阅读说明：本技术 伤口氧疗系统 (Oxygen therapy system for wounds ) 是由 M·Q·尼德尔欧尔 J·P·戴利 J·J·莫菲特 于 2020-04-15 设计创作，主要内容包括：一种伤口治疗系统包括：处理器,所述处理器联接到传感器系统；电力输送系统；制氧机,所述制氧机联接到所述电力输送系统并包括联接到由敷料提供并位于伤口部位附近的气流受限封闭物的氧气出口；和负压系统,所述负压系统包括联接到所述气流受限封闭物的负压出口。所述处理器从所述传感器系统接收第一传感器信息,并使用所述第一传感器信息来控制从所述电力输送系统提供给所述制氧机的电力,以控制由所述制氧机产生并通过所述氧气出口提供给所述气流受限封闭物的氧气流。当所述处理器从所述传感器系统接收到第二传感器信息时,其激活所述负压系统以产生来自所述气流受限封闭物并通过所述负压出口的流体流。(A wound treatment system comprising: a processor coupled to the sensor system; an electric power transmission system; an oxygen generator coupled to the power delivery system and including an oxygen outlet coupled to an airflow-restricted enclosure provided by a dressing and located near a wound site; and a negative pressure system comprising a negative pressure outlet coupled to the airflow-restricted enclosure. The processor receives first sensor information from the sensor system and uses the first sensor information to control the power provided to the oxygen generator from the power delivery system to control the flow of oxygen generated by the oxygen generator and provided to the flow-restricted enclosure through the oxygen outlet. When the processor receives second sensor information from the sensor system, it activates the negative pressure system to generate a flow of fluid from the airflow-restricted enclosure and through the negative pressure outlet.)

1. A wound treatment system, comprising:

a housing;

a processor located within the housing;

at least one sensor system coupled to the processor;

a power delivery system within the housing and coupled to the processor;

an oxygen generator located within the housing and coupled to the power delivery system, wherein the oxygen generator comprises an oxygen outlet coupled to an airflow-restricted enclosure provided by a dressing and located proximate to a wound site; and

a negative pressure system coupled to the processor, wherein the negative pressure system comprises a negative pressure outlet coupled to the airflow-restricted enclosure provided by the dressing and located proximate to the wound site;

wherein the processor is configured to:

receiving first sensor information from the at least one sensor system;

using the first sensor information to control power provided to the oxygen generator from the power delivery system to control the flow of oxygen generated by the oxygen generator and provided to the flow-restricted enclosure through the oxygen outlet;

receiving second sensor information from the at least one sensor system; and

activating the negative pressure system to generate a flow of fluid from the airflow-restricted enclosure and through the negative pressure outlet.

2. The system of claim 1, wherein the second sensor information provides a blockage alarm indicating the presence of a blockage at the junction of the oxygen outlet to the gas flow-restricted enclosure.

3. The system of claim 2, wherein the obstruction is caused by exudate produced at the wound site and located at the junction of the oxygen outlet to the gas flow-restricted enclosure.

4. The system of claim 3, wherein activating the negative pressure system to generate the fluid flow from the gas flow-restricted enclosure and through the negative pressure outlet is intended to remove the exudate at the junction of the oxygen outlet to the gas flow-restricted enclosure.

5. The system of claim 2, wherein the blockage is caused by an amount of oxygen generated by the oxygen generator and provided to the flow-restricted enclosure through the oxygen outlet such that the pressure in the flow-restricted enclosure exceeds a maximum pressure.

6. The system of claim 1, wherein activating the negative pressure system to generate the flow of fluid from the airflow-restricted enclosure and through the negative pressure outlet is intended to remove exudate generated at the wound site from the airflow-restricted enclosure.

7. The system of claim 1, wherein activating the negative pressure system to generate the fluid flow from the air flow-restricted enclosure and through the negative pressure outlet is intended to achieve a dressing seal when a minimum sealing pressure is not maintained for a set period of time.

