Wound oxygen supply system

Abstract

The present invention provides systems and methods for generally accelerating wound healing, more specifically by supplying oxygen to a wound to accelerate the healing of damaged tissue and / or promote tissue viability. [Solution] The oxygen supply system 200 for the wound 602 includes an outer frame 202 that defines an oxygen outlet. An oxygen generation subsystem is included in the outer frame and coupled to the oxygen outlet. A control subsystem is coupled to the oxygen generation subsystem and is configured to receive humidity information indicating the humidity experienced by the oxygen generation subsystem. The control system then uses the humidity information to control the power supplied to the oxygen generation subsystem in order to control the oxygen flow produced by the oxygen generation subsystem and supplied to a restricted airflow enclosure that passes through the oxygen outlet into contact with the wound.

Description

Technical Field

[0001] Related Applications This disclosure claims priority to U.S. Patent Application No. 15 / 639,845, entitled "Wound Oxygen Supply System," filed on June 30, 2017, which is hereby incorporated by reference in its entirety.

Background Art

[0002] This disclosure generally relates to wound healing, and more particularly to systems and methods for supplying oxygen to a wound to accelerate healing of damaged tissue and / or promote tissue viability.

[0003] When tissue is damaged and a wound occurs, a four-stage healing process begins, and for optimal metabolic function of cells in the tissue to regrow the wound, oxygen must be available at all these stages of wound healing. Further, the greater the number of damaged tissue layers, the greater the risk of complications during the wound healing process, and wounds that are difficult to heal encounter obstacles to the wound healing process and may experience delays in one or more of the remaining three wound healing stages. For example, one of the most common factors contributing to delays in wound healing such as venous leg ulcers, diabetic foot ulcers, and pressure ulcers is the problem of chronic wound ischemia. Chronic wound ischemia is a pathological condition that suppresses blood supply, oxygen delivery, and blood requirements for sufficient oxygenation of tissues, preventing normal wound healing.

[0004] One conventional standard of medical care for treating wounds that are difficult to heal involves the use of advanced wound dressings, or combinations of advanced wound dressings that provide a dressing system. Advanced dressings are placed on the wound site or, in some cases, on the surrounding healthy skin to provide enclosure for the wound site. Advanced wound dressings generally contain materials that have properties that promote moist wound healing, manage wound exudate, and help control wound bioburden. Such materials, when provided in combination, act to create limited water vapor permeability, and the more airtight the dressing, the less ambient air (i.e., less oxygen) is available at the wound site.

[0005] 100% oxygen gives a partial pressure of 760 mmHg of mercury (Hg), and since ambient air contains approximately 21% oxygen, the ambient air gives an oxygen partial pressure of approximately 159 mmHg. A typical advanced wound dressing or wound dressing system using a material that provides limited water vapor permeability acts to affect the oxygen available at the wound site, thereby limiting the oxygen partial pressure of the enclosed wound site to approximately 10-60 mmHg. Thus, fresh air (and the associated higher amounts of oxygen) is only provided to the wound site when the dressing is changed, and the dressing may remain covering the wound site for up to 7 days before a dressing change is required. Thus, the limited water vapor permeability properties of advanced wound dressings create a hypoxic wound environment that acts against the optimal metabolic function by which cells regrow the wound throughout all stages of wound healing.

[0006] Specific examples of conventional systems and methods for providing tissue oxygenation for wounds that are difficult to heal include the intermittent or continuous delivery of local hyperbaric oxygen to the wound site. Intermittent local hyperbaric oxygen treatment systems involve providing a sealed extremity or partial body chamber together with a connected, relatively high-flow pure oxygen source, and placing the wounded extremity or body area within the sealed extremity or partial body chamber. The oxygen source then supplies oxygen up to 100% into the chamber at a flow rate that can exceed 300 liters per hour, pressurizing the chamber to 1.05% standard atmospheric pressure, thereby locally increasing the oxygen available for cell treatment at the affected wound site. For example, oxygen During administration, the partial pressure of oxygen applied inside the sealed limb or partial body chamber can reach 798 mmHg and can be applied for approximately 90 minutes. These and similar methods of intermittent local hyperbaric oxygen administration are limited and cumbersome, only providing intermittent oxygen to the affected area and not to the whole body, and providing only a minimal increase from atmospheric pressure (approximately 5%). Consequently, the effectiveness of oxygen therapy for wounds using such methods tends to be minimal, a fact supported by the lack of commercial success in local hyperbaric oxygen limb chambers.

[0007] Other conventional systems and methods for providing tissue oxygenation include disposable devices that provide delivery of ionic gases through ion-specific membranes to deliver oxygen supply directly to the wound site. These devices are typically battery-powered disposable oxygen supply bandages delivered directly onto the wound site and utilize electrochemical oxygen generation using a 4-electron formula variation originally developed for NASA. In such systems, the amount of oxygen that can be delivered to the wound is typically in the range of 3 to 15 milliliters per hour, and the desired oxygen flow rate is generated by using a corresponding pre-selected battery size and a pre-specified current capacity. Thus, these devices are either "on or off" and do not have the ability to deliver a fluctuating or adjustable oxygen flow or oxygen flow rate without a new device and / or a different battery with a current capacity that produces the desired flow rate. Utilizing fixed, non-variable oxygen flow and oxygen flow rate creates limitations in accommodating wound treatment of different sizes and types, resulting in a tendency for wound treatment systems to be either too large or too small to treat.

[0008] The inventors of this disclosure have simultaneously devised a system and method to address the problems of the conventional wound treatment systems discussed above. For example, Patent Documents 1 and 2 describe a wound treatment system that provides low-dose oxygenation and continuous oxygen regulation to one or more wound sites to create a controlled high- and low-oxygen wound environment for damaged tissue, thereby accelerating wound healing and improving tissue viability. Such a system and method is created by an oxygen generation subsystem and includes a restricted airflow enclosure positioned adjacent to the wound site to control the oxygen flow supplied to the restricted airflow enclosure. The system operates by monitoring pressure information indicating the pressure within a flow enclosure (e.g., provided by a wound bandage) and by using this pressure information to control the power supplied to the oxygen generation subsystem. In some embodiments, such a wound treatment system includes a flow sensor that measures the oxygen output of the oxygen generation subsystem, and a pressure sensor downstream of the flow sensor measures the pressure that can be used to control the oxygen flow created by the oxygen generation subsystem as described above.

[0009] However, the inventors of this disclosure have found that such wound treatment systems face many problems. For example, the flow sensors used in such wound treatment systems are relatively large (currently about 36 mm x 20 mm), relatively expensive (currently about 60 US dollars), consume a relatively large amount of energy (up to 40 milliamperes (mA)), and require a "plumbing system" (i.e., piping connecting the flow sensor to the oxygen flow(s) to be measured), which takes up space in the outer frame of the wound treatment system, requiring a larger outer frame than would be necessary without the flow sensor. Furthermore, it has been found that the oxygen generation subsystem used in such wound treatment systems may provide significantly reduced oxygen generation when humidity decreases, which could lead to insufficient oxygen supply to the wound site, and that the wound treatment system may increase the power supplied to the oxygen generation subsystem to a level that could damage the oxygen generation subsystem.

[0010] Therefore, it is desirable to provide an improved wound care system. [Prior art documents] [Patent Documents]

[0011] [Patent Document 1] U.S. Patent No. 8,287,506 [Patent Document 2] U.S. Patent Application No. 2016 / 0082238 [Overview of the Initiative]

[0012] According to one embodiment, the wound oxygen supply system is coupled to a treatment system, and when performed by the treatment system, the treatment system receives humidity information indicating the humidity experienced by the oxygen generation subsystem: and is performed by the oxygen generation subsystem The system includes a memory system that includes a (cause) command that causes the oxygen generation subsystem to perform an operation, which involves controlling the power supplied to the oxygen generation subsystem using humidity information in order to control the oxygen flow that is generated and supplied to the restricted airflow enclosure. [Brief explanation of the drawing]

[0013] [Figure 1A] This is a schematic diagram that specifically illustrates the configuration of the oxygen supply system for a wound. [Figure 1B] Figure 1A is a perspective view that specifically illustrates the configuration of the oxygen supply system for the wound. [Figure 2A] This is a schematic diagram that specifically illustrates the configuration of the oxygen supply system for a wound. [Figure 2B] Figure 2A is a top perspective view that specifically illustrates the configuration of the oxygen supply system for the wound. [Figure 2C] Figure 2A is a lower perspective view that specifically illustrates the configuration of the oxygen supply system for the wound. [Figure 3A] Figures 1A-1B and 2A-2C are exploded perspective views that specifically illustrate the configuration of the oxygen generation subsystem used in the wound oxygen supply system. [Figure 3B] This is a front view that specifically illustrates the configuration of the oxygen generation subsystem shown in Figure 3A. [Figure 3C] Figure 3B is a cross-sectional view specifically illustrating an embodiment of the oxygen generation subsystem. [Figure 4A] Figure 2A-2C is a schematic diagram specifically illustrating an embodiment of a control device that can be used to control the oxygen supply system for the wound. [Figure 4B] This is a perspective view that specifically illustrates the configuration of the control device shown in Figure 4A. [Figure 5] It is a flowchart specifically explaining the mode of oxygen supply method to a wound. [Figure 6] It is a schematic diagram specifically explaining the mode of a patient with a wound. [Figure 7A] It is a cross-sectional view specifically explaining the mode of a dressing subsystem arranged on the wound of the patient in FIG. 5. [Figure 7B] It is a perspective view specifically explaining the mode of a pipe and an oxygen-permeable membrane that may be included in the dressing subsystem in FIG. 7A. [Figure 7C] It is a cross-sectional view specifically explaining the mode of the pipe in FIG. 7B. [Figure 7D] It is a perspective view specifically explaining the mode of the pipe in FIG. 7C. [Figure 8] It is a cross-sectional view specifically explaining the mode of the oxygen supply system for the wound in FIGS. 2A-2C included as part of the dressing subsystem arranged on the wound of the patient in FIG. 6. [Figure 9] It is a front / perspective view specifically explaining the mode of the oxygen supply system for the wound in FIGS. 1A-1B coupled to the dressing subsystem arranged on the wound of the patient in FIG. 6. [Figure 10] It is a front / perspective view specifically explaining the mode of the control device in FIGS. 4A-4B for controlling the oxygen supply system for the wound and the dressing subsystem in FIG. 9A. [Figure 11] It is a schematic diagram specifically explaining the mode of the patient in FIG. 6 with an additional wound, and using the oxygen supply system for the additional wound and the dressing subsystem in FIG. 9A, and the control device in FIGS. 4A-4B. [Figure 12] It is a schematic diagram specifically explaining the mode of the patient in FIG. 6 with an additional wound, and using the oxygen supply system for the wound in FIG. 1 and a number of dressing subsystems in FIGS. 7A-7D.

