Component for attenuating sound in a patient interface

The patient interface with flow management and sound attenuation components addresses noise and fluid distribution issues in surgical wound sites, ensuring effective sound reduction and physiological preservation.

WO2026003790A1PCT designated stage Publication Date: 2026-01-02FISHER & PAYKEL HEALTHCARE LTD
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Patent Information

Application Number
PCT/IB2025/056536
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-06-27
Filing Date
2025-06-27
Publication Date
2026-01-02

AI Technical Summary

Technical Problem

Gas flow to a surgical wound site during surgery can cause noise, which may be exacerbated by high flow rates needed to counter suction and irrigation, potentially leading to tissue damage and contamination.

Method used

A patient interface with flow management and sound attenuation components that alter fluid characteristics and distribute fluid flow evenly, using restrictions and sound dampening materials to reduce noise and maintain physiological conditions at the wound site.

Benefits of technology

The solution effectively attenuates sound, ensures even fluid distribution, and maintains temperature and humidity, preventing tissue desiccation and contamination, thus preserving the wound site's physiological conditions.

✦ Generated by Eureka AI based on patent content.

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Abstract

A flow control component is provided for a patient interface for the supply of fluid to a surgical site. The flow control component includes an inlet, an outlet, and a flow restriction with a first opening and a second opening. The first opening and second opening are configured to alter a fluid characteristic of fluid passing therethrough. The patient interface may include an outer layer configured to enclose at least a portion of the flow control component, with the outer layer configured to contain the flow of fluid through the flow control component and / or along a portion of the flow path of the patient interface.
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Description

COMPONENT FOR ATTENUATING SOUND IN A PATIENT INTERFACEFIELD

[0001] The present disclosure relates to a component for attenuating sound in a patient interface and / or a component of a patient interface for delivery of fluid, such as humidified gasses, to a wound / surgical site. It further relates to a system for the delivery of fluid to a wound / surgical site, and uses of the system in surgical operations and post-surgical operations.BACKGROUND

[0002] Outcomes of open wounds such as those created by surgical incisions may be improved by preserving physiological conditions and preventing contamination while internal tissues are exposed. Providing a flow of gasses to a wound site / surgical site may reduce the likelihood or degree of tissue damage or contamination and / or infection of exposed tissue. The gases may include air, carbon dioxide (CO2), nitrogen, nitric oxide, or any other suitable gases or combination thereof.

[0003] Gasses may be provided to the wound site during open surgery, including orthopaedic (for example, hip, spine and knee), vascular, plastic or cardiac surgery, The effectiveness of a gas flow in preserving physiological conditions over and / or in the wound site and in preventing contamination of exposed internal tissues may be affected at least in part by the manner of its delivery to the wound site.

[0004] Gas flow to the wound site can be a source of noise during surgery. This noise may be increased in applications having a high gas flow rate, for example in applications where increased flow is required to counter the effect from suction and / or irrigation at the site.

[0005] Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present disclosure as it existed before the priority date of the appended claims.SUMMARY

[0006] The present disclosure describes examples of patient interfaces and components for attenuating sound in patient interfaces that may be used to create a fluid flow microenvironmentover, across, about and / or in or adjacent a wound such as a surgical site which may comprise the site of proposed surgery, an open wound such as a surgical wound, and / or a closed wound, such as a post-operative surgical wound, preserving physiological conditions and / or mitigating risk of contamination in the wound. Some examples of the patient interface are configured to deliver, as far as possible, a substantially even distribution of fluid flow to an outlet of the patient interface that can surround the surgical site / wound.

[0007] The fluid flow may be a gas glow. The flow may be warmed and / or humidified. The fluid flow may maintain the temperature of a wound site substantially at a particular temperature and / or humidity and / or prevent unwanted air from entering into the surgical wound site. When the patient interface is configured to deliver warm, humidified air, the fluid flow may assist to prevent desiccation or drying of the tissue.

[0008] Aspects of the disclosure are summarized below. It will be noted that aspects and configurations of the disclosure may be combined such that features and / or examples of one aspect may be used with features and / or configurations of any other aspect where compatible.

[0009] The present disclosure describes a flow management component for a patient interface for the supply of fluid to a surgical site. The patient interface comprises at least one interface fluid flow path in fluid communication with at least one interface inlet, the flow management component comprising a flow restriction having a first opening and a second opening forming a restriction fluid flow path between a restriction inlet and a restriction outlet; wherein the first opening and second opening are configured to alter a fluid characteristic of fluid passing through the restriction fluid flow path.

[0010] The present disclosure describes examples of patient interfaces that may be used to create a fluid flow microenvironment over, across, about and / or in or adjacent a surgical site which may comprise the site of proposed surgery, an open wound such as a surgical wound, and / or a closed wound, such as a post-operative surgical wound preserving physiological conditions and / or mitigating risk of contamination in the wound. Some examples of the patient interface are configured to deliver, as far as possible, a substantially even distribution of fluid flow to an outlet of the patient interface that can surround the surgical site e.g., wound.

[0011] Aspects of the disclosure are summarized below. It will be noted that aspects and configurations of the disclosure may be combined such that features and / or embodiments of one aspect may be used with features and / or configurations of any other aspect where compatible.

[0012] In a first aspect of the disclosure, a flow control component for a patient interface is provided for the supply of fluid to a surgical site. The fluid flow control component comprises: an inlet; an outlet; and a flow restriction comprising a first opening and a second opening. The first opening and second opening are configured to alter a fluid characteristic of fluid passing therethrough.

[0013] The flow control component may comprise a plurality of first openings configured to allow a first volume of fluid to pass through. The first openings may be the same size and shape or may vary in size and / or shape. The first openings may be arranged regularly or irregularly, and / or may be arranged concentrically.

[0014] The flow control component may comprise a plurality of second openings configured to allow a second volume of fluid to pass through. The second openings may be the same size and shape or may vary in size and / or shape. The second openings may be arranged around the first opening(s).

[0015] The second openings may be arranged about the first opening(s), each centred on a path that is concentric with first opening(s). In some configurations, the second openings are located more peripherally than the first opening(s). The second openings may be arranged in an irregular or regular manner. In some embodiments, the arrangement of the first and second openings may be radially symmetric. In some configurations, some second openings may be positioned closer to the first opening(s) than other second openings.

[0016] In some configurations the first opening and second opening form a restriction fluid flow path between the restriction inlet and a restriction outlet; wherein the first opening and second opening are configured to alter a fluid characteristic of fluid passing through the restriction fluid flow path.

[0017] In some configurations, the first opening comprises one or more openings configured to allow a first volume of fluid to pass through.

[0018] In some configurations, the second opening comprises one or more openings configured to allow a second volume of fluid to pass through.

[0019] In some configurations, the first volume is greater than the second volume such that a larger volume of fluid is permitted to pass through the first opening than the second opening.

[0020] In some configurations, the first opening(s) and second opening(s) are different in at least one characteristic.

[0021] In some configurations, the shape of the first opening and / or second opening comprises a circle or rectangle or disco-rectangle or square or oval or semicircle or lune or lens.

[0022] In some configurations, the shape of the first opening and / or second opening is irregular and defined by the area of the first and / or second opening.

[0023] The flow restriction may have a wall with the first opening(s) and second opening(s) provided therethrough. The first opening(s) may be located centrally or non-centrally through the wall.

[0024] In some configurations, the first opening comprises a single opening located centrally through the wall.

[0025] In some configurations, the first and second openings are spaced apart, with the second openings located through the wall more peripherally than the first opening(s).

[0026] In some configurations, the first opening comprises two or more openings arranged concentrically about the center of the wall.

[0027] In some configurations, the two or more openings of the first opening arranged at irregular intervals through the wall.

[0028] In some configurations, the second opening is arranged concentrically about the center of the wall.

[0029] In some configurations, the one or more openings of the second opening are arranged at irregular intervals through the wall.

[0030] In some configurations, the second opening is spaced apart from the first opening such that it is located through the wall at a point further away from the center of the wall and the first opening.

[0031] In some configurations, the flow restriction is a restriction conduit and the outlet is formed by the wall at an outlet end of the restriction conduit. In some configurations, therestriction conduit comprises an inner surface that guides the flow of fluid from the restriction inlet towards the restriction outlet.

[0032] In some configurations, the flow control component comprises channels extending between the second openings and the inner surface.

[0033] In some configurations, the flow control component may comprise one or more channels extending between the first opening(s) and the inner surface.

[0034] In some configurations, the inner surface is a ramp that is straight or tapers or truncates inwardly to gradually change the cross-sectional area of the restriction fluid flow path between the restriction inlet to the restriction outlet.

[0035] In some configurations, the inner surface comprises a ramp extending inwardly to reduce the cross-sectional area of the restriction fluid flow path between the restriction inlet to the restriction outlet.

[0036] In some configurations, the inner surface defines a first lumen of the flow control component. The inner surface may be configured such that at least a portion of the lumen between the inlet and outlet tapers from a larger cross-sectional area to a smaller cross-sectional area. The ramp formed by the inner surface may be linear or curved, for example having convex and / or concave portions.

[0037] In some configurations, the inner surface has linear or curved surface.

[0038] Described herein is a patient interface for the supply of fluid to a surgical site, the patient interface comprising: an interface fluid flow path having at least one interface inlet for receiving a flow of fluid and at least one interface outlet; a flow control component comprising a flow restriction having a first opening and a second opening forming a restriction fluid flow path between a restriction inlet and a restriction outlet; wherein the first opening and second opening are configured to alter a fluid characteristic of fluid passing through the restriction fluid flow path.

[0039] In some configurations, the flow control component is located at least partly within the interface fluid flow path upstream and / or within the at least one interface inlet.

[0040] In some configurations, the flow control component is located at least partly within the interface fluid flow path downstream and / or within the at least one interface inlet.

[0041] In some configurations, the patient interface comprises an outer layer configured to enclose at least a portion of the flow control component, wherein the outer layer is configured to seal the flow of fluid within the restriction fluid flow path and / or the at least one interface fluid flow path.

[0042] In a second aspect, a patient interface is provided for the supply of fluid to a surgical site, comprising a flow control component as described above in relation to the first aspect. The interface comprises an interface inlet in fluid communication with the flow control component inlet. The flow control component outlet is arranged to supply fluid to a flow path of the patient interface.

[0043] The flow control component may be located at the interface inlet and along the flow path of the patient interface.

[0044] The flow control component may be located or downstream of the interface inlet and along the flow path of the patient interface.

[0045] In some configurations, the patient interface comprises an outer layer configured to enclose at least a portion of the flow control component, wherein the outer layer is configured to contain the flow of fluid through the flow control component and / or along a portion of the flow path of the patient interface.

[0046] According to a third aspect, a flow management component for a patient interface for the supply of fluid to a surgical site is provided. The flow management component comprises a component inlet, a chamber, and a sound attenuation component. The chamber has a chamber inlet in fluid communication with the component inlet, a chamber outlet, and a chamber wall configured to direct fluid flow from the chamber inlet to the chamber outlet. The sound attenuation component is positioned at least partially within the chamber such that fluid flowing from the chamber inlet to the chamber outlet passes through the sound attenuation component. The chamber outlet is configured to be in fluid communication with a flow path of the patient interface.

[0047] In some configurations, at least a portion of the chamber wall is positioned substantially opposite the chamber inlet.

[0048] In some configurations, the chamber outlet is at an angle of + / - between about 30 degrees and about 90 degrees to the chamber inlet. For example, the chamber outlet may be at an angle of + / - between about 45 degrees and about 80 degrees to the chamber inlet, or between about 60 degrees and about 80 degrees to the chamber inlet.

[0049] The flow management component may be configured such that flow between the inlet and outlet is nonlinear. For example, the flow management component may be configured to direct flow from the inlet long a curved flow path or through a bend, towards the outlet.

[0050] The chamber wall may comprise a concave portion and a convex portion. In some examples, a lower portion of the chamber wall adjacent the chamber inlet is convex, becoming concave adjacent the outlet. For example, a lower portion of the chamber wall may have a shallow ‘s’ type curve.

[0051] The sound attenuation component may be adjacent and / or abut the chamber wall.

[0052] In some configurations, the sound attenuation component comprises a sound absorbent material and / or a sound dampening material. For example, the sound attenuation component may comprise one or more of expanded polyethylene, polyurethane, silicone, rubber or the like, fabrics, weaves or cellular structures such as com starch.

[0053] The sound attenuation component may define a multiplicity of fluid pathways therethrough. The multiplicity of fluid pathways may be non-linear pathways. The pathways may be interconnected and / or intersecting.

[0054] The sound attenuation component may comprise a porous material. The porous material may comprise one or more of a foam, such as an open cell foam, a fabric, a woven structure, or a cellular structure. The porous material may comprise a multiplicity of interconnected pores. The arrangement of the pores may be random, irregular, or the arrangement may be regular cellular structure arrangement.

[0055] In some configurations, the sound attenuation component is configured to disrupt flow. For example, by splitting the flow into multiple flow streams, causing diffusion of the flow stream, and / or by causing the flow to follow one or more nonlinear, curved, or torturous paths.

[0056] In some configurations, the component inlet comprises an inlet channel extending from the chamber inlet, configured to direct fluid flow to the chamber inlet.

[0057] The inlet channel may extend generally perpendicular to chamber wall.

[0058] For channel may comprise a conduit. The conduit may be rigid or flexible, or may comprise a rigid portion and a flexible portion. The inlet channel may be configured to couple to a gas supply conduit.

[0059] In some configurations, a portion of the sound attenuation component extends into the inlet channel.

[0060] In some configurations the chamber inlet is spaced at a first distance from the chamber wall. The first distance may be selected to reduce a velocity of gasses flowing through the chamber inlet. A larger distance may cause a larger reduction in velocity.

[0061] The spacing of the chamber inlet from the chamber wall may be a function of one or more of the diameter or area of the chamber inlet, a specified gas flow rate for the flow management component, the density of sound attenuation component, and / or the shape of the chamber.

[0062] The spacing of the chamber inlet from the chamber wall may be selected to cause a reduction in flow velocity of at least 20% between the chamber inlet and the opposing chamber wall, when the sound attenuation component is in place. In some configurations, the reduction in flow velocity is at least 30%, 40%, or 50%.

[0063] In some configurations, a cross-sectional area of the chamber increases from a first point adjacent the chamber inlet to a second point distal to the chamber inlet, along at least a portion of the chamber. For example, a cross-sectional area of the chamber adjacent the chamber inlet may be less than a cross-sectional area of the chamber adjacent the chamber outlet.

