Edge Diffuser

Abstract

Disclosed herein is a patient interface for wound treatment and / or management, the patient interface comprising an interface body configurable to substantially or at least partially surround a wound, the interface body comprising a gas inlet and defining a first gas flow path having a first flow resistance and a second gas flow path having a second flow resistance, the first gas flow path being disposed in fluid communication with the gas inlet and the second gas flow path, and the interface body being configurable to comprise or provide a gas outlet at or adjacent to the wound site.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority from U.S. Provisional Patent Application No. 63 / 019,945, filed on May 4, 2020, and U.S. Provisional Patent Application No. 63 / 062,372, filed on August 6, 2020, the contents of which are hereby incorporated by reference in their entirety.

[0002] The present disclosure relates to patient interfaces for wound treatment and / or management. The present disclosure further relates to systems for wound treatment and / or management, methods of managing wounds, and the use of the systems in surgery and post - surgery.

Background Art

[0003] Open wounds may be intentionally created to access a surgical site during surgery, or may occur acutely due to trauma or chronically due to disease. In either case, internal tissues are exposed to air or a non - physiological state. The exposure of vulnerable internal tissues causes cell damage and contamination, both of which impair wound healing. Cell damage is caused by tissue hypothermia, dehydration, and hypoxia. Tissues are essentially non - sterile and pathogens are normally present. In many cases, pathogens are within the range tolerated by the host's immune system. However, open wounds are exposed to higher levels of bioburden from airborne, surgeon - and / or patient - sourced (such as the patient's skin and sebaceous glands, etc.) sources. The open wound and the resulting tissue injury also reduce the body's ability to manage bioburden. By maintaining the physiological state across the open wound and preventing contamination while internal tissues are exposed, the outcome of the open wound can be improved.

[0004] For example, in open surgery, including orthopedic (especially hip and knee), vascular, plastic, or cardiac surgery, insufflation gas may be blown into the wound site. The insufflation gas can be selected from air, carbon dioxide (CO2), nitrogen, nitric oxide, or any suitable gas.

Summary of the Invention

[0005] The performance of the insufflated gas in maintaining the physiological state across and / or within the wound site and preventing contamination of exposed internal tissues is at least partially affected by the method of delivering the insufflated gas to the wound site.

[0006] Nothing included herein should be construed as meaning that any or all of the references, actions, materials, devices, articles, etc., that existed prior to the priority date of each of the attached claims, or that were in common knowledge in the art relating to this disclosure, constituted part of the prior art or was common knowledge. [Means for solving the problem]

[0007] This disclosure describes embodiments of a patient interface that can be used over, around, and / or within or adjacent to a surgical site, including a proposed surgical site, an open wound such as a surgical wound, and / or a closed wound such as a postoperative surgical wound, to provide a gaseous microenvironment that maintains a physiological state and / or reduces the risk of contamination in the wound. Some embodiments of the patient interface are configured to deliver a substantially uniformly distributed gaseous microenvironment to the exit of the patient interface, which can, as far as possible, surround the surgical site, e.g., a wound. The gas flow can be heated and / or humidified. The gas flow can maintain the temperature of the wound site at a substantially specific temperature and / or humidity and / or prevent unwanted air from entering the surgical wound site. If the patient interface is configured to deliver warm, humidified air, the gas flow can help prevent tissue dehydration or drying.

[0008] The aspects of this disclosure are summarized below. It should be noted that the aspects and embodiments of this disclosure can be combined, where applicable, so that features and / or embodiments of one aspect can be used together with features and / or embodiments of any other aspect.

[0009] According to one embodiment, a patient interface for wound treatment and / or management comprises an interface body configurable to substantially or at least partially surround a wound. The interface body includes a gas inlet and defines a first gas channel having a first flow resistance and a second gas channel having a second flow resistance, the first gas channel being arranged in fluid communication with the inlet and the second gas channel, and the interface body may further be configured to include or provide a gas outlet in or adjacent to the wound.

[0010] In some aspects and embodiments, the patient interface may be configured to generate a gas curtain or blanket around and / or within a wound when used around a wound, thereby providing a protective microenvironment on and / or inside the wound. The gas curtain or blanket may be formed from gas exiting the patient interface through at least one gas outlet in or adjacent to the wound.

[0011] The second flow resistance can be greater than the first flow resistance. Therefore, the gas can flow relatively freely through the first gas channel and then slowly through the second gas channel towards the gas outlet. The gas outlet can be located on the inner surface of the interface body to partially or completely surround the wound during use of the patient interface.

[0012] The interface body may include a diffusion material portion, and a second gas channel is defined within the diffusion material portion. The first gas channel may substantially surround the second gas channel and / or the diffusion material portion. The inner surface of the interface body may be the inner surface of the diffusion material portion. The diffusion material portion of the interface body may include a stretchable porous material. The stretchable porous material may include one of foams, fabrics, textiles, or cellular structures. The stretchable porous material may be an open-cell foam. The stretchable nature of the diffusion material portion allows it to conform to the contours of the patient's body and be retracted together with the wound itself to deliver gas over the wound edges.

[0013] The first gas channel can substantially surround the diffusing material portion. Thus, the gas can enter the diffusing material portion from the first gas channel and, therefore, enter the second gas channel from the first gas channel around the outer periphery of the diffusing material portion.

[0014] The interface body may have a surrounding wall or an outer membrane, and the first gas channel may be defined between the outer membrane of the interface body and the diffusion material portion. Throughout this specification, the terms “wall,” “membrane,” “film,” and “coating” are used synonymously, such that a reference to one may include the others.

[0015] The support structure can be positioned within and / or around the first gas channel between the outer membrane and the diffusion material portion of the interface body. In one embodiment, the support structure can be formed integrally with the first gas channel, for example, by being integrated with the outer membrane. Such a support structure prevents the first gas channel from being crushed or compressed by, for example, the force of a retractor, and thus can maintain the first gas channel in an open state. Support structure This could be, for example, a scaffold or a spring. The surrounding wall or outer membrane of the interface body may be translucent or transparent to allow visibility to the first gas channel and / or diffusion material portion and to show any condensations accumulating in the patient interface 10.

[0016] The support structure may include a flexible structure that can be configured to conform to the contour of the patient's body surrounding the wound site. The support structure may be configured to be deformable under the application of forces applied laterally and / or vertically and / or longitudinally. The support structure may have a cross-sectional shape configured to substantially resist vertical and / or laterally applied loads. The support structure may also be configured to substantially resist vertically applied loads while conforming to the contour of the patient's body. It may have a cross-sectional shape configured to substantially resist torsional forces. For example, the support structure may include a substantially square or rectangular cross-sectional shape having a pair of opposing first sides and a pair of opposing second sides positioned substantially perpendicular to the pair of opposing first sides. In this case, the support structure may include connecting members on each of the pair of opposing second sides.

[0017] Alternatively, the support structure may have a substantially C-shaped cross-section having a pair of opposing first sides and a single second side positioned substantially perpendicular to the pair of opposing first sides, with the opposing second side remaining substantially open to the single second side.

[0018] The flexible structure may include multiple interconnected elements arranged in a repeating pattern along the longitudinal axis of the support structure.

[0019] In one embodiment, the multiple interconnecting elements include a plurality of substantial X-shaped elements extending in a repeating pattern along each of a pair of opposing first surfaces, wherein adjacent X-shaped elements share a connecting member extending substantially perpendicular to the pair of opposing first surfaces, such that adjacent X-shaped elements on one of the pair of opposing first surfaces connect to corresponding adjacent X-shaped elements on the other of the pair of opposing first surfaces. The intersection of each of the plurality of substantial X-shaped elements may substantially be at the midpoint of each of the pair of opposing first surfaces. Alternatively, the intersection of each of the plurality of substantial X-shaped elements may be offset from the midpoint of each of the pair of opposing first surfaces. This configuration can provide asymmetrical coincidence, allowing the support structure to be oriented in a direction requiring greater flexibility.

[0020] The connecting member may have a shape that tapers inward toward the midpoint of each of the pair of opposing second sides. In one embodiment, the connecting member is substantially X-shaped.

[0021] In one embodiment, each of a pair of opposing first surfaces includes a repeating rectangular or rounded wave pattern, wherein each repeat of the pattern includes a first slot extending from one of the pair of opposing second surfaces toward the other of the pair of opposing second surfaces, and an adjacent second slot extending from the other of the pair of opposing second surfaces toward the one of the pair of opposing second surfaces.

[0022] The width of each of the first and second slots can be smaller than the width of the portion of the support structure extending between the first and second slots. This configuration has a greater degree of rigidity and a smaller degree of flexibility than an alternative embodiment in which the width of each of the first and second slots is greater than or equal to the width of the portion of the support structure extending between the first and second slots. This configuration can be used when higher flexibility is required.

[0023] The support structure can further include a notch or a cutout in a part of one of a pair of opposing second side surfaces adjacent to each of the slots of the repeating rectangular wave or the repeating rounded wave pattern.

[0024] For embodiments of the support structure having a substantially C-shaped cross-section, each of the pair of opposing first side surfaces can include a repeating rectangular wave or a rounded wave pattern, whereby each repetition of the pattern includes a first slot extending from a single second side surface towards a substantially open side surface of the pair of opposing second side surfaces, and an adjacent second slot extending from the substantially open side surface of the pair of opposing second side surfaces towards a single side surface of the pair of opposing second side surfaces. The open side surface of the C-shaped support structure can sandwich or seal a part of the diffusion material adjacent to the first gas flow path.

[0025] The distal end portion of each of the slots of the repeating rounded wave pattern can be rounded, or each second side surface is rounded with a corresponding curvature.

[0026] The height of the second side surface or each side surface of the pair of opposing second side surfaces can be tapered over at least a part of the longitudinal axis of the support structure. Further, the width of each of the pair of opposing first side surfaces can be tapered over at least a part of the longitudinal axis of the support structure.

[0027] In another embodiment of the support structure, the plurality of interconnected elements includes a plurality of rectangular or square-shaped strips extending in a repeating pattern over the longitudinal axis of the support structure, and the plurality of rectangular or square-shaped strips are interconnected by a longitudinal backbone extending over the length of the support structure at the midpoint of each of the pair of opposing first side surfaces of the support structure.

[0028] In a further embodiment, the support structure includes a flexible structure having a substantially circular or rhomboid cross-section.

[0029] The first gas channel may have a fixed cross-section. Alternatively, the first gas channel may have a variable cross-section. The cross-section of the first gas channel can be controlled to produce desired gas flow characteristics through the first gas channel. For example, the cross-section of the first gas channel can be controlled to provide a more spatially uniform flow rate through the diffusion material. The interface body may have a distal portion opposite to the gas inlet, and in some embodiments, the cross-section of the first gas channel can increase from the gas inlet to the distal portion. This increasing cross-section helps to overcome high-pressure areas at or adjacent to the gas inlet, for example, due to viscosity and friction effects, and thus generates a more uniform flow pressure around the outer periphery of the diffusion material portion, and thus a more spatially uniform flow rate through the diffusion material. In other embodiments, the cross-section of the first gas channel can decrease from the gas inlet to the distal portion. To supply a uniform flow rate through the second gas channel, the flow rate decreases in the first gas channel as it moves away from the gas inlet. By increasing the cross-sectional area at the gas inlet, it is possible to pass a larger flow rate while minimizing viscosity and pressure losses.

[0030] Furthermore, or alternatively, the pressure imbalance in the first gas channel can be compensated for by varying the thickness of the diffusion material portion. In some embodiments, the diffusion material portion defining the second gas channel increases in thickness from the gas inlet to the distal portion. This configuration applies higher resistance to the gas towards the distal portion within the first gas channel. In other embodiments, the diffusion material portion defining the second gas channel decreases in thickness from the inlet to the distal portion. This configuration applies higher resistance to the gas closer to the gas inlet within the first gas channel.

[0031] The first gas channel can be located above, below, and / or at least partially around the second gas channel. In one embodiment, the first gas channel substantially surrounds the periphery of the diffusion material section.

[0032] The outer membrane may include a sealed coating or film extending over at least the top and outer surfaces of the diffusion material portion. In some embodiments, the outer membrane may further extend over the bottom surface of the diffusion material portion. Thus, in some embodiments, the surface of the diffusion material portion exposed to the atmosphere may be only the inner surface surrounding the wound, and therefore, the gas flowing through the second gas pathway may only exit the interface body on the inner surface. Nevertheless, this control of gas flow can also be achieved by adhering the bottom surface to the patient's skin during use, even if the outer membrane does not cover the bottom surface. The outer membrane may include, for example, an elastic material.

[0033] In some embodiments of the patient interface, the bottom surface of the interface body includes an adhesive material. The adhesive material may cover substantially the entire bottom surface. Alternatively, it may cover one or more portions of the bottom surface. For example, the adhesive material may be arranged on the bottom surface or on separate portions in a winding or curving pattern. Such arrangement of the adhesive material can prevent the interface body from becoming lumpy when conforming to the contours of the patient's body.

[0034] As an alternative to adhesive materials, the patient interface may have a fixing material positioned on the bottom surface of the interface body. The fixing material may include one or more of silicone, gel, or other non-adhesive adhesive materials.

[0035] The upper surface of the interface body may include visible incision guide lines. Visible incision guide lines may be perforated and / or printed. In addition or otherwise, the interface body may include pre-formed slots extending through the diffusion material portion. The pre-formed slots may include one or more predefined adjustable portions. One or more predefined adjustable portions may include one or more perforated portions.

[0036] To assist surgeons in making precise or desired surgical incisions at wound sites, the upper surface of the interface body may have a surgical incision length indicator attached along at least one edge of a pre-formed slot. The surgical incision length indicator may be numbered or unnumbered and may be measured in any unit, e.g., millimeters, centimeters, or inches. In one embodiment, the support structure pattern itself may provide the indicator; that is, the repeating pattern may be designed to repeat / period every 5 mm or 10 mm or other preferred interval, so that the incision length can be determined by making an incision extending over a certain number of repeating patterns of the support structure.

[0037] In some embodiments, the interface body may have a height dimension of approximately 10 mm or less. Therefore, the interface body may have a low profile that minimizes visual and physical obstruction to the surgeon at the wound site. The interface body may have a footprint determined to accommodate a specific expected wound size or type of surgical procedure. The pre-formed slot may have a width dimension of 5 mm to 80 mm or 10 to 40 mm in its initial or stationary state.

[0038] The interface body of the patient interface may include a heating element or device. The heating element or device may include heater wires in the first gas channel and / or the second gas channel. Alternatively, or further, the heating element or device may include one or more heater pads or heated fabrics, and / or conductive foam and / or a conductive housing.

[0039] The heating element or device can be positioned on or adjacent to the bottom and / or top surface of the patient interface. The heating element or device can be positioned adjacent to and / or in thermal communication with one or more of the diffusion material portion, the first gas path, and the second gas flow path.

[0040] The heating element or device includes one or more heater pads or heated fabric surfaces. The one or more heater pads or heated fabric surfaces are divided into multiple regions by at least one slit or slot. Preferably, the one or more heater pads or heated fabric surfaces are divided into multiple regions by an alternating pattern of slots or slits.

[0041] One or more heating pads or heated fabric surfaces may include polyethylene terephthalate (PET) monofilaments and conductive fibers. Alternatively, one or more heating pads may include heated wire loops.

[0042] The interface body may include two or more diffusion material portions with different densities, and the second gas channel passes through these two or more diffusion material portions. This configuration provides a means for controlling the passage of gas through the second gas channel by introducing a gradual change or step-like change in the flow resistance to the gas entering the second gas channel at different points in the second gas channel, or at different points along the interface between the first and second gas channels.

[0043] The patient interface may include one or more flow limiters positioned between the first and second gas channels. The flow limiters may include one or more baffles, a series of orifices, a series of slits, or a series of slots. In some embodiments, the flow limiters are configured to restrict fluid flow more at or adjacent to the gas inlet of the interface body than at the distal portion of the interface body. This configuration allows for a slower velocity of gas passing from the first gas channel to the second gas channel at or adjacent to the inlet of the interface body, which can contribute to providing a uniform flow exiting the second gas channel on the inner surface of the diffusion material portion.

[0044] One or more flow guides and / or diverters can be placed at or adjacent to the gas inlet to facilitate the gas flow entering the first gas channel around sharp corners at the junction of the gas inlet and the first gas channel, thereby minimizing turbulence and flow separation that may obstruct the gas flow through the first gas channel. If the outer membrane is transparent or translucent, one or more flow guides and / or diverters may be visible through the outer membrane.

[0045] In some embodiments, the interface body has two or more gas inlets to facilitate a uniform flow of gas through the first gas passage.

[0046] The interface body at the gas outlet can be configured to influence the direction of the gas flow exiting the interface body. In one embodiment, the upper surface of the interface body extends beyond the inner surface of the interface body, for example, radially inward. This configuration facilitates the gas flow exiting the interface body to flow downward or remain near the patient interface and over the wound in order to protect the wound. In another embodiment, the bottom surface of the interface body extends beyond the inner surface of the interface body, for example, radially inward. This configuration helps deflect airborne particles away from the wound, thus avoiding potential contamination.

[0047] The inner surface of the interface body can be sloped inward from top to bottom. This configuration can gently promote the downward flow of gas, creating a protective environment over the wound. Conversely, the inner surface of the interface body may be sloped outward from top to bottom, which can gently promote the upward flow of gas from the inside.

[0048] In some embodiments, a portion of the upper surface of the diffusion material portion adjacent to the gas outlet can be exposed to the atmosphere. Alternatively, or further, a portion of the bottom surface of the diffusion material portion adjacent to the gas outlet can be exposed to the atmosphere. The inner surface of the interface body may have a stepped shape such that the upper portion of the inner surface is concave from the lower portion of the inner surface. Alternatively, or further, the inner surface of the interface body may have a stepped shape such that the lower portion of the inner surface is concave from the upper portion of the inner surface.

[0049] In another embodiment, a patient interface for wound treatment and / or management comprises an interface body configurable to substantially or at least partially surround a wound. The interface body includes a gas inlet and defines a first gas channel and a second gas channel, the first gas channel being in fluid communication with the inlet and the second gas channel, and the interface body may further be configured to include or provide a gas outlet in or adjacent to the wound.

[0050] The patient interface can be configured to release heated and / or humidified gas from the gas outlet.

[0051] The first gas flow path may have a first flow resistance. The second gas flow path may have a second flow resistance.

[0052] The second flow resistance can be greater than the first flow resistance. Therefore, the gas can flow relatively freely through the first gas channel and then slowly through the second gas channel towards the gas outlet. The gas outlet can be located on the inner surface of the interface body to partially or completely surround the wound during use of the patient interface.

[0053] The interface body may include a diffusion material portion, and a second gas channel is defined within the diffusion material portion. The first gas channel may substantially surround the second gas channel and / or the diffusion material portion. The inner surface of the interface body may be the inner surface of the diffusion material portion. The diffusion material portion of the interface body may include a stretchable porous material. The stretchable porous material may include one of foams, fabrics, textiles, or cellular structures. The stretchable porous material may be an open-cell foam. The stretchable nature of the diffusion material portion allows it to conform to the contours of the patient's body and to be pulled along with the wound itself to deliver gas over the wound edges.

[0054] The first gas channel can substantially surround the diffusing material portion. Thus, the gas can enter the diffusing material portion from the first gas channel and, therefore, enter the second gas channel from the first gas channel around the outer periphery of the diffusing material portion.

