Patient Interface

Abstract

To provide a useful patient interface for industry and the public. [Solution] The present invention relates to a patient interface comprising a body positioned over a user (preferably the user's face, etc.), the body comprising at least one (and preferably a pair) nasal prongs, the body comprising a lumen which can be fluidly connected to the body or each nasal prong to fluidly communicate with a source of respiratory gas, the body comprising at least one element which responds to a force or movement or both of the first region of the patient interface.

Description

Technical Field

[0001] The present invention relates to a patient interface, and more particularly, but not limited to, a patient interface for delivering gas to a user, such as a nasal cannula for delivering gas to the nostrils of a user's nose, which can be configured to improve stability when in its original position on the user's face.

Background Art

[0002] There are many forms of patient interfaces for delivering gas to a user, such as full face masks, mouth-nose masks, nasal masks and nasal cannulas.

[0003] There are a significantly diverse number of patient interfaces available to users, and each of them can have its own stability issues.

[0004] The stability of the interface on the user is important, at least for reasons of comfort and maintenance of the desired treatment delivery to the user.

[0005] If the interface is unstable, the interface or components of the interface may come off, which can affect the desired delivery or integrity of the treatment to the user.

[0006] In various modes, the instability of the interface on the user can be a result of loading, for example, when the user talks and by changing the shape of the user's face where the interface is placed. The shape of the face, such as the shape of a human face, varies significantly due to a wide range of factors. These factors can include, but are not limited to, gender, age or a particular medical condition. The inappropriateness of the size and shape of the interface for a particular user can also adversely affect the stability and usefulness of some patient interfaces.

[0007] Regarding facial movements, if the user speaks, eats, cries, or distorts or exaggerates facial features, such movements may affect the stability of the patient interface or its components over the user, such as the nasal prongs of a nasal cannula or its counterparts, which may inadvertently protrude from the gas delivery position for delivering gas to the user's nostrils. Longer-term changes in facial features may also occur due to the user's posture, for example, during sleep. Longer-term changes in shape may also occur due to the user's growth and wound healing.

[0008] In relation to the above, it will be understood that forces and movements may be transmitted to the interface and its components due to changes in the shape of the user to whom the patient interface is placed, or by other forces, such as when the user pulls on the tube or interface or other components attached thereto. The application of such forces can cause problems with the stability, comfort, and operational use of the patient interface for the user. [Overview of the Initiative] [Problems that the invention aims to solve]

[0009] Therefore, an object of the present invention is to provide a patient interface, such as a nasal cannula, that helps at least somewhat address the above-mentioned problems, or at least provides a useful alternative for industry / the public. [Means for solving the problem]

[0010] Where this specification refers to patent specifications, other external documents, or other sources of information, these are generally intended to provide background for describing the features of the invention. Unless otherwise specified, references to such external documents should not be construed as an acknowledgment that such documents or sources of information are, in any right, prior art or form part of the common general knowledge in the art.

[0011] Further aspects and advantages of the present invention will become apparent from the following description, which is given merely as an example.

[0012] In one embodiment, the present invention broadly relates to a patient interface such as a nasal cannula, The main unit is placed on the user (preferably the user's face, etc.). Equipped with, The body comprises at least one (and preferably a pair) nasal prongs, and the nasal prongs or each nasal prongs comprises a lumen that can be fluidly connected to the nasal prongs or each nasal prongs to fluidly communicate with a source of respiratory gas, and the nasal prongs or each nasal prongs are configured to be inserted into one or both nostrils of the user, or to direct a gas flow into one or both nostrils. The body may be a patient interface that includes at least one element that responds (optionally mechanically) to a force or movement or both acting on at least a first region of the patient interface, and optionally or otherwise, the body may be a patient interface that includes at least one element that responds (optionally mechanically) to a force or movement or both acting on at least a first region of the patient interface, such that it is not transmitted to at least other regions of the patient interface.

[0013] Preferably, the element facilitates the reduction of the transmission of force or motion, or both, applied to at least the first region of the interface, so as not to be transmitted to at least another region of the interface.

[0014] Preferably, the element responds in a way that localizes the force and / or motion acting on at least the first region.

[0015] Preferably, the element responds to minimize or prevent the transmission of force or movement, or both, from at least the first region to at least one other region of the patient interface.

[0016] Preferably, the element responds to being maintained in a configuration in which at least one (and preferably a pair) nasal prongs are inserted into one or both nostrils of the user's nose, or in a configuration in which a gas flow is directed to one or both nostrils of the user's nose.

[0017] Preferably, the response is such that at least one (preferably a pair) of nasal prongs maintains a stable position within or adjacent to the nostrils of the user's nose to which the prongs are directed.

[0018] Preferably, the response is such that the interface maintains an operational position on the user.

[0019] Preferably, the response is such that the interface maintains a stable position on the user.

[0020] Preferably, the force or motion or both that the interface receives in at least a first region is The force or movement applied between the nasal prongs and the body of the patient interface, or Force or movement applied between the patient interface body and the nasal prongs It is either one or both of the above.

[0021] Preferably, the element is deformable or deformable in response to a force or motion or both acting on at least a first region of the interface.

[0022] Preferably, the element has a predetermined or preferred mode of deformation in response to a force or motion or both being experienced by at least a first region of the interface.

[0023] Preferably, the element is deformable by one or a combination of compression, tension, torsion, bending, or other deflection.

[0024] Preferably, the element responds to the force or movement or both received by at least the first region of the interface by one or a combination of a change in shape, a change in position, a change in configuration, or a deformation.

[0025] Preferably, the element is a hinge, a pivot, a joint coupling or a joint-connected part of the body or a part related to the body, a swivel, a ball-and-socket type coupling, a pin-in-barrel type coupling a material having relatively lower flexibility than other parts of the interface, a material having relatively higher flexibility than other parts of the interface, a material having properties that change by increasing the resistance to the applied force or movement (or both) or by reducing the resistance to the applied force or movement (or both) when the force or movement is applied, or a material that can be elastically deformed in response to the applied force or movement (or both), or a material that is preferentially deformable in a specific or predetermined shape but can optionally resist deformation in other specific or predetermined shapes including one or any combination of these.

[0026] Preferably, the element is a pivot (or swivel), or a region that can pivot (or swing), or a hinge or hinge region, or a region that can be hingedly attached to another component or another region of the interface, or a joint or joint coupling, or a region that can perform joint movement one or more of these.

[0027] Preferably, the element provides separation of the force or movement (or both) applied to at least the first region of the interface so as not to be transmitted to at least one other region of the interface.

[0028] Preferably, the element is provided, operable, or acts to prevent or minimize the transmission of motion forces from at least a first region of the interface to at least one other region of the interface.

