Systems, devices and methods for performing gas and pressure therapy - Patents.com

Abstract

Apparatus, methods and systems are provided for or for use in administering a multi-pressure treatment protocol to a human limb, which may include a bag configured to surround at least a portion of the limb, a connection piece attached to a wall of the bag at a distal portion of the bag, the connection piece effectively allowing gas flow therethrough between a pressure regulator and an interior space of the bag, and a gas permeable strip attached to or integral with an interior surface of the bag.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application is a continuation-in-part of U.S. Patent Application No. 17 / 239,637, filed April 25, 2021, the entire contents of which are incorporated herein by reference. For purposes of the Paris Convention, this patent application claims priority to U.S. Patent Application No. 17 / 239,637, filed April 25, 2021, and to UK Patent Application No. 2112465.6, filed September 1, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates to articles of manufacture including apparatus for use in gas and pressure therapy administered to the human body and torso, as well as methods for using such articles and methods for using such articles in gas and pressure therapy. [Background technology]

[0003] Pressure regulating devices are utilized in a variety of treatments. In many cases, treatments are performed by improvising a pressure-holding space over and around a wound or incision in a limb or torso. In some cases, a "gas bridge" is also improvised between a connection part placed in the improvised space and the wound itself. This is done, for example, by cutting a piece of open-cell foam to create a gas path in the space. Thus, the approaches disclosed to date are imprecise, ad hoc, and difficult to maintain in a sterile condition. Furthermore, the improvised pressure-holding space is not suitable for combination with other gas therapies or other pressure therapies. Thus, there is a need for a ready-to-use device that can be used in a variety of treatments using pressure regulating devices and / or various gases. Summary of the Invention

[0004] According to an aspect of the present invention, a system for administering a multi-pressure treatment protocol to a human subject is provided.

[0005] According to features in the described preferred embodiments, the system includes a first gas transport section having a first opening for transporting gas therethrough, the first gas transport section being configured (i) to adjust a pressure in a first container arranged in fluid communication with the gas transport section, and (ii) to cause a flow of gas through the first opening, and a second gas transport section having a second opening for transporting gas therethrough, the second gas transport section being configured to adjust a pressure in a second container arranged in fluid communication with the second gas transport section.

[0006] According to still further features in the described preferred embodiments, the system further includes an electronic circuit programmed to sequentially operate in a first mode and a second mode, wherein in the first mode, the first gas-transporting unit causes gas to flow into the first container through the first opening, and in the second mode, while at least a portion of the gas is in the first container, the second gas-transporting unit adjusts, through the second opening, a respective gas pressure in a fluid-retaining compartment of the second container such that the fluid-retaining compartment applies a respective compressive pressure through a wall of the first container to a corresponding portion of the limb.

[0007] According to still further features in the described preferred embodiments, the gas is caused to flow by the first gas transport unit in response to an input confirming that the first container is in fluid communication with the first gas transport unit and that the first container is positioned to surround at least a portion of a longitudinal axis of the subject's limb.

[0008] According to still further features in the described preferred embodiments, the second gas transport section adjusts a respective gas pressure in response to an input confirming that the second vessel is in fluid communication with the second gas transport section and that the second vessel is positioned to surround at least a portion of a longitudinal direction of the first vessel.

[0009] According to still further features in the described preferred embodiments the adjustment causes the gas to flow through at least a portion of the first container surrounded by the second container within an area surrounded by the fluid holding compartment.

[0010] According to still further features in the described preferred embodiments the fluid flow is at least partially effected by a series of expansions and / or contractions of the fluid-holding compartment.

[0011] According to still further features in the described preferred embodiments, the gas flow is at least partially or predominantly through longitudinally disposed gas flow channel strips within the first vessel, the gas flow channel strips being laterally open along their length to the interior space of the first vessel, such that fluid within the first vessel can freely flow into and out of the gas flow channel strips.

[0012] According to still further features in the described preferred embodiments the gas is a therapeutic gas and optionally comprises at least one of ozone, oxygen, and essential oils.

[0013] According to still further features in the described preferred embodiments the first gas transfer section is configured to regulate a pressure in the first vessel in a range from 50 mmHg below ambient or atmospheric pressure to ambient or atmospheric pressure.

[0014] According to still further features in the described preferred embodiments the second gas transfer section is configured to regulate pressure in the second vessel in a pressure range of 0 to 40 mmHg above ambient or atmospheric pressure.

[0015] According to still further features in the described preferred embodiments the first container and the gas flow path strip are mated such that when the first container is exposed to a specific negative pressure in the range of 660-710 mmHg (absolute), at least one wall of the first container collapses and exerts a lateral force on the gas flow path strip, closing the flow path laterally and providing a longitudinally open gas flow path.

[0016] According to still further features in the described preferred embodiments the electronic circuit is further programmed to extract gas present in the first container in a third mode to reduce a pressure in the first container to a first pressure that is below ambient or atmospheric pressure.

[0017] According to still further features in the described preferred embodiments the electronic circuitry is further programmed in a fourth mode subsequent to the third mode to introduce a volume of the or the therapeutic gas into the first container while maintaining a pressure within the first container below ambient or atmospheric pressure.

[0018] Various methods and apparatus as well as additional systems are disclosed herein.

[0019] The invention will be further described, by way of example, with reference to the accompanying drawings, in which dimensions of components and features shown are adopted for convenience and clarity of illustration and are not necessarily drawn to scale, and in which: [Brief description of the drawings]

[0020] [Figure 1] 1 is a schematic diagram of an exemplary apparatus according to an embodiment of the present invention. [Diagram 2] 1 is a schematic diagram of an exemplary apparatus according to an embodiment of the present invention. [Diagram 3] FIG. 2 is a schematic diagram of an apparatus according to an embodiment of the present invention connected to a pressure regulator via a gas connection hose. [Figure 4A] 2 is a schematic top view of a strip according to an embodiment of the present invention. FIG. [Figure 4B] 1 is a schematic cross-sectional view of a strip according to an embodiment of the present invention; [Figure 4C] 1 is a schematic cross-sectional view of a strip according to an embodiment of the present invention; [Figure 4D] 1 is a schematic cross-sectional view of a strip according to an embodiment of the present invention; [Figure 4E] 1 is a schematic cross-sectional view of a strip according to an embodiment of the present invention; [Figure 4F] 1 is a schematic cross-sectional view of a strip according to an embodiment of the present invention; [Figure 5A] FIG. 2 is a schematic diagram showing components of a device according to an embodiment of the invention, comprising a connection piece to which a gas connection hose is connected, two opposing walls of a bag, and a strip, the strip being attached to the wall opposite the connection piece. [Figure 5B] FIG. 2 is a schematic diagram showing components of a device according to an embodiment of the invention, comprising a connection part to which a gas connection hose is connected, two opposing walls of a bag, and a strip, the strip being attached to the same wall as the connection part. [Figure 6] 2 is a schematic diagram of the gas flow path into, through, and out of the strip in accordance with an embodiment of the present invention. [Figure 7] 2 is a schematic diagram of the gas flow path into, through, and out of the strip in accordance with an embodiment of the present invention. [Figure 8] 2 is a schematic diagram of the gas flow path into, through, and out of the strip in accordance with an embodiment of the present invention. [Figure 9A] 2 is a schematic diagram of the gas flow path into, through, and out of the strip in accordance with an embodiment of the present invention. [Figure 9B] 2 is a schematic diagram of the gas flow path into, through and out of a strip under external pressure according to an embodiment of the present invention. FIG. [Figure 10A]2 is a schematic diagram of the flow path of gas entering, passing through, and exiting the strip in an uncompressed state in accordance with an embodiment of the present invention. FIG. [Figure 10B] 2 is a schematic diagram of the flow path of gas entering, passing through, and exiting a partially compressed strip in accordance with an embodiment of the present invention. FIG. [Figure 11A] 1 is a photograph showing an exemplary gas permeable strip and a gas permeable layer of the strip according to an embodiment of the present invention. [Figure 11B] 1 is a photograph showing an exemplary gas permeable strip and a gas permeable layer of the strip according to an embodiment of the present invention. [Figure 11C] 1 is a photograph showing an exemplary gas permeable strip and a gas permeable layer of the strip according to an embodiment of the present invention. [Figure 11D] 1 is a photograph showing an exemplary gas permeable strip and a gas permeable layer of the strip according to an embodiment of the present invention. [Figure 11E] 1 is a photograph showing an exemplary gas permeable strip and a gas permeable layer of the strip according to an embodiment of the present invention. [Figure 11F] 1 is a photograph showing an exemplary gas permeable strip and a gas permeable layer of the strip according to an embodiment of the present invention. [Figure 12A] FIG. 2 is a schematic diagram of an exemplary apparatus according to an embodiment of the present invention comprising an integrally formed strip. [Figure 12B] 1 is a schematic diagram of an exemplary apparatus according to an embodiment of the present invention comprising an integrally formed strip; [Figure 12C] FIG. 2 is a schematic diagram of an exemplary apparatus according to an embodiment of the present invention comprising an integrally formed strip. [Figure 13] 1 is a schematic diagram of devices according to an embodiment of the present invention, each sized and worn on a human body; [Figure 14] FIG. 1 is a schematic diagram illustrating a human user wearing an exemplary full-body sized device in accordance with an embodiment of the present invention. [Figure 15]FIG. 1 is a schematic diagram illustrating a human user wearing an exemplary full-body sized device in accordance with an embodiment of the present invention. [Figure 16] FIG. 1 is a schematic diagram illustrating a human user wearing an exemplary full-body sized device in accordance with an embodiment of the present invention. [Figure 17] 1 is a schematic diagram showing a device according to an embodiment of the present invention worn sized to fit a person's leg, and an elastic ribbon according to an embodiment of the present invention attached as a lateral extension member to the strip of the device. [Figure 18] FIG. 1 is a schematic diagram of a kit according to an embodiment of the present invention, comprising a device and an elastic ribbon for use as a lateral extension member. [Figure 19] 1 is a schematic diagram of a kit according to an embodiment of the present invention comprising a device and an appendage sealing tape. [Figure 20] FIG. 20 is a schematic diagram of a kit according to an embodiment of the present invention, comprising the kit components shown in FIG. 18 and a limb sealing tape. [Figure 21] FIG. 1 is a block diagram of a kit according to an embodiment of the present invention. [Figure 22A] 1 is a schematic cross-sectional view of an exemplary apparatus having first and second portions of a gas flow path each under different pressure conditions according to an embodiment of the present invention. [Figure 22B] 1 is a schematic cross-sectional view of an exemplary apparatus having first and second portions of a gas flow path each under different pressure conditions according to an embodiment of the present invention. [Figure 22C] 1 is a schematic cross-sectional view of an exemplary apparatus having first and second portions of a gas flow path each under different pressure conditions according to an embodiment of the present invention. [Figure 23] FIG. 1 is a schematic diagram illustrating a system according to an embodiment of the present invention for administering a multi-pressure treatment protocol to a human subject. [Figure 24] FIG. 2 illustrates first and second containers according to an embodiment of the invention at least partially surrounding a human limb. [Diagram 25]FIG. 2 illustrates a first and second container according to an embodiment of the invention at least partially surrounding a human limb and connected to a pressure regulating device. [Figure 26A] 13A-13C are schematic diagrams illustrating sequential compression of a second container having multiple compartments partially surrounding a first container that at least partially surrounds a human limb according to an embodiment of the present invention. [Figure 26B] 13A-13C are schematic diagrams illustrating sequential compression of a second container having multiple compartments partially surrounding a first container that at least partially surrounds a human limb according to an embodiment of the present invention. [Figure 26C] 13A-13C are schematic diagrams illustrating sequential compression of a second container having multiple compartments partially surrounding a first container that at least partially surrounds a human limb according to an embodiment of the present invention. [Figure 26D] 13A-13C are schematic diagrams illustrating sequential compression of a second container having multiple compartments partially surrounding a first container that at least partially surrounds a human limb according to an embodiment of the present invention. [Figure 26E] 13A-13C are schematic diagrams illustrating sequential compression of a second container having multiple compartments partially surrounding a first container that at least partially surrounds a human limb according to an embodiment of the present invention. [Figure 26F] 13A-13C are schematic diagrams illustrating sequential compression of a second container having multiple compartments partially surrounding a first container that at least partially surrounds a human limb according to an embodiment of the present invention. [Figure 27A] 1 is a flow chart illustrating method steps for administering a multi-pressure treatment protocol to a human subject in accordance with an embodiment of the present invention. [Figure 27B] 1 is a flow chart illustrating method steps for administering a multi-pressure treatment protocol to a human subject in accordance with an embodiment of the present invention. [Figure 27C] 1 is a flow chart illustrating method steps for administering a multi-pressure treatment protocol to a human subject in accordance with an embodiment of the present invention. [Figure 27D] 1 is a flow chart illustrating method steps for administering a multi-pressure treatment protocol to a human subject in accordance with an embodiment of the present invention. [Figure 27E] 1 is a flow chart illustrating method steps for administering a multi-pressure treatment protocol to a human subject in accordance with an embodiment of the present invention. [Figure 28A] 4 is a flow chart illustrating method steps for providing hypopressure therapy to a human limb in accordance with an embodiment of the present invention. [Figure 28B] 4 is a flow chart illustrating method steps for providing hypopressure therapy to a human limb in accordance with an embodiment of the present invention. [Figure 28C] 4 is a flow chart illustrating method steps for providing hypopressure therapy to a human limb in accordance with an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] The present invention will now be described, by way of example only, with reference to the accompanying drawings. With specific and detailed reference to the drawings, it will be emphasized that the detailed description is merely exemplary and is intended to merely illustratively illustrate preferred embodiments of the invention, presented in the course of providing what is believed to be the most useful and readily understandable explanation of the principles and conceptual aspects of the invention. In this regard, only those structural details of the invention necessary for a basic understanding of the invention are shown, but reading this specification together with the drawings will make it clear to those skilled in the art how various forms of the invention may be embodied in practice. Throughout the drawings, the same reference numerals are typically used to denote the same components. Subscripted reference numerals (e.g., 101) or letter-modified reference numerals (e.g., 100 A ) are used to distinguish between multiple aspects of a component in a single figure, e.g., 101 represents one aspect (of multiple aspects) of component 10, and 100 represents one aspect (of multiple aspects) of component 10. A 1 illustrates one embodiment (of multiple embodiments) of component 100.

[0022] An embodiment of the invention includes a device for use in pressure-related treatment applied to the body of a human user, particularly (but not limited to) one or more of the user's limbs, for use with a pressure regulator capable of increasing, decreasing, and / or maintaining gas pressure within a bag of which the device is a part, and / or exchanging gas within the bag. The bag is configured to surround the limb of the user, and other components of the device are arranged to form a gas flow path to the treatment site, which flow path is capable of functioning even when pressure within the bag is reduced.

[0023] Further embodiments of the present invention include methods and systems for administering a gas and pressure treatment protocol to one or more of a person's limbs. According to embodiments, the protocol synergistically combines three types of treatments to achieve optimal results: variable pressure treatments (i.e., treatments with pressure that can be applied externally with varying magnitude and / or location) to remove edema, treatments with negative pressure (vacuum) to remove edema and other waste products and improve blood flow to the wound, and treatments using therapeutic gases. As used herein, the term "therapeutic gas" refers to gases including one or more of ozone, oxygen, and essential oils. Essential oils are substances often used for disinfection and improving immune system performance.

[0024] Reference is now made to the drawings, and in particular to Figure 1, which illustrates a schematic representation of a therapeutic device 100 in a non-limiting embodiment. The device includes a flexible bag 10. The flexible bag 10 is shown in a two-dimensional projection in Figure 1 in an initial, pre-use mode in an uncoupled state.

[0025] For clarity, the bag is characterized throughout this disclosure as having two opposing walls. However, some bags according to embodiments can be made to have a single "endless" wall, e.g., a continuous polymer sheet closed or sealed at one end and open at the other end. Such a bag, when flattened, still has two opposing walls, or in other words, two opposing "bag portions". The bags disclosed herein can be seamed or seamless. The bag (and / or the device comprising the bag) can be provided as a continuous roll. Alternatively or additionally, the bag (and / or the device comprising the bag) can be provided in an initial (pre-use) form with two sealed ends, where the first end is designated to be opened at the beginning of use. In some designs, the bag can be opened simply by separating the two opposing walls. In some other designs, the user may have to perform additional actions, such as tearing a sealing strip at the top of the bag. All these different aspects of bag design are within the scope of the present invention. Additionally, for clarity, all of the bags illustrated in the accompanying drawings are rectangular bags. However, it will be apparent to one skilled in the art that the embodiments can be implemented with bags of any shape suitable for the application. For example, a bag for a device to be used on a patient's hand may be oval (2D projection) or may have rounded corners.

[0026] The bag according to the embodiment is made of any suitable flexible material. Such a material is capable of maintaining positive and / or negative pressure for a given period of time (i.e., minutes or hours, but not necessarily days or weeks). Suitable materials of construction for low permeability and high flexibility bags include polymers such as various grades of polyethylene, polypropylene and polyvinyl chloride. Low permeability to molecules such as N2, CO2, O2 and O3 is a desirable property, as it allows the interior of the bag, once sealed to the attached limb, to be substantially isolated from the surrounding atmosphere for the duration of the treatment or a portion thereof. The material of construction can be selected for its compatibility with ozone gas, for example polyethylene. The maintenance of pressure generally depends on the permeability of the material(s) of construction of the bag, and in some cases on the thickness of the material. The term "maintaining" pressure as used herein should be understood to mean maintaining a set or specified pressure within 0.1% for one minute, or maintaining within 0.5%, or within 1%, or within 2%, or within 3%, or within 4%, or within 5% for one minute. Maintenance can also include making slight adjustments. For example, it can include making slight adjustments by a pressure regulator connected to the bag to reduce pressure fluctuations. "Positive" and "negative" pressure should be understood to mean pressures higher or lower than ambient pressure, respectively. For example, if ambient pressure is 760 mmHg (millimeters of mercury), 460 mmHg is referred to as negative pressure and 1,060 mmHg is referred to as positive pressure. Thus, negative or low pressure therapy is therapy performed at a pressure lower than ambient pressure. Negative pressure (i.e., pressure above 0 mmHg and lower than ambient pressure) can also be referred to herein as "partial vacuum", "partial evacuation", etc.

