Systems, apparatus, and methods for performing gas therapy and pressure therapy.

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 on April 25, 2021, the entire content of which is incorporated herein by reference. For the purposes of the Paris Convention, this patent application claims priority to U.S. Patent Application No. 17 / 239,637, filed on April 25, 2021, and UK Patent Application No. 2112465.6, filed on September 1, 2021, the entire content of which is incorporated herein by reference.

[0002] The present invention relates to a product including an apparatus for use in gas therapy and pressure therapy performed on a human limb and torso, as well as methods for using such a product and methods for using such a product in gas therapy and pressure therapy. [[ID=1~12]]

Background Art

[0003] Pressure - regulating devices are utilized in various therapies. In many cases, the therapy is performed by immediately creating a pressure - holding space above and around a wound or incision on a limb or torso. In some cases, a "gas bridge" is also immediately created between a connecting component disposed in the immediately created space and the wound itself. This is provided, for example, by cutting a continuous - bubble foam piece to create a gas path within the space. Thus, the methods disclosed to date are inaccurate, makeshift, and difficult to maintain in a sterile state. Further, the immediately created pressure - holding space is not suitable for combination with other gas therapies or other pressure therapies. Therefore, there is a need for a usable device that can be used in pressure - regulating devices and / or various therapies using various gases.

Summary of the Invention

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

[0005] According to the features of the preferred embodiments described, the system comprises a first gas transfer unit having a first opening for transferring gas, the first gas transfer unit being configured to (i) regulate the pressure in a first container disposed in fluid communication with the gas transfer unit, and (ii) to generate a flow of gas through the first opening; and a second gas transfer unit having a second opening for transferring gas, the second gas transfer unit being configured to regulate the pressure in a second container disposed in fluid communication with the second gas transfer unit.

[0006] According to further features of the preferred embodiment described, the system further includes electronic circuitry programmed to operate sequentially in the following first and second modes: In the first mode, the first gas transfer unit causes gas to flow into the first container through the first opening. In the second mode, while at least a portion of the gas is in the first container, the second gas transfer unit adjusts the respective gas pressures in the fluid-holding compartments of the second container through the second opening, so that the fluid-holding compartments apply their respective compressive pressures to the corresponding parts of the limbs through the walls of the first container.

[0007] According to yet another feature of the preferred embodiment described, the first gas transfer unit flows the gas in response to input confirming that the first container is in fluid communication with the first gas transfer unit and that the first container is positioned to surround at least a portion of the longitudinal side of the limb of the object.

[0008] According to yet another feature of the preferred embodiment described, the second gas transfer unit adjusts the respective gas pressures in response to input confirming that the second container is in fluid communication with the second gas transfer unit and that the second container is positioned to surround at least a portion of the longitudinal direction of the first container.

[0009] According to yet another feature of the preferred embodiment described, the adjustment causes the gas to flow over at least a portion of the first container surrounded by the second container to the extent that it is surrounded by the fluid-holding compartment.

[0010] According to yet another feature of the preferred embodiment described, the flow is at least partially caused by a series of expansions and / or contractions of the fluid-holding compartment.

[0011] According to yet another feature of the preferred embodiment described, the flow of the gas is at least partially or largely through a gas flow strip arranged longitudinally within the first vessel, the gas flow strip being laterally open to the internal space of the first vessel along its length, so that fluids within the first vessel can flow freely into and out of the gas flow strip.

[0012] According to yet another feature of the preferred embodiment described, the gas is a therapeutic gas and optionally comprises at least one of ozone, oxygen, and essential oils.

[0013] According to yet another feature of the preferred embodiment described, the first gas transfer unit is configured to adjust the pressure inside the first container in the range of 50 mmHg lower than ambient pressure or atmospheric pressure to ambient pressure or atmospheric pressure.

[0014] According to yet another feature of the preferred embodiment described, the second gas transfer unit is configured to regulate the pressure inside the second container in a pressure range of 0 to 40 mmHg higher than the ambient pressure or atmospheric pressure.

[0015] According to yet another feature of the preferred embodiment described, the first vessel and the gas flow strip are joined so that when the first vessel is subjected to a specific negative pressure in the range of 660 to 710 mmHg (absolute pressure), at least one wall of the first vessel dents, applying a lateral force to the gas flow strip, thereby closing the flow laterally and opening the gas flow path longitudinally.

[0016] According to yet another feature of the preferred embodiment described, the electronic circuit is further programmed in a third mode to extract the gas present in the first vessel and reduce the pressure inside the first vessel to a first pressure lower than ambient pressure or atmospheric pressure.

[0017] According to yet another feature of the preferred embodiment described, the electronic circuit is further programmed, in a fourth mode following the third mode, to introduce a certain volume of a therapeutic gas or the therapeutic gas into the first vessel while maintaining the pressure inside the first vessel below ambient pressure or atmospheric pressure.

[0018] Various methods and apparatuses, as well as further systems, are disclosed herein.

[0019] The present invention will be further described with reference to the attached drawings as an example. The dimensions of the components and features shown in the attached drawings are adopted for the purpose of clear illustration and are not necessarily proportional to the actual size. [Brief explanation of the drawing]

[0020] [Figure 1] This is a schematic diagram of an exemplary apparatus according to an embodiment of the present invention. [Figure 2] This is a schematic diagram of an exemplary apparatus according to an embodiment of the present invention. [Figure 3] This is a schematic diagram of an apparatus according to an embodiment of the present invention, connected to a pressure regulating device via a gas connection hose. [Figure 4A] This is a schematic top view of a strip according to an embodiment of the present invention. [Figure 4B] This is a schematic cross-sectional view of a strip according to an embodiment of the present invention. [Figure 4C] This is a schematic cross-sectional view of a strip according to an embodiment of the present invention. [Figure 4D] This is a schematic cross-sectional view of a strip according to an embodiment of the present invention. [Figure 4E] This is a schematic cross-sectional view of a strip according to an embodiment of the present invention. [Figure 4F] This is a schematic cross-sectional view of a strip according to an embodiment of the present invention. [Figure 5A] This is a schematic diagram showing the components of an apparatus according to an embodiment of the present invention, comprising a connecting component 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 connecting component. [Figure 5B] This is a schematic diagram showing the components of an apparatus according to an embodiment of the present invention, comprising a connecting component 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 connecting component. [Figure 6] This is a schematic diagram of the gas flow path that enters, passes through, and exits the strip according to an embodiment of the present invention. [Figure 7] This is a schematic diagram of the gas flow path that enters, passes through, and exits the strip according to an embodiment of the present invention. [Figure 8] This is a schematic diagram of the gas flow path that enters, passes through, and exits the strip according to an embodiment of the present invention. [Figure 9A] This is a schematic diagram of the gas flow path that enters, passes through, and exits the strip according to an embodiment of the present invention. [Figure 9B] This is a schematic diagram of the gas flow path that enters the strip under external pressure, passes through the strip, and exits the strip, according to an embodiment of the present invention. [Figure 10A]This is a schematic diagram of the gas flow path according to an embodiment of the present invention, showing gas entering, passing through, and exiting an uncompressed strip. [Figure 10B] This is a schematic diagram of the gas flow path that enters, passes through, and exits a partially compressed strip according to an embodiment of the present invention. [Figure 11A] This 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] This 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] This 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] This 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] This 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] This 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] This is a schematic diagram of an exemplary apparatus according to an embodiment of the present invention, comprising an integrally formed strip. [Figure 12B] This is a schematic diagram of an exemplary apparatus according to an embodiment of the present invention, comprising an integrally formed strip. [Figure 12C] This is a schematic diagram of an exemplary apparatus according to an embodiment of the present invention, comprising an integrally formed strip. [Figure 13] This is a schematic diagram of an embodiment of the present invention, each device being fitted to a human limb in a size appropriate for that person. [Figure 14] This is a schematic diagram showing a human user wearing an exemplary full-body device according to an embodiment of the present invention. [Figure 15]This is a schematic diagram showing a human user wearing an exemplary full-body device according to an embodiment of the present invention. [Figure 16] This is a schematic diagram showing a human user wearing an exemplary full-body device according to an embodiment of the present invention. [Figure 17] This is a schematic diagram showing a device according to an embodiment of the present invention, sized to fit a person's leg, and an elastic ribbon according to an embodiment of the present invention, attached to the strip of the device as a lateral extension member. [Figure 18] This is a schematic diagram of a kit according to an embodiment of the present invention, which includes an elastic ribbon used as a device and a lateral extension member. [Figure 19] This is a schematic diagram of a kit according to an embodiment of the present invention, comprising a device and a sealing tape for limbs. [Figure 20] This is a schematic diagram of a kit according to an embodiment of the present invention, comprising the kit components shown in Figure 18 and a sealing tape for limbs. [Figure 21] This is a block diagram of a kit according to an embodiment of the present invention. [Figure 22A] This is a schematic cross-sectional view of an exemplary apparatus according to an embodiment of the present invention, having a first portion and a second portion of a gas flow path under different pressure conditions. [Figure 22B] This is a schematic cross-sectional view of an exemplary apparatus according to an embodiment of the present invention, having a first portion and a second portion of a gas flow path under different pressure conditions. [Figure 22C] This is a schematic cross-sectional view of an exemplary apparatus according to an embodiment of the present invention, having a first portion and a second portion of a gas flow path under different pressure conditions. [Figure 23] This is a schematic diagram showing a system according to an embodiment of the present invention for performing a multi-pressure therapy protocol on a human subject. [Figure 24] This figure shows first and second containers according to embodiments of the present invention that at least partially surround a human limb. [Figure 25]This figure shows first and second containers according to embodiments of the present invention, which at least partially surround a human limb and are connected to a pressure regulating device. [Figure 26A] This schematic diagram illustrates how a second container, having multiple compartments that partially surround a first container that at least partially surrounds a human limb, is sequentially compressed according to an embodiment of the present invention. [Figure 26B] This schematic diagram illustrates how a second container, having multiple compartments that partially surround a first container that at least partially surrounds a human limb, is sequentially compressed according to an embodiment of the present invention. [Figure 26C] This schematic diagram illustrates how a second container, having multiple compartments that partially surround a first container that at least partially surrounds a human limb, is sequentially compressed according to an embodiment of the present invention. [Figure 26D] This schematic diagram illustrates how a second container, having multiple compartments that partially surround a first container that at least partially surrounds a human limb, is sequentially compressed according to an embodiment of the present invention. [Figure 26E] This schematic diagram illustrates how a second container, having multiple compartments that partially surround a first container that at least partially surrounds a human limb, is sequentially compressed according to an embodiment of the present invention. [Figure 26F] This schematic diagram illustrates how a second container, having multiple compartments that partially surround a first container that at least partially surrounds a human limb, is sequentially compressed according to an embodiment of the present invention. [Figure 27A] This flowchart shows the steps of a method for performing a multi-pressure therapy protocol on a human subject according to an embodiment of the present invention. [Figure 27B] This flowchart shows the steps of a method for performing a multi-pressure therapy protocol on a human subject according to an embodiment of the present invention. [Figure 27C] This flowchart shows the steps of a method for performing a multi-pressure therapy protocol on a human subject according to an embodiment of the present invention. [Figure 27D] This flowchart shows the steps of a method for performing a multi-pressure therapy protocol on a human subject according to an embodiment of the present invention. [Figure 27E] This flowchart shows the steps of a method for performing a multi-pressure therapy protocol on a human subject according to an embodiment of the present invention. [Figure 28A] This flowchart shows the steps of a method for performing low-pressure therapy on a human limb according to an embodiment of the present invention. [Figure 28B] This flowchart shows the steps of a method for performing low-pressure therapy on a human limb according to an embodiment of the present invention. [Figure 28C] This flowchart shows the steps of a method for performing low-pressure therapy on a human limb according to an embodiment of the present invention. [Modes for carrying out the invention]

[0021] The present invention will be described with reference to the attached drawings, which are merely illustrative. While the description will proceed with specific and detailed reference to the drawings, it should be emphasized that the detailed descriptions are merely illustrative and intended to illustrate preferred embodiments of the present invention, presented in the process of providing what is considered to be the most useful and easily understandable explanation of the principles and conceptual aspects of the present invention. In this regard, the structural details of the present invention are shown only to the extent necessary for a basic understanding of the invention, but by reading this specification together with the drawings, it will be clear to those skilled in the art how various forms of the present invention can actually be embodied. Throughout the drawings, the same reference numerals are generally used to indicate the same components. Subscript reference numerals (e.g., 101) or letter-qualified reference numerals (e.g., 100) are used. A ) is used to distinguish and show multiple embodiments of a component in a single drawing; for example, 101 shows one embodiment (of multiple embodiments) of component 10, and 100 A This shows one of the (multiple) embodiments of component 100.

[0022] Embodiments of the present invention include a device for use in pressure-related therapy applied to one or more of a human user's body, in particular (but not limited to) one of the user's limbs. The device is used in conjunction with a pressure regulating device that can increase, decrease and / or maintain the gas pressure in a bag which is a component of the device, and / or replace the gas in the bag. The bag is configured to surround the user's limb, and the other components of the device are arranged to form a gas channel to the treatment site. This channel can function even if the pressure in the bag decreases.

[0023] Further embodiments of the present invention include methods and systems for performing gas and pressure-based therapeutic protocols on one or more limbs of a person. According to the embodiments, the protocol synergistically combines three types of therapy to achieve optimal results. The three types of therapy are variable pressure therapy (i.e., therapy with pressure that can be applied externally in varying sizes and / or locations) to remove edema, therapy to remove edema and other discharges by negative pressure (vacuum) to improve blood flow to a wound, and therapy using therapeutic gases. As used herein, the term “therapeutic gas” refers to a gas containing one or more of ozone, oxygen, and essential oils. Essential oils are substances often used for disinfection and improving the capacity of the immune system.

[0024] Here, we refer to the drawings, particularly Figure 1. Figure 1 schematically shows a therapeutic device 100 in a non-limiting embodiment. This device includes a flexible bag 10. The flexible bag 10, shown in a two-dimensional projection in Figure 1, is in an unconnected state in its initial pre-use mode.

[0025] For clarity, the bag is characterized throughout this disclosure as having two opposing walls. However, some bags according to embodiments may be manufactured to have a single “endless” wall, for example, a connected polymer sheet that is closed or sealed at one end and open at the other. Such a bag, when flattened, also has two opposing walls, in other words, two opposing “bag portions.” The bags disclosed herein may be seamed or seamless. The bag (and / or apparatus comprising the bag) may be supplied as a continuous roll. Alternatively or additionally, the bag (and / or apparatus comprising the bag) may be supplied in an initial (pre-use) form having two sealed ends, the first end of which is specified to be opened upon initial use. In one design, the bag can be opened simply by separating the two opposing walls. In another design, the user may have to perform additional work, such as tearing off a sealing strip at the top of the bag. All these different aspects of bag design are within the scope of the present invention. In addition, for clarity, all bags illustrated in the accompanying drawings are rectangular. However, it will be apparent to those skilled in the art that embodiments can be made with bags of any shape suitable for the application. For example, a bag for a device used in a patient's hand may be elliptical (two-dimensional projection) or have rounded corners.