[0029] Preferably, the element may be the structure or mechanism of the interface, or it may be the domain of the interface.

[0030] Preferably, the element is deformable about at least one axis or in at least one plane.

[0031] Preferably, the element is deformable around a preferred first shape.

[0032] Preferably, the element is deformable by one or a combination of compression, tension, torsion, bending, or other deflection.

[0033] Preferably, there are two or more elements arranged around the interface.

[0034] Preferably, the elements are connected to one another to provide a coupled response to force or motion (or both).

[0035] Preferably, the element can respond to force or motion (or both) in different modes, thereby providing a combined response.

[0036] Preferably, the elements are operably coupled to one another or to other parts of the interface to provide a combined response or the combined response.

[0037] Preferably, at least one of the elements or each of these elements is Isolation body or isolation area, Absorbent material or absorbent area, Inhibitor or inhibitory region, Alternatively, any other structure or mechanism that provides a reaction response to a force or movement applied to at least the first region of the patient interface, such that it is not transmitted to at least the second region or another region of the patient interface. It is offered as one or more of the following.

[0038] Preferably, the response is at least one (or combination) of isolating or absorbing or inhibiting or reducing a force or movement applied to at least one other area of ​​the patient interface during use by the user.

[0039] Preferably, the elements are pre-formed to deform or displace in a preferred shape or dimension.

[0040] Preferably, the element facilitates preferential bending or deflection or twisting or torsion of the material or component forming the body of the interface, or preferential or predetermined pivoting or extension or compression.

[0041] Preferably, such forces or movements result from the user of the interface changing the shape of their face in which the interface is held, positioned, or located, or from the user pulling on or applying force or movement to the interface or associated headgear, or from the breathing circuit or other components of the interface pressing down on part of the interface or associated headgear with weight.

[0042] Preferably, any force or movement applied between the nasal prongs and the body of the patient interface, or between the body of the patient interface and the nasal prongs, results from changes in the shape of the user's face, such as during speech, eating, sleep, or other facial distortions between relaxed and exaggerated states.

[0043] Preferably, at least one element, or at least one of the elements, is positioned in the bridge region of the nasal cannula patient interface to facilitate movement of the bridge region in response to force, movement, or both (and may also be substantially adjacent to the user's septum region, etc.).

[0044] Preferably, the interface comprises multiple elements that are used individually or in combination with other elements to provide a response.

[0045] Preferably, at least one element is a hinge portion positioned or configured as a bridge between a left body portion and a right body portion, each of which forms together the body of an interface positioned over the user's face, and such hinge portion provides a preferred area of ​​deformation in response to at least a first region or part of the body receiving forces or movements (or both) resulting from changes in the shape of the user's face.

[0046] Preferably, the patient interface substantially conforms to or fits the shape of the user's face, so that the elements respond to force or movement (or both) to substantially maintain the interface to the user in a preferred therapeutic delivery configuration.

[0047] In a further embodiment, the present invention can broadly relate to a patient interface comprising a pair of left and right body parts, each body part positioned on the user's face during use, with each body part separated from the others, and at least one, preferably both, of the body parts including nasal prongs inserted into one or both nostrils of the user's nose or directed to a gas flow; and a bar extending from a connection point with the left body part to a connection point with the right body part, the bar including a substantially elastically deformable region, wherein displacement of one or both of the left and / or right body parts during use is transmittable to the bar via the connection point, and the substantially elastically deformable region is deformable as a reaction response to that displacement.

[0048] Preferably, the substantially elastically deformable region of the bar includes a substantially flexible portion.

[0049] Preferably, a substantially elastically deformable region of the bar is deformable in such a way that it substantially absorbs displacement.

[0050] Preferably, a substantially elastically deformable region of the bar reduces the transmission of displacement from one body portion to the other body portion.

[0051] Preferably, the connection point of the bar to the main body is via an anchor.

[0052] Preferably, the anchor is an engagement projection that is received by a region of the main body located substantially distal to each prong.

[0053] Preferably, the prongs and the engaging projections are in fluid communication.

[0054] Preferably, the elastically deformable region is substantially aligned with the prongs, or both, in at least one plane.

[0055] Preferably, each connection point of the bar is configured to be in fluid communication with the prongs of the respective body section and to be connected to the gas flow path of the breathing circuit.

[0056] Preferably, a face pad can be associated with each main body portion, and the face pad is contoured to engage with the user's facial area.

[0057] In a further embodiment, the present invention can be a patient interface such as a nasal cannula, comprising a pair of left and right body portions that are positioned over the user's face when in use; a bridge portion extending between each of the left and right body portions; and nasal prongs extending from one or each of the inner ends of the left and / or right body portions, or from a region of one or both of the body portions substantially adjacent to the inner ends, which are inserted into one or both nostrils of the user's nose or directed to a gas flow, wherein the bridge portion allows movement of each body portion so that the inner ends of the body portions are toward each other, but resists movement of each body portion so that the inner ends are toward each other.

[0058] Preferably, when the patient interface is in its original position on the user's face, displacement of one or both of the left and / or right body parts is transmitted to the bridge in such a way that movement of one or more prongs relative to the user's nostrils is minimized.

[0059] Preferably, the bridge portion extends and connects the inner ends of each main body portion.

[0060] Preferably, the bridge portion is made of a material that can be compressed and resist or withstand applied tension in a direction extending between the inner ends of the main body portion.

[0061] Preferably, the direction extending between the inner ends of each body portion is the longitudinal direction extending along each body portion.

[0062] Preferably, the bridge portion includes a fabric material.

[0063] Preferably, the bridge portion is expandable / extendable in the axial direction, but is elastic enough to withstand the movement of each body portion so that its inner ends move away from each other.

[0064] Preferably, the length of the bridge portion between the connection point of the left main body and the connection point of the right main body is greater than the distance between the nasal prongs.

[0065] Preferably, the bridge portion contains a flexible polymer material.

[0066] In a further embodiment, the present invention can be a patient interface such as a nasal cannula, comprising a pair of left and right body portions that are positioned on the user's face when in use; a bridge portion extending between each of the left and right body portions; and nasal prongs extending from one or each of the inner ends of the left and / or right body portions, or from a region of one or both of the body portions substantially adjacent to the inner ends, which are inserted into the nostrils of the user's nose or directed to a gas flow, wherein one, preferably both, of the body portions includes a user face contact surface oriented with respect to the respective nasal prongs, so that, when in its original position, the torsional force applied to the left and / or right body portions substantially holds the nasal prongs in or in a position to direct a gas flow into the nostrils of the user's nose.

[0067] Preferably, the rotation of the main body portion toward the user's face, preferably the rotation of both main body portions, maximizes the contact area between the face contact surface and the user's face, and positions the nasal prongs to direct the gas flow into or into the nostrils of the user's nose.