8. The system of claim 1, wherein activating the negative pressure system via a fluid saturation sensor to generate the fluid flow from the airflow-restricted enclosure and through the negative pressure outlet is intended to remove exudate generated at the wound site from the airflow-restricted enclosure.

9. The system of claim 1, wherein activating the negative pressure system to generate the fluid flow from the gas flow-restricting enclosure and through the negative pressure outlet is intended to maximize an oxygen concentration in the gas flow-restricting enclosure as quickly as possible.

Background

The present disclosure relates generally to wound healing via the supply of oxygen to a wound to accelerate healing of damaged tissue and/or promote tissue viability, and more particularly to utilizing intermittent vacuum/suction of a wound site closure near a wound site to optimize oxygen concentration near the wound while removing exudate and other fluids near the wound site.

When tissue is damaged and a wound develops, the four stages of the healing process begin, and the optimal metabolic function of the tissue to refill the wound requires that oxygen be available for all these stages of wound healing. Furthermore, the greater the number of layers of tissue damaged, the greater the risk of complications in the wound healing process, and difficult to heal wounds may encounter obstacles in the wound healing process and appear delayed in one or more of the final three stages of wound healing. For example, one of the most common factors that contribute to delayed wound healing (e.g., venous leg ulcers, diabetic foot ulcers, and pressure ulcers) is the chronic wound ischemia problem. Chronic wound ischemia is a pathological condition that limits blood supply, oxygen delivery, and the need for adequate oxygenation of tissue by blood, inhibiting normal wound healing.

One common standard of care for treating difficult to heal wounds involves the use of advanced wound dressings or advanced wound dressing combinations that provide a dressing treatment system. Advanced wound dressings may be positioned over a wound site and, in some cases, may be placed over the surrounding intact skin to provide a wound site enclosure. Advanced wound dressings typically include materials having properties that promote wet wound healing, control wound exudate, and help control wound bioburden. The combined provision of these materials is intended to result in limited moisture permeability and the more occlusive the dressing, the lower the amount of ambient air available at the wound site (and hence the corresponding lower the amount of oxygen).

100% oxygen produces a partial pressure of 760 millimeters (mm) of mercury (Hg) and ambient air comprises about 21% oxygen, thus ambient air produces an oxygen partial pressure of about 159mm Hg. Typical advanced wound dressings or wound dressing systems utilize materials that provide limited moisture permeability, intended to affect the available oxygen at the wound site, thereby limiting the partial pressure of oxygen at the occluded wound site to about 10-60mm Hg. Fresh air (and its associated higher oxygen content) is then provided to the wound site only at the time of dressing change, and the dressing may remain covering the wound site for up to seven days before a dressing change is required. Thus, the limited moisture permeability of advanced wound dressings creates an oxygen-reduced wound environment that prevents optimal metabolic function of cells to refill the wound at all stages of wound healing.

Specific examples of conventional systems and methods for providing tissue oxygenation to difficult-to-heal wounds include intermittent or continuous application of topical hyperbaric oxygen to the wound site. An intermittent topical hyperbaric treatment system involves providing a sealed limb or part of a body cavity and an associated source of pure oxygen at a relatively high flow rate and positioning the injured limb or body part within the sealed limb or part of the body cavity. The oxygen source will then provide up to 100% oxygen to the chamber at a flow rate which may exceed 300 litres per hour, pressurising the interior of the chamber at up to 1.05% of normal atmospheric pressure, thereby locally increasing the available oxygen required for cell regulation at the affected wound site. For example, during oxygen application, the partial pressure of oxygen applied within the sealed limb or body cavity may reach 798mm Hg and may be applied for about 90 minutes. These and similar methods of applying intermittent topical hyperbaric oxygen are restrictive, cumbersome, provide only intermittent delivery of oxygen to the affected area without systemic application, and provide only minimal increase in atmospheric pressure (about 5%). Thus, oxygen therapy using these methods tends to be less effective on wounds, as evidenced by the lack of commercial success of localized hyperbaric oxygen limb chambers.

