle threshold. In some embodiments, the threshold may be a preset value, set or changed by the user, and / or varied based on various operating conditions or any combination thereof. If the number of duty cycles exceeding the duty cycle threshold is determined to exceed a certain overload threshold (for example, a number between 1 and 60 or more, such as 30), the pump set may have been configured to transition 1230 to the temporarily stopped state 1216, whereby the therapy is suspended or temporarily stopped as described above. In some embodiments, the pump set may have been configured to turn off the negative pressure supply source, which may provide an indication to the user that the pump is working hard (for example, the duty cycle exceeds the overload threshold). . If the number of duty cycles exceeding the duty cycle threshold is not determined to exceed the overload threshold, the pump set may have been configured to transition 1304 and remain in operating state category 1250. In some embodiments , the pump set may have been configured to return to the same state and / or transition between states from which the pump set has transitioned 1302. In some embodiments, the pump set may have been configured to transition to a state different and / or transition between different states. In some embodiments, the pump set is additionally configured to temporarily suspend or stop therapy if the user presses button 1002 while the pump set is in state category 1250. In some embodiments, the pump set may have been configured to transition to manual temporary hold state 1216. Figure 27 illustrates another state diagram of the operation of the pump set 1000 in accordance with some embodiments. In some embodiments, controller 1140 may have been configured to implement state diagram flow 1400. In some embodiments, flow 1400 may be largely similar to the flow illustrated in Figures 25-26. State 1402 corresponds to state 1202, state 1406 corresponds to state 1206, state category 1410 corresponds to state category 1210, state 1414 corresponds to state 1214, state 1416 corresponds to state 1216, state 1418 corresponds to state 1218, transition 1420 maps to transition 1220, transition 1422 maps to transition 1222, transition 1424 maps to transition 1224, transition 1426 maps to transition 1226, and state 1440 maps to state 1240. In addition, state category 1450 corresponds to state category 1250, state 1460 corresponds to state 1260, transition 1464 corresponds to with transition 1264, state 1466 corresponds to transition 1266, transition 1468 corresponds to transition 1268, transition 1428a corresponds to transition 1228a, state 1470 corresponds to state 1270, and transition 1472 corresponds to transition 1272. On the other hand, transition 1476 corresponds to transition 1276, state 1480 corresponds to state 1280, transition 1482 corresponds to transition 1282, state 1490 corresponds to state 1290, transition 1492 corresponds to transition 1292, state 1494 corresponds to state 1294, transition 1496 corresponds to transition 1296, and transition 1428b corresponds to transition 1228b. In some embodiments, the pump assembly may have been configured to monitor the duty cycle once a desired amount of negative pressure has been established under the bandage 1010 in the MPD state 1490. In some embodiments, the pump assembly may also take into account the length of time the pump has been on while the pump set remains in the IPD state 1460. As illustrated, the device may have been configured to transition 1484 from the MPD state 1490. The transition 1484 may be similar to transition 1284, but instead of transitioning directly to IPD state 1480, the pump set may have been configured to monitor the duty cycle in state 1500. In some embodiments, the pump set may have been configured to monitor the duty cycle for a cumulative period of time that the pump set has been in the monitor state ion 1480 and in the MPD state 1490. In some embodiments, the pump set may have been configured to monitor the duty cycle over the cumulative period of time during the immediately preceding or previous monitoring and MPD cycles. For example, immediately prior to transitioning to state 1500, the pump set may have remained in MPD state 1490 for amount of time X (during which the pump set was active). Furthermore, assuming that immediately prior to transitioning to the MPD state 1490, the pump set remained in the supervisory state 1480 for a magnitude of time Y (during which the pump was not active), the duty cycle (DC -"duty cycle"-) can be expressed (for example, in percentage) as: DC = 100% * [X / (X + Y) ]. (4) To determine the duty cycle, the pump set may have been configured to monitor the length of time the pump has been on and / or off. In some embodiments, the pump set may have been configured to compare the determined duty cycle to a certain duty cycle threshold (eg, 9%), as described above. In some embodiments, the threshold may be a preset value, set or changed by the user, and / or varied based on various operating conditions or any combination thereof. If the duty cycle is determined to be below the threshold, the pump set may have been configured to transition 1502 to supervisory state 1480. Conversely, if the duty cycle is determined to be the same as the threshold or exceeds it, the pump set may have been configured to transition 1504 to state 1506. In some embodiments, the pump set may provide an indication that the duty cycle exceeds the threshold, for example, by deactivating the pump . In some embodiments, the pump set may have been configured to monitor a total or aggregate time over which the duty cycle equals or exceeds the