[0055] The interface body may have a surrounding wall or outer membrane, and the first gas flow path may be defined between the outer membrane of the interface body and the diffusion material portion. The support structure is The first gas channel can be positioned within and / or around the outer membrane and diffusion material portion of the Toughface body. In one embodiment, the support structure can be formed integrally with the first gas channel, for example, and integrated with the outer membrane. Such a support structure prevents the first gas channel from being crushed or compressed by forces, for example, those of a retractor, and thus can maintain the first gas channel in an open state. The support structure may be, for example, a scaffold or a spring. The surrounding wall or outer membrane of the interface body may be translucent or transparent to allow visibility to the first gas channel and / or diffusion material portion and to show any condensation accumulating in the patient interface 10.

[0056] The support structure may include a flexible structure that can be configured to conform to the contour of the patient's body surrounding the wound site. The support structure may be configured to be deformable under the application of forces applied laterally and / or vertically and / or longitudinally. The support structure may have a cross-sectional shape configured to substantially resist vertical and / or laterally applied loads. The support structure may have a cross-sectional shape configured to substantially resist torsional forces. For example, the support structure may include a substantially square or rectangular cross-sectional shape having a pair of opposing first sides and a pair of opposing second sides positioned substantially perpendicular to the pair of opposing first sides. In this case, the support structure may include connecting members on each of the pair of opposing second sides.

[0057] Alternatively, the support structure may have a substantially C-shaped cross-section having a pair of opposing first sides and a single second side positioned substantially perpendicular to the pair of opposing first sides, with the opposing second side remaining substantially open to the single second side.

[0058] The flexible structure may include multiple interconnected elements arranged in a repeating pattern along the longitudinal axis of the support structure.

[0059] In one embodiment, the multiple interconnecting elements include a plurality of substantial X-shaped elements extending in a repeating pattern along each of a pair of opposing first surfaces, wherein adjacent X-shaped elements share a connecting member extending substantially perpendicular to the pair of opposing first surfaces, such that adjacent X-shaped elements on one of the pair of opposing first surfaces connect to corresponding adjacent X-shaped elements on the other of the pair of opposing first surfaces. The intersection of each of the plurality of substantial X-shaped elements may substantially be at the midpoint of each of the pair of opposing first surfaces. Alternatively, the intersection of each of the plurality of substantial X-shaped elements may be offset from the midpoint of each of the pair of opposing first surfaces. This configuration can provide asymmetrical coincidence, allowing the support structure to be oriented in a direction requiring greater flexibility.

[0060] The connecting member may have a shape that tapers inward toward the midpoint of each of the pair of opposing second sides. In one embodiment, the connecting member is substantially X-shaped.

[0061] In one embodiment, each of a pair of opposing first surfaces includes a repeating rectangular or rounded wave pattern, wherein each repeat of the pattern includes a first slot extending from one of the pair of opposing second surfaces toward the other of the pair of opposing second surfaces, and an adjacent second slot extending from the other of the pair of opposing second surfaces toward the one of the pair of opposing second surfaces.

[0062] The width of each of the first and second slots can be smaller than the width of the portion of the support structure extending between the first and second slots. This configuration provides greater rigidity than alternative embodiments in which the width of each of the first and second slots is greater than or equal to the width of the portion of the support structure extending between the first and second slots. It has a small degree of flexibility. This configuration can be used when higher flexibility is required.

[0063] The support structure may further include notches or cutouts in a portion of one of a pair of opposing second sides adjacent to each of the slots of the repeating rectangular wave or repeating rounded wave pattern.

[0064] In embodiments of a support structure having a substantially C-shaped cross-section, each of a pair of opposing first sides may include a repeating rectangular wave or rounded wave pattern, wherein each repeat of the pattern includes a first slot extending from a single second side toward a substantially open side of the pair of opposing second sides, and an adjacent second slot extending from the substantially open side of the pair of opposing second sides toward a single side of the pair of opposing second sides. The open side of the C-shaped support structure may enclose or seal a portion of the diffusion material adjacent to the first gas flow path.

[0065] Each distal end portion of the repeating rounded wave pattern slot can be rounded, and each second side is rounded with a corresponding curvature.

[0066] The height of each side of the second side or a pair of opposing second side surfaces may be tapered over at least a portion of the longitudinal axis of the support structure. Furthermore, the width of each of the pair of opposing first side surfaces may be tapered over at least a portion of the longitudinal axis of the support structure.

[0067] In another embodiment of the support structure, the multiple interconnected elements include a plurality of rectangular or square strips extending in a repeating pattern along the longitudinal axis of the support structure, the plurality of rectangular or square strips being interconnected by a longitudinal spine extending along the length of the support structure at the midpoints of each of a pair of opposing first sides of the support structure.

[0068] In further embodiments, the support structure includes a flexible structure having a substantially circular or rhomboid cross-section.

[0069] The first gas channel may have a fixed cross-section. Alternatively, the first gas channel may have a variable cross-section. The cross-section of the first gas channel can be controlled to produce desired gas flow characteristics through the first gas channel. For example, the cross-section of the first gas channel can be controlled to provide a more spatially uniform flow rate through the diffusion material. The interface body may have a distal portion opposite to the gas inlet, and in some embodiments, the cross-section of the first gas channel can increase from the gas inlet to the distal portion. This increasing cross-section helps to overcome high-pressure areas at or adjacent to the gas inlet, for example, due to viscosity and friction effects, and thus generates a more uniform flow pressure around the outer periphery of the diffusion material portion, and thus a more spatially uniform flow rate through the diffusion material. In other embodiments, the cross-section of the first gas channel can decrease from the gas inlet to the distal portion. To supply a uniform flow rate through the second gas channel, the flow rate decreases in the first gas channel as it moves away from the gas inlet. By increasing the cross-sectional area at the gas inlet, it is possible to pass a larger flow rate while minimizing viscosity and pressure losses.

[0070] Furthermore, or alternatively, the pressure imbalance in the first gas channel can be compensated for by varying the thickness of the diffusion material portion. In some embodiments, the diffusion material portion defining the second gas channel increases in thickness from the gas inlet to the distal portion. This configuration provides greater resistance to the gas toward the distal portion within the first gas channel. In other embodiments, the diffusion material portion defining the second gas flow path is reduced in thickness from the inlet to the distal portion. This configuration applies higher resistance to the gas closer to the gas inlet within the first gas flow path.

[0071] The first gas channel can be located above, below, and / or at least partially around the second gas channel. In one embodiment, the first gas channel substantially surrounds the periphery of the diffusion material section.

[0072] The outer membrane may include a sealed coating or film extending over at least the top and outer surfaces of the diffusion material portion. In some embodiments, the outer membrane may further extend over the bottom surface of the diffusion material portion. Thus, in some embodiments, the surface of the diffusion material portion exposed to the atmosphere may be only the inner surface surrounding the wound, and therefore, the gas flowing through the second gas pathway may only exit the interface body on the inner surface. Nevertheless, this control of gas flow can also be achieved by adhering the bottom surface to the patient's skin during use, even if the outer membrane does not cover the bottom surface. The outer membrane may include, for example, an elastic material.

[0073] In some embodiments of the patient interface, the bottom surface of the interface body includes an adhesive material. The adhesive material may cover substantially the entire bottom surface. Alternatively, it may cover one or more portions of the bottom surface. For example, the adhesive material may be arranged on the bottom surface or on separate portions in a winding or curving pattern. Such arrangement of the adhesive material can prevent the interface body from becoming lumpy when conforming to the contours of the patient's body.

[0074] As an alternative to adhesive materials, the patient interface may have a fixing material positioned on the bottom surface of the interface body. The fixing material may include one or more of silicone, gel, or other non-adhesive adhesive materials.

[0075] The upper surface of the interface body may include visible incision guide lines. Visible incision guide lines may be perforated and / or printed. In addition or otherwise, the interface body may include pre-formed slots extending through the diffusion material portion. The pre-formed slots may include one or more predefined adjustable portions. One or more predefined adjustable portions may include one or more perforated portions.

[0076] To assist surgeons in making precise or desired surgical incisions at wound sites, the upper surface of the interface body may have a surgical incision length indicator attached along at least one edge of a pre-formed slot. The surgical incision length indicator may be numbered or unnumbered and may be measured in any unit, e.g., millimeters, centimeters, or inches. In one embodiment, the support structure pattern itself may provide the indicator; that is, the repeating pattern may be designed to repeat / period every 5 mm or 10 mm or other preferred interval, so that the incision length can be determined by making an incision extending over a certain number of repeating patterns of the support structure.

[0077] In some embodiments, the interface body may have a height dimension of approximately 10 mm or less. Therefore, the interface body may have a low profile that minimizes visual and physical obstruction to the surgeon at the wound site. The interface body may have a footprint determined to fit a specific expected wound size or type of surgical procedure. The pre-formed slots are in their initial or stationary state. In this case, the width dimension can be 5mm to 80mm or 10mm to 40mm.

[0078] The interface body of the patient interface may include a heating element or device. The heating element or device may include a heater wire in the first gas channel and / or the second gas channel. Alternatively or further, the heating element or device may include one or more heater pads or heated fabrics, and / or conductive foam and / or a conductive housing.

[0079] The heating element or device can be positioned on or adjacent to the bottom and / or top surface of the patient interface. The heating element or device can be positioned adjacent to and / or in thermal communication with one or more of the diffusion material portion, the first gas path, and the second gas flow path.

[0080] The heating element or device includes one or more heater pads or heated fabric surfaces. The one or more heater pads or heated fabric surfaces are divided into multiple regions by at least one slit or slot. Preferably, the one or more heater pads or heated fabric surfaces are divided into multiple regions by an alternating pattern of slots or slits.

[0081] One or more heating pads or heated fabric surfaces may include polyethylene terephthalate (PET) monofilaments and conductive fibers. Alternatively, one or more heating pads may include heated wire loops.

[0082] The interface body may include two or more diffusion material portions with different densities, and the second gas channel passes through these two or more diffusion material portions. This configuration provides a means for controlling the passage of gas through the second gas channel by introducing a gradual change or step-like change in the flow resistance to the gas entering the second gas channel at different points in the second gas channel, or at different points along the interface between the first and second gas channels.

[0083] The patient interface may include one or more flow limiters positioned between the first and second gas channels. The flow limiters may include one or more baffles, a series of orifices, a series of slits, or a series of slots. In some embodiments, the flow limiters are configured to restrict fluid flow more at or adjacent to the gas inlet of the interface body than at the distal portion of the interface body. This configuration allows for a slower velocity of gas passing from the first gas channel to the second gas channel at or adjacent to the inlet of the interface body, which can contribute to providing a uniform flow exiting the second gas channel on the inner surface of the diffusion material portion.

[0084] One or more flow guides and / or diverters can be placed at or adjacent to the gas inlet to facilitate the gas flow entering the first gas channel around sharp corners at the junction of the gas inlet and the first gas channel, thereby minimizing turbulence and flow separation that may obstruct the gas flow through the first gas channel. If the outer membrane is transparent or translucent, one or more flow guides and / or diverters may be visible through the outer membrane.

[0085] In some embodiments, the interface body has two or more gas inlets to facilitate a uniform flow of gas through the first gas passage.

[0086] The interface body at the gas outlet can be configured to influence the direction of the gas flow exiting the interface body. In one embodiment, the interface body The top surface extends beyond the inner surface of the interface body, for example, radially inward along the inner surface. This configuration allows the gas flow from the interface body to flow downward or remain near the patient interface and over the wound to protect the wound. In another embodiment, the bottom surface of the interface body extends beyond the inner surface of the interface body, for example, radially inward along the inner surface. This configuration helps deflect airborne particles away from the wound, thus avoiding potential contamination.

[0087] The inner surface of the interface body can be sloped inward from top to bottom. This configuration can gently promote the downward flow of gas, creating a protective environment over the wound. Conversely, the inner surface of the interface body may be sloped outward from top to bottom, which can gently promote the upward flow of gas from the inside.

[0088] In some embodiments, a portion of the upper surface of the diffusion material portion adjacent to the gas outlet can be exposed to the atmosphere. Alternatively, or further, a portion of the bottom surface of the diffusion material portion adjacent to the gas outlet can be exposed to the atmosphere. The inner surface of the interface body may have a stepped shape such that the upper portion of the inner surface is concave from the lower portion of the inner surface. Alternatively, or further, the inner surface of the interface body may have a stepped shape such that the lower portion of the inner surface is concave from the upper portion of the inner surface.

[0089] In another embodiment, a patient interface for wound treatment and / or management comprises an interface body configurable to substantially or at least partially surround a wound, the interface body comprising a gas inlet and defining a gas flow path, the gas flow path being in fluid communication with the gas inlet, the interface body further comprising a functional indicator configured to provide an indication of when gas is flowing through the patient interface, the interface body being configurable to provide or provide a gas outlet in or adjacent to the wound, and

[0090] The function indicator can be configured to provide a visual indication of when gas is flowing through the patient interface. The function indicator can be further configured to provide an indication that the gas flowing through the patient interface is heated and / or humidified and / or of a particular gas type.

[0091] The functional indicator may include thermochromic and / or hydrochromic materials and may be adapted to change color in the presence of a specific gas.

[0092] The interface body can define a first gas channel having a first flow resistance and a second gas channel having a second flow resistance, the first gas channel being arranged in fluid communication with the gas inlet and the second gas channel, and the functional indicator is a support structure positioned within the first gas channel of the interface body. The interface body may include an outer membrane around the first gas channel, the outer membrane being transparent or translucent to allow visualization of the support structure.

[0093] The function indicator can communicate with the first gas flow path. The function indicator may be in one or more states of direct, indirect, or thermal communication with the first gas flow path. The function indicator may be a flow guide and / or diverter located at or adjacent to the gas inlet.

[0094] According to one embodiment, a wound management and / or treatment system comprises a patient interface having a functional indicator and a gas source, the patient interface being in fluid communication with the gas source. The functional indicators of the patient interface are positioned as in-line flow indicators that are in fluid communication with the gas source and the patient interface.

[0095] In a further embodiment, a patient interface for wound treatment and / or management comprises an interface body configurable to substantially or at least partially surround a wound, the interface body comprising a gas inlet and defining a gas flow path, the gas flow path being arranged in fluid communication with the gas inlet, the interface body further configurable to comprise or provide a gas outlet in or adjacent to the wound, and the interface body comprising a heating element or device.

[0096] The interface body can define a first gas flow path having a first flow resistance and a second gas flow path having a second flow resistance, the first gas flow path is arranged in fluid communication with the gas inlet and the second gas flow path, the interface body includes a diffusion material portion, and the second gas flow path is defined within the diffusion material portion.

[0097] The heating element or device can be positioned on or adjacent to the bottom and / or top surface of the patient interface. The heating element or device can be positioned adjacent to and / or in thermal communication with one or more of the diffusion material portion, the first gas path, and the second gas flow path. The heating element or device may include one or more heater pads or heated fabric surfaces. One or more heating pads or heated fabric surfaces may be divided into multiple regions by at least one slit or slot. One or more heating pads or heated fabric surfaces may be divided into multiple regions by an alternating pattern of slots or slits.

[0098] One or more heating pads or heated fabric surfaces may include polyethylene terephthalate (PET) monofilaments and conductive fibers. Alternatively, one or more heating pads may include heated wire loops.

[0099] In a further embodiment, a patient interface for wound treatment and / or management comprises an interface body configured or configurable to substantially or at least partially surround a surgical site, e.g., a wound. The interface body includes a gas inlet and defines a gas flow path, the gas flow path being arranged in fluid communication with a gas outlet. The interface body is configured to discharge a gas flow from the gas outlet that is one or more of the following: an omnidirectional gas flow, a gas flow uniformly distributed across the gas outlet, a non-turbulent gas flow, and a gas flow with uniform velocity.

[0100] The gas can flow relatively freely through the first gas channel and then slowly through the second gas channel toward the gas outlet. The gas outlet can be located on the inner surface of the interface body so as to partially or completely surround the wound during use of the patient interface.

[0101] The gas flow path may include a first gas flow path and / or a second gas flow path.

[0102] The interface body may include a diffusion material portion, and a second gas channel is defined within the diffusion material portion. The first gas channel may substantially surround the second gas channel and / or the diffusion material portion. The inner surface of the interface body may be the inner surface of the diffusion material portion. The diffusion material portion of the interface body may include a stretchable porous material. The stretchable porous material may include one of foams, fabrics, textiles, or cellular structures. The stretchable porous material may be an open-cell foam. Due to the stretchable nature of the diffusion material portion, it conforms to the contours of the patient's body and delivers gas over the wound edges. This allows the wound itself to be pulled along with the wound.

[0103] The first gas channel can substantially surround the diffusing material portion. Thus, the gas can enter the diffusing material portion from the first gas channel and, therefore, enter the second gas channel from the first gas channel around the outer periphery of the diffusing material portion.

[0104] The interface body may have a surrounding wall or outer membrane, and a first gas channel may be defined between the outer membrane of the interface body and the diffusion material portion. A support structure may be placed within the first gas channel between the outer membrane of the interface body and the diffusion material portion. Such a support structure prevents the first gas channel from being crushed or compressed by forces, for example, from a retractor, and thus can maintain the first gas channel in an open state. The support structure may be as described in any aspect of the present disclosure, and may be, for example, a scaffold or a spring. The outer membrane of the interface body may be translucent or transparent to allow visibility to the first gas channel and / or the diffusion material portion and to show any condensation accumulating in the patient interface 10.

[0105] The first gas channel may have a fixed cross-section. Alternatively, the first gas channel may have a variable cross-section. The cross-section of the first gas channel can be controlled to produce desired gas flow characteristics through the first gas channel. For example, the cross-section of the first gas channel can be controlled to provide a more spatially uniform flow rate through the diffusion material. The interface body may have a distal portion opposite to the gas inlet, and in some embodiments, the cross-section of the first gas channel can increase from the gas inlet to the distal portion. This increasing cross-section helps to overcome high-pressure areas at or adjacent to the gas inlet, for example, due to viscosity and friction effects, and thus generates a more uniform flow pressure around the outer periphery of the diffusion material portion, and thus a more spatially uniform flow rate through the diffusion material. In other embodiments, the cross-section of the first gas channel can decrease from the gas inlet to the distal portion. To supply a uniform flow rate through the second gas channel, the flow rate decreases in the first gas channel as it moves away from the gas inlet. By increasing the cross-sectional area at the gas inlet, it is possible to pass a larger flow rate while minimizing viscosity and pressure losses.

[0106] Furthermore, or alternatively, the pressure imbalance in the first gas channel can be compensated for by varying the thickness of the diffusion material portion. In some embodiments, the diffusion material portion defining the second gas channel increases in thickness from the gas inlet to the distal portion. This configuration applies higher resistance to the gas towards the distal portion within the first gas channel. In other embodiments, the diffusion material portion defining the second gas channel decreases in thickness from the inlet to the distal portion. This configuration applies higher resistance to the gas closer to the gas inlet within the first gas channel.

[0107] The first gas channel can be located above, below, and / or at least partially around the second gas channel. In one embodiment, the first gas channel substantially surrounds the periphery of the diffusion material section.

[0108] The outer membrane may include a sealed coating or film extending over at least the top and outer surfaces of the diffusion material portion. In some embodiments, the outer membrane further extends over the bottom surface of the diffusion material portion. Thus, in some embodiments, the surface of the diffusion material portion exposed to the atmosphere may be only the inner surface surrounding the wound, and therefore, the gas flowing through the second gas pathway may only exit the interface body on the inner surface. Nevertheless, this control of gas flow can also be achieved by adhering the bottom surface to the patient's skin during use, even if the outer membrane does not cover the bottom surface. The outer membrane may, for example, It may contain stretchable materials.