[0026] The bag according to the embodiment is made from any suitable flexible material. Such a material is capable of maintaining positive and / or negative pressure for a predetermined period of time (i.e., several minutes or several hours, but not necessarily several days or weeks). Suitable constituent materials for a bag with low permeability and high flexibility include polymers such as polyethylene, polypropylene, and polyvinyl chloride in various grades. Low permeability to molecules such as N2, CO2, O2, and O3 is a desirable property, as it is desirable for substantially isolating the inside of the bag, once sealed, from the ambient atmosphere to the attached limb for the duration of treatment or part thereof. The constituent material can be selected based on its compatibility with ozone gas, for example, polyethylene. The maintenance of pressure generally depends on the permeability of the bag's constituent material(s), and in some cases, on the thickness of the material. As used herein, the term “maintaining” pressure should be understood to mean maintaining a set or specified pressure within 0.1% of its value for one minute, or within 0.5%, 1%, 2%, 3%, 4%, or 5% of its value for one minute. Maintaining may also include making minor adjustments. For example, it may include making minor adjustments by a pressure regulator connected to the bag to suppress pressure fluctuations. “Positive” and “negative” pressure should be understood to mean pressure higher or lower than ambient pressure, respectively. For example, if the ambient pressure is 760 mmHg (millimeters of mercury), 460 mmHg is called negative pressure and 1,060 mmHg is called positive pressure. Therefore, treatment of negative or low pressure is treatment performed at a pressure lower than the ambient pressure. Negative pressure (i.e., pressure greater than 0 mmHg and lower than ambient pressure) may also be referred to herein as “partial vacuum,” “partial exhaust,” etc.

[0027] The apparatus 100 in Figure 1 further comprises a strip 50 and connecting parts 20. The bag 10 shown in Figure 1, like all other bags 10 shown in the accompanying drawings, is shown as at least partially “transparent” so that the strip 50 inside is “visible.” While it may be operationally advantageous for the bag 10 to be at least partially transparent or at least translucent, it is not essential in the embodiments disclosed herein. Thus, in some embodiments, the bag 10 is opaque. In some exemplary embodiments, the strip 50 is a multilayer strip, i.e., a strip comprising two or more layers. This is described below with reference to Figures 4B-4E. In some embodiments, the strip 50 is a gas-permeable strip comprising one or more layers. This is described below with reference to Figures 4D and 4F. The strip 50 is attached to the inner surface of the bag 10; that is, it is attached to the bag surface that is in direct fluid communication with the internal space of the bag. In some embodiments, this attachment involves bonding (e.g., adhering) the strip 50 to the inner surface of the bag 10 by applying an adhesive. In one embodiment, this attachment is performed by heat-welding the strip 50 to the inner surface of the bag 10 by a thermal process such as heat welding, in a non-limiting embodiment. In one embodiment, the strip 50 can be formed integrally with the bag 10, for example, as shown in Figures 12A to 12C.

[0028] The connector 20 is for connecting a gas connection hose to it, which is introduced to mediate between the pressure regulating device and the bag. The connector has an opening 25. The opening 25 allows gas to flow between the pressure regulating device and the inside of the bag, for example, when the pressure increases or decreases. That is, the pressure inside the bag is regulated by connecting the pressure regulating device to the connector 20. In one embodiment, the opening 25 of the connector is a simple hole, and in other embodiments, the opening 25 is one side of a male-female connector or any other type of connector that fits a gas connection hose suitable for use with a pressure regulating device. In one embodiment, further components may be provided between the bag and the pressure regulating device. Such components may be, for example, a container for collecting spills, a biofilter, and one or more check valves, as shown in Figure 21, provided on the “device” side of the connector 20.

[0029] The "distal" and "proximal" directions are indicated by arrows 210 in Figure 1, respectively. The proximal end 12 of the bag 10 is the portion or end through which the user's limb can be inserted, and the distal end 13 is the opposite end. The connecting component 20 is attached to the wall of the bag 10 near the distal portion or distal end 13. The distal end of the strip 50 is in direct fluid communication with the connecting component 20 (particularly including the opening 25), and the proximal end of the strip 50 is located in the proximal portion of the bag 10. The proximal portion of the bag occupies 50%, 40%, 30%, 25%, 20%, or less of the bag 10. Thus, in one embodiment, the length of the strip 50 (in its longitudinal dimension, shown in Figure 4A) is L STRIP The length of the bag 10 (as shown in Figure 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 L in Figure 1. BAG It is shown as follows: Length L BAGmay be the maximum dimension of the bag 10 as shown in FIG. 1, but this may not apply to all embodiments. Thus, the length L BAG can be regarded as the distance from the proximal end 12 to the distal end 13 of the bag 10.

[0030] In certain embodiments, for example, in order to eliminate the possibility of causing discomfort, it may be desirable to "space apart" the connecting component 20 so that it does not contact the user's limb. FIG. 2 shows a non-limiting example of an apparatus 100 comprising a bag 10, the bag 10 having a distal extension in the form of a tab 15. The tab 15 is open to the internal space of the remainder of the bag 10. In the embodiment of FIG. 2, the connecting component 20 is attached to the inner wall of the bag within the tab portion 15, thereby substantially eliminating the chance that the user's limb will come into direct contact with the connecting component 20. In order to particularly effectively prevent direct contact with the user, the tab portion 15 is preferably narrower than the remainder of the bag 10. For example, the width of the tab portion 15 (designated as W TAB in FIG. 2) is limited to less than 30% of the width (W BAG ) of the bag 10. In certain embodiments, W TAB is less than 25%, or less than 20%, or less than 15%, or less than 10% of W BAG . In certain embodiments, the length of the tab 15 (designated as L TAB in FIG. 2) is less than 25% of L BAG (the total length of the bag 10 including the tab portion 15 shown in FIG. 2).

[0031] Figure 3 shows the device 100 directly connected to the pressure regulator 70 by a gas connection hose 72. In some embodiments, this connection is not direct. In some embodiments, the hose 72 may have a gas switching function and / or multiple inlet / outlet connections. In some embodiments, the hose 72 is part of the pressure regulator 70 or permanently attached to the pressure regulator 70, and in other embodiments, it is a separate element. The pressure regulator 70 can be any device suitable for applying and / or maintaining a pressure higher or lower than the ambient pressure, and may be any device suitable for treating, for example, the limbs or torso of a user. Suitable embodiments of the pressure regulator include, but are not limited to, negative pressure therapy devices, ozone therapy devices, sequential pressurization therapy devices, and devices combining two or more of these therapies.

[0032] In one embodiment, the pressure regulator (70 or 550) is programmed to assume an ambient pressure of 760 mmHg. In one embodiment, the pressure regulator is programmed to pre-set to a predetermined ambient pressure (e.g., a typical ambient pressure or near-ambient pressure required to raise the user's position). In one embodiment, the pressure regulator measures and uses the ambient pressure before or during a treatment period, during device setup, or at any other time. In one embodiment, the pressure regulator is configured to raise or lower the pressure inside the container by a predetermined amount. In one embodiment, the pressure regulator is configured to raise or lower the pressure inside the container to a predetermined or pre-calculated pressure. In any of the disclosed embodiments, the pressure regulator can combine any of the features and configurations described above.

[0033] Refer to Figures 4A to 4F here.

[0034] Figure 4A is a top view of the strip 50 according to an embodiment. The strip 50 has a certain length L STRIP A certain width W STRIPIt has the following characteristics. In one embodiment, the length L STRIP is width W STRIP At least three times longer, or at least five times longer, or at least ten times longer. In one embodiment, L STRIP :W STRIP The ratios are 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 a more concrete example, length L STRIP The width W 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. In the embodiment, the width W STRIP The width is 1cm to 6cm, or 2cm to 5cm, or 2.5cm to 4.5cm. In one embodiment, the width W STRIP The ranges are 1cm to 2cm, or 1cm to 3cm, or 1cm to 4cm, or 1cm to 5cm, or 2cm to 3cm, or 2cm to 4cm, or 2cm to 5cm, or 2cm to 6cm, or 3cm to 4cm, or 3cm to 5cm, or 3cm to 6cm, or 4cm to 5cm, or 4cm to 6cm, or 5cm to 6cm. All ranges shown throughout this specification include both ends of the range. In embodiments, the area (i.e., length L) of the strip 50 is... STRIP Width W STRIP The value obtained by multiplying by is the area of ​​bag 10 (i.e., length L). BAG Width W BAG It is smaller than the value obtained by multiplying by . In one embodiment, 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] Figures 4B to 4F are schematic diagrams showing cross-sections of various strips 50 according to embodiments, each diagram following line AA in Figure 4A. The strip 501 shown in Figure 4B has a lower layer 60, an intermediate layer 57, and an upper layer 55. The upper layer 55 contains a partially compressible gas-permeable material. In one embodiment, the lower layer 60 is an adhesive layer. In another embodiment, the lower layer 60 contains a cloth that can be attached to the wall of a bag by heat (e.g., heat welding). In one embodiment, the intermediate layer 57 contains a fine woven or nonwoven fabric, and the upper layer 55 contains one of a coarse woven fabric, loop cloth, or felt. As shown in Figure 4C, the upper layer 55 has a certain thickness T UL The strip 50 has a total thickness T STRIP It has a total thickness T of the strip 50 in one embodiment. STRIP The thickness is 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 55 is 3.5 mm or less, or 5 mm or less, or 7.5 mm or less, or 10 mm or less. In one embodiment, it may be preferable for the strip 50 to be rather "soft" so as not to cause excessive discomfort to the user when, for example, the user's limbs rest on part of the strip 50. In one embodiment, the Shore A hardness of the strip 50 is 70 or less, or 60 or less, or 50 or less, or 40 or less. In one embodiment, the Shore A hardness of the gas permeable upper layer 55 is 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 Characterized by: In an embodiment, T STRIP / W STRIP The ratio is 1:1.5 to 1:20, or 1:5 to 1:15, or 1:8 to 1:12. In one embodiment, T STRIP / W STRIPThese are 1:1.5~1:5, or 1:1.5~1:10, or 1:1.5~1:15, or 1:1.5~1:20, or 1:1.5~1:30, or 1:5~1:10, or 1:5~1:12, or 1:5~1:20, or 1:1.5~1:30, or 1:8~1:15, or 1:8~1:20, or 1:8~1:30, or 1:10~1:15, or 1:10~1:20, or 1:10~1:30, or 1:12~1:20, or 1:12~1:30, or 1:15~1:20, or 1:15~1:30, or 1:20~1:30.

[0038] The upper layer 55 has a dimensionless aspect ratio T. UL / W STRIP Characterized by: In one embodiment, T UL / W STRIP The ratio is 1:1.5 to 1:20, or 1:5 to 1:15, or 1:8 to 1:12. In one embodiment, T UL / W STRIP These are 1:1.5~1:5, or 1:1.5~1:10, or 1:1.5~1:15, or 1:1.5~1:20, or 1:1.5~1:30, or 1:5~1:10, or 1:5~1:12, or 1:5~1:20, or 1:1.5~1:30, or 1:8~1:15, or 1:8~1:20, or 1:8~1:30, or 1:10~1:15, or 1:10~1:20, or 1:10~1:30, or 1:12~1:20, or 1:12~1:30, or 1:15~1:20, or 1:15~1:30, or 1:20~1:30.

[0039] The strip 502 in Figure 4D has a partially compressible upper layer 55 and a lower layer 60 as described above. The strip 503 in Figure 4E has a partially compressible upper layer 55, a lower layer 60, and an uppermost layer 58 (e.g., a coating applied to the upper layer 55). The strip 504 in Figure 4F has a partially compressible gas permeable layer 55. In one embodiment, this gas permeable layer 55 is attached to the wall of the bag, for example, by adhesive or heat.

[0040] Figures 5A and 5B show details of the apparatus 100 and illustrate the flow of gas entering the bag 10 and exiting the bag 10 via the connecting component 20. In Figure 5A, the connecting component 20 is attached to the wall 11B of the bag 10, and the strip 50 is attached to the first wall 11 B The second wall that "opposes" it 11 A It is attached to the bag 10. That is, the strip 50 is separated from the connecting component 20 by the internal space 12 of the bag 10. The internal space 12 does not have to 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 internal space 12 is always formed within the bag 10, for example, to accommodate the user's limbs for treatment. Therefore, in the initial state, the strip 50 and connecting component 20 in Figure 5A are separated from the opposing wall 11 A and 11 B Although they are located above, there does not necessarily have to be an internal space separating them. As shown in the embodiment in Figure 5A, the lower layer 60 is the wall 11 of the bag 10. A This is the layer to which the strip is attached. Therefore, the term "lower layer" should be interpreted as meaning the layer closest to the wall of the bag to which it is attached, and therefore the term "upper layer" should be interpreted as meaning the layer further from the wall to which the strip is attached than the lower layer. In the embodiment of Figure 5A, the connecting component 20 is in direct fluid communication with the upper layer 55 of the strip 50. The gas flow between the pressure regulator (not shown in Figures 5A-5B) and the internal space 12 of the bag 10 is indicated by arrow 201. The direction of arrow 201 in Figures 5A and 5B is not to indicate a limited direction but is merely illustrative. The gas can flow in either direction (i.e., both in the direction of entering the bag 10 and in the direction of leaving the bag 10) depending on the increase or decrease in pressure inside the bag 10. In the embodiment of Figure 5B, the connecting component 20 is in direct fluid communication with the same wall 11 to which the strip 50 is attached. BIt is attached to the lower layer 60. In order to establish fluid communication between the connecting component 20 and the gas-permeable upper layer 55, the lower layer 60 is always at least partially open to the gas flow (for example, if the lower layer 60 contains a gas-permeable material and / or a porous or discontinuous material).

[0041] Refer to Figures 6-9A here. Figures 6-9A are schematic diagrams of the gas flow paths in strip 50, respectively. In Figures 6-9, the flow arrows 201, 203, and 205 are all depicted as if they only indicate the inflow of gas into the bag. However, as with Figures 5A and 5B, the apparatus 100 is configured to allow gas to flow in either direction (i.e., both in the direction of entering the bag 10 and in the direction of leaving the bag 10) depending on whether the pressure in the bag 10 is rising or falling. Figure 6 shows a portion of strip 50. Strip 50 has only a gas-permeable upper layer 55, similar to the example of strip 504 shown in Figure 4F. The illustrated gas flow 201 enters from "below" (i.e., from the direction of the connecting component 20 attached to the same wall 11 to which strip 50 is attached (as in the embodiment in 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 intermittent application of adhesive (not shown) or intermittent heat fusion so 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., can exit 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 some applications, the bag 10 is partially evacuated. This evacuation removes gas from the internal space 12 of the bag 10 through the connecting component 20, and the two walls 11 of the bag 10 are attracted to each other by "negative pressure". "Partially evacuated" means reducing the gas pressure inside the bag to 560 mmHg or less, or to 660 mmHg or less. The strip 50 (which is at most partially compressible) maintains the gas flow path. This gas passage extends from the connecting component 20 (for example, where arrow 201 indicates "entry" into strip 50) to any point on the upper surface of the strip (for example, where pressure-related treatment is performed). As mentioned earlier, the gas passage is not directional.The term “maintain gas flow path” and other similar terms mean that the path is open for a gas flow to pass through it, where the gas flow is suitable for the applicable treatment or other purpose. 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 any remaining air in the gas flow path (i.e., air remaining in the gas-permeable strip or layer or material), thereby “maintaining” the gas flow path (i.e., there is sufficient gas flow to transmit negative pressure from the connecting component to, for example, a wound in fluid communication with a gas-permeable material).