Mode for Carrying Out the Invention

[0014] Detailed Description Several embodiments of wound oxygen supply systems and methods will now be described with reference to the drawings, but a person skilled in the art who owns this disclosure will recognize that extensive modifications to those embodiments are also within the scope of this disclosure. Thus, different combinations of different components and arrangements of wound oxygen supply systems considered below, substitutions of different components in different wound oxygen supply systems, and / or other modifications that are obvious to a person skilled in the art who owns this disclosure are assumed to be within the scope of this disclosure.

[0015] Now, with reference to Figures 1A and 1B, embodiments of the wound oxygen supply system 100 will be described in detail. The wound oxygen supply system 100 described in detail in Figures 1A and 1B provides an example of a wound treatment device that includes an oxygen generation subsystem, a sensor subsystem, a power subsystem, and a control subsystem within a single outer frame, the outer frame can be coupled to oxygen delivery piping further coupled to a bandage subsystem. In the embodiments described in detail, the wound oxygen supply system 100 includes an outer frame 102 that houses the components of the wound oxygen supply system 100, some of which are specifically described in Figure 1A. For example, the outer frame 102 can house a processing subsystem (not specifically described, but this may include one or more hardware processors known in the art) and a storage subsystem (not specifically described, but this may include one or more storage devices known in the art), the storage subsystem includes commands that, when executed by the processing subsystem, cause the processing subsystem to provide an oxygen generation control engine 104 configured to perform the functions of the wound oxygen supply system described below. The outer frame 102 can also house a storage subsystem (which may include one or more storage devices known in the art, though not specifically described), which is coupled to the oxygen generation control engine 104 (for example, via a coupling between the storage subsystem and the processing subsystem) and stores an oxygen generation control database 106 which may contain any information used to provide the functionality discussed below.

[0016] The outer frame 102 may also house and / or include a display subsystem 108, which is coupled to the oxygen generation control engine 104 (for example, via a coupling between the display subsystem 108 and the processing subsystem) and configured to display any information as discussed below. The outer frame 102 may also house an input subsystem 110, which is coupled to the oxygen generation control engine 104 (for example, via a coupling between the input subsystem 110 and the processing subsystem) and configured to receive any input information (for example, via input buttons 110a and 110b, specifically described in Figure 1B) and provide it to the oxygen generation control engine 104, as discussed below. Although the display subsystem 108 and the input subsystem 110 are specifically described and presented as separate subsystems, those skilled in the art who own this disclosure will recognize that they can be combined within the scope of this disclosure (for example, in a touch-input display subsystem). The outer frame 102 can also house a power subsystem 112, which is coupled to the oxygen generation control engine 104 (for example, via a coupling between the power subsystem 112 and the processing subsystem) and may include one or more of various other power components such as batteries, adapters, converters and / or other components that would be obvious to those skilled in the art who own this disclosure. For example, in some specific embodiments discussed below, the power subsystem 112 includes a rechargeable battery and is coupled to a power connector 114, which is connected to a power source and configured to supply power to the power subsystem 112 to charge the rechargeable battery. However, those skilled in the art who own this disclosure may also include a direct power supply system within the scope of this disclosure (for example, a system connected to an external power source of the outer frame 102, and therefore not requiring an internal battery or other storage power source to supply power, but in some embodiments They will recognize that they can provide a system that can also be used with a separate battery.

[0017] The outer frame 102 also houses an oxygen generation subsystem 116, which is coupled to a power subsystem 112 and configured to generate oxygen in response to power supplied by the power subsystem 112, as described in detail below. The oxygen generation subsystem 116 is coupled to an oxygen inlet 118 configured to direct ambient air adjacent to the outer frame 102 into the oxygen generation subsystem 116, as discussed below, and an oxygen outlet 120 configured to direct the oxygen flow generated by the oxygen generation subsystem 116 out of the outer frame 102. For example, the outer frame 102 and / or the oxygen outlet 120 may include various fittings, connectors and / or other couplings that provide attachment of piping or bandage systems to the outer frame 102, as discussed below. In a specific example, the oxygen outlet 120 may include a Luer locking fitting, which is configured to engage piping and maintain an airtight seal, but other couplings are also within the scope of this disclosure. Although the oxygen outlet 120 is specifically described as a single oxygen outlet in Figure 1B, the outer frame 102 can define a number of oxygen outlets similar to the oxygen outlet 120 but which can be used to provide oxygen to different wounds in a patient, as will be discussed below, and the oxygen generation subsystem 116 can be coupled to these oxygen outlets. Thus, each oxygen outlet can be coupled to the oxygen generation subsystem 116, or to an oxygen generation subsystem substantially similar to the oxygen generation subsystem 116 described herein, to enable treatment of a number of different wounds in a patient. In the embodiments described herein, the outer frame 102 houses a number of sensor subsystems, including a humidity sensor subsystem 122a, a pressure sensor subsystem 122a, and one or more other sensor subsystems 122c, as will be discussed below. Furthermore, in embodiments in which a number of oxygen outlets receive oxygen from one or more oxygen generation subsystems in the outer frame 102, one or more sensor subsystems may be provided in the same manner as the sensor subsystems described below.

[0018] In one embodiment, a humidity sensor subsystem 122a is located in the outer frame 102 and coupled to the oxygen generation control engine 104 (for example, via a coupling between the humidity sensor subsystem 122a and the processing subsystem), and is configured to monitor the humidity within the outer frame 102 and provide the oxygen generation control engine 104 with humidity information indicating the humidity level within the outer frame 102. For example, the humidity sensor subsystem 122a may include a Si7007-A20 relative humidity (RH) sensor, available from Silicon Labs in Austin, Texas, USA, as well as fittings, connectors, and / or other couplings for coupling the humidity sensor to the processing subsystem. As will be described in more detail below, such a humidity sensor is relatively small (currently about 3mm x 3mm), relatively inexpensive (currently about US$1.50), and provides the functionality described below using a relatively simple coupling system. However, although specific humidity sensor subsystems have been described, those skilled in the art who own this disclosure will recognize that humidity sensors may be located in different places (e.g., on the surface of the outer frame 102 to measure humidity outside the outer frame 102, coupled to the oxygen outlet 120 to measure humidity inside the restricted airflow enclosure, etc., and / or may be used in alternative ways of teaching this disclosure, while still within the scope of this specification. Furthermore, although the embodiment specifically described in Figure 1A includes several other sensor subsystems, as will be considered below, in some circumstances these other sensor subsystems specifically described in Figure 1A may be omitted, and the only sensor subsystem used in the wound oxygen supply system 100 may be the humidity sensor subsystem.

[0019] In one embodiment, the pressure sensor subsystem 122b is located within the outer frame 102 and is coupled to the oxygen flow coupling between the oxygen generation subsystem 116 and the oxygen outlet 120, and to the oxygen generation control engine 104 (for example, between the pressure sensor subsystem 122b and the processing subsystem). The oxygen generation subsystem 116 is coupled (via a coupling between them) and is configured to monitor the pressure in the oxygen flow coupling between the oxygen generation subsystem 116 and the oxygen outlet 120, and to provide the oxygen generation control engine 104 with pressure information indicating the pressure in the restricted airflow enclosure coupled to the oxygen outlet 120, as will be discussed in detail below. For example, the pressure sensor subsystem 122b may include a pressure sensor available from Honeywell International Inc. of Morris Plains, New Jersey, USA, as well as fittings, connectors and / or other couplings for coupling the pressure sensor to the processing subsystem and the oxygen flow coupling.