[0064] In some configurations, the chamber walls may diverge along a main flow path between the chamber inlet and the chamber outlet. The chamber may have a cross-sectional profile that varies along the main flow path. In alternative embodiments, the cross-sectional profile may be substantially constant along the main flow path.

[0065] In some configurations, the chamber comprises a hollow volume. The chamber may be enclosed by the chamber wall. The chamber may comprise an open portion, configured suchthat a portion of the patient interface, such as a membrane component, covers the open portion to enclose the chamber.

[0066] In some configurations, the flow management component may comprise a flow restriction arranged to induce a pressure drop in fluid travelling through the component. The flow restriction may comprise a first opening and one or more second openings for flow therethrough.

[0067] In some configurations, the flow restriction comprises a plurality of second openings. The second openings may be smaller than the first opening. In some configurations, a plurality of first openings may be provided.

[0068] The flow restriction may include a plurality of channels, each channel configured to direct flow through a respective second opening. The channels may comprise conduits. The conduits may have any suitable circular or non-circular cross section. The conduits may vary in length.

[0069] The channels may comprise an entry ramp any / or have an entry end that lies on a plane that is at a non-perpendicular angle to the general flow direction such that the channel is enlarged at its opening. For example, the conduits may have a frusto cylindrical shape. This may assist to direct flow into the channel.

[0070] The channels may have a substantially constant cross section, or the cross section may vary along its length. In some examples, each channel tapers towards the respective second opening.

[0071] In some configurations the channels associated with the second openings each have a length that is longer than a diameter or width of the respective second opening.

[0072] In some configurations, the flow restriction is positioned downstream of the chamber inlet. For example, the flow restriction may be positioned at or adjacent a respective chamber outlet.

[0073] The flow restriction may be provided by a flow restriction component or may be integrally formed, for example, integral with the chamber wall.

[0074] In some configurations, the flow restriction comprises a plate with one or more openings therethrough, such as an orifice plate. The plate may extend from one side of the respective outlet. The plate may fully or partially cover the outlet.

[0075] In some configurations, the flow restriction comprises an end cap component. The end cap may be positioned at or adjacent to the chamber outlet. The end cap may be partly or fully with the chamber. The end cap may be removably attached to the chamber, for example, through a threaded, push, snap or other removable connection. Alternatively, the end cap may be permanently fixed in place.

[0076] In some configurations, the flow restriction comprises a component having a plurality of guide vanes. The vanes may comprise fins, for example. The vanes may straighten flow through the component, which may help to reduce noise. The fins may comprise substantially flat or planar surfaces. Alternatively, the fins may comprise one or more contoured surfaces.

[0077] The vanes may be arranged radially. In some examples, the vanes are arranged radially around the first opening(s). The vanes may project from a peripheral part of the component towards a midline of the component.

[0078] In some configurations, the vanes are arranged downstream of the first and second opening(s).

[0079] The end cap may comprise one or more of the features described in relation to the flow management component of the first aspect.

[0080] In some configurations, the chamber comprises two chamber outlets.

[0081] The flow management component may have a generally T-shape or Y-shape.

[0082] In some configurations, the flow management comprises a flow splitter configured to split flow from the component inlet into two streams. The flow splitter comprises an apex positioned at or adjacent the chamber inlet, and two diverging surfaces, each surface directing fluid flow towards a respective outlet.

[0083] The flow splitter may be separate component, may be integral with the chamber wall or chamber inlet, or may be provided by the sound attenuation device.

[0084] In some configurations, the flow splitter comprises a pair of surfaces. The pair of surfaces may comprise oppositely facing surfaces. The surfaces may be diverging, for example, diverging from apex. The Apex may be a point or edge. It may be sharp, blunt, or rounded.

[0085] In one configuration, the flow splitter is arranged with an apex of the flow splitter positioned adjacent the chamber inlet. The apex may be positioned in the chamber inlet or spaced from the chamber inlet either with the apex positioned in the chamber or in the inlet channel

[0086] In some configurations, the flow splitter is configured to split flow from the chamber inlet substantially equally between the chamber outlets. For example, the apex may be centrally located relative to the chamber inlet.

[0087] In some configurations the flow splitter may be configured to split flow from the chamber inlet between the chamber outlets in as asymmetrical manner. This may be according to a pre-determined flow ratio. For example, the apex may be positioned to create a larger opening on one side of the apex. The apex may be positioned off-center, such as closer to one side of the chamber inlet. In another example, the apex may comprise a non-linear edge that creates a larger opening on one side of the edge.

[0088] According to a fourth aspect, a patient interface is provided for the supply of fluid to a surgical site. The patient interface comprises a flow management component as described above in relation to the third aspect. The interface has an inlet arranged to supply fluid to the chamber inlet, and the chamber outlet is arranged to supply fluid to a flow path of the patient interface.

[0089] In some configurations, the component inlet forms the interface inlet.

[0090] Described herein is a flow management component for a patient interface for the supply of fluid to a surgical site is disclosed, the patient interface comprising at least one interface fluid flow path in fluid communication with at least one interface inlet, the flow management component comprising: a body comprising a chamber, the chamber having a chamber inlet, at least one chamber outlet in fluid communication with at least one interface inlet; wherein the chamber defines a chamber fluid flow path between the chamber inlet and the at least one chamber outlet; wherein the chamber comprises at least one wall defining thechamber fluid flow path; wherein the chamber further comprises a sound attenuation component located in the chamber fluid flow path.

[0091] In some configurations, the at least one wall of the chamber fluid flow path is a top wall orientated at least partly opposite the chamber inlet.

[0092] In some configurations, the sound attenuation component comprises a first sound attenuation component and / or a second sound attenuation component.

[0093] In some configurations, the first sound attenuation component comprises a sound absorbent material and / or a sound dampening material.

[0094] In some configurations, the first sound attenuation component is fluid permeable.

[0095] In some configurations, the first sound attenuation component substantially fills a volume of at least a portion of the chamber.

[0096] In some configurations, the first sound attenuation component abuts the top wall and / or chamber.

[0097] In some configurations, the first sound attenuation component is adjacent the top wall and / or chamber.

[0098] In some configurations, the first sound attenuation component is inserted and / or confined within the chamber fluid flow path.

[0099] In some configurations, the first sound attenuation component comprises a porous or microporous material.

[0100] In some configurations, the porous or microporous material comprises one or more of a foam, a fabric, a woven structure, or a cellular structure.

[0101] In some configurations, the porous or microporous material comprises an open cell foam.

[0102] In some configurations, the chamber inlet is fluidly connected to a fluid inlet for providing a flow of fluid to the chamber.

[0103] In some configurations, the chamber inlet comprises a fluid inlet structure that extends outwardly from the chamber.

[0104] In some configurations, the fluid inlet structure comprises a fluid inlet channel fluidly connected to the chamber inlet, wherein the fluid inlet channel at least partly forms part of the chamber fluid flow path.

[0105] In some configurations, the fluid inlet structure is configured to connect to a fluid inlet tube and / or a connector of a fluid inlet tube for providing a flow of fluid to the fluid inlet channel.

[0106] In some configurations, the fluid inlet channel is spaced apart at a first distance from the chamber inlet and / or the top wall from the fluid inlet.

[0107] the top wall is at the first distance from the fluid inlet channel to slow the velocity of the flow of fluid as it reaches the top wall.

[0108] In some configurations, the first sound attenuation component is located in the chamber and the fluid inlet structure.

[0109] In some configurations, the chamber fluid flow path has a constant and / or varying cross-sectional area along a constant and / or varying profile of the chamber fluid flow path between the chamber inlet and the chamber outlet.

[0110] In some configurations, the chamber comprises two chamber outlets and at least one wall of the chamber is configured to split the flow of fluid from the chamber inlet between the two chamber outlets.[OHl] In some configurations, the top wall of the chamber comprises a pair of surfaces extending from the edge of each chamber outlet to meet at an apex, wherein the apex extends toward the chamber inlet and splits the flow of fluid from the chamber inlet in two directions.

[0112] In some configurations, the structural element comprises two curved surfaces that meet at an apex.

[0113] In some configurations, at least one wall of the chamber is configured to split the flow of fluid equally between two chamber outlets.

[0114] In some configurations, the apex is aligned above the center of the chamber inlet.

[0115] In some configurations, at least one wall of the chamber is configured to split the flow of fluid according to a flow ratio between two chamber outlets.

[0116] In some configurations, the apex is aligned to one side of the center of the chamber inlet, such that it is closer to one of the two chamber outlets.

[0117] In some configurations, the chamber fluid flow path varies in cross-section and orientation along a constant and / or varying profile of the chamber fluid flow path to smoothen the chamber fluid flow path and reduce the occurrence of undesirable noise as the flow of fluid is directed to the two chamber outlets.

[0118] In some configurations, the top wall is at a second distance from the chamber inlet to slow the velocity of the flow of fluid as it reaches the top wall.

[0119] In some configurations, the at least one interface inlet is an inlet of a patient interface that is fluidly connected to at least one interface fluid flow path of the patient interface such that the chamber fluid flow path is in fluid communication with the at least one interface fluid flow path.

[0120] In some configurations, the flow management component is arranged at a juncture of the fluid inlet and the at least one interface inlet.

[0121] In some configurations, the second sound attenuation component is a flow control component comprising a flow restriction having a first opening and a second opening forming a restriction fluid flow path between a restriction inlet and a restriction outlet, wherein the first opening and second opening are configured to alter a fluid characteristic of fluid passing through the restriction fluid flow path.

[0122] In some configurations, the flow control component is located at least partly within the chamber fluid flow path upstream the chamber inlet and / or fluid inlet.

[0123] In some configurations, the flow control component is located at least partly within the chamber fluid flow path downstream of the at least one interface inlet and / or positioned within the at least one chamber outlet.

[0124] In some configurations, the first opening and / or second opening attenuate a fluid characteristic of the flow of fluid travelling from the chamber outlet to the at least one interface inlet to control the sound pressure and / or sound frequency of the flow of fluid as it enters the at least one interface inlet.

[0125] In some configurations, the flow control component is integrally formed with at least one interface wall and / or the at least one wall of the chamber.

[0126] In some configurations, the flow control component is configured to be removably inserted into the at least one chamber outlet.

[0127] In a fifth aspect of the disclosure, a patient interface for the supply of fluid to a surgical site is disclosed, the patient interface comprising: an interface body comprising a fluid inlet, a first fluid flow path, and a second fluid flow path; wherein the first fluid flow path at least partially surrounds the second fluid flow path and is in fluid communication with the fluid inlet and the second fluid flow path; wherein the fluid inlet is configured to fluidly connect to a first portion of the first fluid flow path positioned substantially in line with the fluid inlet, such that flow is directed from the fluid inlet to the first fluid flow path substantially unobstructed.

[0128] In some configurations, the patient interface comprises a flow director for guiding the flow of fluid from the fluid inlet to the first portion of the first fluid flow path.

[0129] In some configurations, the first portion is adjacent a second portion of the second fluid flow path.

[0130] In some configurations, the second portion comprises a first diffusing material portion having a first width and the second portion is located opposite a second diffusing material portion having a second width.

[0131] In some configurations, the second fluid flow path is provided through a diffusing material, the diffusing material comprising a first portion having a first width and a second portion having a second width.

[0132] In some configurations, the first width is larger than the second width to increase the resistance to fluid flow in first portion.

[0133] In some configurations, the first width is smaller than the second width to decrease the resistance to fluid flow in first portion.

[0134] In some configurations, the diffusing material of the second fluid flow path tapers in the direction the flow of fluid is travelling and the first width is larger than the second width.

[0135] Throughout this disclosure, a controller can be one or more hardware processors executing software instructions that cause the one or more hardware processors to perform tasks specified by the software programming.

[0136] Features from one or more configurations or aspects of the disclosure may be combined with features of one or more other configurations or aspects of the disclosure. Additionally, more than one configuration or aspect may be used together in a respiratory therapy system during a process of providing respiratory therapy to a patient.

[0137] As used herein the term "(s)" following a noun means the plural and / or singular form of that noun. As used herein the term "and / or" means "and" or "or", or where the context allows both.

[0138] The term "comprising" as used in this specification means "consisting at least in part of. When interpreting each statement in this specification that includes the term "comprising", features other than that or those prefaced by the term may also be present. Related terms such as "comprise" and "comprises" are to be interpreted in the same manner.

[0139] It is intended that reference to a range of numbers disclosed herein (for example, 1 to 10) also incorporates reference to all rational numbers within that range (for example, 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9 and 10) and also any range of rational numbers within that range (for example, 2 to 8, 1.5 to 5.5 and 3.1 to 4.7) and, therefore, all sub-ranges or all ranges are hereby expressly disclosed. These are only examples of what is specifically intended and all possible combinations of numerical values between the lowest value and the highest value enumerated are to be considered expressly stated in this application in a similar manner.

[0140] Where specific integers are mentioned herein which have known equivalents in the art to which this disclosure relates, such known equivalents are deemed to be incorporated herein as if individually set forth.