[0042] Figure 7 also shows another strip 50. This is similar to the strip 50 in Figure 5B, and the gas channel passes through the lower layer 60 (arrow 201) (for example, through holes and / or regions where thermal bonding or adhesion is discontinuous). In a non-limiting embodiment, the lower layer 60 is removed from the region of the strip 50 located directly above the opening 25 of the connecting component 20. Figure 8 shows a gas channel in another exemplary strip 50. This is similar to the strip 50 in Figure 5A, and the gas-permeable upper layer 55 is attached to the wall opposite the wall to which the connecting component is attached and is in direct fluid communication with the connecting component 20. The strip 50 in Figure 9A is similar to the strip 503 in Figure 4E, where at least partially gas-permeable upper layer (or coating) 58 is located between the gas-permeable upper layer 55 and the interior 12 of the bag 10.

[0043] In all embodiments shown in Figures 6-9A, the configuration and selection of constituent materials of the apparatus 100 are such that the gas flow path is maintained across the gas-permeable upper layer 55 (e.g., the flow paths indicated by arrows 201, 203, and 205 (in any direction)) over a wide range of pressures for pressure-related treatment. The appropriate gas flow path is suitable for the gas flow required for pressure-related treatment. For example, the pressure adjustment mode of the apparatus 100 may include bringing the pressure in the bag 10 to and / or maintaining a pressure in the range of 460 mmHg to 1060 mmHg, or 460 mmHg (i.e., negative pressure 300 mmHg) to 760 mmHg, or 560 mmHg to 760 mmHg, or 760 mmHg to 1060 mmHg (i.e., positive pressure 300 mmHg), or 760 mmHg to 960 mmHg. In embodiments, it is desirable that the material(s) of the gas-permeable upper layer 55 be selected such that the upper layer 55 (and the strip 50 as a whole) is at most partially compressible (i.e., not completely compressible). This is because if it were completely compressible, the gas passage would be closed at one or more locations, or completely, by negative pressure (i.e., exhaust of the bag 10).

[0044] Figure 9B shows the strip 50 from Figure 9A, to which pressure (e.g., mechanical pressure) is applied from the outside (indicated by arrow 206 in Figure 9B). This pressure is applied from the outside of the bag 10, for example, to the bag wall 11 in Figure 5A. BIt is applied to the outer surface. Examples of external mechanical pressure are described below with reference to Figures 23, 24, 25 and 26A-26F. Note: Except for the external pressure shown in Figure 9B, all other pressures disclosed herein are gas pressures. Furthermore, any pressure shown in this disclosure or appended claims that is at least 460 mmHg is an “absolute” pressure, unless otherwise explicitly stated, while pressures of 100 mmHg or less are “gauge” pressures, unless otherwise explicitly stated. The pressure is transmitted to the uppermost layer 58 of the strip through the bag wall 11 (not shown in Figure 9B), causing compression of the gas permeable layer 55. In some embodiments, the compression of the gas permeable layer 55 by the externally applied pressure 206 is performed in addition to the compression caused by negative (lower than ambient) pressure (i.e., partial exhaust of the bag 10) in, for example, a pressure adjustment mode. Another type of mechanical pressure applied to the gas permeable layer 55 is the force between the two opposing walls of the bag under negative pressure, as described below with reference to Figures 22A-22C.

[0045] In the embodiment shown in Figure 9B, the configuration and selection of constituent materials of the apparatus 100 are such that the gas flow path is maintained across the gas-permeable upper layer 55 (e.g., the flow paths indicated by arrows 201, 203, and 205 (in any direction)) within a wide range of externally applied pressures for pressure-related treatment. The appropriate gas flow path is suitable for the gas flow required for pressure-related treatment. For example, the pressure adjustment mode of the device 100 may include applying external pressure 206 to achieve and / or maintain a pressure transmitted to the gas permeable layer through the bag wall 11 and the uppermost layer 58 (if present) within the range of 0mmHg to 20mmHg, or 0mmHg to 30mmHg, or 0mmHg to 40mmHg, or 0mmHg to 50mmHg, 0mmHg to 60mmHg, or 0mmHg to 70mmHg, or 0mmHg to 80mmHg, or 0mmHg to 90mmHg, or 0mmHg to 100mmHg.

[0046] The partially compressible gas-permeable upper layer 55 is as shown in Figure 10A when uncompressed and as shown in Figure 10B when partially compressed. The thickness of the upper layer 55 is T due to partial compression. UL From T UL-PC This is reduced. This partial compression is due to compressive force (for example, by partial exhaust of bag 10 by a pressure regulator (e.g., pressure regulator 70 in Figure 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 shown in Figure 10B.

[0047] Refer to Figures 11A–11F here. These show photographs of six exemplary partially compressible gas-permeable upper layers 55 according to one embodiment.

[0048] The partially compressible, gas-permeable upper layer 55 in Figure 11A is made of felt cloth.

[0049] The partially compressible, gas-permeable upper layer 55 in Figure 11B is made of French terry cloth.

[0050] The partially compressible, gas-permeable upper layer 55 in Figure 11C is made of nylon loop fabric. The foreground of the photograph shows the base fabric layer (e.g., the intermediate layer 57 in Figures 4B-4C).

[0051] The partially compressible, gas-permeable upper layer 55 in Figure 11D is made of cotton terry cloth.

[0052] The partially compressible, gas-permeable upper layer 55 in Figure 11E is composed of a polyurethane foam sheet.

[0053] The partially compressible, gas-permeable upper layer 55 in Figure 11F consists of a partially compressed mat of nonwoven synthetic fibers (e.g., nylon or cellulose).

[0054] All six non-limiting embodiments of the material suitable for the gas-permeable upper layer 55 can maintain an effective gas flow path when partially compressed, as shown in Figure 10B, for example.

[0055] Refer now to Figures 12A, 12B, and 12C, which schematically show an exemplary apparatus 100 according to one embodiment. Apparatus 100 has a strip 505 integrally formed with the wall of the bag 10. In the non-limiting embodiments of Figures 12A-12C, the strip 505 has a plurality of parallel grooves 48 separated by grooves 49. The grooves 48 may, but do not necessarily, be formed from the same material as the wall(s) of the bag 10. Each of the grooves 48 has a certain height H RAIL , a certain width W RAIL It has a width W. On the other hand, each of the grooves 49 has a width W. GROOVE It has the following characteristics. The “height” of the groove as described herein corresponds to the “thickness” of the strip as described elsewhere herein.

[0056] In the illustrated embodiment, the outermost groove is wider and taller than the other grooves 48. In other embodiments, all grooves are the same size and spacing, and in yet another embodiment, many or all grooves are different or each has different dimensions and spacing. The selection of height and width can be based on the conditions necessary to maintain a gas flow path with sufficient capacity and robustness in the longitudinal direction. For example, it is preferable to select groove heights that are not too short and / or spacing that is not too narrow. If they are too short and / or spacing that is not too narrow, the gas flow will be insufficient, or when the bag is partially evacuated, the bag walls will dent, forcing all the gas flow to pass through the grooves. Conversely, it is preferable to select groove heights that are not too long. If they are too long, for example, depending on the selection of groove material and groove width, the grooves may bend due to the force of the denting wall when the bag is partially evacuated. The spacing between adjacent grooves, i.e., W GROOVEIt is preferable to choose a width that is not too wide. This way, when the bag is partially vented, the bag walls will not dent or fold into the groove.

[0057] In one embodiment, the height H of each groove RAIL These ranges are 1mm-3mm, 1mm-4mm, or 1mm-5mm, or 2mm-3mm, or 2mm-4mm, or 2mm-5mm.

[0058] In one embodiment, the integrally formed strip 505 may have a configuration other than straight grooves 48 and grooves 49. In one embodiment (not shown), a plurality of protrusions form a gas passage. This gas passage is at most partially compressible when the bag 10 is partially evacuated (for example, 100 mmHg lower than the surroundings).

[0059] The integrally formed strip 505 in Figures 12A to 12C shares many features with, for example, the strip 50 in Figures 1, 2, and 3. Such features include, but are not limited to, length and its ratio, width and its ratio, area and its ratio, position in the bag or tab extension, and function as a gas flow path.

[0060] In the embodiment, it is desirable to determine the size of the device 100 to fit a specific type of adult limb. The schematic diagram in Figure 13 shows four embodiments of the device 100 sized to fit a limb. Each of these is attached to four locations on the limb 90 of a human user. From left to right, clockwise, the device 100... ARM It is sized to be easily and conveniently used on an adult's arm, and device 100 HAND It is sized to be easily and conveniently used by an adult's hand, and device 100 LEG It is sized to be easily and conveniently used on an adult's leg, and device 100 FOOTThe devices are sized to be easily and conveniently used on adult feet. In one embodiment, each limb-specific device can be sized to accommodate at least a large portion of a particular limb, or the majority of a limb, or the entire limb up to the joint (e.g., up to the wrist in the case of a hand device, up to the shoulder in the case of an arm device). None of these devices have to have the tab extension portion 15 (device 100). HAND and apparatus 100 FOOT (as shown in the case of) or it may have a tab extension 15 (apparatus 100 ARM and apparatus 100 LEG (As shown in the example). In each embodiment, it is preferable that the connecting component 20 be positioned so as not to cause discomfort to the user's limbs. In one embodiment, a limb sealing member 30 (e.g., adhesive tape) can be provided, which seals the space between the limb and the periphery of the open proximal end of the bag 10.

[0061] Figures 14, 15, and 16 show non-limiting embodiments of the apparatus 100, which are intended for use on the torso of a user, or at least two limbs (e.g., both legs), or a portion of the torso including at least two limbs. Figure 14 shows the apparatus 100 comprising a single simple strip 50 and a single connecting component. Figure 15 shows another configuration of the apparatus 100 comprising a single but composite strip 50, where a single connecting component 20 is in fluid communication with two branches of the strip 50. Figure 16 shows another configuration of one apparatus 100, which comprises two separate connecting components 20, which are positioned laterally apart from each other at the distal end of the bag 10. This configuration also comprises two strips 50, each in fluid communication with the corresponding connecting component 20. Those skilled in the art will understand that the alternative configurations shown in Figures 15 and 16 can be easily modified into the conventional apparatus 100. In other words, the device can be changed to one that fits the size of each individual limb, rather than one that fits the torso (for example, the exemplary devices shown in Figures 1-3 and 13).

[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 if the strip 50 does not come into direct contact with a sensitive area (e.g., a wound). In addition, or as an alternative, in some embodiments, it may be inconvenient to position the connecting component 20 relative to the user's wound so as to keep the strip in a straight line. Therefore, it may be desirable to extend the gas channel provided by the strip 50 laterally around the leg. Thus, as shown in Figure 17, an elastic ribbon 32 of the gas channel material is provided and positioned on the limb as a laterally extended portion of the gas channel (i.e., extending laterally from the strip and positioned around the limb). In some embodiments, a sponge 31 or a similarly soft material is provided to be inserted between the wound and the strip 50, or between the wound and the elastic ribbon 32.

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

[0064] Figure 18 shows Kit 300. Kit 300 comprises an apparatus 100 according to one or more embodiments disclosed herein, along with an elastic ribbon 32 and a wound dressing sponge 31.

[0065] Figure 19 shows Kit 310. Kit 310 comprises a limb sealing tape 30 along with an apparatus 100 according to one or more embodiments disclosed herein.

[0066] Figure 20 shows kit 320. Kit 320 comprises an apparatus 100 according to one or more embodiments disclosed herein, along with an elastic ribbon 32, a wound dressing sponge 31, and a limb sealing tape 30.

[0067] Figure 21 shows Kit 340. Kit 340, along with a device 100 according to one or more embodiments disclosed herein, comprises an elastically compressible member (e.g., open-cell foam or open-cell sponge 31), a recovery canister 43 (e.g., for exudate), a biofilter 42, and one or more check valves 41. Kit 340 is in communication with a pressure regulating device 550 as schematically shown.

[0068] One embodiment of the present invention relates to a system for carrying out a treatment protocol. In one embodiment, the system comprises a gas transfer device with a negative pressure pump capable of operating to a pressure at least 50, 75, 100, 150, or 200 mmHg lower than the ambient pressure, a supply system for the treatment gas, and / or a compressor capable of operating to increase the gas pressure at least 40, 70, 100, 130, or 160 mmHg. The system may further comprise one or more closed-end containers, such as disposable bags. The bags have gas passages within them that are effectively maintained under the negative pressure and / or externally applied pressure of the treatment protocol. The system may further comprise a wound sponge for communicating the negative pressure to a target site such as a wound, and, if necessary, additional gas passage members for ensuring a continuous gas passage at one end of the passage to or from the wound and a connection to the gas transfer device at the other end. The system may also be provided with reusable compression sleeves, which are sized to partially surround the closed-end container housing each limb(s). The compression sleeves can withstand repeated pressurization up to 60 mmHg, 80 mmHg, or 100 mmHg higher than the surrounding pressure.

[0069] An exemplary treatment protocol according to one embodiment has a first step of performing variable compression therapy in the presence of a therapeutic gas.

[0070] Another exemplary treatment protocol has a second stage in which additional gas therapy is performed using negative pressure (i.e., a pressure lower than ambient pressure or atmospheric pressure).

[0071] More typically, such exemplary treatment protocols include both a first stage of variable compression therapy in the presence of a gas (e.g., a therapeutic gas) and a second stage of additional gas therapy with negative pressure.

[0072] In one embodiment, treatment begins with removing edema from the wound site to improve blood flow to the injured tissue, and removing edema and any other discharges from the wound in the presence of a therapeutic gas. After removal and initial disinfection, the therapeutic gas can be delivered directly to the injured tissue by negative pressure (partial vacuum).

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

[0074] a. An elastically compressible member 31 (for example, a wound sponge containing open-cell foam) is placed on the target area (for example, a wound on a limb).

[0075] b. Insert the limb into the first container (for example, the bag 10 provided with the gas flow strip 50) and close the upper (proximal) opening.

[0076] c. A portion of the gas 14 is released from the bag 10 using the pressure regulator 550. In one embodiment, as much gas as possible is actually released, and the sealing condition is checked during release.

[0077] d. Attach the second container (e.g., the sequential compression sleeve 200) to surround the first container 100 (this step may be performed earlier, for example, before partially evacuating the first container).

[0078] e. The therapeutic gas (for example, a gas containing ozone) is produced as a mixture with oxygen, for example, by introducing an oxygen source into an ozone generator.

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

[0080] g. The sequential compression sleeve 200 applies pressure to the bag 10. The pressure causes the (therapeutic) gas to flow longitudinally, for example, through the strip 50. This procedure may be continued for a period of at least 3 minutes and no more than 120 minutes, or at least 5 minutes and no more than 90 minutes, or at least 7 minutes and no more than 75 minutes, or any intermediate period.

[0081] h. (Therapy) A portion of the gas 14 is released from the bag 100, reducing the pressure inside the bag 100 to a first low pressure, for example, 60-100 mmHg (gauge pressure) lower than the surroundings. The vacuum level is sufficient to at least partially crush the elastically compressible member 31, as shown in Figure 22B.

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

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

[0084] k. Maintain a vacuum in bag 100 for at least 3 minutes, or at least 5 minutes, or at least 7 minutes, or longer.

[0085] l. A vacuum can be repeated between a first pressure range lower than the ambient pressure and a second pressure range lower than the ambient pressure.