[0020] In some embodiments, the pressure sensor subsystem 122b can measure pressure relative to atmospheric pressure regardless of gas concentration. However, in some embodiments, the pressure sensor subsystem 122b may include an oxygen partial pressure sensor subsystem, which measures the oxygen partial pressure in the oxygen flow coupling between the oxygen generation subsystem 116 and the oxygen outlet 120 and is configured to provide the oxygen generation control engine 104a with oxygen partial pressure information indicating the oxygen partial pressure in the restricted flow enclosure coupled to the oxygen outlet 120, as will be discussed in more detail below. However, although specific pressure sensor subsystems have been described, those skilled in the art who own this disclosure will recognize that pressure sensors are provided to be used in different locations (e.g., in piping coupled to the restricted flow enclosure, inside the restricted flow enclosure itself (e.g., as part of the bandage subsystem discussed below, etc.), inside or under a wound (i.e., under the wound bed)) and / or in alternative ways of teaching the present disclosure, while within the scope of this specification. Furthermore, as will be discussed below, depending on the circumstances, the pressure sensor subsystem, which is specifically described in Figure 1A, can be omitted, and the only sensor subsystem used in the wound oxygen supply system 100 may be the humidity sensor subsystem.

[0021] In one embodiment, other sensor subsystems 122c may be located within the outer frame 102 and, in some cases, coupled to an oxygen flow coupling between the oxygen generation subsystem 116 and the oxygen outlet 120, and coupled to an oxygen generation control engine 104 (e.g., via a coupling between the other sensor subsystem 122c and the processing subsystem), and configured to perform various sensor monitoring link functions. For example, a flow sensor subsystem monitors the oxygen flow generated by the oxygen generation subsystem 116 and provided through the oxygen flow coupling between the oxygen generation subsystem 116 and the oxygen outlet 120, and is configured to provide flow information to an oxygen generation control engine 104 indicating the oxygen flow generated by the oxygen generation subsystem 116 and provided to a restricted airflow enclosure coupled to the oxygen outlet 120, as will be discussed in more detail below. However, while specific flow sensor subsystems have been described, those skilled in the art who own this disclosure will recognize that flow sensors may be provided in different locations (e.g., in piping coupled to a restricted airflow enclosure) and / or in alternative ways of teaching the present disclosure, while still within the scope of this specification. Furthermore, as will be discussed below, depending on the circumstances, the flow sensor subsystem specifically described in Figure 1A may be omitted, and the only sensor subsystem used within the wound oxygen supply system 100 may be the humidity sensor subsystem.

[0022] In another example, the temperature sensor subsystem is configured to monitor the temperature during coupling between the oxygen generation subsystem 116 and the oxygen outlet 120, and to provide the oxygen generation control engine 104 with temperature information indicating the temperature inside the restricted airflow enclosure coupled to the oxygen outlet 120, as will be discussed in more detail below. However, while a specific temperature sensor subsystem has been described, those skilled in the art who own this disclosure will recognize that temperature sensors may be provided in different locations (e.g., in piping coupled to the restricted airflow enclosure, inside the restricted airflow enclosure itself (e.g., as part of the bandage subsystem discussed below), etc.) within the scope of this specification. Furthermore, as will be discussed below, depending on the circumstances The temperature sensor subsystem, specifically described in Figure 1A, can be omitted, and the only sensor subsystem used in the wound oxygen supply system 100 may be the humidity sensor subsystem.

[0023] In another example, the pH sensor subsystem is configured to monitor the pH during coupling between the oxygen generation subsystem 116 and the oxygen outlet 120 and to provide the oxygen generation control engine 104 with pH information indicating the pH in the restricted airflow enclosure coupled to the oxygen outlet 120, as will be discussed in more detail below. However, while a specific pH sensor subsystem has been described, those skilled in the art who own this disclosure will recognize that pH sensors may be provided in different locations (e.g., in piping coupled to the restricted airflow enclosure, or within the restricted airflow enclosure itself (e.g., as part of the bandage subsystem discussed below)) while still within the scope of this specification. Furthermore, as will be discussed below, in some circumstances the pH sensor subsystem specifically described in Figure 1A may be omitted, and the only sensor subsystem used in the wound oxygen supply system 100 may be the humidity sensor subsystem.

[0024] In another example, the perfusion sensor subsystem is configured to monitor perfusion during coupling between the oxygen generation subsystem 116 and the oxygen outlet 120 and to provide the oxygen generation control engine 104 with perfusion information indicating perfusion within a restricted airflow enclosure coupled to the oxygen outlet 120, as will be discussed in more detail below. The perfusion information may include information describing measurements of oxygen content in a relative or absolute sense, such as measurements of molar concentration, hemoglobin saturation and / or various other properties that will be obvious to those skilled in the art who own this disclosure. However, although a specific perfusion sensor subsystem has been described, those skilled in the art who own this disclosure will recognize that perfusion sensors may be provided in different locations (e.g., in piping coupled to a restricted airflow enclosure, or within the restricted airflow enclosure itself (e.g., as part of the bandage subsystem discussed below)) while still within the scope of this specification. Furthermore, as will be discussed below, in some circumstances the perfusion sensor subsystem specifically described in Figure 1A may be omitted, and the only sensor subsystem used in the wound oxygen supply system 100 may be the humidity sensor subsystem. While several specific sensor subsystems have been described, those skilled in the art who own this disclosure will recognize that various other sensors can be used in the wound oxygen supply system 100 to provide the functionality described below, while remaining within the scope of this disclosure.

[0025] Furthermore, while a specific wound oxygen supply system 100 has been described, a person skilled in the art who owns this disclosure will recognize that various other functions can be included in the wound oxygen supply system 100, even within the scope of this disclosure. For example, as specifically illustrated in Figure 1B, the wound oxygen supply system 100 may include a speaker and / or microphone system 124 coupled to a processing subsystem within the wound oxygen supply system 100 and configured to receive and transmit audible information, an input connector 126 configured to connect an external subsystem to the wound oxygen supply system 100 (for example, the input connector may be a power connector, a computer device connector such as a universal serial path (USB) connector, a headphone connector, and / or other input connectors known in the art, as discussed above with reference to Figure 1A), a wired and / or wireless communication subsystem providing data communication such as a BLUETOOTH® subsystem, a near-field communication (NFC) subsystem, a WiFi communication subsystem (providing communication over a limited area network (LAN), the Internet, etc.), a wired connector subsystem, and / or various other functions that will be obvious to a person skilled in the art who owns this disclosure. Thus, the addition of other functions and / or subsystems to the wound oxygen supply system 100 is also conceived to be within the scope of this disclosure.

[0026] Now, with reference to Figures 2A, 2B, and 2C, another embodiment of the wound oxygen supply system 200 will be specifically described. The wound oxygen supply system 200 specifically described in Figures 2A-2C provides an example of a wound treatment system that includes an oxygen generation subsystem, a sensor subsystem, and a power subsystem in a single outer frame, which can be coupled to or integrated with a bandage subsystem and a communication subsystem that can be coupled to communicate with another control device. In the embodiment specifically described, the wound oxygen supply system 200 includes an outer frame 202 that houses the components of the wound oxygen supply system, only some of which are specifically described in Figure 2A. For example, the outer frame 202 can house a control device communication subsystem 204 which may include wired and / or wireless communication components that provide control device communication functions as described below (e.g., a processing subsystem, a storage subsystem, a Bluetooth® subsystem, a near-field communication (NFC) subsystem, a Wi-Fi communication subsystem (which provides communication over a limited area network (LAN), the Internet, etc.), a wired connector subsystem, etc.).

[0027] The outer frame 202 is also coupled to the control device communication subsystem 204 and can house a power subsystem 206 which may include a battery, adapter, converter and / or various other power components that would be obvious to those skilled in the art who own this disclosure. For example, in some specific examples considered below, the power subsystem 206 may include a rechargeable battery and may include a power connector (similar to the power connector 114 discussed above with respect to Figures 1A and 1B, though not specifically described) and is configured to connect to a power source that provides power to the power subsystem 206 in order to charge the rechargeable battery. However, those skilled in the art who own this disclosure will recognize that it is possible to provide a direct power supply system (e.g., a system for connecting the outer frame 202 to an external power source, which does not require an internal battery or other storage power source to supply power, but can be used in conjunction with an internal battery) or an external battery subsystem (considered below) within the scope of this disclosure.

[0028] The outer frame 202 also houses an oxygen generation subsystem 208, which is coupled to a power subsystem 206 and configured to generate oxygen in response to power supplied by the power subsystem 206, as described below. The oxygen generation subsystem 208 is coupled to an oxygen inlet 210 configured to direct ambient air adjacent to the outer frame 202 into the oxygen generation subsystem 208, as discussed below, and an oxygen outlet 212 configured to direct the oxygen flow generated by the oxygen generation subsystem 208 out of the outer frame 202. For example, the outer frame 202 and / or the oxygen outlet 212 may include various fittings, connectors and / or other couplings that provide attachment of the bandage subsystem to the outer frame 202, as discussed below. Referring to Figures 2B and 2C, the outer frame 202 is specifically described as having an upper surface 202a and a lower surface 202b located opposite (and facing in the opposite direction to) the upper surface 202a of the outer frame 202. As will be specifically described, the outer frame 102 extends to the upper surface 202a and defines a plurality of openings providing an oxygen inlet 210, and extends to the lower surface 202b and defines an opening providing an oxygen outlet 212. The embodiments of the wound oxygen supply system 200 specifically described in Figures 2B and 2C provide an example of form factor, particularly using a smaller form factor sensor subsystem (e.g., the humidity sensor subsystem discussed below) and omitting a larger form factor sensor subsystem (e.g., the flow sensor subsystem discussed below), which may be provided using the teachings of this disclosure. However, those skilled in the art who own this disclosure will recognize that other form factors relating to the outer frame 202 of the wound oxygen supply system 200, and other arrangements of the oxygen inlet 210 and oxygen outlet 212 are also within the scope of this disclosure.