threshold. This solution can help smooth or average duty cycle variation, for example, to avoid one or more erratic cycles that can be caused by transient leakage from therapy interruption. Supervision can be accomplished by maintaining a timer (in firmware, software, hardware, or any combination thereof), which can be reset (eg, on transition 1476) and updated (eg, in state 1506). ). In some embodiments, the pump set may be configured to determine if the duty cycle equals or exceeds the threshold over a certain aggregate time period, which may be compared to a certain aggregate duration threshold. The threshold may be selected from a range between 5 minutes or less and 2 hours or more, such as 30 minutes. In some embodiments, the threshold may be a preset value, set or changed by the user, and / or varied based on various operating conditions or any combination thereof. If the added time period equals or exceeds the threshold, the pump set may have been configured to transition 1508 to the temporarily stopped state 1418, in which the pump set may have been configured to suspend or temporarily stop therapy delivery . In some embodiments, the pump assembly may indicate this transition to the user, for example, by deactivating the pump. Conversely, if the aggregate time period is determined to be less than the threshold, the pump set may have been configured to perform the transition 1510 to the supervisory state 1480. The pump set may have been configured to indicate the transition 1510 to the user, for example, by causing the 'OK' indicator 1062 to blink or flash and deactivating the bandage indicator 1064. Figure 28 illustrates a graph 1600 depicting a duty cycle determination for pump set 1000 in accordance with some embodiments. The x axis represents time and the y axis represents pressure. In some embodiments, the pump assembly may have been configured to establish a negative pressure magnitude of -100 mm Hg under bandage 1010, as represented by position 1606. For example, this may be done during pumping of initial vacuum at state 1260. The pump set may have been configured to monitor the magnitude of negative pressure under the bandage 1010. For example, this may be carried out performed in monitoring state 1280. As illustrated, the pump set may monitor pressure over time period a, as represented by interval 1602. The amount of negative pressure under the bandage 1010 may decay with time (for example, due to leaks in the system), as illustrated by line 1620. In some embodiments, the pump assembly may be configured to restore or reset the amount of negative pressure under the bandage 1010 when the pressure decreases to or exceeds a threshold of approximately -70 mm Hg, as represented by the position 1608. In some embodiments, the pump assembly may have been configured to activate the pump, as illustrated by line 1622. For example, this may be accomplished by transitioning to the maintenance vacuum pump state 1290. As illustrated, the pump assembly may activate the pump for a duration time b (1604) until the negative pressure magnitude of -100 mm Hg is re-established under the bandage 1010. The pump assembly may have been configured to deactivate the pump when the pressure magnitude under the bandage 1010 reaches -100 mm Hg at position 1610. For example, this may be accomplished by transitioning to monitoring state 1280. The cycle of work (DC) over the period illustrated by the reference 1600 (that is, a + b) can be expressed (for example, in percentage) as: DC = 100% * [b / (a ​​+ b) ]. (5) Figure 29 illustrates a non-limiting example of normal operation (eg, no leak or low leak) 1700 of some embodiments of the pump set 1000. The pump set may have been configured to establish a desired amount of negative pressure under the bandage 1010, as illustrated in box 1702. The pump assembly may have been configured such that if the magnitude of pressure under bandage 1010 rises above a certain desired magnitude (for example, the value of the first set point, such as -70 mm Hg), the source of negative pressure supply (eg, a pump) will be activated and begin to work to reduce the amount of pressure under the bandage 1010 to the desired value. For example, the desired value may lie approximately within the range between the first and second set point values, or be approximately the second set point value (eg, -100 mm Hg). In some embodiments, this may be accomplished in the initial pumpdown state 1260. In some embodiments, when the magnitude of pressure under the bandage 1010 reaches a desired value, the pump assembly may have been configured to deactivate the pump and monitor the magnitude of pressure under the bandage, as illustrated within box 1704. For example , this can be accomplished in monitoring state 1280. The pump set may have been configured to periodically or continuously monitor the magnitude of the pressure under the bandage 1010, for example, by reading or sampling sensor 1070. Based on the monitored pressure, the The pump assembly can determine, within the box 1706, whether it is necessary to activate or restart the pump to re-establish the desired magnitude of negative pressure under the bandage 1010. If the monitored pressure is determined to be low (for example, less, or less than or equal to, the value of the first setting set), the pump set may have been configured to activate the pump, as illustrated within box 1708. For example, this can be accomplished by transitioning to the state of MPD 1290. Conversely, if the pressure monitored magnitude has not been determined to be low (for example, greater than, or greater than or equal to, the value of the first set point), the pump set may