[0086] Refer to Figures 22A, 22B, and 22C here.

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

[0088] Figure 22B shows partial evacuation of bag 100. Partial evacuation is evacuation to a pressure up to 100 mmHg lower than the ambient pressure (e.g., 60-100 mmHg lower). Partial evacuation is indicated by arrows 207 and 202. This partial evacuation is a typical example of step "h" in the embodiment described above. Vacuum is applied to the wall 11 of bag 10. A , 11 B This will create a dent. A , 209 B As shown, force is applied to the items inside the bag. The second part, namely sponge 31, is subjected to these forces 209 A and 209 B It is compressed by the force 209, resulting in a second thickness T312. This thickness is at least 40% smaller than the original thickness T311. The first part, strip 50, is also compressed by the force 209 A and 209 B It is compressed, but to a negligible degree (e.g., less than 5% of the original thickness T501).

[0089] Figure 22C shows 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 a typical example of step "j" in the embodiments described above. The pressure inside bag 100 rises to a pressure 20-88 mmHg lower than the ambient pressure, and the gas passage may partially expand. Accordingly, arrow 209 A and 209 B The wall 11 covering the contents, as shown by A and 11 B The force decreases. In particular, the second portion 31 is biased to expand when the vacuum is reduced or removed. This is shown in Figure 22C. Here, the thickness of the second portion 31 increases to a third thickness T313. This thickness is greater than T312 but still less than the original thickness T311. This is because even when the vacuum is reduced, the bag is still under partial vacuum. According to the embodiment, when ambient pressure is restored, the second portion 31 returns to its original thickness T311.

[0090] Refer again to Figure 1. Figure 1 shows a non-limiting embodiment of a closed-end container for use in a therapeutic device 100. The closed-end container 100 includes a flexible bag 10. The flexible bag 10, shown in a two-dimensional projection in Figure 1, is in an unconnected state in its initial pre-use mode. The bag 10 according to the embodiment is made from any suitable flexible material. Such a material is capable of maintaining positive and / or negative pressure for a predetermined period of time (i.e., a few minutes or a few hours, but not necessarily a few days or weeks).

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

[0092] The closed-end container 100 shown in Figure 1 further comprises a gas flow strip 50 and a connecting component 20. The bag 10 shown in Figure 1 is shown as at least partially "transparent" so that the strip 50 inside is "visible," but transparency is not required in the embodiments disclosed herein. In some embodiments, the strip 50 is a multilayer strip, i.e., a strip comprising two or more layers (e.g., a gas flow channel layer and one or more further layers for attachment to the inner wall of the bag). The strip 50 is attached to the inner surface of the bag 10; that is, it is attached to the bag surface that is in direct fluid communication with the internal space of the bag. In some embodiments, this attachment involves bonding (e.g., adhering) the strip 50 to the inner surface of the bag 10 by applying an adhesive. In some embodiments, in non-limiting embodiments, this attachment is performed by heat welding the strip 50 to the inner surface of the bag 10 by a thermal process such as heat welding.

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

[0094] The "distal" and "proximal" directions are indicated by arrows 210 in Figure 1, respectively. The proximal end 12 of the bag 10 is the portion or end through which the user's limb can be inserted, and the distal end 13 is the opposite end. The connecting component 20 is attached to the wall of the bag 10 near the distal portion or distal end 13. The distal end of the strip 50 is in direct fluid communication with the connecting component 20 (particularly including the opening 25), and the proximal end of the strip 50 is located in the proximal portion of the bag 10. The proximal portion of the bag occupies 50%, 40%, 30%, 25%, 20%, or less of the bag 10. Thus, in one embodiment, the length of the strip 50 (in its longitudinal dimension, shown in Figure 4A) is L STRIP The length of the bag 10 (as shown in Figure 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 L in Figure 1. BAG It is shown as follows: Length L BAG This may be the maximum dimension of the bag 10 as shown in Figure 1, but this may not apply to all embodiments. Therefore, the length L BAG This 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 "position the connecting component 20 separately" so that it does not come into contact with the user's limbs, for example, to eliminate the possibility of causing discomfort. Figure 2 shows a non-limiting embodiment of a device 100 comprising a bag 10, the bag 10 having a distal extension in the form of a tab 15. The tab 15 is open to the internal space of the rest of the bag 10. In the embodiment of Figure 2, the connecting component 20 is attached to the inner wall of the bag within the tab portion 15, thereby minimizing the opportunity for the user's limbs to come into direct contact with the connecting component 20. To make the use of the tab portion 15 particularly effective in preventing direct contact with the user's limbs, it is preferable that the tab portion 15 has a narrower width than the rest of the bag 10.

[0096] Figure 5A is a schematic diagram of a cross-sectional view of the container 100 showing the flow of gas entering the bag 10 through the connecting component 20 and exiting the bag 10. The connecting component 20 is attached to the wall 11B of the bag 10, and the strip 50 is attached to the first wall 11 B The second wall that "opposes" it 11 A It is attached to the bag 10. That is, the strip 50 is separated from the connecting component 20 by the internal space 12 of the bag 10. The internal space 12 does not have to 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 internal space 12 is always formed within the bag 10, for example, to accommodate the user's limbs for treatment. Therefore, in the initial state, the strip 50 and connecting component 20 in Figure 5A are separated from the opposing walls 11A and 11 B Although they are located above, there does not necessarily have to be an internal space separating them. As shown in the embodiment of Figure 5A, the connecting component 20 is in direct fluid communication with the upper layer 55 of the strip 50 (i.e., the layer furthest from the wall 11 to which the strip 50 is attached). The gas flow between the pressure regulator (not shown in Figure 5A) and the internal space 12 of the bag 10 is indicated by arrow 201. The direction of arrow 201 in Figures 5A and 5B is illustrative and does not indicate a limited direction. The gas can flow in either direction (i.e., both into and out of the bag 10) depending on the increase or decrease in pressure within the bag 10.

[0097] Refer to Figures 6 and 8 here. Figures 6 and 8 are schematic diagrams of the gas flow path in the strip 50, respectively. In Figures 6 and 8, the flow arrows 201, 203, and 205 are all depicted as if they only indicate the inflow of gas into the bag 10. However, typically the device 100 is configured to allow gas to flow in either direction (i.e., both in the direction of entering the bag 10 and the direction of leaving the bag 10) depending on whether the pressure in the bag 10 is rising or falling.

[0098] Figure 6 shows a portion of the gas channel, which consists of a strip 50 containing a gas permeable layer 55. As shown, the gas flow 201 enters the strip 50, propagates along the length of the strip (arrow 203), and can "exit" the strip 50 through any surface as indicated by arrow 205. In a certain use, the bag 10 is partially evacuated. This evacuation removes the gas in the internal space 12 of the bag 10 through the connector 20, and the two walls 11 of the bag 10 are attracted to each other by "negative pressure". "Partial evacuation" means reducing the gas pressure inside the bag to 560 mmHg or less, or to 660 mmHg or less. The strip 50 (which is at most partially compressible) maintains the gas channel. This gas channel exists from the connector 20 (e.g., where arrow 201 indicates "entry" into the strip 50) to any point on the upper surface of the strip (e.g., where pressure-related treatment is performed). As previously stated, the gas channel is not directional. The term “maintain the gas channel” and other similar terms mean that it is open for a gas flow to pass through, where the gas flow is suitable for the applicable treatment or other purpose. In a non-limiting embodiment relating to negative pressure wound treatment, the bag is partially evacuated to an absolute gas pressure of 560 mmHg to remove all air from the bag except for any remaining air in the gas channel (i.e., air in the gas-permeable strip or layer or material) and “maintain” the gas channel (i.e., there is enough gas flow to transmit negative pressure from the connecting component to, for example, the wound which is in fluid communication with the gas-permeable material). As shown in Figure 8, the strip may have one or more layers 60 for, for example, attachment to the wall 11 of the bag 10.

[0099] In the embodiments shown in Figures 6 and 8, the configuration and selection of constituent materials of the container 100 are such that gas flow paths are maintained across the gas-permeable layer 55 (e.g., the flow paths indicated by arrows 201, 203, and 205 (in any direction)) over a wide range of pressures for pressure-related treatment. The appropriate gas flow paths are those suitable for the gas flow required for pressure-related treatment. For example, the pressure adjustment modes of the device 100 may include bringing the pressure inside the bag 10 to and / or maintaining a pressure in the range of 460 mmHg to 1060 mmHg, or 460 mmHg (i.e., negative pressure 300 mmHg) to 760 mmHg, or 560 mmHg to 760 mmHg, or 760 mmHg to 1060 mmHg (i.e., positive pressure 300 mmHg), or 760 mmHg to 960 mmHg. In one embodiment, it is desirable that the material(s) of the gas permeable layer 55 be selected such that the layer 55 (and the strip 50 as a whole) is at most partially compressible (i.e., not completely compressible). This is because if it were completely compressible, the gas passage would be closed at one or more locations, or completely, by negative pressure (i.e., exhaust of the bag 10).

[0100] Figure 17 shows the container 100 being deployed on a limb of a human subject 90 according to an embodiment. A limb sealing member 30 (e.g., adhesive tape) is provided to seal the area around the near end of the opening of the bag 10 and the limb. A gas flow channel ribbon 32 (e.g., a ribbon that is at least partially elastic of the gas flow channel material) is provided and positioned as a lateral extension of the gas flow channel (i.e., a portion that extends laterally from the strip and around the limb). A sponge 31 or a similarly soft material is inserted between the wound and the elastic ribbon 32, or alternatively between the wound and the strip 50.

[0101] Refer to Figures 23 and 24 here. Figure 23 shows a non-limiting embodiment of the system. This system is for performing a multi-pressure therapy protocol on a human subject according to one embodiment. This system comprises a gas transfer device 550. The gas transfer device 550 has a first opening 51 and a second opening 52 for gas transfer through it. Figure 24 shows the arrangement of the first container 100 and the second container 200 attached to the limbs of the 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 illustrative, and the respective arrangements and positions will differ in other embodiments. In other embodiments (not shown), the connecting component 20 between the first container 100 and the gas transfer device 550 is provided only at the distal part of the container 100, i.e., only at the distal end or distal extension 15 of the bag 10.

[0102] The first gas transfer unit 501 has a first opening 51 for passing and transferring gas. The first gas transfer unit 501 is configured to i) adjust the pressure in a first container 100, which is arranged in fluid communication with it, over a range from a pressure 200 mmHg lower than the ambient pressure to a pressure 160 mmHg higher than the ambient pressure, and ii) allow a gas, such as a therapeutic gas 140, to flow through the first opening 51. In one embodiment, the first container is comprised of a closed-end bag 10 (for example, one of the bags 10 shown in Figure 1 or 2).

[0103] The second gas transfer unit 502 has a second opening 52 for passing and transferring gas. The second gas transfer unit 502 is configured to regulate the pressure in a second container 200, which is arranged in fluid communication with it, over a range of ambient pressures that are up to 100 mmHg higher than the ambient pressure. A 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 sequentially or in parallel in each of the following modes. In this disclosure, the term “electronic circuit” is a term widely used to describe any combination of hardware, software, and / or firmware. The electronic circuit may include any executable code module (i.e., stored in a computer-readable medium) and / or firmware and / or hardware elements, which include, but are not limited to, field-programmable logic array (FPLA) elements, hardwired logic elements, field-programmable gate array (FPGA) elements, and application-specific integrated circuit (ASIC) elements. Any instruction set architecture may be used, including but not limited to reduced instruction set computer (RISC) architectures and / or composite instruction set computer (CISC) architectures. The electronic circuit may be located in a single location or distributed across multiple locations. In the multiple locations, various circuit elements may communicate electronically with each other, either wired or wirelessly.

[0105] In one embodiment, the pressure regulator 550 may include, but is not limited to, any or all of the following components: a power inlet having 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, a solenoid valve, a pressure pump, a vacuum pump, a DC actuator for operating the pump and valve, a control module, a chemical ozone destroyer, and an internal silicone gas hose.

[0106] In a first mode of the system, the first gas transfer unit 501 introduces a gas, such as a therapeutic gas 140, into the first container 100 through the first opening 51. This is done in response to input confirming 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 portion 95 in the longitudinal direction 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 has visually checked the connection between the first container 100 and the first gas transfer unit 501.

[0107] In the second mode of the system, the second gas transfer unit 502 controls the respective gas pressures within the fluid-holding compartments 225 of the second container 200, which are higher than the surrounding gases. This control is performed so that the fluid-holding compartments 225 apply their respective compressive pressures to the corresponding portions 98 of the limbs 90 through the walls 11 of the first container 100. This adjustment is made through the second opening 52, during which time at least a portion of the gas 140 is present within the first container 100. This control causes the gas 140 to flow ("inductive flow," "indirect flow"). This flow occurs over a portion 115 of the first container 100 that is surrounded by the second container 200. This portion 115 is within the range surrounded by the fluid-holding compartments 225. This adjustment is performed in response to input. The input is one that confirms that the second container 200 is in fluid communication with the second gas transfer unit 502 and that the second container 200 is positioned to surround at least a portion 105 in the longitudinal direction of the first container 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 by a human user who has visually checked the connection between the second container 200 and the second gas transfer unit 502.

[0108] In a second non-limiting embodiment of the treatment protocol, the system comprising the electronic circuit 65 and the pressure regulator 550 has two main operating modes that are performed continuously and / or in parallel. The two operating modes are (1) lymphatic massage and ozone disinfection, and (2) pulsed vacuum + ozone. For clarification, “ozone” or more appropriately ozone-containing gas is a non-limiting embodiment of the therapeutic gas that can be used according to the embodiment.

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

[0110] a. A live test of the apparatus 100, which includes the first container 10, is performed. The apparatus 550 operates a vacuum pump until a negative pressure of approximately 100 mmHg lower in gauge pressure than the ambient pressure is reached inside the first container 10. After waiting for 10 seconds, the pressure is checked. The apparatus 550 allows a pressure drop of 15 mmHg negative pressure. If this value is exceeded, the test is a failure.

[0111] b. Ozone filling: Partially fill the first container with a predetermined amount of ozone.

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

[0113] d. Ozone removal: A vacuum pump is operated to remove ozone from the first container 100, achieving a negative pressure approximately 100 mmHg lower in gauge pressure than the surroundings. The removed ozone is destroyed (i.e., converted back to oxygen) by an ozone depletion device.

[0114] e. Vacuum treatment: The vacuum pump is restarted to achieve a negative pressure in the first container 100 that is approximately 100 mmHg lower than the ambient pressure, and this negative pressure is maintained for a predetermined time. Once the negative pressure is released, the vacuum pump is restarted to achieve the required negative pressure. Ozone is reintroduced into the first container 100 to a negative pressure approximately 20 mmHg lower than the ambient pressure, and this is maintained for a predetermined time. The cycle of discharge and ozone reintroduction is repeated until the predetermined treatment time is reached.

[0115] f. Ozone removal: A vacuum pump is operated to remove ozone from the first container 100, achieving a negative pressure approximately 100 mmHg lower than the ambient pressure. The removed ozone is destroyed (i.e., returned to oxygen) by an ozone depletion device.