[0109] In some embodiments of the patient interface, the bottom surface of the interface body includes an adhesive material. The adhesive material may cover substantially the entire bottom surface. Alternatively, it may cover one or more portions of the bottom surface. For example, the adhesive material may be arranged on the bottom surface or on separate portions in a winding or curving pattern. Such arrangement of the adhesive material can prevent the interface body from becoming lumpy when conforming to the contours of the patient's body.

[0110] As an alternative to adhesive materials, the patient interface may have a fixing material positioned on the bottom surface of the interface body. The fixing material may include one or more of silicone, gel, or other non-adhesive adhesive materials.

[0111] The upper surface of the interface body may include visible incision guide lines. Visible incision guide lines may be perforated and / or printed. In addition or otherwise, the interface body may include pre-formed slots extending through the diffusion material portion. The pre-formed slots may include one or more predefined adjustable portions. One or more predefined adjustable portions may include one or more perforated portions.

[0112] To assist surgeons in making precise or desired surgical incisions at wound sites, the upper surface of the interface body may have a surgical incision length indicator attached along at least one edge of a pre-formed slot. The surgical incision length indicator may or may not be numbered and may be measured in any unit, such as millimeters, centimeters, or inches.

[0113] In some embodiments, the interface body may have a height dimension of approximately 10 mm or less. Therefore, the interface body may have a low profile that minimizes visual and physical obstruction to the surgeon at the wound site. The interface body may have a footprint determined to accommodate a specific expected wound size or type of surgical procedure. The pre-formed slot may have a width dimension of 5 mm to 80 mm or 10 to 40 mm in its initial or stationary state.

[0114] The interface body may include two or more diffusion material portions with different densities, and the second gas channel passes through these two or more diffusion material portions. This configuration provides a means for controlling the passage of gas through the second gas channel by introducing a gradual change or step-like change in the flow resistance to the gas entering the second gas channel at different points in the second gas channel, or at different points along the interface between the first and second gas channels.

[0115] The patient interface may include one or more flow limiters positioned between the first and second gas channels. The flow limiters may include one or more baffles, a series of orifices, a series of slits, or a series of slots. In some embodiments, the flow limiters are configured to restrict fluid flow more at or adjacent to the gas inlet of the interface body than at the distal portion of the interface body. This configuration allows for a slower velocity of gas passing from the first gas channel to the second gas channel at or adjacent to the inlet of the interface body, which can contribute to providing a uniform flow exiting the second gas channel on the inner surface of the diffusion material portion.

[0116] One or more flow guides and / or diverters are placed at or adjacent to the gas inlet. This facilitates the gas flow entering the first gas channel to flow around sharp corners at the junction of the gas inlet and the first gas channel, minimizing turbulence and flow separation that could obstruct the gas flow through the first gas channel. If the outer membrane is transparent or translucent, one or more flow guides and / or flow dividers may be visible through the outer membrane.

[0117] In some embodiments, the interface body has two or more gas inlets to facilitate a uniform flow of gas through the first gas passage.

[0118] The interface body at the gas outlet can be configured to influence the direction of the gas flow exiting the interface body. In one embodiment, the upper surface of the interface body extends beyond the inner surface of the interface body, for example, radially inward. This configuration can facilitate the gas flow exiting the interface body to flow downward or remain near the patient interface and over the wound to protect the wound. In another embodiment, the bottom surface of the interface body extends beyond the inner surface of the interface body, for example, radially inward. This configuration helps deflect airborne particles away from the wound, thus avoiding potential contamination.

[0119] The inner surface of the interface body can be sloped inward from top to bottom. This configuration can gently promote the downward flow of gas, creating a protective environment over the wound. Conversely, the inner surface of the interface body may be sloped outward from top to bottom, which can gently promote the upward flow of gas from the inside.

[0120] In some embodiments, a portion of the upper surface of the diffusion material portion adjacent to the gas outlet can be exposed to the atmosphere. Alternatively, or further, a portion of the bottom surface of the diffusion material portion adjacent to the gas outlet can be exposed to the atmosphere. The inner surface of the interface body may have a stepped shape such that the upper portion of the inner surface is concave from the lower portion of the inner surface. Alternatively, or further, the inner surface of the interface body may have a stepped shape such that the lower portion of the inner surface is concave from the upper portion of the inner surface.

[0121] In a further embodiment, a patient interface for wound treatment and / or management comprises an interface body configured or configurable to substantially or at least partially surround a surgical site, e.g., a wound. The interface body comprises a first gas channel and a second gas channel. The first gas channel may have a fixed cross-section. The second gas channel may have a variable cross-section.

[0122] The pressure imbalance in the first gas channel can be compensated for by varying the thickness of the diffusion material portion. In some embodiments, the diffusion material portion defining the second gas channel increases in thickness from the gas inlet to the distal portion. This configuration applies higher resistance to the gas towards the distal portion within the first gas channel. In other embodiments, the diffusion material portion defining the second gas channel decreases in thickness from the inlet to the distal portion. This configuration applies higher resistance to the gas closer to the gas inlet within the first gas channel.

[0123] In a further embodiment, a patient interface for wound treatment and / or management comprises an interface body configured or configurable to substantially or at least partially surround a wound. The interface body comprises a gas inlet, a first gas channel, and a second gas channel. The first gas channel may have a variable cross-section. The second gas channel may have a substantially constant cross-section.

[0124] The interface body may have a distal portion opposite to the gas inlet, and in some embodiments, the cross-section of the first gas channel can increase from the gas inlet to the distal portion. This increased cross-section helps overcome high-pressure regions at or adjacent to the gas inlet, for example, due to viscosity and friction effects, and thus generates more uniform flow pressure around the outer periphery of the diffusion material portion, and thus generates a more spatially uniform flow rate through the diffusion material. In other embodiments, the cross-section of the first gas channel can decrease from the gas inlet to the distal portion. To supply a uniform flow rate through the second gas channel, the flow rate decreases in the first gas channel as it moves away from the gas inlet. The larger cross-sectional area at the gas inlet allows this larger flow rate to pass through while minimizing viscosity and pressure losses.

[0125] In a further embodiment, a patient interface for wound treatment and / or management comprises an interface body configured or configurable to substantially or at least partially surround a surgical site, e.g., a wound. The interface body comprises a gas inlet, a first gas channel, and a second gas channel. The first gas channel is held open by a support structure. The support structure may be as described in any embodiment of this disclosure.

[0126] The support structure can be positioned within and / or around the first gas channel. The interface body may have an outer membrane, and the first gas channel can be defined between the outer membrane and the diffusion material portion of the interface body. In one embodiment, the support structure can be formed integrally with the first gas channel, for example, by being integrated with the outer membrane.

[0127] The support structure may be a scaffold or a spring. The support structure may include a long, flexible structure having a longitudinal axis and configured to be elastically deformable under the application of forces applied laterally and / or vertically and / or longitudinally.

[0128] The support structure can be configured to bend laterally with respect to its longitudinal axis. The support structure can also be configured to bend to conform to the contours of the patient's body surrounding the wound.

[0129] The support structure may have a cross-sectional shape configured to substantially resist compressive forces. The support structure may also be configured to allow torsional motion.

[0130] The support structure may have a substantially square or rectangular cross-sectional shape having a pair of opposing first sides and a pair of opposing second sides positioned substantially perpendicular to the pair of opposing first sides. Each of the pair of opposing first sides may include a repeating rectangular wave or rounded wave pattern, so that each repeat of the pattern defines a first slot extending from one of the pair of opposing second sides toward the other of the pair of opposing second sides, and an adjacent second slot extending from the other of the pair of opposing second sides toward the one of the pair of opposing second sides. Each of the first and second slots may include a right-angled or rounded wall on its respective opposing second side that forms a structural portion between the opposing first sides. The width of each of the first and second slots may be less than the width of the portion of the support structure extending between the first and second slots when in its first position. Alternatively, the width of each of the first and second slots is greater than or equal to the width of the portion of the support structure that extends between the first and second slots when they are in their first position.

[0131] In a further embodiment, a support structure providing structural support to a patient interface has a longitudinal axis and also in the lateral and / or vertical and / or longitudinal direction The support structure includes a long, flexible structure configured to be elastically deformable under the application of a force. The support structure can be used in any other aspect of the present disclosure of a patient interface.

[0132] The support structure may be a scaffold or a spring. The support structure may include a long, flexible structure having a longitudinal axis and configured to be elastically deformable under the application of forces applied laterally and / or vertically and / or longitudinally.

[0133] The support structure can be configured to bend laterally with respect to its longitudinal axis. The support structure can also be configured to bend to conform to the contours of the patient's body surrounding the wound.

[0134] The support structure may have a cross-sectional shape configured to substantially resist compressive forces. The support structure may also be configured to allow torsional motion.

[0135] The support structure may have a substantially square or rectangular cross-sectional shape having a pair of opposing first sides and a pair of opposing second sides positioned substantially perpendicular to the pair of opposing first sides. Each of the pair of opposing first sides may include a repeating rectangular wave or rounded wave pattern, so that each repeat of the pattern defines a first slot extending from one of the pair of opposing second sides toward the other of the pair of opposing second sides, and an adjacent second slot extending from the other of the pair of opposing second sides toward the one of the pair of opposing second sides. Each of the first and second slots may include a right-angled or rounded wall on its respective opposing second side that forms a structural portion between the opposing first sides. The width of each of the first and second slots may be less than the width of the portion of the support structure extending between the first and second slots when in its first position. Alternatively, the width of each of the first and second slots is greater than or equal to the width of the portion of the support structure that extends between the first and second slots when they are in their first position.

[0136] The surrounding wall or outer membrane of the interface body may be translucent or transparent to allow visibility to the first gas channel and / or diffusion material portion, and to show any condensations that accumulate within the patient interface 10.

[0137] The support structure may be configured to conform to the contour of the patient's body surrounding the wound site. The support structure may be configured to be deformable under the application of forces applied laterally and / or vertically and / or longitudinally. The support structure may have a cross-sectional shape configured to substantially resist vertical and / or laterally applied loads. The support structure may have a cross-sectional shape configured to substantially resist torsional forces. For example, the support structure may include a substantially square or rectangular cross-sectional shape having a pair of opposing first sides and a pair of opposing second sides positioned substantially perpendicular to the pair of opposing first sides. In this case, the support structure may include connecting members on each of the pair of opposing second sides.

[0138] Alternatively, the support structure may have a substantially C-shaped cross-section having a pair of opposing first sides and a single second side positioned substantially perpendicular to the pair of opposing first sides, with the opposing second side remaining substantially open to the single second side.

[0139] The flexible structure may include multiple interconnected elements arranged in a repeating pattern along the longitudinal axis of the support structure.

[0140] In one embodiment, multiple interconnection elements are arranged along each of a pair of opposing first sides The structure includes a plurality of substantial X-shaped elements extending in a repeating pattern, wherein adjacent X-shaped elements share a connecting member that extends substantially perpendicular to the pair of opposing first surfaces, connecting an adjacent X-shaped element on one side of a pair of opposing first surfaces to a corresponding adjacent X-shaped element on the other side of the pair of opposing first surfaces. Each intersection of the plurality of substantial X-shaped elements may be substantially at the midpoint of each of the pair of opposing first surfaces. Alternatively, each intersection of the plurality of substantial X-shaped elements may be offset from the midpoint of each of the pair of opposing first surfaces.

[0141] The connecting member may have a shape that tapers inward toward the midpoint of each of the pair of opposing second sides. In one embodiment, the connecting member is substantially X-shaped.

[0142] In one embodiment, each of a pair of opposing first surfaces includes a repeating rectangular or rounded wave pattern, wherein each repeat of the pattern includes a first slot extending from one of the pair of opposing second surfaces toward the other of the pair of opposing second surfaces, and an adjacent second slot extending from the other of the pair of opposing second surfaces toward the one of the pair of opposing second surfaces.

[0143] The width of each of the first and second slots can be smaller than the width of the portion of the support structure extending between the first and second slots. This configuration has a greater degree of rigidity and a smaller degree of flexibility than an alternative embodiment in which the width of each of the first and second slots is greater than or equal to the width of the portion of the support structure extending between the first and second slots. This configuration can be used when higher flexibility is required.

[0144] The support structure may further include notches or cutouts in a portion of one of a pair of opposing second sides adjacent to each of the slots of the repeating rectangular wave or repeating rounded wave pattern.

[0145] In embodiments of a support structure having a substantially C-shaped cross-section, each of a pair of opposing first sides may include a repeating rectangular wave or rounded wave pattern, wherein each repeat of the pattern includes a first slot extending from a single second side toward a substantially open side of the pair of opposing second sides, and an adjacent second slot extending from the substantially open side of the pair of opposing second sides toward a single side of the pair of opposing second sides. The open side of the C-shaped support structure may enclose or seal a portion of the diffusion material adjacent to the first gas flow path.

[0146] Each distal end portion of the repeating rounded wave pattern slot can be rounded, and each second side is rounded with a corresponding curvature.

[0147] The height of each side of the second side or a pair of opposing second side surfaces may be tapered over at least a portion of the longitudinal axis of the support structure. Furthermore, the width of each of the pair of opposing first side surfaces may be tapered over at least a portion of the longitudinal axis of the support structure.

[0148] In another embodiment of the support structure, the multiple interconnected elements include a plurality of rectangular or square strips extending in a repeating pattern along the longitudinal axis of the support structure, the plurality of rectangular or square strips being interconnected by a longitudinal spine extending along the length of the support structure at the midpoints of each of a pair of opposing first sides of the support structure.

[0149] In further embodiments, the support structure includes a flexible structure having a substantially circular or rhomboid cross-section.

[0150] The support structure may be provided in the first gas flow path as a continuous single structure. Alternatively, the support structure may include at least two or more separate repeating length sections. The separate length sections may be positioned end-to-end to form the support structure, and / or connected together or assembled.

[0151] In a further embodiment, a patient interface for wound treatment and / or management comprises an interface body having a gas inlet and a gas flow path, wherein the gas flow path is arranged in fluid communication with the gas inlet, and the interface body may be configured to further have or provide a gas outlet; and an enclosing wall or outer membrane defining at least a portion of the gas flow path, wherein at least one region of the enclosing wall or outer membrane is made of a material that allows the passage of water vapor. This material allows the passage of water vapor, thereby reducing or eliminating the condensation and / or accumulation of liquid moisture in the first gas flow path.

[0152] Throughout this specification, a material that allows the passage of water molecules through its walls without allowing the bulk passage of liquid water or bulk flow of gas to completely pass through the material walls is referred to as a "permeable" material. The passage of water molecules through such walls, such as monolithic walls, can occur via a solution diffusion mechanism. Those skilled in the art will understand that water molecules within the wall are molecularly dispersed in the medium and, therefore, without regard to their state (solid, liquid, or gas), may be referred to as vapor in this art. The rate of movement is often referred to as water vapor permeability.

[0153] "Breathable" materials can be breathable due to their composition, physical structure, or a combination thereof. Examples of breathable materials include block copolymers, hydrophilic polyester block copolymers, thermoplastic elastomers, styrene block polymers, copolyester elastomers, thermoplastic polyolefin elastomers, thermoplastic polyurethane elastomers, nonporous monolithic polymers, polyurethanes, hydrophilic thermoplastic resins, hydrophilic polyesters, perfluoropolymers, polyamides, and breathable woven fabrics.

[0154] At least a portion of the first gas channel, or an outer membrane defining it, can be made from a breathable material. Various designs of patient interfaces utilizing breathable materials are possible; for example, the entire surrounding wall / outer membrane of the interface body may be formed from the breathable material, a portion of the surrounding wall / outer membrane over the first gas channel may be formed from the breathable material, or a portion of the surrounding wall / outer membrane over the upper part of the first gas channel may be formed from the breathable material. One or more regions, e.g., multiple parts, of the surrounding wall / outer membrane or the first gas channel may be formed from the breathable material. The breathable material may be placed on and / or bonded to the support structure of the first gas channel. The breathable material may be located within the "gap" of the support structure. The interface body may include one or more layers of breathable material. The breathable material can provide a water vapor channel from the interface body to the ambient air.

[0155] The breathable material may consist of a film, such as a thin film. Throughout this specification, the terms film, thin film, and membrane can be understood to be synonymous. Furthermore, the breathable material may be transparent and / or translucent.

[0156] The breathable area of ​​the interface body allows for the diffusion of water vapor from the interface. As a result, the accumulation of condensation in the interface body, particularly in the first gas flow path, is eliminated or reduced. Therefore, the permeable region can reduce the risk of condensation accumulation and potential saturation of the diffuser material.

[0157] A monolithic wall is a wall that does not contain open channels or through-holes from one main surface to another.

[0158] Alternatively, the interface body may have a surrounding wall or outer membrane that defines at least a portion of the gas flow path, and at least one region of the surrounding wall or outer membrane is a microporous or porous material that allows water vapor to pass through. For example, the region of the surrounding wall or outer membrane may include a microporous polymer film. The small pore size of such a film prevents the penetration of liquid water but allows the permeation of water vapor.

[0159] Porous or microporous materials can be porous due to their composition, physical structure, or a combination thereof. Examples of porous or microporous materials include thermoplastic elastomers, thermoplastic polyurethane elastomers, polyurethanes, hydrophilic thermoplastic resins, and polyolefins. Porous or microporous materials can be films or membranes. For example, porous or microporous materials can be stretched polytetrafluoroethylene (PTFE) or precipitated cast polyurethane.

[0160] In a further embodiment, a patient interface for wound treatment and / or management comprises an interface body configurable to substantially or at least partially surround a wound, the interface body comprising a gas inlet and defining a first gas channel and a second gas channel, the first gas channel being arranged in fluid communication with the gas inlet and the second gas channel, the interface body further configurable to provide or have a gas outlet in or adjacent to the wound, and the interface body being configured to be pullable from a first position to a second traction position while substantially maintaining the first and second gas channels.

[0161] The gas outlet can be provided on the inner surface of the interface body. The interface body may include a diffusion material portion. A second gas flow path can be defined in the diffusion material portion. The diffusion material portion may include a stretchable porous material, such as a foam, fabric, textile, or cellular structure. In one embodiment, the stretchable porous material is an open-cell foam.

[0162] The interface body may have a surrounding wall or outer membrane, and the first gas flow path is defined between the surrounding wall or outer membrane and the diffusion material portion.

[0163] A support structure is positioned between the outer membrane of the interface body and the diffusion material portion within the first gas flow path.

[0164] The support structure may be a scaffold or a spring. The support structure may include a long, flexible structure having a longitudinal axis and configured to be elastically deformable under the application of forces applied laterally and / or vertically and / or longitudinally.

[0165] The support structure can be configured to bend laterally with respect to its longitudinal axis. The support structure can also be configured to bend to conform to the contours of the patient's body surrounding the wound.

[0166] The support structure may have a cross-sectional shape configured to substantially resist compressive forces. The support structure can be configured to allow torsional motion.

[0167] The support structure may have a substantially square or rectangular cross-sectional shape having a pair of opposing first sides and a pair of opposing second sides positioned substantially perpendicular to the pair of opposing first sides. Each of the pair of opposing first sides may include a repeating rectangular wave or rounded wave pattern, so that each repeat of the pattern defines a first slot extending from one of the pair of opposing second sides toward the other of the pair of opposing second sides, and an adjacent second slot extending from the other of the pair of opposing second sides toward the one of the pair of opposing second sides. Each of the first and second slots may include a right-angled or rounded wall on its respective opposing second side that forms a structural portion between the opposing first sides. The width of each of the first and second slots may be less than the width of the portion of the support structure extending between the first and second slots when in its first position. Alternatively, the width of each of the first and second slots is greater than or equal to the width of the portion of the support structure that extends between the first and second slots when they are in their first position.