Other conventional systems and methods of providing tissue oxygenation include disposable devices that provide for the delivery of gases in ionic form through ion-specific membranes for the application of supplemental oxygen directly to a wound site. These devices are typically battery-powered disposable oxygen supplement bandages that are provided directly on the wound site and utilize electrochemical oxygen production achieved in a variation of the four-electron formula originally developed for NASA. In such systems, the amount of oxygen that can be applied to the wound is typically in the range of 3 to 15 milliliters per hour, and the required flow rate of oxygen is generated by using a corresponding preselected battery size with a predetermined amperage. Thus, these devices are "on" or "off" and cannot provide a variable or adjustable oxygen flow rate or oxygen flow rate without obtaining a new device and/or another battery having an amperage that will produce the desired flow rate. The use of fixed, non-variable oxygen flow rates and oxygen flow rates places corresponding limitations on the treatment of wounds of different sizes and types, and often results in wound treatment systems that are oversized or undersized for the wound to which they are applied.

The inventors of the present disclosure have collectively invented systems and methods that address the problems of conventional wound therapy systems discussed above. For example, U.S. patent No. 8,287,506, U.S. patent No. 10,226,610, and U.S. patent publication No. 2019/0001107 (collectively, "incorporated by reference," the disclosures of which are incorporated herein in their entirety by reference) describe wound therapy systems that provide low flow tissue oxygenation and sustained oxygen tunability to a wound site in order to create a controlled high-oxygen and oxygen-deficient wound environment for damaged tissue, accelerate wound healing, and promote tissue viability. These systems and methods operate by: monitoring pressure information indicative of pressure in an airflow-restricted enclosure (e.g., provided by a wound dressing) located proximate to a wound site; monitoring humidity information indicative of ambient humidity; and/or using other characteristics to control power provided to the oxygen generation subsystem to control the flow of oxygen generated by the oxygen generation subsystem and provided to the gas flow-restrictive enclosure. In some embodiments, these wound therapy systems include a flow sensor that measures the oxygen output of the oxygen generation subsystem; a pressure sensor located downstream of the flow sensor and measuring a pressure of the oxygen stream that is usable to control the oxygen production subsystem discussed above; a humidity sensor that measures an ambient humidity that can be used to control the oxygen stream produced by the oxygen generation subsystem discussed above; and/or other sensor subsystems for controlling the oxygen stream produced by the oxygen generation subsystem discussed above.

However, the inventors of the present disclosure have found that achieving oxygen concentrations that provide enhanced or optimal wound healing may require a relatively long time because the wound site enclosure formed when the wound dressing is applied to a wound typically includes a relatively large volume of relatively low oxygen concentration air (which increases as the size of the wound dressing increases) that must be replaced by the high concentration of oxygen produced by the oxygen generation subsystem discussed above. In addition, changing a wound dressing releases a relatively high concentration of oxygen that has been provided in the wound site enclosure by the oxygen generation subsystem discussed above, and thus each time the wound dressing is changed, the "reset clock" problem discussed above is presented, namely the accumulation of a relatively high concentration of oxygen in the wound site enclosure and in the vicinity of the wound site, thereby providing the benefits described above. Still further, exudate and/or other fluids produced by and/or near the wound site may cause problems with the wound oxygen therapy systems described above, including blockage of the oxygen supply conduit/line, thereby preventing the provision of relatively high concentrations of oxygen in the wound site enclosure and near the wound site.

Accordingly, there is a need to provide an improved wound treatment system.