[0116] Figure 25 shows another non-limiting embodiment of the system. This system is for performing a multi-pressure therapy protocol on a human subject according to one embodiment. Apparatus 100 is shown in a “site” where the components of a first container (bag) 10 surround a limb 90 of a human subject. Apparatus 100 includes a connecting component 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 part including a gas flow path strip 50 and a second part including an elastically compressible member 31 that communicates with a target portion 95 (not shown) of the limb 90. The second container 200 includes four fluid compartments 2251, 2252, 2253, and 2254, which are connected to the second opening 52 of the pressure regulator 550 via gas hoses 2201, 2202, 2203, and 2204, respectively.

[0117] Figures 26A, 26B, 26C, 26D, 26E, and 26F show a sequence of exemplary operating modes of the system (for example, the system shown in Figure 25). The exemplary operating modes include limb “peristaltic massage.” Limb “peristaltic massage” is a sequential compression protocol that utilizes the expansion and contraction of four fluid compartments 2251, 2252, 2253, and 2254 to peristaltically circulate a gas contained in the first container 10 that is in fluid communication with the target limb 90 (and, if necessary, a target part 95 of the limb).

[0118] The limb 90 is at least partially inserted into a first container 10 containing a certain amount of gas 14. In one embodiment, the first container 10 is provided with a gas channel (e.g., a gas channel strip 50 and an elastically compressible member 31). In such an embodiment, 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 channel, as in the embodiments shown in Figures 26A to 26F. A second container 200, comprising four fluid compartments 2251, 2252, 2253, and 2254, surrounds the first container 10, and a force is applied to the first container by the expansion of one or more of the fluid compartments 2251, 2252, 2253, and 2254. This force is transmitted through the walls of the first container 10 to the limb and / or components provided in the first container 10 (e.g., gas channel portions 50 and 31).

[0119] In Figure 26A, none of the fluid compartments 2251, 2252, 2253, and 2254 are expanded, and the available gas 14 is being delivered into the first container 10 (e.g., into a gas flow path (not shown)) without any action by the second container 200. In Figure 26B, the first fluid compartment 2251 is expanded, causing some of the gas 14 to flow proximally, as indicated by the small arrow. In Figure 26C, the first compartment 2251 remains expanded, and the second compartment 2252 is expanded, allowing more gas 14 to flow proximally. In Figure 26D, the first compartment 2251 is contracted, while the second compartment 2252 remains expanded, and the third compartment 2253 is expanded, causing some of the gas 14 to flow distally. In Figure 26E, the second compartment 2252 also contracts, while the third compartment 2253 remains expanded and the fourth compartment 2254 expands, allowing more gas 14 to flow distally. In Figure 26F, the third compartment 2253 also contracts, while the fourth compartment 2254 remains expanded, causing the gas 14 to flow in the initial state shown in Figure 26A. As will be apparent to those skilled in the art, the next step in this sequence is to contract the fourth compartment 2254 to return to the conditions of Figure 26A, and then repeat the cycle as programmed. In some embodiments, the pressure due to expansion may vary from compartment to compartment and from cycle to cycle.

[0120] Refer to Figures 27A, 27B, 27C, 27D, and 27E here.

[0121] A method according to one embodiment is disclosed. This method is for performing a multipressure therapy protocol on a limb 90 of a human subject using a gas transfer system 550 according to any embodiment disclosed herein. An exemplary gas transfer system 550 has a first opening 51 and a second opening 52 for passing and transferring gas. 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 can be opened to the gas transfer system 550. In one embodiment, one or both of the first container 10 and the second container 200 are flexible. As shown in the flowchart of Figure 27A, the method includes at least steps S01 and S02.

[0122] Step S01: With the first container 10 surrounding at least a portion 95 of the limb 90 of the subject, a flow of gas 140 is created into the first container through the first opening. In one embodiment, the gas includes a therapeutic gas, in which case the therapeutic gas includes at least one of ozone, oxygen, and essential oils.

[0123] Step S02: While at least a portion of the therapeutic gas 140 is present in the first container 10, the second container 200 surrounds at least a portion 105 in the longitudinal direction of the first container 10, and the respective gas pressures in the fluid-holding compartment 225 of the second container 200 are adjusted through the second opening 52 to be higher than the surroundings, so that the fluid-holding compartment 225 applies the respective compressive pressure to the corresponding portion 98 of the limb 90 through the wall 11 of the first container 10. In one embodiment, adjusting the respective gas pressures in the fluid-holding compartment 225 to be higher than the surroundings includes repeating a sequence of differential pressure adjustments over a period of time defined by the therapeutic protocol. In one embodiment, adjusting the respective gas pressures in the fluid-holding compartment 225 to be higher than the surroundings includes adjusting the respective pressures to be 20 to 100 mmHg higher than the surroundings. That is, the pressure in the inflated fluid-holding compartment 225 can be any pressure within the range of 20 to 100 mmHg higher gauge pressure than the surroundings, according to the user or the clinical selection of the desired pressure.

[0124] According to this method, gas (e.g., therapeutic gas 140) is circulated over at least a portion 115 of the first container 10 by adjusting the respective gas pressures, which are higher than the surroundings. Here, the first container 10 is surrounded by the second container 200 to the extent that "at least a portion 115" of it is enclosed by the fluid-holding compartment 225. In one embodiment, adjusting the respective gas pressures in the fluid-holding compartment 225, which are higher than the surroundings, involves repeating a differential pressure adjustment sequence.

[0125] While we do not wish to be bound by theory, the inventors believe that such a flow will result in a higher effective concentration of the therapeutic agent in the therapeutic gas near the wound. Furthermore, the inventors believe that such a flow will increase the concentration difference propulsion (mol / m³) near the wound. 3 We believe that the mass transfer rate improves as the mass transfer coefficient increases.

[0126] In one embodiment, the flow of the therapeutic gas 140 is at least partially through a flow path 55 within the first container 10 (for example, through a gas flow path in a gas flow path strip 50 or through a tubular system (not shown)). In one embodiment, the gas flow path strip is laterally open to the internal space of the first container along its length, so that fluids in the first container can freely enter and exit the gas flow path strip.

[0127] In one embodiment, the method includes the following steps prior to step S01, as shown in the flowchart of Figure 27B.

[0128] Step S03: Evaporate the first container 10 (for example, by evacuating through the first opening 51).

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

[0130] Step S04: With the first container 10 surrounding at least a portion 95 of the limb 90, a gas (e.g., therapeutic gas 140) is discharged from the first container 10 through the first opening 51 to reduce the pressure inside the first container 10 to a first pressure lower than the ambient pressure. In one embodiment, the first pressure lower than the ambient pressure is 10 to 50 mmHg lower than the ambient pressure. In one embodiment, the pressure is maintained at the first pressure lower than the ambient pressure for at least 3 minutes, at least 5 minutes, at least 10 minutes, or within the range of 3 to 90 minutes, 5 to 75 minutes, 10 to 60 minutes, or 15 to 60 minutes.

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

[0132] In one embodiment, the difference between a first pressure lower than the ambient pressure and a second pressure lower than the ambient pressure is 40 to 88 mmHg gauge pressure.

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

[0134] Step S06: Repeat the process of applying a first pressure lower than ambient pressure and a second pressure lower than ambient pressure over a period of time defined by the treatment protocol. In some embodiments, the first and second pressures lower than ambient pressure may differ with each repetition. In some embodiments, the first and second pressures lower than ambient pressure may be substantially the same with each repetition.

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

[0136] Step S07: An elastically compressible member is positioned so as to be in contact with the target area of ​​the limb. The elastically compressible member 31 can be made of a "wound sponge" or any open-cell foam. In one embodiment, releasing gas from the first container (e.g., step S03 or step S04) is effective in at least partially compressing the elastically compressible member 31. In one embodiment, creating a gas flow through the first opening (e.g., step S01 or step S05) is effective in expanding the elastically compressible member that has been at least partially compressed. If step S07 is performed, introducing the therapeutic gas 140 in step S05 causes the foam to act like a spring, partially releasing from its compressed state, allowing the therapeutic gas to be delivered to the area near the wound.

[0137] A method according to one embodiment is disclosed, which is a method for performing low-pressure therapy on a human limb 90. As shown in the flowchart of Figure 27A, the method includes at least steps S11, S12, S13, and S14.

[0138] Step S11: Position the pressure regulator 550 and the bag assembly. The bag assembly comprises a bag 10 and a gas flow strip 50. The bag 10 includes a connecting component 20, which is attached to the wall 11 of the bag 10 at its distal end. The gas flow strip 50 is positioned longitudinally within the bag 50 between the connecting component 20 and the proximal end of the bag. In this manner, the strip 50 is laterally open to the internal space 12 of the bag 10 along its length. Thus, when the bag 10 is in a non-evacuated state, the fluid 14 inside the bag 10 can freely flow into and out of the gas flow strip. In an embodiment, the strip 50 is sufficiently incompressible to maintain the gas flow through it even when the bag 10 is partially evacuated and the wall 11 of the bag 10 is indented. Accordingly, this gas passage (including the strip 50, and optionally including an elastically compressible member 31 that is in fluid communication with both the strip 50 and the target area 95 of the limb 90 (e.g., a wound)) is maintained from the bag's connecting component 20 to the target area (e.g., the target area 95). The strip can be formed according to any of the embodiments and examples disclosed herein.

[0139] Step S12: Place at least a portion of the limb 90 into the bag 10 through the proximal opening.

[0140] Step S13: The pressure regulator 550 is connected to the connecting component 20, allowing the flow of gas 140 between the pressure regulator 550 and the internal space 12 of the bag 10. In one embodiment, the supply of gas 14 (e.g., therapeutic gas) to the internal space 12 is at least partially via the gas flow strip 50. In one embodiment, the supply of gas 14 (e.g., therapeutic gas) to the internal space 12 is substantially entirely via the gas flow strip 50. In one embodiment, the strip 50 is integrally formed with the bag 10. In another embodiment, 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 is implementable with all the devices, systems, and methods disclosed herein).

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

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

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

[0144] In one embodiment, a first pressure lower than the ambient pressure is 10 to 50 mmHg lower than the ambient pressure. In another embodiment, a second pressure lower than the ambient pressure is 60 to 100 mmHg lower than the ambient pressure.

[0145] In one embodiment, as shown in the flowchart of Figure 28C, the method further includes the following steps prior to step S11.

[0146] Step S16: An elastically compressible member 31 is positioned to be in fluid communication with the gas flow path strip 50 and the target portion 95 of the limb 90. In one embodiment, the elastically compressible member 31 is at least partially compressed at a first pressure lower than the ambient pressure, while being biased to expand when the pressure rises to a second pressure lower than the ambient pressure. In one embodiment, the elastically compressible member 31 includes an open-cell foam.

[0147] Further description of embodiments Embodiments of the present invention relate to a device used in conjunction with a pressure regulating device when performing treatment on a human limb. According to the embodiment, the device used in conjunction with a pressure regulating device when performing treatment on a human limb comprises: (a) a flexible bag formed to accommodate at least a portion of the limb through an opening in the proximal part of the bag in a fitting mode; (b) a multilayer strip including a lower layer attached to the inner surface of the bag, the distal end of which is positioned in the distal part of the bag and the proximal end of which is positioned in the proximal part of the bag; and (c) a connecting component attached to the wall of the bag at the distal part of the bag, the connecting component effectively enabling gas flow between the pressure regulating device and the internal space of the bag in a pressure regulating mode, wherein the multilayer strip further has an upper layer including a partially compressible material, the partially compressible material forming a longitudinally oriented gas channel within the bag between the connecting component and the proximal part of the bag. In one embodiment, the longitudinal gas channel can be maintained when the gas pressure in the bag is 660 mmHg or less. In one embodiment, the longitudinal gas flow path can be maintained when the gas pressure inside 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 walls of the bag to the top layer of the multilayer strip. In another 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 walls of the bag to the top layer of the multilayer strip.

[0149] In one embodiment, the Shore A hardness of the multilayer strip may be 70 or less, or 60 or less, or 50 or less, or 40 or less. In one embodiment, the Shore A hardness of the upper layer of the strip may be 70 or less, or 60 or less, or 50 or less, or 40 or less. In one embodiment, the distal end of the multilayer strip is in fluid communication with the connecting component, thereby allowing the partially compressible material to form a gas channel from the connecting component to the proximal end of the multilayer strip. In one embodiment, the multilayer strip may have a length-to-width ratio of at least 3:1, or at least 5:1, or at least 10:1. In one embodiment, the length of the multilayer 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 one embodiment, the thickness of the multilayer 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 one embodiment, the thickness of the upper layer can be 3.5 mm or less, 5 mm or less, 7.5 mm or less, or 10 mm or less.

[0150] In one embodiment, the bag may be sized to accommodate a hand or a foot. In one embodiment, the bag may be sized to accommodate at least a large portion of an adult's arm in the longitudinal direction. In one embodiment, the bag may be sized to accommodate at least a large portion of an adult's leg in the longitudinal direction. In one embodiment, the length of the multilayer strip may be at least 70% of the length of the bag. In one embodiment, (i) the distal portion of the bag may have a tab portion located distally and open to the internal space of the bag, the width of which may be less than 25% of the maximum width of the distal portion of the bag, and / or (ii) the connecting component may be attached to at least a portion thereof within the distal tab portion.

[0151] In one embodiment, the treatment may include negative pressure wound treatment. In one embodiment, the pressure adjustment mode may include creating a vacuum inside the bag. In one embodiment, the pressure adjustment mode may include setting the pressure inside the bag to a range of 460 mmHg to 1060 mmHg, or 460 mmHg to 760 mmHg, or 560 mmHg to 760 mmHg, or 760 mmHg to 1060 mmHg, or 760 mmHg to 960 mmHg. In one embodiment, the multilayer 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 one embodiment, the lower layer may include an adhesive. In one embodiment, the multilayer strip may be attached to a first wall of the bag, and the connecting component may be attached to a second wall of the bag. In one embodiment, the multilayer strip may be attached to the same wall to which the connecting component is attached, and / or the lower layer of the multilayer strip may be in mechanical contact with the connecting component, and / or the upper layer may be in fluid communication with the connecting component through the lower layer. In one embodiment, the inside of the bag may be pre-sterilized. In one embodiment, the bag may include an ozone-resistant material. In one embodiment, the multilayer strip may effectively maintain fluid communication along the longitudinal flow path when a portion of the flow path is subjected to a positive pressure applied from the outside of 100 mmHg.

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

[0154] According to embodiments of the present invention, a device used in conjunction with a pressure regulating device when performing treatment on a human limb comprises: (a) a flexible bag, the bag being formed to surround at least a portion of the limb in the attachment mode; (b) a connecting component attached to the wall of the bag at the distal end of the bag, the connecting component effectively enabling the flow of gas between the internal space of the bag and the pressure regulating device in the pressure regulating mode; and (c) a gas permeable strip attached to the inner surface of the bag and having a length of 70% or more of the length of the bag, the gas permeable strip comprising a partially compressible gas permeable material, the distal end of which communicates with the connecting component at the distal end of the bag, the proximal end of which is positioned at the proximal end of the bag, and which forms a longitudinal gas passage. In one embodiment, the partially compressible gas permeable material can form a longitudinal gas passage when the bag is at least partially evacuated. In one embodiment, 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 one embodiment, the partially compressible gas-permeable material can form a gas channel from the connecting component to the proximal end of the gas-permeable strip. In one embodiment, the gas-permeable strip may have a length-to-width ratio of at least 3:1, or at least 5:1, or at least 10:1. In one embodiment, the length of the gas-permeable 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 one embodiment, 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. In one embodiment, the bag may be sized to accommodate a hand or a foot. In one embodiment, the bag may be sized to accommodate at least a large portion of an adult's arm longitudinally. In one embodiment, the bag may be sized to accommodate at least a large portion of an adult's leg longitudinally.