[0141] The disclosure consists in the foregoing and also envisages constructions of which the following gives examples only.BRIEF DESCRIPTION OF DRAWINGS

[0142] One or more examples of the present disclosure will now be described by way of specific example(s) with reference to the accompanying drawings, in which:

[0143] Fig. l is a view of an example of a system for the supply of gasses to a surgical site;

[0144] Fig. 2 is a perspective view of an example of a patient interface for the supply of gasses to a wound or surgical site;

[0145] Fig. 3 is a schematic cross-sectional view showing gas flow paths through an example of a patient interface having a first fluid flow path;

[0146] Fig. 4(a) is a schematic cross-sectional view of an example of a patient interface having a support structure in a first fluid flow path;

[0147] Fig. 4(b) gives two cross-sectional views, each taken through line A-A of Fig. 4(a) showing two alternative configurations for the interface outer layer;

[0148] Fig. 5 is a schematic cross-sectional view of a further example of a patient interface having two fluid inlets;

[0149] Fig. 6 is a schematic cross-sectional view of a further example of a patient interface having an inlet positioned on a side of the interface;

[0150] Fig. 7 is a schematic cross-sectional view of an example of a patient interface including an example of a flow management component;

[0151] Fig. 8 is a schematic cross-sectional view of an example of a patient interface including an example of a flow management component;

[0152] Fig. 9 is a schematic cross-sectional view of an example of a patient interface including an example of a flow management feature;

[0153] Fig. 10 is a schematic cross-sectional view of an example of a patient interface having an example of a flow management feature;

[0154] Fig. 11 is a schematic cross-sectional view of an example of a patient interface having non-uniform second fluid flow path;

[0155] Fig. 12 is a perspective view of an example of a flow management component;

[0156] Fig. 13(a) is a side view of an example of a flow management component of Fig. 11;

[0157] Fig. 13(b) is a cross-sectional view of an example of a chamber of the flow management component taken through line A- A of Fig. 12(a);

[0158] Fig. 14 is a partial cross-sectional views of an example of a chamber within a flow management component;

[0159] Fig. 15(a) is a cross-sectional view corresponding to Fig. 14, additionally showing the inlet channel;

[0160] Fig. 15(b) is a cross-sectional view taken through line B-B of Fig. 15(a)

[0161] Fig. 16(a) is a cross-sectional view of an example of a flow management component having a flow splitter;

[0162] Fig. 16(b) is a cross-sectional view of a further example of a flow management component having a flow splitter;

[0163] Fig. 16(c) is a cross-sectional view of yet a further example flow management component;

[0164] Fig. 17 is a cross-sectional view of a further example of flow management component having a Y-shape chamber;

[0165] Fig. 18 is a cross-sectional view of yet a further example flow management component;

[0166] Fig. 19 is a cross-sectional view of an example flow management component having a sound attenuation component within a fluid flow path;

[0167] Fig. 20 is a cross-sectional view of a further example of a flow management component with an alternative example sound attenuation component;

[0168] Fig. 21 is a cross-sectional view of yet a further example of a flow management component with a further alternative example sound attenuation component;

[0169] Fig. 22 is a cross-sectional view of a flow management component with a flow restriction provided at each outlet;

[0170] Fig. 23 is a perspective view of an example of a flow control component;

[0171] Figs. 24(a) to 24(f) illustrate example alternative arrangements of the first and second openings for the component of Figure 23;

[0172] Figs. 25(a) and 25(b) show an example flow control component, where Fig. 25(a) is a front perspective view and Fig. 25(b) is a back perspective view;

[0173] Figs. 26(a) and 26(b) show a further example of a flow control component, where Fig. 26(a) is a front perspective view and Fig. 26(b) is a back perspective view;

[0174] Fig. 27(a) and 27(b) show yet a further example of a flow control component, where Fig. 27(a) is a front perspective view and Fig. 27(b) is a back perspective view;

[0175] Fig. 28 is a perspective view of an example of a flow management component having a removable flow control component;

[0176] Fig. 29 is a perspective view of an example of a flow management component having an integral flow control component;

[0177] Fig. 30(a) is a side view of an example of the flow management component of Fig.28;

[0178] Fig. 30(b) is a cross-sectional view of the flow management component of Fig. 30(a) taken through line B-B of Figure 30(a).DETAILED DESCRIPTION

[0179] In the following description, various specific details are set forth in order to provide an understanding of the various principles of the disclosure. Those skilled in the art will appreciate that not all these details are necessarily always required for practicing embodiments according to the disclosure.

[0180] A flow management component and / or flow control component according to the present disclosure may form part of a patient interface for delivery or introduction of gases to a patient. For example, the flow management component and / or flow control component may form part of a patient interface for delivery of a gas to a wound site, such as a surgical site or surgical wound.

[0181] It will be appreciated that “fluid” as referred to herein may refer to a gas, liquid, or a combination thereof. The fluid may include components that may be carried in fluid flow, such as aerosolized medicaments, and / or water vapor, for example. Flow management components, flow control components according to the present disclosure, and patient interfaces incorporating said flow management and / or control components, may be used in medical procedures for the delivery of fluids to a patient.

[0182] An example fluid delivery system 101 is shown in Fig. 1. The example shown in Figure 1 illustrates a system suitable for the supply of gases to a patient interface, including to an interface at a wound site, such as a surgical site, for example, a surgical cavity. The system 101 of Fig.1 includes a patient interface 110 that may be connected via a circuit to a fluid source 114. The fluid source 114 provides a fluid, for example insufflation fluid, to the patient interface 110. In some examples, the fluid may include air, CO2 gas, nitric oxide, other suitable fluids, or mixtures thereof. Further disclosure related to system 101 is provided below.

[0183] The system shown in Fig. 1 includes a flow controller 116 and a humidifier 117 as separate units. However, alternative arrangements are possible and will be apparent to a skilled person. In system 101, the flow controller 116, which may be an insufflator or similar device, can receive fluid from a fluid source 114, for example, in the form of a bottle or wall source. However, it is also possible to entrain air into the flow controller 116 such that it also functions as a flow generator. The entrained air may be mixed with other fluids. The fluid may be conditioned if desired, for example heated and / or humidified, for delivery to the patient interface 110 and to the surgical site.

[0184] In another example of system 101 (not shown), the fluid source in the form of room air may be entrained into a combined flow generator / humidifier unit. Such a combined flow generator / humidifier unit may entrain room air and may mix it with a secondary fluid via a separate inlet port on the unit. The flow generator / humidifier unit may be a combined flowgenerator and humidifier unit. In Fig. 1, a flow controller 116 and a humidifier 117 are shown as separate units.

[0185] In another example system (not shown), a fluid source may be in the form of room air with a flow meter. The air may be delivered to a humidifier 117 before it is supplied to the patient interface.

[0186] The fluid may be delivered to the patient interface 110 via a suitable tube or conduit 112. The tube or conduit 112 may be actively heated and / or thermally insulated, to maintain temperature and / or humidity of the fluid until it is delivered to the patient interface 110.

[0187] The fluid source 114 may take several different forms, including room air (not shown), fluid bottle, such as compressed gas, and / or wall source as shown in Fig. 1.

[0188] Fluid delivery system 101 may include a flow controller 116 in fluid communication with the patient interface. The flow controller 116 may facilitate movement of fluid from the fluid source 114 to the patient interface 110. Flow controller 116 may be an insufflator or similar device, which can receive fluid from the fluid source 114. In the example shown in Figure 1, the flow controller 116 can receive fluid from a bottle 114a and / or wall source 114b.

[0189] Fluid can refer to a gas and / or liquid. In some cases, the fluid may be relatively dry gases, which may cause damage to tissues. The fluid may be conditioned as desired, for example, heated and / or humidified, prior to delivery to the patient interface 110 and the patient. In the example shown in Figure 1, system 101 includes a humidifier 117. For example, a humidifier 117 may be located between the fluid source and the patient interface.

[0190] In the example shown in Figure 1, the humidifier 117 is located downstream of the fluid source 114 and flow controller 116. A controller of the system may provide power to a heater of the humidifier 117 to heat and / or humidify a humification fluid. The heated and / or humidified fluid is delivered to the fluid flow stream prior to the fluid being delivered to the patient interface 110. The humidification fluid may be water or any other suitable humidification fluid. The humidified and / or heated fluid can be delivered to the patient via a tube or conduit 112.

[0191] The controller may be included within the humidifier 117 and may be an electronic, analog, or digital controller. The controller may be a microprocessor-based controller executing computer software commands stored in associated memory.

[0192] When present, various styles or types of humidifiers may be used in combination with other elements of the fluid delivery system. The humidifier may include a chamber that holds a volume of humidification fluid, for example, a “pass-over” type humidifier, as shown in Figure 1. Other humidifier types are also contemplated, such as a humidifier including a wicking or other suitable absorbent material for holding humidification fluid. Other humidifier types may include humidifiers in cannulae. A suitable humidifier may comprise a humidifier chamber and / or medium to hold humidification fluid. The humidification chamber may be removable from the humidifier. Where the humidifier may be a pass-over type humidifier, the humidifier chamber may include a heat-conductive base (for example, an aluminum or steel base) contacting or associated with a heater plate on the humidifier. The humidifier may comprise a heater wire. For example, the heater wire may be present in a tube or in a wicking material.

[0193] The patient interface 110 is configured to deliver fluid around and / or to a surgical site. It will be appreciated that the patient interface 110 (or other example patient interfaces disclosed or referred to herein) is not limited to use within the illustrated system and may be used with a variety of types of surgical systems. For example, the patient interface may be used in connection with a fluid source such as a flow generator, blower, insufflator, high-pressure wall source, fluid bottle, fluid recirculation system or other suitable fluid source.

[0194] In some examples of system 101, the patient interface 110 may be in use for an orthopaedic surgical procedure, namely a hip surgical procedure.

[0195] The system 101 is shown in use in Fig.l, as an example of a surgical procedure on a patient lying in a supine position on an operating table for ease of illustration. In another example of system 101, the position of the patient is, in practice dependent on the procedure to be performed. In some orthopaedic procedures, for example, the one or more limbs of a patient may be moved during the procedure. The patient interface 110 may be positioned on the patient at the site of the surgical operation such that, in use, it substantially surrounds the surgical site at which an incision will be made to create an open wound. It will be understood, however, that in some instances of surgery, for example following a trauma, a wound may already exist. In this event, the patient interface 110 may be positioned on the patient around the existing wound. Accordingly, whilst the patient interface 110 is shown placed on a substantially horizontal surface of the patient’s body, it need not be in order to perform its function.

[0196] The fluid from the fluid source 114 may be provided to a patient interface 110 through a fluid inlet 122, as shown in Fig. 2. The fluid entering the fluid inlet 122 may be, for example, a pressurised compressed fluid set at a predetermined pressure range, higher than that of atmospheric pressure. Flow of the pressurised compressed fluid may contribute to production of sound as the fluid enters and travels through a fluid flow path of the patient interface 110. In some instances, the produced sound may be above a threshold sound frequency, sound pressure (decibel) or the like. The produced sound may be unpleasant or otherwise irritating to those in the vicinity of the sound.

[0197] Flow rate of fluid from the fluid source 114, through the system and to the patient interface 110 or a flow rate delivered to the patient interface 110 may contribute to the produced sound. For example, in some surgical procedures, the flow rate of the flow of fluid may be sufficiently low such that minimal sound is produced, or the sound produced has qualities that render the sound acceptable or tolerable to persons in the vicinity. Other terms describing a parameter of flow, for example the flow velocity, flow direction or flow pressure may be referenced herein as factors that may contribute to the produced sound.

[0198] In some surgical procedures, a higher flow rate may be required to achieve an intended effect of the fluid delivery system. For example, in some types of orthopaedic surgery, energy emitting surgical tools such as harmonic scalpels, for example, may be used. The surgical procedure may generate surgical debris, for example, bone or tissue fragments. In some cases, suction and / or irrigation of the surgical site may be required. In such cases, a higher flow rate of fluid may be introduced to counter the effect from the suction and / or irrigation. A higher flow rate of fluid may help ensure the intended effect of the fluid delivery system is maintained during use of suction and / or irrigation. Providing fluid to the system at a higher flow rate may contribute to sound production, where the sound produced may exceed an acceptable sound threshold. For example, sound produced may exceed an acceptable decibel level.

[0199] In some uses of the system 101, a turbulent interaction between a flow of fluid and a structure of a fluid flow path, may produce an undesired sound having one or more undesirable sound properties. Such undesirable sound properties may be frequency and / or sound pressure. As an example, as the flow rate of the flow of fluid entering the fluid inlet 122 increases, there may be an increasingly unpleasant sound frequency or sound pressure level emitted as the fluid contacts a surface of the patient interface 110. Other sources of sound in system 101 are described below.

[0200] In some examples of the patient interface 110 as shown in Figs. 7 to 10, the fluid inlet 122 may be positioned substantially opposite a surface of the patient interface 110 or a surface of a component of the patient interface 110. For example, as shown in Figs 7 to 10, the surface may be a surface of a flow management component 182, 188, 184 positioned substantially opposite and / or close to the fluid inlet 122 such that the flow of fluid entering the fluid inlet 122 impacts the surface. The flow rate at which the flow of fluid may impact the surface, may be higher than a flow rate threshold. This arrangement may be an example of a source of noise where an undesired sound may occur during use of some examples of the patient interface 110. In some cases, above the flow rate threshold, an undesired noise may be emitted.

[0201] In some examples of the patient interface 110 as shown in Fig. 8 or 10, a flow of fluid may travel through a fluid flow path of the patient interface 110 and / or a fluid flow path of flow management component 184, 188 of the patient interface 110. The flow of fluid may enter an area of the fluid flow path in such a way as to cause turbulent flow. The turbulent flow may be caused, for example, in part of the fluid flow path that bends to direct flow around a portion of the fluid flow path. In another example, turbulent flow may be caused, in part of the fluid flow path where a flow of fluid may contact a region of substantially stagnant fluid within a region of the fluid flow path. An example of this region, as shown in Fig. 10, may be where the flow management component 188 of the patient interface 110 fluidly connects to an inlet of the patient interface 152. The turbulent flow that may be caused by these example arrangements may be further examples of a source of noise where an undesired sound may occur during use of some examples of the patient interface 110.

[0202] In some examples of the patient interface 110, sources of noise may not be limited to the phenomena described above. As another example, an undesired noise may be caused by the collision of fluid into any structure defining or surrounding or adjacent the fluid flow path. In particular, where there are sharp angles or substantially perpendicular bends within the fluid flow path or where the flow of fluid impacts any structure at above a flow threshold. There may be other instances in which an undesired noise may be emitted, for example in a region of the fluid flow path having a varying cross-section and / or orientation of the fluid flow path throughout the patient interface 110.

[0203] Figures 2 to 11 illustrate examples of a patient interface 110, of the present disclosure that may include a flow management component 288 and / or a flow control component 490 (not shown). Any example of the flow management component and / or flow control component ofthe present disclosure may be configured to manage or control the flow of fluid entering from a fluid inlet through a flow path of a patient interface 110. Any example of a patient interface 110 and / or flow management component 288 of the present disclosure may be configured to include a sound attenuation component 370 and / or a flow control component 490 or any other feature for reducing noise as described further below.

[0204] The patient interface 110 may take various forms, described herein with reference to examples shown in Figs. 2 to 10. Further disclosure of examples of systems for the supply of gases to a surgical or wound site and in particular examples of a patient interface 110 are disclosed in PCT applications with application numbers PCT / IB2021 / 053697, published as WO2021224768A1 on 11 November 2021, and PCT / IB2021 / 055346, published as WO2021255677A1 on 23 December 2021, each of which are incorporated by reference herein in their entireties.

[0205] Each example of the patient interface 110 may have an interface body 120, e.g., as seen in Fig. 2, that comprises a fluid inlet 122 through which fluid enters the interface body 120. The patient interface, for example, may include a first fluid flow path 100, seen in Figs. 3 to 11, and / or a second fluid flow path 102. The first fluid flow path 100 may be positioned in fluid communication with the fluid inlet 122 and / or the second fluid flow path 102.