Disclosure of Invention

According to one embodiment, a wound treatment system comprises: a housing; a processor located within the housing; at least one sensor system coupled to the processor; a power delivery system within the housing and coupled to the processor; an oxygen generator located within the housing and coupled to the power delivery system, wherein the oxygen generator comprises an oxygen outlet coupled to an airflow-restricted enclosure provided by a dressing and located proximate to a wound site; and a negative pressure system coupled to the processor, wherein the negative pressure system comprises a negative pressure outlet coupled to the airflow-restricted enclosure provided by the dressing and located proximate to the wound site, wherein the processor is configured to: receiving first sensor information from the at least one sensor system; using the first sensor information to control power provided to the oxygen generator from the power delivery system to control the flow of oxygen generated by the oxygen generator and provided to the flow-restricted enclosure through the oxygen outlet; receiving second sensor information from the at least one sensor system; and activating the negative pressure system to generate a flow of fluid from the airflow-restricting enclosure and through the negative pressure outlet.

Drawings

Fig. 1 is a schematic diagram illustrating one embodiment of a wound oxygen therapy system provided in accordance with the teachings of the present disclosure.

Fig. 2 is a schematic diagram illustrating one embodiment of a wound oxygen therapy system provided in accordance with the teachings of the present disclosure.

Fig. 3 is a schematic diagram illustrating one embodiment of a wound oxygen therapy system provided in accordance with the teachings of the present disclosure.

Figure 4a is a schematic diagram illustrating one embodiment of a wound oxygen therapy system provided in accordance with the teachings of the present disclosure.

Figure 4b is a schematic diagram illustrating one embodiment of a wound oxygen therapy system provided in accordance with the teachings of the present disclosure.

Figure 4c is a schematic diagram illustrating one embodiment of a wound oxygen therapy system provided in accordance with the teachings of the present disclosure.

Fig. 5 is a schematic diagram illustrating one embodiment of a wound oxygen therapy system provided in accordance with the teachings of the present disclosure.

Fig. 6 is a schematic diagram illustrating one embodiment of a wound oxygen therapy system provided in accordance with the teachings of the present disclosure.

Detailed Description

Some embodiments of the present disclosure are based on the teachings provided by at least some of the inventors of the present disclosure in incorporated references, the disclosures of which are incorporated herein by reference in their entirety.

Us patent No. 8,287,506 discloses a non-invasive tissue oxygenation system for accelerating healing of damaged tissue and promoting tissue viability comprising a lightweight portable electrochemical oxygen generator, a power management system, a microprocessor, memory, a pressure sensing system, a temperature monitoring system, an oxygen flow rate monitoring and control system, a display screen and a keyboard navigation control device as a means of providing a continuously variable controlled low dose of oxygen to a wound site and monitoring the healing process.

Us patent No. 10,226,610 discloses a wound treatment system comprising: a housing; a processor located within the housing; a pressure monitoring system coupled to the processor to monitor pressure in the airflow-restricted enclosure alongside the wound site; a power delivery system within the housing and coupled to the processor; an oxygen generator located within the housing and coupled to the power delivery system; and a plurality of oxygen outlets located within the oxygen generator and coupled to the airflow-restricted enclosure, wherein the processor receives pressure information from the pressure monitoring system and uses the pressure information to control the power provided to the oxygen generator from the power delivery system to control the flow of oxygen provided to the airflow-restricted enclosure through an oxygen generator outlet.

U.S. patent publication No. 2019/0001107 discloses a wound oxygen supply system comprising: a chassis defining an oxygen outlet; an oxygen generation subsystem located within the chassis and coupled to the oxygen outlet; and a control subsystem coupled to the oxygen generation subsystem, wherein the control subsystem receives humidity information from the oxygen generation subsystem and uses the humidity information to control power provided to the production subsystem to control the flow of oxygen through the oxygen outlet to the airflow-restricted enclosure beside the wound site.