[0156] In one embodiment, (i) the distal portion of the bag may have a distally positioned tab portion that is open to the internal space of the bag, the width of which may be less than 25% of the maximum width of the distal portion of the bag, and / or (ii) the connecting component may be mounted, at least a portion thereof, within the distal tab portion. In one embodiment, the treatment may include negative pressure wound treatment. In one embodiment, the pressure adjustment mode may include creating a vacuum inside the bag. In one embodiment, the pressure adjustment mode may include setting the pressure inside the bag to a range of 460 mmHg to 1060 mmHg, or 460 mmHg to 760 mmHg, or 560 mmHg to 760 mmHg, or 760 mmHg to 1060 mmHg, or 760 mmHg to 960 mmHg.

[0157] In one embodiment, 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 one embodiment, the gas permeable strip may be attached to a first wall of the bag, and the connecting component may be attached to a second wall of the bag. In one embodiment, the gas permeable strip may be attached to the same wall to which the connecting component is attached. In one embodiment, the inside of the bag may be pre-sterilized. In one embodiment, the bag may contain an ozone-resistant material. In one embodiment, the gas permeable strip may effectively maintain fluid communication along the longitudinal flow path when a portion of the flow path is subjected to a positive pressure applied from the outside of 100 mmHg.

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

[0159] According to embodiments of the present invention, a device used in conjunction with a pressure adjustment device when performing treatment on a human limb comprises: (a) a flexible bag formed to surround at least a portion of the limb in wearing mode; (b) a connecting component attached to the wall of the bag at the distal end of the bag, which effectively enables the flow of gas between the pressure adjustment device and the internal space of the bag in pressure adjustment mode; and (c) a gas permeable strip attached to the inner surface of the bag, the gas permeable strip having a distal end in communication with the connecting component at the distal end of the bag, the proximal end positioned at the proximal end of the bag, and comprising a partially compressible gas permeable material that forms a gas channel in the longitudinal direction, and having a dimensionless aspect ratio of thickness to width of 1:5 to 1:15.

[0160] In one embodiment, the longitudinal gas flow path can be maintained when the gas pressure inside the bag is 660 mmHg or less. In another embodiment, the longitudinal gas flow path can be maintained when the gas pressure inside the bag is 560 mmHg.

[0161] 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 walls of the bag to the top layer of the multilayer 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 walls of the bag to the top layer of the multilayer strip. In one embodiment, 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 one embodiment, the partially compressible gas permeable material can form a gas flow path from the connecting component to the proximal end of the gas permeable strip. In one embodiment, the gas permeable strip may have a length-to-width ratio of at least 3:1, or at least 5:1, or at least 10:1. In one embodiment, the length of the gas permeable 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 one embodiment, the thickness of the gas-permeable strip can be 3.5 mm or less, 5 mm or less, 7.5 mm or less, or 10 mm or less.

[0162] In one embodiment, the bag may be sized to accommodate a hand or a foot. In one embodiment, the bag may be sized to accommodate at least a large portion of an adult's arm longitudinally. In one embodiment, the bag may be sized to accommodate at least a large portion of an adult's leg longitudinally. In one embodiment, (i) the distal portion of the bag may have a tab portion located distally to the internal space of the bag, the width of which may be less than 25% of the maximum width of the distal portion of the bag, and / or (ii) the connecting component may be attached to at least a portion of which is located within the distal tab portion. In one embodiment, the treatment may include negative pressure wound treatment. In one embodiment, the pressure adjustment mode may include creating a vacuum inside the bag. In one embodiment, the pressure adjustment mode may include setting the pressure inside the bag to a range of 460 mmHg to 1060 mmHg, or 460 mmHg to 760 mmHg, or 560 mmHg to 760 mmHg, or 760 mmHg to 1060 mmHg, or 760 mmHg to 960 mmHg.

[0163] In one embodiment, the length of the gas permeable strip may be at least 70% of the length of the bag. In one embodiment, the gas permeable strip may be attached to a first wall of the bag, and the connecting component may be attached to a second wall of the bag. In one embodiment, the gas permeable strip may be attached to the same wall to which the connecting component is attached. In one embodiment, the inside of the bag may be pre-sterilized. In one embodiment, the bag may contain ozone-resistant material. In one embodiment, the gas permeable strip may effectively maintain fluid communication along the longitudinal flow path when a portion of the flow path is subjected to a positive pressure applied from the outside of 100 mmHg.

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

[0165] Embodiments of the present invention relate to a device used in conjunction with a pressure regulating device when performing treatment on a human limb.According to an embodiment, a device is provided for use in conjunction with a pressure regulating device when performing treatment on a human limb, the device comprising: (a) a bag, formed to accommodate at least a portion of the limb through an opening in the proximal part of the bag in a fitting mode; (b) a multilayer strip including a lower layer attached to the inner surface of the bag, the distal end of which is positioned in the distal part of the bag and the proximal end of which is positioned in the proximal part of the bag; and (c) a connecting component attached to the wall of the bag at the distal part of the bag, the connecting component effectively enabling a gas flow between the pressure regulating device and the internal space of the bag in a pressure regulating mode, wherein the multilayer strip further has an upper layer comprising a partially compressible material, the partially compressible material forming a gas channel arranged longitudinally within the bag between the connecting component and the proximal part of the bag.

[0166] In one embodiment, the longitudinal gas flow path can be maintained when the gas pressure inside the bag is 660 mmHg or less. In another embodiment, the longitudinal gas flow path can be maintained when the gas pressure inside the bag is 560 mmHg.

[0167] In one embodiment, the multilayer 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 walls of the bag to the top layer of the multilayer strip. In another 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 walls of the bag to the top layer of the multilayer strip.

[0169] In one embodiment, the Shore A hardness of the multilayer strip can be 70 or less, or 60 or less, or 50 or less, or 40 or less.

[0170] In one embodiment, the distal end of the multilayer strip is in fluid communication with the connecting component, thereby allowing the partially compressible material to form a gas channel from the connecting component to the proximal end of the multilayer strip.

[0171] In one embodiment, the multilayer strip may have a length-to-width ratio of at least 3:1, or at least 5:1, or at least 10:1. In one embodiment, the length of the multilayer 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 one embodiment, the thickness of the multilayer 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 one embodiment, 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 one embodiment, the bag may be sized to accommodate a hand or a foot. In one embodiment, the bag may be sized to accommodate at least a large portion of an adult's arm in the longitudinal direction. In one embodiment, the bag may be sized to accommodate at least a large portion of an adult's leg in the longitudinal direction.

[0173] In one embodiment, the length of the multilayer strip can be at least 20% of the length of the bag.

[0174] In one embodiment, the length of the multilayer strip can be at least 30% of the length of the bag.

[0175] In one embodiment, the length of the multilayer strip can be at least 40% of the length of the bag.

[0176] In one embodiment, the length of the multilayer strip can be at least 50% of the length of the bag.

[0177] In one embodiment, the length of the multilayer strip can be at least 60% of the length of the bag.

[0178] In one embodiment, the length of the multilayer strip can be at least 70% of the length of the bag.

[0179] In one embodiment, (i) the distal portion of the bag may have a tab portion located distally to the internal space of the bag, the width of which may be less than 25% of the maximum width of the distal portion of the bag, and / or (ii) the connecting component may be attached to at least a portion of which is located within the distal tab portion.

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

[0181] In one embodiment, the pressure adjustment mode may include applying pressure from the outside to the bag and transmitting it through the walls of the bag to the top layer of the multilayer strip, wherein the pressure applied from the outside may be in the range of 0 mmHg to 30 mmHg. In another embodiment, the pressure adjustment mode may include applying pressure from the outside to the bag and transmitting it through the walls of the bag to the top layer of the multilayer strip, wherein the pressure applied from the outside may be in the range of 0 mmHg to 80 mmHg.

[0182] In one embodiment, the multilayer 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 one embodiment, the lower layer may include an adhesive. In one embodiment, the multilayer strip may be attached to a first wall of the bag, and the connecting component may be attached to a second wall of the bag.

[0184] In one embodiment, the multilayer strip can effectively maintain fluid communication along the longitudinal flow path when a portion of the flow path is subjected to a positive pressure applied from outside at 100 mmHg.

[0185] According to one embodiment, the device used in conjunction with a pressure adjustment device when performing treatment on a person's limb comprises: (a) a bag formed to surround at least a portion of the limb in the attachment mode; (b) a connecting component attached to the wall of the bag at the distal end of the bag, which effectively enables the flow of gas between the pressure adjustment device and the internal space of the bag in the pressure adjustment mode; and (c) a gas permeable strip attached to the inner surface of the bag and having a length of 70% or more of the length of the bag, wherein the distal end of the gas permeable strip communicates with the connecting component at the distal end of the bag, and the proximal end of the gas permeable strip is positioned at the proximal end of the bag and comprises a partially compressible gas permeable material that forms a longitudinal gas flow path.

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

[0187] According to an embodiment of the present invention, a device used in conjunction with a pressure adjustment device when performing treatment on a human limb comprises: (a) a bag formed to surround at least a portion of the limb in the attachment mode; (b) a connecting component attached to the wall of the bag at the distal end of the bag, which effectively enables the flow of gas between the pressure adjustment device and the internal space of the bag in the pressure adjustment mode; and (c) a gas permeable strip attached to the inner surface of the bag, wherein its distal end communicates with the connecting component located at the distal end of the bag, its proximal end is located at the proximal end of the bag, and the gas permeable strip comprises a partially compressible gas permeable material that forms a gas flow path in the longitudinal direction, and has a dimensionless aspect ratio of thickness to width of 1:5 to 1:15.

[0188] In one embodiment, the strip or the multilayer strip forms a longitudinal gas flow path, at least in the pressure adjustment mode.

[0189] In one embodiment, the strip or the multilayer 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 multilayer 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 the multilayer 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 1:2.5 to 1:20, and a length to width ratio of at least 3:1, wherein the strip or the multilayer strip comprises a partially compressible gas permeable material, which forms longitudinal gas channels in pressure regulation modes (at least) over a range of absolute pressures in the bag from 560 mmHg to 960 mmHg.

[0192] In one embodiment, the strip or the multilayer strip may 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 the multilayer strip comprises a partially compressible gas permeable material which forms longitudinal gas channels in a pressure adjustment mode (at least) over a range of absolute pressure inside the bag of 560 mmHg to 960 mmHg, and the strip or the multilayer strip comprises a partially compressible gas permeable material which forms longitudinal gas channels in a pressure adjustment mode (at least) which includes applying external pressure in a gauge pressure range of 0 mmHg to 30 mmHg.

[0193] A method according to an embodiment is disclosed, which is a method for performing a multipressure therapy protocol on a human subject using a gas transfer system having first and second openings for passing and transferring gas. The first opening is in fluid communication with a first container, and the second opening is in fluid communication with a second container, the second container having at least a number of fluid-holding compartments that are open to each other. The method includes (a) creating a flow of therapeutic gas into the first container through the first opening, with the first container surrounding at least a longitudinal portion of the limb of the subject; and (b) controlling the respective gas pressures in the fluid-holding compartments of the second container to be higher than the surrounding area, with the second container surrounding at least a longitudinal portion of the first container, while at least a portion of the therapeutic gas is present in the first container, via the second opening, so that the fluid-holding compartments apply respective compressive pressures to the corresponding portions of the limb through the walls of the first container.

[0194] Other embodiments of the method are disclosed, which is a method for performing a multipressure therapy protocol on a human subject using a gas transfer system having first and second openings for passing and transferring gas. 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-holding compartment. The method includes (a) creating a flow of therapeutic gas into the first container through the first opening, and (b) controlling at least one gas pressure higher than the surroundings in at least one fluid-holding compartment of the second container via the second opening, with at least a portion of the therapeutic gas present in the first container and the second container surrounding at least a portion of the first container in the longitudinal direction, so that the at least one fluid-holding compartment applies compressive pressure to the corresponding portion of the limb through the wall of the first container.

[0195] According to this method, the therapeutic gas is circulated through at least a portion of the first container by adjusting the gas pressure, which is higher than the surrounding gas pressure. Here, the first container is surrounded by the second container to the extent that at least a portion of it is enclosed by the fluid-holding compartment.

[0196] In one embodiment, the first container may be flexible, and is typically flexible.

[0197] In one embodiment, the second container may be flexible, and is typically flexible.

[0198] In one embodiment, the method may further include evacuating the first container through the first opening before generating a flow of therapeutic gas.

[0199] In one embodiment, adjusting the gas pressure in the fluid-holding compartment, which is higher than the surrounding gas pressure, may include repeating a sequence of differential pressure adjustments over a period of time defined by the treatment protocol.

[0200] In one embodiment, the method may further include, after adjusting the respective gas pressures in the fluid-holding compartment to be higher than the surroundings, (i) discharging 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 inside the first container to a first pressure lower than the surroundings, and (ii) introducing the therapeutic gas into the evacuated first container through the first opening, thereby increasing the pressure inside the first container to a second pressure lower than the surroundings.

[0201] In one embodiment, the method may include repeating first and second pressures lower than the ambient pressure over a period of time defined by the treatment protocol.

[0202] In one embodiment, adjusting the gas pressure in the fluid holding compartment to be higher than the surroundings may include adjusting the pressure to be 20 to 100 mmHg higher than the surroundings.

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

[0204] In one embodiment, the flow of the therapeutic gas can be at least partially through the flow path within the first container.

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

[0206] According to the embodiment, a system for performing a multi-pressure therapy protocol on a human subject includes: (a) a first gas transfer unit having a first opening for passing and transferring gas, (i) configured to adjust the pressure in a first container arranged in fluid communication with the first gas transfer unit over a range of pressure from 200 mmHg lower than ambient pressure to 160 mmHg higher than ambient pressure, and (ii) configured to generate a flow of therapeutic gas through the first opening; (b) a second gas transfer unit having a second opening for passing and transferring gas, configured to adjust the pressure in a second container arranged in fluid communication with the second gas transfer unit over a range of ambient pressure higher than the ambient pressure, up to 100 mmHg higher than ambient pressure; and (c) an electronic circuit, (i) configured such that the first container is in fluid communication with the first gas transfer unit and the first container surrounds at least a portion of the limb of the subject in the longitudinal direction. (ii) an electronic circuit programmed to operate sequentially in one of the following modes: (ii) in response to an input confirming that the container is located in the first container, the first gas transfer unit introduces a therapeutic gas into the first container through the first opening; and (ii) in response to an input confirming that the second container is in fluid communication with the second gas transfer unit and that the second container is located surrounding at least a portion of the longitudinal direction of the first container, the second gas transfer unit adjusts the respective gas pressures in the fluid-holding compartments of the second container through the second opening to be higher than the surroundings, thereby causing the fluid-holding compartments to apply their respective compressive pressures to the corresponding portions of the limbs through the walls of the first container, thereby circulating the therapeutic gas over at least a portion of the first container surrounded by the second container to the extent surrounded by the fluid-holding compartments.