[0068] Preferably, the bridge portion has a diameter that is relatively smaller than the left and right body portions.

[0069] Preferably, each body portion includes a channel at one end that is fluidly connected to the respective nasal prongs and at the opposite end that is open to fluidly connect the gas flow path of the breathing circuit.

[0070] Preferably, at least one of the left and right body portions, preferably each, includes an axially twisted face contact surface that is movable between a relaxed position and a twisted position, which increases the surface area adjacent to the user's face.

[0071] Preferably, the face contact surface is twisted axially along the length of the main body portion, from the inner end to the outer end of the main body portion.

[0072] Preferably, the face contact surface extends spirally along the length of the main body portion.

[0073] Preferably, the face contact surface, in the relaxed position, faces away from the direction of extension of the nasal prongs at its distal end, and in the twisted position, faces the direction of extension of the nasal prongs and is substantially planar along the substantial length of the main body portion.

[0074] Preferably, one or more nasal prongs are angled relative to the left and right main body portions, respectively, so as to apply a twisting force to the main body portion when the nasal prongs are inserted into the nostrils of the user's nose.

[0075] Preferably, the face contact surfaces of each left and / or right body portion are contoured to engage with the cheeks of the user's face.

[0076] In a further embodiment, the present invention may broadly be a patient interface such as a nasal cannula, comprising: a pair of left and right body portions, each positioned over the user's face when in use; a bridge portion extending between each of the left and right body portions; nasal prongs extending from one or each of the inner ends of the left and / or right body portions, or from a region of one or both of the respective body portions substantially adjacent to the inner ends, which are inserted into or directed into the nostrils of the user's nose; and a series of discontinuous, separate facial contact surfaces movable relative to each other to respond to and at least partially mitigate the transmission of such forces and / or movements to the nasal prongs.

[0077] In a further embodiment, the present invention can be a patient interface such as a nasal cannula, comprising a pair of left and right body portions that are positioned over the user's face when in use; a bridge portion extending between each of the left and right body portions; and nasal prongs extending from one or each of the inner ends of the left and / or right body portions, or from a region of one or both of the respective body portions substantially adjacent to the inner ends, which are inserted into or directed into the nostrils of the user's nose, wherein the cannula is pivotable relative to another region of the cannula at least about substantially orthogonal axes of the pair, or along a substantially orthogonal plane of the pair, or both, thereby responding to and at least partially reducing the transmission of such forces and / or movements to the nasal prongs.

[0078] Preferably, at least one hinge region is pivotable about three substantially orthogonal axes, or along three substantially orthogonal planes, or both.

[0079] Preferably, the bridge comprises a bridge hinge adjacent to or between a pair of nasal prongs.

[0080] Preferably, the bridge hinge is pre-oriented to have a sharp curve.

[0081] Preferably, the bridge hinge is pre-oriented to bend inward toward the user and downward so as to move away from the nostrils in its original position.

[0082] Preferably, the bridge further comprises a second hinge on one side of the bridge hinge, or a pair of opposing second hinges on either side of the bridge hinge and adjacent to one or more nasal prongs.

[0083] Preferably, each hinge of the second hinge, or the pair of second hinges, is pre-oriented to have a sharp curve.

[0084] Preferably, each hinge of the second hinge, or the pair of second hinges, is pre-oriented in its original position to bend upward toward the user's nostrils and outward toward the user.

[0085] Preferably, the bridge comprises a third hinge adjacent to the left body portion or the right body portion, or a pair of third hinges positioned adjacent to the left body portion and the right body portion, respectively.

[0086] Preferably, each of the third hinges, or the pair of third hinges, is pre-oriented to have a sharp curve.

[0087] Preferably, each of the third hinges, or pairs of third hinges, is pre-oriented to bend downwards away from the nostrils and outwards away from the user in its original position.

[0088] Preferably, one end of the bridge portion extends substantially perpendicularly from the third hinge, or either end of the bridge portion extends substantially perpendicularly from one of the pair of third hinges in its original position and inward toward the cheek of the user's face.

[0089] Preferably, each body portion includes a face pad that is contoured to engage with the user's face.

[0090] Preferably, one end of the bridge portion extends along at least a portion of the face pad.

[0091] Preferably, the bridge portion is substantially hollow at at least one end of the bridge portion to allow gas flow to pass through it.

[0092] Preferably, one end of the bridge portion is configured to connect to the gas flow path of the breathing circuit.

[0093] Preferably, the nasal prongs or each nasal prong extend from and are fluidly coupled to the respective ends of the bridge portion.

[0094] Preferably, the bridge portion has an annular cross-section along at least substantially a portion of the length of the bridge portion.

[0095] Preferably, the bridge further comprises a fourth hinge adjacent to a third hinge, or a pair of fourth hinges adjacent to each pair of third hinges.

[0096] Preferably, each hinge of the fourth hinge, or the pair of fourth hinges, is pre-oriented to have a sharp curve.

[0097] Preferably, the fourth hinge, or each hinge of the pair of fourth hinges, is pre-positioned to curve downward away from the user's nostrils and inward toward the user's cheeks in its original position.

[0098] Preferably, each body portion includes a face pad that is contoured to engage with the user's face.

[0099] In a further embodiment, the present invention may broadly be a nasal interface configured to stabilize prongs on a patient's face when force is applied to the interface, comprising: an elongated body having an overall curvature substantially corresponding to the shape of the patient's face, configured to be coupled to a gas flow source, and having at least one lumen extending at least partially through the body; a pair of prongs extending from the body and in fluid communication with at least one lumen; and one or more hinges, at least one of which is positioned between the pair of prongs and pre-directed to bend in a predefined direction.

[0100] Preferably, the system further comprises one or more face pads configured to rest on the patient's face.

[0101] Preferably, at least one hinge positioned between the pair of prongs has a curve that is substantially inverted from the overall curve of the elongated body.

[0102] Preferably, at least one hinge positioned between the pair of prongs is configured to bend inward toward the patient's face.

[0103] Preferably, the nasal interface has a roughly gull-wing shape.

[0104] Preferably, the nasal interface has a wavy shape.

[0105] Preferably, the nasal interface has a curved space frame-like support structure.

[0106] Preferably, the nasal interface is curved in two or more dimensions.

[0107] Preferably, one or more hinges are provided with notches.

[0108] Preferably, one or more hinges have a variable cross-sectional area.

[0109] Preferably, one or more hinges have a variable thickness.

[0110] Preferably, one or more hinges include two or more materials with different flexibility.

[0111] Preferably, one or more hinges include elastic hinges configured to be pre-stressed before being applied to a patient.

[0112] Preferably, one or more hinges include a barrel and a pin.