[0027] The device 100 of FIG. 1 further comprises a strip 50 and a connecting piece 20. The bag 10 shown in FIG. 1, as well as all other bags 10 shown in the accompanying drawings, is shown as being at least partially "transparent" so that the strip 50 inside can be "seen". Although it may be advantageous in operation that the bag 10 is at least partially transparent or at least translucent, it is not required in the embodiments disclosed herein. Thus, in some examples, the bag 10 is opaque. In some exemplary embodiments, the strip 50 is a multi-layer strip, i.e., a strip including two or more layers, as described below with reference to FIGS. 4B-4E. In some embodiments, the strip 50 is a gas-permeable strip including one or more layers, as described below with reference to FIGS. 4D and 4F. The strip 50 is attached to an inner surface of the bag 10, i.e., to a surface of the bag that is in direct fluid communication with the interior space of the bag. In some embodiments, this attachment includes applying an adhesive to bond (e.g., adhere) the strip 50 to the inner surface of the bag 10. In some embodiments, this attachment is achieved by heat welding strip 50 to the interior surface of bag 10 by a thermal process, such as, by way of non-limiting example, heat welding. In some embodiments, strip 50 can be integrally formed with bag 10, as shown, for example, in Figures 12A-12C.

[0028] The connecting piece 20 is for connecting a gas connection hose thereto, which is introduced to mediate between the pressure regulator and the bag. The connecting piece has an opening 25. The opening 25 allows the flow of gas between the pressure regulator and the interior of the bag, for example when the pressure increases or decreases. That is, the pressure in the bag is adjusted by connecting the pressure regulator to the connecting piece 20. In one embodiment, the opening 25 of the connecting piece is a simple hole, in another embodiment, the opening 25 is one side of a male-female connecting piece or any other type of connecting piece that fits a gas connection hose suitable for use with a pressure regulator. In one embodiment, further parts can be provided between the bag and the pressure regulator. Such parts are, for example, a container for collecting the effluent(s), a biofilter, and one or more check valves, as shown in FIG. 21, provided on the "apparatus" side of the connecting piece 20.

[0029] The directions "distal" and "proximal" are respectively indicated by arrows 210 in FIG. 1. Proximal end 12 of bag 10 is the portion or end through which a user's limb can be inserted, and distal end 13 is the opposite end. Connection piece 20 is attached to the wall of bag 10 near the distal portion or distal end 13. The distal end of strip 50 is in direct fluid communication with connection piece 20 (including, in particular, opening 25), and the proximal end of strip 50 is disposed in the proximal portion of bag 10. The proximal portion of bag 10 thus occupies 50%, or 40%, or 30%, or 25%, or 20%, or less of bag 10. Thus, in one embodiment, the length of strip 50 (its longitudinal dimension, denoted L in FIG. 4A ) is the length of bag 10. STRIP 1) is equal to at least 50%, or at least 60%, or at least 70%, or at least 75%, or at least 80%, or at least 85%, or at least 90%, or at least 95% of the length of the bag 10. The length of the bag 10 is shown as L BAG The length L BAGmay be the maximum dimension of the bag 10 as shown in FIG. 1, but this may not be true in all embodiments. Thus, the length L BAG can be considered as the distance from the proximal end 12 to the distal end 13 of the bag 10.

[0030] In certain embodiments, it may be desirable to "space" the connection piece 20 so that it does not come into contact with the user's body, e.g., to avoid potential discomfort. FIG. 2 shows a non-limiting example of a device 100 comprising a bag 10 having a distal extension in the form of a tab 15. The tab 15 is open to the interior space of the remainder of the bag 10. In the example of FIG. 2, the connection piece 20 is attached to the inner wall of the bag within the tab portion 15, which reduces the chance of the user's body coming into direct contact with the connection piece 20. To provide a particularly effective prevention of direct contact with the user by the tab portion 15, the tab portion 15 is preferably narrower than the remainder of the bag 10, e.g., the width of the tab portion 15 (W in FIG. 2) is preferably less than the width of the remainder of the bag 10, e.g., the width of the tab portion 15 (W TAB ) is the width (W BAG In one embodiment, W TAB is W BAG In one embodiment, the length of the tab 15 (L in FIG. 2) is less than 25%, or less than 20%, or less than 15%, or less than 10% of the length of the tab 15. TAB (denoted as L BAG (the total length of the bag 10 including the tab portion 15 shown in FIG. 2) is less than 25%.

[0031] FIG. 3 shows the device 100 connected directly to a pressure regulator 70 by a gas connection hose 72. In some embodiments, this connection is not a direct connection. In some embodiments, the hose 72 can have gas switching capabilities and / or multiple inlet and outlet connections. In some embodiments, the hose 72 is part of the pressure regulator 70 or is permanently attached to the pressure regulator 70, while in other embodiments it is a separate element. The pressure regulator 70 can be any device suitable for applying and / or maintaining a pressure above or below ambient pressure, for example, any device suitable for providing therapy to a user's limbs or torso. Examples of suitable pressure regulators include, but are not limited to, negative pressure therapy devices, ozone therapy devices, sequential pressure therapy devices, and devices that combine two or more of these therapies.

[0032] In some embodiments, the pressure regulator (70 or 550) is programmed to assume an ambient pressure of 760 mmHg. In some embodiments, the pressure regulator is programmed to be preset to a predetermined ambient pressure (e.g., at or near a typical ambient pressure for elevating the user's position). In some embodiments, the pressure regulator measures and uses the ambient pressure before or during a treatment session, during device setup, or at any other time. In some embodiments, the pressure regulator is configured to increase or decrease the pressure in the container by a preset amount. In some embodiments, the pressure regulator is configured to increase or decrease the pressure to cause the pressure in the container to reach a preset or precalculated pressure. In any of the disclosed embodiments, the pressure regulator can combine any of the features and configurations described above.

[0033] Reference is now made to Figures 4A-4F.

[0034] 4A is a top view of a strip 50 according to an embodiment. The strip 50 has a length L STRIP A certain width W STRIPIn one embodiment, the length L STRIP is the width W STRIP In one embodiment, L is at least 3 times longer, or at least 5 times longer, or at least 10 times longer. STRIP :W STRIP The ratio is 3:1 to 5:1, or 3:1 to 10:1, or 3:1 to 20:1, or 3:1 to 30:1, or 5:1 to 10:1, or 5:1 to 20:1, or 5:1 to 30:1, or 10:1 to 20:1, or 10:1 to 30:1, or 20:1 to 30:1.

[0035] In the embodiment, the length L STRIP is at least 10 cm, or at least 15 cm, or at least 20 cm, or at least 25 cm, or at least 30 cm. STRIP In one embodiment, the width W STRIP is 1 cm to 2 cm, or 1 cm to 3 cm, or 1 cm to 4 cm, or 1 cm to 5 cm, or 2 cm to 3 cm, or 2 cm to 4 cm, or 2 cm to 5 cm, or 2 cm to 6 cm, or 3 cm to 4 cm, or 3 cm to 5 cm, or 3 cm to 6 cm, or 4 cm to 5 cm, or 4 cm to 6 cm, or 5 cm to 6 cm. All ranges given throughout this specification are inclusive. In an embodiment, the area (i.e., length L STRIP Width W STRIP multiplied by the area of ​​the bag 10 (i.e., the length L BAG Width W BAG In certain embodiments, the area of ​​the strip is less than 20%, or less than 15%, or less than 10%, or less than 5% of the area of ​​the bag.

[0036] 4B-4F are schematic diagrams showing cross-sections of various strips 50 according to embodiments, each taken along line AA in FIG. 4A. The strip 501 shown in FIG. 4B has a bottom layer 60, a middle layer 57, and a top layer 55. The top layer 55 comprises a partially compressible gas-permeable material. In one embodiment, the bottom layer 60 is an adhesive layer. In another embodiment, the bottom layer 60 comprises a fabric that can be attached to the wall of the bag by heat (e.g., heat welding). In one embodiment, the middle layer 57 comprises a fine woven or non-woven fabric, and the top layer 55 comprises one of an open woven fabric, a loop fabric, or a felt. As shown in FIG. 4C, the top layer 55 has a thickness T UL and the strip 50 has a total thickness T STRIP In one embodiment, the strip 50 has a total thickness T STRIP is 3.5 mm or less, or 5 mm or less, or 7.5 mm or less, or 10 mm or less. In some embodiments, the thickness of top layer 55 is 3.5 mm or less, or 5 mm or less, or 7.5 mm or less, or 10 mm or less. In some embodiments, it may be desirable for strip 50 to be rather "soft" so that a user does not experience undue discomfort when a user's limb rests, for example, on a portion of strip 50. In some embodiments, strip 50 has a Shore A hardness of 70 or less, or 60 or less, or 50 or less, or 40 or less. In some embodiments, gas permeable top layer 55 has a Shore A hardness of 70 or less, or 60 or less, or 50 or less, or 40 or less.

[0037] Strip 50 has a dimensionless aspect ratio T STRIP / W STRIP In an embodiment, T STRIP / W STRIP In one embodiment, the ratio of T STRIP / W STRIPis 1:1.5 to 1:5, or 1:1.5 to 1:10, or 1:1.5 to 1:15, or 1:1.5 to 1:20, or 1:1.5 to 1:30, or 1:5 to 1:10, or 1:5 to 1:12, or 1:5 to 1:20, or 1:1.5 to 1:30, or 1:8 to 1:15, or 1:8 to 1:20, or 1:8 to 1:30, or 1:10 to 1:15, or 1:10 to 1:20, or 1:10 to 1:30, or 1:12 to 1:20, or 1:12 to 1:30, or 1:15 to 1:20, or 1:15 to 1:30, or 1:20 to 1:30.

[0038] The top layer 55 has a dimensionless aspect ratio T UL / W STRIP In one embodiment, T UL / W STRIP In one embodiment, the ratio of T UL / W STRIP is 1:1.5 to 1:5, or 1:1.5 to 1:10, or 1:1.5 to 1:15, or 1:1.5 to 1:20, or 1:1.5 to 1:30, or 1:5 to 1:10, or 1:5 to 1:12, or 1:5 to 1:20, or 1:1.5 to 1:30, or 1:8 to 1:15, or 1:8 to 1:20, or 1:8 to 1:30, or 1:10 to 1:15, or 1:10 to 1:20, or 1:10 to 1:30, or 1:12 to 1:20, or 1:12 to 1:30, or 1:15 to 1:20, or 1:15 to 1:30, or 1:20 to 1:30.

[0039] Strip 502 of Figure 4D has a partially compressible upper layer 55 and a lower layer 60 as described above. Strip 503 of Figure 4E has a partially compressible upper layer 55, a lower layer 60, and a top layer 58 (e.g., a coating applied to upper layer 55). Strip 504 of Figure 4F has a partially compressible gas permeable layer 55, which in some embodiments is attached to the wall of the bag, for example by adhesive or heat.

[0040] 5A and 5B show details of the device 100, illustrating the flow of gas into and out of the bag 10 via the connecting piece 20. In FIG. 5A, the connecting piece 20 is attached to the wall 11B of the bag 10, and the strip 50 is attached to the first wall 11B of the bag 10. B The second wall 11 A 5A , i.e., the strip 50 is separated from the connecting piece 20 by the interior space 12 of the bag 10. The interior space 12 may not be an actual space in the initial state when the device 100 is first manufactured or provided. However, once the device 100 is ready for use, the interior space 12 must be formed in the bag 10 to accommodate, for example, a user's limb for treatment. Thus, in the initial state, the strip 50 and the connecting piece 20 of FIG. 5A are spaced apart by the opposing walls 11 and 12 of the bag 10. A and 11 B As shown in the embodiment of FIG. 5A, the bottom layer 60 is disposed on the wall 11 of the bag 10. A The term "lower layer" should therefore be construed to mean the layer closest to the wall of the bag to which it is attached, and the term "upper layer" should therefore be construed to mean the layer further from the wall to which the strip is attached than the lower layer. In the embodiment of FIG. 5A, the connection piece 20 is in direct fluid communication with the upper layer 55 of the strip 50. The flow of gas between the pressure regulator (not shown in FIGS. 5A-5B) and the interior space 12 of the bag 10 is indicated by arrows 201. The direction of the arrows 201 in FIGS. 5A and 5B is not intended to be directional, but is merely exemplary. Gas can flow in either direction (i.e., both into and out of the bag 10) in response to an increase or decrease in pressure within the bag 10. In the embodiment of FIG. 5B, the connection piece 20 is in direct fluid communication with the same wall 11 to which the strip 50 is attached. BTo establish fluid communication between the connection piece 20 and the gas permeable upper layer 55, the lower layer 60 must be at least partially open to gas flow (e.g., if the lower layer 60 comprises a gas permeable material and / or a porous or discontinuous material).

[0041] Reference is now made to Figures 6-9A, which are schematic diagrams of the gas flow paths in strip 50, respectively. In Figures 6-9, flow arrows 201, 203, and 205 are all drawn as if to show only the inflow of gas into the bag. However, as was the case for Figures 5A and 5B, device 100 is configured to allow gas to flow in either direction (i.e., both into and out of bag 10) in response to an increase or decrease in pressure within bag 10. Figure 6 shows a portion of strip 50, which has only a gas-permeable top layer 55, similar to the example of strip 504 shown in Figure 4F. Gas flow 201 as shown is coming from "below" (i.e., from the direction of connecting piece 20 attached to the same wall 11 to which strip 50 is attached (as in the example of Figure 5B)). If the gas-permeable layer 55 is attached to the wall 11 of the bag 10 by adhesive or heat, such attachment is made by a non-continuous adhesive application (not shown) or by a non-continuous heat seal in such a way that gas flow 201 is still possible. The gas flow propagates along the length of the strip (arrow 203) and can "exit" the strip 50 through the top surface (i.e. through the surface furthest from the wall 11 of the bag 10 to which the strip 50 is attached, as shown by arrow 205). In one use case, the bag 10 is partially evacuated. By this evacuation, gas in the interior space 12 of the bag 10 is removed through the connecting piece 20 and the two walls 11 of the bag 10 are drawn together by a "negative pressure". "Partially evacuated" means that the gas pressure in the bag is reduced to 560 mmHg or below 560 mmHg or to 660 mmHg or below 660 mmHg. The strip 50 (which is at most partially compressible) maintains the gas flow path. This gas flow path exists from connection piece 20 (e.g., where arrow 201 indicates the "entry" into strip 50) to any location on the top surface of the strip (e.g., the location where pressure-related therapy is to be administered). As previously noted, the gas flow path is not directional.The term "maintaining a gas flow path" and other similar terms mean open for gas flow therethrough, where the gas flow is appropriate for the treatment or other purpose in question. In a non-limiting exemplary embodiment relating to negative pressure wound treatment, the bag is partially evacuated to an absolute gas pressure of 560 mmHg, removing all air from the bag except for air remaining in the gas flow path (i.e., air remaining in the gas permeable strip or layer or material), and "maintaining" the gas flow path (i.e., there is sufficient gas flow to transmit negative pressure from the connection piece to, for example, the wound in fluid communication with the gas permeable material).

[0042] 7 also shows another strip 50, similar to the strip 50 of FIG. 5B, with the gas flow path (arrows 201) through the bottom layer 60 (e.g., through holes and / or areas of discontinuous thermal bonding or adhesion). In a non-limiting example, the bottom layer 60 has been removed from the area of ​​the strip 50 located directly above the opening 25 of the connection piece 20. FIG. 8 shows the gas flow path in another exemplary strip 50, similar to the strip 50 of FIG. 5A, with the gas permeable top layer 55 attached to the wall opposite the wall to which the connection piece is attached and in direct fluid communication with the connection piece 20. The strip 50 of FIG. 9A is similar to the strip 503 of FIG. 4E, where an at least partially gas permeable top layer (or coating) 58 is disposed between the gas permeable top layer 55 and the interior 12 of the bag 10.

[0043] In all of the embodiments of Figures 6-9A, the construction of device 100 and the selection of materials of construction are such that gas flow paths can be maintained across gas permeable upper layer 55 (e.g., flow paths (in any direction) as indicated by arrows 201, 203, 205) over a wide range of pressures for pressure-related treatments. A suitable gas flow path is one that is appropriate for the flow of gas required for pressure-related treatment. For example, a pressure regulation mode of device 100 may include achieving and / or maintaining a pressure within bag 10 within the range of 460 mmHg to 1060 mmHg, or within the range of 460 mmHg (i.e., "negative" 300 mmHg) to 760 mmHg, or within the range of 560 mmHg to 760 mmHg, or within the range of 760 mmHg to 1060 mmHg (i.e., positive 300 mmHg), or within the range of 760 mmHg to 960 mmHg. In embodiments, the material(s) of gas permeable top layer 55 are desirably selected so that top layer 55 (and strip 50 as a whole) is at most partially compressible (i.e., not fully compressible), since being fully compressible would result in the gas flow paths being closed in one or more places, or entirely, by a "negative" pressure (i.e., evacuating bag 10).