[0207] According to the embodiment, a system for performing a multi-pressure therapy protocol on a human subject includes: (a) a first gas transfer unit having a first opening for passing and transferring gas, (i) configured to adjust at least one of a pressure (A) in a first container located in fluid communication with the first gas transfer unit that is between 50 mmHg lower than the ambient pressure and within the range of the ambient pressure, and a pressure (B) in a first container located in fluid communication with the first gas transfer unit that is between the ambient pressure and within the range of 50 mmHg higher than the ambient pressure, and (ii) configured to generate a flow of therapeutic gas through the first opening; (b) a second gas transfer unit having a second opening for passing and transferring gas, configured to adjust the pressure in a second container located in fluid communication with the second gas transfer unit; and (c) an electronic circuit comprising (i) the first container being in fluid communication with the first gas transfer unit and the first container being at least the length of the limb of the subject. (ii) an electronic circuit programmed to operate sequentially in one of the following modes: (ii) a first mode in which the first gas transfer unit introduces therapeutic gas into the first container through the first opening in response to an input confirming that it is positioned to surround a portion of the hand; and (ii) a second mode in which, while at least a portion of the therapeutic gas is present in the first container, the second gas transfer unit adjusts the respective gas pressures in the fluid-holding compartments of the second container through the second opening to be higher than the surroundings, thereby causing the fluid-holding compartments to apply their respective compressive pressures to the corresponding portions of the limbs through the walls of the first container, thereby allowing the therapeutic gas to circulate over at least a portion of the first container surrounded by the second container to the extent surrounded by the fluid-holding compartments.

[0208] Further embodiments Further embodiments (or "Clauses") 1 to 111 are shown below.

[0209] Embodiment 1 A method for performing a multipressure therapy protocol on a human subject using a gas transfer system, wherein the gas transfer system has first and second openings for passing and transferring gas, the first opening being in fluid communication with a first container, the second opening being in fluid communication with a second container, the second container comprising a plurality of fluid holding compartments, and the method is as follows: a. With the first container surrounding at least a portion of the limb of the target in the longitudinal direction, a gas flow is generated into the first container through the first opening, and b. The method, comprising, while at least a portion of the gas is present in the first container, the second container surrounds at least a portion of the first container in the longitudinal direction, and adjusting the respective gas pressures through the second opening to be higher than the surrounding area within the fluid-holding compartment of the second container, so that the fluid-holding compartment applies respective compressive pressures to the corresponding portion of the limb through the wall of the first container.

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

[0211] Embodiment 1B: A method according to either Embodiment 1 or 1A, wherein (1) the second container and (2) at least one of the fluid holding compartments are sealed relative to the first container.

[0212] Embodiment 2: A method according to Embodiment 1, wherein the gas includes a therapeutic gas.

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

[0214] Embodiment 4 A method according to any prior embodiment, wherein the gas is circulated over at least a portion of the first container surrounded by the second container in the area enclosed by the fluid holding compartment by adjusting the respective gas pressures which are higher than the surrounding area.

[0215] Embodiment 5: A method according to any prior embodiment, in which adjusting the gas pressure in the fluid-holding compartment to be higher than the surrounding gas pressure is a method comprising repeating a differential pressure adjustment sequence.

[0216] Embodiment 6 A method according to either Embodiment 4 or 5, wherein the flow of the gas passes at least partially through a gas flow strip located in the first container, the gas flow strip being laterally open to the internal space of the first container along its length, so that the fluid in the first container can freely flow into and out of the gas flow strip.

[0217] Embodiment 6A: A method according to Embodiment 6, wherein the gas flow path strip is arranged in the longitudinal direction, i.e., the longitudinal direction, within the first container.

[0218] Embodiment 6B: A method according to either Embodiment 6 or 6A, wherein the gas flow strip comprises a material that is at most partially compressible, and when the first vessel is at least partially evacuated, the gas flow strip allows gas to flow along its entire length.

[0219] Embodiment 6C A method according to Embodiment 6B, wherein when the first container is at least partially evacuated under negative pressure (vacuum), one or more walls of the first container are dented, a lateral force is applied to the gas flow path strip, and the strip becomes a gas flow path that is closed laterally and open longitudinally.

[0220] Embodiment 6D A method according to any one of Embodiments 6 to 6C, wherein when one or more walls of the first container are indented due to the expansion of one or more of the fluid-holding compartments of the second container, the gas flow path strip maintains a flow path effective for gas transfer in at least the extent of the first container surrounded by the fluid-holding compartments of the second container.

[0221] Embodiment 6E: A method according to any one of Embodiments 6 to 6D, wherein the strip is aligned along the longitudinal direction of the fluid-holding compartment.

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

[0223] Embodiment 8 After adjusting the gas pressure in the fluid holding compartment, which is higher than the surrounding area, i. With the first container surrounding at least a portion of the limb, the gas is discharged from the first container through the first opening, thereby reducing the pressure inside the first container to a first pressure lower than the ambient pressure, ii. A method according to any prior embodiment, further comprising introducing the gas into the evacuated first container through the first opening, thereby raising the pressure inside the first container to a second pressure lower than the ambient pressure.

[0224] Embodiment 9 A method according to Embodiment 8, further comprising repeating first and second pressures lower than the ambient pressure over a period of time defined by the treatment protocol.

[0225] Embodiment 10 A method according to any prior embodiment, in which adjusting each gas pressure in the fluid holding compartment to a value within a range of 20 to 100 mmHg higher than the ambient pressure is performed.

[0226] Embodiment 11 A method according to any prior embodiment, wherein the first pressure lower than the ambient pressure is within the range of 10 to 50 mmHg lower than the ambient pressure.

[0227] Embodiment 12 A method according to any prior embodiment, wherein the second pressure, which is lower than the ambient pressure, is within the range of 60 to 100 mmHg lower than the ambient pressure.

[0228] Method according to any preceding embodiment, wherein the difference between the first pressure lower than the surroundings and the second pressure lower than the surroundings is 40 to 88 mmHg.

[0229] Method according to embodiment 13, wherein a gas flow path is maintained in the gas flow path strip at both the first and second pressures lower than the surroundings.

[0230] Method according to any one of embodiments 6 to 14, wherein the gas flow path strip is integrally formed with the first container.

[0231] Method according to any one of embodiments 6 to 14, wherein the gas flow path is attached to the inner surface of the first container.

[0232] Method according to any preceding embodiment, further comprising arranging an elastically compressible member to contact the target site of the limb.

[0233] Method according to embodiment 17, wherein the elastically compressible member also contacts 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] Method according to embodiment 17A, wherein the contact with the gas flow path strip is a direct contact.

[0235] Method according to any one of embodiments 17 to 17B, wherein when the first container is evacuated through the first opening to reduce the pressure in the first container to the first pressure lower than the surroundings, the elastically compressible member is at least partially compressed.

[0236] Method according to embodiment 18, wherein the first container is fully evacuated through the first opening to hermetically cover the limb with the first container.

[0237] Embodiment 19 A method according to Embodiment 18 or 18A, wherein generating the gas flow through the first opening is effective in expanding the elastically compressible member which is at least partially compressed.

[0238] Embodiment 20: A method according to any one of Embodiments 17 to 19, wherein the elastically compressible member includes an open-cell foam.

[0239] Embodiment 21 A method according to any prior embodiment, wherein the volume of at least a portion of the gas is in the range of 0.3 to 10 liters.

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

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

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

[0243] Embodiment 21D: A method according to any one of Embodiments 21 to 21C, wherein the volume is 8 liters or less.

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

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

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

[0247] Embodiment 22 A method according to any prior embodiment, which includes adjusting each gas pressure higher than the ambient pressure to produce continuous compression of the gas in the first container.

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

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

[0250] Embodiment 25 A system for performing a multi-pressure therapy protocol on a human subject, wherein the system is a. A first gas transfer unit having a first opening for transferring gas, wherein (i) the first gas transfer unit is configured to adjust the pressure inside a first container arranged in fluid communication with the first gas transfer unit, and (ii) the first gas transfer unit is configured to generate a flow of gas through the first opening, b. A second gas transfer unit having a second opening for passing and transferring gas, wherein the second gas transfer unit is configured to adjust the pressure inside a second container which is arranged in fluid communication with the second gas transfer unit, c. An electronic circuit, i. A first mode in which the first gas transfer unit allows gas to flow into the first container through the first opening, and ii. The system comprising: an electronic circuit programmed to operate sequentially in one of two second modes, while at least a portion of the gas is present in the first container, the second gas transfer unit adjusts the gas pressure in each fluid-holding compartment of the second container through the second opening, thereby causing the fluid-holding compartment to apply its respective compressive pressure to the corresponding portion of the limb through the wall of the first container.

[0251] System according to Embodiment 25, in which, in response to an input for confirming that the first container is in fluid communication with the first gas transfer portion and is arranged so as to surround at least a longitudinal part of the target limb, the gas is caused to flow by the first gas transfer portion in the first mode.

[0252] System according to either one of Embodiments 25 or 26, in which, in response to an input for confirming that the second container is in fluid communication with the second gas transfer portion and is arranged so as to surround at least a longitudinal part of the first container, each gas pressure is adjusted by the second gas transfer portion in the second mode.

[0253] System according to any one of Embodiments 25 to 27, in which the gas is caused to flow by the adjustment over at least a part of the first container surrounded by the second container within the range surrounded by the fluid holding section.

[0254] System according to Embodiment 28A, in which the flow is caused to occur at least partially by a series of expansions and / or contractions of the fluid holding section.

[0255] System according to any one of Embodiments 25 to 28A, in which adjusting each gas pressure within the fluid holding section includes repeating a differential pressure adjustment sequence.

[0256] Embodiment 30 A method according to either Embodiment 28 or 29, wherein the flow of the gas is at least partially (for example, at least 30%, at least 50%, at least 70%, at least 90%, or at least 95%) through a gas flow strip arranged longitudinally within the first vessel, the gas flow strip being laterally open to the internal space of the first vessel along its length, thereby allowing fluids within the first vessel to flow freely into and out of the gas flow strip.

[0257] Embodiment 31: A system according to any one of Embodiments 25 to 30, wherein the gas includes a therapeutic gas.

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

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

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

[0261] Embodiment 35 A system according to any one of Embodiments 25 to 34, wherein the second gas transfer unit is configured to adjust the pressure in the second container over a pressure range of 0 to 100 mmHg higher than ambient pressure or atmospheric pressure.

[0262] Embodiment 36: A method according to any one of Embodiments 30 to 35, wherein the gas flow path strip is integrally formed with the first container.

[0263] Embodiment 37 A system according to any one of Embodiments 30 to 35, wherein the gas flow path is attached to the inner surface of the first container, and may, if necessary, be directly attached to the inner surface of the first container.

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

[0265] Embodiment 37B A system according to any one of Embodiments 25 to 37A, wherein the first gas transfer unit comprises a container for storing or containing the therapeutic gas in order to supply 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 unit is configured to adjust the pressure in the first container over a range from a pressure 50 mmHg lower than ambient pressure or atmospheric pressure to ambient pressure or atmospheric pressure.

[0267] Embodiment 37D A system according to any one of Embodiments 25 to 37C, wherein the second gas transfer unit is configured to adjust the pressure in the second container over a pressure range of 0 to 40 mmHg higher than ambient pressure 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 joined together so that when the first container is subjected to a specific negative pressure in the range of 660 to 710 mmHg (absolute pressure), at least one wall of the first container dents, applying a lateral force to the gas flow path strip, thereby closing the strip laterally and creating a gas flow path that is open longitudinally.

[0269] Embodiment 37F: A system according to any one of Embodiments 25 to 37E, wherein the electronic circuit is further programmed in a third mode to extract the gas present in the first container and reduce the pressure inside the first container to a first pressure lower than ambient pressure or atmospheric pressure.

[0270] Embodiment 37G: A system according to Embodiment 37F, wherein the electronic circuit is further programmed, in a fourth mode following the third mode, to introduce a certain volume of a therapeutic gas or the therapeutic gas into the first vessel while maintaining the pressure in the first vessel below ambient pressure or atmospheric pressure.

[0271] Embodiment 38 A method for performing low-pressure therapy on a person's limbs, a. Includes providing a pressure regulating device and a bag assembly, wherein the bag assembly is i. A bag comprising a connecting component attached to the wall of the bag at the distal end of the bag, ii. A gas flow path strip disposed within the bag between the connecting component and the proximal portion of the bag, the gas flow path strip being laterally open to the internal space of the bag along its length, thereby allowing fluid inside the bag to flow freely into and out of the gas flow path strip when the bag is not evacuated, the method further comprises: b. To accommodate at least a portion of the limb in the bag through the opening in the proximal part of the bag, c. Connect the pressure regulating device to the connecting component, and in pressure regulating mode, enable gas flow between the pressure regulating device and the internal space of the bag, d. The method comprising controlling the pressure regulating device to remove a portion of the gas from the internal space of the bag and to reduce the pressure in the internal space to a first pressure lower than the ambient pressure.

[0272] Embodiment 38A: A method according to Embodiment 38, wherein the gas flow path strip is arranged longitudinally between the connecting component and the proximal portion of the bag.

[0273] Embodiment 38B: A method according to either Embodiment 38 or 38A, wherein the gas flow path strip comprises a material that is at most partially compressible, and the gas flow path strip is configured to maintain an effective gas flow when one or more walls of the bag dent due to a first pressure lower than the surroundings, thereby applying a compressive force to the gas flow path strip.

[0274] Embodiment 39 A method according to any one of Embodiments 38 to 38B, further comprising controlling the pressure regulating device to supply a certain amount of therapeutic gas to the internal space, thereby raising the pressure in the internal space to a second pressure lower than the ambient pressure.

[0275] Embodiment 40 A method according to Embodiment 38 or 39, wherein the gas flow path is maintained within the gas flow path strip at both the first and second pressures which are lower than the ambient pressure.

[0276] Embodiment 41 A method according to any one of Embodiments 38 to 40, further comprising providing an elastically compressible member that is in fluid communication with or in fluid contact with the gas flow path strip and the target portion of the limb.

[0277] Embodiment 42: A method according to Embodiment 41, wherein the elastically compressible member is at least partially compressed at a first pressure lower than the surroundings within the internal space, and is biased to expand when the pressure is increased to a second pressure lower than the surroundings.

[0278] Embodiment 43 A method according to either Embodiment 41 or 42, wherein the elastically compressible member includes an open-cell foam.

[0279] Embodiment 44 A method according to any one of Embodiments 39 to 43, wherein the supply of a certain amount of the therapeutic gas to the internal space is carried out at least partially through the gas flow strip.

[0280] Embodiment 45 A method according to any one of Embodiments 39 to 44, wherein the supply of a certain amount of the therapeutic gas to the elastically compressible member is substantially entirely carried out through the gas flow strip.

[0281] Embodiment 46: A 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 A method according to any one of Embodiments 38 to 45, wherein the gas flow path is attached to the inner surface of the first container.

[0283] Embodiment 48 A method according to any one of Embodiments 38 to 47, wherein the first pressure lower than the ambient pressure is within the range of 10 to 50 mmHg lower than the ambient pressure.

[0284] Embodiment 49 A method according to any one of Embodiments 39 to 48, wherein the second pressure, which is lower than the ambient pressure, has a value in the range of 60 to 100 mmHg lower than the ambient pressure.