[0113] Preferably, one or more hinges include a ball and a socket.

[0114] In a further embodiment, the present invention may broadly be a nasal interface comprising: an elongated body having at least one lumen extending at least partially through the body and configured to be coupled to a gas source; one or more prongs extending from the body and in fluid communication with at least one lumen; and one or more hinges pre-oriented to bend in a predefined direction, wherein one or more hinges are configured to stabilize the position of one or more prongs on the patient's face when force is applied to the nasal interface.

[0115] Preferably, the system further comprises one or more face pads configured to rest on the patient's face.

[0116] Preferably, at least one of the one or more hinges is positioned adjacent to or between one or more prongs.

[0117] Preferably, at least one of the one or more hinges is configured to bend inward toward the patient's face.

[0118] Preferably, at least one of the one or more hinges is configured to bend downward.

[0119] Preferably, the nasal interface has a roughly gull-wing shape.

[0120] Preferably, the nasal interface has a wavy shape.

[0121] Preferably, the nasal interface has a curved space frame-like support structure.

[0122] Preferably, the nasal interface is curved in two or more dimensions.

[0123] Preferably, the nasal interface comprises two separate lateral sections connected by an overstrap bridge.

[0124] Preferably, one or more hinges are provided with notches.

[0125] Preferably, one or more hinges have a variable cross-sectional area.

[0126] Preferably, one or more hinges have a variable thickness.

[0127] Preferably, one or more hinges include two or more materials with different flexibility.

[0128] Preferably, one or more hinges include elastic hinges configured to be pre-stressed before being applied to a patient.

[0129] Preferably, one or more hinges include a barrel and a pin.

[0130] Preferably, one or more hinges include a ball and a socket.

[0131] In a further embodiment, the present invention may broadly be a nasal interface comprising an elongated body having at least one lumen extending at least partially through the body and configured to be coupled to a gas source, and one or more prongs coupled to the body and in fluid communication with the at least one lumen, wherein the elongated body has a shape substantially corresponding to the anatomical contour of the facial shape of a patient or group of patients.

[0132] Preferably, the patient group consists of one of the following: premature infants, neonates, toddlers, children, or adults.

[0133] Preferably, the tubular body is initially malleable.

[0134] Preferably, the shape of the tubular body is fixed through the curing process.

[0135] As used herein, the term "comprising" means "composed of at least part of." When interpreting each sentence containing the term "comprising" in this specification, other features may exist besides those preceding the term. Related terms such as "comprise" and "comprises" should be interpreted similarly.

[0136] As used herein, the term “gull-wing type” means a shape, when viewed as either a top or bottom view of the patient interface (for example, when each of the series of vertices or valleys is depicted as a line diagram), comprising two vertices (or vertex regions) and a valley (or valley region) located between these vertices, or two valleys (or valley regions) and a vertex (or vertex region) located between these valleys. These vertices or valleys may transition between each other in a relatively arched or curved manner. Optionally, each vertex or valley may be shaped or curved to substantially match or assimilate the facial contour or shape of a typical user's face.

[0137] As used herein, the term “wavy” means a shape, when viewed as either a top or bottom view of the patient interface (for example, when each of the series of vertices or valleys is depicted as a line diagram), comprising multiple vertices (or vertex regions) and multiple valleys (or valley regions), wherein each valley (or valley region) comprises at least one vertex (or vertex region) or at least one valley (or valley region) positioned between each pair of vertices (or vertex regions). Such vertices or valleys may transition between each other in a relatively arcuate or curved manner. Optionally, each vertex or valley may be shaped or curved to substantially match or assimilate the contour or outline of a typical user's face.

[0138] As used herein, the term “space frame” means a substantially hollow scaffold or support structure that provides a gas delivery line or conduit to which gas delivery lines or conduits are connected or otherwise attached or supported for delivering gas to a gas outlet of a user or patient interface (e.g., a nasal prong or pair of nasal prongs).

[0139] When we say "pre-formed," such pre-formed elements mean elements that are manufactured, molded, configured, or assembled to provide a shape or configuration that can provide a deformable or displaceable response in a preferred shape.

[0140] When we say "preferred shape," this means a predetermined or preferred plane (or more planes) or axis (or more axes) of the hinge, bend, deformation, or displacement.

[0141] When we speak of "separation," this means that there is at least partial isolation, suppression, or absorption (or some other mode), preferably a mechanical mode, such that any force or movement (or both) applied to or exerted on a first region or part of the interface is minimized so as not to be fully transmitted to another region or part of the interface.

[0142] It is also possible to say, in a broad sense, that the present invention lies in the parts, elements and features referred to or shown in the specification of this application, individually or collectively, and in any combination of any two or more such parts, elements or features, and where the present invention refers herein to a certain complete body having known equivalents in the art to which it pertains, such known equivalents shall be deemed incorporated herein as if they were individually shown.

[0143] The present invention is based on the above, and also assumes the following structure, which is merely an example.

[0144] Preferred embodiments of the present invention will be described simply as examples and with reference to the drawings, where Figures 1 to 20 show embodiments of the patient interface according to the present invention. [Brief explanation of the drawing]