For example, the wound oxygen therapy systems described above may be configured according to the teachings of the present disclosure to intermittently remove excess fluid (e.g., wound exudate) from a wound dressing provided in proximity to a wound using a negative pressure system, a vacuum system, and/or a Suction Management System (SMS). Such intermittent removal of exudate and/or other fluids from a wound dress is intended to control wound exudate levels in the wound dressing and near the wound site, to protect tissue from maceration, to extend the useful life of the wound dressing (e.g., by increasing the time between changes to the wound dressing), and to remove air from the flow-restricting enclosure disposed between the wound dressing and the wound site, so that higher oxygen concentrations may be achieved in a shorter time relative to conventional systems (e.g., by removing nitrogen from the flow-restricting enclosure and reducing the volume of air within the flow-restricting enclosure disposed between the wound dressing and the wound site). Excessive wound exudate may be produced during the early stages of continuous oxygen diffusion (CDO) therapy, where the level of wound exudate varies with time and the amount of oxygen delivered. Better prognosis and user satisfaction are achieved by removing wound exudate, and clinical management interventions are reduced (e.g., reducing the overall cost of the healthcare system).

The negative pressure, vacuum, and/or suction provided via the present disclosure may be achieved via mechanical techniques, electromechanical techniques, and/or other techniques that will be apparent to those possessing an ordinary skill in the pertinent arts and having possession of the present disclosure. In some examples, the negative pressure, vacuum, and/or suction lines may be separate from the oxygen supply line. In some examples, the negative pressure, vacuum, and/or suction system may be incorporated into the oxygen generating device, attached thereto, or may be provided by a separate device. In addition, the negative pressure, vacuum, and/or suction system may include a container for collecting wound exudate and/or other fluids.

In some embodiments, the oxygen generator and/or a sensor in the wound dressing may be configured to indicate saturation and/or presence of excess wound exudate in the wound dressing and/or near the wound site, and may trigger initiation of exudate removal via negative pressure, vacuum, and/or suction. Alternatively, the negative pressure, vacuum, and/or suction system may utilize a timing algorithm based on feedback from the sensors to predict the presence of excess wound exudate, and in response initiate negative pressure, vacuum, and/or suction to remove wound exudate and/or prevent the accumulation of excessively high levels of wound exudate.

In some embodiments, the negative pressure, vacuum, and/or suction system may remove wound exudate for multiple wound oxygen therapy systems and/or multiple wound dressings, or a single wound oxygen therapy system and a single wound dressing may be equipped.

The wound oxygen therapy system may be capable of controlling the flow of oxygen provided to the wound site based on the humidity of air entering an electrolysis cell disposed in the oxygen generator. The use of air humidity to control oxygen flow takes advantage of the fact that the oxygen flow produced by an oxygen generator is affected by the relative humidity of the air, and the efficiency of the cell decreases as the perfluorosulfonic polymer (Nafion) proton exchange membrane dries out. Above a threshold humidity, the cell operates at full efficiency, the oxygen flow is linearly proportional to the applied current, while below a threshold humidity, the cell's efficiency is affected and has a non-linear response to the current input. Therefore, more current is required to maintain the required oxygen flow at relatively low humidity. In some embodiments, pressure may also be used in combination with humidity to modify the oxygen flow generated by the oxygen generator and prevent over-pressurization of the flow-restricting enclosure provided by the wound dressing and located near the wound site. The humidity sensor in the wound oxygen therapy system may be positioned to be exposed to ambient air to humidify the incoming air before or after (or both before and after) humidity control within the device is activated (e.g., using a humidifier pack).

The wound oxygen therapy system may include batteries, power controls, humidity and/or pressure sensors, and may use a smartphone or other computing device to monitor, control and provide power to the wound oxygen therapy system. Thus, the wound oxygen therapy system may include remote wound monitoring sensors, remote data communication, and/or other advanced functionality, but may also be minimized to a simple local device (e.g., tethered to a smartphone as discussed above) that provides oxygen without other input.

The negative pressure, vacuum, and/or suction systems of the present disclosure may provide intermittent negative pressure, vacuum, and/or suction to optimize the oxygen concentration in the airflow-restricted enclosure provided by the wound dressing proximate the wound site and to remove excess fluid and/or wound exudate from the proximate wound site. The negative pressure, vacuum, and/or suction may be attached to the wound dressing using a bifurcated tube, which may include a microporous oxygen line and a mesoporous vacuum line.