have been set to continue to monitor the magnitude of the pressure under the bandage 1010. During this flow of operation, the pump set may have been set to indicate to the user that it is operating normally. As illustrated at 1060a, the pump set may activate or cause the 'OK' indicator 1062 to blink or flash, which is represented at 1062a. In addition, the pump assembly can deactivate the bandage indicator 1064 and the battery indicator 1066, which is represented by the references 1064a and 1066a, respectively. Figure 30 illustrates a non-limiting example of the operation 1800 of some embodiments of the pump assembly 1000 in the presence of a major leak. As described above in connection with Figure 29, the pump assembly may have been configured to establish a desired amount of negative pressure under the bandage 1010, as illustrated in box 1802. In some embodiments, when the amount of pressure under bandage 1010 reaches the desired value, the pump set may have been configured to deactivate the pump and monitor the magnitude of pressure under the bandage, as illustrated in box 1804. The pump set may have been configured to monitor periodically or continuously the amount of pressure under the bandage 1010, for example, by reading or sampling the sensor 1070. Based on the monitored amount of pressure, the pump set can determine if it is necessary to activate or reset the pressure to re-establish the desired amount of pressure negative under the bandage 1010. If the pressure monitored magnitude is determined to be low (for example, less than, or less than or equal to, the value of the first set point), the pump set may have been configured to activate the pump, as illustrated in box 1808. Once the desired amount of pressure has been re-established under the bandage 1010, the pump set it may restart monitoring the magnitude of negative pressure under the bandage (eg, transition to monitoring state 1280). In some embodiments, due to the presence of a leak or leaks in the system, the pump set 1010 may have been configured to perform multiple pump monitoring and reactivation cycles. During this operational flow, the pump set may have been configured to indicate to the user that the pump set pump is working normally. As illustrated by 1060b, the pump set can activate or cause the 'OK' indicator 1062 to blink or flash, which is represented by 1062b. In addition, the pump assembly can deactivate the bandage indicator 1064 and the battery indicator 1066, which is represented by the references 1064b and 1066b, respectively. The pump set may have been configured to continuously or periodically determine if the pump is pumping too often, as illustrated in box 1810. As illustrated, in some embodiments, the pump set may have been configured to use the duty cycle as a representation or reference to determine if the pump is pumping too often. For example, the pump set may have been configured to determine if the pump is "working hard", that is, determine if the pump is running for more than a threshold duration, such as 9% of the total therapy time. . In other words, the pump set may have been configured to determine if the duty cycle of the pump meets or exceeds the duty cycle threshold. In some embodiments, the pump set may have been configured to suspend or temporarily stop the operation of the pump if it is determined that the pump has been working hard for a certain temporary duration (for example, the pump is running for longer than that). of about 2 hours in a day, or is running for more than a predetermined amount of time), even if the desired magnitude of negative pressure has been set (for example, the second setpoint value). As illustrated in box 1812, the pump set may have been configured to determine if the pump is working hard for 30 minutes or more. For example, the pump set may have been configured to determine if the monitored duty cycle(s) over the last 30 minutes exceed(s) the duty cycle threshold. For example, the pump set can determine if the pump has been running for approximately 2 minutes and 42 seconds or longer over the last 30 minutes, which corresponds to a duty cycle threshold of 9%. In some embodiments, the pump set may have been configured to temporarily stop or suspend therapy if the pump is determined to be working hard, as illustrated in box 1814. The pump set may additionally have been configured to turn on a "Leakage Alarm" indicator. As illustrated by reference 1060c, the pump assembly can activate or flash the bandage indicator 1064, which is represented by reference 1064b, and deactivate the 'OK' indicator 1062 and the battery indicator 1066 , which have been represented by the reference 1062c and 1066c. In order to restart therapy, the user may need to straighten the bandage, fix the leak, and / or activate the pump once more. In some embodiments, the pump may be reactivated by pressing the existing start or run button on the pump, due to a timeout, etc. In the event that a dressing leak or leaks are present, in some embodiments, the pump set 1000 may have been programmed or otherwise configured to suspend or temporarily stop therapy if the second set point value is not reached. after a predetermined amount of pump run time has elapsed. For example, in some embodiments, if the pump has been running continuously for X minutes and the second set point pressure value has not been reached, the pump assembly may activate an alarm which may comprise an LED indicator, an indicator LED “Leak Detected” 1064 or other alarm, and temporarily stop therapy. In some embodiments, the predetermined amount of time may be about 5% of the total planned duration of negative pressure therapy for the