[0168] In a further embodiment, a support structure providing structural support to a patient interface includes an elongated flexible structure having a longitudinal axis and is configured to be elastically deformable under the application of forces applied laterally and / or vertically and / or longitudinally. This support structure can be used in any other embodiment of the patient interface of the present disclosure.

[0169] The support structure may be a scaffold or a spring. The support structure may include a long, flexible structure having a longitudinal axis and configured to be elastically deformable under the application of forces applied laterally and / or vertically and / or longitudinally.

[0170] The support structure can be configured to bend laterally with respect to its longitudinal axis. The support structure can also be configured to bend to conform to the contours of the patient's body surrounding the wound.

[0171] The support structure may have a cross-sectional shape configured to substantially resist compressive forces. The support structure may also be configured to allow torsional motion.

[0172] The support structure may have a substantially square or rectangular cross-sectional shape having a pair of opposing first sides and a pair of opposing second sides positioned substantially perpendicular to the pair of opposing first sides. Each of the pair of opposing first sides may include a repeating rectangular wave or rounded wave pattern, so that each repeat of the pattern defines a first slot extending from one of the pair of opposing second sides toward the other of the pair of opposing second sides, and an adjacent second slot extending from the other of the pair of opposing second sides toward the one of the pair of opposing second sides. Each of the first and second slots may include a right-angled or rounded wall on its respective opposing second side that forms a structural portion between the opposing first sides. The width of each of the first and second slots may be less than the width of the portion of the support structure extending between the first and second slots when in its first position. Alternatively, the width of each of the first and second slots is greater than or equal to the width of the portion of the support structure that extends between the first and second slots when they are in their first position.

[0173] The surrounding wall or outer membrane of the interface body may be translucent or transparent to allow visibility to the first gas channel and / or diffusion material portion, and to show any condensations that accumulate within the patient interface 10.

[0174] The support structure may be configured to conform to the contour of the patient's body surrounding the wound site. The support structure may be configured to be deformable under the application of forces applied laterally and / or vertically and / or longitudinally. The support structure may have a cross-sectional shape configured to substantially resist torsional forces. For example, the support structure may include a substantially square or rectangular cross-sectional shape having a pair of opposing first sides and a pair of opposing second sides positioned substantially perpendicular to the pair of opposing first sides. In this case, the support structure may include connecting members on each of the pair of opposing second sides.

[0175] Alternatively, the support structure may have a substantially C-shaped cross-section having a pair of opposing first sides and a single second side positioned substantially perpendicular to the pair of opposing first sides, with the opposing second side remaining substantially open to the single second side.

[0176] The flexible structure may include multiple interconnected elements arranged in a repeating pattern along the longitudinal axis of the support structure.

[0177] In one embodiment, the multiple interconnecting elements include a plurality of substantial X-shaped elements extending in a repeating pattern along each of a pair of opposing first surfaces, wherein adjacent X-shaped elements share a connecting member that extends substantially perpendicular to the pair of opposing first surfaces, connecting an adjacent X-shaped element on one of the pair of opposing first surfaces to a corresponding adjacent X-shaped element on the other of the pair of opposing first surfaces. The intersection of each of the plurality of substantial X-shaped elements may be substantially at the midpoint of each of the pair of opposing first surfaces. Alternatively, the intersection of each of the plurality of substantial X-shaped elements may be offset from the midpoint of each of the pair of opposing first surfaces.

[0178] The connecting member may have a shape that tapers inward toward the midpoint of each of the pair of opposing second sides. In one embodiment, the connecting member is substantially X-shaped.

[0179] In one embodiment, each of a pair of opposing first surfaces includes a repeating rectangular or rounded wave pattern, wherein each repeat of the pattern includes a first slot extending from one of the pair of opposing second surfaces toward the other of the pair of opposing second surfaces, and an adjacent second slot extending from the other of the pair of opposing second surfaces toward the one of the pair of opposing second surfaces.

[0180] The width of each of the first and second slots can be smaller than the width of the portion of the support structure extending between the first and second slots. This configuration has a greater degree of rigidity and a smaller degree of flexibility than an alternative embodiment in which the width of each of the first and second slots is greater than or equal to the width of the portion of the support structure extending between the first and second slots. This configuration can be used when higher flexibility is required.

[0181] The support structure may further include notches or cutouts in a portion of one of a pair of opposing second sides adjacent to each of the slots of the repeating rectangular wave or repeating rounded wave pattern.

[0182] In embodiments of a support structure having a substantially C-shaped cross-section, each of a pair of opposing first sides may include a repeating rectangular wave or rounded wave pattern, thereby each repeat of the pattern having a first slot extending from a single second side toward a substantially open side of the pair of opposing second sides, and of the pair of opposing second sides It includes an adjacent second slot extending from a substantially open side toward one of a pair of opposing second sides. The open side of the C-shaped support structure can trap or seal a portion of the diffusion material adjacent to the first gas flow path.

[0183] Each distal end portion of the repeating rounded wave pattern slot can be rounded, and each second side is rounded with a corresponding curvature.

[0184] The height of each side of the second side or a pair of opposing second side surfaces may be tapered over at least a portion of the longitudinal axis of the support structure. Furthermore, the width of each of the pair of opposing first side surfaces may be tapered over at least a portion of the longitudinal axis of the support structure.

[0185] In another embodiment of the support structure, the multiple interconnected elements include a plurality of rectangular or square strips extending in a repeating pattern along the longitudinal axis of the support structure, the plurality of rectangular or square strips being interconnected by a longitudinal spine extending along the length of the support structure at the midpoints of each of a pair of opposing first sides of the support structure.

[0186] In further embodiments, the support structure includes a flexible structure having a substantially circular or rhomboid cross-section.

[0187] In a further embodiment, a wound management and / or treatment system comprises a patient interface according to any embodiment of the present disclosure and a gas source. The patient interface, for example, its gas inlet, is arranged in fluid communication with the gas source.

[0188] The system may further include a gas controller that controls one or more functions, including, but is not limited to, gas flow rate, pressure, gas mixing, delivery of drugs or medications to gas mixtures (for example, some gas types such as CO2 and nitric oxide may be considered drugs), and delivery of liquid medications. The system may further include a gas regulator that heats and / or humidifies the gas supplied from the gas source before it enters the patient interface.

[0189] In a further embodiment, a method for treating a wound using a patient interface or system of any embodiment of the present disclosure includes the steps of applying the patient interface to a wound site or intended wound site before an incision is made at the wound site or intended wound site, and turning on the flow of gas from a gas source to the patient interface. The step of applying the patient interface to the wound site or intended wound site may include applying multiple patient interfaces to the wound site or intended wound site in order to adequately surround the wound site or intended wound site.

[0190] This method may further include a step of preparing the gas before it enters the patient interface. The step of preparing the gas may include adjusting one or more of the following: the temperature, humidity level, carbon dioxide level, or composition of the gas.

[0191] In a further embodiment, a method of protecting a patient from one or more of surgical site infection, moisture loss, and / or heat loss using a patient interface or support structure or system of any embodiment of the present disclosure includes the steps of applying the patient interface adjacent to a wound site or intended wound site, and turning on the flow of gas from a gas source to the patient interface.

[0192] The step of applying the patient interface to the wound site or intended wound site is performed on the wound site This may include applying multiple patient interfaces to the wound site or intended wound site in order to adequately surround the wound site or intended wound site.

[0193] This method may further include a step of adjusting the gas before entering the patient interface. The step of adjusting the gas may include adjusting one or more of the following: the temperature, humidity level, or oxygen level of the gas.

[0194] In a further aspect, the use of any aspect of the present disclosure of a patient interface and / or support structure and / or system in a surgical procedure is provided.

[0195] In a further embodiment, the use of any embodiment of the present disclosure of a patient interface and / or support structure and / or system in the management of a postoperative wound site is provided.

[0196] Here, for the purpose of outlining the disclosed apparatus, system, and method, several aspects, advantages, and novel features of the disclosed apparatus, system, and method have been described. It should be understood that not all advantages can necessarily be achieved by any particular embodiment of the disclosed apparatus, system, and method. Accordingly, the disclosed apparatus, system, and method can be embodied or implemented in a manner that achieves or optimizes one or more advantages or sets of advantages taught herein, without necessarily achieving other advantages that may be taught or suggested herein. [Brief explanation of the drawing]

[0197] Herein, one or more embodiments of the present disclosure will be described by specific examples with reference to the attached drawings.

[0198] [Figure 1a] This is a diagram of a first embodiment of a system for wound management and / or treatment. [Figure 1b] This is a diagram of a further embodiment of a system for wound management and / or treatment. [Figure 1c] This is a diagram of a further embodiment of a system for wound management and / or treatment. [Figure 2] This is a perspective view of one embodiment of a patient interface. [Figure 3a] A perspective view of a further embodiment of the patient interface. [Figure 3b] This is a perspective view of the patient interface in traction configuration shown in Figure 3a. [Figure 4] A perspective view of a further embodiment of the patient interface. [Figure 5a] A perspective view of a further embodiment of the patient interface. [Figure 5b] This is a schematic plan view of a further embodiment of the patient interface. [Figure 6a] This is a schematic bottom view of an embodiment of a patient interface with adhesive backing. [Figure 6b] This is a schematic bottom view of an embodiment of a patient interface with adhesive backing. [Figure 6c] This is a schematic bottom view of an embodiment of a patient interface with adhesive backing. [Figure 6d] This is a schematic bottom view of an embodiment of a patient interface with adhesive backing. [Figure 7] This is a perspective view of one embodiment of a patient interface having a support wire. [Figure 8] This is a perspective view of one embodiment of a patient interface having a heater element. [Figure 9] This is a perspective view of one embodiment of a patient interface including a transparent film. [Figure 10] This is a schematic cross-sectional view of one embodiment of a patient interface having a peripheral first gas flow path. [Figure 11] This is a schematic cross-sectional view of the patient interface in Figure 10, including the scaffolding or support structure. [Figure 12a] This is a schematic cross-sectional view of the patient interface in Figure 10, including the spring. [Figure 12b] Figure 12a shows two possible options for the cross-sectional view of the patient interface at AA. [Figure 13a] This is a schematic cross-sectional view of one embodiment of a patient interface having various configurations of the first gas channel and diffusion material portion. [Figure 13b] This is a schematic cross-sectional view of one embodiment of a patient interface having various configurations of the first gas channel and diffusion material portion. [Figure 13c] This is a schematic cross-sectional view of one embodiment of a patient interface having various configurations of the first gas channel and diffusion material portion. [Figure 13d] This is a schematic cross-sectional view of one embodiment of a patient interface having various configurations of the first gas channel and diffusion material portion. [Figure 13e] This is a schematic cross-sectional view of one embodiment of a patient interface having various configurations of the first gas channel and diffusion material portion. [Figure 13f] This is a schematic cross-sectional view of one embodiment of a patient interface having various configurations of the first gas channel and diffusion material portion. [Figure 14] This is a schematic cross-sectional view of one embodiment of a patient interface having two stages of diffusion material with different densities. [Figure 15] This is a schematic cross-sectional view of one embodiment of a patient interface having one or more flow regulators. [Figure 16] This is a schematic cross-sectional view of one embodiment of a patient interface having two or more entrances. [Figure 17] This is a schematic cross-sectional view of one embodiment of a patient interface having an alternative entry point. [Figure 18a] This is a schematic cross-sectional view of one embodiment of a patient interface including a flow shunt. [Figure 18b] This is a schematic cross-sectional view of one embodiment of a patient interface including a flow shunt. [Figure 18c] This is a schematic cross-sectional view of one embodiment of a patient interface including a flow guide. [Figure 18d] This is a schematic cross-sectional view of one embodiment of a patient interface including a flow guide. [Figure 18e] This is a schematic cross-sectional view of one embodiment of a patient interface having a flow shunt. [Figure 19] Figure 19a is a schematic diagram of the longitudinal section AA of the patient interface shown in Figure 19b. Figure 19b is a partial schematic longitudinal section of one embodiment of the patient interface. [Figure 20] Figures 20a-20p are schematic partial cross-sectional views of the patient interface in cross-section AA of Figure 19a, showing different exit configurations. [Figure 21]Figures 21a-b are partial cross-sectional views of an embodiment of a patient interface, showing two options for the configuration of the outer membrane of the patient interface. [Figure 22] Figures 22a-22e are schematic cross-sectional views of one embodiment of a patient interface having different positional configurations of the first gas flow path and diffusion material portion. [Figure 23] This is a partial cross-sectional view of one embodiment of a patient interface including a liner in the first gas channel. [Figure 24] This is a schematic diagram outlining the steps involved in wound treatment. [Figure 25a] This is a cross-sectional view of one embodiment of a patient interface including a heating pad or a heated fabric surface. [Figure 25b] This is a cross-sectional view of one embodiment of a patient interface including a heating pad or a heated fabric surface. [Figure 25c] This is a cross-sectional view of one embodiment of a patient interface including a heating pad or a heated fabric surface. [Figure 26] This is a top or bottom view of a heating pad or heated fabric surface applied to a patient interface. [Figure 27] This is a perspective view of a support structure according to one embodiment of a patient interface. [Figure 28] This is a perspective view of a support structure according to one embodiment of a patient interface. [Figure 29] Figure 28 is a plan view of the support structure. [Figure 30] This is a perspective view of a support structure according to one embodiment of a patient interface. [Figure 31] This is a perspective view of a support structure according to one embodiment of a patient interface. [Figure 32] This is a perspective view of a support structure according to one embodiment of a patient interface. [Figure 33] This is a perspective view of a support structure according to one embodiment of a patient interface. [Figure 34] This is a perspective view of a support structure according to one embodiment of a patient interface. [Figure 35]This is a perspective view of a C-shaped support structure according to one embodiment of a patient interface. [Figure 36] This is a perspective view of a further embodiment of a C-shaped support structure according to one embodiment of a patient interface. [Figure 37] This is a partial cross-sectional view of a patient interface having a support structure with a C-shaped cross-section, partially encapsulating a diffusion material. [Figure 38a] Plan and perspective views of further embodiments of the support structure for the patient interface. [Figure 38b] Plan and perspective views of further embodiments of the support structure for the patient interface. [Figure 39a] Plan and perspective views of further embodiments of the support structure for the patient interface. [Figure 39b] Plan and perspective views of further embodiments of the support structure for the patient interface. [Figure 40a] Plan and perspective views of further embodiments of the support structure for the patient interface. [Figure 40b] Plan and perspective views of further embodiments of the support structure for the patient interface. [Figure 41a] Plan and perspective views of further embodiments of the support structure for the patient interface. [Figure 41b] Plan and perspective views of further embodiments of the support structure for the patient interface. [Figure 42a] Plan and perspective views of further embodiments of the support structure for the patient interface. [Figure 42b] Plan and perspective views of further embodiments of the support structure for the patient interface. [Figure 43] This is a perspective view of the support structure in the embodiment shown in Figures 38a and 38b, which is in a bent state. [Figure 44] This is a plan view of an inline function indicator. [Figure 45]This is a perspective view of a patient interface including a surgical incision length indicator. [Figure 46] Figures 46-46c are schematic cross-sectional views of a patient interface having one or more semi-impermeable or substantially gas-permeable portions. [Figure 47] Figures 47a and 47b are plan and perspective views of the support structure for a patient interface with a grip portion. [Figure 48] Figures 48a-48b are schematic cross-sectional views of a patient interface with a flow shunt and a perspective view of the flow shunt. [Figure 49] This is a schematic cross-sectional view of a patient interface with additional gas channels to a secondary device. [Figure 50] Figures 50a-f are schematic cross-sectional views of a patient interface with a fixed flange and schematic partial side views of an embodiment of a fixed tab. [Figure 51] This is a schematic diagram of the method steps for protecting a wound. [Modes for carrying out the invention]

[0199] Figures 1a, 1b, and 1c illustrate embodiments of a system for treating and / or managing wounds. System 1 in Figures 1a and 1b includes a patient interface 10 connected to a gas source 14 via a circuit 12. The gas source 14 supplies gas to the patient interface 10. The gas source 14 can take several different forms, including room air as shown in Figure 1a, or a gas container or wall gas source as shown in Figure 1b.

[0200] In the embodiment shown in Figure 1a, the gas source 14 in the form of indoor air is a combined flow generator / humidifier. The air is taken into unit 15. These combined flow generator / humidifier units 15 can take in indoor air and mix it with a secondary gas through a separate inlet port on the device. The flow generator / humidifier unit 15 is a commercially available Airvo unit from Fisher & Paykel Healthcare Limited. TMThe device may have generally similar functions. In Figure 1b, the flow controller 16 and humidifier 17 are shown as separate units. As depicted, the flow controller 16, which may be an inhaler or similar device, can receive gas from a gas source 14 in the form of a container or wall gas source. However, it is also possible to take in air into the flow controller 16 and mix the taken-in air with other gases so that it also functions as a flow generator. In either the embodiment of Figure 1a or Figure 1b, the gas can be adjusted, for example, heated and / or humidified, for delivery to the patient interface 10 and wound / wound edge, as desired.

[0201] In the embodiment shown in Figure 1c, a gas source in the form of room air is directed to a humidifier 17 using a flow meter 19. The gas can be adjusted by the humidifier 17, for example, by heating and / or humidifying, before being delivered to the surgical site or wound. The gas can be delivered to the patient interface 10 via a suitable tube or conduit 13. The tube or conduit can be actively heated and / or insulated to maintain the temperature and / or humidity of the gas until it is delivered to the patient interface 10. In the illustrated embodiment, the patient interface 10 is used for orthopedic procedures, i.e., spinal surgery.

[0202] In Figures 1a, 1b, and 1c, System 1 is shown being used in a surgical procedure on a patient. In Figures 1a and 1b, for ease of explanation, the patient is lying supine on the operating table. In Figure 1c, the patient is lying prone on the operating table. However, the patient's position is actually determined by the procedure to be performed, and in some orthopedic procedures, for example, the patient's limbs may even be moved during the procedure. When in use, the patient interface 10 is positioned on the surgical site on the patient so as to surround the surgical site where an incision is made to create an open wound. However, it will be understood that in some cases of surgery performed as a result of trauma, for example, a wound may already exist. In this case, the patient interface 10 is positioned on the patient around the existing wound. Thus, although the patient interface 10 is shown to be positioned on a substantially horizontal surface of the patient's body, this is not essential for it to perform its function.

[0203] The patient interface 10 can take various forms, as described below with reference to the exemplary embodiments shown in Figures 2 to 23 and Figures 25 to 50. In each embodiment, the patient interface 10 has an interface body 20, for example, as shown in Figure 2, which includes a gas inlet 22 through which gas enters the interface body 20. The patient interface also includes a first gas channel 100 and a second gas channel 102, as shown in Figures 10 to 23. The first gas channel 100 is positioned to be in fluid communication with the gas inlet 22 and also in fluid communication with the second gas channel 102.

[0204] The first gas flow path may have a first flow resistance, and the second gas flow path may have a second flow resistance. The second flow resistance may be generally greater than the first flow resistance. The flow resistance does not need to be constant throughout the entire first and second gas flow paths. For example, if the flow path itself is not constant throughout, the flow resistance may not be constant throughout the entire first gas flow path.