[0029] In the embodiments described in detail, the outer frame 202 houses a plurality of sensor subsystems, including a humidity sensor subsystem 214a which may be substantially similar to the humidity sensor subsystem 122a discussed above with reference to Figure 1A, a pressure sensor subsystem 214b which may be substantially similar to the pressure sensor subsystem 122b discussed above with reference to Figure 1A, and one or more other sensor subsystems 214c which may be substantially similar to the other sensor subsystems 122c discussed above with reference to Figure 1A. A specific wound oxygen supply system 200 has been described, but those skilled in the art who own this disclosure will recognize that various other functions may be included in the wound oxygen supply system 200 while remaining within the scope of this disclosure, and therefore the addition of other functions and / or subsystems to the wound oxygen supply system 200 is also conceivable to be within the scope of this disclosure.

[0030] Now, with reference to Figures 3A, 3B, and 3C, embodiments of the oxygen generation subsystem 300 are described, which may also be the oxygen generation subsystems 116 and / or 208 discussed above. In the embodiments described specifically, the oxygen generation subsystem 300 is provided as an electrochemical oxygen generator / ion exchange oxygen concentrator, but other oxygen generation subsystems are also within the scope of this disclosure. The oxygen generation subsystem 300 in the embodiments described specifically includes a proton exchange membrane (PEM) 302 positioned between a cathode plate 304 and an anode plate 306. In one embodiment, the PEM 302 may include a NAFION® oxygen transfer membrane as the proton conductor for the PEM 302, which may utilize a sulfonated tetrafluoroethylene copolymer and is available from DuPont® in Wilmington, Delaware, USA. However, other PEMs and PEM materials may also be available, while still within the scope of this disclosure. In the embodiments described in detail, the PEM 302 includes a gasket 302a that seals the PEM 302 between the cathode plate 304 and the anode plate 306. In one embodiment, the PEM 302 is fully compressed between the cathode plate 304 and the anode plate 306 (e.g., using a force of about 3 to 6 Newton-meters (Nm)), and the gasket 302a is sealed using a flange bolting subsystem 308. The cathode plate 304 defines an air inlet 304a which can be covered by a polarization film 304b configured to allow water vapor to pass in only one direction and to maintain the containment of other gases (e.g., hydrogen). In one embodiment, the polarization film 304b may be provided by GORETEX®, available from WLGORE & ASSOCIATES® of Newark, Delaware, USA, but other films are also within the scope of this disclosure.

[0031] Each of the cathode plate 304 and anode plate 306 may include a carbon-reinforced metallized substrate having a titanium mesh substrate plated on a carbon film, which provides a full range of application for electrical conductivity to the PEM 302. Electrical contact to the power subsystem 112 / 206, and power transfer from the power subsystem 112 / 206 to the cathode and anode plates 304 and 306, may be provided by attaching copper pieces to the titanium mesh substrates of the cathode plate 304 and anode plate 306 (e.g., using epoxy) using a compressive force applied by a flange bolting subsystem 308 that operates to provide the necessary adhesion to the surfaces of the cathode plate 304 and anode plate 306. The valve 310 may include fittings, connectors, and / or other couplings configured to couple to an oxygen outlet 306a defined by the anode plate 306 and to an oxygen flow coupling extending to an oxygen outlet 120 / 212. For example, valve 310 may be provided with a 304L stainless steel needle release valve using a Viton seat and machined to connect to anode plate 306 using a Viton O-ring (not specifically described). While a specific oxygen generation subsystem 300 has been described, those skilled in the art who own this disclosure will recognize that other oxygen generation subsystems can also be provided in the wound oxygen supply systems described herein, while still within the scope of this disclosure.

[0032] Now, with reference to Figures 4A and 4B, one embodiment of the control device 400 will be described in detail. In the embodiment described in detail and discussed below, the control device 400 is provided as a mobile phone. However, other computing devices, such as tablet computers, laptop computers, desktop computers, smartwatches, fitness trackers, or other wrist-mounted devices, and / or various other computing devices, can be provided as the control device 400, although these are within the scope of the disclosure. The control device 400 includes an outer frame 402 that houses the components of the control device, only some of which are specifically described in Figure 4A. For example, the outer frame 402 may house a processing subsystem (which may include one or more hardware processors known in the art, though not specifically described) and a storage subsystem (which may include one or more storage devices known in the art, though not specifically described), the storage subsystem including a command that, when executed by the processing subsystem, causes the processing subsystem to provide an oxygen generation control engine 404 configured to perform the functions of the oxygen generation control engine and control device discussed below. The outer frame 402 can also house a storage subsystem (which, although not specifically described, may include one or more storage devices known in the art), which is coupled to the oxygen generation control engine 404 (for example, via coupling between the storage subsystem and the processing subsystem), and stores an oxygen generation control database 406 which may contain any information used to provide the functionality discussed below.

[0033] The outer frame 402 may also house and / or include a display subsystem 408, which is coupled to the oxygen generation control engine 404 (for example, via a coupling between the display subsystem 408 and the processing subsystem) and configured to display any information as considered below. The outer frame 402 may also house an input subsystem 410, which is coupled to the oxygen generation control engine 404 (for example, via a coupling between the input subsystem 410 and the processing subsystem) and configured to receive and provide any input information as considered below to the oxygen generation control engine 404. Although the display subsystem 408 and the input subsystem 410 are described and presented as separate subsystems, a person skilled in the art who owns this disclosure will recognize that they can be combined within the scope of this disclosure (for example, in a touch-input display subsystem). Furthermore, the outer frame 402 can house a wound oxygen supply system communication subsystem 412, which may include wired and / or wireless communication components (e.g., a Bluetooth® subsystem, a near-field communication (NFC) subsystem, a Wi-Fi communication subsystem, a wired connector subsystem, etc.) to provide the communication functionality of the wound oxygen supply device discussed below. Thus, the wound oxygen supply system communication subsystem 412 can provide the controls described below via various wireless or wired connections (e.g., wired or wireless connections within a limited area, wired or wireless internet connections, etc.). Although a specific control device 400 has been described and explained in detail, a person skilled in the art who owns this disclosure will recognize that the control devices used in this disclosure may include various other components (e.g., mobile phone components) that provide various conventional functionalities in addition to the functionalities described below, while remaining within the scope of this disclosure.

[0034] Referring to Figure 5, an embodiment of the method 500 for supplying oxygen to a wound will be specifically described. As discussed above, the inventors of this disclosure have devised the systems and methods described in Patent Document 1 and its sub-patents such as Patent Document 2, which consider and claim a wound treatment system that provides low-dose tissue oxygenation and continuous oxygen regulation to one or more wound sites, and monitor pressure information indicating the pressure in a restricted airflow enclosure (e.g., provided by a wound bandage) located adjacent to the wound site, and oxygen generated by an oxygen generation subsystem and supplied to the restricted airflow enclosure. To control the flow, the system operates by using pressure information to control the power supplied to the oxygen generation subsystem. Such a wound treatment system may include a flow sensor that measures the oxygen flow generated by the oxygen outlet of the oxygen generation subsystem, and a pressure sensor downstream of the flow sensor, the outputs of which can be used to control the oxygen flow generated by the oxygen generation subsystem as discussed above. However, as also discussed above, the flow sensors used in such wound treatment systems are relatively large, relatively expensive, require a "piping system" that takes up space in the outer frame of the wound treatment system, and result in a relatively large outer frame. Furthermore, it has been found that the oxygen generation subsystem used in such a wound treatment system may have reduced oxygen production when humidity decreases, which may result in insufficient oxygen supply to the wound site, and the wound treatment system may increase the power supplied to the oxygen generation subsystem to a level that could damage the oxygen generation subsystem.

[0035] The systems and methods of this disclosure address these problems by providing a humidity sensor subsystem to a wound oxygen supply system, using the humidity sensor subsystem to monitor the humidity experienced by the oxygen generation subsystem, and reporting the humidity information to an oxygen generation control engine indicating that humidity. The oxygen generation control engine then uses the humidity information to control the power supplied to the oxygen generation subsystem by the power subsystem in order to control the oxygen flow generated by the oxygen generation subsystem and supplied to a restricted airflow enclosure adjacent to the wound through the oxygen outlet. In some examples, for several different amounts of power, oxygen generation control data can be created relating to the oxygen output of the oxygen generation subsystem, which fluctuates over a range of varying humidity levels, and this oxygen generation control data can be stored in an oxygen generation control database. Thus, the oxygen generation control engine can have access to data indicating the power that can be applied to the oxygen generation subsystem to produce a desired oxygen output and associated oxygen flow rate for any given specific humidity level. That is, using the humidity information received from the humidity sensor subsystem, the oxygen generation control engine can cause the power subsystem to supply the oxygen generation subsystem with an amount of power that produces oxygen, and subsequently the desired oxygen output / oxygen flow to the restricted airflow enclosure adjacent to the wound.