[0206] Reference to features of a patient interface 110 herein includes examples of a patient interface 110 according to Figs. 2 to 11, having a first fluid flow path 100 and a second fluid flow path 102. However, these examples are not meant to limit the present disclosure to the examples of the patient interface 110 as shown in Figs. 2 to 11. In another example of a patient interface 110, not shown in Figs. 2 to 11, the patient interface 110 may comprise a single fluid flow path in fluid communication with the fluid inlet 122 and at least one outlet of the patient interface.

[0207] In the embodiments shown, the first fluid flow path 100 is an outer flow path and the second fluid flow path is an inner flow path 102. The first flow path 100 may form a loop, the loop being continuous as shown in Figures 3 to 7, or may terminate at the inlet as illustrated in Figure 8. The first fluid flow path may be arranged peripherally on the interface. The second fluid flow path 104 may be adjacent a slot or opening 132 of the interface, for placing adjacent and around a wound such as a surgical site.

[0208] In examples of the patient interface having first and second fluid flow paths, the first fluid flow path 100 may have a first flow resistance. The second fluid flow path 102 may have a second flow resistance. The second flow resistance may be overall greater than the first flow resistance.

[0209] The second fluid flow path 102 may comprise a diffusing material 104 that contributes to the second flow resistance. The flow resistance may not be constant throughout the first fluid flow path 100 and / or the second fluid flow path 102. For example, the flow resistance may not be uniform throughout the second fluid flow path 102 or another fluid flow path of the patient interface 110. In some examples, the resistance to flow may be greater at one end or in one portion of the second fluid flow path. The resistance to flow may change along the first or second flow path in a gradual or stepwise manner. A higher resistance to flow may be provided by a denser diffusing material in the flow path, for example.

[0210] Other characteristics of the second fluid flow path 102 or another fluid flow path of the patient interface 110 may not be constant throughout. For example, the width or another dimension of the flow path may change. Such changes may correspond to a variation in the flow resistance along the respective flow path. For example, a thinner width of the diffusing material at one end of the interface may shorten the second flow path in that portion, reducing the resistance to flow. A wider width of the diffusing material at the other end of the interface may lengthen the second flow path in that portion, increasing the resistance to flow.

[0211] The flow resistance may not be uniform throughout the second fluid flow path 102. For example, this may be true where the flow path includes pockets or obstacles that might affect flow resistance. Overall, the second flow resistance may be greater than the first flow resistance. For example, the second flow resistance may be greater than the first flow resistance when taking a cross-section slice through the patient interface that is parallel to the direction that the fluid exits the diffusing material 104. Fluid entering the fluid inlet 122 may flow easily through the first fluid flow path 100 and passes into the second fluid flow path 102 where the fluid may be met with a higher resistance as will be explained herein.

[0212] The diffusing material 104 may be included in the interface body 120. The diffusing material 104 may include a portion made from a porous or open cell material that may act to diffuse the fluid, in use, for example, around the periphery of a wound edge or surgical site.

[0213] The porous or open cell material may be stretchable. For example, it may be conformable or pliant such that it may conform to the shape and / or contour of a patient’s body.

[0214] The diffusing material 104 may be made from a suitable diffusing material. The diffusing material may define a multiplicity of fluid pathways therethrough. For example, by way of a multiplicity of interconnected pores. The pores may be uniform or non-uniform, for example randomly distributed.

[0215] The diffusing material may include an open cell foam. The open cell foam may be made from expanded polyethylene, polyurethane, silicone, rubber or the like, fabrics, weaves or cellular structures such as corn starch. The diffusing material 104 may conform to the contours of the patient’s body and / or it may be retracted, together with the wound itself, so as to deliver fluid over the wound edge or surgical site. The diffusing material may be stretchable.

[0216] In some examples, the patient interface 110 includes a pre-marked visible incision guideline on a top surface thereof. The visible incision guideline may be printed on the top surface and / or it may be perforated to allow the guideline corresponding to a desired wound length to be easily torn.

[0217] Referring to Figures 1 and 2, the patient interface may comprise a slot or opening 132. This slot or opening may be for placing around the surgical or wound site. The interface may be adjusted to increase the width of the slot to accommodate the wound as required.

[0218] The patient interface 110 may be tom along the guideline to form the slot or opening 132. In some embodiments (not shown), the patient interface 110 may be torn to form an open shape, for example a U-shape. Different sizes and / or shapes of interface body 120 which may be intended for different surgical procedures may include different length visible incision guidelines.

[0219] In the patient interface 110 shown in Fig. 1, the patient interface 110 is placed onto the patient. It may be placed onto the patient before a surgical incision is made. The patient interface 110 can then be retracted along with the incision at the surgical site at the commencement of surgery. Fig. 2 shows an example of the opening in the form of a slot 132 in an initial configuration or state. The same patient interface 110, in another example as shown in Fig. 1, has the slot 132 and the interface body 120 in a retracted state, in which the slot 132 may be retracted into an expanded configuration with the use of a surgical retractor 134 or similar.

[0220] As described above, the diffusing material 104 of the interface body 120, may be for example a porous material such as foam. The diffusing material 104 may be substantially elastic in some examples, such that it may recoil or spring back into its initial shape once a force, for example the force applied by the surgical retractor, is removed. The diffusing material 104 can stretch or deform out with the wound retraction without significantly compromising the fluid flow through the second fluid flow path 102. This may advantageously allow the diffusing material 104 to deform when forces are applied to it, such as from surgical instruments or a surgeon’s hand during a surgical procedure.

[0221] The diffusing material 104 may have a porosity and / or density that is substantially uniform along the length of the second fluid flow path 102. The porosity / density may vary at different portions of the second fluid flow path 102. For example, the diffusing material 104 may include portions of denser foam material or a semi-impermeable or permeable foam portion or portions.

[0222] In some embodiments (not shown), the interface body 120 may include a pair of generally opposing semi-impermeable portions of the diffusing material 104. The semi- impermeable portions of the diffusing material 104 may be located, for example, approximately mid-way along the length of the patient interface 110. The semi-impermeable portion(s) may extend over a portion of the length of the interface 110 at which the retractor 134 is most likely to contact the patient interface 110. The portions of semi-impermeable or denser diffuser material may prevent or mitigate disruption of flow path from compression by the retractor 134.

[0223] The patient interface may have a support structure 142, for example, as shown in Figure 4a and Figure 11. The support structure may be structured and / or configured to allow the patient interface 110 to bend or deform to take on a different shape. The support structure may be located in the patient interface to maintain a substantially constant cross section and flow resistance through at least part of the body of the patient interface, for example, the first fluid flow path 100.

[0224] In examples of the patient interface having a first fluid flow path 100 and second fluid flow path 102, the first and second fluid flow paths 100, 102 may have differing deformation properties. For example, a second fluid flow path 102 with diffusing material portion 104 may deform in the directions a force is applied. However, the support structure 142 may substantially resist or only allow deformation in certain directions. For example, the supportstructure may resist compression in a vertical direction but allow longitudinal compression. This allows the support structure 142 to maintain a fluid flow path, for example, first fluid flow path 100 open. The first fluid flow path 100 may be maintained open with a substantially constant cross section.

[0225] In the example shown in Figure 2, the interface body 120 has a generally elongate oval shape, with the inlet 122 positioned at one end thereof. However, other examples of the interface body may be shaped differently, e.g., in a round, oval or irregular configuration. The shape may be selected to fit a pre-existing wound of any shape or size.

[0226] As illustrated in Figs. 4(a) and 4(b), the patient interface 110 may comprise an outer layer 136. The outer layer 136 is shown adjacent the top surface 126, an outer peripheral surface or surfaces 136 and optionally a bottom surface of the interface body 120. The outer layer 136 may cover, surround, or enclose the top surface 126, the outer peripheral surface or surfaces 136 and optionally the bottom surface of the interface body 120. The outer layer may be in the form of a wall or skin. The outer layer 146 may comprise a membrane, a film, or other thin flexible member, for example. The outer layer may comprise an adhesive surface for adhering to the interface body. The outer layer may be substantially air impermeable and seal the interface to contain gases within the interface.

[0227] The outer layer may be manufactured as a result of a moulding process of the interface body 120, for example. The outer layer 146 may be formed by over moulding.

[0228] The outer layer 146 can be adhered to or otherwise secured to the interface body 120. The outer layer 146 may extend around the edges of the interface body 120. The outer layer 146 may comprise a single piece or may comprise multiple pieces attached together. For example, referring to Figure 4(b), the outer layer may comprise a top layer and a lower layer, sealed together at a peripheral edge.

[0229] The outer layer 146 may be translucent or transparent at least to allow visibility into part of an interior of the interface body 120. For example, fluid flow paths, such as the first fluid flow path 102 and / or the diffusing material portion 104. Visibility into the interior of the interface body 120 may allow for visualization and monitoring of condensate that may build up inside the patient interface 110 that may adversely affect its performance.

[0230] The outer layer 146 may seal part of the interface body 120, for example, the open cell foam or other porous diffusing material portion 104, at least partially from the atmosphere such that fluid cannot pass through those surfaces that have been sealed.

[0231] The outer layer 146 may be made of a translucent or transparent film such as a polyurethane film.

[0232] The outer layer 146 may have a moisture vapour transmission rate that is at least a proportion of, or greater than, a rate of condensation build-up in the interface body 120.

[0233] A surface of the interface body is in fluid communication with the wound site, to deliver gasses thereto. In the examples shown, an inner surface 137 of the device is arranged to supply gasses to the wound site. In these examples, the fluid flow path through the interface terminates at this inner surface, which acts as the outlet of the interface.

[0234] In some examples of a patient interface 110, such as the example of Fig. 2, the only surface of interface body 120 that is open to the atmosphere is an inner surface 137. In the example shown in Figure 2, the inner surface 137 at least partly defines the opening. The opening may be in the form of any one or more of a slot 132, a void, a space, and a slit. The inner surface 137 therefore may define an outlet of the interface body 120 and of the patient interface 110.

[0235] In some examples, the inner surface 137 of the open cell foam or other diffusing material portion 104 may be open to atmosphere. Other surfaces of the diffusing material portion 104 may be fully or partially exposed to the atmosphere such that those surfaces form part of the outlet of the interface body 120. In some examples, both the inner surface 137 and other surfaces of the diffusing material portion 104 are fully or partially exposed to atmosphere to form part of the outlet of the interface body 120.

[0236] The patient interface may have an adhesive patient facing surface, for securing to the patient. For example, an adhesive material may be provided on an underside of the interface body 120 to affix the patient interface 110 to the skin of the patient or to a surgical dressing or surgical apparatus. The adhesive material may be biocompatible. The adhesive material may be applied over the entire bottom surface or over one or more portions of the bottom surface of the interface body 120.

[0237] The adhesive material may be provided as a backing material, applied to the underside of the interface body. The backing material may have one or more slits, slots, or perforations to enable it to conform to an underlying curved surface and / or to adapt to changes in the underlying surface. The slits, slots, or perforations may extend from an outer edge and / or an inner edge of the backing material. The slits, slots or perforations may be linear, straight, or curved and may be arranged in a regular, staggered, or irregular manner.

[0238] In some examples of the patient interface 110, the interface body 120 may be partially or substantially secured to the patient, surgical dressing or other surface by other non-adhesive mechanisms. Such mechanisms include applying a pad, for example but not limited to a silicone pad, to the bottom surface, which becomes sufficiently tacky or malleable to adhere to the patient via a suction effect. Other mechanisms include a gel fixing material that may be tackified or other non-adhesive material having a physical and / or chemical structure that creates an adhesive effect.

[0239] In some examples, the patient interface 110 may include a partially or fully circumferential malleable element that can be bent or moulded or formed into a desired contour shape such that the interface body 120 retains this shape. Such a malleable element can be integrally formed with the interface body 120. The malleable element may comprise, for example, a metal wire or strip.

[0240] Some examples of the patient interface 110 may include one or more heating elements. For example, the patient interface 110 may include a heater wire, or one or more heater pads or fabric surfaces. The use of heating elements and / or heating pads or fabric surfaces may reduce condensation of water vapour in the patient interface 110. It may also deliver additional warmth to the wound, for example to help maintain fluid temperature and / or maximise humidity.

[0241] A heating element may be positioned on top of the interface body 120 and / or on the bottom surface. A heating element may be sandwiched between layers of the interface body 120, for example, between foam and / or membrane or film. A heating element may be overmoulded onto one or more components of the patient interface 110.

[0242] The heating element may be present in at least part of the flow path of the interface body 120. For example, the heating element may be present in the first fluid flow path 100 and / or, within the diffusing material portion 104.

[0243] An electrical connection may be made at a connection of the patient interface 110 to the circuit. The connection may facilitate an identification that a patient interface 110 has been connected with a circuit and to identify the interface 110 using the known electrical resistance of a heating element, for example, heater wire used within a particular patient interface 110.

[0244] The patient interface 110 is configured to provide a flow of gases 105 from the interface over and / or to the wound site. This delivery of gases may create a protective fluid barrier over the wound. This may prevent or minimise the risk of airborne particles in the surrounding environment from entering / coming into contact with exposed tissue. The delivery of gases to and / or over the wound site may create a positive pressure zone which may deflect particles away from the wound site.

[0245] It may be desirable for a patient interface 110 used with system 101 to deliver, as much as possible, an even distribution fluid flow at and / or from the inner surface 137 of the patient interface 110. An even distribution of flow at and / or from the inner surface 137 may create a fluid curtain or blanket around and / or over the wound site that forms a protective microenvironment over the wound site and may prevent it from drying out or cooling.

[0246] The first fluid flow path 100 may be arranged peripherally around the second fluid flow path 102, such as shown in the example of Figs. 3 to 11. The first fluid flow path may be in fluid communication with the second fluid flow path 102 substantially along the whole length of the first fluid flow path 100, or along at least a portion of the first fluid flow path.

[0247] The second fluid flow path 102 may extend in a generally radial direction. The second fluid flow path may extend in an inward direction. The second fluid flow path may be through a diffusing material portion 104, such as those described above.

[0248] The peripheral first fluid path 100 allows a fluid or fluids entering the inlet 122 to pass freely around the second fluid flow path 102. In examples where the second fluid flow path 102 comprises diffusing material portion 104, this arrangement may provide for a substantially even distribution of the fluid flow from the fluid source 114 to an outer periphery 106 of the diffusing material portion 104 of the interface body 120.

[0249] The fluid may flow through the second fluid path 102, for example, from the outer periphery 106 of the diffusing material portion 104, through the diffusing material. The flow of fluid may then be delivered in an even distribution to the outlet at the inner surface 137 ofinterface body 120. In some examples, the second fluid path 102 may be formed through the porous, open structure of the foam or other open cell material, which presents a higher flow resistance to the fluid flow than does the first fluid flow path 100.