[0145] [Figure 1]This is a front elevation view of a nasal interface known in the art. [Figure 2] This is a top view showing the bending of the nose interface in Figure 1 when force is applied. [Figure 3A] This is a bottom view of the nasal interface shown in Figure 1 on the patient's face. [Figure 3B] This is a bottom view of an anatomically formed nasal interface embodiment located on the patient's face. [Figure 4A] These are various images of the faces of patients in a relaxed state. [Figure 4B] These are various images of the faces of patients in a relaxed state. [Figure 4C] This is the wireframe outline of an embodiment of a dynamic interface in a relaxed state. [Figure 5A] These are various images of the faces of patients in a stressed state. [Figure 5B] These are various images of the faces of patients in a stressed state. [Figure 5C] This is the wireframe outline of the dynamic interface in Figure 4C under stress. [Figure 6A] This is the wireframe outline of an embodiment of a dynamic interface in a relaxed state. [Figure 6B] This is the wireframe outline of the dynamic interface in Figure 6A when an external force is applied under stress. [Figure 7A] For example, these are various diagrams of a dynamic interface embodiment with a gullwing shape. [Figure 7B] For example, these are various diagrams of a dynamic interface embodiment with a gullwing shape. [Figure 7C] These are top views showing the bending of the gull-wing type dynamic interface in Figures 7A and 7B when a force is applied. [Figure 8A] For example, these are various diagrams of embodiments of a wave-shaped dynamic interface. [Figure 8B] For example, these are various diagrams of embodiments of a wave-shaped dynamic interface. [Figure 8C] For example, these are various diagrams of embodiments of a wave-shaped dynamic interface. [Figure 9A] This is a top perspective view embodiment of a space frame dynamic interface. [Figure 9B] Figure 9A shows various diagrams of the spaceframe dynamic interface located above the patient's face. [Figure 9C] Figure 9A shows various diagrams of the spaceframe dynamic interface located above the patient's face. [Figure 9D] Figure 9A shows various diagrams of the spaceframe dynamic interface located above the patient's face. [Figure 10A] These are various diagrams illustrating embodiments of a multidirectional dynamic interface. [Figure 10B] These are various diagrams illustrating embodiments of a multidirectional dynamic interface. [Figure 10C] This shows natural wrinkles on the patient's face. [Figure 10D] Figures 10A and 10B show various diagrams of the multi-directional dynamic interface on the patient's face. [Figure 10E] Figures 10A and 10B show various diagrams of the multi-directional dynamic interface on the patient's face. [Figure 10F] Figures 10A and 10B show various diagrams of the multi-directional dynamic interface on the patient's face. [Figure 11A] These are various diagrams of an overstrap dynamic interface embodiment. [Figure 11B] These are various diagrams of an overstrap dynamic interface embodiment. [Figure 11C] These are various diagrams of an overstrap dynamic interface embodiment. [Figure 12A] These are various diagrams illustrating embodiments of a notched hinge. [Figure 12B] These are various diagrams illustrating embodiments of a notched hinge. [Figure 13A] These are various diagrams of different embodiments of a notched hinge. [Figure 13B] These are various diagrams of different embodiments of a notched hinge. [Figure 13C] These are various diagrams of different embodiments of a notched hinge. [Figure 13D] These are various diagrams of different embodiments of a notched hinge. [Figure 14A] These are various diagrams illustrating embodiments of a variable section hinge. [Figure 14B] These are various diagrams illustrating embodiments of a variable section hinge. [Figure 15A] These are various diagrams illustrating embodiments of a variable cross-sectional hinge having a cutout portion. [Figure 15B] These are various diagrams illustrating embodiments of a variable cross-sectional hinge having a cutout portion. [Figure 16A] These are various diagrams illustrating embodiments of a variable-thickness hinge. [Figure 16B] These are various diagrams illustrating embodiments of a variable-thickness hinge. [Figure 17A] These are various diagrams of embodiments of a composite hinge. [Figure 17B] These are various diagrams of embodiments of a composite hinge. [Figure 18A] These are various diagrams illustrating embodiments of an elastic hinge. [Figure 18B] These are various diagrams illustrating embodiments of an elastic hinge. [Figure 18C] These are various diagrams illustrating embodiments of an elastic hinge. [Figure 18D] These are various diagrams illustrating embodiments of an elastic hinge. [Figure 19A] These are various diagrams of barrel and pin hinge embodiments. [Figure 19B] These are various diagrams of barrel and pin hinge embodiments. [Figure 19C] These are various diagrams of embodiments of barrel and pin hinges with directional motion. [Figure 19D] These are various diagrams of embodiments of barrel and pin hinges with directional motion. [Figure 20]This is a front elevation view of a dynamic nose interface with a ball and socket hinge. [Figure 21A] This section presents alternative embodiments of the patient interface from various angles. [Figure 21B] This section presents alternative embodiments of the patient interface from various angles. [Figure 21C] This section presents alternative embodiments of the patient interface from various angles. [Figure 22] A front view of another embodiment of the patient interface is shown. [Figure 23A] This section presents alternative embodiments of the patient interface from various angles. [Figure 23B] This section presents alternative embodiments of the patient interface from various angles. [Figure 23C] This section presents alternative embodiments of the patient interface from various angles. [Figure 24A] This section presents alternative embodiments of the patient interface from various angles. [Figure 24B] This section presents alternative embodiments of the patient interface from various angles. [Figure 24C] This section presents alternative embodiments of the patient interface from various angles. [Figure 25A] This section presents alternative embodiments of the patient interface from various angles. [Figure 25B] This section presents alternative embodiments of the patient interface from various angles. [Figure 25C] This section presents alternative embodiments of the patient interface from various angles. [Figure 26] This section presents alternative embodiments of the patient interface from various angles. [Figure 27A] This section presents alternative embodiments of the patient interface from various angles. [Figure 27B] This section presents alternative embodiments of the patient interface from various angles. [Figure 27C] This section presents alternative embodiments of the patient interface from various angles. [Figure 28]This section presents alternative embodiments of the patient interface from various angles. [Modes for carrying out the invention]

[0146] The above description of the present invention includes preferred embodiments. Modifications to those embodiments can be made without departing from the scope of the present invention.

[0147] It is desirable to provide a patient interface that is configured to conform to the changing shape of the user's face, to maintain a stable position on the user, or to help improve the maintenance of stability when external forces are applied.

[0148] To achieve one or both of these outcomes, or even all of them, it is useful to provide an alternative patient interface that offers improved stability and / or performance on the user's face.

[0149] In one embodiment, the present invention relates to a patient interface such as a nasal cannula, comprising a body positioned over a user (preferably the user's face, etc.). The body includes at least one (and preferably a pair) nasal prongs, which include a lumen that can be fluidly connected to the nasal prongs to fluidly communicate with a source of respiratory gas. The body is configured to be inserted into one or both nostrils of the user's nose, or to direct a gas flow to one or both nostrils. The body includes at least one element that responds to a force or movement, or both, acting on at least one first region of the patient interface, so as not to be transmitted to at least one other region of the patient interface.

[0150] In relation to these inventions, refer to the accompanying drawings which detail specific embodiments thereof. Details of specific embodiments are described in the following sections.

[0151] Before going into detail about specific embodiments, the following description relates to the invention as detailed above. For example, such interfaces may include elements that facilitate the reduction of the transmission of force and / or movement applied to at least a first area of ​​the interface so as not to be transmitted to at least another area of ​​the interface. It will be understood that such elements may be hinge portions, as will be detailed later with reference to the figures and the description of specific embodiments. It will also be understood that the first area may be any part, component, zone, or area of ​​the patient interface that may be subjected to force and / or movement (or both) directly applied by the user or applied by the breathing circuit or headgear, or other components related to the breathing circuit that enable the supply of the patient interface and breathing gas, or other items that may be near the user, such as pacifiers, blankets, cushions, toys, etc.

[0152] The elements of the present invention are designed to respond in a way that localizes forces, motions, or both acting on at least one first region.

[0153] The elements may also be able to respond in a way that minimizes or prevents the transmission of force or movement, or both, from at least one first region of the patient interface to at least one other region. The consequence or result from this response is that such interfaces may be more stable when installed or positioned on the user.

[0154] In this regard, it will be understood that the patient interface can be a patient interface in particular, such as a nasal cannula.