[0205] As described later, if the flow path contains pockets or obstacles that may affect the flow resistance, the flow resistance may not be uniform in cross-section throughout the second gas flow path. Overall, the second flow resistance is greater than the first resistance. In one embodiment, the gas expands When a cross-sectional slice is taken through the patient interface, parallel to the direction of exit from the diffuser, the second flow resistance is greater than the first resistance. Thus, the gas entering the gas inlet 22 flows easily through the first gas channel 100, and then enters the second gas channel 102, where the gas experiences higher resistance, as described herein.

[0206] The interface body 20 includes a portion made of a porous or open-cell material that, when in use, acts to diffuse gas around the periphery of the wound edge. The porous or open-cell material may be stretchable. For example, it may be conformable or flexible so that it can conform to the shape and / or contour of the patient's body. The porous or open-cell material will be referred to as the diffusion material portion throughout this specification. Suitable diffusion materials include open-cell foams, fabrics, textiles, or cellular structures such as cornstarch, made from expanded polyethylene, polyurethane, silicone, rubber, etc. Due to its stretchable nature, the diffusion material can conform to the contour of the patient's body and can be pulled together with the wound itself to deliver gas across the wound edge.

[0207] The interface body 20 has a thickness that is significantly smaller than either its length or width, as shown, for example, in Figures 2 and 3a and 3b. In a preferred embodiment, the interface body 20 has a vertical height of 30 mm or less, preferably 20 mm or less, more preferably 10 mm or less, and even more preferably 6 mm, so as to reduce the possibility that the interface body 20 may visually and / or physically obstruct the surgeon's workflow. The patient interface 10 can be manufactured in any preferred size, and the footprint of the patient interface 10 is determined according to the expected required surgical incision length or to suit a particular type of surgical procedure. For example, a patient interface for large existing wound sites or for long surgical incision lengths must have a larger footprint than a patient interface intended for use in ophthalmic surgery. The patient interface 10 can be used for very small incisions (e.g., 1 cm) to very large incisions (e.g., more than 1 m from the groin to the ankle in femoral-knee joint bypass). As a further example, an incision for total hip replacement may be 12 cm long. For an incision of this size, a slot length of approximately 16 cm is preferable, and if a larger incision is needed to provide greater access, it is preferable to provide 2 cm of space at each end of the wound.

[0208] The slot can be 0 mm wide (incision made through the diffusion material itself, exposing the diffusion edge) to 80 mm wide (providing a gap of up to 40 mm from the edge of the diffusion medium to the wound edge). Preferably, if the slot is a pre-formed slot 32, the slot can have a width dimension of about 5 to 80 mm, or about 5 to 60 mm, preferably 10 to 40 mm, and more preferably 10 to 30 mm.

[0209] In some embodiments, the patient interface 10 includes a pre-printed visible incision guideline 24 on its upper surface 26. The visible incision guideline 24 may be printed on the upper surface 26 and / or perforated so that the guideline 24 corresponding to the desired wound length can be easily torn off. Interface bodies 20 of different sizes intended for different surgical procedures may include visible incision guideline 24 of different lengths.

[0210] In some embodiments, a pre-formed slot 32 is cut into the interior of the interface body 20, as shown in Figure 3a, to allow unobstructed access and visibility to the incision site. This may be useful in surgical situations where the surgeon wishes to pre-mark the surgical incision line. The slot 32 allows the interface body 20 to be applied to the patient before the surgical incision without obscuring the pre-marked incision line. The length dimension of the slot 32 is determined by the size of the interface body 20 intended for the surgical procedure. This is how it is determined. Typically, the width of the slot 32 is small enough to maintain the performance of the interface body 20, but large enough so that the interface body 20 does not obstruct, interfere with, or interact with the incision. For example, the width of the slot 32 can be large enough so that the interface body 20 does not melt during electrosurgical procedures performed through the slot 32. To help the surgeon make an accurate or desired surgical incision at the wound site, the upper surface of the interface body may have a surgical incision length indicator 90 attached along at least one edge of the pre-formed slot 32. Figure 45 shows an exemplary embodiment of a patient interface 10 with surgical incision length indicators 90 attached on both sides of the pre-formed slot 32. The surgical incision length indicators 90 may or may not be numbered and may be measured in any unit, such as millimeters, centimeters or inches.

[0211] When using the patient interface, the patient interface 10 is ideally placed on the patient before a surgical incision is made. The patient interface 10 can then be pulled along with the surgical site. Figure 3a shows the slot 32 in its initial form or state. Figure 3b shows the same patient interface 10 with the slot 32 and interface body 20 in a pulled state, in which the slot 32 is pulled into an expanded form using a surgical retractor 34 or similar.

[0212] The porous, stretchable material (e.g., diffusion material), such as foam, of the interface body 20 is substantially elastic in some embodiments and, when a force, such as a force applied by a surgical retractor 34, is removed, it rebounds or bounces back to its initial shape. The diffusion material 104 can be stretched or deformed to spread by wound traction without significantly impairing the gas flow through the second gas channel 102. Similarly, the diffusion material 104 can be deformed when a force is applied during a surgical procedure, such as from a surgical instrument or the surgeon's hand.

[0213] The porous or open-cell diffusion material may have substantially uniform porosity or density along the length of the second gas channel 102, or its porosity / density may vary. For example, the diffusion material 104 may include a portion of relatively high-density foamed material, or one or more semi-impermeable or permeable foamed portions, as shown in Figure 46. Figure 46a shows one embodiment of the patient interface 10 in which the interface body 20 includes a pair of generally opposing semi-impermeable portions 204 of the diffusion material 104. The semi-impermeable portions 204 of the diffusion material 104 are located approximately midway along the length of the patient interface 10 and extend over the portion of the length of the slot 32 in which the retractor 34 is most likely to come into contact with the patient interface 10. The portions of the semi-impermeable or relatively high-density diffusion material 204 can prevent or mitigate the disruption of the channel from compression by the retractor.

[0214] Figure 46b shows one embodiment of the patient interface 10 in which the interface body 20 includes a pair of opposing substantially gas-impermeable portions 206 of the diffusion material 104. The relatively dense substantially gas-impermeable portions 206 can increase resistance to the force applied by the surgical retractor 34 when pressed against the side of the slot 32, thereby improving the robustness of the patient interface 10. The substantially gas-impermeable portions 206 may block the gas flowing through the second gas channel 102, but can help mitigate deformation of the porous foam by the retractor 34. In this embodiment, turbulence in the flow within the second gas channel 102 is controlled rather than incidentally occurring from the compression of the diffusion material 104 that could otherwise occur during the use of the surgical retractor 34.

[0215] The interface body 20 may include multiple instances of semi-impermeable portions 204 or substantially gas-impermeable portions 206 along each side of the slot 32 to further enhance the robustness of the patient interface. For example, the interface body 20 may be as shown in Figure 46c The interface may include two separated, opposing pairs of substantially gas-impermeable portions 206 along each side of the slot 32. This embodiment can be used when surgical procedures are expected to require the use of two or more surgical retractors 34 in different parts of the entire length of the patient interface 10. The semi-impermeable portions 204 or substantially gas-impermeable portions 206 can be positioned at several intervals along a 16 cm long slot, for example, required for hip surgery. Figures 46a to 46c show the semi-impermeable portions 204 and substantially gas-impermeable portions of the interface body extending across the entire width of the second gas channel 102, although they may occupy only a portion of the second gas channel 102 such that the density or porosity of the second gas channel 102 changes between the first gas channel 100 and the slot 32.

[0216] The semi-impermeable portion 204 and / or substantially gas-impermeable portion 206 of the interface body 20 can be made from a material other than the diffusion material 104, for example, a separate foamed component or other material component suitable for resisting the force applied by the surgical retractor 34.

[0217] The support structure 112 is structured and / or configured to allow the patient interface 10 to bend or deform to take on different shapes, while maintaining an essentially constant cross-section and flow resistance through the first gas channel 100.

[0218] The first gas channel 100 and the second gas channel 102 have different deformation characteristics. For example, the diffusion material portion 104 deforms in almost all directions when force is applied. However, the support structure 112 substantially resists deformation or allows deformation in some directions. For example, the support structure resists compression in the vertical direction but allows compression in the longitudinal direction. This allows the support structure 112 to maintain the first gas channel 100 in an open state. The first gas channel 100 can be maintained in an open state with a substantially constant cross-section.

[0219] Figure 4 shows an embodiment of the interface body 20 in which the length of the pre-formed slot 32 is adjustable by including perforations that define portions 42, 44 which can be optionally torn to increase the length of the slot 32 according to a desired or intended wound size. The width and / or diameter of the pre-formed slot 32 may also be adjustable.

[0220] The interface body 20 shown in Figures 2, 3, and 4 is generally elongated elliptical, with an inlet 22 located at one end. However, embodiments of the interface body may be pre-formed in different shapes, for example, circular, elliptical, or irregular. The shape can be selected to fit an existing chronic wound of any shape or size. In Figure 5a, the interface body 20 has a pre-formed elliptical shape. Figure 5b shows one embodiment of the interface body 20 having a pre-formed round or circular shape and a circular slot 32. Two concentric perforations surround the circular slot 32, thereby allowing the size of the circular slot 32 to be increased as desired by tearing off the portions 52, 54 defined by the perforations.

[0221] As best shown in Figures 12b and 21, the top surface 26, one or more outer surfaces 36, and optionally the bottom surface 61 of the interface body 20 are sealed by a coating or outer film 126, which can be manufactured as a result of the molding process of the foam body 20, or formed by overmolding or by a film material bonded to the interface body 20. Alternatively, the outer film 126 can be bonded to and around the diffusion material portion 104 after the portion has been manufactured or otherwise positioned. The outer membrane 126 of the interface body 20 may be semi-transparent or transparent to allow visibility to at least the first gas channel 102 and / or the diffusion material portion 104, as well as visibility to any condensates that may accumulate inside the patient interface 10 and adversely affect its performance.

[0222] The wall, outer membrane, or coating 126 can seal the open-cell foam or other porous diffusion material portion 104 of the interface body 20 from the atmosphere so that gases cannot pass through their surfaces. Alternatively, the outer membrane 126 may be at least partially permeable to moisture; for example, at least a portion of the outer membrane 126 defining the first gas channel 100 may be permeable to moisture. That is, it can be permeable / allow water vapor permeability while providing a liquid barrier. The outer membrane 126 may have a high water vapor permeability so that water vapor in the patient interface 10 can diffuse through the outer membrane 126 so as to prevent or at least mitigate the possibility of water vapor condensing into liquid water in the first gas channel 100. Thus, condensation in the device can be minimized. The outer membrane 126 may be made from a translucent or transparent film such as a polyurethane film. The outer membrane 126 may have a water vapor permeability of at least a certain percentage, or greater than, the rate of condensation accumulation in the interface body 20 or the first gas channel 100.

[0223] In some embodiments, for example in the embodiment shown in Figure 3a, the only surface of the open-cell foam or other diffusion material portion 104 that is open to the atmosphere is the inner surface 37, which defines a slot 32 or, if no pre-formed slot 32 exists in the interface body 20, is created by an incision cut through the interface body 20 by a surgeon. Thus, the inner surface 37 defines the exit between the interface body 20 and the patient interface 10. However, in some other embodiments described later, other surfaces of the diffusion material portion 104 may be fully or partially exposed to the atmosphere so that those surfaces also form part of the exit of the interface body 20.

[0224] The patient interface 10 can be attached to the patient's skin or surgical dressing by applying a biocompatible adhesive backing material 62 to the bottom surface 61 of the interface body 20. Figures 6a to 6c show three different adhesive configurations on the bottom surface 61 of the interface body 20 according to the embodiment of Figure 2. The adhesive material can be applied over the entire bottom surface 61 of the interface body 20 or over one or more portions of the bottom surface 61.

[0225] In Figure 6a, the adhesive backing material 62 or layer is applied over the entire bottom surface 61 of the interface body 20. In Figure 6b, the adhesive 62 is applied to a portion of the bottom surface 61 that is divided into multiple areas by at least one slit or slot, so that the bottom surface 61 can substantially conform to the curved surface below, for example, the patient's skin. This configuration may be advantageous in that the interface body 20 does not adhere excessively strongly to the patient's skin, thus avoiding bundling of the interface body 20 or a reduction in its ability to conform to irregular body or wound shapes. In Figure 6d, the adhesive backing material or layer 62 is applied on the bottom surface 61 in a regular or irregular, winding or substantially wavy pattern. The width of the adhesive backing material or layer 62 can be reduced or increased according to the level of flexibility required to adhere to a particular part of the body that may have greater or lesser undulations. For similar reasons, the adhesive material 62 can be applied to separate parts, for example, two strips as shown in the embodiment of Figure 6c.

[0226] The adhesive backing material 62 or layer may be provided as a separate layer applied to the bottom surface 61 of the interface body 20. Alternatively, the adhesive may be provided directly to the bottom surface 61 of the interface body 20.

[0227] As an alternative to adhesive materials, the interface body 20 may be partially or substantially attached to the patient by other non-adhesive mechanisms. Such mechanisms include applying a pad, for example, a silicone pad, to the bottom surface 61 so that it becomes sufficiently tacky or malleable and adheres to the patient via an adhesive effect. Other mechanisms include adhesive gel fixatives or other non-adhesive materials having a physical and / or chemical structure that provides an adhesive effect.

[0228] In some embodiments, for example, in the embodiment shown in Figure 7, the patient interface 10 also includes a partially or fully circumferentially malleable metal wire or strip 72 that can be bent, shaped, or formed into a desired contour so that the interface body 20 can maintain this shape. Such a metal wire or strip can be formed integrally with the interface body 20.

[0229] The patient interface 10 may include one or more heating elements, such as a heater wire loop 82 as shown in Figure 8, or one or more pads or fabric surfaces 84 as seen in Figures 25a-25c. The use of heating elements and / or heating pads or fabric surfaces reduces water vapor condensation in the patient interface 10. It delivers additional heat to the wound, for example, to help maintain the gas temperature and / or maximize humidity. The heating element 82 or heating pad / heated fabric surface 84 may be positioned on the top of the interface body 20 as shown in Figure 25c, on the bottom surface 61 as shown in Figure 25a, or on both the top and bottom surfaces 61 of the interface body 20, or sandwiched between layers of foam and / or membrane or film, or overmolded on one or more components of the patient interface 10. The heating element 82 and / or heating pad or heated fabric surface 84 may be located within the first gas flow path 100, or, in the case of a heater wire loop 82, within the diffusion material portion 104. Referring to the embodiment in Figure 8, the heater wire loop 82 enters the gas inlet 22 through the circuit 12 and enters the interface body 20, where the loop surrounds a pre-formed slot 32. Heating can be achieved by the conductive housing, by heating pads 84 positioned on both sides of the diffusion material portion 104, or by using conductive foam within the interface body 20. In the last example, the conductive foam is isolated from the patient's skin during use. In one embodiment, an electrical connection is made at the connection point of the patient interface 10 to the circuit 12. This connection makes it easy to identify that the patient interface 10 is connected to the circuit 12 and to identify the interface 10 using the known electrical resistance of the heater wire 82 used within a particular patient interface 10.

[0230] In Figure 25a, one or more heating pads 84 are positioned on the bottom surface 61 of the patient interface. The heating pads 84 extend over the first gas channel 100 and also over the diffusion material portion 104. A single heating pad or surface 84 may cover the entire surface area, or alternatively, multiple separate heating pads 84 may be used. In Figure 25b, one or more heating pads 84 are positioned only on the portion of the bottom surface 61 corresponding to the first gas channel 100. In another embodiment (not shown), the heating pads may extend over a surface area corresponding only to the diffusion material portion 104. It is assumed that one or more of the heating pads 84 can cover any desired area of ​​the bottom surface 61 of the patient interface 10. As described above, by positioning one or more heating pads 84 on the bottom surface 61 of the patient interface, heat can be conducted to the patient during use, and the wound site can be actively heated. This can increase perfusion because the warming of the tissue leads to vasodilation, allowing more blood to flow. This effect is thought to optimize the surgical or post-surgical wound condition, and can help prevent hypothermia in surgery, i.e., from prolonged skin exposure during anesthetics and / or surgery. It may also help mitigate the potential decrease in body temperature that can occur as a result of surgery, especially when normal temperature regulation is impaired before, during, and / or after surgery.

[0231] In Figure 25c, at least one heating pad or fabric surface 84 extends over the upper surface of the interface body 20. This configuration may be advantageous in minimizing condensation within the patient interface 10. The bottom surface 61 is already somewhat insulated from heat loss by being in contact with the patient. Therefore, heating the top surface eliminates a low-temperature surface on the top surface where condensation could form. This configuration also allows for higher heating element temperatures because the heating element is not in contact with the skin and therefore less likely to burn the skin. However, any combination of the embodiments in Figures 25a to 25c may be implemented.

[0232] The heating pad 84 can be made from a filling material in which heated filaments or wires are placed through the filling material beneath the surface. Alternatively, a heated textile may be knitted with conductive yarn to provide a heated fabric surface 84. A known type of heated fabric material is the "SEFAR PowerHeat NT" made from polyethylene terephthalate (PET) monofilament and conductive fibers. TM The fabric is a cloth. The heated fabric surface 84 may be functionally similar to this fabric, but may be adapted to ensure that it is suitable and safe for use during surgical procedures.

[0233] In one embodiment, one or more heating pads or heated fabric surfaces 84 are divided into multiple regions by at least one slit or slot 86. As shown in Figure 26, one or more heating pads or heated fabric surfaces can be divided into multiple regions by an alternating pattern of slots or slits 86 configured to allow or increase the flexibility of the patient interface 10 so that it can conform to the contours of the body during use.

[0234] FIG. 9 shows one embodiment in which a transparent film 92 is provided to be applied over the interface body 20, particularly but not exclusively, during the postoperative wound management phase to aid in the healing process. The transparent film 92 seals moisture to prevent dehydration of the wound and heat loss due to evaporative cooling. The transparency of the film 92 allows the wound to be viewed and / or its health status to be visually monitored without the need to remove a film that could interfere with the healing process. In some embodiments, the transparent film 92 is removably attached as needed so that the wound can be addressed without the need to remove the entire patient interface 10 from the wound site. In other embodiments, the transparent film 92 is not easily removable from the patient interface 10, which can have performance advantages in maintaining a gas flow near the wound during a surgical procedure. For example, the transparent film 92 can be non-removably attached to the upper surface 26 of one embodiment of the patient interface 10 that includes pre-formed slots 32 as shown in FIG. 9. The incision is then made so that it passes through the transparent film 92 but not through the diffusive material portion 104. The transparent film 92 can then form an overhang that extends over the pre-formed slot 32 beyond the diffusive material portion 104, which can serve to direct the gas flow exiting the patient interface 10 downwardly toward the wound. FIG. 20c schematically shows an example of a patient interface 10 having an outlet configuration that provides a similar effect.

[0235] An important aspect of the patient interface 10 and system 1 of the present disclosure is directed, insofar as possible, to delivering a gas flow with a uniform distribution at the inner surface 37 of the patient interface 10. The uniform distribution of the flow at the inner surface 37 can result in a gas curtain or blanket that forms a protective microenvironment over the wound site, preventing the wound site from dehydrating or becoming hypothermic. FIGS. 10-23 show various embodiments of the configuration of the patient interface 10 aimed at delivering a more uniform flow.