[0044] 9B shows the strip 50 of FIG. 9A with pressure (e.g., mechanical pressure) applied to it from the outside (indicated by arrows 206 in FIG. 9B). This pressure is applied from the outside of the bag 10, e.g., against the bag wall 11 of FIG. 5A. B9B, all other pressures disclosed herein are gas pressures. Furthermore, any pressures set forth in this disclosure or the appended claims that are at least 460 mmHg are "absolute" pressures, even if not expressly stated as such, whereas pressures that are 100 mmHg or less are "gauge" pressures, even if not expressly stated as such. The pressure is transmitted through the bag wall 11 (not shown in FIG. 9B) to the top layer 58 of the strip, causing compression of the gas-permeable layer 55. In some embodiments, compression of the gas-permeable layer 55 by the externally applied pressure 206 is in addition to compression caused by negative (below ambient) pressure (i.e., partial evacuation of the bag 10), e.g., in a pressure regulation mode. Another type of mechanical pressure that can be applied to the gas permeable layer 55 is the force of two opposing walls of the bag under negative pressure, as described below with reference to Figures 22A-22C.

[0045] 9B embodiment, the construction of device 100 and the materials of construction are selected such that gas flow paths can be maintained across gas permeable upper layer 55 (e.g., flow paths (in any direction) indicated by arrows 201, 203, 205) within a wide range of externally applied pressures for pressure-related treatments. Suitable gas flow paths are those appropriate for the flow of gas required for pressure-related treatments. For example, the pressure regulation mode of the device 100 may include applying pressure 206 from the outside to achieve and / or maintain a pressure transmitted to the gas permeable layer through the bag wall 11 and top layer 58 (if present) within the range of 0 mmHg to 20 mmHg, or 0 mmHg to 30 mmHg, or 0 mmHg to 40 mmHg, or 0 mmHg to 50 mmHg, or 0 mmHg to 60 mmHg, or 0 mmHg to 70 mmHg, or 0 mmHg to 80 mmHg, or 0 mmHg to 90 mmHg, or 0 mmHg to 100 mmHg.

[0046] The partially compressible gas permeable top layer 55 is in an uncompressed state as shown in FIG. 10A and in a partially compressed state as shown in FIG. 10B. The thickness of the top layer 55 is reduced by the partial compression to T UL From T UL-PC The partial compression is due to a compressive force (e.g., due to partial venting of bag 10 by a pressure regulator (e.g., pressure regulator 70 of FIG. 3). The bidirectional gas flow indicated by arrows 201, 203, and 205 continues to provide an effective gas flow path in the partially compressed state of FIG. 10B.

[0047] Reference is now made to Figures 11A-11F, which show photographs of six exemplary partially compressible gas permeable top layers 55 according to certain embodiments.

[0048] The partially compressible gas permeable top layer 55 in FIG. 11A is constructed from a felt fabric.

[0049] The partially compressible gas permeable top layer 55 in FIG. 11B is constructed from French terry fabric.

[0050] The partially compressible gas permeable top layer 55 in Figure 11C is constructed from nylon loop fabric, and the foreground of the photograph shows a base fabric layer (e.g., middle layer 57 in Figures 4B-4C).

[0051] The partially compressible gas permeable top layer 55 in FIG. 11D is constructed from cotton terry fabric.

[0052] The partially compressible gas permeable top layer 55 in FIG. 11E is constructed from a polyurethane foam sheet.

[0053] The partially compressible gas permeable top layer 55 of FIG. 11F is composed of a partially compressed mat of nonwoven synthetic fibers (eg, nylon or cellulose).

[0054] All six of the above non-limiting examples of materials suitable for gas permeable top layer 55 are capable of maintaining effective gas flow paths when partially compressed, for example, as shown in FIG. 10B.

[0055] Reference is now made to Figures 12A, 12B and 12C, which show schematic diagrams of an exemplary device 100 according to one embodiment. Device 100 has a strip 505 integrally formed with the wall of bag 10. In the non-limiting example of Figures 12A-12C, strip 505 has a plurality of parallel ridges 48 separated by grooves 49. The ridges 48 may, but need not, be formed from the same material as the wall(s) of bag 10. Each of ridges 48 has a height H RAIL , a certain width W RAIL Meanwhile, each of the grooves 49 has a width W GROOVE The "height" of the streaks as described herein corresponds to the "thickness" of the strip as described elsewhere in this specification.

[0056] In the illustrated embodiment, the outermost striations are wider and taller than the remaining striations 48. In other embodiments, all striations are the same size and spaced the same, and in still other embodiments, many or all striations are different or spaced differently. The height and width can be selected based on what is needed to maintain a gas flow path of sufficient capacity and robustness in the longitudinal direction. For example, the striation height is preferably selected not to be too short and / or too closely spaced, which may result in insufficient gas flow or when the bag is partially evacuated, the walls of the bag may collapse and all gas flow may have to pass through the grooves. Conversely, the striation height is preferably selected not to be too long, which may result in the striations being bent by the force of the collapsing walls when the bag is partially evacuated, depending, for example, on the striation material selection and striation width. The spacing between adjacent striations, i.e. W GROOVEis preferably selected not to be too wide so that the walls of the bag are less likely to fold into the grooves if they collapse when the bag is partially evacuated.

[0057] In one embodiment, the height H of each of the stripes RAIL is 1mm to 3mm, 1mm to 4mm, or 1mm to 5mm, or 2mm to 3mm, or 2mm to 4mm, or 2mm to 5mm.

[0058] In some embodiments, the integrally formed strips 505 can have configurations other than straight ridges 48 and grooves 49. In one embodiment (not shown), a plurality of protrusions form gas flow paths that are at most partially compressible when the bag 10 is partially evacuated (e.g., 100 mmHg below ambient).

[0059] The integrally formed strip 505 of Figures 12A-12C has many characteristics in common with strip 50 of Figures 1, 2, and 3, for example, including, but not limited to, length and ratios, width and ratios, area and ratios, location in the bag or tab extension, and function as a gas flow passage.

[0060] In embodiments, it may be desirable to size device 100 for a particular type of adult anatomy. The schematic diagram of FIG. 13 shows four examples of an adaptively sized device 100, each of which may be worn in four locations on a human user's anatomy 90. Clockwise from the left, device 100 ARM The device 100 is sized for easy and convenient use on an adult arm. HAND The device 100 is sized for easy and convenient use by an adult hand. LEG The device 100 is sized for easy and convenient use on an adult's leg. FOOTis sized for easy and convenient use on an adult's foot. In some embodiments, the devices dedicated to each limb can be sized to accommodate at least a majority of the particular limb, or most of the limb, or all of the limb up to the joint (e.g., up to the wrist for a hand device, up to the shoulder for an arm device, etc.). None of these devices may have tab extensions 15 (device 100). HAND and device 100 FOOT 1), or may have a tab extension 15 (as shown in the case of device 100 ARM and device 100 LEG In each embodiment, the connection piece 20 is preferably positioned so as not to cause discomfort against the user's limb. In one embodiment, a limb sealing member 30 (e.g., an adhesive tape) can be provided, which seals between the limb and the periphery of the open proximal end of the bag 10.

[0061] 14, 15 and 16 show non-limiting examples of devices 100 for use on the torso of a user, or on at least two limbs (e.g., both legs), or on a portion of the torso including at least two limbs. FIG. 14 shows a device 100 with a single simple strip 50 and a single connecting piece. FIG. 15 shows another configuration of a device 100 with a single but multiple strip 50, where a single connecting piece 20 is in fluid communication with two branches of the strip 50. FIG. 16 shows another configuration of one device 100. This configuration includes two separate connecting pieces 20, which are laterally spaced apart from each other at the distal portion of the bag 10. This configuration also includes two strips 50, each in fluid communication with a corresponding connecting piece 20. Those skilled in the art should understand that the alternative configurations shown in FIGS. 15 and 16 can be easily modified into the conventional device 100. That is, the size of the device can be changed to suit the individual limbs (eg, the exemplary devices of Figs. 1-3 and 13) rather than to suit the torso.

[0062] As previously described herein, the strip 50 is preferably sufficiently "soft" so as not to cause discomfort to the user. Nevertheless, it may be more comfortable for the user to have the strip 50 not come into direct contact with a sensitive area (e.g., a wound). Additionally or alternatively, in some embodiments, it may be inconvenient to position the connection piece 20 against the user's wound to keep the strip straight. It may therefore be desirable to have the gas flow path provided by the strip 50 extend laterally around the leg. Thus, as shown in FIG. 17, an elastic ribbon 32 of gas flow path material is provided and placed on the limb (i.e. extending laterally from the strip and placed around the limb) as a lateral extension of the gas flow path. In some embodiments, a sponge 31 or similarly soft member is provided to be inserted between the wound and the strip 50, or between the wound and the elastic ribbon 32.

[0063] Any of the features described herein for the various devices and their respective components may be combined to create new combinations, which are within the scope of the present invention even if, for the sake of brevity, they are not specifically disclosed herein.

[0064] 18 shows a kit 300. The kit 300 includes an elastic ribbon 32 and a wound dressing sponge 31, along with a device 100 according to any one or more of the embodiments disclosed herein.

[0065] 19 illustrates a kit 310. The kit 310 includes an appendage sealing tape 30 along with a device 100 according to any one or more of the embodiments disclosed herein.

[0066] 20 illustrates a kit 320. The kit 320 includes an elastic ribbon 32, a wound dressing sponge 31, and an appendage sealing tape 30, along with a device 100 according to any one or more of the embodiments disclosed herein.

[0067] 21 illustrates a kit 340. The kit 340 includes a device 100 according to any one or more of the embodiments disclosed herein, along with a resiliently compressible member (e.g., an open-cell foam or sponge 31), a collection canister 43 (e.g., for exudate fluid), a biofilter 42, and one or more check valves 41. The kit 340 is in communication with a pressure regulator 550, as shown diagrammatically.

[0068] An embodiment of the present invention relates to a system for performing a treatment protocol. In an embodiment, the system comprises a gas delivery device comprising a negative pressure pump operable to reduce pressure to at least 50, 75, 100, 150 or 200 mmHg below ambient pressure, a supply of treatment gas, and / or a compressor operable to increase the pressure of the gas to at least 40, 70, 100, 130 or 160 mmHg. The system may further comprise one or more closed-end containers. Such containers may be, for example, wearable disposable bags. The bags have gas flow paths therein that are effectively maintained under the negative pressure of the treatment protocol and / or externally applied pressure. The system may further comprise a wound sponge for communicating the negative pressure to a target site such as a wound, and, if necessary, an additional gas flow path member for ensuring a continuous gas flow path to or from the wound at one end of the flow path and a connection to the gas delivery device at the other end. The system may further comprise a reusable compression sleeve sized to partially surround the closed ended container housing each limb(s), the compression sleeve being usable for repeated compression up to 60 mmHg, up to 80 mmHg, or up to 100 mmHg above ambient.

[0069] An exemplary treatment protocol according to one embodiment includes a first phase of variable compression therapy in the presence of a treatment gas.

[0070] Another exemplary treatment protocol has a second phase of additional gas treatment with negative pressure (ie, pressure below ambient or atmospheric pressure).

[0071] More typically, such an exemplary treatment protocol includes both a first phase of variable compression treatment in the presence of gas (e.g., therapeutic gas) and a second phase of additional gas treatment with negative pressure.

[0072] In one embodiment, treatment begins with clearing edema from the wound site to improve blood flow to the injured tissue, and clearing the wound of edema and any other waste in the presence of therapeutic gas. After clearing and initial disinfection, negative pressure (partial vacuum) allows the therapeutic gas to reach the injured tissue directly.

[0073] A first non-limiting example of a treatment protocol includes the following steps:

[0074] a. Place an elastically compressible member 31 (eg, a wound sponge comprising open cell foam) at the target site (eg, a wound on an extremity).

[0075] b. Insert the appendage into a first container (eg, bag 10 with gas flow strip 50) and close the top (proximal) opening.

[0076] c. Use pressure regulator 550 to vent some of the gas 14 from bag 10. In one embodiment, vent as much gas as practical, checking the seal while venting.

[0077] d. A second container (eg, sequential compression sleeve 200) is applied to surround the first container 100 (this step may be performed earlier, eg, before partially evacuating the first container).

[0078] e. A therapeutic gas (eg, a gas containing ozone) is generated in a mixture with oxygen, for example, by introducing a source of oxygen into an ozone generator.

[0079] f. Introduce therapeutic gas 14 into first container 100. The gas, which does not necessarily have to be a therapeutic gas, is introduced in a volume between 0.3 liters and 10 liters and / or 5% to 60% of the maximum volume of first container 100.

[0080] g. Sequential compression sleeve 200 applies pressure to bag 10. The pressure, for example, forces (therapeutic) gas to flow longitudinally through strip 50. This procedure may continue for at least 3 minutes and up to 120 minutes, or at least 5 minutes and up to 90 minutes, or at least 7 minutes and up to 75 minutes, or any intermediate range.

[0081] h. A portion of the (therapeutic) gas 14 is evacuated from the bag 100, reducing the pressure within the bag 100 to a first low pressure, e.g., 60-100 mmHg (gauge pressure) below ambient. The level of vacuum is sufficient to at least partially collapse the resiliently compressible member 31 as shown in FIG. 22B.

[0082] i. Remove the second container (sequential compression sleeve 200).

[0083] j. Introduce a second amount of gas (e.g., a second amount of therapeutic gas) into the bag 10 and reduce the vacuum level (increasing the internal pressure of the bag 10) by 40-88 mmHg (gauge pressure) to a second pressure below ambient. This can be done once or intermittently.

[0084] k. The vacuum is held in the bag 100 for at least 3 minutes, or at least 5 minutes, or at least 7 minutes, or more.

[0085] l. The vacuum can be cycled between a first range of pressure below ambient and a second range of pressure below ambient.

[0086] Reference is now made to Figures 22A, 22B and 22C.

[0087] 22A is a partial schematic cross-section showing an appendage 90 (e.g., a leg) placed in the interior space 12 of the bag 10 (of an embodiment of the device 100). The gas flow path includes two parts: a first part consisting of a gas flow path strip 50, and a second part consisting of an elastically compressible member 31 (e.g., a wound sponge 31 consisting of open-cell foam). The elastically compressible member 31 is in fluid communication (directly in the illustrated embodiment) with a target site 95 (e.g., a wound) of the appendage 90, and the first part (strip 50) is in fluid communication with the connecting piece 20. The second part is preferably thicker but more compressible than the first part. For example, at the above mentioned vacuum levels (up to 100 mmHg gauge pressure below ambient), the second portion retains less than 80%, or less than 70%, or less than 60%, or less than 50% of its original thickness T311, while the first portion retains at least 80%, or at least 90%, or at least 95% of its original thickness T501.

[0088] FIG. 22B illustrates partial evacuation of bag 100. Partial evacuation is, for example, evacuation to a pressure up to 100 mmHg gauge below ambient (e.g., 60-100 mmHg gauge below). Partial evacuation is indicated by arrows 207 and 202. This partial evacuation is representative of step "h" in the embodiment described above. A vacuum is applied to walls 11 of bag 10. A , 11 B This causes the arrow 209 A , 209 B The second part, i.e., sponge 31, is subjected to these forces 209 A and 209 B The first portion, strip 50, is compressed by force 209 to a second thickness T312, which is at least 40% less than the original thickness T311. A and 209 B However, the compression is negligible (e.g., less than 5% of the original thickness T501).

[0089] FIG. 22C illustrates the introduction of gas (e.g., therapeutic gas) into bag 100. The introduction is indicated by arrows 203 and 208. This introduction of gas is representative of step "j" in the embodiment described above. The pressure within bag 100 may rise to 20-88 mmHg below ambient, and the gas flow passage may partially expand. In response, the pressure within bag 100 may rise to 20-88 mmHg below ambient, and the gas flow passage may partially expand, as indicated by arrows 209. A and 209 B Wall of contents 11, indicated by A and 11 B The force of the second portion 31 decreases. In particular, the second portion 31 is biased to expand when the vacuum is reduced or removed. This is shown in FIG. 22C, where the thickness of the second portion 31 increases to a third thickness T313, which is greater than T312 but still less than the original thickness T311. This is because even though the vacuum is reduced, the bag is still under a partial vacuum. According to an embodiment, when the ambient pressure is restored, the second portion 31 returns to its original thickness T311.

[0090] Reference is again made to FIG. 1, which illustrates a non-limiting example of a closed-ended container for use with a therapeutic device 100. The closed-ended container 100 includes a flexible bag 10. The flexible bag 10 is shown in a two-dimensional projection in FIG. 1 in an uncoupled state in an initial, pre-use mode. The bag 10 according to the embodiment is made from any suitable flexible material that is capable of maintaining positive and / or negative pressure for a given period of time (i.e., minutes or hours, but not necessarily days or weeks).

[0091] The material of construction of the bag 10 may be selected for its compatibility with ozone gas, and may be, for example, polyethylene. The maintenance of pressure generally depends on the permeability of the material(s) of construction of the bag, and in some cases on the thickness of the material. The term "maintaining" pressure as used herein should be understood to mean maintaining a set or specified pressure within 0.1% for one minute, or within 0.5%, or within 1%, or within 2%, or within 3%, or within 4%, or within 5%, or within 10%, or within 20%, or within 30% for one minute. Maintenance may also include making slight adjustments. For example, by a pressure regulator connected to the bag to reduce pressure fluctuations. "Positive" and "negative" pressures should be understood to mean pressures higher or lower than ambient pressure, respectively. For example, if ambient pressure is 760 mmHg (millimeters of mercury), 460 mmHg would be referred to as negative pressure and 1,060 mmHg would be referred to as positive pressure. Thus, negative pressure therapy is therapy that is performed at a pressure less than ambient pressure. Negative pressure (i.e., a pressure greater than 0 mmHg and less than ambient pressure) may also be referred to herein as a "partial vacuum" or the like.