[0250] The first fluid flow path 100 may have a low resistance to flow. For example, the path may comprise a substantially clear and / or unobstructed lumen, or it may comprise a diffusing material of lower flow resistance than the diffusing material 104 of second fluid flow path 102, for example a material with high porosity. In such examples, the first fluid flow path 100 may still have a lower resistance to fluid flow than that of the second fluid flow path 102.

[0251] In the examples of patient interface 110 shown in Figure 4a and Figure 11, the support structure 142 may be positioned at least partially throughout a fluid flow path of the interface body 120, for example, the first fluid flow path 100. The support structure 142 may be configured to deform upon retraction of the patient interface 110 yet maintain a substantially flat profile.

[0252] The support structure 142 may be configured to maintain a cross-section of the fluid flow path, for example, first fluid flow path, that may be substantially unaffected by retraction. The support structure 142 may also assist with the ability of the patient interface 110 to expand / retract with wound retraction. Retraction of the patient interface 110 may occur with the retraction of a surgical incision or wound as the incision or wound edges are separated and held apart to access underlying organs or tissues. As the wound or incision is retracted, so too is the patient interface 110, including the support structure 142. The adhesive material may assist the patient interface 110 to adhere to the patient during retraction.

[0253] The support structure 142 may be configured to resist forces, such as compressive forces, such as may be applied by the pushing of the surgical retractor 134 laterally against the interface body 120 or by surgical instruments generally.

[0254] The support structure may, for example, be in the form of a helical coil, as shown in Figure 4(a). Other variations are possible, such as those disclosed in the aforementioned PCT application PCT / IB2021 / 053697, with particular reference to the disclosure at

[0296] to

[0328] ,

[0255] The support structure may support at least part of the interface body 120, for example, the outer layer 146 as illustrated in Fig. 4 (b). The support structure 142 may help to retain theshape of the fluid flow path of the interface body 120, which may include the first fluid flow path 100.

[0256] In some examples, such as the example shown in Fig. 5, the patient interface 110 may have more than one fluid inlet 122. In the example shown in Fig. 5, the patient interface 110 has two fluid inlets 122, with a second fluid inlet 122b positioned opposite the first fluid inlet 122a at the distal portion of the interface body. Any number of fluid inlets 122 of the same or different sizes may be used to provide flow to the first fluid flow path 100. The fluid inlets 122 may be positioned or otherwise configured to distribute the flow evenly throughout the patient interface body 120.

[0257] Other arrangements of inlet(s) 122 are possible. In the embodiment of Fig. 6, a single fluid inlet 122 may be provided as disclosed in previous examples. The fluid inlet 122 may be positioned, for example, mid-way or approximately mid-way along an outer peripheral wall of the interface body 120. The fluid inlet 122 or plurality of fluid inlets 122 may be positioned anywhere around the patient interface.

[0258] Figures 7 to 11 show examples of the patient interface 110 having a flow management component 182, 184, 188, 288 in accordance with the present disclosure. The flow management component 182, 184, 188, 288 may include a flow splitter 182 or a flow director 184 that encourages distribution of fluid flow entering the patient interface 110. In the examples shown in Figures 7 to 10, the flow management component 182, 184, 188, 288 encourages distribution of fluid flow around the first fluid flow path. The flow splitter 182 and / or the flow director 184 may be configured to reduce flow turbulence and / or separated flow caused by an abrupt change in direction in the geometry of the flow path, such as the first fluid flow path 100.

[0259] Referring to the example patient interface 110 shown in Fig. 7, a flow management component, which in this example, is a flow splitter 182, may be located at a juncture of the fluid inlet 122 and the interface body 120.

[0260] In the example shown in Fig. 7, the flow splitter 182 has a generally triangular shaped configuration in plan view. In this example, the flow splitter 182 has at least one surface generally opposite the fluid inlet 122. The flow splitter 182 may comprise a pair of surfaces, each extending from edges of the surface 185 and meeting at an apex 187, which in the example shown, is adjacent and / or proximate the fluid inlet 122. The surface 185 may be substantially flat as shown in Fig. 7, or curved.

[0261] As shown in Fig. 7, each of the pair of surfaces may be curved. In the example shown, the flow splitter 182 has a pair of concave curved surfaces 186 facing the fluid inlet 122, meeting at the apex. Fluid flow entering the patient interface 110 at the fluid inlet 122 may be split into two flow streams at the apex 187. Approximately 50% of the fluid flow may be directed to a first side of the apex 187 and the other approximately 50% being directed to a second side of the apex 187. The concave curved surfaces 186 may guide the fluid flow around the sharp corners at the juncture of the fluid inlet 122 and the interface body 120.

[0262] The flow splitter 182 may split the fluid flow into two flow streams having a flow ratio other than 50:50. For example, the splitter 182 may be configured to split the fluid flow into two streams having a flow ratio of 70:30 or 30:70 or 60:40 or 40:60 or another desired flow ratio. For example, the flow splitter 182 may be adjustable or moveable within the interface body 120 to achieve a desired flow ratio.

[0263] As shown in Fig. 8, the flow management component may be provided as a flow director 184. The flow director 184 may be located at the juncture of the inlet 122 and interface body 120. In the example shown, the flow director 184 comprises a curved wall. The curved wall is oriented to guide or otherwise direct fluid entering the fluid inlet 122 in a single direction around the interface body 120. In the example shown, the flow director is oriented to guide fluid in a clockwise direction around the first fluid flow path.

[0264] Fig. 9 illustrates a further example a patient interface 110 that includes another example of a flow director 184. The flow director 184 may be located at the juncture of the inlet 122 and the interface body 120. In the example shown, the flow director 184 may be positioned to guide the fluid flow in a direction that aligns with a first portion 100a of the first fluid flow path. The first portion 100a of the first fluid flow path may extend at least a partial distance of the longitudinal length of the patient interface 110. For example, the first portion 100a of the first fluid flow path may extend at least halfway or substantially the entire longitudinal length of the patient interface 110.

[0265] A second portion 100b of the second fluid flow path 102 may receive a flow of fluid from the first portion 100a. In Fig.9, the dashed box that surrounds the first portion 100a and second portion 100b is indicative of an example of a region comprising the first portion 100a and the second portion 100b and should be taken to be non-limiting.

[0266] As shown in Fig. 9, the flow of fluid entering the fluid inlet 122 is guided by the flow director 184 to the first fluid flow path 100 substantially unobstructed. That is, most of the flow of fluid travelling from the fluid inlet may not be impeded by a surface positioned directly opposite the inlet. In the example shown, the flow director 184 comprises a straight wall 184. The straight wall 184 may partially block a part of the first fluid flow path 100 in one direction and encourage flow in a single direction. This may encourage the flow of fluid to travel from the fluid inlet to the inlet 152 of the patient interface 110 in a way that reduces the occurrence of undesired sound.

[0267] In the example of Fig. 9, the second portion 100b may comprise the diffusing material 104 that has a first width W 1. For example, the first width W 1 may refer to the width and / or thickness of the diffusing material portion 104 that is located adjacent to first portion 100a. A second width W2 may refer to the width and / or thickness of an opposite portion to the second portion 100b in the second fluid flow path 102. The first width W1 and second width W2 may be selected according to the size of the patient interface 100 and / or flow rate of the flow of fluid entering the fluid inlet 122.

[0268] The first width W 1 may be selected to be larger than the second width W2 to increase the resistance to fluid flow of the second portion 100b. This may assist the flow of fluid to be distributed evenly through the first fluid flow path and / or the diffusing material portion 104. This example may be suited to applications of the patient interface 110 where the flow of fluid enters the fluid inlet 122 at a low velocity.

[0269] Alternatively, the first width W 1 may be selected to be smaller than the second width W2 to decrease the resistance to fluid flow to assist the flow of fluid to be distributed evenly through the diffusing material portion 104. This example may be suited to applications of the patient interface 110 where the flow of fluid enters the fluid inlet 122 at a high velocity.

[0270] In some examples, the diffusing material portion 104 may comprise a constant width along the second fluid flow path 102. In some examples, the diffusing material portion 104 may comprise a tapering width in the direction the flow of fluid is travelling such that the first width W1 is larger than the second width W2. In some examples, the diffusing material portion 104 may have an increasing width along the second fluid flow path 102 such that the first width W1 is smaller than the second width W2. The width of the diffusing material portion 104 may be tapered or increased along the second fluid flow path 102 to encourage the flow of fluidtravelling from the first fluid flow path 100 to diffuse evenly across the diffusing material portion 104

[0271] Varying the width of the diffusing portion may promote an even diffusion of gas from the outlet to and / or over the wound / surgical site.

[0272] The flow splitter 182 or the flow director 184 may be constructed into the shape of the diffusing material portion 104, when present, and / or can be formed integrally with the outer layer 146. The flow splitter 182 or the flow director 184 may be a separate component. The flow splitter 182 or the flow director 184 may be manufactured, by overmoulding it with the outer layer 146 of the interface body 120, for example.

[0273] Figures 10 and 11 show further examples of a flow splitter 188. In these examples, flow splitter 188 comprises a separate component that may be positioned in patient interface 110. The flow splitter 188 may comprise a substantially tubular T-piece that may be located at the junction of the fluid inlet 122 and the interface body 120. When present, the flow splitter 188 may be positioned at the junction of fluid inlet 122 and first fluid flow path 100. Fluid flow entering the fluid inlet 122 passes through the flow splitter 188 and is split into two streams passing into the interface body 120, for example, into the first fluid flow path 100.

[0274] In examples of the patient interface 110 in which the outer layer 146 is translucent or transparent, the flow director 184 or flow splitter 182, 188 may be visible through the outer layer 146. The flow director 184 or flow splitter 182, 188 may comprise or contain a thermochromic material or other material that changes colour or appearance in response to a variation in temperature and / or humidity.

[0275] Features of the example patient interface 110 are described with relation to the flow management component 288 in Figs. 12 to 22, 28 to 30. Features that correspond to the features of the patient interface 110 described above, share the same or similar reference numerals in the following description unless described otherwise.

[0276] Figure 12 to 13 (a) are perspective views of an example of a flow management component 288 for a patient interface for the supply of fluid to a surgical site. Some features described with reference to the flow management component 288 apply also to some examples of the flow management component 182, 184, 188, described herein. Fig 13 (b) is a schematiccross-sectional view of section A- A of Fig 13 (a) illustrating the internal features that some examples of the flow management component 288 may comprise.

[0277] Referring to Figs. 12, 13(a), and 13(b), the flow management component 288 comprises a component inlet 122 and a chamber 250. The chamber 250 has a chamber inlet in fluid communication with the component inlet 122, a chamber outlet 240, and a chamber wall 260 configured to direct fluid flow from the chamber inlet to the chamber outlet. The chamber outlet 240 is configured to be in fluid communication with a flow path of the patient interface.

[0278] The flow management component 288 may have a body 289. The body 289 may comprise a rigid material or a semi-flexible material. The body 289 may comprise a transparent or translucent material. The body may form the walls of the chamber.

[0279] The chamber 250 comprises a hollow volume defined at least partly by the chamber wall.

[0280] The chamber may be fully or partly enclosed by the chamber wall. In some embodiments, the chamber may comprise an open portion, configured such that a portion of the patient interface, such as a membrane component, covers the open portion to enclose the chamber.3

[0281] With reference to the example of the flow management component 288 illustrated in Figs. 12 and 13, the body 289 comprises an internal cavity surrounded by at least one wall to form a chamber 250. The chamber 250 has an opening forming a chamber inlet 242 and at least one opening forming at least one chamber outlet 240. For example, the chamber 250 illustrated in Figure 13 has two chamber outlets 240. The chamber 250 may have only a single chamber outlet 240 or it may have more than two chamber outlets 240.

[0282] The chamber 250, chamber inlet 242 and at least one chamber outlet 240 are in fluid communication to form a chamber fluid flow path 252. The fluid inlet 122 is configured to be in fluid communication with the chamber inlet 242 to provide, in use, a flow of fluid to the flow management component 288.

[0283] The, or each, chamber outlet may be at an angle to the inlet. For example, at an angle of + / - between about 30 degrees and about 90 degrees to the chamber inlet. For example, in the embodiment of Figures 16(a) to (c), the outlets are at an angle of about 60 degrees to the inlet.In the embodiments of Figures 17 and 18, the outlets 240 are at an angle of about 45 degrees.These embodiments are included as examples only and other angles are envisaged.

[0284] Flow through the flow management component 288 between the inlet 122 and outlet 240 is nonlinear. For example, the flow management component may be configured to direct flow from the inlet through a bend, towards the outlet. To cause the flow to follow a non-linear path, the walls of the flow management component 288 may comprise a bend and / or the walls of the chamber may be non-linear. For example, the chamber wall may comprise a concave portion and / or a convex portion.

[0285] Figures 12 to 22, 28 to 30 illustrate various examples of a flow management component 288 that may be a variation of a flow splitter 182, 188 or flow director 184 as described above. For example, wherein the flow management component 288 is an example of a flow director 184, the chamber 250 may comprise of a single chamber outlet 250 (not shown). In this example, the flow management component 288 shown in Figures 12 to 22, 28 to 28, one of the two chamber outlets 250 shown may be sealed or the body 289 may be modified to comprise a curved wall (not shown) that replaces substantially one half of the component shown. In another example, wherein the flow management component 288 may comprise a flow splitter 182, the body 289 may be the walls of the patient interface 110 which form the chamber 250 (not shown). The flow management component 288 may be configured to direct and / or split the flow of fluid to attenuate noise from the flow of fluid and / or reduce and / or mitigate sources of noise in the patient interface 110, such as the sources of noise discussed above.

[0286] Features of the flow management component 288, shown in Figs. 12 to 22, 28 to 30 correspond to the features of the flow management component 288 described above and like features, share the same reference numerals in the following description.

[0287] The at least one chamber outlet 240 is fluidly connected to at least one patient interface inlet 152 of a fluid flow path of the patient interface 110. For example, where the flow management component 288 is a flow director 184 as illustrated in Fig. 8 and in fluid communication with the first fluid flow path 100 (if present), the patient interface 110 may have one patient interface inlet 152. In another example, where the flow management component 288 is a flow splitter 188 as illustrated in Fig. 10, the patient interface 110 may have two patient interface inlets 152. In another example, as shown in Fig. 6, the fluid inlet 122 may be locatedin another location of the patient interface, such as adjacent and / or proximate the chamber outlet 240 (not shown).

[0288] The patient interface may have more than one flow management component 288. In one such example, shown in Fig. 5, the patient interface has two fluid inletsl22a, 122b, each in fluid communication with at least one chamber outlet 240 (not shown).