[0236] ​FIG. 10 is a cross-sectional view of one embodiment of a patient interface 10 in which a first gas path 100 is disposed peripherally so as to substantially surround a diffusion material portion 104 (e.g., an open cell foam) of an interface body 20. By the peripheral first gas path 100, one or more gases entering at inlet 22 can freely pass around the diffusion material portion 104, providing a more uniform distribution of the gas flow from gas source 14 to the outer peripheral portion 106 of the diffusion material portion 104 of the interface body 20. The gas flows through the second gas path 102, i.e., from the outer peripheral portion 106 of the diffusion material portion 104, through the diffusion material, and is delivered to an outlet at the inner surface 37 of the diffusion material portion 104 in a more uniform distribution. The second gas path 102 is formed through the porous open structure of a foam or other open cell material and exhibits a higher flow resistance to gas flow than the first gas flow path 100.

[0237] The first gas flow path 100 may be completely empty as seen in FIG. 10 or may be filled with a stretchable porous material having a substantially lower flow resistance than the diffusion material so as to have a substantially lower resistance to gas flow than the diffusion material. In the embodiment of FIG. 11, a support structure or scaffold structure 112 is positioned throughout the first gas flow path 100. The support structure 112 is configured to deform upon traction of the patient interface 10 but maintain a substantially flat outer profile. The support structure 112 is configured to maintain a cross-section of the first gas flow path that is substantially unaffected by traction. Traction of the patient interface 10 occurs with traction of a surgical incision or wound when an incision or wound edge is separated and held apart to access underlying organs or tissues. When a wound or incision is tractioned, the patient interface 10 including the support structure 112 is also tractioned. The support structure 112 is configured to resist forces such as compressive forces that can be applied by pushing a surgical retractor 34 laterally against the outer periphery of the slot 32 of the patient interface 10 or generally by surgical instruments. ]]

[0238] In the embodiment shown in Figure 12, the support structure is in the form of a helical spring 122 positioned in the first gas channel 100 over substantially the entire periphery of the diffusion material portion 104 of the interface body 20. Other modifications are described later. Each of the modifications, as shown in Figure 12b, helps to support the outer membrane 126 of the interface body 20 and maintain the shape of the first gas channel 100. The support structures 112, 122 also provide structures over which a sealing film can be wrapped to form the outer membrane 126.

[0239] Including a support structure 112 or a spring 122 as a support structure offers further advantages. During use, the retractor 34 often applies considerable force to the wound edge to separate it, allowing sufficient physical access for the surgeon and surgical instruments. The force on the retractor 34 may cause the first gas channel 100 to collapse and become blocked. The spring 122 can have sufficient spring force to physically resist being crushed and / or twisted while maintaining its flexibility. Thus, the spring 122 can maintain the gas flow through the first gas channel 100 in such situations. The spring 122 can be made from a metal that can provide sufficient reinforcement against crushing or deformation, such as stainless steel or spring steel that can be coated. In some embodiments, the spring 122 is formed from medical-grade stainless steel, but non-medical materials can also be used, along with a biocompatible layer or a sealing coating that presents a sterilization and corrosion barrier. Alternatively, the spring 122 may be made from plastic, or a combination of metal and plastic. When made from a thermally conductive material, the spring 122 is suitable for allowing the spring 122 itself to act as a heater wire. It can have a firm resistance. The spring 122 may be a spirally wound metal wire. Its diameter can be selected to provide the desired support to the outer film 126, and it may be coated with a coating that allows the spring 122 to also function as a heater wire 82.

[0240] The spring 122 may have too low a resistance to function as a heater wire 82. In this case, the spring 122 may include or constitute a heating element. Alternatively, the spring 122 may have an insulating coating that allows a second wire having a resistance suitable for use as a heater wire 82 to be wound around the spring 122 or passed through the coil of the spring 122. An example of a suitable insulating coating or casing is a thermoplastic sheath, such as a low-density polyethylene (LDPE) sheath.

[0241] The spring 122 can be positioned on the outer surface of the flow guide insert 124 or within its internal bore. The spring 122 and the flow guide insert 124 may be held together by overmolding of a surrounding outer membrane 126, or the spring itself may be overmolded on or inside the flow regulator insert 124. Alternatively, the outer membrane 126 may be bonded or otherwise positioned on or around its diffusion material portion 104 after the portion has been manufactured.

[0242] The support structure 112 is designed to prevent collapse from the forces of wound retractors and other surgical instruments, but to have a flexible structure that can conform to the contour of the body surrounding the wound site, and to deform with the wound edge when pulled without substantially affecting the first gas channel and / or its flow resistance. The integrity of the first gas channel 100 is maintained while preventing collapse of the support structure 112. The shape and structure of the support structure 112 are deformable under the application of lateral forces, for example, when the patient interface 10 is pulled along with the wound. The support structure 112 may be fabricated to have multiple geometric features or repeating patterns to allow flexibility in one or more directions and / or rigidity in one or more directions.

[0243] The support structure can be made from any number of suitable materials, such as polymers (nylon, polyurethane, PTFE, polypropylene), carbon fibers, or plant-based materials, such as sugarcane plastic. The support structure 112 can be made from or may contain materials suitable for intraoperative imaging techniques. For example, the material may be free of metal components so that the support structure 112 does not interfere with imaging of the surgical site, such as intraoperative imaging. Alternatively, the support structure 112 may include materials or elements that can be seen by imaging techniques. In some embodiments, another component of the interface 10 may include materials or elements that can be seen by imaging techniques.

[0244] The material of the support structure 112 may include portions that can be cut open with a simple instrument, such as surgical scissors, while providing the necessary structural integrity. This may be necessary at the end of a surgical procedure, for example, to remove the patient interface 10 from the patient. Therefore, the support structure may include one or more brittle or fragile portions to facilitate cutting. The fragile or fragile portions may be made visible to the surgeon to facilitate cutting by marking them in a suitable location on the support structure 112 or elsewhere on the patient interface 10, for example, on the outer membrane 126, or by other means. The support structure 112 may have a substantially rectangular, circular, rhomboid (or any shape) cross-section. Figures 27 to 43 and 47 show various embodiments of the support structure 112 as described below.

[0245] In the embodiment shown in Figure 27, the support structure 112 has a rectangular cross-section with a pair of opposing first sides 210a, 210b (upper and lower sides as seen in Figure 27) and a pair of opposing second sides 215a, 215b (vertical sides as seen in Figure 27) positioned substantially perpendicular to the pair of opposing first sides. The support structure 112 comprises a plurality of interconnected elements 220 arranged in a repeating pattern along the longitudinal axis of the support structure 112. The plurality of interconnected elements 220 include a plurality of substantially X-shaped elements 220 extending in a repeating pattern along each of the pair of opposing first sides 210a, 210b. Adjacent X-shaped elements 220 share a vertically oriented connecting member 230 that extends substantially perpendicularly to a pair of opposing first sides 210a, 210b, connecting adjacent X-shaped elements 220 on the upper side 210a of the pair of opposing first sides to the corresponding adjacent X-shaped elements 220 on the lower side 210b of the pair of opposing first sides. The vertical connecting member 230 has a shape that tapers inward from each of the upper side 210a and lower side 210b toward their midpoints. In the embodiment of Figure 27, the intersection 240 of each of the multiple substantially X-shaped elements 220 is substantially at the midpoint of each of the pair of opposing first sides 210a, 210b. The support structure 112 of this embodiment can be stretched longitudinally and bent in both directions laterally, thus providing flexibility in three directions. Its structure also resists torsion. These properties of the support structure 112 allow the patient interface 10 to closely conform to the traction wound. In particular, longitudinal stretching allows the patient interface 10 to expand and conform to the wound when traction is applied.

[0246] In the modified configuration shown in Figures 28 and 29, the intersection 240 of the multiple substantial X-shaped elements 220 is offset from the midpoint of each of the pair of opposing first sides 210a and 210b. The intersection 240 is otherwise the same as in the embodiment of Figure 27. This configuration also has flexibility and resistance to torsion in three directions. However, this support structure 112 has greater flexibility than that shown in Figure 27 in bending in one horizontal plane direction, where the connecting members 230 of the sides 215b are bent toward each other when viewed from above. This is due to the asymmetric nature of the X-shaped elements 220. This property of the support structure 112 can be advantageous because, during use, the support structure 112 is bent at least partially around a circular shape at the distal and / or proximal ends of the patient interface 10.

[0247] In the embodiments shown in Figures 27 to 29, the pitch (p) or spacing between the connecting members 230 is shorter than or equal to the width of the connecting members 230. This configuration provides the flexible structure with rigidity to resist lateral and vertical forces applied by the retractor 34 or other surgical instruments.

[0248] Figure 30 shows one embodiment of the support structure 112 having a wider pitch (p) between connecting members 230 than that of the embodiment shown in Figure 29. The connecting members 230 are also X-shaped. The X-shaped elements 220 on the upper sides 210a and 210b have a larger intersection angle than the X-shaped elements 220 in the embodiments of Figures 27 to 29. This embodiment provides greater flexibility to the support structure 112. This embodiment may have lower crush resistance compared to the support structure 112 of Figures 27 to 29. In each of the embodiments of Figures 27 to 30, the X-shaped elements 220 can have a thickness of about 1.5 mm. The connecting members 230 can be about 2.5 mm wide (i.e., extending longitudinally with respect to the longitudinal axis of the support structure 112) and can have a thickness of about 1.0 to 1.5 mm. The pitch between the connecting members 230 can be any of 2 to 10 mm, more preferably 4 to 8 mm.

[0249] Figures 31 to 33 show embodiments of a support structure 112 that utilize a repeating rectangular wave pattern to achieve the desired rigidity of the structure while providing a flexible structure. Each of the first sides 210a and 210b includes a structural portion 211 defining a repeating alternating rectangular wave pattern, wherein each repetition of the rectangular wave pattern includes a first slot 250a extending from one of a pair of opposing second sides 215a toward the other of a pair of opposing second sides 215b, and an adjacent second slot 250b extending from the other of a pair of opposing second sides 215b toward the one of a pair of opposing second sides 215a. The degree of flexibility and crush resistance can be adjusted by changing the width and / or pitch of the structural portions 211 of sides 210a and 210b, thereby effectively changing the pitch of the repeating rectangular wave pattern. For example, in the support structure 112 of Figure 32, the structural portions 211 of the pair of opposing first sides 210a and 210b have a rectangular wave pattern with a larger pitch than that shown in the support structure 112 of Figure 31, as the longitudinal spacing between the structural portions increases. Increasing the pitch of the structural portion 211 widens the width of slots 250a and 250b. The pitch of the rectangular wave pattern can be further or otherwise varied by implementing a larger or smaller width of the structural portion 211 in the longitudinal direction of the support structure 112. Furthermore, the pitch of the rectangular wave pattern can be varied across opposing first sides 210a and 210b.

[0250] Figure 33 shows another embodiment of the support structure 112, which is the same as the embodiment in Figure 31, in which notches or cutouts 255 are added to portions of the vertical second sides 215a, 215b on both sides of the slots 250a, 250b. In this embodiment, the notches or cutouts 255 are circular. However, they may be diamond-shaped or other preferred shapes. The cutouts 255 can be made on either or both of the vertical second sides 215a, 215b, but it is preferable to include the cutouts 255 on only one of the second sides in order to maintain the crush resistance of the support structure 112. The cutouts 255 function to maintain an open gas flow path through the patient interface 10 when the support structure 112 is in a bent shape. For example, in Figure 33, the cutout 55 is shown on the second side 215a. When the support structure 112 is fully bent laterally toward the second side surface 215a, the vertical slot 250a may be substantially or completely closed when the vertical section of the second side surface 215a abuts against it, but the cutout 255 functions to maintain an open gas path from the first gas channel 100 to the second gas channel 102 through the diffusion material located adjacent to the support structure 112 when the patient interface 10 is in its original position. This embodiment can be used for particularly good effects on the inner surface of the support structure 112 or the second side surface 215a when bent around the distal end of the patient interface 10, as shown in Figure 43. The support structure 112 can be fully bent around the radius, but gas is still supplied to the diffusion material through the inner side surface 215a of the support structure 112.

[0251] The support structure in Figure 34 includes a series of repeating rectangular cross-section strips 260, which are interconnected by a central longitudinal spine 265 that extends along the length of the support structure 112 at the midpoints of the upper side 210a and lower side 210b of the support structure 112. The strips 260 are spaced longitudinally apart from one another at a pitch narrower than the width of the strips 260, so as to form narrow slots between them.

[0252] The above configuration has a repeating pattern that provides flexibility in all planes while resisting both tension and compression and vertical bending. The spine portion 265 running through the center of the upper side 210a and lower side 210b may be made of the same material as the band portion 260 of the support structure 112, or it may be made of a significantly softer or more flexible material such as silicone, rubber, or thermoplastic elastomer to allow for some vertical flexibility. A balance between vertical flexibility and resistance may be desired so that the patient interface 10 conforms to the contours of the body but can resist crushing forces caused by retractors and / or other surgical instruments.

[0253] Figures 35 and 36 show examples of support structures 112 having a substantially C-shaped cross-section, respectively. The remaining sides of the structure are left open. The embodiment in Figure 35 is otherwise identical to the embodiment in Figure 31. Each of the pair of opposing first sides 210a, 210b includes a repeating alternating slot pattern, so that each repeat of the pattern includes a first slot 250a extending from a single second side 215b toward the open side 215a, and an adjacent second slot 250b extending from the open side 215a toward a single second side 215a. The embodiment in Figure 36 is very similar to the support structure in Figure 27, except that the second side 215a is left open and does not have a support structure. Multiple substantially X-shaped elements 220 extend in a repeating pattern along each of the pair of opposing first sides 210a, 210b. Adjacent X-shaped elements 220 share a vertically oriented connecting member 230 that extends substantially perpendicularly to a pair of opposing first sides 210a, 210b, connecting adjacent X-shaped elements 220 on the upper side 210a of the pair of opposing first sides to the corresponding adjacent X-shaped elements 220 on the lower side 210b of the pair of opposing first sides. The vertical connecting member 230 has a shape that tapers inward from each of the upper side 210a and lower side 210b toward their midpoints. In the embodiment of Figure 27, the intersection 240 of each of the multiple substantially X-shaped elements 220 is substantially at the midpoint of each of the pair of opposing first sides 210a, 210b.

[0254] The respective "C"-shaped cross-sections in the embodiments of Figures 35 and 36 function to maintain open gas channels defined within the diffusion material 104, from the first gas channel 100 to the second gas channel 102. This allows the support structure 112 to cup-like surround, clamp, and / or partially seal or hold the periphery of the diffusion material of the patient interface 10. To facilitate this functionality, the support structure 112 can partially clamp and / or adhere to the diffusion material, as shown in Figure 37.

[0255] Figures 38a and 38b show another embodiment of the support structure 112 similar to the embodiment in Figure 32. However, in this embodiment, the slots 250 are substantially trapezoidal when viewed in plan, and adjacent slots 250 have different widths. Slots of different widths are repeated along the length of the support structure 112. Each connecting member 230 has an hourglass shape that effectively forms a notch or cutout 255 between two adjacent connecting members 230 so as to maintain an open gas path through the side surface 215a of the support structure 112 when the support structure is fully bent toward the side surface 215a, as in the embodiment of Figure 33. Alternatively, the connecting members may include a notch 255, as in the embodiment of Figure 33.

[0256] Figures 39a and 39b show another embodiment of the support structure 112, which is very similar to the embodiment in Figure 32, but has rounded cutouts 255 on opposing second sides. In this embodiment, adjacent slots 250 are positioned substantially perpendicular to the longitudinal axis of the support structure 112. Figures 40a and 40b show another modification of the embodiment in Figure 32. In this embodiment, the structural portion 211 is shaped such that each slot 250 has a rounded distal end. The second sides 215a and 215b have corresponding rounded curves adjacent to the distal ends of the slots 250. The rounded curves reduce stress concentration and minimize the use of sharp edges in the support structure that could injure the patient or user of the patient interface 10.

[0257] This embodiment utilizes a repeating rounded wave pattern to achieve a desired rigidity of the structure while providing a flexible structure. Each of a pair of opposing first side surfaces 210a, 210b includes a structural portion 211 that defines a repeating alternating rounded wave pattern. Each repetition of the rounded wave pattern includes a first slot 250a that extends from one of a pair of opposing second side surfaces 215a to the other of a pair of opposing second side surfaces 215b. An adjacent second slot 250b extends from the other of a pair of opposing second side surfaces 215b to one of a pair of opposing second side surfaces 215a. The degree of flexibility and crush resistance can be adjusted, at least in part, by varying the width and / or pitch and / or radius of curvature of the structural portion 211 of the side surfaces 210a, 210b that define the slots 250a, 250b and effectively changing the pitch of the repeating rounded wave pattern. For example, by reducing the pitch between the repeating structural portions 211, the number of vertical structural portions on the opposing second side surfaces 215a, 215b increases, and the strength in the vertical direction increases. Similar to other embodiments of the support structure 112, the patient interface 10 conforms to the body contour before, during, and after a surgical procedure and can resist the crushing force caused by the trocar and / or other surgical instruments. In some cases, a balance between vertical flexibility and resistance to vertical forces may be desired.

[0258] In some embodiments, the pitch between the structural portions 211, i.e., the spacing between the structural portions 211, may be uniform along the length of the support structure 112, but in other embodiments, the pitch between the structural portions 211 may vary along the length of the support structure 112.

[0259]

[0260] ​Each of the slots 250a and 250b includes a wall on its respective opposing second side surface 215a, 215b, forming a vertical structural portion between the opposing first side surfaces. In the embodiments of Figures 40a and 40b, the structural portion is rounded, but this is not required in other embodiments. For example, the structural portion may be square. The structural portions 215a and 215b are narrow and occupy only a portion of the rounded ends of the wave-patterned portions of the opposing first side surfaces 210a and 210b. The narrow structural portions 215a and 215b provide a gap 216 on both sides of the structural portions 215a and 215b, as seen in Figure 40b, which functions similarly to the notch or cutout 255 in the embodiment of Figure 33, for example, allowing the gas flow in the gas channel 100 to pass through the support structure 112 under bending load. The narrow structural portions 215a and 215b in the embodiments of Figures 40a and 40b provide sufficient structural strength against vertical compressive forces that may act on the patient interface 10.

[0261] The support structure 112 is a long, flexible structure having a longitudinal axis, and is configured to be elastically deformable under the application of forces applied laterally and / or vertically and / or longitudinally, such as those that may be applied during traction from the first stationary position to the traction position of the patient interface 10. For example, the support structure is configured to bend laterally with respect to the longitudinal axis. Thus, the support structure can accommodate traction of the patient interface 10 so as to maintain that the first gas flow path 100 is not substantially affected by the changing form of the patient interface 10 when the patient interface 10 is tractioned.

[0262] Under bending load, some of the structural parts of one of the opposing second sides 215a, 215b move closer to each other on one of the opposing second sides 215a, 215b, and some of the structural parts of the other of the opposing second sides 215a, 215b move further away from each other, thereby enabling the structural support 112 and the first gas channel 100 to accommodate the traction. Even when the gas flow in the gas channel 100 moves closer to each other during bending, it can still pass through the gap between the structural parts 215a, 215b and then through the diffusion material part 104. In some cases of traction of the patient interface 10, the support structure may be subjected to longitudinal stretching and compression. In particular, the rectangular or rounded wave shapes (some of which will be described later) of the embodiments in Figures 31-33, 35 and 38-43 can accommodate this stretching and compression while substantially maintaining the structural integrity of the first gas channel 100.