[0092] The closed-ended container 100 shown in FIG. 1 further comprises a gas flow strip 50 and a connection piece 20. The bag 10 shown in FIG. 1 is shown as being at least partially "transparent" so that the strip 50 can be "seen" therein, but transparency is not required in the embodiments disclosed herein. The strip 50, in some embodiments, is a multi-layer strip, i.e., a strip that includes two or more layers (e.g., a gas flow path layer and one or more additional layers for attachment to the inner wall of the bag). The strip 50 is attached to the inner surface of the bag 10, i.e., to a bag surface that is in direct fluid communication with the interior space of the bag. In some embodiments, this attachment includes applying an adhesive to bond (e.g., adhere) the strip 50 to the inner surface of the bag 10. In some embodiments, this attachment is achieved by heat welding the strip 50 to the inner surface of the bag 10 by a heat-based process, such as heat welding, in a non-limiting example.

[0093] The connecting piece 20 is for connecting a gas connection hose thereto, which is introduced to mediate between the pressure regulator and the bag. The connecting piece has an opening 25. The opening 25 allows the flow of gas between the pressure regulator and the interior of the bag, for example when the pressure increases or decreases. That is to say, the pressure in the bag is adjusted by connecting the pressure regulator to the connecting piece 20. In one embodiment, the opening 25 in the connecting piece is a simple hole. In other embodiments, the opening 25 comprises one side of a male-female connecting piece, a valve that can be opened by connecting the correct gas hose to it, or any other type of connecting piece that fits a gas connection hose suitable for use with a pressure regulator.

[0094] The directions "distal" and "proximal" are respectively indicated by arrows 210 in FIG. 1. Proximal end 12 of bag 10 is the portion or end through which a user's limb can be inserted, and distal end 13 is the opposite end. Connection piece 20 is attached to the wall of bag 10 near the distal portion or distal end 13. The distal end of strip 50 is in direct fluid communication with connection piece 20 (including, in particular, opening 25), and the proximal end of strip 50 is disposed in the proximal portion of bag 10. The proximal portion of bag 10 thus occupies 50%, or 40%, or 30%, or 25%, or 20%, or less of bag 10. Thus, in one embodiment, the length of strip 50 (its longitudinal dimension, denoted L in FIG. 4A ) is the length of bag 10. STRIP 1) is equal to at least 50%, or at least 60%, or at least 70%, or at least 75%, or at least 80%, or at least 85%, or at least 90%, or at least 95% of the length of the bag 10. The length of the bag 10 is shown as L BAG The length L BAG may be the maximum dimension of the bag 10 as shown in FIG. 1, but this may not be true in all embodiments. Thus, the length L BAG can be considered as the distance from the proximal end 12 to the distal end 13 of the bag 10.

[0095] In some embodiments, it may be desirable to "space" the connection piece 20 so that it does not come into contact with the user's body, e.g., to avoid potential discomfort. FIG. 2 shows a non-limiting example of a device 100 including a bag 10 having a distal extension in the form of a tab 15. The tab 15 is open to the interior space of the remainder of the bag 10. In the example of FIG. 2, the connection piece 20 is attached to the inner wall of the bag within the tab portion 15, which minimizes the opportunity for the user's body to come into direct contact with the connection piece 20. To make use of the tab portion 15 particularly effective in preventing direct contact with the user's body, the tab portion 15 preferably has a narrower width than the remainder of the bag 10.

[0096] 5A is a schematic diagram of a cross-sectional detail of the container 100 showing the flow of gas into and out of the bag 10 through the connecting piece 20. The connecting piece 20 is attached to the wall 11B of the bag 10, and the strip 50 is attached to the first wall 11B of the bag 10. B The second wall 11 A 5A , i.e., the strip 50 is separated from the connecting piece 20 by the interior space 12 of the bag 10. The interior space 12 may not be an actual space in the initial state when the device 100 is first manufactured or provided. However, once the device 100 is ready for use, the interior space 12 must be formed in the bag 10, for example to accommodate a user's limb for treatment. Thus, in the initial state, the strip 50 and the connecting piece 20 of FIG. 5A are spaced apart by the opposing walls 11A and 11B. B 5A, the connecting piece 20 is in direct fluid communication with the top layer 55 of the strip 50 (i.e., the layer furthest from the wall 11 to which the strip 50 is attached). The flow of gas between the pressure regulator (not shown in FIG. 5A) and the interior space 12 of the bag 10 is indicated by arrows 201. The direction of the arrows 201 in FIGS. 5A and 5B is not intended to be directional, but is merely exemplary. Gas can flow in either direction (i.e., both into and out of the bag 10) in response to an increase or decrease in pressure within the bag 10.

[0097] Reference is now made to Figures 6 and 8, which are schematic diagrams of the gas flow paths in strip 50, respectively. In Figures 6 and 8, flow arrows 201, 203, and 205 are all drawn as if to indicate only the inflow of gas into bag 10. However, device 100 is typically configured to allow gas to flow in either direction (i.e., both into and out of bag 10) in response to an increase or decrease in pressure within bag 10.

[0098] FIG. 6 shows a portion of a gas flow path made up of a strip 50 including a gas permeable layer 55. As shown, gas flow 201 can enter the strip 50, propagate along the length of the strip (arrow 203), and "exit" the strip 50 through any side as indicated by arrow 205. In one use case, the bag 10 is partially evacuated. By this evacuation, gas in the interior space 12 of the bag 10 is removed through the connecting piece 20, and the two walls 11 of the bag 10 are drawn together by a "negative pressure". By "partially evacuated" is meant reducing the gas pressure in the bag to 560 mmHg or below 560 mmHg or to 660 mmHg or below 660 mmHg. The strip 50 (which may be at most partially compressible) maintains a gas flow path. This gas flow path exists from the connecting piece 20 (e.g., where the arrow 201 indicates the "entry" into the strip 50) to any location on the top surface of the strip (e.g., where a pressure-related treatment is performed). As previously mentioned, the gas flow path is not directional. The term "maintaining the gas flow path" and other similar terms means open for gas flow therethrough, where the gas flow is appropriate for the treatment or other purpose in question. In a non-limiting example for negative pressure wound treatment, the bag is partially evacuated to an absolute gas pressure of 560 mmHg, removing all air from the bag except for the air remaining in the gas flow path (i.e., air in the gas permeable strip or layer or material) to "maintain" the gas flow path (i.e., there is sufficient gas flow to transmit negative pressure from the connection piece to, for example, the wound in fluid communication with the gas permeable material). As shown in FIG. 8, the strip may have one or more layers 60, for example, for attachment to the wall 11 of the bag 10.

[0099] In the embodiment of Figures 6 and 8, the construction and materials of construction of container 100 are selected such that a gas flow path can be maintained across gas permeable layer 55 (e.g., flow paths (in any direction) as indicated by arrows 201, 203, 205) within a wide range of pressures for pressure-related treatments. A suitable gas flow path is one that is appropriate for the flow of gas required for pressure-related treatments. For example, a pressure regulation mode of device 100 may include achieving and / or maintaining a pressure within bag 10 within the range of 460 mmHg to 1060 mmHg, or within the range of 460 mmHg (i.e., "negative" 300 mmHg) to 760 mmHg, or within the range of 560 mmHg to 760 mmHg, or within the range of 760 mmHg to 1060 mmHg (i.e., positive 300 mmHg), or within the range of 760 mmHg to 960 mmHg. In certain embodiments, the material(s) of gas permeable layer 55 are desirably selected so that layer 55 (and strip 50 as a whole) is at most partially compressible (i.e., not fully compressible), since being fully compressible would cause the gas flow paths to close in one or more places, or even completely, upon application of "negative" pressure (i.e., evacuating bag 10).

[0100] 17 illustrates the deployment of the container 100 on the limb of a human subject 90 according to an embodiment. An appendage seal member 30 (e.g., an adhesive tape) is provided to seal between the limb and the periphery of the open proximal end of the bag 10. A gas flow path ribbon 32 (e.g., an at least partially elastic ribbon of gas flow path material) is provided and positioned as a lateral extension of the gas flow path (i.e., the portion extending laterally from the strip and extending around the limb). A sponge 31 or similarly soft member is inserted between the wound and the elastic ribbon 32, or alternatively between the wound and the strip 50.

[0101] Reference is now made to Figures 23 and 24. Figure 23 shows a non-limiting example of a system for performing a multi-pressure treatment protocol on a human subject according to an embodiment. The system includes a gas transfer device 550. The gas transfer device 550 has a first opening 51 and a second opening 52 for gas transfer therethrough. Figure 24 shows the arrangement of a first container 100 and a second container 200 attached to the limb of a subject 90. Figure 23 shows the arrangement of hoses and tubes, as well as the respective connection arrangements and positions of the hoses and tubes in the gas transfer device 550 and the first container 100. This is exemplary and in other embodiments the respective arrangements and positions will be different. In other embodiments (not shown), the connection piece 20 between the first container 100 and the gas transfer device 550 is provided only at the distal portion of the container 100, i.e., only at the distal end or distal extension 15 of the bag 10.

[0102] The first gas transfer section 501 has a first opening 51 for transferring gas therethrough. The first gas transfer section 501 is configured to i) regulate the pressure in a first container 100 disposed in fluid communication therewith over a range of 200 mmHg below ambient to 160 mmHg above ambient, and ii) allow a gas, such as a therapeutic gas 140, to flow through the first opening 51. The first container, in one embodiment, comprises a closed-ended bag 10 (e.g., one of the bags 10 shown in FIG. 1 or 2).

[0103] The second gas transfer section 502 has a second opening 52 for transferring gas therethrough. The second gas transfer section 502 is configured to regulate the pressure within the second container 200 disposed in fluid communication therewith over a range of pressures above ambient up to 100 mmHg above ambient. The preferred second container 200 is a compression sleeve having multiple gas pockets or compartments.

[0104] The system further comprises an electronic circuit 65. The electronic circuit 65 is programmed to operate in each one of the following modes, either sequentially or in parallel: For the purposes of this disclosure, the term "electronic circuit" is a term used broadly to describe any combination of hardware, software, and / or firmware. The electronic circuit may include any executable code module (i.e., stored on a computer-readable medium) and / or firmware and / or hardware element(s), including, but not limited to, Field Programmable Logic Array (FPLA) element(s), hardwired logic element(s), Field Programmable Gate Array (FPGA) element(s), and Application Specific Integrated Circuit (ASIC) element(s). Any instruction set architecture may be used, including, but not limited to, Reduced Instruction Set Computer (RISC) and / or Complex Instruction Set Computer (CISC) architectures. The electronic circuit may be located at a single location or distributed across multiple locations. At the multiple locations, the various circuit elements may be in wired or wireless electronic communication with each other.

[0105] In one embodiment, the pressure regulating device 550 can include any or all of the following components, but are not limited to: a power inlet with a switch fuse and an EMI filter, an ozone generator using high voltage corona discharge, a solid state relay for operating the ozone generator, a DC power supply, solenoid valves, a pressure pump, a vacuum pump, DC actuators for operating the pump and valves, a control module, a chemical ozone destroyer, and an internal silicone based gas hose.

[0106] In a first mode of the system, the first gas transfer unit 501 allows gas, such as therapeutic gas 140, to flow into the first container 100 through the first opening 51. This is done in response to an input that confirms that the first container 100 is in fluid communication with the first gas transfer unit 501 and that the first container 100 is positioned to surround at least a longitudinal portion 95 of the limb of the subject 90. In one embodiment, the input is a user input received by the gas transfer device 550 from a user (i.e., a human user). In another embodiment, the input is received by the gas transfer device 550 from a sensor (not shown), such as an imaging sensor or an electromechanical sensor (e.g., a pressure switch). In yet another embodiment, the input is received by a human user who visually checks the connection between the first container 100 and the first gas transfer unit 501.

[0107] In a second mode of the system, the second gas transfer portion 502 controls a respective gas pressure above ambient within the fluid-holding compartment 225 of the second container 200 such that the fluid-holding compartment 225 exerts a respective compressive pressure through the wall 11 of the first container 100 to a corresponding portion 98 of the limb 90. The control is through the second opening 52 while at least a portion of the gas 140 is present within the first container 100. The control causes a flow of the gas 140 ("induced flow", "indirect flow") through the portion 115 of the first container 100 that is surrounded by the second container 200. The portion 115 is within the area surrounded by the fluid-holding compartment 225. The control is responsive to an input. The input is an input that confirms that the second vessel 200 is in fluid communication with the second gas transfer portion 502 and that the second vessel 200 is positioned to surround at least a longitudinal portion 105 of the first vessel 100. In one embodiment, the input is a user input received by the gas transfer device 550 from a user (i.e., a human user). In another embodiment, the input is received by the gas transfer device 550 from a sensor (not shown), such as an imaging sensor or an electromechanical sensor (e.g., a pressure switch). In yet another embodiment, the input is received from a human user visually checking the connection between the second vessel 200 and the second gas transfer portion 502.

[0108] In a second non-limiting example of a treatment protocol, the system including electronic circuitry 65 and pressure regulator 550 has two main modes of operation that are performed sequentially and / or in parallel. The two modes of operation are (1) lymphatic massage and ozone disinfection, and (2) vacuum + ozone pulsing. For clarity, "ozone" or more appropriately ozone-containing gas is a non-limiting example of a treatment gas that may be used in accordance with this example.

[0109] According to this embodiment, the operation sequence includes the following six steps:

[0110] Perform a live test of the apparatus 100 with the first container 10. The apparatus 550 runs the vacuum pump until a negative pressure of approximately 100 mmHg gauge pressure below ambient is reached in the first container 10. Wait 10 seconds and then check the pressure. The apparatus 550 allows a pressure bleed of 15 mmHg negative pressure. If this value is exceeded the test fails.

[0111] b. Ozone filling: A first container is partially filled with a predetermined amount of ozone.

[0112] c. Lymphatic massage: With the first container 100 attached to the limb 90 and surrounded by the second container 200, the pressure pump and valve are operated to perform a peristaltic massage of the leg for a preset period of time.

[0113] d. Ozone Extraction: Operate the vacuum pump to extract ozone from the first vessel 100 and achieve a negative pressure of approximately 100 mmHg gauge pressure below ambient. The extracted ozone is destroyed (i.e., converted back to oxygen) by the ozone destroyer.

[0114] e. Vacuum Treatment: The vacuum pump is turned on again to achieve a negative pressure in the first container 100 of approximately 100 mmHg below ambient and this negative pressure is maintained for a predetermined period of time. Once the negative pressure is relieved, the vacuum pump is turned on again to achieve the required negative pressure. Ozone is again introduced into the first container 100 to a pressure of approximately 20 mmHg below ambient and maintained for a predetermined period of time. The cycle of evacuation and reintroduction of ozone is repeated until the predetermined treatment time is reached.

[0115] f. Ozone Extraction: Operate the vacuum pump to extract ozone from the first vessel 100, achieving a negative pressure of approximately 100 mmHg below ambient. The extracted ozone is destroyed (i.e., converted back to oxygen) by the ozone destroyer.

[0116] FIG. 25 shows another non-limiting example of a system for administering a multi-pressure treatment protocol to a human subject according to an embodiment. The device 100 is shown "in situ" with the components of the first container (bag) 10 surrounding the limb 90 of the human subject. The device 100 includes a connection piece 20 for connecting to a first opening 51 of a pressure regulator 550 via a gas hose 72. The gas flow path has a first portion including a gas flow path strip 50 and a second portion including a resiliently compressible member 31 in communication with a target site 95 (not shown) of the limb 90. The second container 200 includes four fluid compartments 2251, 2252, 2253, and 2254, which are connected to a second opening 52 of the pressure regulator 550 via gas hoses 2201, 2202, 2203, and 2204, respectively.

[0117] 26A, 26B, 26C, 26D, 26E and 26F show a sequence of exemplary operational modes of a system (e.g., the system shown in FIG. 25). Exemplary operational modes include "peristaltic massage" of the limb. "Peristaltic massage" of the limb is a sequential compression protocol that utilizes the expansion and contraction of four fluid compartments 2251, 2252, 2253 and 2254 to peristaltically distribute gas contained in the first container 10 in fluid communication with the target limb 90 (and optionally in fluid communication with the target portion 95 of the limb).

[0118] The appendage 90 is at least partially inserted into a first container 10 containing a quantity of gas 14 therein. In some embodiments, the first container 10 is provided with a gas flow path (e.g., including a gas flow path strip 50 and a resiliently compressible member 31). In such embodiments, when at least the first container 10 is partially evacuated, some, most or substantially all of the gas 14 may be contained within the space of the gas flow path, as in the example of Figures 26A-26F. A second container 200 with four fluid compartments 2251, 2252, 2253, and 2254 surrounds the first container 10 such that expansion of any one or more of the fluid compartments 2251, 2252, 2253, and 2254 exerts a force on the first container. This force is transmitted through the walls of the first container 10 to the appendage and / or components provided in the first container 10 (e.g., gas flow path portions 50 and 31).