[0036] The systems and methods of this disclosure enable the replacement of conventional flow sensor subsystems used in wound treatment systems discussed above with the humidity sensor subsystems described herein, providing a reduction in the cost and space required for the sensor subsystems used to control oxygen generation by the oxygen generation subsystem. For example, as discussed above, conventional flow sensor subsystems cost approximately US$60, measure approximately 36 mm x 20 mm, consume relatively high amounts of energy (up to 40 milliamperes (mA)), and require a "piping system" that connects the flow sensor to the oxygen flow(s) it measures and describes the specific placement of the flow sensor within the outer frame that allows for such piping routes. In contrast, the humidity sensor subsystem of this disclosure costs approximately US$1.50, measures approximately 3 mm x 3 mm, consumes minimal energy (less than 1 milliampere (mA)), and utilizes a relatively simple coupling system that can be mounted anywhere on the substrate (e.g., it includes a processing system that provides an oxygen generation control engine). Thus, a reduction in the size of the outer frame of the wound treatment system is provided, while enabling low-dose tissue oxygenation to the wound site and continuous oxygen regulation. Furthermore, the humidity-based oxygen generation control experienced by the oxygen generation subsystem prevents the deficient oxygen supply to the wound site in low-humidity environments experienced by conventional wound treatment systems, and avoids the problems associated with increased power supplied to the oxygen generation subsystem that would otherwise result from reduced oxygen generation capacity in such low-humidity environments.

[0037] Method 500 begins with block 502, where the bandaging subsystem and wound oxygen supply are located. The supply system is applied to a wound. Referring here to Figure 6, patient 600 may have at least one wound in or before block 502. In many specific embodiments considered below, at least one wound is a single wound 602 on the surface of patient 600's leg 604 and may extend at least partially into patient 600's leg 604. However, in some embodiments, as considered below, patient may have more than one wound, and wounds may be located in any part of patient 600's body. Furthermore, in some embodiments, wounds may be located inside patient 602, such as on an organ of patient 600 (e.g., not wounded, repaired (e.g., surgically repaired), or not under the patient's healthy skin), and thus the wound oxygen supply system of this disclosure can be provided inside patient 600, while still within the scope of this disclosure. In such an internal wound oxygen supply system, the functionality described below may be enhanced by the removal of oxygen supplied to the wound (e.g., via oxygen removal piping similar to the oxygen provisioning piping considered below). Wounds treated using the wound oxygen supply systems and methods of this disclosure may include ulcers (diabetic, venous, arterial, hypertensive, etc.), surgical incisions or sutures, amputations, burns, frostbites, insect or animal punctures, organ or tissue transplants, organ or tissue implants, tissue grafting, and / or any other wounds that would be obvious to a person skilled in the art who owns this disclosure.

[0038] Referring to Figure 7A, in one embodiment, the bandage subsystem 700 can be positioned in block 502 adjacent to a wound 602 on the leg 604 of a patient 600. In the embodiment described in detail, the bandage subsystem 700 includes a pipe 702, which can be connected at a first end (not specifically described) to an oxygen outlet 120 on the wound oxygen supply system 100, as discussed above, and includes a second end 704 located opposite the first end of the pipe 702. An oxygen-permeable membrane 706 extends from the second end 704 of the pipe 702 and is integrated with the pipe 702, coupled to the pipe 702, and / or can be provided in various forms that will be obvious to those skilled in the art who own this disclosure. For example, the oxygen-permeable membrane 706 can be provided by an oxygen distribution tape positioned on the second end 704 of the pipe and on the wound 602 (e.g., to match the complete skin in contact with the wound 602). However, the oxygen-permeable membrane 706 can be provided using various materials that will be obvious to those skilled in the art who own this disclosure. As can be seen from the embodiments described in detail, the oxygen-permeable membrane 706 can be positioned around or otherwise adjacent to a wound 602 on the leg 604 of a patient 600, and can be covered with a moisture-absorbing dressing 708 (covering the oxygen-permeable membrane 706 and, if present, the exposed wound 602), which is further covered with a low vapor pressure permeable occlusive dressing 710 (e.g., covering the moisture-absorbing dressing 708, the oxygen-permeable membrane 706, the wound 602 and part of the piping 702), creating a restricted airflow enclosure adjacent to the wound 602 (e.g., between the wound and the dressing 710). In one embodiment, the dressing 710 is made of a transparent material and is configured to trap oxygen introduced into the restricted airflow enclosure adjacent to the wound 602, thereby creating and maintaining an oxygen-rich environment. In experimental embodiments, it was found that the local partial pressure of oxygen in wound 602 can be increased from a low range of 10–60 mmHg to an oxygen-rich environment range of 200–760 mmHg using the bandage subsystem and wound oxygen supply system of the present disclosure.In some embodiments, the bandage subsystem 700 may include an exhaust valve configured to ensure that the pressure in the restricting airflow enclosure provided by the bandage 710 does not exceed a desired maximum level.

[0039] In some embodiments, the bandage system 700 may include sensors that can be located in the piping 702 and / or the oxygen-permeable membrane 706 (i.e., the sensors may be located in a restricted airflow enclosure provided by the bandage subsystem 700). For example, Figure 7B shows how the sensor couplings 712 and 714 pass through the piping 702. This section specifically describes whether sensors 712a and 712b may be included, which are located at their distal ends and are positioned in the piping 702 and / or the oxygen-permeable membrane 706. For example, the sensor coupling 712 / 714 and sensors 712a / 714a may be part of or provided by the humidity sensor subsystem 122a / 214a, the pressure sensor subsystem 122b / 214b, and / or other sensor subsystems 122c / 214c (e.g., the flow sensor subsystem, the temperature sensor subsystem and / or other sensor subsystems described herein, as well as sensors that may be provided for other monitoring of the wound 602). In a specific example, the sensor coupling 712 / 714 may be provided by a sensor wire extending through the piping 702 between the sensor 712a / 714a and a sensor transducer in the outer frame 102 that provides input to the oxygen generation control engine. However, while specific embodiments of the sensor subsystem located outside the outer frame 102 of the wound oxygen supply system 100 have been described, the sensor subsystem can be located inside and outside the outer frame 102 of the wound oxygen supply system 100 in various ways, even within the scope of this disclosure.

[0040] Referring now to Figure 7C, the piping 702 may include multiple lumens, including an internal lumen 716, which in the embodiment described in detail acts to prevent kinking of the piping 702, while simultaneously being provided with a star-shaped form that allows oxygen flow even when the piping 702 is bent. However, various other kink-resistant components and / or materials can be provided to the piping 702 to provide similar functionality, while remaining within the scope of this disclosure. Referring now to Figure 7D, how the piping 702 may be defined to include multiple openings 718 adjacent to the second end 704 of the piping 702, which help deliver oxygen to the wound 602. That is, the oxygen flow 720 generated by the oxygen generation subsystem and directed through the piping 702 to the wound 602 can exit the piping 702 and enter a restricting airflow enclosure adjacent to the wound 702 through a number of different openings 718, as well as through the distal end of the internal lumen 716, thereby improving the oxygen flow to the wound 602.

[0041] Referring to Figure 8, in one embodiment, the bandage subsystem / wound oxygen supply system 800 (which includes the wound oxygen supply system 200 in Figures 2A-2C, which is coupled to or integrated with the bandage system) in block 502 can be positioned adjacent to a wound 602 on the leg 604 of a patient 600. In the embodiment described in detail, the bandage subsystem 800 includes a moisture-absorbing bandage 802 covering the wound 602, and a low vapor pressure permeable occlusive bandage 804 (i.e., covering the moisture-absorbing bandage 802 and the wound 602), creating a restricted airflow enclosure adjacent to the wound 602 (e.g., between the wound and the bandage 804). In one embodiment, the bandage 804 is made of a transparent material and is configured to trap oxygen introduced into the restricted airflow enclosure adjacent to the wound 602 to create and maintain an oxygen-rich environment. In the embodiments described in detail, the wound oxygen supply system 200 is coupled to or integrated with a bandage 804, which includes an oxygen channel 806 configured to direct the oxygen generated by the wound oxygen supply system 200 and provided via the oxygen outlet 212 to a restricted airflow enclosure created by the bandage 804 and located adjacent to the wound 602. In experimental embodiments, it has been found that the local partial pressure of oxygen in the wound 602 can be increased from a low range of 10–60 mmHg to an oxygen-rich environment range of 200–760 mmHg using the bandage subsystem / wound oxygen supply system of the present disclosure.

[0042] Although not specifically described in the embodiment of Figure 8, in some embodiments the bandage subsystem / wound oxygen supply system 800 may include an oxygen permeable membrane similar to the oxygen permeable membrane 706 discussed above. For example, the oxygen permeable membrane can be coupled to the oxygen outlet 212 on the wound oxygen supply system 200 (e.g., via the oxygen channel 806) and positioned directly adjacent to the wound 602 (e.g., extending through the moisture-absorbing bandage 802, e.g., oxygen (via the flow path 806). However, a person skilled in the art who owns this disclosure will recognize that the oxygen-permeable membrane can be provided to the bandage subsystem / wound oxygen supply system 800 in various ways, while still within the scope of this disclosure. Also, although not specifically illustrated in the aspect of Figure 8, the bandage subsystem / wound oxygen supply system 800 may include sensors located outside the outer frame 202 of the wound oxygen supply system 200 in substantially the same manner as those described in the wound oxygen supply system 100 above (i.e., so that they are located within the oxygen flow path 806, the oxygen-permeable membrane included in the bandage subsystem / wound oxygen supply system 800, and / or within the restricting airflow enclosure provided to the bandage subsystem / wound oxygen supply system 800).