In some embodiments, use of the wound oxygen therapy system initially includes applying an oxygen-distributing wound dressing over the wound bed and near the wound site, connecting the wound dressing to a connecting tube connected to an oxygen generator in the wound oxygen therapy system, and activating the wound oxygen therapy system. Activating the wound oxygen therapy system may cause oxygen to be generated at a maximum flow rate while creating a negative pressure, vacuum, or suction that may be provided by a mechanical or low-power electric vacuum pump. The negative pressure, vacuum and/or suction may be continued until a relative pressure (e.g., maximum vacuum) of between-200 and-10 mmHg, preferably between-100 and-70 mmHg, is reached in the air flow-restricted enclosure provided between the wound dressing and the wound site. Once the maximum negative pressure, vacuum, and/or suction is reached, the wound oxygen therapy system may produce oxygen at a maximum oxygen flow rate until the relative pressure in the airflow-restricted enclosure provided by the wound dressing reaches 0 mmHg. At this point, the oxygen generator may continue to produce oxygen at a predetermined flow rate set point (e.g., a "steady state" flow rate), which may be selected by the physician.

At steady state flow rates, the wound oxygen therapy system may continue to produce oxygen at the oxygen flow rate set point, as discussed above, and negative pressure, vacuum, and/or suction may be applied when the wound oxygen therapy system detects:

an occlusion alarm indicating that oxygen flow from the oxygen generator to the wound site is occluded, which may enable activation of negative pressure, vacuum and/or suction to remove excess fluid and also relieve the occlusion in the process.

Fluid saturation in the wound dressing, which may be detected by a low power Surface Mount Technology (SMT) fluid sensing film in the wound dressing (e.g. in the dressing layer) which may be used to measure saturation rate, and may be used to signal activation of negative pressure, vacuum and/or suction via micro-wiring through a connection tube between the dressing and the wound oxygen therapy system.

Loss of dressing seal, which may be monitored by the wound oxygen therapy system via monitoring pressure in the air flow-restricted enclosure provided by the wound dressing in the vicinity of the wound site, and may indicate activation of negative pressure, vacuum and/or suction to reseal the wound dressing when the minimum sealing pressure is not maintained for a set period of time.

Too long between the application of negative pressure, vacuum and/or suction. When the time between negative pressure, vacuum and/or suction application events exceeds a maximum time period (e.g., which may be based on wound dressing type, wound dressing size, wound type, wound size and/or combinations of these (and other) variables).

Dressing changes, which may result in the wound oxygen therapy system initiating a start-up protocol to remove excess nitrogen from the flow-restricting enclosure provided by the wound dressing near the wound site and to maximize the oxygen concentration in the flow-restricting enclosure as quickly as possible.

In all of these cases, the negative pressure, vacuum, and/or suction may continue until a relative pressure (e.g., "Max Vac") of between-200 and-10 mmHg, preferably between-100 and-70 mmHg, is achieved in the airflow-restricted enclosure provided by the wound dressing near the wound site. Once the maximum vacuum is reached, the wound oxygen therapy system can generate oxygen at the maximum oxygen flow rate until the relative pressure in the dressing reaches 0mm Hg. At this point, the oxygen generator may continue to produce oxygen at a predetermined flow rate set point, which may be selected by the physician and referred to as steady state above.

Several embodiments of the above wound oxygen therapy system will now be described with reference to the drawings, but those skilled in the art who have the benefit of this disclosure will recognize that various modifications to these embodiments will also fall within the scope of this disclosure. Thus, different combinations of different components and configurations of the wound oxygen supply system discussed below, substitutions of different components in different wound oxygen supply systems, and/or any other modifications apparent to those skilled in the art having the benefit of this disclosure are deemed to be within the scope of the present disclosure.