[0119] In FIG. 26A, none of the fluid compartments 2251, 2252, 2253, and 2254 are inflated and the available gas 14 is routed into the first container 10 (e.g., into the gas flow path (not shown)) without action from the second container 200. In FIG. 26B, the first fluid compartment 2251 is inflated, which forces some of the gas 14 to flow proximally, as indicated by the small arrows. In FIG. 26C, the first compartment 2251 remains inflated and the second compartment 2252 is inflated, which forces more gas 14 to flow proximally. In FIG. 26D, the first compartment 2251 is deflated while the second compartment 2252 remains inflated and the third compartment 2253 is inflated, which forces some of the gas 14 to flow distally. In Fig. 26E, the second compartment 2252 also contracts while the third compartment 2253 remains inflated and the fourth compartment 2254 expands, allowing more gas 14 to flow distally. In Fig. 26F, the third compartment 2253 also contracts while the fourth compartment 2254 remains inflated, allowing more gas 14 to flow in the distal direction. As will be apparent to one skilled in the art, the next step in this sequence is to contract the fourth compartment 2254, returning to the conditions of Fig. 26A, and repeating the cycle as programmed. In some embodiments, the pressure from the inflation may vary from compartment to compartment and from cycle to cycle.

[0120] Reference is now made to Figures 27A, 27B, 27C, 27D and 27E.

[0121] A method according to an embodiment is disclosed for performing a multi-pressure treatment protocol on a limb 90 of a human subject using a gas delivery system 550 according to any of the embodiments disclosed herein. The exemplary gas delivery system 550 has a first opening 51 and a second opening 52 for transferring gas therethrough. The first opening 51 is in fluid communication with a first container 10, and the second opening 52 is in fluid communication with a second container 200. The second container 200 has a plurality of fluid holding compartments 225 that are openable to the gas delivery system 550. In an embodiment, one or both of the first container 10 and the second container 200 are flexible. As shown in the flow chart of FIG. 27A, the method includes at least steps S01 and S02.

[0122] Step S01: With the first container 10 surrounding at least a longitudinal portion 95 of the subject's limb 90, a flow of gas 140 is caused to flow through a first opening into the first container 10. In some embodiments, the gas comprises a therapeutic gas, which in such embodiments comprises at least one of ozone, oxygen, and essential oils.

[0123] Step S02: While at least a portion of the therapeutic gas 140 is present within the first container 10, and with the second container 200 surrounding at least a longitudinal portion 105 of the first container 10, adjust respective gas pressures above ambient in the fluid-holding compartments 225 of the second container 200 via the second openings 52 such that the fluid-holding compartments 225 apply respective compressive pressures to the corresponding portions 98 of the limb 90 via the wall 11 of the first container 10. In one embodiment, adjusting respective gas pressures above ambient in the fluid-holding compartments 225 includes repeating a sequence of differential pressure adjustments over a period of time defined by a treatment protocol. In one embodiment, adjusting respective gas pressures above ambient in the fluid-holding compartments 225 includes adjusting respective pressures between 20 and 100 mmHg above ambient. That is, the pressure within the inflated fluid-holding compartments 225 can be any pressure within a range of 20 to 100 mmHg gauge pressure above ambient, according to the user or clinical selection of the desired pressure.

[0124] According to this method, gas (e.g., therapeutic gas 140) is distributed across at least a portion 115 of a first container 10, which is surrounded by a second container 200 to the extent that "at least a portion 115" of the first container 10 is surrounded by a fluid-holding compartment 225, by adjusting the respective gas pressure above ambient. In one embodiment, adjusting the respective gas pressure above ambient in the fluid-holding compartment 225 includes repeating a sequence of differential pressure adjustments.

[0125] Without wishing to be bound by theory, the inventors believe that such flow results in a higher effective concentration of the therapeutic agent in the therapeutic gas adjacent to the wound. The inventors also believe that such flow increases the concentration differential driving force (mol / m 3 It is believed that the mass transfer rate is improved by increasing the mass transfer coefficient and the mass transfer rate.

[0126] In some embodiments, the flow of therapeutic gas 140 is at least partially through the flow paths 55 in the first container 10 (e.g., through gas flow paths in the gas flow path strip 50 or through tubing (not shown)). In some embodiments, the gas flow path strip is laterally open along its length to the interior space of the first container, allowing fluid within the first container to freely enter and exit the gas flow path strip.

[0127] In one embodiment, the method further includes the following steps before step S01, as shown in the flowchart of FIG. 27B.

[0128] Step S03: The first container 10 is evacuated (eg, evacuated through the first opening 51).

[0129] In one embodiment, the method further includes the following steps after step S02, as shown in the flowchart of FIG. 27C:

[0130] Step S04: With the first container 10 surrounding at least a portion 95 of the appendage 90, gas (e.g., therapeutic gas 140) is evacuated from the first container 10 through the first opening 51 to reduce the pressure within the first container 10 to a first subambient pressure. In some embodiments, the first subambient pressure is 10-50 mmHg below ambient pressure. In some embodiments, the pressure is maintained at the first subambient pressure for at least 3 minutes, at least 5 minutes, at least 10 minutes, or within a range of 3-90 minutes, 5-75 minutes, 10-60 minutes, or 15-60 minutes.

[0131] Step S05: Cause a flow of therapeutic gas 140 (the same or a different gas as in step S01) through the first opening 51 into the evacuated first container 10, increasing the pressure in the first container 10 to a second sub-ambient pressure. In one embodiment, the second sub-ambient pressure is 60-100 mmHg lower than ambient pressure.

[0132] In one embodiment, the difference between the first subambient pressure and the second subambient pressure is between 40 and 88 mmHg gauge pressure.

[0133] In one embodiment, the method further includes the following steps after step S05, as shown in the flowchart of FIG. 27D.

[0134] Step S06: Repeating a first subambient pressure and a second subambient pressure for a period of time defined by a treatment protocol. In some embodiments, the first and second subambient pressures may be different for each repetition. In some embodiments, the first and second subambient pressures are substantially the same for each repetition.

[0135] In one embodiment, the method further includes the following steps before step S01, as shown in the flowchart of FIG. 27E.

[0136] Step S07: Placing an elastically compressible member in contact with the target site on the limb. The elastically compressible member 31 can be comprised of a "wound sponge" or any open-cell foam. In some embodiments, venting gas from the first container (e.g., step S03 or step S04) is effective to at least partially compress the elastically compressible member 31. In some embodiments, causing a flow of gas through the first opening (e.g., step S01 or step S05) is effective to expand the at least partially compressed elastically compressible member. If step S07 is performed, introducing the therapeutic gas 140 in step S05 causes the foam to act like a spring, moving from a compressed state to a partially released state, allowing the therapeutic gas to be delivered to the site near the wound.

[0137] A method according to an embodiment is disclosed for administering hypobaric therapy to a human limb 90. As shown in the flow chart of Figure 27A, the method includes at least steps S11, S12, S13, and S14.

[0138] Step S11: Arrange the pressure regulator 550 and the bag assembly. The bag assembly includes the bag 10 and the gas flow path strip 50. The bag 10 includes a connection piece 20, which is attached to the wall 11 of the bag 10 at a distal portion of the bag 10. The gas flow path strip 50 is disposed within the bag 50 along a longitudinal direction between the connection piece 20 and a proximal portion of the bag. In accordance with the method, the strip 50 is laterally open to the interior space 12 of the bag 10 along its length. Thus, when the bag 10 is placed in a non-evacuated state, the fluid 14 within the bag 10 can freely flow into and out of the gas flow path strip. In an embodiment, the strip 50 is sufficiently incompressible to maintain a gas flow path therethrough even when the bag 10 is partially evacuated and the wall 11 of the bag 10 is collapsed. Thus, the gas flow path (which includes the strip 50 and may optionally include a resiliently compressible member 31 in fluid communication with both the strip 50 and the target site 95 (e.g., a wound) on the appendage 90) is maintained from the bag connection piece 20 to the desired site (e.g., target site 95). The strip may be formed according to any of the embodiments and examples disclosed herein.

[0139] Step S12: At least a part of the limb 90 is placed in the bag 10 through the opening in the proximal portion.

[0140] Step S13: Connect the pressure regulator 550 to the connection piece 20 to allow the flow of gas 140 between the pressure regulator 550 and the interior space 12 of the bag 10. In some embodiments, the supply of gas 14 (e.g., therapeutic gas) to the interior space 12 is at least partially through the gas flow strip 50. In some embodiments, the supply of gas 14 (e.g., therapeutic gas) to the interior space 12 is substantially entirely through the gas flow strip 50. In some embodiments, the strip 50 is integrally formed with the bag 10. In other embodiments, the strip 50 is separately formed and then attached to the wall 11 of the bag 10 (this is interchangeable with the integrally formed strip 505 and can be implemented with all of the devices, systems, and methods disclosed herein).

[0141] Step S14: The pressure regulator 550 is controlled to remove the gas 14 from the interior space 12 of the bag 10, thereby reducing the pressure in the interior space 12 to a first pressure that is lower than ambient.

[0142] In one embodiment, as shown in the flowchart of FIG. 28B, the method further includes the following steps:

[0143] Step S15: The pressure regulator 550 is further controlled to supply a quantity of gas 140 to the interior space 12, thereby increasing the pressure in the interior space 12 to a second pressure below ambient. In one embodiment, the gas flow path is maintained in the gas flow path strip 50 at both the first and second pressures below ambient.

[0144] In one embodiment, the first sub-ambient pressure is 10-50 mmHg below ambient pressure, hi one embodiment, the second sub-ambient pressure is 60-100 mmHg below ambient pressure.

[0145] In one embodiment, as shown in the flowchart of FIG. 28C, the method further includes the following steps before step S11:

[0146] Step S16: Placing a resiliently compressible member 31 in fluid communication with the gas flow path strip 50 and the target area 95 of the appendage 90. In one embodiment, the resiliently compressible member 31 is at least partially compressed at a first pressure below ambient, and biased to expand when the pressure is increased to a second pressure below ambient. In one embodiment, the resiliently compressible member 31 comprises open cell foam.

[0147] Further description of the embodiments An embodiment of the present invention relates to an apparatus for use with a pressure regulator in administering treatment to a human limb. According to an embodiment, the apparatus for use with a pressure regulator in administering treatment to a human limb includes: (a) a flexible bag configured to receive at least a portion of the limb through an opening in a proximal portion of the bag in a wear mode; (b) a multi-layer strip including a lower layer attached to an inner surface of the bag, the multi-layer strip having a distal end disposed at the distal portion of the bag and a proximal end disposed at the proximal portion of the bag; and (c) a connecting piece attached to a wall of the bag at the distal portion of the bag, the connecting piece effectively allowing gas flow between the pressure regulator and an interior space of the bag in a pressure regulation mode, the multi-layer strip further including an upper layer including a partially compressible material, the partially compressible material forming a gas flow path disposed longitudinally within the bag between the connecting piece and the proximal portion of the bag. In one embodiment, the longitudinal gas flow path can be maintained when the gas pressure within the bag is equal to or less than 660 mmHg. In one embodiment, the longitudinal gas flow path can be maintained when the gas pressure within the bag is 560 mmHg.

[0148] In one embodiment, the longitudinal gas flow path can be maintained when a mechanical pressure of 20 mmHg gauge pressure is applied to the bag from the outside and transmitted through the wall of the bag to the top layer of the multi-layer strip. In one embodiment, the longitudinal gas flow path can be maintained when a mechanical pressure of 60 mmHg gauge pressure is applied to the bag from the outside and transmitted through the wall of the bag to the top layer of the multi-layer strip.

[0149] In some embodiments, the Shore A hardness of the multi-layer strip can be 70 or less, or 60 or less, or 50 or less, or 40 or less. In some embodiments, the Shore A hardness of the top layer of the strip can be 70 or less, or 60 or less, or 50 or less, or 40 or less. In some embodiments, the distal end of the multi-layer strip is in fluid communication with the connection piece, whereby the partially compressible material can form a gas flow path from the connection piece to the proximal end of the multi-layer strip. In some embodiments, the multi-layer strip can have a length to width ratio of at least 3:1, or at least 5:1, or at least 10:1. In some embodiments, the length of the multi-layer strip can be at least 10 cm, or at least 15 cm, or at least 20 cm, or at least 25 cm, or at least 30 cm. In some embodiments, the thickness of the multi-layer strip can be 3.5 mm or less, or 5 mm or less, or 7.5 mm or less, or 10 mm or less. In one embodiment, the thickness of the upper layer may be 3.5 mm or less, or 5 mm or less, or 7.5 mm or less, or 10 mm or less.

[0150] In some embodiments, the bag can be sized to accommodate a hand or foot. In some embodiments, the bag can be sized to accommodate at least a majority of an adult's arm in a longitudinal direction. In some embodiments, the bag can be sized to accommodate at least a majority of an adult's leg in a longitudinal direction. In some embodiments, the length of the multi-layer strip can be at least 70% of the length of the bag. In some embodiments, (i) the distal portion of the bag can have a distally disposed tab portion open to an interior space of the bag, and a width of the distal tab portion can be less than 25% of a maximum width of the distal portion of the bag, and / or (ii) the connecting piece can be at least partially attached within the distal tab portion.

[0151] In some embodiments, the treatment may include negative pressure wound therapy. In some embodiments, the pressure regulation mode may include applying a vacuum to the interior of the bag. In some embodiments, the pressure regulation mode may include providing a pressure within the bag in the range of 460 mmHg to 1060 mmHg, or in the range of 460 mmHg to 760 mmHg, or in the range of 560 mmHg to 760 mmHg, or in the range of 760 mmHg to 1060 mmHg, or in the range of 760 mmHg to 960 mmHg. In some embodiments, the multi-layer strip may have a dimensionless aspect ratio of thickness to width of 1:1.5 to 1:20, or 1:5 to 1:15, or 1:8 to 1:12.

[0152] In some embodiments, the bottom layer can include an adhesive. In some embodiments, the multi-layer strip can be attached to a first wall of the bag and the connection piece can be attached to a second wall of the bag. In some embodiments, the multi-layer strip can be attached to the same wall to which the connection piece is attached, and / or the bottom layer of the multi-layer strip can be in mechanical contact with the connection piece, and / or the top layer can be in fluid communication with the connection piece through the bottom layer. In some embodiments, the interior of the bag can be pre-sterilized. In some embodiments, the bag can include an ozone-resistant material. In some embodiments, the multi-layer strip can effectively maintain fluid communication along a longitudinal flow path when a portion of the flow path is exposed to an externally applied positive pressure of 100 mmHg.

[0153] According to embodiments of the invention, a kit may comprise (i) a device according to any of the embodiments disclosed above, and / or (ii) an elastic ribbon of gas flow path material for application to and placement on the limb as a lateral extension of a gas flow path around the limb. In some embodiments, the kit may further comprise a sponge for interfacing between the partially compressible material and a wound. In some embodiments, the kit may further (or alternatively) comprise an appendage sealing tape.

[0154] According to an embodiment of the present invention, a device for use with a pressure regulating device in administering treatment to a human limb comprises: (a) a flexible bag, the bag being configured to encircle at least a portion of the limb in a wearing mode; (b) a connecting piece attached to a wall of the bag at a distal portion of the bag, the connecting piece effectively allowing gas flow between an interior space of the bag and a pressure regulating device in a pressure regulating mode; and (c) a gas permeable strip attached to an inner surface of the bag and having a length of at least 70% of the length of the bag, the gas permeable strip having a distal end communicating with a connecting piece at the distal portion of the bag and a proximal end disposed at a proximal portion of the bag, the gas permeable strip including a partially compressible gas permeable material forming a longitudinal gas flow path. In some embodiments, the partially compressible gas permeable material is capable of forming a longitudinal gas flow path when the bag is at least partially evacuated. In some embodiments, the Shore A hardness of the gas permeable strip can be 70 or less, or 60 or less, or 50 or less, or 40 or less.

[0155] In some embodiments, the partially compressible gas permeable material can form a gas flow path from the connection piece to a proximal end of the gas permeable strip. In some embodiments, the gas permeable strip can have a length to width ratio of at least 3:1, or at least 5:1, or at least 10:1. In some embodiments, the length of the gas permeable strip can be at least 10 cm, or at least 15 cm, or at least 20 cm, or at least 25 cm, or at least 30 cm. In some embodiments, the thickness of the gas permeable strip is 3.5 mm or less, or 5 mm or less, or 7.5 mm or less, or 10 mm or less. In some embodiments, the bag can be sized to accommodate a hand or foot. In some embodiments, the bag can be sized to accommodate at least a majority of an adult's arm in a longitudinal direction. In some embodiments, the bag can be sized to accommodate at least a majority of an adult's leg in a longitudinal direction.

[0156] In some embodiments, (i) the distal portion of the bag may have a distally disposed tab portion open to an interior space of the bag, and a width of the distal tab portion may be less than 25% of a maximum width of the distal portion of the bag, and / or (ii) the connecting piece may be at least partially attached within the distal tab portion. In some embodiments, the treatment may include negative pressure wound treatment. In some embodiments, the pressure adjustment mode may include applying a vacuum to the interior of the bag. In some embodiments, the pressure adjustment mode may include applying a pressure within the bag within a range of 460 mmHg to 1060 mmHg, or within a range of 460 mmHg to 760 mmHg, or within a range of 560 mmHg to 760 mmHg, or within a range of 760 mmHg to 1060 mmHg, or within a range of 760 mmHg to 960 mmHg.

[0157] In some embodiments, the gas permeable strip may have a dimensionless aspect ratio of thickness to width of 1:1.5 to 1:20, or 1:5 to 1:15, or 1:8 to 1:12. In some embodiments, the gas permeable strip may be attached to a first wall of the bag and the connecting piece may be attached to a second wall of the bag. In some embodiments, the gas permeable strip may be attached to the same wall to which the connecting piece is attached. In some embodiments, the interior of the bag may be pre-sterilized. In some embodiments, the bag may include an ozone resistant material. In some embodiments, the gas permeable strip may effectively maintain fluid communication along a longitudinal flow path when a portion of the flow path is exposed to an externally applied positive pressure of 100 mmHg.