[0155] The invention can be extended to other interfaces, such as masks or other derivatives or variations thereof (whether full-face, mouth, nose, nose pillow, or mouth-nose).

[0156] The element(s) incorporated into the interface preferably respond to maintain at least one (and preferably a pair) of nasal prongs in a configuration that is inserted into one or both nostrils of the user's nose, or in a configuration that directs a gas flow towards one or both nostrils of the user's nose. For example, another desired outcome is that the response is such that at least one (or preferably a pair) of nasal prongs maintains a stable position within or adjacent to the nostril of the user's nose to which the prongs are directed.

[0157] The element's response operates in such a way that it helps, at least somewhat, prevent or minimize the transmission of force or motion from at least one first region of the interface to at least one other region of the interface. Thus, a more stable interface can be provided for the user. By providing a more stable interface overall, improved user comfort can be achieved. Improved delivery of treatment to the user can also be achieved. Achieving both of these results in a more user-friendly interface or device.

[0158] Advantageously, the present invention makes it possible for the interface to include elements having the ability or inclusion of elements that are responsive to maintain an operable position above the user.

[0159] Furthermore, any force or movement, or both, experienced by at least a first region of the interface is either (i) a force or movement applied between the nasal prongs and the body of the patient interface, or (ii) a force or movement applied between the body of the patient interface and the nasal prongs. The element responds to such force or movement by making the above improvements such as at least substantially improving the transmission of the force or movement to other parts of the interface, or at least maintaining the interface in an operational or comfortable configuration on the user, or at least reducing the possibility that the interface would become uncomfortable or move away from a therapeutically operational configuration for the user.

[0160] In some embodiments, the element is a deformable member, or a member that can be deformed in response to force or motion (or both).

[0161] The interface can provide a predetermined or preferred mode of deformation by the element in response to an applied force or motion, or both, being acted upon by at least a first region of the interface. For example, an element may be deformable in several preferred shapes, such as around at least one axis or in at least one plane or both. The deformation may be in multiple axes or planes or shapes, and it will be understood that such deformations are in preferred directions in order to provide the element's response to an applied force or motion (or both). It will also be understood that such deformations may be one or a combination of at least compression or tension or torsion or bending or other deflection of the element or multiple elements.

[0162] With respect to an element, the response may be one or any combination of a change in shape, a change in position, or a change in configuration.

[0163] Various embodiments of these elements, though not particularly limited, include one or more of the following, each of which can be used in combination with one another, or connected by members or other parts or components to provide multiple elements, which together provide a desired response to improve the transmission of force or motion from at least a first region to the interface. Hinges, pivots, articulated joints or articulated parts of a body or part related to a body, swivels, ball-socket joints, pin-in-barrel joints, Materials that are relatively less flexible than other parts of the interface, materials that are relatively more flexible than other parts of the interface, materials that have changing properties by increasing or decreasing resistance to applied force or motion (or both) when force or motion is applied, or materials that are elastically deformable in response to applied force or motion (or both), or materials that are preferentially deformable in a particular or given shape but can selectively resist deformation in other particular or given shapes. A region that can pivot (or swivel), or pivot (or rotate), A hinge or hinge area, or an area that can be hinged to another component of the interface or another area of ​​the interface. A joint or articulation, or a region in which joint movement is possible.

[0164] The elements may be configured to provide, operate, or act in response to a force or motion or both, such as to block, minimize, or at least reduce the overall force of motion experienced by at least one first region of the interface, so as not to be transmitted to at least one other region of the interface.

[0165] The elements may be mechanisms or material properties incorporated into the interface, or any combination of structure, mechanism, and material specificity, or may be areas of the interface that incorporate one or more such elements within or on the interface.

[0166] In some forms, an element may have a predetermined or preferred mode of deformation in response to an applied force or motion. For example, an element may be deformable about at least one axis or in at least one plane, or around a preferred first shape, or it may be deformable by compression or tension or torsion or bending or one or a combination of such deflections.

[0167] One or more elements can be utilized and incorporated into the interface, and these elements can operate, act, or provide responses individually, or in combination with each other. Several combined responses from multiple elements may have the advantage that some elements provide responses that improve the transmission of force or motion from one area of ​​the interface to another, while others respond differently. For example, different elements may have different modes of response, or different elements may be connected to each other or to other parts of the interface in a desired manner, either operably or inoperably. Such combined responses or uses of elements preferably enable an overall improvement in the comfort or stability of the interface during use on the user.

[0168] Elements incorporated into the interface of the present invention are preferably, Isolation body or isolation area, Absorbent material or absorbent area, Inhibitor or inhibitory region, Alternatively, any other structure or mechanism that provides a reaction response to a force or movement applied to at least the first region of the patient interface, such that it is not transmitted to at least the second region or another region of the patient interface. It can be provided as one or more of the following. In some forms, the element can enable so-called isolation of forces or movements (or both) applied to at least one first region of the interface so as not to be transmitted to at least one other region of the interface.

[0169] The element's response may be at least one (or a combination) of isolating, absorbing, inhibiting, reducing, or separating a force or movement applied to at least one other area of ​​the patient interface during use by the user.

[0170] The elements can be prepared to include elements that are pre-formed to deform or displace in a preferred shape or dimension in response to force or motion (or both).

[0171] For example, the element can facilitate preferential bending or deflection or twisting or torsion of the material or component forming the body of the interface, or preferential or predetermined pivoting or extension or compression.

[0172] The elements may be in the realm of different material properties or structures, such as spongy materials, or materials that can withstand tension but not compression, or can withstand compression but not tension, or materials that allow the stretching or expansion (or compression) of the element's material or components in some shapes, but resist stretching or tension in other shapes.

[0173] Various components such as ball socket joints can be provided, which are placed between different regions of the interface, for example, between the off-center body portion (e.g., the left body portion, the right body portion, or both) and the central portion or region (e.g., the bridge portion which may be located in the user's septum). These components facilitate a response that reduces the transmission of force or movement to other parts of the interface, thereby helping to improve user interface comfort and the maintenance of continuous therapeutic delivery.

[0174] Further variations include interface portions in which the elements are positioned, for example, as hinge portions, pivots, or swivel joint portions or regions, so that the elements can bend preferentially or adapt to applied forces or movements.

[0175] Forces or movements can be any forces or movements that are applied to or that the interface may experience. Typically, some forces or movements may result from the user of the interface changing the shape of their face in which the interface is held, positioned, or placed; or from the user pulling on the interface or its associated headgear, or from the breathing circuit or other components of the interface pressing down on part of the interface or its associated headgear with weight.

[0176] Changes in the shape of the interface user's face, such as during speech, feeding, or other facial distortions, and between relaxed and exaggerated states, can also cause forces or movements to be applied to or given to one or more areas of the interface.