[0043] While a few specific examples of bandage subsystems coupled to and integrated with wound oxygen supply systems 100 and 200 have been described and explained, various modifications and combinations of such examples are also conceived to be within the scope of this disclosure. For example, wound oxygen supply system 200 can be coupled to piping similar to the piping 702 discussed above, and which provides the oxygen produced by wound oxygen supply system 200 to a bandage subsystem similar to the bandage subsystem 700 discussed above. Similarly, wound oxygen supply system 200 can be coupled to or integrated with a bandage subsystem similar to the bandage subsystem / wound oxygen supply system 800 discussed above. Furthermore, those skilled in the art who own this disclosure will recognize how bandage subsystems can be modified to provide bandage subsystems (wound oxygen supply systems with coupled piping, integrated wound oxygen supply systems, etc.) configured to provide oxygen to wounds located inside patient 600 (e.g., subcutaneously in the patient, such as in internal organs of patient 600) using the teachings of this disclosure. Therefore, a person skilled in the art who owns this disclosure will recognize that the broad modifications to the teachings of this disclosure thus fall within that scope.

[0044] Method 500 then proceeds to block 504, where humidity information is received indicating the humidity experienced by the oxygen generation subsystem in the wound oxygen supply system. Referring to Figures 7A and 79, a bandage subsystem 700 is specifically described, which is coupled to the patient 600 and provides a restricted airflow enclosure adjacent to the wound 602, and includes piping 702 extending from the bandage subsystem 700 to an oxygen outlet 120 on the wound oxygen supply system 100. Those skilled in the art who own this disclosure will recognize that the arrangement of the bandage subsystem 700 and the wound oxygen supply system 100 allows the wound oxygen supply system 100 to be comfortably placed on and / or adjacent to various locations on the patient (e.g., on a belt, in a pocket, in a bag, secured to a limb, etc.). In one embodiment, in block 504, the humidity sensor subsystem 122a of the wound oxygen supply system 100 can be activated to sense the humidity level (e.g., inside the outer frame 102 of the wound oxygen supply system 100, adjacent to or outside the outer frame 102 of the wound oxygen supply system 100, inside the piping 702, inside the restricted airflow enclosure provided by the bandage subsystem 700, etc.) and in response to generate humidity information indicating the humidity level experienced by the oxygen generation subsystem 116 (and affecting the oxygen generation operation of the oxygen generation subsystem 116 as discussed above). The humidity sensor subsystem 122a and / or the oxygen generation control engine 104 can then be activated in block 504 so that the oxygen generation control engine 104 receives the humidity information generated by the humidity sensor subsystem 122a.

[0045] Referring to Figures 8 and 10, the bandage subsystem / wound oxygen supply system 800 is specifically described, which is coupled to the patient 600 and provides a restricted airflow enclosure in contact with the wound 602, and includes a control device 400 which is communicatively coupled to the wound oxygen supply system 200. For example, in block 504 or 504, the wound oxygen supply system communication subsystem 412 in the control device 400 and the control device communication subsystem 204 in the wound oxygen supply system 200 are described below. The devices are to be paired (e.g., via Bluetooth® or other wireless pairing protocols), linked, and / or otherwise able to establish a communication channel so that data or other information can be exchanged as described. Those skilled in the art who own this disclosure will recognize that the arrangement of the bandage subsystem / wound oxygen supply system 800 and the control device 400 allows the bandage subsystem / wound oxygen supply system 800 to be supplied to the wound and the control device 400 to be comfortably placed in various locations on the patient and / or adjacent to the patient (e.g., on a belt, in a pocket, in a bag, attached to a limb, etc.) while simultaneously enabling control of the wound oxygen supply system 200.

[0046] In one embodiment, the humidity sensor subsystem 214b in the wound oxygen supply system 200 in block 504 can be activated to sense the humidity level (e.g., inside the outer frame 202 of the wound oxygen supply system 200, adjacent to or outside the outer frame 202 of the wound oxygen supply system 200, inside the oxygen channel 806, inside the restricted airflow enclosure provided by the bandage subsystem / wound oxygen supply system 800, etc.) and in response to generate humidity information indicating the humidity level experienced by the oxygen generation subsystem 208 (and affecting the oxygen generation operation of the oxygen generation subsystem 208 as discussed above). The humidity sensor subsystem 122a and / or the control device communication subsystem 204 can then be activated to allow the control device communication subsystem 204 to receive the humidity information generated by the humidity sensor subsystem 122a. Next, the control device communication subsystem 204 operates to transmit humidity information to the control device 400 via a communication connection with the control device 400 established as discussed above, so that the oxygen generation control engine 404 in block 504 receives its humidity information through the wound oxygen supply system communication subsystem 412.

[0047] Method 500 then proceeds to block 506, where humidity information is used to control the power supplied to the oxygen generation subsystem. In one embodiment, with reference to the bandage subsystem 700 and wound oxygen supply system 100 discussed above, in block 506, the oxygen generation control engine 104 uses humidity information received from the humidity sensor subsystem 122a to control the power supplied to the oxygen generation subsystem 116 by the power subsystem 112. For example, as discussed above, the oxygen generation control database 106 may include oxygen generation control data relating to the oxygen output of the oxygen generation subsystem 116, which varies over a range of different humidity levels for each of several different power quantities. Thus, in block 506, the oxygen generation control engine 104 can determine a desired oxygen flow rate or pressure in the restricted airflow enclosure (for example, as programmed to the wound oxygen supply system 100), access the oxygen generation control data, and, using a specific humidity level indicated by the humidity information received in block 504, determine a specific power quantity that causes the oxygen generation subsystem 116 to produce an oxygen output that provides that desired oxygen flow rate or pressure in the restricted airflow enclosure. The oxygen generation control engine 104 can then cause the power subsystem 112 to provide a specific amount of energy to the oxygen generation subsystem 116 by, for example, sending a command to the power subsystem 112 to transmit that amount of energy to the oxygen generation subsystem 116. However, although the use of pre-prepared oxygen generation control data has been described, a person skilled in the art who owns this disclosure will recognize that other methods of controlling the power supplied to the oxygen generation subsystem 116 by the power subsystem 112, such as using humidity information (e.g., through a formula that calculates the amount of energy in response to a given humidity level), are also within the scope of this disclosure.

[0048] In another embodiment, referring to the bandage subsystem / wound oxygen supply system 800 and control device 400 discussed above, in block 506, the oxygen generation control engine 404 uses humidity data received from the humidity sensor subsystem 214a to control the power supplied to the oxygen generation subsystem 208 by the power subsystem 206. Similarly, the oxygen generation control database 406 can include oxygen generation control data relating to the oxygen output of the oxygen generation subsystem 208, which varies across a range of different humidity levels, for each of several different energy quantities. Thus, in block 506, the oxygen generation control engine 404 can determine a desired oxygen flow rate or pressure in the restricted airflow enclosure (for example, as programmed in the wound oxygen supply system 100), access the oxygen generation control data, and, using a specific humidity level indicated by the humidity information received in block 504, determine a specific energy quantity that causes the oxygen generation subsystem 208 to produce an oxygen output that provides the desired oxygen flow rate or pressure in the restricted airflow enclosure. The oxygen generation control engine 404 can then transmit a command to the control device communication subsystem 204 in the wound oxygen supply system 200 via the wound oxygen supply system communication subsystem 412, and the control device communication subsystem 204 can respond by, for example, forwarding the command to the power subsystem 206 and transmitting the energy quantity to the oxygen generation subsystem 208, thereby causing the power subsystem 206 to provide the specific energy quantity to the oxygen generation subsystem 208. However, while the use of pre-prepared oxygen generation control data has been described, a person skilled in the art who owns this disclosure will recognize that other methods of controlling the power supplied to the oxygen generation subsystem 208 by the power subsystem 206 using humidity information (e.g., via a formula that calculates the amount of energy in response to a given humidity level) are also within the scope of this disclosure.

[0049] Method 500 then proceeds to block 508, where the oxygen generation subsystem generates an oxygen stream using power provided according to humidity information. In one embodiment, with reference to either the bandage subsystem 700 and wound oxygen supply system 100 or the bandage subsystem / wound oxygen supply system 800 described above, in block 508 the oxygen generation subsystem 116 / 208 uses power provided by the power subsystem 112 / 206 in block 506 to create an oxygen stream of oxygen and products. For example, upon receiving power from the power subsystem 112 / 206, the oxygen generation subsystem 116 / 208 is activated to draw in air containing about 21% oxygen through the oxygen inlet 118 / 210, and this air is then directed to pass through the oxygen generation subsystem 116 / 208, which is activated to perform an electrochemical process to concentrate the oxygen contained in the air to produce an oxygen mixture of about 99% pure oxygen, and provides the oxygen mixture to be directed to the oxygen outlet 120 / 212 as an oxygen stream. The amount of energy (e.g., current) provided by the power subsystem 112 / 206 operates to be proportional to, or not related to, oxygen production (i.e., oxygen concentration from the air received through the oxygen inlet 118 / 210), thereby producing an oxygen flow of an oxygen velocity proportional to, or not related to, the amount of energy supplied by the power subsystem 112 / 206 to the oxygen production subsystem 116 / 208 (for example, an increase in current increases the electrochemical process carried out by the oxygen production subsystem 116 / 208, and thereby increases the subsequent oxygen flow velocity produced by the oxygen production subsystem 116 / 208, while a decrease in current decreases the electrochemical process carried out by the oxygen production subsystem 116 / 208, and thereby decreases the subsequent oxygen flow velocity produced by the oxygen production subsystem 116). In a specific example, the power subsystem 112 / 206 may include a lithium battery (e.g., a 7.4-volt lithium battery) and a regulator configured to vary the current over a range of approximately 15 milliamperes to approximately 150 milliamperes, which operates to provide an oxygen flow rate in the range of approximately 1.0 ml / hour to approximately 15.0 ml / hour.However, within the scope of this disclosure, various other power subsystem configurations can be used to provide a variety of different power outputs and subsystem oxygen flow rates.