system, or from about 3% or less to about 15% or more of the total planned duration. of negative pressure therapy for the system. In some embodiments, the predetermined amount of time may be about 9 minutes, or from about 4 minutes or less to about 40 minutes or more, or from about 6 minutes to about 10 minutes. Figure 31 illustrates a non-limiting example of the operation 1900 of some embodiments of the pump assembly 1000, in the presence of a major leak. As described above in connection with Figure 29, the pump assembly may be configured to establish a desired amount of negative pressure under bandage 1010, as illustrated in box 1902. In some embodiments, when the amount of pressure under If the bandage 1010 reaches the desired value, the pump set may have been configured to deactivate the pump and monitor the magnitude of pressure under the bandage, as illustrated in box 1904. The pump set may be configured to monitor periodically or continuously the magnitude of the pressure under the bandage 1010, for example, by reading or sampling the sensor 1070. Based on the monitored magnitude of the pressure, the pump set can determine if the pump needs to be activated or restarted to re-establish the desired magnitude of negative pressure under bandage 1010. If the pressure monitored magnitude is determined to be low (e.g., less than, or less than or equal to, the pressure r of the first set point) , the pump set may have been configured to activate the pump, as illustrated in box 1908. During this operating flow, the pump set may have been configured to indicate to the user that the pump set it is working normally. As illustrated by reference 1060d, the pump set may activate the 'OK' indicator 1062 or cause it to blink or flash, which is represented by reference 1062d. In addition, the pump assembly can deactivate the bandage indicator 1064 and the battery indicator 1066, which is represented by the references 1064d and 1066d, respectively. In some embodiments, due to the leak(s) (for example, a leak that has a relatively very high flow rate), the pump assembly may not be able to achieve a desired negative pressure magnitude and / or second value. set point under the bandage 1010. If, after a predetermined amount of run time, the desired magnitude of negative pressure is not achieved under the bandage, the pump set may have been configured to suspend or temporarily stop the pump, as illustrated in box 1914. For example, this can be accomplished by transitioning to wait state 1270. In some embodiments, the default amount of pump run time can be 10 seconds (as illustrated in Figure 31). . In some embodiments, the predetermined amount of pump run time can be between about 5 seconds or less and about 60 seconds or more. In some embodiments, the pump set may have been configured to provide a limited number of retry cycles before temporarily stopping or suspending therapy. As illustrated in boxes 1920, 1922, and 1924, the pump set may have been configured to go through three retry cycles before suspending or temporarily stopping therapy (1914) and / or activating an alarm, such as the "Alarm on the run." Some embodiments of the pump set may go through two retry cycles, four retry cycles, etc., before temporarily stopping therapy and / or activating an alarm. As illustrated by 1060e, the pump assembly can activate or cause the bandage indicator 1064 to blink or flash, which is represented by reference 1064c, and deactivate the 'OK' indicator 1062 and the 'OK' indicator 1066. battery, which has been represented by the references 1062e and 1066e, respectively. Figure 32 illustrates a non-limiting example of the operation 2000 of some embodiments of the pump assembly 1000 in the presence of an extremely large leak. The pump set may have been configured to quickly go into a therapy hold or suspend mode to avoid wasting batteries trying to deal with a high flow rate leak. As illustrated in box 2001, the pump set can be turned on, which can be accomplished, for example, by transitioning to state category 1250. As described above in connection with Figure 29, the pump assembly may have been configured to establish a desired amount of negative pressure under the bandage 1010, as illustrated in box 2002. In some embodiments, if the leak is extremely significant, such as when the pump is turned on but has not yet been connected to the dressing, or has not been properly connected to the dressing, the pump set may have been set to run for a certain amount of time. while trying to bring the pressure under the bandage 1010 to a desired amount of negative pressure (for example, approximately the value of the second set point or a value in the range between the values ​​of the first and second set points ). The pump set may have been configured to temporarily suspend or stop therapy when the predetermined amount of time expires. For example, this may be accomplished by transitioning to the wait state 1270. As illustrated, the pump set may have been configured to run the pump for 30 seconds. If, during this period of time, the pressure under the bandage 1010 has not been brought to the desired negative pressure, the pump set may go into a 2020 time count mode for another predetermined amount of time (for example, 15 seconds , as illustrated in Figure 32). During this operational flow, the pump set may have been configured to indicate to the user that the pump set is operating normally. As illustrated by reference 1060f, the pump set may activate or cause the 'OK' indicator 1062 to blink or flash, which is represented by reference 1062f. In addition, the pump assembly can deactivate the bandage indicator 1064 and the battery indicator 