[0158] According to embodiments of the invention, a kit may comprise (i) a device according to any of the embodiments disclosed above, and / or (ii) an elastic ribbon of gas flow path material for application to and placement on the limb as a lateral extension of a gas flow path around the limb. In some embodiments, the kit may further comprise a sponge for interfacing between the partially compressible material and a wound. In some embodiments, the kit may further (or alternatively) comprise an appendage sealing tape.

[0159] According to an embodiment of the invention, an apparatus for use with a pressure regulating device in delivering treatment to a human limb comprises: (a) a flexible bag configured to encircle at least a portion of the limb in a wear mode; (b) a connection piece attached to a wall of the bag at a distal portion of the bag, the connection piece effectively allowing gas flow between the pressure regulating device and an interior space of the bag in a pressure regulating mode; and (c) a gas permeable strip attached to an interior surface of the bag, the gas permeable strip having a distal end in communication with the connection piece at the distal portion of the bag and a proximal end disposed at the proximal portion of the bag, the gas permeable strip comprising a partially compressible gas permeable material forming a gas flow path in a longitudinal direction, the gas permeable strip having a dimensionless aspect ratio of thickness to width of 1:5 to 1:15.

[0160] In some embodiments, the longitudinal gas flow path can be maintained when the gas pressure within the bag is 660 mmHg or less.In some embodiments, the longitudinal gas flow path can be maintained when the gas pressure within the bag is 560 mmHg.

[0161] In some embodiments, the longitudinal gas flow path can be maintained when a mechanical pressure of 20 mmHg gauge pressure is applied to the bag from the outside and transmitted through the wall of the bag to the top layer of the multi-layer strip. In some embodiments, the longitudinal gas flow path can be maintained when a mechanical pressure of 60 mmHg gauge pressure is applied to the bag from the outside and transmitted through the wall of the bag to the top layer of the multi-layer strip. In some embodiments, the Shore A hardness of the gas permeable strip can be 70 or less, or 60 or less, or 50 or less, or 40 or less. In some embodiments, the partially compressible gas permeable material can form a gas flow path from the connection piece to a proximal end of the gas permeable strip. In some embodiments, the gas permeable strip can have a length to width ratio of at least 3:1, or at least 5:1, or at least 10:1. In some embodiments, the length of the gas permeable strip can be at least 10 cm, or at least 15 cm, or at least 20 cm, or at least 25 cm, or at least 30 cm. In certain embodiments, the thickness of the gas permeable strip may be 3.5 mm or less, or 5 mm or less, or 7.5 mm or less, or 10 mm or less.

[0162] In some embodiments, the bag can be sized to accommodate a hand or foot. In some embodiments, the bag can be sized to accommodate at least a majority of an adult's arm in a longitudinal direction. In some embodiments, the bag can be sized to accommodate at least a majority of an adult's leg in a longitudinal direction. In some embodiments, (i) the distal portion of the bag can have a distally disposed tab portion that is open to an interior space of the bag, and a width of the distal tab portion can be less than 25% of a maximum width of the distal portion of the bag, and / or (ii) the connection piece can be at least partially attached within the distal tab portion. In some embodiments, the treatment can include negative pressure wound treatment. In some embodiments, the pressure adjustment mode can include applying a vacuum to the interior of the bag. In one embodiment, the pressure adjustment mode may include setting the pressure in the bag to within a range of 460mmHg to 1060mmHg, or within a range of 460mmHg to 760mmHg, or within a range of 560mmHg to 760mmHg, or within a range of 760mmHg to 1060mmHg, or within a range of 760mmHg to 960mmHg.

[0163] In some embodiments, the length of the gas permeable strip can be at least 70% of the length of the bag. In some embodiments, the gas permeable strip can be attached to a first wall of the bag and the connecting piece can be attached to a second wall of the bag. In some embodiments, the gas permeable strip can be attached to the same wall to which the connecting piece is attached. In some embodiments, the interior of the bag can be pre-sterilized. In some embodiments, the bag can include an ozone resistant material. In some embodiments, the gas permeable strip can effectively maintain fluid communication along a longitudinal flow path when a portion of the flow path is exposed to an externally applied positive pressure of 100 mmHg.

[0164] According to embodiments of the invention, a kit may comprise (i) a device according to any of the embodiments disclosed above, and / or (ii) an elastic ribbon of gas flow path material for application to and placement on the limb as a lateral extension of a gas flow path around the limb. In some embodiments, the kit may further comprise a sponge for interfacing between the partially compressible material and a wound. In some embodiments, the kit may further (or alternatively) comprise an appendage sealing tape.

[0165] An embodiment of the present invention relates to an apparatus for use with a pressure regulating device in administering treatment to a human limb. According to an embodiment, an apparatus for use with a pressure regulating device in administering treatment to a human limb is provided, the apparatus comprising: (a) a bag configured to receive at least a portion of the limb through an opening in a proximal portion of the bag in a wearing mode; (b) a multi-layer strip including a lower layer attached to an inner surface of the bag, the multi-layer strip having a distal end disposed in the distal portion of the bag and a proximal end disposed in the proximal portion of the bag; and (c) a connecting piece attached to a wall of the bag at the distal portion of the bag, the connecting piece effectively allowing gas flow between the pressure regulating device and an interior space of the bag in a pressure regulation mode, the multi-layer strip further comprising an upper layer including a partially compressible material, the partially compressible material forming a gas flow path disposed longitudinally within the bag between the connecting piece and the proximal portion of the bag.

[0166] In some embodiments, the longitudinal gas flow path can be maintained when the gas pressure within the bag is 660 mmHg or less.In some embodiments, the longitudinal gas flow path can be maintained when the gas pressure within the bag is 560 mmHg.

[0167] In some embodiments, the multi-layer strip may have a dimensionless aspect ratio of thickness to width of 1:2.5 to 1:20.

[0168] In one embodiment, the longitudinal gas flow path can be maintained when a mechanical pressure of 20 mmHg gauge pressure is applied to the bag from the outside and transmitted through the wall of the bag to the top layer of the multi-layer strip. In one embodiment, the longitudinal gas flow path can be maintained when a mechanical pressure of 60 mmHg gauge pressure is applied to the bag from the outside and transmitted through the wall of the bag to the top layer of the multi-layer strip.

[0169] In certain embodiments, the Shore A hardness of the multi-layer strip may be 70 or less, or 60 or less, or 50 or less, or 40 or less.

[0170] In one embodiment, a distal end of the multi-layer strip is in fluid communication with the connecting piece, thereby allowing the partially compressible material to form a gas flow path from the connecting piece to the proximal end of the multi-layer strip.

[0171] In some embodiments, the multi-layer strip may have a length to width ratio of at least 3:1, or at least 5:1, or at least 10:1. In some embodiments, the length of the multi-layer strip may be at least 10 cm, or at least 15 cm, or at least 20 cm, or at least 25 cm, or at least 30 cm. In some embodiments, the thickness of the multi-layer strip may be 3.5 mm or less, or 5 mm or less, or 7.5 mm or less, or 10 mm or less. In some embodiments, the thickness of the top layer may be 3.5 mm or less, or 5 mm or less, or 7.5 mm or less, or 10 mm or less.

[0172] In some embodiments, the bag can be sized to accommodate a hand or foot. In some embodiments, the bag can be sized to accommodate at least a majority of an adult's arm longitudinally. In some embodiments, the bag can be sized to accommodate at least a majority of an adult's leg longitudinally.

[0173] In some embodiments, the length of the multi-layer strip may be at least 20% of the length of the bag.

[0174] In some embodiments, the length of the multi-layer strip may be at least 30% of the length of the bag.

[0175] In some embodiments, the length of the multi-layer strip may be at least 40% of the length of the bag.

[0176] In some embodiments, the length of the multi-layer strip may be at least 50% of the length of the bag.

[0177] In some embodiments, the length of the multi-layer strip may be at least 60% of the length of the bag.

[0178] In some embodiments, the length of the multi-layer strip may be at least 70% of the length of the bag.

[0179] In some embodiments, (i) the distal portion of the bag can have a distally disposed tab portion that is open to the interior space of the bag, and the width of the distal tab portion can be less than 25% of the maximum width of the distal portion of the bag, and / or (ii) the connection piece can be at least partially attached within the distal tab portion.

[0180] In some embodiments, the treatment may include negative pressure wound therapy. In some embodiments, the pressure adjustment mode may include creating a vacuum inside the bag. In some embodiments, the pressure adjustment mode may include setting the absolute pressure inside the bag to within a range of 460mmHg to 1060mmHg, 560mmHg to 960mmHg, or 460mmHg to 760mmHg, or 560mmHg to 760mmHg, or 760mmHg to 1060mmHg, or 760mmHg to 960mmHg, or 760mmHg to 850mmHg.

[0181] In some embodiments, the pressure regulation mode can include applying pressure to the bag from the outside and transmitting it through a wall of the bag to the top layer of the multi-layer strip, and the applied pressure from the outside can be in the range of 0 mmHg to 30 mmHg. In some embodiments, the pressure regulation mode can include applying pressure to the bag from the outside and transmitting it through a wall of the bag to the top layer of the multi-layer strip, and the applied pressure from the outside can be in the range of 0 mmHg to 80 mmHg.

[0182] In certain embodiments, the multi-layer strip may have a dimensionless aspect ratio of thickness to width of 1:1.5 to 1:20, or 1:2.5 to 1:15, or 1:5 to 1:15, or 1:8 to 1:12.

[0183] In some embodiments, the bottom layer can include an adhesive. In some embodiments, the multi-layer strip can be attached to a first wall of the bag and the connecting piece can be attached to a second wall of the bag.

[0184] In one embodiment, the multi-layer strip is capable of effectively maintaining fluid communication along a longitudinal flow path when a portion of the flow path is subjected to an externally applied positive pressure of 100 mmHg.

[0185] According to an embodiment, an apparatus for use with a pressure regulating device in providing treatment to a human limb comprises: (a) a bag configured to surround at least a portion of the limb in a wearing mode; (b) a connection piece attached to a wall of the bag at a distal portion of the bag, the connection piece effectively allowing gas flow between the pressure regulating device and an interior space of the bag in a pressure regulating mode; and (c) a gas permeable strip attached to an inner surface of the bag and having a length of at least 70% of the length of the bag, the gas permeable strip having a distal end communicating with a connection piece at the distal portion of the bag and a proximal end located at the proximal portion of the bag, the gas permeable strip comprising a partially compressible gas permeable material forming a longitudinal gas flow path.

[0186] According to embodiments of the invention, a kit may comprise (i) a device according to any of the embodiments disclosed above, and / or (ii) an elastic ribbon of gas flow path material for application to and placement on the limb as a lateral extension of a gas flow path around the limb. In some embodiments, the kit may further comprise a sponge for interfacing between the partially compressible material and a wound. In some embodiments, the kit may further (or alternatively) comprise an appendage sealing tape.

[0187] According to an embodiment of the invention, an apparatus for use with a pressure regulating device in delivering treatment to a human limb comprises: (a) a bag configured to surround at least a portion of the limb in a wear mode; (b) a connection piece attached to a wall of the bag at a distal portion of the bag, the connection piece effectively allowing gas flow between the pressure regulating device and an interior space of the bag in a pressure regulating mode; and (c) a gas permeable strip attached to an interior surface of the bag, the gas permeable strip having a distal end in communication with the connection piece at the distal portion of the bag and a proximal end disposed at a proximal portion of the bag, the gas permeable strip comprising a partially compressible gas permeable material forming a gas flow path in a longitudinal direction, the gas permeable strip having a dimensionless aspect ratio of thickness to width of 1:5 to 1:15.

[0188] In one embodiment, the strip or the multi-layer strip defines a longitudinal gas flow passage at least in the pressure regulation mode.

[0189] In one embodiment, the strip or the multi-layer strip may have a length equal to at least 40% of the length of the bag, a dimensionless aspect ratio of thickness to width of 1:1.5 to 1:20, and a length to width ratio of at least 3:1.

[0190] In one embodiment, the strip or the multi-layer strip may have a length equal to at least 50% of the length of the bag, a dimensionless aspect ratio of thickness to width of 1:2.5 to 1:20, and a length to width ratio of at least 5:1.

[0191] In one embodiment, the strip or multi-layer strip can have a length equal to at least 40% of the length of the bag, a dimensionless aspect ratio of thickness to width of 1:2.5 to 1:20, and a length to width ratio of at least 3:1, and the strip or multi-layer strip comprises a partially compressible gas permeable material that forms a longitudinal gas flow path in a pressure regulation mode (at least) over a range of absolute intra-bag pressures of 560 mmHg to 960 mmHg.

[0192] In one embodiment, the strip or multi-layer strip can have a length equal to at least 60% of the length of the bag, a dimensionless aspect ratio of thickness to width of 1:2.5 to 1:20, and a length to width ratio of at least 3:1, and the strip or multi-layer strip comprises a partially compressible gas permeable material that defines a longitudinal gas flow path in a pressure regulation mode (at least) over a range of absolute intra-bag pressures of 560 mmHg to 960 mmHg, and the strip or multi-layer strip comprises a partially compressible gas permeable material that defines a longitudinal gas flow path in a pressure regulation mode (at least) including external application of pressure in a gauge pressure range of 0 mmHg to 30 mmHg.

[0193] A method according to an embodiment is disclosed for administering a multi-pressure treatment protocol to a human subject using a gas delivery system having first and second openings for delivery of gas therethrough, the first opening being in fluid communication with a first container and the second opening being in fluid communication with a second container having a plurality of fluid-retaining compartments at least openable to one another, the method including: (a) causing a flow of therapeutic gas into the first container through the first opening while the first container surrounds at least a portion of a longitudinal length of the limb of the subject; and (b) controlling respective gas pressures above ambient within the fluid-retaining compartments of the second container via the second openings while at least a portion of the therapeutic gas is present within the first container while the second container surrounds at least a portion of a longitudinal length of the first container, such that the fluid-retaining compartments apply respective compressive pressures to corresponding portions of the limb via a wall of the first container.

[0194] Another aspect of the present invention discloses a method for administering a multi-pressure treatment protocol to a human subject using a gas delivery system having first and second openings for delivery of gas therethrough. The first opening may be in fluid communication with a first container and the second opening may be in fluid communication with a second container, the second container may have at least one fluid-retaining compartment. The method includes: (a) causing a flow of therapeutic gas into the first container through the first opening; and (b) while at least a portion of the therapeutic gas is present in the first container, with the second container surrounding at least a portion of the length of the first container, controlling at least one gas pressure higher than ambient in at least one fluid-retaining compartment of the second container through the second opening such that the at least one fluid-retaining compartment applies a compressive pressure through a wall of the first container to a corresponding portion of the limb.

[0195] According to this method, therapeutic gas is passed through at least a portion of the first container, the first container being surrounded by the second container to the extent that the first container is at least partially surrounded by the fluid-holding compartment, by adjusting the respective gas pressures above ambient.

[0196] In some embodiments, the first container may be, and typically is, flexible.

[0197] In some embodiments, the second container may be, and typically is, flexible.

[0198] In some embodiments, the method can further include evacuating the first container through the first opening prior to generating a flow of therapeutic gas.

[0199] In some embodiments, adjusting the respective gas pressure above ambient within the fluid-holding compartment can include repeating a sequence of differential pressure adjustments over a period of time defined by a treatment protocol.

[0200] In some embodiments, after adjusting the respective gas pressures above ambient in the fluid-holding compartments, the method may further include: (i) exhausting the therapeutic gas from the first container through the first opening while the first container surrounds at least a portion of the limb, thereby reducing the pressure in the first container to a first pressure below ambient; and (ii) flowing the therapeutic gas into the evacuated first container through the first opening, thereby increasing the pressure in the first container to a second pressure below ambient.

[0201] In some embodiments, the method may include cycling the first and second subambient pressures for a period of time defined by a treatment protocol.

[0202] In some embodiments, adjusting the respective gas pressure above ambient within the fluid holding compartment may include adjusting the respective pressure between 20 and 100 mmHg above ambient.

[0203] In one embodiment, the first subambient pressure is 10-50 mmHg lower than ambient pressure. In one embodiment, the second subambient pressure is 60-100 mmHg lower than ambient pressure. In one embodiment, the difference between the first subambient pressure and the second subambient pressure may be 40-88 mmHg gauge pressure.

[0204] In some embodiments, the flow of the therapeutic gas may be at least partially through a flow path within the first container.

[0205] In another aspect, a system is provided for performing a multi-pressure treatment protocol or method according to any of the embodiments disclosed herein.

[0206] According to an embodiment, a system for performing a multi-pressure treatment protocol on a human subject includes: (a) a first gas transport unit having a first opening for transporting gas therethrough, the first gas transport unit configured to (i) adjust a pressure in a first container disposed in fluid communication with the first gas transport unit over a range of 200 mmHg below ambient to 160 mmHg above ambient, and (ii) cause a flow of therapeutic gas through the first opening; (b) a second gas transport unit having a second opening for transporting gas therethrough, the second gas transport unit configured to adjust a pressure in a second container disposed in fluid communication with the second gas transport unit over a range of pressures above ambient, up to 100 mmHg above ambient; and (c) an electronic circuit configured to (i) determine whether the first container is in fluid communication with the first gas transport unit and whether the first container is configured to surround at least a longitudinal portion of the limb of the subject. and (ii) a second mode in which, in response to an input confirming that the second container is in fluid communication with the second gas transport unit and that the second container is disposed surrounding at least a portion of a longitudinal axis of the first container, the second gas transport unit regulates, via the second opening, a respective gas pressure above ambient within a fluid-retaining compartment of the second container while at least a portion of the therapeutic gas is present in the first container, thereby causing the fluid-retaining compartment to apply a respective compressive pressure through a wall of the first container to a corresponding portion of the limb, thereby causing the therapeutic gas to flow through at least a portion of the first container surrounded by the second container within the area surrounded by the fluid-retaining compartment.