[0177] The elements of the present invention are advantageously configured to help reduce the possibility that such forces or movements may affect comfort or the delivery of treatment to the user of the interface.

[0178] In various cases, when the patient interface is a nasal cannula, any force or movement applied between the nasal prongs and the body of the patient interface, or between the body of the patient interface and the nasal prongs, can exacerbate the problem of the prongs detaching (the nasal prongs of the interface may move with the user's nostrils, or even detach completely from the nostrils). Nasal prongs moving within the nostrils can irritate the user, and the removal or detachment of the prongs from the nostrils can affect the preferred delivery of treatment to the user. A system or method that helps prevent the prongs from detaching is therefore desirable.

[0179] In one particular embodiment, at least one element, or at least one of the elements, is located in the bridge region of the cannula patient interface, such as substantially adjacent to the user's septal region.

[0180] In other embodiments, the interface may comprise several elements that are used individually or in combination with other elements to provide a response.

[0181] In further embodiments, at least one element may be a hinge portion positioned or configured as a bridge between a left body portion and a right body portion, each of which forms together the body of an interface positioned over the user's face, and such hinge portion provides a region of preferential deformation in response to at least a first region or part of the body receiving forces or movements (or both) resulting from changes in the shape of the user's face.

[0182] In all embodiments discussed herein, there may be additional, optional configurations of the interface that substantially conform to, fit into, or anatomically mold to the face or part of the user's body on which the interface is placed. Thus, a patient interface that substantially conforms to or fits the shape of the user's face allows the elements to respond to force or movement (or both) such that the interface substantially maintains the interface in a preferred therapeutic delivery configuration for the user.

[0183] Further specific embodiments of the present invention are provided below with reference to the accompanying drawings.

[0184] At least one aspect of the embodiments disclosed herein includes the understanding that, at least at the nasal interface, the stability of the nasal interface on the face is important because movement of the nasal interface could result in severe irritation to the nostrils or displace the prongs so as to protrude from the patient's nostrils (which could thereby prevent or interrupt treatment).

[0185] Current methods for holding a nasal interface to a patient's face have the drawback of potentially displacing the prongs so that they protrude from the nostrils or irritating sensitive areas of the nostrils. These undesirable consequences can arise from a variety of reasons, including, but are not limited to, improper application, inappropriate sizing, patient posture, facial movements, and abnormal facial shape.

[0186] In the case of a tube that passes around the patient's ear, the tube may fall out of the ear, dislodging the prongs from the nostrils. The tube can also be displaced when the patient lies face down, causing the prongs to dislodge from the nostrils or rub against the sides of the nostrils. Furthermore, the use of straps or elastic bands unfortunately tends to cause the nasal interface to slide against the patient's head, especially when the patient turns their head on the pillow, causing the prongs to dislodge from the nostrils or resulting in severe irritation. Other external forces, such as the supply tube getting caught on another object or the patient pulling on the tube, can also cause the nasal prongs to dislodge from the nostrils or irritate the nostrils.

[0187] Previously, medical adhesive tape was used to hold the nasal interface in place. However, it has been found that securing the interface to the patient's face presents problems in holding the prongs within the patient's nostrils, particularly in infants and newborns. When the patient's face is compressed from lying face down, current nasal interfaces tend to bend away from the face at the bridge of the interface. This bending of the interface causes the prongs to displace out of the patient's nostrils or to be compressed against the sides of the patient's nose, resulting in at least partial obstruction of the gas being delivered to the patient.

[0188] In some embodiments, patient interfaces such as those described herein may be used in conjunction with a headgear system for positioning or securing such patient interfaces on the user's face, although it will be understood that such patient interfaces may still be capable of responding to force and / or movement when used in such configurations.

[0189] In yet another embodiment, it will be understood that the headgear arrangement or configuration operates to remove some of the loads that the patient interface may experience due to forces or movements (or both) that the interface experiences, and the interface also operates to remove some of the loads.

[0190] Accordingly, according to at least one of the embodiments disclosed herein, a nasal interface can be used that prevents or substantially reduces the possibility of the prongs being displaced so as to protrude from the patient's nostrils or irritate the nostrils as a result of facial movement or external force.

[0191] The nasal interface may be configured to stabilize the prongs on the patient's face when force is applied to the interface. The nasal interface may include an elongated body having an overall curvature substantially corresponding to the contour of the patient's face, the body having at least one lumen that extends at least partially through the body and is configured to connect to a gas flow source. The nasal interface may have prongs that extend from the body and are in fluid communication with at least one lumen. The nasal interface may have one or more hinges, at least one of which may be positioned between a pair of prongs or between the nostrils when in use, and which is pre-oriented to bend in a predefined direction.

[0192] The nasal interface may include one or more face pads configured to rest on the patient's face. In some embodiments, at least one hinge positioned between a pair of prongs may have a curve that is substantially inverted from the overall curve of the elongated body. At least one hinge positioned between a pair of prongs may be configured to bend inward toward the patient's face. The nasal interface may bend in two or more dimensions.

[0193] The nasal interface may have a substantially gull-wing shape. In some embodiments, the nasal interface may have a wave-like shape. In some embodiments, the nasal interface may have a curved space frame-like support structure.

[0194] One or more hinges may include notches. One or more hinges may include a variable cross-sectional area. One or more hinges may include a variable thickness. One or more hinges may include two or more materials with different flexibility. One or more hinges may include elastic hinges configured to be pre-stressed before being applied to a patient. One or more hinges may include a barrel and a pin. One or more hinges may include a ball and a socket.

[0195] In some embodiments, the nasal interface may include an elongated body having at least one lumen extending at least partially through the body and configured to be coupled to a gas source. One or more prongs may extend from the body and be in fluid communication with at least one lumen. The nasal interface may include one or more hinges pre-directed to bend in a predefined direction, and the one or more hinges may be configured to stabilize the position of one or more prongs on the patient's face when force is applied to the nasal interface.

[0196] The nasal interface may include one or more face pads configured to rest on the patient's face. At least one of the one or more hinges may be positioned adjacent to or between one or more prongs, or further along one of the face pads. At least one of the one or more hinges may be configured to bend inward toward the patient's face. At least one of the one or more hinges may be configured to bend downward. The nasal interface may bend in two or more dimensions.

[0197] The nasal interface may have a substantially gull-wing shape. In some embodiments, the nasal interface may have a wave-like shape.

[0198] The nasal interface may have a curved space frame-like support structure.

[0199] In some embodiments, the nasal interface may have two separate sides connected by an overstrap bridge.