1066, which are represented by the references 1064f and 1066f, respectively. In some embodiments, the pump set may have been configured to provide a limited number of retry cycles to establish the desired amount of negative pressure under the bandage 1010. As illustrated, after the first test (or any number of additional tests) , the pump assembly may have been configured to set or reset the desired amount of negative pressure under the dressing, as illustrated in box 2002. In some embodiments, as illustrated in box 2014, if the pump assembly operates for another predetermined amount of time without bringing the pressure under the bandage 1010 to the desired magnitude (for example, approximately to the second set point value or to a value within the range between the first and second set point values ) after a first attempt, the pump set may have been configured to temporarily suspend or stop therapy without retrying vacuum pumping. The pump set may have been configured to remain in the suspended or temporarily stopped state until the pump set is reactivated (eg, due to a timeout, due to the user pressing a button, etc.). The pump set may have been configured to alarm in this state. During this operational flow, the pump set may have been configured to indicate to the user that a leak or leaks are present. As illustrated by reference 1060g, the pump assembly can activate the bandage indicator 1064 or cause it to blink or flash, which has been represented by reference 1064g, and deactivate the 'OK' indicator 1062 and the 'OK' indicator 1066. battery, which has been represented by the references 1062g and 1066g, respectively. Throughout the description and claims of this specification, the words "comprising" and "contain" and variants of these words, for example, "comprising" and "comprising", mean "including, but not is limited to”, and is not intended to (and does not) exclude other species, additives, components, elements members or stages. Throughout the description and claims of this specification, the singular encompasses the plural, unless the context otherwise requires. In particular, in the event that the indefinite article is used, the report must be understood in such a way that it contemplates plurality as well as singularity, unless the context otherwise requires it. On the other hand, in some embodiments, the term "about" is intended to refer to values ​​within 10% of the stated values, unless otherwise stated herein. Any value of a threshold, limit, duration, time count, retry count, etc. provided herein is not intended to be absolute and may therefore be approximate. In addition to this, any threshold, limit, duration, time count, retry count, etc. provided herein may be fixed or varied, either automatically or by the user. Furthermore, as used herein, it is intended that relative terminology such as "exceeds", "greater than", "less than", etc. in relation to a reference value, also encompasses being equal to the reference value. For example, exceeding a reference value that is positive may encompass being equal to or greater than the reference value. Properties, constituent elements, characteristics, compounds, species or chemical groups that are described in conjunction with a particular aspect, embodiment or example, are to be understood as applicable to any other aspect, embodiment or example described in this specification, unless it is incompatible. with them. All features disclosed in this specification (including any accompanying claims, abstracts, and drawings) and / or all steps of any method or procedure so disclosed, may be combined in any combination, except combinations in which at least some of such characteristics and / or stages are mutually exclusive. The protection is not restricted to the details of any of the preceding claims. Protection extends to any new feature, or any new combination of features disclosed in this specification (including any accompanying claims, abstracts, and drawings), or to any new step, or any new combination of steps, in any method or procedure so disclosed. While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of protection. Indeed, the new methods and systems described herein can be embodied in a variety of other different ways. Furthermore, it is possible to make various omissions, substitutions, and changes in the form of the methods and systems described herein. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the illustrated and / or described procedures may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be eliminated, and others may be added. Accordingly, the scope of the present invention is intended to be defined solely by reference to the appended claims. The accompanying claims and their equivalents are intended to cover such forms or modifications to the extent that they fall within the scope and spirit of the protection. For example, the various components illustrated in the figures can be implemented as software and / or firmware on a processor, controller, ASIC [Application Specific Integrated Circuit], FPGA [Programmable Gate Array in the field -"Field Programmable Gate Array"-] and / or hardware for exclusive or dedicated use. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present invention. While this disclosure provides certain preferred embodiments and applications, other embodiments that are apparent to those of ordinary skill in the art are also within the scope of this invention, including embodiments that do not provide all of the features and advantages set forth herein. . Accordingly, it is intended that the scope of the present invention be defined solely by reference to the appended claims.