[0263] The support structure is designed to be flexible to conform to the contours of the patient's body surrounding the wound. The support structure allows the patient interface 10 to accommodate the formation of lumps of skin or flesh at the edges of the wound when it is pulled. The support structure 112 has a cross-sectional shape configured to substantially resist compressive forces applied vertically, i.e., substantially perpendicular to the plane of the opposing first side surface, which also helps to maintain the first gas channel 100 when the patient interface is pulled and while it is in the pulled position. The support structure 112 allows for torsional motion that may be applied to the support structure 112 during the pulling of the patient interface. The support structure 112 can be made from a non-metallic material that provides the necessary mechanical and structural properties while also providing compatibility between the patient interface 10 and imaging devices that may be used during surgical procedures. For example, the support structure can be made from high-density polyethylene (HDPE).

[0264] Figures 42a and 42b show an embodiment of the support structure 112 which is very similar to the embodiments in Figures 40a and 40b, but in this embodiment, the structural portion 211 has a shape in which the slot 250 tapers in width from one second side surface 215a or 215b toward the other second side surface 215a, 215b, thereby reducing the width of the slot opening.

[0265] The embodiments shown in Figures 41a and 41b are very similar to the embodiments in Figures 38a and 38b. However, in these embodiments, the support structure 112 is tapered when viewed in a plan view along the longitudinal axis of the support structure 112. The support structure 112 is also gradually tapered in height along its length such that the top surface or upper side surface 210a of the support structure is not parallel to the bottom surface 210b. This embodiment may be useful in embodiments of the patient interface 10 in which the length and / or height are similarly tapered as desired to generate desired gas flow characteristics through the first gas flow path 100.

[0266] Each embodiment of the support structure 112 described herein may include one or more grip portions on its surface that is in contact with or adjacent to the diffusion material 104. For example, as shown in Figure 47, the grip portion 218 extends laterally from the second side surface 215b of the support structure 112. In this embodiment, each element of the second side surface 215b has upper and lower grip portions 218 extending laterally from there. In other embodiments, each element may include only a single grip portion 218, or only some of the elements of the second side surface may include grip portions 218. The grip portions 218 can help the support structure 112 engage with the foam or other diffusion material portion 104 of the interface body 20 and hold the support structure 112 in place within the first gas flow path 100.

[0267] The support structure 112 can be provided in the first gas flow path 100 as a continuous single structure. Alternatively, the support structure 112 may include at least two or more distinct repeating length sections. The distinct length sections may be positioned end-to-end and / or assembled together to form the support structure 112. For example, one embodiment of the support structure has three distinct length sections positioned end-to-end throughout substantially the entire first gas flow path 100.

[0268] Figures 13a to 13f show various configurations of the first gas channel 100 and the second gas channel 102. The peripheral first gas channel 100 may have a constant cross-sectional area as seen in Figures 10 to 12, or it may have a variable cross-sectional area. The variable cross-sectional area can be achieved by eccentricity, different outer boundary shapes, different shapes of the diffusion material portion 104, or any combination thereof. The first gas channel 100 having a variable cross-sectional area can help to bring about a flow that is uniformly dispersed from the inner surface 37 over the wound.

[0269] Figures 13a to 13d show embodiments of a patient interface 10 in which the interface body 20 has an elongated asymmetrical shape. In the embodiment of Figure 13a, the interface body 20 is The width of the first gas channel 100 is wider closer to the gas inlet 22 than towards the distal end or portion 130 of the interface body 20 on the opposite side of the gas inlet 22. The cross-sectional area of ​​the first gas channel 100 is larger closer to the gas inlet 22 and decreases towards the distal portion 130 of the interface body on the opposite side of the gas inlet 22. This configuration is intended to provide sufficient gas flow to ensure a continuous supply through the porous diffusion material portion 104 both on the side closer to the gas inlet 22 and on the side distal to the gas inlet 22.

[0270] According to Bernoulli's equation, for a given flow rate, there is lower pressure in areas of a narrow channel where the flow velocity is higher. However, fluid flow is disturbed by viscosity and friction, and the pressure is always higher at the source of the flow compared to downstream. To produce a uniform flow around the outer periphery of the diffusion material portion 104, it is advantageous for these two effects to cancel each other out where possible. This can be achieved by having a narrow first gas channel 100 proximal to the gas inlet 22 and widening distally from the gas inlet 22. In the embodiment of Figure 13b, the cross-sectional area of ​​the first gas channel 100 is narrower closer to the gas inlet 22 and increases toward the distal portion 130 of the interface body 20. As a result, the pressure distribution around the outer periphery of the diffusion material portion 104 becomes more uniform, and therefore the flow rate through the diffusion material portion 104 becomes more spatially uniform.

[0271] Alternative configurations of the relative cross-sectional areas of the first gas channel 100 and the second gas channel 102 are shown in Figures 13c to 13f. In Figure 13c, the first gas channel 100 has a constant cross-sectional area from the gas inlet 22 toward the distal portion 130 of the interface body 20. However, the diffusion material portion 104 where the second gas channel 102 is formed is thicker toward the inlet 22 than toward the distal portion 130 of the interface body 20. Therefore, gas entering the second gas channel 102 closer to the gas inlet 22 experiences higher resistance through the second gas channel 102 than gas entering the second gas channel 102 toward the distal portion 130 of the interface body 20, at least partially offsetting the increase in resistance the gas experiences during the time it takes for the gas to pass through the first gas channel 100 and reach the distal portion 130 of the interface body 20.

[0272] Figure 13d shows one embodiment in which the cross-sectional area of ​​the first gas channel 100 is wider closer to the gas inlet 22 and decreases towards the distal portion 130 of the interface body 20, as shown in Figure 13a. In addition, the diffusion material portion 104 in which the second gas channel 102 is formed is thicker towards the gas inlet 22 than in the distal portion 130 of the interface body 20, as shown in Figure 13c. Therefore, the diffusion material portion 104 provides higher resistance to the gas flow closer to the inlet 22, which can compensate for the preferential imbalance of the gas flow exiting the first gas channel 100 closer to the gas inlet 22.

[0273] Figures 13e and 13f show examples of embodiments of a circular interface body 20 in which the configuration of the first gas flow path 100 can be achieved by equipping the diffusion material portion 104 eccentrically from the center of the circular interface body 20. In Figure 13e, the diffusion material portion 104 is positioned eccentrically away from the gas inlet 22, creating a first gas flow path 100 with a larger cross-sectional area closer to the gas inlet 22, and its cross-sectional area decreases toward the distal portion 130 of the interface body 20. The embodiment in Figure 13f has the opposite configuration to Figure 13e, while aiming to achieve the same effect. The diffusion material portion 104 is positioned closer to the gas inlet 22, creating a narrow first gas flow path 100 toward the gas inlet 22, and the first gas flow path 100 extends toward the distal portion 130 of the interface body 20 to a larger cross-sectional area. The thickness of the diffusion material portion 104 is constant in both Figure 13e and Figure 13f. Although the embodiments in Figures 13e and 13f are illustrated and described as having a circular shape, it is not essential that the shape be circular, and other shapes, such as oval or similar shapes, may be used to achieve a similar effect.

[0274] In another embodiment shown in Figure 14, instead of increasing the thickness of the diffusion material portion 104 to create higher flow resistance to the flow entering the second gas channel 102, the diffusion material portion 104 is composed of stages of foam or other diffusion material with different flow resistances. Higher-resistance diffusion material portions 142 are positioned closer to the gas inlet 22 and gas source 14. The high-resistance diffusion material portion 142 has a decreasing cross-sectional area toward the distal portion 130 of the interface body 20. Correspondingly, the low-resistance diffusion material portion 144 has an increasing cross-sectional area toward the distal portion 130 of the interface body 20. The total cross-sectional area of ​​the diffusion material portions 142 and 144 is constant along the length of the interface body 20. A gradual change in the resistance of the diffusion material portion can be created by using any number of stages of diffusion material with different resistances. Alternatively, to achieve the same effect, foam or other diffusion material with a continuous gradient of flow resistance decreasing toward the direction away from the gas inlet 22 can be used.

[0275] As schematically shown in Figure 15, one or more flow limiting sections 152 can be positioned between the first gas flow path 100 and the second gas flow path 102. The flow limiting sections 152 facilitate a more uniform distribution of flow delivery to the outlet on the inner surface 37 of the diffusion material section 104. Such flow limiting sections 152 include one or more baffles, a series of orifices, slits, slots, or any collection or combination of such flow limiting sections 152 positioned between the peripheral first gas flow path 100 and the diffusion material section 104.

[0276] In some embodiments, the flow limiting section may be more restrictive closer to the gas inlet 22 and less restrictive distal to the gas inlet 22. For example, in one embodiment, the flow limiting section 152 may include orifices. The orifices may have a larger diameter and / or narrower spacing toward the distal portion 130 of the interface body 20, and a smaller diameter and / or wider spacing toward the gas inlet 22.

[0277] In another embodiment, the flow limiter 152 may include slots that extend partially, in segments, or continuously around the diffusion material portion 104. At the inlet 22, the slots may be solid walls so that the jet of gas originating from the curved neck of the gas inlet 22 is deflected entirely radially around the first gas flow path 100. Alternatively, the slots may be left partially open so that the jet and a small portion of the delivered gas can pass through. In another embodiment, the flow limiter 152 includes a baffle. The baffle may widen distal to the gas inlet 22 so as to impose greater obstruction on the gas flow entering the second gas flow path 102 closer to the gas inlet 22.

[0278] In the embodiment shown in Figure 16, the patient interface 10 has two gas inlets 22, the second gas inlet 22 being located on the distal portion 130 of the interface body opposite the first gas inlet 22. Any number of gas inlets 22 of the same or different sizes can be used to provide flow to the first gas channel 100 and to distribute the flow more uniformly along the first gas channel 100. In Figure 17, a single gas inlet 22 is provided, as in the preceding embodiment, but the gas inlet 22 is positioned midway along the outer periphery wall of the interface body 20. The gas inlets 22 or more gas inlets 22 can be positioned at any location around the patient interface.

[0279] Figures 18a to 18e show embodiments of the patient interface 10 that include a flow divider 182 or flow guide 184 which facilitates the movement of the gas flow entering the patient interface 10 around the surrounding first gas flow path. The flow divider 182 and flow guide 184 reduce turbulence and flow separation caused by abrupt changes in direction in the shape of the flow path. In the embodiments of Figures 18a to 18e, the patient interface has a long interface body 20 of a constant width. The first gas flow path 100 surrounds the periphery of the diffusion material portion 104. 02 exits from the diffusion material portion 104 at the outlet defined by the inner surface 37.

[0280] In Figure 18a, a flow divider 182 is installed at the junction of the gas inlet 22 and the first gas flow path 100. The flow divider 182 is a device with a roughly triangular shape in plan view, having a flat surface 185 that faces and is flush with the diffusion material portion 104, and two concave curved surfaces 186 that face the gas inlet 22 and meet at a vertex 187 directly adjacent to the gas inlet 22. The gas flow entering the patient interface 10 at the gas inlet 22 is divided into two flows at the vertex 187, with approximately 50% of the gas flow directed to the left of the vertex 187 and the other approximately 50% directed to the right of the vertex 187. The concave curved surfaces 186 guide the gas flow into the first gas flow path 100 by rounding the sharp corner at the junction of the gas inlet 22 and the first gas flow path 100.

[0281] In Figure 18b, a smaller version of the flow divider 182 is installed at the junction of the gas inlet 22 and the first gas flow path 100. In this embodiment, the flow divider 182 is positioned within the first gas flow path 100 such that a gap exists between its flat surface 185 and the diffusion material portion 104. The offset gap has the effect of allowing a certain proportion of the gas flow to pass through the diffusion material immediately behind the flow divider 182. In some embodiments, the flow divider 182 can divide the gas flow into two flow streams having a flow ratio other than 50:50. For example, the flow divider 182 can be configured to divide the gas flow into two streams having a flow ratio of 70:30 or 30:70 or 60:40 or 40:60 or other desired flow ratio. In one embodiment, the flow divider 182 may be adjustable or movable within the interface body 20 to achieve the desired flow ratio.

[0282] In Figure 18c, the flow guide 184 includes a curved wall, which is installed at the junction of the inlet 22 and the first gas channel 100 and is directed to guide all the gas entering the gas inlet 22 in a clockwise direction across the first gas channel 100. In this embodiment, the flow guide bridges the first gas channel 100 so that all gas entering the patient interface 10 is directed to follow this path. In the embodiment of Figure 18d, the flow guide 184 is offset from the diffusion material section 104 so that the gas flow can pass behind the flow guide 184 and proceed toward the diffusion material section 104 behind it.

[0283] The shunts 182 and guides 184 can be configured to have the shape of the diffusion material portion 104, or they can be formed integrally with the outer membrane 126 or coating if the outer membrane 126 or coating is a separate component. Alternatively, the shunts may be the separate component itself that is overmolded by the outer membrane 126 or coating of the interface body 20. The embodiment in Figure 18e shows a further example of a shunt 188 that includes a separate component incorporated into the patient interface 10, for example by overmolding. The shunt 188 includes a tubular T-piece installed at the junction of the gas inlet 22 and the first gas flow path 100. All gas flow entering the gas inlet 22 is divided into two streams that pass through the shunt 188 and enter the first gas flow path 100.

[0284] Figure 48 shows a modified example of the flow divider 188. The flow divider 288 has the same characteristics as the flow divider 188 and includes a tubular T-piece installed at the junction of the gas inlet 22 and the first gas flow path 100. All gas flow entering the gas inlet 22 passes through the flow divider 188 and is divided into two streams that enter the first gas flow path 100 around the diffusion material section 104. The flow divider 288 also includes at least one aperture 284 on its downstream surface 286, which is located adjacent to the upstream surface of the diffusion material section 104.

[0285] The embodiment in Figure 48 shows five apertures 284 arranged horizontally across the downstream surface 286. The apertures 286 may be the same size or different sizes, and it is not necessary for them to be arranged in a straight line. Multiple apertures 284 of different sizes In some cases, one or more smaller apertures are located in the middle of the shunter surface. Larger apertures may be located at or toward both ends of the shunter surface, adjacent to each opening of the shunter 288 to the first gas flow path 100. Intermediate-sized apertures may exist between the smaller and larger apertures. At least one aperture 284 allows some of the gas passing through the shunter 188 to pass through aperture 284 and enter the diffusion material portion 104. At least one aperture 284 can prevent, or at least mitigate, gas buildup in or behind (i.e., on the second gas flow path side) the shunter 288 as it attempts to flow around the corners of the T-piece. It can also increase the reach of the gas flow around the surgical or wound site near the gas inlet 22.

[0286] In embodiments of the patient interface where the outer membrane 126 is translucent or transparent, the flow guide 184 or flow shunts 182, 188, 288 may be visible through the outer membrane 126. The flow guide 184 or flow shunts 182, 188, 288 may comprise or include a thermochromic material or other material that changes color in response to changes in temperature and / or humidity.

[0287] The gas flow exiting the patient interface 10 at the outlet of the diffusion material portion 104 of the interface body 20 can be influenced by different outlet configurations to achieve a desired flow pattern and performance. For example, at the outlet, i.e., on the inner surface 37 of the diffusion material portion 104 of the interface body 20, the outer membrane 126, coating, or film may terminate coplanar with the inner surface 37 of the diffusion material, or it may protrude from the inner surface 37, or it may terminate before the inner surface 37, leaving an exposed portion of the diffusion material on the upper surface 26 and / or bottom surface 61 of the interface body 20. The protruding upper surface 26, as shown in Figures 20b and 20c, has the effect of preventing the regulated gas from flowing upward away from the wound site, maintaining the microenvironment close to the wound, and improving the performance of the patient interface 10. A similar effect can be achieved by an inwardly inclined inner surface 37, as shown in Figures 20i and 20k. However, as shown in Figures 20g and 20h, exposing a portion of the upper surface 26 to the atmosphere can help direct the flow upward and deflect airborne particles away from the wound. Therefore, the outlet configuration can be selected to achieve the desired gas flow characteristics adjacent to the wound site.

[0288] Figure 19a shows a schematic diagram of the vertical cross section AA of the interface body 20 in Figure 19b. In the illustrated embodiment, the patient interface 10 has an essentially flat and low profile, i.e., it is considerably wider than it is tall when in use. The low profile provides the necessary functionality without being cumbersome to the surgeon when used at a surgical wound site. In an alternative embodiment, the patient interface 10 has a raised profile, being taller than the low profile embodiment. For example, its height may be 50% or more of its width. The raised profile of the patient interface can create a wall around the surgical wound site. Delivery of warm / humid gas to the walled area can create an additional microenvironment above and / or spaced from the surgical wound site, thereby increasing protection of the surgical site against temperature and moisture loss. One embodiment of such a raised profile patient interface 10 may include two or more gas inlets 22 for multiple levels of gas delivery to the patient interface 10, i.e., layered gas delivery.

[0289] Figures 20a to 20p schematically show examples of different outlet configurations. In the embodiment of Figure 20a, the outer film 126, coating, or film at the outlet, i.e., on the inner surface 37 of the diffusion material portion 104 of the interface body 20, terminates coplanar with the inner surface 37 of the diffusion material. However, in Figure 20b, the outer film 126 or coating protrudes onto the inner surface 37 on both the top surface 26 and the bottom surface 61. In Figure 20c, the top surface protrudes from the inner surface 37, and the bottom surface 61 In Figure 20d, the bottom surface 61 protrudes from the inner surface 37, while the top surface 26 remains coplanar with the inner surface 37. In Figure 20e, both the top surface 26 and the bottom surface 61 are partially exposed to the atmosphere adjacent to the inner surface 37. In Figure 20f, only the bottom surface 61 is partially exposed to the atmosphere adjacent to the inner surface 37, while the top surface 26 remains coplanar with the inner surface 37. In Figure 20g, only the top surface 26 is exposed to the atmosphere adjacent to the inner surface 37, while the bottom surface 61 remains coplanar with the inner surface 37. In Figure 20h, a larger portion of the top surface 26 is exposed to the atmosphere adjacent to the inner surface 37.

[0290] Figure 20i shows one embodiment in which the inner surface 37 is formed at an angle to the vertical plane, specifically, the upper surface 26 is inclined inward so as to extend further into the pre-formed slot 32 than the bottom surface 61. This inwardly inclined surface has the effect of promoting the retention of the escaping gas near the wound edge. Conversely, in Figure 20j, the inner surface 37 is inclined outward so as to extend beyond the upper surface 26. This configuration has the effect of promoting the upward flow of gas to deflect airborne particles. In Figure 20k, the inner surface 37 is inclined inward as in Figure 20i, but the bottom surface 61 extends so as to terminate in the same plane as the upper surface 61. In Figure 20l, the inner surface 37 terminates in the same plane as the upper surface 26, but at least a portion of the bottom surface 61 is exposed to the atmosphere.

[0291] Figure 20m shows one embodiment in which the outer surface of the diffusion material portion 104 is flat, but the inner surface 37 is inclined inward to facilitate a larger proportion of the flow exiting the inner surface 37 toward its lower portion. Figure 20n also shows a flat outer surface of the diffusion material portion 104. However, in this embodiment, the inner surface 37 is inclined outward. In Figure 20o, the inner surface 37 of the diffusion material portion 104 is formed with a stepped outer shape such that the lower portion of the inner wall 37 extends further into the slot 32 than the upper half of the inner surface 37. This configuration also deflects airborne particles upward. In the embodiment of Figure 20p, the inner surface 37 of the diffusion material portion 104 is formed with a stepped outer shape such that the lower portion of the inner wall 37 is concave relative to the upper half of the inner surface 37. This configuration facilitates the gas flow toward the wound edge.