Referring to fig. 1, one embodiment of a wound oxygen therapy system of the present disclosure is shown. Fig. 1 shows how atmospheric oxygen supplied by ambient air 50 containing about 21% oxygen can enter an electrolyzer ion-exchange electrochemical oxygen generator 11 that is intended to concentrate oxygen in ambient air 50 to produce a stream of high concentration oxygen or O2 (e.g., 99% pure oxygen). The high concentration O2 is provided to the oxygen delivery conduit 12, thereby providing a high concentration O2 to the damaged tissue or wound site 20 via an Oxygen Delivery System (ODS) 101.

The ODS 101 may be composed of one or more of: perforating the pipeline; a porous membrane or tube; a dressing having an oxygen distribution function; a soft, flexible oxygen permeable tape or film; oxygen permeable bandage subsystems or sections; or oxygen delivery materials or subsystems described in the incorporated references. In a basic form, ODS 101 may not include a sensor for measuring a characteristic or feature thereof. Alternatively, ODS 101 can incorporate one or more optional sensors or sensor interfaces 102 for measuring one or more characteristics, such as a temperature sensor, pH sensor, oxygen saturation sensor, or other related sensors or sensor interfaces. If ODS 101 includes optional sensor 102, their output can be provided to one or more ODS sensor transmitters 103.

Pressure sensor 30a or pressure sensor interface is coupled to pipe 12 and provides information to microprocessor controller 58 via pressure transmitter 56. Microprocessor controller 58 can also receive user inputs and set points 65, as well as information from any optional sensors 102 present in ODS 101 and via optional ODS sensor transmitter 103. The microprocessor controller 58 outputs control displays and alarms 68 and controls the power management system 52 which provides power to the electrolyzer ion-exchange electrochemical oxygen generator 11. Thus, information from pressure sensor 30a can be used by microprocessor controller 58 to control power management system 52 to regulate power to electrolyzer ion-exchange electrochemical oxygen generator 11, and thus to regulate the oxygen (O2) provided to ODS 101 and wound site 20 via conduit 12. In addition, a Suction Management System (SMS)130 is connected to ODS 101 and includes a liquid reservoir or container 131 and a suction system 132 that can draw exudates and other fluids from wound site 20 via ODS 101 and store the exudates and other fluids in the liquid container 131. The aspiration management system 130 is also coupled to the microprocessor controller 58, for example, to allow the microprocessor controller 58 to control the aspiration produced by the aspiration and fluid system.

Referring to fig. 2, there is shown one embodiment of a wound oxygen therapy system of the present disclosure substantially similar to that shown and discussed above with reference to fig. 1, but having an atmospheric humidity sensor 140 providing information to the microprocessor controller 58 via an atmospheric humidity transducer 141. Thus, information from atmospheric humidity sensor 140 can be used by microprocessor controller 58 to control power management system 52 to regulate power to electrolyzer ion-exchange electrochemical oxygen generator 11, and thus O2, which is provided to ODS 101 and wound site 20 via conduit 12.

Referring to fig. 3, there is shown one embodiment of the wound oxygen therapy system of the present disclosure that is substantially similar to the wound oxygen therapy system shown and discussed above with reference to fig. 2, but with the pressure sensor 30a and pressure transducer 56 removed. Accordingly, microprocessor controller 58 may only require information from atmospheric humidity sensor 140 to control power management system 52 to regulate power to electrolyzer ion-exchange electrochemical oxygen generator 11, and thus O2, which is provided to ODS 101 and wound site 20 via conduit 12.

Referring to fig. 4a, 4b and 4c, different embodiments of a wound oxygen therapy system are shown that may be controlled by a smartphone or other mobile device 400 a.

For example, in fig. 4a, the suction management system 130 can be integrated with a single ODS 101 and can provide suction and liquid storage for the single ODS 101, which is controlled by a single smartphone/mobile device 400a via an oxygen generation and wound monitoring (O2 GWM) device 150.