[0285] Embodiment 50 A device used in conjunction with a pressure adjustment device when performing treatment on a human limb, wherein the device is a. A bag, which is formed to accommodate at least a portion of the limb through an opening in the proximal part of the bag in the wearing mode, b. A multilayer strip including a lower layer attached to the inner surface of the bag, wherein the distal end of the multilayer strip is positioned in the distal part of the bag and the proximal end of the multilayer strip is positioned in the proximal part of the bag, c. A connecting component attached to the wall of the bag at the distal portion of the bag, the connecting component comprising a component that effectively enables the flow of gas between the pressure regulating device and the internal space of the bag in pressure regulating mode, The apparatus wherein the multilayer strip further comprises an upper layer containing a partially compressible material, the partially compressible material forming a gas channel arranged longitudinally within the bag between the connecting component and the proximal portion of the bag.

[0286] Embodiment 51 The apparatus according to Embodiment 50, wherein the multilayer strip is laterally open to the internal space of the bag along its length from the distal to the proximal part of the bag, so that when the bag is not vented, the fluid inside the bag can freely flow into and out of the partially compressible upper layer material.

[0287] Embodiment 52: An apparatus according to either Embodiment 50 or 51, wherein the longitudinal gas flow path is maintained when the gas pressure in the bag is 660 mmHg (absolute pressure) or less.

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

[0289] Embodiment 54: An apparatus according to any one of Embodiments 50 to 53, wherein the longitudinal gas flow path is maintained when the gas pressure inside the bag is 560 mmHg (absolute pressure).

[0290] Embodiment 55 An apparatus according to any one of Embodiments 50 to 54, 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 (for example, by a partially inflatable sleeve surrounding the bag) and transmitted through the walls of the bag to the uppermost layer of the multilayer strip.

[0291] Embodiment 56 (i) A device according to any one of Embodiments 50 to 55, in which 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 walls of the bag to the uppermost layer of the multilayer strip, thereby maintaining the longitudinal gas flow path.

[0292] Embodiment 57: An apparatus according to any one of Embodiments 50 to 56, wherein the Shore A hardness of the multilayer strip is 70 or less.

[0293] Embodiment 58 An apparatus according to any one of Embodiments 50 to 57, wherein the distal end of the multilayer strip is in fluid communication with the connecting component, thereby the partially compressible material forms the gas channel from the connecting component to the proximal end of the multilayer strip.

[0294] Embodiment 59: An apparatus 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] Embodiment 60: An apparatus according to any one of Embodiments 50 to 59, wherein the length of the multilayer strip is at least 10 cm.

[0296] Embodiment 61: An apparatus according to any one of Embodiments 50 to 60, wherein the thickness of the multilayer strip is 5 mm or less.

[0297] Embodiment 62: An apparatus 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: A device according to any one of Embodiments 50 to 62, wherein the limb is either a hand or a foot.

[0299] Embodiment 64: An apparatus according to any one of Embodiments 50 to 63, wherein the length of the multilayer 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 multilayer strip is laid flat without wrinkles or creases, and has an area of ​​less than 10% of the area of ​​the bag.

[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 that is open to the internal space of the bag, the width of which is less than 25% of the maximum width of the distal portion of the bag, and (ii) the connecting component is mounted in part within the distal tab portion.

[0302] Embodiment 67: The apparatus according to Embodiment 66, wherein the connecting component is entirely mounted within the distal tab portion.

[0303] Embodiment 68: An apparatus according to any one of Embodiments 50 to 67, wherein the lower layer contains an adhesive.

[0304] Embodiment 69: An apparatus according to any one of embodiments 50 to 68, wherein the multilayer strip is attached to the first wall of the bag and the connecting component is attached to the second wall of the bag.

[0305] Embodiment 70 An apparatus according to any one of Embodiments 50 to 69, wherein 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, the multilayer strip effectively maintains fluid communication along the longitudinal flow path.

[0306] Embodiment 71 A device used in conjunction with a pressure adjustment device when performing treatment on a target area of ​​a person's limb, wherein the device is (a) a bag comprising (i) two opposing bag portions and (ii) a connecting component attached to a first bag portion located distal to the bag, (b) A strip extending longitudinally along the bag portion from the distal part of the bag to the proximal part of the bag, the strip having fluid communication with the connecting component and having a first uncompressed thickness, (c) A porous, compressible member having dimensions set to fit inside the bag and having a second uncompressed thickness, The porous, compressible member and the proximal end of the strip are arranged side by side to form a gas flow channel structure. The apparatus wherein the porous, compressible member, when placed in the structure and subjected to forces from the two bag portions under negative pressure on the bag, is compressed more relatively than the strip.

[0307] Embodiment 72: An apparatus according to Embodiment 71, wherein the second uncompressed thickness is greater than the first uncompressed thickness.

[0308] Embodiment 73: An apparatus according to either Embodiment 71 or 72, wherein the second uncompressed thickness is at least twice the first uncompressed thickness.

[0309] Embodiment 74: An apparatus according to any of Embodiments 71 to 73, wherein, when subjected to the force when the negative pressure inside the bag is 100 mmHg (absolute pressure of 660 mmHg), the strip retains at least 90% of the first uncompressed thickness.

[0310] Embodiment 75: An apparatus according to any of Embodiments 71 to 73, wherein, when subjected to the force when the negative pressure inside the bag is 100 mmHg (absolute pressure of 660 mmHg), the strip retains at least 95% of the first uncompressed thickness.

[0311] Embodiment 76: An apparatus according to any of Embodiments 71 to 75, wherein when subjected to the force when the negative pressure inside the bag is 100 mmHg (absolute pressure of 660 mmHg), the porous compressible member retains less than 80% of the second uncompressed thickness.

[0312] Embodiment 77: An apparatus according to any of Embodiments 71 to 75, wherein when subjected to the force when the negative pressure inside the bag is 100 mmHg (absolute pressure of 660 mmHg), the porous compressible member retains less than 50% of the second uncompressed thickness.

[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: An apparatus according to any one of Embodiments 71 to 79, wherein the porous, compressible member is biased to expand relatively more than the strip as the pressure inside 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 internal space of the bag along its length, so that when the bag is not vented, the gas inside the bag can freely flow into and out of the strip.

[0317] Embodiment 82: An apparatus according to any one of Embodiments 71 to 81, wherein the strip is formed integrally with the bag or attached to the inner surface of the bag.

[0318] Embodiment 83 The apparatus according to any one of Embodiments 71 to 82, wherein the apparatus 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 to which the first part is integrally formed, and the second element comprising the second part.

[0319] Embodiment 84: An apparatus according to any one of Embodiments 71 to 83, wherein the porous compressible member comprises an elastically compressible material.

[0320] Embodiment 85: An apparatus according to Embodiment 84, wherein the elastically compressible material includes an open-cell foam.

[0321] Embodiment 86 A device used in conjunction with a pressure adjustment device when performing treatment on a human limb, wherein the device is a. A bag, which is formed to accommodate at least a portion of the limb through an opening in the proximal part of the bag in the wearing mode, b. A connecting component attached to the wall of the bag at the distal end of the bag, which, when connected to the adjustment device, effectively enables the flow of gas between the pressure adjustment device and the internal space of the bag, c. The apparatus comprising a strip provided on the inner surface of the bag, the strip forming a longitudinal gas flow path between the connecting component and the proximal portion of the bag within the bag.

[0322] Embodiment 87: An apparatus according to Embodiment 86, wherein the strip is integrally formed with the bag.

[0323] Embodiment 88: An apparatus according to Embodiment 86 or 87, wherein the longitudinal gas flow path extends to the connecting component.

[0324] Embodiment 89: An apparatus according to any one of Embodiments 86 to 88, wherein the strip has a plurality of parallel raised grooves and a plurality of grooves between adjacent grooves.

[0325] Embodiment 90: An apparatus according to Embodiment 89, wherein, for at least some of the plurality of grooves, the width of one or more grooves is less than or equal to the height of each adjacent groove.

[0326] Embodiment 91: The strip has a plurality of raised protrusions, and the device is according to any one of Embodiments 86 to 88.

[0327] Embodiment 92: An apparatus according to Embodiment 91, wherein, for at least some of the plurality of raised protrusions, the spacing between adjacent raised protrusions is smaller than the height of each of the adjacent protrusions.

[0328] Embodiment 93: An apparatus according to Embodiments 86-92, wherein the strip is laterally open to the internal space of the bag along its length from the distal end of the bag to the proximal end of the bag, so that when the bag is not vented, the fluid inside the bag can flow freely into the strip and out of the strip.

[0329] Embodiment 94: An apparatus according to any one of Embodiments 86 to 93, wherein the longitudinal gas flow path is maintained when the gas pressure inside the bag is 660 mmHg (absolute pressure) or less.

[0330] Embodiment 95: An apparatus 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: An apparatus 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 pressure).

[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 to the top of the strip through the walls of the bag.

[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 walls of the bag.

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

[0335] Embodiment 100 An apparatus 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: An apparatus according to any one of Embodiments 86 to 100, wherein the length of the strip is at least 10 cm.

[0337] Embodiment 102: An apparatus according to any one of Embodiments 86 to 101, wherein the thickness of the strip is 7 mm or less.

[0338] Embodiment 102A: An apparatus according to Embodiment 105, wherein the thickness of the strip is 5 mm or less.

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

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

[0341] Embodiment 103: An apparatus 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 An apparatus according to any one of Embodiments 86 to 103, wherein the bottom surface of the strip is laid flat without wrinkles or creases, and has an area of ​​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 that is open to the internal space of the bag, the width of the distal tab portion is less than 25% of the maximum width of the distal portion of the bag, and (ii) the connecting component is mounted in part within the distal tab portion.

[0344] Embodiment 106: The apparatus according to Embodiment 105, wherein the connecting component is entirely mounted within the distal tab portion.

[0345] Embodiment 107: An apparatus according to any one of Embodiments 86 to 106, wherein the strip and the bag are formed from the same material.

[0346] Embodiment 108: An apparatus according to any one of embodiments 86 to 107, wherein the strip is formed on the first wall of the bag and the connecting component is attached to the second wall of the bag.

[0347] Embodiment 109: An apparatus according to any one of Embodiments 86 to 108, wherein 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, the strip effectively maintains fluid communication along the longitudinal flow path.

[0348] Embodiment 110: An apparatus according to any one of Embodiments 86 to 109, wherein the thickness of the strip is at least 1.0 mm.

[0349] Embodiment 111: An apparatus according to Embodiment 110, wherein the thickness of the strip is at least 2.0 mm.

[0350] As used herein and in the following claims, the term “atmospheric pressure” refers to 760 mmHg (absolute pressure).

[0351] While embodiments of the present invention have been described in detail, these embodiments are illustrative and do not limit the scope of the invention. The embodiments described include various features, but not all of them are required in all embodiments of the present invention. Some embodiments of the present invention utilize only some of the described features, or possible combinations thereof. Embodiments of the present invention, including modifications of the described embodiments and different combinations of the features shown in the embodiments, are readily apparent to those skilled in the art.

Claims

1. A system for performing a multi-pressure therapy protocol on a human subject, wherein the system is A first gas transfer unit having a first opening for transferring gas, wherein the first gas transfer unit is configured to (i) adjust the pressure inside a first container arranged in fluid communication with the first gas transfer unit, and (ii) generate a flow of gas through the first opening, A second gas transfer unit having a second opening for passing and transferring gas, wherein the second gas transfer unit is configured to adjust the pressure inside a second container that is arranged in fluid communication with the second gas transfer unit, The following modes: A first mode in which the first gas transfer unit causes gas to flow into the first container through the first opening, when the first container is arranged to surround at least a portion of the limb of the object in the longitudinal direction and is in fluid communication with the first gas transfer unit, and In a second mode, while at least a portion of the gas is present in the first container, the second gas transfer unit adjusts the gas pressure in each fluid-holding compartment of the second container through the second opening, so that the fluid-holding compartment applies its respective compressive pressure to the corresponding portion of the limb through the wall of the first container. Each of them operates sequentially, Furthermore, the following modes: The first gas transfer unit operates in a third mode in which it extracts at least a portion of the gas present in the first container so as to reduce the pressure inside the first container to a first pressure lower than the ambient pressure, and A fourth mode in which the first gas transfer unit introduces a certain volume of therapeutic gas into the first container while maintaining the pressure inside the first container lower than the ambient pressure or atmospheric pressure. An electronic circuit programmed to operate sequentially with each of these, A system that includes these features.

2. The system according to claim 1, wherein in a first mode, the gas is flowed by the first gas transfer unit in response to an input confirming that the first container is in fluid communication with the first gas transfer unit and that the first container is positioned to surround at least a portion of the limb of the object.

3. The system according to claim 1 or 2, wherein in a second mode, the gas pressures are adjusted by the second gas transfer unit in response to an input confirming that the second container is in fluid communication with the second gas transfer unit and that the second container is positioned to surround at least a portion of the longitudinal direction of the first container.

4. The system according to claim 1, wherein adjusting the gas pressure in each of the fluid holding compartments includes repeating a differential pressure adjustment sequence.

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

6. The system according to claim 1, wherein the first gas transfer unit is configured to adjust the pressure inside the first container over a range from a pressure 50 mmHg lower than the ambient pressure or atmospheric pressure to the ambient pressure or atmospheric pressure.

7. The system according to claim 1, wherein the second gas transfer unit is configured to adjust the pressure inside the second container over a pressure range of 0 to 40 mmHg higher than the ambient pressure or atmospheric pressure.

8. A system for performing a multi-pressure therapy protocol on a human subject, wherein the system is A first gas transfer unit having a first opening for transferring gas, wherein the first gas transfer unit is configured to (i) adjust the pressure inside a first container arranged in fluid communication with the first gas transfer unit, and (ii) generate a flow of gas through the first opening, A second gas transfer unit having a second opening for passing and transferring gas, wherein the second gas transfer unit is configured to adjust the pressure inside a second container that is arranged in fluid communication with the second gas transfer unit, The following modes: A first mode in which the first gas transfer unit causes gas to flow into the first container through the first opening, when the first container is arranged to surround at least a portion of the limb of the object in the longitudinal direction and is in fluid communication with the first gas transfer unit, and In a second mode, while at least a portion of the gas is present in the first container, the second gas transfer unit adjusts the gas pressure in each fluid-holding compartment of the second container through the second opening, so that the fluid-holding compartment applies its respective compressive pressure to the corresponding portion of the limb through the wall of the first container. An electronic circuit programmed to operate sequentially with each of these, Equipped with The adjustment causes the gas to flow over at least a portion of the first container surrounded by the second container, in a range where at least a portion of the first container is surrounded by the fluid holding compartment. The flow is at least partially caused by a series of expansions and / or contractions of the fluid-holding compartment. The gas flow is at least partially or almost entirely through a gas flow strip arranged longitudinally within the first container, the gas flow strip being laterally open to the internal space of the first container along its length, thereby allowing fluids within the first container to flow freely into and out of the gas flow strip.

9. The system according to claim 8, wherein the gas flow path strip is integrally formed with the first container.

10. The system according to claim 8, wherein the gas flow strip is attached to the inner surface of the first container.

11. The system according to claim 8, wherein the first container and the gas flow path strip are joined together such that when the first container is subjected to a specific negative pressure in the range of 660 to 710 mmHg (absolute pressure), at least one wall of the first container dents, applying a lateral force to the gas flow path strip, thereby closing the gas flow path strip laterally and opening it longitudinally.

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