Claims

1. A pump assembly (104, 1000) for reduced pressure wound therapy, comprising: a housing (120, 1020); a pump (232, 1090), supported within or by the housing, such that the pump comprises: a motor (1092); an inlet (250) and an outlet (252); a first valve, configured to control a flow of a fluid through the inlet; and a second valve, configured to control a flow of a fluid through the outlet; a flow path through the pump assembly; and characterized in that a one-way flow valve (246, 1030) is in fluid communication with the pump and is supported inside a manifold (240) arranged within the housing and coupled to the pump inlet, such that the one-way flow valve is configured to substantially impede the flow of a gas through the flow path, in a flow direction away from the pump,1. The pump assembly has been sterilized in such a way that at least one inside and one outside of the housing, the flow path, the first and second valves, and the pump itself have been sterilized.

2. The pump assembly according to claim 1, wherein the first and second valves are configured to allow a flow of sterilizing gas through the first and second valves during the sterilization process.

3. The pump assembly according to any one of the preceding claims, wherein the first and second valves leak at flow rates of approximately 0.1 ml / min and 10 ml / min, respectively, at nominal working pressures.

4. The pump assembly according to any one of the preceding claims, wherein the pump assembly comprises one or more batteries (142, 1130) and weighs between approximately 70 and 90 grams.including the weight of one or more batteries.

5. The pump assembly according to any one of the preceding claims, wherein an external surface of the pump assembly defines a volume of approximately 50 to 80 cubic centimeters.

6. The pump assembly according to any one of the preceding claims, further comprising: a controller (1160) supported within or by the housing, such that the controller is configured to control the operation of the pump; and a single switch or button (122, 1002) configured to operate the pump, such that the switch or button is supported by the housing and accessible to a user, and is in communication with the controller.

7. The pump assembly according to any one of the preceding claims, wherein the pump assembly is cartridge-free.

8. A negative pressure therapy kit,comprising: the pump assembly according to any one of the preceding claims; a bandage (102, 1010); a conduit (106, 114, 140), attachable to the bandage and to the pump assembly and configured to provide a reduced-pressure fluid path to the bandage; one or more batteries; and a first packing element (150), having recesses (190, 192, 194, 196, 200a, 200b) to receive the pump assembly, the bandage, the conduit, and the one or more batteries, such that the negative pressure therapy kit has been sterilized.

9. The negative pressure therapy kit according to claim 8, wherein the first packing element supports the one or more batteries in such a manner,that the one or more batteries are supported outside the housing during sterilization of the negative pressure therapy kit.

10. The negative pressure therapy kit according to any one of claims 8 to 9, wherein the negative pressure therapy kit has been sterilized with ethylene oxide.

11. The negative pressure therapy kit according to any one of claims 8 to 10, further comprising a second packing element (151) configured to be detachably coupled to the first packing element, wherein the second packing element is permeable to a sterilizing gas and impermeable to bacteria.

12. The negative pressure therapy kit according to claim 11, wherein the pump assembly, the bandage,The conduit and one or more batteries are supported within at least one of the first and second packing elements before the pump assembly, dressing, conduit, or one or more batteries have been sterilized.

13. The negative pressure therapy kit according to any one of claims 8 to 12, wherein the dressing comprises: a transmission layer comprising a knitted or 3D fabric material configured to remain open upon application of negative pressure to the dressing; an absorbent layer intended to absorb wound exudate, such that the absorbent layer is overlaid on the transmission layer; and a cover layer overlaid on the absorbent layer.

14. The negative pressure therapy kit according to any one of claims 8 to 13, wherein the dressing further comprises: a suction port (108),for applying negative pressure to a bandage in order to apply negative pressure to a wound site, such that the suction port comprises a connector portion, intended to connect the suction port to the pump assembly, and a sealing surface, intended to form a hermetic seal of the suction port with the bandage cover layer; and a liquid-impermeable, gas-permeable filter element, arranged to prevent liquid from entering the connector portion.

15. The negative pressure therapy kit according to any one of claims 8 to 14, wherein the first packing element comprises PETG.

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