[0289] The flow management component 288 may comprise a sound attenuation component 370. The sound attenuation component is positioned at least partially within the chamber such that fluid flowing from the chamber inlet to the chamber outlet passes through the sound attenuation component.

[0290] Examples of the sound attenuation component are illustrated in Figs. 19 to 22 and 30(b). The sound attenuation component 370 may be located in the chamber fluid flow path 252 for reducing and / or mitigating sources of noise, such as described in this disclosure.

[0291] In another example, wherein the flow management component 288 is an example of a flow splitter 182 as previously described, the sound attenuation component 370 may be located in a fluid flow path (not shown) of the patient interface 110 instead.

[0292] At least a portion of the chamber wall 260 may be positioned substantially opposite the chamber inlet 242. For example, the chamber 250 may have a rear wall 260 as shown in Fig.13 (b). In use, at least part of flow of fluid in the chamber fluid flow path 252 may contact the rear wall 260 and / or any other surface of the chamber before being directed to the one or more chamber outlets 240. An example of this is illustrated in Fig 13 (b), wherein the dashed arrows are indicative of the direction of the flow of fluid entering the fluid inlet 122 as it passes into the chamber 250 but is not intended to represent the actual flow pattern of the fluid in the chamber fluid flow path 252. As such, the actual flow of fluid in the chamber fluid flow path 252 may bend, divert, or contact at least one surface of the chamber 250, according to the shape and area of the chamber cross-section 250 which is defined by the profile and orientation of the chamber walls relative to the chamber inlet 242.

[0293] Some examples, as shown in Fig. 12 to 13, 15 to 22, of the flow management component 288 may include a fluid inlet structure 280 extending between the fluid inlet 122 and the chamber inlet 242. The fluid inlet structure 280 may comprise an internal bore that fluidly connects the fluid inlet 122 to the chamber inlet 242.

[0294] Figures 19 to 22 and 30 illustrate examples of the flow management component 288 comprising a sound attenuation component 370 for attenuating the flow of fluid to reduce noise. The sound attenuation component may be configured to disrupt flow through the chamber. For example, by splitting the flow into multiple flow streams, causing diffusion of the flow, and / or by causing the flow to follow one or more nonlinear, curved, or torturous paths.

[0295] The sound attenuation component 370 may be a sound absorbent material and / or sound dampening material and / or may be fluid permeable. For example, the sound attenuation component 370 may define a multiplicity of fluid pathways therethrough. The multiplicity of fluid pathways may be non-linear interconnected and / or intersecting pathways.

[0296] The sound attenuation component 370 may comprise a porous or microporous material. The porous or microporous material may comprise one or more of a foam, a fabric, a woven structure, or a cellular structure. The porous or microporous material may comprise an open cell foam. The porous material may comprise a multiplicity of interconnected pores. The arrangement of the pores may be random, irregular, or the arrangement may be a regular cellular structure arrangement.

[0297] The sound attenuation component may comprise one or more of expanded polyethylene, polyurethane, silicone, rubber or the like, fabrics, weaves or cellular structures such as corn starch.

[0298] In any example of the flow management component 288, the sound attenuation component 370 may include any of these features, configured to reduce sound to an acceptable level, wherein an acceptable level of noise is circumstantial and may change depending on the application.

[0299] With reference to examples shown in Figs. 19 to 22 and 30(b), the sound attenuation component 370 of the flow management component 288 may substantially fill a volume of at least a portion of the chamber 250. In some examples, the sound attenuation component 370 may partially or substantially fill a volume of the chamber 250 in a space between the chamber inlet 242 and fluid inlet 122 as shown in figs. 21 and 22. The sound attenuation component 370 may partially or substantially fill a volume of the chamber 250 in a space between the chamber inlet 242 and the at least one chamber outlet 240, as illustrated in Figs. 19-22 and 30(b). In an example of the flow management component 288 having a fluid inlet structure 280, a portion of the sound attenuation component 370 may extend into the inlet channel. For example, such thatthe sound attenuation component 370 fills a volume of the fluid inlet structure 280 and / or the chamber 250. The sound attenuation component 370 may fill any combination of the spaces mentioned herein.

[0300] In any example of the flow management component 288, the sound attenuation component 370 may substantially fill a volume of the chamber 250 between the rear wall 260 and the fluid inlet 122 and / or the chamber inlet 242, as illustrated in Figs. 19-22, and 30(b).

[0301] Referring to Fig. 20, the sound attenuation component 370 may substantially fill a portion of the chamber wherein a noise having an undesired sound frequency or sound pressure level may be emitted. The sound attenuation component may be inserted and / or confined within the chamber fluid flow path 252.

[0302] As shown in Fig. 22, the flow management component 288 may comprise an outlet restriction 350 on each chamber outlet 240. The outlet restriction 350 may narrow the chamber fluid flow path 252 at the at least one chamber outlet 240 such that the flow of fluid travels from a wider opening defined by at least one wall of the chamber 250 to a smaller opening at least partially defined by the outlet restriction 350. The outlet restriction 350 may be narrowed to enable the flow of fluid travelling from the chamber inlet 242 to bounce around within the chamber 250 before travelling to the at least one chamber outlet 240. This may increase the total length of the chamber fluid flow path 252.

[0303] The outlet restriction 350 may be in the form of a plate with one or more flow apertures therethrough. For example, the outlet restriction 350 may comprise an orifice plate.

[0304] In the example shown in Fig. 22, the flow management component 288 may comprise the sound attenuation component 370 as previously described and the outlet restriction 350 on each of the at least one chamber outlets 240. In this example, the outlet restriction 350 may enable the flow of fluid to bounce around through a portion of the sound attenuation component 370 to reduce the velocity of the flow of fluid exiting the chamber outlet and reduce noise. The outlet restriction 350 may create a pressure drop. This pressure drop may be between the chamber and a fluid flow path of the patient interface. In some examples (not shown), the outlet restriction 350 may only be present on one of the chamber outlets 240.

[0305] In some examples of the flow management component 288, at least a portion of the sound attenuation component 370 may be adjacent to and / or may abut the rear wall 260 and / orany wall of the chamber 250. The sound attenuation component 370 may conform to the shape of an abutting wall. As illustrated in Fig. 20, at least a portion of the sound attenuation component 370 may be positioned adjacent the rear wall 260 and / or any wall of the chamber 250. The sound attenuation component 370 may not contact all walls and / or surfaces of the chamber and / or the at least one chamber outlet 240. As shown in fig. 20 the sound attenuation component may only contact a partial length of a wall of the chamber such as the rear wall 260.

[0306] In another example, the sound attenuation component 370 may be located such that it may abut and / or be adjacent any wall(s) of the chamber and the fluid inlet 122 and / or chamber inlet 242. The sound attenuation component 370 may be configured to slow the velocity of the flow of fluid through the chamber 250, reducing the speed of fluid that may contact any wall of the chamber 250. For example, the sound attenuation component may be located between the rear wall 260 and the fluid inlet 122 and / or chamber inlet 242 and configured to slow the velocity of the flow of fluid that may contact the rear wall 260.

[0307] Referring to Figs. 13 to 22 and 30, there are shown various examples of a cross- sectional view of the chamber 250 of the flow management component 288. Fig. 13b is a schematic cross-sectional view at section A-A of the flow management component 288 as shown in Fig. 13a. The chamber fluid flow path 252 is defined by the one or more walls of the chamber 250 and / or the fluid inlet structure 280. In any example of the flow management component 288, at least one wall of the chamber 250 forms part of the chamber fluid flow path 252 and may contact the flow of fluid to encourage or otherwise direct the flow of fluid from the chamber inlet 242 to the at least one chamber outlet 240.

[0308] In some examples of the flow management component 288, the chamber fluid flow path 252 may have a constant and / or varying cross-sectional area along a constant and / or varying profile of the chamber fluid flow path 252 between chamber inlet 242 and the at least one chamber outlet 240. A shape of the cross-sectional area may be any regular shape including but not limited to a square, rectangle, circle, oval, prism or triangle. In another example, the shape of the cross-sectional area may be any shape configured to deliver a desired flow rate through the chamber fluid flow path 252 to the at least one chamber outlet 240 and / or the at least one patient interface inlet 152.

[0309] Referring to Figure 13, the size and shape of the cross-sectional area at any point along the chamber fluid path 252 may be constant. The chamber fluid path 252 may be any of a linearor non-linear profile. In the example shown in Fig 14, the chamber fluid flow path 252 as defined by the one or more walls of the chamber 250 may have a widening cross-sectional area along the chamber fluid path 252, such that the cross-sectional area may be smaller at the chamber inlet 242 than at the at least one chamber outlet 240.

[0310] In another example of the flow management component 288, as shown in Fig 18, the chamber fluid flow path may have a narrowing cross-sectional area from a point in the chamber, along the chamber fluid path 252 towards the outlet. For example, such that the cross- sectional area may be larger at a point in the chamber than at the, or each, chamber outlet 240.

[0311] Figures 16a to 16c show examples of a flow management component 288, wherein the rear wall 260 may have at least one curved surface facing the chamber inlet 242. In each of the examples shown in Figures 16a to 16c, the curved surface comprises a concave portion facing chamber inlet 242. The concave portion of the curved surface may guide the flow of fluid, mitigating the effect of any sharp corners at the juncture of the chamber inlet 242 and the chamber fluid flow path 252 and the chamber outlet 240.

[0312] As shown in the examples of the flow management components 288 of Figs. 16a to 16c, the at least one curved surface and / or at least one wall of the chamber fluid flow path 252 may be configured as a continuous curve to provide a smooth profile for guiding the flow of fluid. In each of the examples of the flow management component 288 shown in Figs. 16a to 16c, the concave portion of the at least one curved surface extends and transitions to a substantially convex portion.

[0313] In some examples, such as shown in Figs. 16a to 16c, the flow management component 288 comprises a flow splitter, configured to split flow from the component inlet into two streams.

[0314] The flow splitter may comprise an apex positioned at or adjacent the chamber inlet, and two diverging surfaces, each surface directing fluid flow towards a respective outlet. For example, the rear chamber wall 260 may have two concave curved surfaces meeting at an apex 267 adjacent the chamber inlet 242.

[0315] The apex may be centred relative to the chamber inlet, or it may be off-centre.

[0316] The flow splitter may split flow from the chamber inlet substantially equally between the chamber outlets. Fluid flow entering the chamber 250 at the chamber inlet 242 may be splitinto two flow streams at the apex 267, with approximately 50% of the fluid flow being directed to a first side of the apex 267 and the other approximately 50% being directed to a second of the apex 267.

[0317] In another example, the flow management flow splitter 288 may split the fluid flow into two flow streams in an asymmetrical manner, with a flow ratio other than 50:50. For example, it may be configured to split the fluid flow into two streams having a flow ratio of 70:30 or 30:70 or 60:40 or 40:60 or any other desired flow ratio. In some examples, the apex 267 may be adjustable or be moved within the chamber 250 to achieve a desired flow ratio. Referring to Fig. 17, the apex 267 may be spaced apart from the fluid inlet 122 by a distance H4. The apex 267 may be spaced apart to increase the distance H4 so that the flow of fluid may have a reduced velocity as it contacts the apex 267.

[0318] The flow splitter may be configured such that an apex of the flow splitter is positioned adjacent the chamber inlet, in the chamber inlet, or spaced from the chamber inlet - either with the apex positioned in the chamber or in the inlet channel. In the examples of Figs. 16a to 16c, the rear wall 260 having the two concave surfaces extend into the chamber inlet 242 such that the apex 267 may be positioned to contact the flow of fluid in the fluid inlet structure 280.

[0319] In some examples, as illustrated in Figs. 16a to 16c, wherein the flow management component 288 is a flow splitter, the chamber 250 may comprise a front wall 263 that extends from the chamber inlet 242 to the at least one chamber outlet 240. In these examples the rear wall 260 may comprise the two concaved surfaces as previously described. As shown in Fig. 16a, in some embodiments, the front wall may be substantially flat or a curved surface. This may be to partially expand the chamber fluid flow path 252 between the rear wall 260 and the front wall 263 to control a parameter of the flow of fluid travelling from the chamber inlet 242 to the at least one chamber outlet 240.

[0320] As shown in Figs. 16b and 16c the front wall 263 may comprise one or more concave surfaces that extends and transitions to a substantially convex or flat portion configured to follow the curvature of the rear wall 260. The front wall 263 may be curved to guide the flow of fluid, mitigating effects of any sharp corners at the juncture of the chamber inlet 242 and the chamber fluid flow path 252.

[0321] In the example of Fig. 17, the flow management component comprises a flow splitter, the rear wall 260 may have two concave curved surfaces meeting at the apex 267 adjacent thechamber inlet 242. In this example, the flow of fluid entering the chamber 250 at the chamber inlet 242 may be split into two flow streams at the apex 267, and the flow of fluid may be divided according to a flow ratio as previously described. At least one wall of the chamber 250 and the two concave surfaces of the rear wall 260 may extend in a direction away from the chamber inlet 242 at an angle. The angle may be acute and extend the distance between the chamber inlet 242 to the at least one chamber outlet 240.

[0322] As shown in Fig. 17, the flow of fluid may be directed by the elongation of at least one wall of the chamber 250 that is / are angled at an acute angle away from the chamber inlet 242 to reduce the impact and / or surface area that the flow of fluid may contact as it travels from the chamber inlet 242 to the at least one chamber outlet 240. The flow of fluid may be directed from the chamber inlet 242 by the elongation of at least one wall of the chamber 250 along a substantially uninterrupted pathway to reduce the occurrence of noise caused by the flow of fluid contacting any wall of the chamber fluid flow path 252.

[0323] Examples of the flow management component 288 may be configured such that the chamber fluid flow path 252 can receive and / or deliver a predetermined fluid flow rate to the chamber outlet 240 and / or an inlet of a patient interface 110. The flow management component 288 may be further configured to reduce and / or mitigate sources of noise caused by the flow of fluid contacting any wall of the chamber fluid flow path 252, as described below.

[0324] Figure 18 is an example of the flow management component 288, wherein the chamber 250 may be configured to increase a distance Hl between the chamber inlet 242 and the rear wall 260. The distance may be configured such that the velocity of the flow of fluid contacting the rear wall 260 may be lower than the velocity of the flow of fluid entering the chamber inlet 242. The distance may be configured such that reducing the velocity of the flow of fluid contacting the rear wall 260 may reduce and / or mitigate a source of noise.

[0325] Referring to Fig. 15, the flow management component 288 may comprise an inlet channel extending from the chamber inlet to the fluid inlet 122, configured to direct fluid flow to the chamber inlet.