[0207] According to an embodiment, a system for performing a multi-pressure treatment protocol on a human subject includes: (a) a first gas transport unit having a first opening for transporting gas therethrough, the first gas transport unit configured to (i) regulate at least one of a pressure (A) within a range of 50 mmHg below ambient to ambient pressure in a first container disposed in fluid communication with the first gas transport unit and a pressure (B) within a range of ambient to 50 mmHg above ambient pressure in a first container disposed in fluid communication with the first gas transport unit, and (ii) configured to cause a flow of therapeutic gas through the first opening; (b) a second gas transport unit having a second opening for transporting gas therethrough, the second gas transport unit configured to regulate a pressure in a second container disposed in fluid communication with the second gas transport unit; and (c) an electronic circuit configured to (i) determine whether the first container is in fluid communication with the first gas transport unit and whether the first container is in fluid communication with at least a length of the limb of the subject. and (ii) in response to an input confirming that the second container is in fluid communication with the second gas transport unit and that the second container is disposed to surround at least a portion of the longitudinal axis of the first container, the second gas transport unit regulates, via the second opening, a respective gas pressure above ambient within a fluid-retaining compartment of the second container while at least a portion of the therapeutic gas is present in the first container, thereby causing the fluid-retaining compartment to apply a respective compressive pressure through a wall of the first container to a corresponding portion of the limb, thereby causing the therapeutic gas to flow through at least a portion of the first container surrounded by the second container within an area surrounded by the fluid-retaining compartment.

[0208] Further embodiments Further embodiments (or "clauses") 1-111 are set out below.

[0209] Embodiment 1. A method for administering a multi-pressure treatment protocol to a human subject using a gas delivery system having first and second openings for delivering gas therethrough, the first opening being in fluid communication with a first container and the second opening being in fluid communication with a second container, the second container comprising a plurality of fluid-retaining compartments, the method comprising: a. causing a flow of gas into the first container through the first opening while the first container surrounds at least a longitudinal portion of the subject's limb; and b. while at least a portion of the gas is present within the first container, adjusting a respective higher than ambient gas pressure within the fluid-holding compartment of the second container via the second opening while the second container surrounds at least a portion of the longitudinal direction of the first container, such that the fluid-holding compartment applies a respective compressive pressure through a wall of the first container to a corresponding portion of the limb.

[0210] Embodiment 1A The method according to embodiment 1, wherein the second container and the fluid-holding compartment are sealed to the atmosphere.

[0211] Embodiment 1B The method according to any one of Embodiments 1 or 1A, wherein at least one of (1) the second container and (2) the fluid-holding compartment is sealed to the first container.

[0212]

[0023] Embodiment 2. The method according to embodiment 1, wherein the gas comprises a therapeutic gas.

[0213] Embodiment 3. The method according to any preceding embodiment, wherein the gas comprises at least one of ozone, oxygen, and essential oils.

[0214] Embodiment 4. The method according to any preceding embodiment, wherein the gas is caused to flow through at least a portion of the first container surrounded by the second container within the fluid-retaining compartment by adjusting the respective gas pressures above the ambient.

[0215]

[0023] Embodiment 5. The method according to any preceding embodiment, wherein adjusting the respective gas pressure above ambient in the fluid-holding compartment comprises repeating a sequence of differential pressure adjustments.

[0216] Embodiment 6. The method according to any one of embodiments 4 or 5, wherein the flow of the gas is at least partially through a gas flow path strip disposed within the first vessel, the gas flow path strip being laterally open along its length to an interior space of the first vessel, such that fluid within the first vessel can freely flow into and out of the gas flow path strip.

[0217]

[0031] Embodiment 6A The method according to embodiment 6, wherein the gas flow channel strips are disposed vertically, i.e., longitudinally, within the first vessel.

[0218] Embodiment 6B. The method of any one of embodiments 6 or 6A, wherein the gas flow channel strip comprises at most a partially compressible material, and wherein the gas flow channel strip permits gas flow along its entire length when the first container is at least partially evacuated.

[0219] Embodiment 6C The method according to embodiment 6B, wherein when the first vessel is at least partially evacuated under negative pressure (vacuum), one or more walls of the first vessel collapse, exerting a lateral force on the gas flow path strips, causing the strips to become laterally closed and longitudinally open gas flow paths.

[0220] Embodiment 6D: A method according to any one of embodiments 6-6C, wherein when one or more walls of the first container collapse due to expansion of one or more of the fluid holding compartments of the second container, the gas flow path strip maintains an effective flow path for gas transport at least in the area of ​​the first container surrounded by the fluid holding compartments of the second container.

[0221] Embodiment 6E The method according to any one of embodiments 6 to 6D, wherein the strip runs along the length of the fluid-holding compartment.

[0222] Embodiment 7. The method according to any preceding embodiment, further comprising evacuating the first container through the first opening prior to generating a flow of gas.

[0223]

[0026] Embodiment 8: after adjusting each gas pressure above ambient in the fluid-holding compartment, i. exhausting the gas from the first container through the first opening while the first container surrounds at least a portion of the limb to reduce pressure within the first container to a first pressure that is less than ambient; ii. flowing the gas into the evacuated first vessel through the first opening, increasing the pressure in the first vessel to a second pressure below ambient.

[0224] Embodiment 9. The method according to embodiment 8, further comprising cycling said first and second subambient pressures for a period of time defined by a treatment protocol.

[0225] Embodiment 10. The method according to any preceding embodiment, wherein adjusting the respective gas pressures above ambient in the fluid-holding compartments comprises adjusting the respective pressures to a value within a range of 20 to 100 mmHg above ambient pressure.

[0226] Embodiment 11. The method according to any preceding embodiment, wherein the first sub-ambient pressure has a value in the range of 10 to 50 mmHg below ambient pressure.

[0227] Embodiment 12. The method according to any preceding embodiment, wherein the second sub-ambient pressure has a value in the range of 60 to 100 mmHg below ambient pressure.

[0228] Embodiment 13. The method according to any preceding embodiment, wherein the difference between the first subambient pressure and the second subambient pressure is 40 to 88 mmHg.

[0229]

[0031] Embodiment 14. The method according to embodiment 13, wherein a gas flow path is maintained within the gas flow path strip at both the first and second subambient pressures.

[0230]

[0031] Embodiment 15. The method according to any one of embodiments 6 to 14, wherein the gas flow path strip is integrally formed with the first vessel.

[0231] Embodiment 16. The method according to any one of embodiments 6 to 14, wherein the gas flow passage is attached to an inner surface of the first container.

[0232] Embodiment 17. The method according to any preceding embodiment, further comprising placing a resiliently compressible member in contact with the target site on the limb.

[0233] Embodiment 17A A method according to embodiment 17, wherein the elastically compressible member is also in contact with the gas flow path strip, thereby forming a gas flow path connecting the elastically compressible member and the connection component via the gas flow path strip.

[0234] Embodiment 17B The method according to embodiment 17A, wherein the contacting with the gas flow path strips is direct contact.

[0235] Embodiment 18. The method according to any one of embodiments 17-17B, wherein the resiliently compressible member is at least partially compressed when the first container is evacuated through the first opening to reduce the pressure within the first container to a first pressure that is less than the ambient pressure.

[0236] Embodiment 18A A method according to embodiment 18, wherein the first container is substantially evacuated through the first opening and the first container is hermetically covering the body.

[0237] Embodiment 19. The method according to embodiment 18 or 18A, wherein causing the flow of gas through the first opening is effective to expand the at least partially compressed elastically compressible member.

[0238] Embodiment 20. The method according to any one of embodiments 17-19, wherein the resiliently compressible member comprises open-cell foam.

[0239]

[0036] Embodiment 21. The method according to any preceding embodiment, wherein the volume of the at least a portion of the gas is in the range of 0.3 to 10 liters.

[0240] Embodiment 21A The method according to embodiment 21, wherein the volume is at least 0.5 liters.

[0241] Embodiment 21B The method according to embodiment 21, wherein the volume is at least 1 liter.

[0242] Embodiment 21C The method according to embodiment 21, wherein the volume is at least 1.5 liters.

[0243] Embodiment 21D The method of any one of embodiments 21 to 21C, wherein the volume is 8 liters or less.

[0244] Embodiment 21E The method according to embodiment 21D, wherein the volume is 6 liters or less.

[0245] Embodiment 21F The method according to embodiment 21D, wherein the volume is 5 liters or less.

[0246] Embodiment 21G The method according to embodiment 21D, wherein the volume is 4 liters or less.

[0247] Embodiment 22. The method according to any preceding embodiment, wherein adjusting the respective gas pressures above ambient includes adjusting the respective gas pressures above ambient to cause continuous compression of the gas within the first container.

[0248] Embodiment 23. The method according to any preceding embodiment, wherein the first container is flexible.

[0249] Embodiment 24. The method according to any preceding embodiment, wherein the second container is flexible.

[0250]

[0023] Embodiment 25. A system for administering a multi-pressure treatment protocol to a human subject, said system comprising: a. a first gas transfer section having a first opening for transferring a gas therethrough, the first gas transfer section being configured (i) to regulate a pressure within a first container disposed in fluid communication with the first gas transfer section, and (ii) to cause a flow of gas through the first opening; b. a second gas transfer section having a second opening for transferring gas therethrough, the second gas transfer section configured to adjust pressure within a second vessel disposed in fluid communication with the second gas transfer section; c. An electronic circuit, i. a first mode in which the first gas transfer section flows gas into the first container through the first opening; and ii. the electronic circuitry is programmed to sequentially operate in a respective one of second modes in which, while at least a portion of the gas is present in the first container, the second gas transfer portion adjusts respective gas pressures in the fluid holding compartments of the second containers via the second openings, thereby causing the fluid holding compartments to apply respective compressive pressures to corresponding portions of the limb through the walls of the first container.

[0251] Embodiment 26. A system according to embodiment 25, wherein the gas is caused to flow by the first gas transport unit in the first mode in response to an input confirming that the first container is in fluid communication with the first gas transport unit and that the first container is positioned to surround at least a longitudinal portion of the subject's limb.

[0252] Embodiment 27. A system according to any one of embodiments 25 or 26, wherein in the second mode, the respective gas pressures are adjusted by the second gas transport section in response to an input confirming that the second container is in fluid communication with the second gas transport section and that the second container is positioned to surround at least a portion of the longitudinal length of the first container.

[0253] Embodiment 28. A system according to any one of embodiments 25 to 27, wherein the adjustment causes the gas to flow through at least a portion of the first container surrounded by the second container within the area surrounded by the fluid holding compartment.

[0254] Embodiment 28A The system according to embodiment 28, wherein said flow is at least partially effected by a series of expansions and / or contractions of said fluid-holding compartments.

[0255] Embodiment 29. The system according to any one of embodiments 25 to 28A, wherein adjusting the respective gas pressures in the fluid-holding compartments includes repeating a sequence of differential pressure adjustments.

[0256] Embodiment 30. The method according to any one of embodiments 28 or 29, wherein the flow of the gas is at least partially (e.g., at least 30%, at least 50%, at least 70%, at least 90%, or at least 95%) through longitudinally disposed gas flow strips within the first vessel, the gas flow strips being laterally open along their length to the interior space of the first vessel, such that fluid within the first vessel can freely flow into and out of the gas flow strips.

[0257] Embodiment 31. The system according to any one of embodiments 25 to 30, wherein the gas comprises a therapeutic gas.

[0258] Embodiment 32. The system according to any one of embodiments 25 to 31, wherein the gas comprises ozone, oxygen, and essential oils.

[0259] Embodiment 33. The system according to any one of embodiments 25 to 32, wherein the gas comprises at least one of oxygen and essential oils.

[0260] Embodiment 34. A system according to any one of embodiments 25 to 33, wherein the first gas transfer section is configured to adjust the pressure in the first container over a range from 200 mmHg below ambient or atmospheric pressure to 160 mmHg above ambient or atmospheric pressure.

[0261] Embodiment 35. A system according to any one of embodiments 25 to 34, wherein the second gas transfer section is configured to regulate the pressure in the second container over a pressure range of 0 to 100 mmHg above ambient or atmospheric pressure.

[0262]

[0081] Embodiment 36. The method according to any one of embodiments 30 to 35, wherein the gas flow path strip is integrally formed with the first vessel.

[0263] Embodiment 37. The system according to any one of embodiments 30 to 35, wherein the gas flow path is attached to an inner surface of the first container, and may optionally be attached directly to the inner surface of the first container.

[0264] Embodiment 37A The system according to any one of embodiments 25 to 37, wherein the first gas transfer section comprises an ozone generator for supplying an ozone-containing gas to the first vessel.

[0265] Embodiment 37B The system according to any one of embodiments 25 to 37A, wherein the first gas transfer section comprises a container for storing or containing a therapeutic gas for supplying the therapeutic gas to the first container.

[0266] Embodiment 37C: A system according to any one of embodiments 25 to 37B, wherein the first gas transfer section is configured to adjust the pressure in the first container over a range from ambient pressure or 50 mmHg below atmospheric pressure to ambient pressure or atmospheric pressure.

[0267] Embodiment 37D. The system according to any one of embodiments 25 to 37C, wherein the second gas transfer section is configured to regulate the pressure in the second container over a pressure range of 0 to 40 mmHg above ambient or atmospheric pressure.

[0268] Embodiment 37E A system according to any one of embodiments 25 to 37D, wherein the first container and the gas flow path strip are mated such that when the first container is exposed to a specific negative pressure in the range of 660 to 710 mmHg (absolute), at least one wall of the first container collapses and exerts a lateral force on the gas flow path strip, causing the strip to become laterally closed and longitudinally open gas flow paths.

[0269] Embodiment 37F. The system according to any one of embodiments 25 to 37E, wherein the electronic circuit is further programmed to extract the gas present in the first container in a third mode to reduce the pressure in the first container to a first pressure that is ambient or less than atmospheric pressure.

[0270] Embodiment 37G. The system according to embodiment 37F, wherein the electronic circuitry is further programmed to, in a fourth mode subsequent to the third mode, introduce a volume of the therapeutic gas or the therapeutic gas into the first container while maintaining the pressure in the first container below ambient or atmospheric pressure.

[0271] Embodiment 38. A method for administering hypobaric therapy to a human limb, comprising: a. providing a pressure regulating device and a bag assembly, the bag assembly comprising: i. a bag comprising a connection piece attached to a wall of the bag at a distal portion of the bag; ii. a gas flow path strip disposed within the bag between the connecting piece and a proximal portion of the bag, the gas flow path strip being laterally open along its length to an interior space of the bag such that fluid within the bag can freely flow into and out of the gas flow path strip when the bag is in a non-evacuated condition, the method further comprising: b. receiving at least a portion of the limb into the bag through an opening in the proximal portion of the bag; c. connecting the pressure regulator to the connection piece to allow gas flow between the pressure regulator and an interior space of the bag in a pressure regulation mode; d. controlling the pressure regulator to remove a portion of the gas from the interior volume of the bag to reduce pressure within the interior volume to a first pressure below ambient.

[0272] Embodiment 38A The method according to embodiment 38, wherein the gas flow path strip is disposed longitudinally between the connection piece and the proximal portion of the bag.

[0273] Embodiment 38B: The method according to either embodiment 38 or 38A, wherein the gas flow path strip comprises at most a partially compressible material, and the gas flow path strip is configured to maintain an effective gas flow path when a first pressure below the ambient causes one or more walls of the bag to collapse and apply a compressive force to the gas flow path strip.

[0274] Embodiment 39. The method according to any one of embodiments 38-38B, further comprising controlling the pressure regulator to supply a quantity of therapeutic gas to the interior space, thereby increasing the pressure within the interior space to a second pressure that is lower than ambient.

[0275]

[0046] Embodiment 40. The method according to embodiment 38 or 39, wherein a gas flow path is maintained within the gas flow path strip at both the first and second subambient pressures.

[0276] Embodiment 41. The method according to any one of embodiments 38-40, further comprising providing a resiliently compressible member in fluid communication with or in fluid contact with the gas flow path strip and the target site on the limb.

[0277] Embodiment 42. The method according to embodiment 41, wherein the elastically compressible member is at least partially compressed at a first pressure below the ambient in the interior space, and biased to expand when the pressure is raised to a second pressure below the ambient.

[0278] Embodiment 43. The method according to any one of embodiments 41 or 42, wherein the resiliently compressible member comprises open-cell foam.

[0279] Embodiment 44. The method according to any one of embodiments 39 to 43, wherein the supply of the amount of the therapeutic gas to the interior space is at least partially through the gas flow path strip.

[0280] Embodiment 45. The method according to any one of embodiments 39 to 44, wherein the supply of the amount of the therapeutic gas to the resiliently compressible member is substantially all through the gas flow path strip.

[0281]

[0081] Embodiment 46. The method according to any one of embodiments 38 to 45, wherein the gas flow path strip is integrally formed with the first container.

[0282] Embodiment 47. The method according to any one of embodiments 38 to 45, wherein the gas flow passage is attached to an inner surface of the first container.