[0292] The foam diffusion material can be slightly compressed within the housing (not shown in the diagram) to help hold and position the foam and / or manipulate the pore size of the foam. By applying varying amounts of compression along the length of the interface body 20, the pore size can be changed to facilitate uniform flow delivery on the inner surface 37.

[0293] The first gas channel 100 is part of the outer membrane 126 and can therefore be fabricated from a thin film material so that it self-expands when gas enters the gas inlet 22 of the patient interface 10. In the embodiment of Figure 21, the thin film is bonded to the surface of the diffusion material portion 104 by an adhesive, an overmolding process, or a heat treatment process, such as laminating a polyurethane film onto a polyurethane foam. In the embodiment of Figure 21a, the thin film material is formed by bonding, overmolding, or laminating a film onto the diffusion material portion to create the first gas channel 100. Similarly, as seen in Figure 21b, an adhesive or heat treatment process can be used when the upper and lower films are joined and sealed to create the first gas channel 100.

[0294] As schematically shown in Figure 23, the first gas channels can be covered on the inside with a backing 232 to prevent the inner surfaces of the thin film material 92 from sticking together and blocking the first gas channels. The backing 232 may be a powder and / or other material having low adhesion properties. In some embodiments, the powder may contain an antibiotic.

[0295] Up to this point, embodiments of the present disclosure have been described as having a peripheral first gas channel 100. In practice, as can be seen in the cross-sectional views of the interface body in Figures 22a to 22e, the first gas channel may be located above, below, and / or around the diffusion material. In Figure 22a, the first gas channel 100 is positioned above the diffusion material so that the gas enters the second gas channel 102 from above. In Figure 22b, the first gas channel 100 extends above and around the diffusion material, and therefore the gas can enter the second gas channel 102 from above or around the diffusion material. In Figure 22c, the first gas channel 100 is below the diffusion material. The gas in the first gas channel 100 enters the second gas channel 102 from below the diffusion material accordingly. In Figure 22d, the first gas channel 100 extends beneath the diffusion material and around its periphery, so that the gas can enter the second gas channel 102 from beneath or around the diffusion material. In Figure 22e, the first gas channel 100 extends above the top of the diffusion material, beneath the diffusion material, and around its periphery, so that it substantially surrounds the diffusion material except for the inner surface 37. The gas in the first gas channel can access the second gas channel 102 from above, below, or around the periphery of the diffusion material.

[0296] The gas inlet into the interface body 20 of the patient interface 10, through which the gas enters, can be configured to divert a portion of the gas flow to a further channel. Figure 49 shows a patient interface 10 having a gas inlet 222 that introduces the gas flow into a first gas channel 100, but also having an aperture to a tube 225 that defines a further channel upstream of the first gas channel 100 to divert a portion of the gas in the gas inlet 222 toward a secondary device 230. The secondary device 230 is, for example, a second patient interface 10, or Cardia Innovation. TM Vita-Diffuser manufactured by TMThis could be a diffuser or other surgical wound protection diffuser. The secondary device 230 can integrate with or operate in communication with the primary patient interface 10 to provide a secondary stream of regulated gas to the wound site. For example, the secondary device 230 can be operably connected to the primary patient interface 10 via a Luer lock connection. The patient interface 10 can be advantageously used for large, deep, and / or difficult-to-reach wound sites where additional humidity may be required from the secondary device 30.

[0297] The patient interface 10 may include one or more flanges 240 extending laterally from the patient interface 10. Figure 50 shows one embodiment of the patient interface 10, which includes multiple flanges 240 spaced apart around the periphery of the patient interface 10. The flanges 240 may be extensions of the adhesive layer 62 and / or outer membrane / enveloping wall / thin film 126 on the top surface 26 and / or bottom surface 61 of the patient interface 10, as shown in Figures 50b to 50f.

[0298] In Figure 50b, the flange tab 240 includes extensions of both the thin film 126 and the adhesive layer 62 on the bottom surface 61 of the patient interface 10. In Figure 50c, the flange tab 240 includes an extension of only the thin film 126 on the bottom surface 61. In Figure 50d, the flange tab 240 includes an extension of only the adhesive layer 62 on the bottom surface 61. In Figure 50e, the flange tab 240 includes an extension of the thin film 240 on the top surface 26 of the patient interface. In Figure 50f, the flange tab 240 also includes an extension of the thin film 240 on the top surface 26 of the patient interface, and extensions of both the thin film 126 and the adhesive layer 62 on the bottom surface 61. The flange tab can be used as a surface area for lifting the patient interface 10 from the patient after use and / or for attaching it to the patient's skin by staples, screws or similar. This can be particularly applied in surgical procedures where the mounting surface is very uneven. Figure 50 shows six flange tabs 240, but any suitable number may be used as required or as needed. It is possible.

[0299] Further features of the embodiment of the patient interface 10 are described below.

[0300] Components of the patient interface 10, such as the diffusion material portion 104 and the outer membrane 126, may include bacteriostatic or bactericidal additives to reduce the risk of infection. Materials that naturally inhibit microbial growth, such as ether-based polyurethane materials, can also be used. The patient interface 10 can be pre-loaded with antibiotics; for example, the diffusion material portion 104 may be pre-moistened with an aqueous antibiotic solution. Alternatively, the patient interface 10 may be pre-loaded with powdered antibiotics.

[0301] Components of the patient interface 10, such as the diffusion material portion 104 and the outer membrane 126, may also include flame-retardant additives to reduce the risk of fire and combustion during electrosurgical procedures, for example.

[0302] The patient interface 10 can be made from the exact same material to facilitate its recycling and / or disposal after use. For example, the polyurethane diffusion material portion 104 and outer membrane film 126 inevitably determine that the flow dividers 182, 188, and 288 can also be constructed from polyurethane. Having all components made from the same material facilitates the disposal of the patient interface 10 after the end of its service life.

[0303] As shown in Figure 3b, when the patient interface 10 is pulled from its initial state, some areas of the diffusion material portion 104 may be compressed more than other areas. To compensate for this, the diffusion material portion 104 can be cut into a shape that partially or completely represents the pulled state shown in Figure 3b in which it is intended to be used. Thus, the diffusion material portion 104 is in its compressed, stretched, or other deformed state before pulling, and in a more natural state when pulled. Therefore, the performance of the patient interface 10 may be sacrificed initially before the incision so that the pore size and performance are optimized when the patient interface 10 is pulled and the wound is at its maximum. A removable film 92 can be placed over the wound to hold the diffusion material under tension in its initial state so that the diffusion portion 104 does not open forcefully. Once the patient interface 10 is adhered to the patient, the removable film 92 can be cut along with the incision.

[0304] The patient interface 10 and / or system 1 can assist the surgeon during surgery by incorporating a visual indication, for example, that the gas is heated and / or humidified, when the gas flow is on and / or system 1 is on and functioning correctly. For example, the color of components of the patient interface 10 can change in response to detected changes in temperature, flow rate, pH, humidity, gas concentration, or pressure. For example, the patient interface 10 may include a CO2 indicator, pressure-sensitive paint, or heat-sensitive material. The indication can be both mechanical and visual, and may be, for example, a wind vane or propeller that rotates in the presence of flow. An inline flow indicator can be connected between the patient interface and the gas source to indicate that the gas flow is on. An example of such an inline flow indicator 88 is a wind vane or propeller sealed in a housing, as shown in Figure 44.

[0305] The components of the patient interface mentioned above may be the flow guide 184 or flow dividers 182, 188, 288 and / or support structure 112 in embodiments where the outer membrane 126 is translucent or transparent. Other components of the patient interface 10 are also possible, insofar as they communicate directly, indirectly, and / or thermally with the gas flow. The flow guide 184 or flow dividers 182, 188, 288 and / or support structure 112 are thermochromic and / or It can be made from hydrochromic materials. Thermochromic materials change color when the temperature rises from room temperature in the presence of a heated delivery gas. Similarly, hydrochromic materials can change color when the material is exposed to an elevated level of moisture due to the presence of a humidified delivery gas. The flow guide 184 or flow dividers 182, 188, 288 or the support structure 112 or other components can be made from materials that are both thermochromic and hydrochromic. In such embodiments, a specific color of the gas can provide an indication of the state of the delivered gas. For example, color "A" may indicate that the gas is off, color "B" may indicate that gas heating is functioning, color "C" may indicate that humidification is working, and color "D" may indicate that both heating and humidification are working. Color "B" can serve as a warning indicator, for example, that heated gas without humidification may pose a risk of wound tissue dehydration. The above example provides four options for recognizing the state or characteristics of a gas, but any combination of indicators, for example, more or fewer indicators as required, can be provided using the gas's color. Other gas state indicators, beyond those described above, can be derived from different or additional colors as appropriate.

[0306] The interface components mentioned above can similarly change color in the presence of a delivery gas type; for example, if CO2 gas is used as the delivery gas, they can change color in the presence of CO2 gas. The interface components can similarly change color in the presence of a specific drug or pharmaceutical.

[0307] The patient interface 10 may include one or more sensors (not shown). The patient interface 10 may incorporate a temperature sensor, a humidity sensor, a stretch or strain sensor, or a color detector. For example, a stretch sensor can detect, monitor, and report on swelling. It may also indicate safe or damaging / harmful traction forces. Color temperature can detect, monitor, and report on redness / inflammation at the wound margin. A humidity sensor can detect, monitor, and report on moisture levels and the degree of wound exudate. One or more temperature sensors can be used as indicators of temperature conditions and for temperature control and / or the state of delivered gases in the patient interface 10. The temperature sensor may include any suitable type of sensor, such as a thermocouple, thermistor, or infrared sensor / camera / detector. A motion sensor (e.g., an accelerometer) can detect, monitor, and report on the quantity and quality of patient movement. Patient mobilization is crucial for the recovery of orthopedic patients.

[0308] Further details of System 1 are described below. Referring further to Figures 1a and 1b, System 1 includes a patient interface 10, a gas source 14, a combined flow generator and humidifier unit 15 or a separate flow generator or flow controller 16, a flow humidifier 17 and a circuit 12. The flow controller 16, or a flow controller (not shown) which can typically be incorporated into the flow generator / humidifier unit 15 and / or humidifier 17, can be used to control the flow rate and characteristics of the gas to the circuit 12 and / or patient interface 10. The gas source 14 may be bottled or wall-supplied air, CO2, nitrogen or nitric oxide, or any other suitable gas or mixture thereof. The circuit 12 is insulated, heated, flexible, and small in diameter, for example, greater than 15 mm.

[0309] If the flow generators 15, 16 are units having a blower, pump, or fan that takes in air from, for example, the operating room environment, then a suitable filter is included through which the air must pass. It may be advantageous to add a supplemental therapeutic gas flow to the intake airflow, for example, by adding CO2 through an inlet valve. The added CO2 gas provides a patient interface The oxygenation of tissues to which the gas is applied through the face can be improved.

[0310] In some embodiments, a mist of drugs can be added to the gas entering the patient interface 10. These drugs can, for example, assist in pain management (analgesics), bleeding control, and / or infection control (antibiotics). The patient interface 10, circuit 12, humidifier 17, and / or flow generators 15, 16 may facilitate the connection of nebulizers or have built-in nebulizers for delivering aerosolized drugs and / or fluids such as local anesthetics, analgesics, and warmed saline. Warm saline can enhance the system 1's ability to deliver heat to the patient and reduce intraoperative hypothermia.

[0311] Those skilled in the art will understand that the features of various embodiments of the patient interface 10 described herein can be used in combination with each other where possible. As one non-limiting example, the features of Figures 18a–18e can be used in combination with the features of Figures 13a–13f and / or Figures 20a–20p.

[0312] The patient interface 10 described herein can be used in connection with any number or type of surgical procedure, such as orthopedic, neurosurgical, vascular, reconstructive, or any other type of "open" surgery, without limitation. Referring to Figure 24, the patient interface 10 and system 1 are used as follows: In step 242, before an incision is made at the wound site or intended wound site, the patient interface 10 is applied to the wound site or intended wound site by positioning it around the wound site or intended wound site. In step 244, the gas source 14 is turned on, and a flow of gas is supplied from the gas source 14 to the patient interface 10 via the circuit 12 connected to the flow generator and / or humidifiers 15, 16, 17. The gas or liquid can be adjusted in the flow generator / humidifier 15 or 16, 17. Specifically, the gas can be heated to physiological temperature (nominal 37°C) and humidified to a relative humidity above approximately 80%. In step 246, an incision can be made once System 1 has delivered a controlled or uncontrolled gas to surround or at least partially surround the wound, creating a protective microenvironment over it. In some embodiments, a feedback loop may relay the detected conditions back to the controller for adjusting and / or maintaining conditions such as gas temperature and / or humidity, but is not limited to these conditions.

[0313] Thus, the wound site or intended wound site is immediately protected by a controlled gas released from the patient interface around the wound site before the incision is made. However, it is also conceivable that steps 244 and 246 may be reversed in some cases.

[0314] Referring to Figure 51, the patient interface 10 and system 1 can be used to protect the patient from infection at the surgical site and / or moisture loss and / or heat loss. The method includes, in step 252, applying the patient interface adjacent to or on the wound site or intended wound site, and in step 254, turning on the flow of gas from the gas source to the patient interface. The method may include adjusting the gas before it enters the patient interface, and adjusting the gas may include adjusting one or more of the gas temperature, humidity level, or oxygen level. Applying the patient interface adjacent to or on the wound site or intended wound site may include applying multiple patient interfaces on or adjacent to the wound site or intended wound site in order to adequately surround the wound site or intended wound site.

[0315] Table 1 below shows the performance test results of patient interfaces fabricated according to embodiments of this disclosure, measured against commercially available diffuser products. In each test, the gas was humidified using a commercially available humidifier platform, such as one commercially available from Fisher & Paykel Healthcare Limited. Performance is measured by the reduction of heat and moisture loss from a model of an open surgical wound.

[0316] Commercial diffusers resulted in a heat loss of 7.7 W and a wound moisture loss of 5.4 ml / hour. Patient interfaces fabricated according to embodiments of this disclosure exhibited improved performance compared to commercial diffusers in tests where the gas was CO2 or air. Heat and moisture loss from the wound can be eliminated by increasing the temperature of the humidifier's heater plate and the duty cycle of the heater wire.

[0317] [Table 1]

[0318] This specification describes embodiments of the patient interface 10 and system 1 for treating and / or managing wounds. Those skilled in the art will understand that embodiments of the patient interface 10, system 1, and their use in methods for managing and / or treating wounds can produce a uniform distribution of a controlled gas flow to the edges of the wound site and / or provide a protective microenvironment over the wound that has improved performance than known diffusers. While various embodiments have been described, those skilled in the art will see that one or more features from one embodiment can be combined with features from another embodiment without departing from the scope of this disclosure.

[0319] Throughout this specification, the word “comprise,” or variations such as “comprises” or “comprising,” shall be understood to mean that they include the elements, completes, or steps, or groups of elements, completes, or steps described herein, and not to mean that they exclude any other elements, completes, or steps, or groups of elements, completes, or steps.

[0320] Those skilled in the art will understand that numerous modifications and / or changes can be made to the embodiments described above without departing from the broad overall scope of this disclosure. Therefore, these embodiments should be considered illustrative rather than restrictive in all respects.

Claims

1. A patient interface for wound management, The interface body comprises an opening formed therein and configurable to surround the wound at least partially. The aforementioned interface body, A surrounding wall having a side opening positioned facing the opening so as to be adjacent to the wound when in use, Gas inlet and A first gas passage is located in the first part of the space inside the surrounding wall and is in fluid communication with the gas inlet, A second gas passage is located in the space inside the surrounding wall, in a second portion on the opening side of the first portion, and is in fluid communication with the first gas passage. The second gas passage is in fluid communication with the gas outlet located at the side opening, Equipped with, The first gas flow path includes a support structure disposed in the first gas flow path, The second gas flow path has a volume that fills the second portion of the space inside the surrounding wall, continuously surrounds the entire circumference of the opening, and includes a diffusion material portion that connects the first gas flow path and the gas outlet, and is formed of a diffusion material that diffuses the gas passing through the diffusion material portion. The first gas flow path surrounds the peripheral portion of the diffusion material, A patient interface in which the support structure is configured to maintain at least the first gas passage open while the interface body is being pulled between a first position in a stationary state and a second traction position in which the interface body has an expanded form while a traction force is applied.

2. The patient interface according to claim 1, wherein the support structure is arranged in the space inside the surrounding wall along the outer circumferential surface of the surrounding wall located opposite the opening.

3. The patient interface according to claim 1 or 2, wherein the support structure includes a flexible structure that can be configured to conform to the contours of the patient's body.

4. The patient interface according to any one of claims 1 to 3, wherein the support structure is configured to be elastically deformable under the application of a force applied in at least one of the lateral, vertical, and longitudinal directions.

5. The patient interface according to any one of claims 1 to 4, wherein the support structure is configured to resist compressive forces and / or to allow torsional motion.

6. The patient interface according to any one of claims 1 to 5, wherein the support structure is configured to maintain the first gas passage open in a constant cross-sectional area while the interface body is being pulled between the first position in a stationary state and the second traction position in which a traction force is applied.

7. The patient interface according to any one of claims 1 to 6, wherein the support structure includes a plurality of interconnected elements arranged in a repeating pattern along the longitudinal axis of the support structure.

8. The patient interface according to any one of claims 1 to 7, wherein the diffusion material portion defines the gas outlet.

9. The patient interface according to any one of claims 1 to 8, wherein the interface body comprises an outer membrane as the surrounding wall, and the first gas flow path is at least partially defined between the outer membrane and the diffusion material portion.

10. The patient interface according to any one of claims 1 to 9, wherein the diffusion material portion includes a porous material.

11. The patient interface according to any one of claims 1 to 10, wherein the diffusion material portion includes open-cell foam.

12. The patient interface according to any one of claims 1 to 11, wherein the interface body has a distal portion on the side opposite to the gas inlet, and the diffusion material portion defining the second gas flow path has an increasing thickness from the gas inlet to the distal portion of the interface body.

13. The patient interface according to any one of claims 1 to 11, wherein the interface body has a distal portion on the side opposite to the gas inlet, and the diffusion material portion defining the second gas flow path has a reduced thickness from the gas inlet to the distal portion.

14. The patient interface according to any one of claims 1 to 13, wherein the bottom surface of the interface body includes a fixing material for adhering the interface body to the surface.

15. The patient interface according to any one of claims 1 to 14, further comprising at least one flow guide, which is positioned adjacent to the gas inlet and guides the gas that has entered from the gas inlet in a predetermined direction.

16. The patient interface according to claim 15, wherein the at least one flow guide is located at the junction of the gas inlet and the first gas flow path.

17. The patient interface according to claim 15 or 16, wherein the flow guide is a flow divider configured to divide the gas flow entering the patient interface at the gas inlet into two flows.

18. The patient interface according to any one of claims 15 to 17, wherein the flow guide includes a tubular T-piece disposed at the junction of the gas inlet and the first gas flow path.

19. The patient interface according to any one of claims 1 to 18, further comprising a functional indicator for providing an indication when the gas is flowing through the patient interface.

20. The patient interface according to claim 19, wherein the function indicator is configured to indicate whether the gas flowing through the patient interface is heated, humidified, or of one or more of a particular gas type.

21. The patient interface according to claim 19 or 20, wherein the functional indicator comprises a thermochromic and / or hydrochromic material.

22. The patient interface according to any one of claims 1 to 21, wherein the first gas flow path has a first flow resistance and the second gas flow path has a second flow resistance.

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