[0326] The inlet channel may extend generally perpendicular to the chamber wall. The inlet channel may extend in a non-perpendicular manner.

[0327] The inlet channel may be provided by a fluid inlet structure 280 sized appropriately to enable physical and pneumatic connection to the tube or conduit tube 112 or a connector of the tube or conduit tube. The connector of the tube or conduit may, for example, be a male end of a standard luer connector configured to connect within the fluid inlet structure 280.

[0328] The inlet channel may be provided by a conduit. The conduit may be rigid or flexible or may comprise a rigid portion and a flexible portion.

[0329] The tube or conduit 112 or a connector of the inlet tube may be configured to attach (not shown) within or external to the inlet 122, for example, by coupling to the fluid inlet structure 280 and consequently a portion of the body 289. In some embodiments, an end of the tube or conduit 112 or connector of the tube or conduit may be positioned to be flush with the chamber inlet 242, such that the chamber inlet 242 and the fluid inlet 122 are in substantially the same location. An example of this is illustrated in Fig. 14 (tube or conduit 112 or connector of the tube or conduit not shown).

[0330] In some examples of the flow management component 288, such as shown in Fig. 15, the fluid inlet structure 280 may be any length such that the fluid inlet 122 is a distance from the chamber inlet 242, forming a fluid inlet channel 282. In some examples, the fluid inlet channel 282 defined by the fluid inlet structure 280 may comprise a circular shaped bore and may have a constant cross-section defined by a single diameter D3.

[0331] The fluid inlet channel 282 may comprise a constant circular cross-section having the diameter D3 as illustrated in Fig. 15. The cross-sectional area and / or length of the fluid inlet channel 282 may influence a property of the flow of fluid entering the chamber inlet 242. The cross-sectional area at any point along the length of the fluid inlet channel 282, may vary to be smaller or larger than the cross-sectional area of the opening of either the fluid inlet 122 or the chamber inlet 242.

[0332] The fluid inlet structure 280 may define a fluid inlet channel 282 having a cross- sectional area that varies along a distance H3. A shape and / or size of the cross-sectional area may be any shape including but not limited to a square, rectangle, oval, prism. The shape and / or size of the cross-sectional area may be configured as any shape and / or size that delivers a specific flow rate and / or pressure and / or velocity of the flow of fluid to the chamber inlet 242.

[0333] In some examples of the flow management component 288, such as shown in Figs. 12 to 18, wherein the cross-section of the fluid inlet channel 282 varies between the fluid inlet 122 and the chamber inlet 242, the fluid inlet channel 282 may be configured to alter a property of the flow of fluid entering the chamber inlet 242. In some examples, as shown in Figs.16a to 16 c, the cross-sectional area may be wider at an end of the fluid inlet channel 282 that is proximate or abuts the fluid inlet 122. The cross-sectional area may be narrower at the end of the fluid inlet channel 282 that is proximate or abuts the chamber inlet 242. In such an arrangement, the fluid inlet channel 282 has a narrowing profile, which may increase the velocity of the fluid entering the chamber inlet 242.

[0334] In some embodiments, (not shown), the fluid may flow from the fluid inlet 122 through the fluid inlet channel 282 having a constant cross-sectional area along the distance H3 to the chamber inlet 242. The flow of fluid may travel from the fluid inlet channel 282 having a constant or varying profile to an expanded area formed by the at least one wall of the chamber 250. This may be to control a fluid characteristic of the fluid to reduce the occurrence of undesirable sound.

[0335] Referring to Fig. 18, the front wall 263 of the chamber 250, may be spaced apart from the top wall by the distance Hl and / or the distance H3 as described previously. As shown in Fig. 18, Hl is a distance between the chamber inlet 242 and the rear wall 260. The front wall 263 may be angled away from a central axis 254 of the chamber inlet 242. The front wall 263 may be offset from the central axis 254 by a fluid expansion angle Al. For example, the fluid expansion angle Al may represent the gradual expansion of the chamber fluid flow path 252 defined in part by a gradual curvature of the front wall 263 relative to the central axis 254.

[0336] The fluid expansion angle Al may be wider where the distance Hl and / or the distance H3 are increased and / or the front wall 263 is spaced further away from the central axis 254. The fluid expansion angle Al may widen to assist the flow of fluid travelling between the chamber inlet 242 to the chamber outlet 240 to have minimal or substantially no detachment with the front wall 263. This may reduce the occurrence of turbulent flow. In some examples of the flow management component 288, the fluid expansion angle Al may be greater than or equal to 60 degrees. In some examples of the flow management component 288, the fluid expansion angle Al may be selected to be greater or equal to a value ranging between 50 degrees to 90 degrees. In some examples of the flow management component 288, the fluid expansion angle Al may be selected to be less than or equal to 30 degrees.

[0337] In some examples, the fluid expansion angle Al may be narrower to guide the flow of fluid along the chamber fluid flow path 252 in a substantially smooth manner from the chamber inlet 242 to the chamber outlet 240 with minimal or substantially no contact with the front wall 263. In one example, the fluid expansion angle Al may be less than or equal to 15 degrees. In one example, the distance Hl and / or the distance H3 may be any length selected in combination with the fluid expansion angle Al to slow the velocity of the flow of fluid at the rear wall 260 and / or reduce or minimise detachment between the flow of fluid and the front wall 263 travelling to the chamber outlet 240 and / or reduce or minimise contact between the flow of fluid and the rear wall 260. In another example, such as shown in Fig. 13b, the fluid inlet channel 282 may be configured to have a widening profile between the fluid inlet 122 and the chamber inlet 242. In this example, the fluid inlet channel 282 may be configured to decrease the velocity of the fluid entering the chamber inlet 242. The cross-sectional area along the profile of the fluid inlet channel may change according to any example of the flow management component 288, such as illustrated in Figs. 12 to 22, 28 to 30.

[0338] The rear wall 260 may be located substantially opposite the chamber inlet 242 spaced a distance Hl, from the chamber inlet 242, as shown in Fig. 14. Hl may be a predetermined distance that influences a property of the flow of fluid entering the chamber inlet 242 before the flow of fluid may exit at the chamber outlet 240. The fluid inlet 122 may be spaced apart a relatively longer distance, for example, distance H3 from the chamber inlet 242, as shown in Fig 15a, for example.

[0339] The distance of Hl and / or H3 may be configured, for example, increased or decreased, to change the velocity of the flow of fluid entering the fluid inlet 122 and / or the velocity of the flow of fluid contacting the rear wall 260. Hl and / or H3 may be any length configured to decrease the velocity of the flow of fluid contacting the rear wall 260. Decreasing this velocity may attenuate the sound of the flow of fluid such that it reduces noise. In another example, Hl and / or H3 may be any length configured to increase the velocity of the flow of fluid entering the chamber inlet 242, such that the flow of fluid reaches the chamber outlet 240 faster. In another example, Hl and / or H3 may be any length configured to change a characteristic of the flow of fluid entering the chamber inlet 242. For example, such that the flow of fluid reaches the chamber outlet 240 at a predetermined flow rate.

[0340] The flow management component may comprise a flow restriction arranged to induce a pressure drop in fluid travelling therethrough. The flow restriction may be provided by a flow control component 490.

[0341] Figures 23 to 26 illustrate examples of a flow control component 490. The fluid flow control component comprises an inlet 481, an outlet 491, and a flow restriction 489. The flow restriction 489 may have a plurality of openings. The plurality of openings may include a first opening 494 and / or a second opening 495.

[0342] Figures 23 to 26 show a single first opening 494 and a plurality of second openings 495. However, the component 490 may include a plurality of first openings and / or a single second opening. The component 490 may include a plurality of first openings and a plurality of second openings.

[0343] Referring to the example shown in Fig. 23, the first opening 494 and / or the second opening 495 may fluidly connect a restriction inlet 492 and a restriction outlet 491 to form a restriction fluid flow path 493. An example of the restriction fluid flow path 493 is illustrated in Fig.23, wherein the dashed arrows are indicative of the direction of flow of fluid exiting the restriction outlet 491 and passing through the first opening 494 and / or the second opening 495. The dashed arrows are not meant to represent the actual flow pattern exiting the plurality of openings forming the first opening 494 and / or the second opening 495. The actual flow of fluid in the restriction fluid flow path 493 may bend, divert, or contact at least a surface of flow restriction 489, according to the shape and area of the first opening 494 and / or second opening 495.

[0344] The first opening 494 and / or second opening 495 of the flow control component 490, such as shown in the examples of Figs. 23 to 26, may be configured to alter a fluid characteristic of the flow of fluid passing through the flow control component 490. The flow restriction 489 may be configured to reduce pressure fluctuations caused by, for example, the contact of moving fluid with still fluid, or between fluids of different velocity, which may contribute to noise. The flow restriction 489 may be configured to disrupt a still or almost still area of air or other fluid upstream of the flow control component 490 such that the flow restriction may reduce and / or mitigate pressure fluctuations causing noise.

[0345] The flow restriction 489 may comprise a wall comprising the first opening 494 and second opening 495. The first opening(s) 494 may allow a first volume of fluid to pass therethrough.

[0346] The second opening(s) may allow a second volume of fluid to pass therethrough.

[0347] The first volume of fluid may be greater than the second volume of fluid. With this configuration, a larger volume of fluid may be permitted to flow through the restriction fluid flow path 493 through the first opening than the second opening. For example, the first opening(s) may have a total first opening area, and the second opening(s) have a total second opening area that is less than the first opening area.

[0348] In the examples shown in figures 23 to 26, a single first opening 494 is provided. In other examples, two or more first openings may be provided. The two or more openings may be of the same size and / or shape. The first opening may comprise two or more openings of a different size and / or shape.

[0349] In the example shown in Fig. 24a to 24f, any opening of the first opening 494 and / or second opening 495 may have a shape that is, but is not limited to any of a circle, rectangle, disco-rectangle, square, oval, semicircle, lune or lens. The shape of the first opening 494 and / or second opening 495 may be irregular and defined by the area of the first opening 494 and / or second opening 495. The shape of the first opening 494 may be the same or different to the shape of the second opening 495.

[0350] The first opening 494 may be located at or adjacent a substantially central point of the flow restriction 489. For example, as shown in Fig. 24a the first opening 494 may be located at the center of the wall. In some embodiments of the flow control component 490, the first opening 494 may comprise a single opening that extends through the plane of the wall. The first opening 494 may be arranged substantially at the center of the wall. In another example (not shown), the flow control component 490may comprise two or more first openings 494. The first openings may be arranged in an area proximate to or adjacent the center of the wall. The first opening 494 may comprise two or more openings that may be arranged at regular and / or irregular positions at any location on the wall.

[0351] The flow control component 490 may comprise a plurality of second openings 495. The second openings 495 may be arranged about the center of the wall and / or the first opening494. The second openings 495 may surround the center of the wall and / or the first opening(s) 494. The one or more openings of the second opening 495 may share one or more axes with the one or more first openings 494. In another example, the second opening 495 may be spaced apart from the first opening 494 such that it may be located through the wall at a point further away from the centre of the wall than the first opening 494. The one or more openings of the second opening 495 may be arranged at regular and / or irregular positions on any location on the wall. Figures 24a to 24f illustrates some non-limiting example configurations of the flow restriction 489 having the first opening 494 and / or second opening 495.

[0352] The second openings 495 may be arranged about the first opening(s) 494. For example such that the second openings are located more peripherally than the first opening(s). The first opening(s) 495 may be positioned centrally. The second openings may be arranged in an irregular or regular manner. The second openings may be arranged about the first opening 495 in a radially symmetric manner.

[0353] In the embodiments shown, the second openings 495 are smaller than the first opening 494. The first and second openings may be the same size. The second openings may be larger than the first opening or openings.

[0354] The first and second openings may be provided in the same plane, for example in the same plate or wall. The first and second openings may be provided in different planes. For example, with the first opening(s) downstream or upstream of the second openings.

[0355] In the example flow control component 490 illustrated in Figs. 23 to 26, the flow restriction 489 may be a restriction conduit 498. The restriction conduit 498 may extend through a wall through which the first and / or second openings 494, 495 are provided. In some examples, the wall forms the restriction outlet 491.

[0356] The restriction conduit may comprise a conduit axis that extends through the component inlet and outlet. The restriction conduit is configured for placement in a flow path, with the conduit axis extending in the direction of the flow path.

[0357] The restriction conduit 498 may comprise an inner surface 484. The inner surface 484 may be configured to guide the flow of fluid from the restriction inlet 492 towards the first and / or second openings 494, 495.

[0358] One or more channels may be provided extending between each second opening 495 and the inner surface 484. One or more channels may be provided extending between the, or each, first opening 494 and the inner surface 484.

[0359] The channels may all be substantially the same length or may vary in length. In the examples of Figs. 25 and 26, the channels extending from the second openings 495 are the same length and longer than the channel extending from the first opening 494.

[0360] The channels may each have a length that is longer or shorter than the diameter or a dimension of the respective opening. The channels associated with the second openings 495 may each have a length that is longer than a diameter or width of the respective second opening 495. The channel associated with the first opening 494 may have a length that is shorter than a diameter or width of the first opening 494.

[0361] The channels may direct fluid into the respective opening. The channels may have a cross section that substantially corresponds to the shape of the respective opening. Each cross section may be constant. The cross section may vary along the length of the channel and / or conduit. For example, the cross section may taper towards the respective outlet.

[0362] At the entry end of the channels 492, the inner surface 484 may be non-perpendicular. This creates an enlarged opening at the entry end of the channels that may assist to direct flow into the channel. The non-perpendicular intersection of the channel with the inner surface 484 may form a frustum. In the case of circular openings, this may form channels with a frusto cylindrical shape.

[0363] The channels 492 may be in the form of conduits.

[0364] The first opening 494 and / or second opening and / or the inner surface may at least partly define the restriction fluid flow path 493.

[0365] At least part of the inner surface 484 may be angled, for example angled inwardly. At least a part of the inner surface 484 may comprise a ramp 484 or a ramp portion. The ramp 484 may extend inwardly within the conduit, to reduce the cross-sectional area of the restriction fluid flow path between the restriction inlet and the restriction outlet. For example, the ramp 484 may be configured to generally taper inwardly from the restriction inlet 492 to the restriction outlet 491, such that it narrows the cross-sectional area of restriction fluid flow path 493 as shown, for example in the flow control component 490 of Figs. 25-26.