In another example, as shown in fig. 4b, a single puff management system 130 can provide puff and liquid storage for multiple ODS 101 devices (ODS 101a, ODS 101b, and ODS 101c) controlled by a single smartphone/mobile device 400a via a single O2 GWM device 150.

In yet another example, as shown in fig. 4c, multiple puff management systems 130(SMS 130a, SMS 130b, and SMS 130c) may provide puff and liquid storage for a single respective ODS 101 device (ODS 101a, ODS 101b, and ODS 101c), which single respective ODS 101 device is controlled by a single smartphone/mobile device 400a via multiple respective O2 GWM devices 150(O2 GWM 150a, O2 GWM 150b, and O2 GWM 150 c). Thus, the wound oxygen therapy system of fig. 4c has one O2 GWM device 150 for each ODS 101 and suction management system 130, as shown.

O2 GWM device 150 may be wirelessly controlled or tethered to smartphone/mobile device 400 a. In the case of a tethered connection, O2 GWM 150 may be powered by smartphone/mobile 400 a. In a similar manner, each suction management system 130 may be incorporated into the O2 GWM device 150, or it may be separate and be controlled or tethered to the O2 GWM device 150. For embodiments without O2 GWM device 150, the puff management system 130 may be controlled wirelessly or tethered to the microprocessor controller 48 or smartphone/mobile device 400 a.

Referring to fig. 5, there is shown one embodiment of the wound oxygen therapy system of the present disclosure that is substantially similar to the wound oxygen therapy system shown and discussed above with reference to fig. 2, but with a flow sensor 54 that provides information to the microprocessor controller 58 via a flow transmitter 55 regarding the flow of oxygen from the electrolyzer ion-exchange electrochemical oxygen generator 11 to the conduit 12, and illustrates how different devices (e.g., smartphone 400a and O2 GWM 150) may provide different components. Thus, information from the flow sensor 54 in the O2 GWM 150 can be used by the microprocessor controller 58 in the smartphone 400a to control the power management system 52 in the smartphone 400a to regulate power to the electrolyzer ion-exchange electrochemical oxygen generator 11 in the O2 GWM 150, thereby regulating the oxygen (O2) provided to the ODS 101 and the wound site 20 through tubing 12.

Referring to fig. 6, there is shown one embodiment of the wound oxygen therapy system of the present disclosure that is substantially similar to the wound oxygen therapy system shown and discussed above with reference to fig. 5, but with the pressure sensor 30a and pressure transducer 56 and flow sensor 54 and flow transducer 55 removed. Accordingly, microprocessor controller 58 may only require information from atmospheric humidity sensor 140 to control power management system 52 to regulate power to electrolyzer ion-exchange electrochemical oxygen generator 11, and thus the oxygen (O2) profile provided to ODS 101 and wound site 20 via conduit 12.

Although fig. 4a, 4b, 4c, 5, and 6 illustrate an embodiment using a smartphone/mobile device 400a as the control device for the wound oxygen therapy system of the present disclosure, other computing devices such as, for example, a tablet computing device, a laptop/notebook computing device, a desktop computing device, a smart watch, a fitness tracker, or other wrist-worn device, and/or various other computing devices, may be provided as the control device while remaining within the scope of the present disclosure.

Also, while fig. 1-6 illustrate separate sensors and transducers for measuring pressure, humidity, flow or other characteristics of the wound oxygen therapy system of the present disclosure and providing measurements in a form that can be used by microprocessor controller 58, the sensors and their corresponding transducers may be combined into a single component or element that both measures characteristics of the system and converts the measurements into electrical or other signals that can be used by microprocessor controller 58.

While illustrative embodiments have been shown and described, various modifications, changes, and substitutions are contemplated in the foregoing disclosure and, in some instances, some features of the embodiments may be employed without a corresponding use of the other features. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the scope of the embodiments disclosed herein.