[0050] Next, the oxygen flow generated by the oxygen generation subsystem 116 / 208 is directed out of the outer frame 102 / 202 via the oxygen outlet 120 / 212. In one embodiment, with reference to the bandage subsystem 700 and the wound oxygen supply system 100 described above, the oxygen generation subsystem The oxygen flow generated by the stem 116 can exit the oxygen outlet 120 and enter the piping 702, which can direct the oxygen flow to an oxygen-permeable membrane 706 so that it is introduced into a restricted airflow enclosure provided by the bandage subsystem 700. In another embodiment, with reference to the bandage subsystem / wound oxygen supply system 800 described above, the oxygen flow generated by the oxygen generation subsystem 208 can exit the oxygen outlet 202 and be directed by the oxygen channel 806 so that it is introduced into a restricted airflow enclosure provided by the bandage subsystem 700. In either embodiment, the increased available oxygen provided to the oxygen flow introduced into the restricted airflow enclosure can be metabolized at the cellular level and act to stimulate growth factor increase, epithelialization, granulation tissue formation, glycosaminoglycan production, and collagen synthesis.

[0051] Method 500 then proceeds to selection block 510, where other sensor information can be received. In some embodiments, other sensor information can be generated by the wound oxygen supply system and used in various ways, some of which are discussed below. However, in embodiments where the size and cost of the system are minimized, the use of humidity information to control the oxygen flow generated by the humidity sensor subsystem and the oxygen generation subsystem has been found to be sufficient to provide enhanced wound healing as described above. In one embodiment, with reference to the bandage subsystem 700 and the wound oxygen supply system 100 described above, any other sensor subsystem(s) provided to the wound oxygen supply system 100 in block 510 may be operated to sense, measure and / or otherwise detect various factors (e.g., within the outer frame 102 of the wound oxygen supply system 100, in contact with and outside the outer frame 102 of the wound oxygen supply system 100, within the piping 702, within the restricted airflow enclosure provided by the bandage subsystem 700, etc.) and to respond by creating information indicating those factors. Such other sensor subsystem(s) and / or oxygen generation control engine 104 may then be operated in block 504 to receive other sensor information created by the other sensor subsystem(s).

[0052] In another embodiment, with reference to the bandage subsystem / wound oxygen supply system 800 described above, any other arbitrary sensor subsystem(s) provided to the wound oxygen supply system 200 in block 510 may be operated to sense, measure and / or otherwise detect various factors (e.g., within the outer frame 202 of the wound oxygen supply system 200, in contact with and outside the outer frame 202 of the wound oxygen supply system 200, in the oxygen channel 806, in the restricted airflow enclosure provided by the bandage subsystem / wound oxygen supply system 800, etc.) and to produce information indicating those factors in response. Such other sensor subsystem(s) and / or the control device communication subsystem 204 may then be operated to receive other sensor information produced by such other sensor subsystem(s). The control device communication subsystem 204 can then be operated to transmit other sensor information to the control device 400 via a communication connection established as discussed above in block 504, so that the oxygen generation control engine 404 receives other sensor information through the wound oxygen supply system communication subsystem 412.

[0053] As discussed above, other sensor subsystems of the wound oxygen supply systems 100 and 200 may include pressure sensor subsystems 122b and 214b, each capable of providing pressure information to the oxygen production control engines 104 and 404, respectively, and this pressure information indicates the pressure in the restricted airflow enclosure provided by the bandage subsystem 700 and the bandage subsystem / wound oxygen supply system 800, respectively. As discussed above, other sensor subsystems of the wound oxygen supply systems 100 and 200 may include a flow rate sensor subsystem, which provides flow rate information to the oxygen production The oxygen flow rate information can be operated to provide to the oxygen generation control engines 104 and 404, respectively, and this oxygen flow rate information indicates the oxygen flow rate in the restricted airflow enclosure provided by the bandage subsystem 700 and the bandage subsystem / wound oxygen supply system 800, respectively. Also, as discussed above, other sensor subsystems of the wound oxygen supply systems 100 and 200 may include a temperature sensor subsystem, which can be operated to provide temperature information to the oxygen generation control engines 104 and 404, respectively, and this temperature information indicates the temperature in the restricted airflow enclosure provided by the bandage subsystem 700 and the bandage subsystem / wound oxygen supply system 800, respectively. Also, as discussed above, other sensor subsystems of the wound oxygen supply systems 100 and 200 may include a pH sensor subsystem, which can be operated to provide pH information to the oxygen generation control engines 104 and 404, respectively, and this pH information indicates the pH in the restricted airflow enclosure provided by the bandage subsystem 700 and the bandage subsystem / wound oxygen supply system 800, respectively. Furthermore, as discussed above, other sensor subsystems of the wound oxygen supply systems 100 and 200 may include perfusion sensor subsystems which can be operated to provide perfusion information to the oxygen generation control engines 104 and 404, respectively, and this perfusion information indicates the perfusion within the restricted airflow enclosure provided by the bandage subsystem 700 and the bandage subsystem / wound oxygen supply system 800, respectively.

[0054] Method 500 then proceeds to selection block 512, where other sensor information can be used to control the power supplied to the oxygen generation subsystem. In one embodiment, with reference to the bandage subsystem and wound oxygen supply system 100 described above, in block 512 the oxygen generation control engine 104 can use other sensor information received from other sensor subsystems (one or more) to control the power supplied to the oxygen generation subsystem 116 by the power subsystem 112. In a specific example, in block 512 the wound oxygen supply systems 100 and / or 200 can provide the humidity sensor subsystem and its functionality described above to generate a desired oxygen flow to the restricted airflow enclosure in the oxygen generation subsystem, while simultaneously using a pressure sensor subsystem to measure when the pressure in the restricted airflow enclosure reaches a maximum level and, in response, prevent the oxygen generation subsystem from generating oxygen until it drops below the maximum level. Using humidity and pressure sensor subsystems as replacements for conventional flow sensor subsystem / pressure sensor subsystem devices offers a smaller enclosure size and the ability to address humidity-related issues with the oxygen generation subsystem, while also enabling precise control of oxygen supply to the restricted airflow enclosure adjacent to the wound.

[0055] However, in block 512, the oxygen generation control engine 104 uses arbitrary pressure information, flow rate information, temperature information, pH information and / or perfusion information together with humidity information to determine the amount of power to be supplied to the oxygen generation subsystem 116, and then causes the power subsystem 112 to supply a specific amount of power to the oxygen generation subsystem 116, for example by sending a command to the power subsystem 112 to transmit that amount of power to the oxygen generation subsystem 116. However, in other embodiments, other sensor information received in block 510 does not have to be used to control the power supplied to the oxygen generation subsystem 116, but rather can be used instead to monitor the wound 602 or to perform other functions. For example, other sensor information such as pressure information can be used to ensure that the pressure in the restricted airflow enclosure is at a desired level, to confirm that the patient 600 is using the wound oxygen supply system, or to perform other functions that are obvious to those skilled in the art who own this disclosure.

[0056] In another embodiment, with reference to the bandage subsystem / wound oxygen supply system 800 and control device 400 described above, the oxygen generation control engine 404 in block 506 uses other sensor information received from other sensor subsystems (one or more) to power the power subsystem. The stem 206 controls the power supplied to the oxygen generation subsystem 208. Thus, in block 512, the oxygen generation control engine 104 uses arbitrary pressure information, flow rate information, temperature information, pH information, and / or perfusion information, together with humidity information, to determine the amount of power supplied to the oxygen generation subsystem 208, and then transmits a command to the control device communication subsystem 204 in the wound oxygen supply system 200 via the wound oxygen supply system communication subsystem 412, and the control device communication subsystem 204 responds by, for example, forwarding the command to the power subsystem 206 and transmitting the amount of power to the oxygen generation subsystem 208, thereby causing the power subsystem 206 to supply the oxygen generation subsystem 208 with that specific amount of power. However, in other embodiments, other sensor information received in block 510 does not have to be used to control the power supplied to the oxygen generation subsystem 208, but rather can be used instead to monitor the wound 602. The method then proceeds to selection block 514, where the oxygen generation subsystem can generate an oxygen flow using the power supplied according to the other sensor information in substantially the same manner as described above, with reference to block 508.

[0057] Next, method 500 returns to block 504, where humidity information indicating the humidity experienced by the oxygen generation subsystem in the wound oxygen supply system is received, and method 500 loops back to blocks 504-508, and in some cases loops back to selected blocks 510-514, providing an oxygen flow to the restricted airflow enclosure. In this way, oxygen is supplied to the wound and, in some cases, continuously fluctuates to enhance wound healing. Furthermore, combinations of the above teachings can provide more than one enhanced wound healing. For example, Figure 11 specifically illustrates patient 600 of Figure 6, who has a wound 602 on leg 604, which also has a second, smaller wound on leg 1100. In the embodiments described in detail, an embodiment of the bandage subsystem / wound oxygen supply system 800 is provided for a relatively large wound 602, which uses a connection to an external portable power source 1102 (e.g., a battery, solar energy collecting clothing, etc.) via a power connector provided by the power subsystem 206, which is provided to increase the oxygen production level by the wound oxygen supply system 200 for larger wounds 602, and which can be worn by the patient 600 (e.g., on a belt, in a pocket, etc.). In addition, an embodiment of the bandage subsystem / wound oxygen supply system 800 is provided for a relatively small wound on the leg 1100, which includes sufficient internal power (e.g., via an internal battery) to provide sufficient oxygen production by the wound oxygen supply system 200 for smaller wounds on the leg 1100. As described in detail, the control device 400 can be provided to control multiple wound oxygen supply systems used by the patient 600 in substantially the same manner as described above.