[0283] Embodiment 48. The method according to any one of embodiments 38 to 47, wherein the first subambient pressure has a value in the range of 10 to 50 mmHg below ambient pressure.

[0284] Embodiment 49. The method according to any one of embodiments 39 to 48, wherein the second subambient pressure has a value in the range of 60 to 100 mmHg below ambient pressure.

[0285] Embodiment 50. A device for use with a pressure regulating device in administering treatment to a human limb, comprising: a bag configured to receive at least a portion of the limb through an opening in a proximal portion of the bag in a worn mode; b. a multi-layer strip including a sublayer attached to an inner surface of the bag, the multi-layer strip having a distal end disposed at a distal portion of the bag and a proximal end disposed at a proximal portion of the bag; c. a connection piece attached to a wall of the bag at the distal portion of the bag, the connection piece effectively allowing gas flow between the pressure regulator and an interior space of the bag in a pressure regulation mode; The device, wherein the multi-layer strip further has an upper layer comprising a partially compressible material, the partially compressible material forming a gas flow path longitudinally disposed within the bag between the connection piece and the proximal portion of the bag.

[0286] Embodiment 51. A device according to embodiment 50, wherein the multilayer strip is laterally open to the interior space of the bag along its length from the distal portion of the bag to the proximal portion of the bag, such that when the bag is in a non-evacuated state, fluid within the bag can freely flow into and out of the upper layer of partially compressible material.

[0287] Embodiment 52. A device according to any one of embodiments 50 or 51, wherein the longitudinal gas flow path is maintained when the gas pressure within the bag is equal to or less than 660 mmHg (absolute).

[0288] Embodiment 53. The device according to any one of embodiments 50 to 52, wherein the multilayer strip has a dimensionless aspect ratio of thickness to width of 1:2.5 to 1:20.

[0289] Embodiment 54. A device according to any one of embodiments 50 to 53, wherein the longitudinal gas flow path is maintained when the gas pressure in the bag is 560 mmHg (absolute).

[0290] Embodiment 55: An apparatus according to any one of embodiments 50 to 54, wherein the longitudinal gas flow path is maintained when mechanical pressure of 20 mmHg gauge pressure is applied to the bag from the outside (e.g., by a partially inflatable sleeve surrounding the bag) and transmitted through the wall of the bag to the top layer of the multilayer strip.

[0291] Embodiment 56 (i) An apparatus according to any one of embodiments 50 to 55, wherein the longitudinal gas flow path is maintained when a mechanical pressure of 60 mmHg gauge pressure is applied to the bag from the outside by a partially inflatable sleeve surrounding the bag and transmitted through the wall of the bag to the top layer of the multilayer strip.

[0292]

[0046] Embodiment 57. An apparatus according to any one of embodiments 50 to 56, wherein the multilayer strip has a Shore A hardness of 70 or less.

[0293] Embodiment 58. A device according to any one of embodiments 50 to 57, wherein the distal end of the multilayer strip is fluidly connected to the connection part, whereby the partially compressible material forms the gas flow path from the connection part to the proximal end of the multilayer strip.

[0294] Embodiment 59. The device according to any one of embodiments 50 to 58, wherein the multilayer strip has a length to width ratio of at least 3:1.

[0295]

[0046] Embodiment 60. The device according to any one of embodiments 50 to 59, wherein the length of the multilayer strip is at least 10 cm.

[0296]

[0041] Embodiment 61. The device according to any one of embodiments 50 to 60, wherein the thickness of the multilayer strip is 5 mm or less.

[0297] Embodiment 62. The device according to any one of embodiments 50 to 61, wherein the thickness of the upper layer is 3.5 mm or less.

[0298] Embodiment 63. An apparatus according to any one of embodiments 50 to 62, wherein the limb is one of a hand and a foot.

[0299] Embodiment 64. A device according to any one of embodiments 50 to 63, wherein the length of the multi-layer strip is at least 70% of the length of the bag.

[0300] Embodiment 65. An apparatus according to any one of embodiments 50 to 64, wherein the bottom surface of the multi-layer strip has an area that is less than 10% of the area of ​​the bag when laid flat without wrinkles or creases.

[0301] Embodiment 66: A device according to any one of embodiments 50 to 65, wherein (i) the distal portion of the bag has a distal tab portion open to the internal space of the bag, the width of the distal tab portion being less than 25% of the maximum width of the distal portion of the bag, and (ii) the connection part is at least partially attached within the distal tab portion.

[0302]

[0046] Embodiment 67. A device according to embodiment 66, wherein the connecting part is entirely mounted within the distal tab portion.

[0303] Embodiment 68. The device according to any one of embodiments 50 to 67, wherein the underlayer comprises an adhesive.

[0304] Embodiment 69. A device according to any one of embodiments 50 to 68, wherein the multi-layer strip is attached to a first wall of the bag and the connecting piece is attached to a second wall of the bag.

[0305] Embodiment 70. A device according to any one of embodiments 50 to 69, wherein the multilayer strip effectively maintains fluid communication along the longitudinal flow path when a portion of the flow path is exposed to a positive pressure of 100 mmHg gauge pressure applied from the outside by a partially inflatable sleeve surrounding the bag.

[0306] Embodiment 71. A device for use with a pressure regulating device in administering treatment to a target area of ​​a human body, the device comprising: (a) a bag having (i) two opposing bag portions and (ii) a connecting piece attached to a first bag portion at a distal portion of the bag; (b) a strip extending longitudinally along a bag portion from the distal portion of the bag to a proximal portion of the bag, the strip being in fluid communication with the connection piece and having a first uncompressed thickness; (c) a porous compressible member sized to fit within the bag and having a second uncompressed thickness; the porous compressible member and the proximal end of the strip mated to form a gas flow path structure when juxtaposed; The apparatus, wherein the porous compressible member compresses relatively more than the strip when placed in the structure and subjected to forces from the two bag portions under negative pressure on the bag.

[0307] Embodiment 72. The device according to embodiment 71, wherein the second uncompressed thickness is greater than the first uncompressed thickness.

[0308] Embodiment 73. A device according to any one of embodiments 71 or 72, wherein the second uncompressed thickness is at least twice the first uncompressed thickness.

[0309] Embodiment 74. A device according to any of embodiments 71 to 73, wherein the strip retains at least 90% of the first uncompressed thickness when exposed to the force when the negative pressure in the bag is 100 mmHg (660 mmHg absolute).

[0310] Embodiment 75. A device according to any of embodiments 71 to 73, wherein the strip retains at least 95% of the first uncompressed thickness when exposed to the force when the negative pressure in the bag is 100 mmHg (660 mmHg absolute).

[0311] Embodiment 76. A device according to any of embodiments 71 to 75, wherein the porous compressible member retains less than 80% of the second uncompressed thickness when exposed to the force when the negative pressure in the bag is 100 mmHg (660 mmHg absolute).

[0312] Embodiment 77. A device according to any of embodiments 71 to 75, wherein the porous compressible member retains less than 50% of the second uncompressed thickness when exposed to the force when the negative pressure in the bag is 100 mmHg (660 mmHg absolute).

[0313] Embodiment 78. A device according to any one of embodiments 71 to 77, wherein the strip is integrally formed with the bag.

[0314] Embodiment 79. A device according to any one of embodiments 71 to 78, wherein the strip is attached to the inner surface of the bag.

[0315] Embodiment 80. A device according to any one of embodiments 71 to 79, wherein the porous compressible member is biased to expand relatively more than the strip when pressure within the bag increases.

[0316] Embodiment 81. An apparatus according to any one of embodiments 71 to 80, wherein the strip is laterally open to the interior space of the bag along its length, such that when the bag is in a non-evacuated state, gas within the bag can flow freely into and out of the strip.

[0317] Embodiment 82. A device according to any one of embodiments 71 to 81, wherein the strip is integrally formed with the bag or attached to the inner surface of the bag.

[0318] Embodiment 83. A device according to any one of embodiments 71 to 82, wherein the device is provided as a kit comprising a first and a second element, the first element comprising the bag to which the first part is attached or integrally formed, and the second element comprising the second part.

[0319] Embodiment 84. The device according to any one of embodiments 71 to 83, wherein the porous compressible member comprises an elastically compressible material.

[0320] Embodiment 85. The device according to embodiment 84, wherein the resiliently compressible material comprises open-cell foam.

[0321] Embodiment 86. An apparatus for use with a pressure regulating device in administering treatment to a human limb, comprising: a bag configured to receive at least a portion of the limb through an opening in a proximal portion of the bag in a worn mode; b. a connection piece attached to a wall of the bag at a distal portion of the bag, the connection piece, when connected to the regulator, effectively permitting gas flow between the pressure regulator and an interior space of the bag; c. the device comprising a strip on an inner surface of the bag, the strip forming a longitudinal gas flow path within the bag between the connecting piece and a proximal portion of the bag.

[0322] Embodiment 87. The device according to embodiment 86, wherein the strip is integrally formed with the bag.

[0323]

[0082] Embodiment 88. The device according to embodiment 86 or 87, wherein the longitudinal gas flow path extends to the connecting piece.

[0324] Embodiment 89. A device according to any one of embodiments 86 to 88, wherein the strip has a plurality of parallel raised streaks and a plurality of grooves between adjacent streaks.

[0325]

[0046] Embodiment 90. The device according to embodiment 89, wherein, for at least some of the plurality of grooves, the width of each of the one or more grooves is less than or equal to the height of each of the striations adjacent thereto.

[0326] Embodiment 91. A device according to any one of embodiments 86 to 88, wherein the strip has a plurality of raised protrusions.

[0327]

[0081] Embodiment 92. A device according to embodiment 91, wherein for at least some of the plurality of raised protrusions, the spacing between adjacent raised protrusions is less than the height of each of the adjacent protrusions.

[0328] Embodiment 93. A device according to embodiments 86 to 92, wherein the strip is laterally open to the interior space of the bag along its length from the distal portion of the bag to the proximal portion of the bag, such that when the bag is in a non-evacuated state, fluid within the bag can flow freely into and out of the strip.

[0329] Embodiment 94. A device according to any one of embodiments 86 to 93, wherein the longitudinal gas flow path is maintained when the gas pressure in the bag is equal to or less than 660 mmHg (absolute).

[0330] Embodiment 95. The device according to any one of embodiments 86 to 94, wherein the strip has a dimensionless aspect ratio of thickness to width of 1:2.5 to 1:20.

[0331] Embodiment 96. A device according to any one of embodiments 86 to 95, wherein the longitudinal gas flow path is maintained when the gas pressure in the bag is 560 mmHg (absolute).

[0332] Embodiment 97 An apparatus according to any one of embodiments 86 to 96, wherein the longitudinal gas flow path is maintained when a mechanical pressure of 20 mmHg gauge pressure is applied to the bag from the outside by a partially inflatable sleeve surrounding the bag and transmitted through the wall of the bag to the top of the strip.

[0333] Embodiment 98: An apparatus according to any one of embodiments 86 to 97, wherein the longitudinal gas flow path is maintained when a mechanical pressure of 60 mmHg gauge pressure is applied to the bag from the outside by a partially inflatable sleeve surrounding the bag and transmitted to the top of the strip through the wall of the bag.

[0334] Embodiment 99. An apparatus according to any one of embodiments 86 to 98, wherein the strip has a Shore A hardness of 70 or less.

[0335] Embodiment 100. The device according to any one of embodiments 86 to 94, wherein the strip has a length to width ratio of at least 3:1.

[0336] Embodiment 101. A device according to any one of embodiments 86 to 100, wherein the length of the strip is at least 10 cm.

[0337] Embodiment 102. The device according to any one of embodiments 86 to 101, wherein the thickness of the strip is 7 mm or less.

[0338]

[0041] Embodiment 102A The apparatus according to embodiment 105, wherein the thickness of the strip is 5 mm or less.

[0339] Embodiment 102B The apparatus according to embodiment 105, wherein the thickness of the strip is 4 mm or less.

[0340] Embodiment 102C The apparatus according to embodiment 105, wherein the thickness of the strip is 3 mm or less.

[0341] Embodiment 103. A device according to any one of embodiments 86 to 102, wherein the length of the strip is at least 70% of the length of the bag.

[0342] Embodiment 104. A device according to any one of embodiments 86 to 103, wherein the bottom surface of the strip, when laid flat without wrinkles or creases, has an area that is less than 10% of the area of ​​the bag.

[0343] Embodiment 105. A device according to any one of embodiments 86 to 104, wherein (i) the distal portion of the bag has a distal tab portion open to the internal space of the bag, the width of the distal tab portion being less than 25% of the maximum width of the distal portion of the bag, and (ii) the connection part is at least partially attached within the distal tab portion.

[0344]

[0081] Embodiment 106. A device according to embodiment 105, wherein the connecting part is entirely mounted within the distal tab portion.

[0345] Embodiment 107. A device according to any one of embodiments 86 to 106, wherein the strip and the bag are formed from the same material.

[0346] Embodiment 108. A device according to any one of embodiments 86 to 107, wherein the strip is formed on a first wall of the bag and the connecting piece is attached to a second wall of the bag.

[0347] Embodiment 109. A device according to any one of embodiments 86 to 108, wherein the strip effectively maintains fluid communication along the longitudinal flow path when a portion of the flow path is exposed to a positive pressure of 100 mmHg gauge pressure applied from the outside by a partially inflatable sleeve surrounding the bag.

[0348]

[0041] Embodiment 110. The device according to any one of embodiments 86 to 109, wherein the thickness of the strip is at least 1.0 mm.

[0349]

[0046] Embodiment 111. The apparatus according to embodiment 110, wherein the thickness of the strip is at least 2.0 mm.

[0350] As used in this specification and the claims that follow, the term "atmospheric pressure" refers to 760 mmHg (absolute).

[0351] In describing the present invention, the embodiments have been described in detail, but the described embodiments are merely examples and do not limit the scope of the present invention. The described embodiments include various features, not all of which are required in all embodiments of the present invention. Some embodiments of the present invention utilize only some of the described features or utilize possible combinations of the described features. Modifications of the described embodiments of the present invention and embodiments of the present invention including different combinations of the features shown in the embodiments will naturally occur to those skilled in the art.

Claims

1. 1. A system for administering a multi-pressure treatment protocol to a human subject, the system comprising: a first gas transfer section having a first opening for transferring a gas therethrough, the first gas transfer section configured to (i) regulate a pressure within a first container disposed in fluid communication with the first gas transfer section, and (ii) cause a flow of gas through the first opening; a second gas transfer section having a second opening for transferring a gas therethrough, the second gas transfer section configured to regulate a pressure within a second vessel disposed in fluid communication with the second gas transfer section; The following modes: a first mode in which the first gas transfer section flows gas into the first container through the first opening; and a second mode in which, while at least a portion of the gas is present within the first container, the second gas transfer portion adjusts respective gas pressures within the fluid-retaining compartments of the second containers via the second openings, thereby causing the fluid-retaining compartments to apply respective compressive pressures through a wall of the first container to corresponding portions of the limb. an electronic circuit programmed to operate in sequence on each of the A system comprising:

2. 2. The system of claim 1, wherein the gas is caused to flow by the first gas transport unit in the first mode in response to an input confirming that the first container is in fluid communication with the first gas transport unit and that the first container is positioned to surround at least a portion of the longitudinal axis of the subject's limb.

3. 3. The system of claim 1, wherein in the second mode, the second gas transport section adjusts the respective gas pressures in response to an input confirming that the second vessel is in fluid communication with the second gas transport section and that the second vessel is positioned to surround at least a portion of the longitudinal length of the first vessel.

4. The system described in claim 1, wherein the adjustment causes the gas to flow across at least a portion of the first container that is surrounded by the second container to the extent that the portion is surrounded by the fluid holding compartment.

5. The system of claim 4 , wherein the fluid flow is at least partially effected by a series of expansions and / or contractions of the fluid-holding compartment.

6. The system of claim 1 , wherein adjusting the respective gas pressures in the fluid-holding compartments comprises repeating a sequence of differential pressure adjustments.

7. 7. The system of claim 5 or 6, wherein the gas flow is at least partially or mostly through longitudinally disposed gas flow path strips within the first vessel, the gas flow path strips being laterally open along their length to the interior space of the first vessel, such that fluid within the first vessel can freely flow into and out of the gas flow path strips.

8. The system of claim 1 , wherein the gas comprises at least one of ozone, oxygen, and essential oils.

9. 2. The system of claim 1, wherein the first gas transfer section is configured to regulate pressure within the first vessel over a range from 50 mmHg below ambient or atmospheric pressure to ambient or atmospheric pressure.

10. 10. The system of claim 1, wherein the second gas transfer section is configured to regulate pressure within the second vessel over a pressure range of 0 to 40 mmHg above ambient or atmospheric pressure.

11. The system of claim 7 , wherein the gas flow path strip is integrally formed with the first vessel.

12. The system of claim 7 , wherein the gas flow path strip is attached to an interior surface of the first vessel.

13. 8. The system of claim 7, wherein the first container and the gas flow path strip are mated such that when the first container is subjected to a specific negative pressure in the range of 660-710 mmHg (absolute), at least one wall of the first container collapses and exerts a lateral force on the gas flow path strip, causing the strip to have a laterally closed and longitudinally open gas flow path.

14. 10. The system of claim 1, wherein the electronic circuit is further programmed to, in a third mode, evacuate gas present in the first container to reduce pressure in the first container to a first pressure that is ambient or less than atmospheric pressure.

15. 15. The system of claim 14, wherein the electronic circuitry is further programmed to, in a fourth mode subsequent to the third mode, introduce a volume of therapeutic gas into the first container while maintaining a pressure within the first container below the ambient or atmospheric pressure.

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