[0366] The ramp 484 may be a linear or straight or curved surface. The ramp 484 may have a varying gradient along the restriction fluid flow path 493. The ramp 484 may be configured to have a linear or straight or curved surface or a varying gradient along the restriction fluid flow path 493 that is different in various examples of the flow control component 490. The inner surface 484 may form a cavity. The cavity may, for example, have a concave surface or an elliptic paraboloid.

[0367] As referenced in Fig. 23 the inner surface 484 may be a substantially flat surface of the restriction conduit 498. Though the inner surface 484 is not visible in Fig. 23, it can be inferred that it may substantially mirror the flat surface of the restriction outlet 491 shown in the same figure. The inner surface 484 may have a flat surface that may be orientated substantially in parallel or at another angle in relation to the restriction outlet 491.

[0368] The flow control component 490 may be located within or integrally formed with part of the flow management component 288, such as shown in the example of Fig. 29. The flow control component 490 may be in or adjacent at least one chamber outlet 240. The flow control component 490 may be an integrated component, for example as shown in Fig. 29. The flow control component 490 may be a separate component, for example as shown in Fig. 28. The flow control component 490 may be located at least partly within the fluid flow path 252 of the flow management component 288 and / or a fluid flow path of the patient interface 110.

[0369] The restriction inlet 492 of the flow control component 490 may be configured to receive a flow of fluid from the fluid inlet 122 and / or the chamber inlet 242 and / or the chamber outlet 240. The restriction outlet 491 of the flow control component 490 may be configured to deliver a flow of fluid to the chamber outlet 240 and / or an inlet of the first fluid flow path 100 and / or the second fluid flow path 102 and / or an outlet of the patient interface 100.

[0370] In some configurations, the flow control component is in the form of an end cap component. The end cap may be configured for insertion into the outlet of a flow management component, for example.

[0371] Figure 28 illustrates an example of the flow control component 490, wherein the flow control component 490 is configured to be at least partly inserted into at a chamber outlet 240 of a flow management component 288. The flow control component 490 may be in the form of a component that may be inserted into an intermediate portion of a fluid flow path, for example, first fluid flow path 100 of the patient interface 110.

[0372] The flow control component 490 may be inserted into a chamber outlet 240 such that it is partly or fully positioned with the chamber. The flow control component 490 may be removably attached to an outlet, for example, through a threaded, push, snap or other removable connection. The flow control component may be permanently fixed in place.

[0373] In some examples, the restriction conduit 498 of the flow control component 490 may comprise an attachment structure 497. The attachment structure 497 may be for attaching the restriction conduit 498 and / or the flow control component 490 to a fluid flow path of the patient interface 110 and / or the chamber fluid flow path 252 of the flow management device 288. An example of the attachment structure 497 is illustrated in Fig. 27. In this example, the attachment structure 497 comprises one or more securement tabs for inserting the flow control component 490 into a structure such as one or more of the chamber outlets 240, the first fluid flow path 100, and the second fluid flow path 102. This insertion forms a fluid flow path in the patient interface 110 and / or the flow management component 288.

[0374] The attachment structure 497 may abut, attach, and / or otherwise be connected with a lip 496 of the flow control component 490. The lip 496 may at least partly form a cap for the flow control component 490 when inserted, for example, into a chamber outlet 240 of the flow management component 288.

[0375] The lip 496 may have an outer rim. As shown in Fig. 28, the outer rim of the lip 496 may be flush with the edge and / or external wall of a chamber outlet 240. In another example, the lip 496 may be configured, as shown in Fig. 26, to have an overhanging structure 499. The overhanging structure 499 may be configured to secure the flow control component 490 to a chamber outlet 240, for example. The overhanging structure 499 may wrap or otherwise extend, at least partly around an external wall of at least one chamber outlet 240. The overhang structure may abut an internal wall of at least one chamber outlet 240.

[0376] The flow control component 490, may comprise one or more guides 485, an example of which is as shown in Fig. 27. The guides 485 may comprise guide vanes such as fins.

[0377] The guides 485 may be positioned downstream of the first and second opening(s) 494, 495. For example, they may be provided at the outlet of the flow control component. The guides 485 may be provided at least partly externally of the restriction conduit 498.

[0378] The guides may straighten flow through the component, which may help to reduce noise. The guides may comprise substantially flat or planar surfaces. The guides may comprise one or more contoured surfaces. The guides may be arranged radially. In some embodiments, the guides are arranged radially around the first opening(s) 494. The guides may project from a peripheral part of the component towards a midline or the centre of the component.

[0379] The guiding structure 485 may further comprise the lip 496 and the attachment structure 497 as described above. In the example of Fig. 27 the lip 496 and the attachment structure 497 may comprise a guiding structure opening 486 that functions as the restriction outlet 491.

[0380] The guiding structure opening 486 may be spaced from the first opening 494 and / or the second opening 495 and / or the restriction conduit 498.

[0381] The attachment structure 497 may comprise a third opening for guiding the flow of fluid to the restriction outlet 491. The guiding structure opening 486 may be configured to extend the restriction fluid flow path 493 to guide the flow of fluid from the first opening 494 and / or second opening 495 and / or third opening to the restriction outlet 491.

[0382] As illustrated in Fig. 30a and 30b, the flow management component 288 may comprise the sound attenuation component 370 and / or the flow control component 490. The sound attenuation component 370 may be a first sound attenuation component for reducing a first source of noise as previously described. In this example, the sound attenuation component 370 may be arranged for example, as shown in Figs. 19 to 22 as described previously. The flow control component 490 may be a second sound attenuation component for reducing or further reducing the first source of noise or a second source of noise as previously described. In this example, the flow control component 490 may be arranged within the chamber fluid flow path as described previously.

[0383] Examples of a flow management component 288, a flow control component 490, a patient interface 110 and a system 101 for attenuating sound during delivery of fluid to a wound, for example a surgical cavity of a patient have been described herein. It will be appreciated by the skilled person that embodiments of the flow management component 288, the flow control component 490, the patient interface 110 and the system 101 and their use in a method of management and / or treatment of a wound can produce a distribution of flow ofconditioned fluid to a wound site, and / or to create a protective microenvironment over the wound that has an improved performance over known patient interfaces.

[0384] Whilst features of the various embodiments have been described, it will be apparent to the skilled person that a feature or features from one embodiment may be used in conjunction with features from another embodiment without departing from the scope of the disclosure. Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

[0385] It will be appreciated by persons skilled in the art that numerous variations and / or modifications may be made to the above-described embodiments, without departing from the broad general scope of the present disclosure. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

1. CLAIMS1. A flow control component for a patient interface for the supply of fluid to a surgical site, the flow control component comprising: an inlet; an outlet; and a flow restriction comprising a first opening and a second opening; wherein the first opening and second opening are configured to alter a fluid characteristic of fluid passing therethrough.

2. A flow control component as claimed in claim 1, comprising a plurality of first openings configured to allow a first volume of fluid to pass through.

3. A flow control component as claimed in claim 2, wherein the first openings are arranged concentrically.

4. A flow control component as claimed in claim 2 or 3, wherein the first openings are arranged at irregular intervals.

5. A flow control component as claimed in any of the preceding claims, comprising a plurality of second openings configured to allow a second volume of fluid to pass through.

6. A flow control component as claimed in claim 3, wherein the second openings are of the same size and shape.

7. A flow control component as claimed in claim 3 or 6, wherein the second openings are arranged around the first opening(s).

8. A flow control component as claimed in any one of claims 1 to 7, wherein the first opening(s) have a total first opening area, and the second opening(s) have a total second opening area that is less than the first opening area.

9. A flow control component as claimed in any one of claims 1 to 8, wherein the flow restriction comprises a wall with the first opening(s) and second opening(s) provided therethrough.

10. A flow control component as claimed in claim 9, wherein the first opening is located centrally through the wall.

11. A flow control component as claimed in claim 9 or 10, wherein the first and second openings are spaced apart, with the second openings located through the wall more peripherally than the first opening(s).

12. A flow control component as claimed in any of claims 9 to 11, wherein the flow restriction is a restriction conduit and the outlet is formed by the wall at an outlet end of the restriction conduit.

13. A flow control component as claimed in claim 12, wherein the restriction conduit comprises an inner surface that guides the flow of fluid from the restriction inlet towards the restriction outlet.

14. A flow control component as claimed in claim 13, comprising channels extending between the second openings and the inner surface.

15. A flow control component as claimed in claim 14, wherein the inner surface comprises a ramp extending inwardly to reduce the cross-sectional area of the restriction fluid flow path between the restriction inlet to the restriction outlet.

16. A flow control component as claimed in claim 15, wherein the inner surface has a linear or curved surface.

17. A patient interface for the supply of fluid to a surgical site, comprising a flow control component as claimed in any one of claims 1 to 16, wherein the interface comprises an interface inlet in fluid communication with the flow control component inlet; and wherein the flow control component outlet is arranged to supply fluid to a flow path of the patient interface.

18. A patient interface as claimed in claim 17, wherein the flow control component is located at the interface inlet and along the flow path of the patient interface.

19. A patient interface as claimed in claim 17 or 18, wherein the flow control component is located or downstream of the interface inlet and along the flow path of the patient interface.

20. A patient interface as claimed in any one of claims 17 to 19, wherein the patient interface comprises an outer layer configured to enclose at least a portion of the flow control component, wherein the outer layer is configured to contain the flow of fluid through the flow control component and / or along a portion of the flow path of the patient interface.

21. A flow management component for a patient interface for the supply of fluid to a surgical site, the flow management component comprising: a component inlet; a chamber having a chamber inlet in fluid communication with the component inlet, a chamber outlet, and a chamber wall configured to direct fluid flow from the chamber inlet to the chamber outlet; and a sound attenuation component positioned at least partially within the chamber such that fluid flowing from the chamber inlet to the chamber outlet passes through the sound attenuation component; wherein the chamber outlet is configured to be in fluid communication with a flow path of the patient interface.

22. The flow management component as claimed in claim 21, wherein at least a portion of the chamber wall is positioned substantially opposite the chamber inlet23. The flow management component as claimed in claim 21 or 22, wherein the chamber outlet is at an angle of + / - between about 30 degrees and about 90 degrees to the chamber inlet.

24. The flow management component as claimed in any one of claims 21 to 23, wherein the sound attenuation component is adjacent the chamber wall.

25. The flow management component as claimed in any one of claims 21 to 24, wherein the sound attenuation component defines a multiplicity of fluid pathways therethrough.

26. The flow management component as claimed in any one of claims 21 to 25, wherein the sound attenuation component comprises a sound absorbent material and / or a sound dampening material.

27. The flow management component as claimed in any one of claims 21 to 26, wherein the sound attenuation component comprises a porous material.

28. The flow management component as claimed in claim 27, wherein the porous material comprises an open cell foam.

29. The flow management component as claimed in any one of claims 21 to 28, wherein the component inlet comprises an inlet channel extending from the chamber inlet, configured to direct fluid flow to the chamber inlet.

30. The flow management component as claimed in claim 29, wherein a portion of the sound attenuation component extends into the inlet channel.

31. The flow management component as claimed in any one of claims 21 to 30, wherein the chamber inlet is spaced at a first distance from the chamber wall, wherein the first distance is selected to reduce a velocity of gasses flowing through the chamber inlet32. The flow management component as claimed in any one of claims 21 to 31, wherein a cross-sectional area of the chamber increases from a first point adjacent the chamber inlet to a second point distal to the chamber inlet, along at least a portion of the chamber.

33. The flow management component as claimed in any one of claims 21 to 32, wherein a cross-sectional area of the chamber adjacent the chamber inlet is less than a cross- sectional area of the chamber adjacent the chamber outlet.

34. The flow management component as claimed in any one of claims 21 to 33, comprising a flow restriction arranged to induce a pressure drop in fluid travelling through the flow management component.

35. The flow management component as claimed in claim 34, wherein the flow restriction comprises a first opening and one or more second openings for flow therethrough.

36. The flow management component as claimed in claim 35, wherein the flow restriction comprises a plurality of second openings.

37. The flow management component as claimed in claim 36, wherein the flow restriction comprises a plurality of channels, each channel configured to direct flow through a respective second opening.

38. The flow management component as claimed in any one of claims 34 to 37, wherein the flow restriction is positioned downstream of the chamber inlet.

39. The flow management component as claimed in any one of claims 34 to 38 wherein the flow restriction is positioned at or adjacent a respective chamber outlet.

40. The flow management component as claimed in any one of claims 34, wherein the flow restriction comprises a plate with one or more openings provided therethrough.

41. The flow management component as claimed in any one of claims 34 to 39, wherein the flow restriction comprises an end cap component positioned partly with the chamber.

42. The flow management component as claimed in any one of claims 34 to 41, wherein the flow restriction comprises a component having a plurality of guide vanes.

43. The flow management component as claimed in any one of claims 21 to 42, wherein the chamber comprises two chamber outlets.

44. The flow management component as claimed in claim 43, comprising a flow splitter configured to split flow from the component inlet into two streams.

45. The flow management component as claimed in claim 44, wherein the flow splitter comprises an apex positioned at or adjacent the chamber inlet, and two diverging surfaces, each surface directing fluid flow towards a respective outlet.

46. A patient interface for the supply of fluid to a surgical site, comprising a flow management component as claimed in any one of claims 21 to 45, wherein the interface comprises an inlet arranged to supply fluid to the chamber inlet; and wherein the chamber outlet is arranged to supply fluid to a flow path of the patient interface.

47. A patient interface as claimed in claim 46, wherein the component inlet forms the interface inlet.

48. A patient interface for the supply of fluid to a surgical site, the patient interface comprising: an interface body comprising a fluid inlet, a first fluid flow path, and a second fluid flow path; wherein the first fluid flow path at least partially surrounds the second fluid flow path and is in fluid communication with the fluid inlet and the second fluid flow path; wherein the fluid inlet is configured to fluidly connect to a first portion of the first fluid flow path positioned substantially in line with the fluid inlet, such that flow is directed from the fluid inlet to the first fluid flow path substantially unobstructed.

49. A patient interface as claimed in claim 48, wherein the patient interface comprises a flow director for guiding the flow of fluid from the fluid inlet to the first portion of the first fluid flow path.

50. A patient interface as claimed in claim 48, wherein the second fluid flow path is provided through a diffusing material, the diffusing material comprising a first portion having a first width and a second portion having a second width.

51. A patient interface as claimed in claim 50, wherein the first width is larger than the second width to increase the resistance to fluid flow in first portion.

52. A patient interface as claimed in claim 50, wherein the first width is smaller than the second width to decrease the resistance to fluid flow in first portion.

53. A patient interface as claimed in claim 50, wherein the diffusing material of the second fluid flow path tapers in the direction the flow of fluid is travelling, and the first width is larger than the second width.

Citation Information

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