[0058] Furthermore, Figure 12 specifically illustrates how a single wound oxygen supply system 100 can be used to treat multiple wounds in the patient as described above. For example, in Figure 12, the first bandaging subsystem 700 is placed on a wound on the shoulder of patient 600, A second bandage subsystem 700 is placed in a wound on the leg 604 of the patient 600, and each of these first and second bandage subsystems 700 is coupled to one or more oxygen outlets of the outer frame 102 of the wound oxygen supply system 100. Thus, the outer frame 102 can accommodate a number of oxygen generation subsystems, each having its own dedicated oxygen outlet, sensor subsystem and / or other functions as described above, and each is configured to supply oxygen to the wound in substantially the same manner as described above. Furthermore, in some embodiments, a single oxygen generation subsystem may be coupled to a single oxygen outlet, include a single set of sensor subsystems, and be coupled to a number of wounds (e.g., via a number of pipe branches) to supply oxygen to those many wounds in substantially the same manner as described above. Thus, a person skilled in the art who owns the present disclosure will recognize that various modifications can be made to the systems and methods of the present disclosure to enable the treatment of many wounds, while remaining within the scope of the present disclosure.

[0059] In addition to the functionalities described above, the wound oxygen supply systems 100 and 200 can be operated to receive various input information via their input subsystems (e.g., input subsystem 110 of wound oxygen supply system 100, input subsystem 410 on control device 400 which can use wound oxygen supply system communication subsystem 412 to transmit input information to wound oxygen supply system 200, etc.) and / or to display various display information via their display subsystems (e.g., display subsystem 108 on wound oxygen supply system 100, display subsystem 408 on control device 400 which can use wound oxygen supply system communication subsystem 412 to receive display information from wound oxygen supply system 200, etc.). For example, the input information may include control commands to adjust to a desired oxygen flow rate generated by the oxygen generation subsystem 116 / 208, cause software on which wound oxygen supply systems 100 and / or 200 are updated, and / or any other various input information which would be obvious to those skilled in the art who own this disclosure. In another example, the display information may include the current oxygen flow rate generated by the oxygen generation subsystem 116 / 208, the software update status of the wound oxygen supply system 100 and / or 200, and / or any other variety of display information that would be obvious to a person skilled in the art who owns this disclosure.

[0060] Furthermore, the communication subsystem provided within the wound oxygen supply system 100 and / or 200 (and / or in association with the wound oxygen supply system 200 in the case of the control device 400) can also be used to communicate with other entities. For example, the wound oxygen supply system 100 can use its communication subsystem to download data (e.g., commands to operate) to be used for at least one subsequent operation of the wound oxygen supply system 100, and / or to upload data (e.g., pre-created data) describing the prior operations of the wound oxygen supply system 100. Similarly, the control device 400 can use its communication subsystem to download data (e.g., commands to operate) to be used for at least one subsequent operation of the wound oxygen supply system 200, and optionally to provide that data to the wound oxygen supply system 200, and / or to upload data (e.g., pre-created data) describing the prior operations of the wound oxygen supply system 100. Data generated by the wound oxygen supply system, and describing the use of the wound oxygen supply system, is stored and reported to the caregiver or other entity, and the caregiver or other entity can remotely control the operation of the wound oxygen supply system to remotely care for the patient.

[0061] This disclosure describes a system and method that monitors the humidity experienced by the oxygen generation subsystem and uses that humidity level to control the oxygen flow produced by the oxygen generation subsystem and supplied to a restricted airflow enclosure adjacent to the wound through an oxygen outlet, and to control the power supplied to the oxygen generation subsystem by the power subsystem. The system and method of this disclosure allows for the replacement of the conventional flow sensor subsystem used in the above wound treatment system with the humidity sensor subsystem described herein, providing a reduction in the cost and size of the wound oxygen supply system, while still enabling low-dose tissue oxygenation to the wound site and continuous oxygen regulation, preventing the deficient oxygen supply to the wound site experienced by conventional wound treatment systems in low-humidity environments, and also avoiding problems associated with increased power supplied to the oxygen generation subsystem, thus addressing the reduced oxygen generation capacity resulting from such low-humidity environments.

[0062] While specific descriptions and embodiments have been provided, a wide range of modifications, alterations, and substitutions are intended in the foregoing disclosure, and in some cases, some functions of these embodiments may be used without corresponding uses of other functions. Therefore, the scope of the attached claims is broad, and this specification... It is appropriate to interpret the document in a manner consistent with the scope of disclosures made in the document.

Claims

1. Outer frame section that defines the oxygen outlet; An oxygen generation subsystem included in the outer frame and coupled to the oxygen outlet; and It is coupled to the oxygen generation subsystem, and The oxygen generation subsystem receives humidity information indicating the humidity it experiences; and Created by the oxygen generation subsystem and passing through the oxygen outlet to the restricted airflow enclosure. To control the oxygen flow supplied to the generator, humidity information is used in the oxygen generation subsystem. A control subsystem configured to control the power supplied to it. A wound oxygen supply system comprising:

2. moreover: The system according to claim 1, further comprising a power subsystem located in the outer frame, coupled to an oxygen generation subsystem and a control subsystem, and configured to supply power to the oxygen generation subsystem.

3. moreover: The system according to claim 1, further comprising a pressure sensor located in the outer frame and configured to provide pressure information to a control subsystem.

4. The control subsystem is: The system includes an oxygen generation control database containing oxygen generation control data relating to the fluctuating oxygen output of the oxygen generation subsystem across a range of different humidity levels for each of several different power values, and the control subsystem: Using humidity information from the oxygen generation control database, retrieve the first oxygen generation control data, which includes the first power that causes the oxygen generation subsystem to generate the desired oxygen output; and The power subsystem provides the first power to the oxygen generation subsystem. The system according to claim 1, configured as follows.

5. moreover: A display subsystem included on the outer frame and coupled to the control subsystem; and It comprises an input subsystem included on the outer frame and coupled to a control subsystem, wherein the control subsystem is: Provide display information to the display on the display subsystem; and Receive input information from the input subsystem. The system according to claim 1, configured in such a way.

6. The system according to claim 5, wherein the input subsystem includes a touchscreen input subsystem incorporated into the display subsystem.

7. moreover: The control subsystem includes a data communication subsystem coupled to it, wherein the control subsystem: Using the data communication subsystem to download data for use in at least one subsequent operation of the system; and Upload data created during at least one pre-operation of the system using the data communication subsystem. The system according to claim 1, configured to perform at least one of the following.

8. A method of supplying oxygen to a wound: The control subsystem receives humidity information from a humidity sensor, indicating the humidity experienced by the oxygen generation subsystem coupled to the restricted airflow enclosure; The power supplied to the oxygen generation subsystem is controlled by the control subsystem using humidity information; and Oxygen is generated by the oxygen generation subsystem using power controlled by the control subsystem so that oxygen is supplied to the restricted airflow enclosure. The method comprising the following:

9. moreover: The method according to claim 8, further comprising providing power controlled by a control subsystem to an oxygen generation subsystem via a power subsystem.

10. moreover: The control subsystem retrieves first oxygen generation control data, including a first power that causes the oxygen generation subsystem to generate the desired oxygen output, from the oxygen generation control database using humidity information; and The power subsystem provides the first power to the oxygen generation subsystem. The method according to claim 8, comprising the action of

11. moreover: The control subsystem provides display information to the display on the display subsystem; and The control subsystem receives input information from the input subsystem. The method according to claim 8, comprising the action of

12. The method according to claim 11, wherein the input subsystem includes a touchscreen input subsystem incorporated into the display subsystem.

13. moreover: The data communication subsystem is used to download data to the control subsystem for use in at least one wound to be treated thereafter; and The control subsystem uploads data created during at least one pre-wound treatment using the data communication subsystem. The method according to claim 8, comprising the following:

14. A wound oxygen supply system: Processing system: and When combined with a processing system and executed by the processing system, the processing system: Receiving humidity information indicating the humidity experienced by the oxygen generation subsystem; and Created by the oxygen generation subsystem and supplied to the restricted airflow enclosure. To control the oxygen flow, the power supplied to the oxygen generation subsystem is controlled by humidity information. To use and control, A memory system that includes a command to perform an operation that includes The system comprising the above.

15. Further steps: The first oxygen generation control data, which includes the first power that causes the oxygen generation subsystem to generate the desired oxygen output, is retrieved from the oxygen generation control database using humidity information; and The power subsystem provides the first power to the oxygen generation subsystem. The system according to claim 14, comprising the following:

16. Further steps: The system according to claim 14, further comprising providing display information to a display on a display subsystem.

17. Further steps: The system according to claim 16, further comprising receiving input information from an input subsystem.

18. The system according to claim 17, wherein the input subsystem includes a touchscreen input subsystem incorporated into the display subsystem.

19. Further steps: The system according to claim 14, further comprising using a data communication subsystem to download data for use in at least one subsequent operation of the system.

20. Further steps: The system according to claim 14, further comprising using a data communication subsystem to upload data created during at least one prior operation of the system via a control subsystem.

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