[0200] One or more hinges may include notches. One or more hinges may include a variable cross-sectional area. One or more hinges may include a variable thickness. One or more hinges may include two or more materials with different flexibility. One or more hinges may include elastic hinges configured to be pre-stressed before being applied to a patient. One or more hinges may include a barrel and a pin. One or more hinges may include a ball and a socket.

[0201] In some embodiments, the nasal interface may include an elongated body having at least one lumen extending at least partially through the body and configured to be coupled to a gas source. One or more prongs may be coupled to the body, and one or more prongs may be in fluid communication with at least one lumen. The elongated body may have a shape that substantially corresponds to the anatomical contour of the facial outline of a patient or group of patients.

[0202] The patient group may be one of the following: premature infants, neonates, toddlers, children, teenagers, or adults. In some embodiments, the tubular body may be malleable initially. The shape of the tubular body can be fixed through a hardening process.

[0203] It has been found that the behavior of a nasal interface under load can be controlled to improve its stability performance. This disclosure describes a nasal interface that prevents or substantially reduces the possibility of the prongs being displaced so as to protrude from the patient's nostrils or to irritate the patient's nostrils as a result of facial movement or external force.

[0204] Human facial features vary significantly due to a wide range of factors, including, but are not limited to, sex, ethnicity, age, and medical conditions. Inappropriate size and shape of the nasal interface can negatively affect its stability and effectiveness. Other factors that may affect stability include, but are not limited to, improper application, patient posture, patient crying, and abnormal facial features.

[0205] Furthermore, if a patient speaks, eats, cries, or distorts or exaggerates their facial features in any way, this can affect the stability of the interface on the patient's face. Longer-term changes in facial features may arise from various factors, such as the patient's posture during sleep. Long-term changes in shape may result from the patient's growth and wound healing.

[0206] When supporting an object on a patient's face, any external force can similarly affect the device's stability. In the case of a lateral nasal interface, external forces can arise from a wide range of sources, such as the patient pulling on the interface, the weight of the breathing circuit being transmitted to the interface, the holding force of the head strap, or any connecting tube getting caught on other devices.

[0207] Conventionally, the nasal interface 10 has a manifold 20, as shown in Figure 1, from which prongs 30 extend. A bridge 40 is connected between the prongs 30, allowing fluid communication between them. This design can be unstable on the patient's face, which can cause the nasal prongs to detach from the patient's nostrils, negatively impacting the patient's treatment. Often, the detachment of the prongs from the nostrils is a result of the interface's mechanical response to certain forces applied to it.

[0208] The behavior of a nasal interface under load, such as when a patient speaks or lies face down, can be influenced by various different interface characteristics or combinations thereof, including the shape and material properties of the interface. For example, Figure 2 shows a conventional nasal interface 10 with a force 50 applied to the side of the interface. The force 50 may be applied to the interface, for example, when the patient is lying face down or when the patient's face is compressed. In Figure 2, the dotted line shows the conventional nasal interface 10 in a relaxed state. Figure 2 also shows the nasal interface in a compressed state when the force 50 is applied to the interface. Continuing to refer to Figure 2, when the force 50 is applied to the side of the nasal interface, most conventional interfaces, due to their geometric design and material properties, naturally tend to bend upward in the figure, i.e., away from the patient, near the middle of the prongs 30. The bending of the interface causes the prongs 30 to be displaced, which can cause them to either pop out of the patient's nostril or rub against the side of the nostril, irritating the delicate skin of the nostril. Figure 2 shows the prongs 30 displaced by a distance Y from their normal relaxed position.

[0209] As described herein, the stability of the nasal interface can be improved by utilizing one or more of the anatomically formed shapes and geometrically dynamic forms in the interface design. These designs can be mechanically responsive to facial movements or external forces to help maintain the stability of the nasal prongs.

[0210] Conventional linear interface designs often require additional retainers, such as adhesive tape, to secure the interface to the shape of the patient's face. Figure 3A is a bottom view showing a conventional interface 10 on a patient's face 60. As shown in this figure, a retaining force F may be required to secure the interface 10 on the patient's face 60. However, the retaining force F can alter the shape of the interface 10, and the elastic properties of the nasal interface may provide a restorative force that counteracts the retaining force. These restorative forces can cause the retaining method to detach, potentially leading to the prongs applying stress to the inside of the nostrils and causing injury. An unnatural curved shape of the nasal interface can also prevent the prongs from fitting properly, similarly potentially causing injury.

[0211] The components and characteristics of the nasal interface examples are described in more detail below. Subtitles such as "anatomically formed interface" and "dynamic interface" are used. These subtitles are not limiting and should not be interpreted as limiting. For example, one or more embodiments described under the subtitle "anatomically formed interface" may also apply to one or more embodiments described under the subtitle "dynamic interface," and vice versa.

[0212] Anatomically formed interface The anatomically formed interface 100 is shaped to conform to the facial contours of a given population, as shown in Figure 3B. These interfaces 100 incorporate anatomically curved shapes to conform to specific demographics, such as the three-dimensional facial contours of premature infants, neonates, toddlers, children, and adults. The anatomically curved shape of the interface 100 can significantly improve the stability of the interface on the patient's face 60 and reduce the incidence of prong displacement from the patient's nostrils.

[0213] While not limiting, the illustrated embodiments may be particularly applicable to newborns. For example, such interfaces may be particularly suitable for use with newborns because the small size of the newborn's head / face increases the occurrence of facial distortion in newborns, and any movement may be amplified by the relatively small size of the newborn.

[0214] The anatomically formed interface 100 conforms to the contours of the patient's face while it is in its natural, relaxed state. The interface does not need to be bent by retaining forces to stabilize it on the patient's face 60, and therefore no resilience is generated. Even if adhesive tape is used to secure the anatomically formed interface to the patient's face, the tape does not bend the interface, and therefore no resilience is present. The prongs remain in the patient's nose in a natural, stress-free position, reducing the likelihood of them coming loose or damaging the patient's nostrils compared to conventional interfaces. Another advantage of the anatomically formed interface 100 is the reduced need for adhesive tape to hold the interface on the patient's face 60, thus reducing the possibility of skin irritation or damage. The anatomically formed interface 100 offers improved stability compared to conventional interfaces, and there is less need to tape the interface to the patient's face to maintain stability.

[0215] The anatomically formed interface 100 can be manufactured using a plastic molding method that forms a predetermined curved shape identified to fit a given demographic of the patient. For example, since the facial features of underdeveloped premature infants differ from those of well-developed full-term infants, a common facial feature that appeals to the high percentile of each of these demographics can be identified. Multiple interfaces of different sizes and shapes can be manufactured to fit a wide variety of facial features.

[0216] In some embodiments, the anatomically formed interface can be modified by the patient or caregiver after manufacturing. The anatomically formed interface may be flexible and can be formed into a specialized shape to fit the patient's face. For example, the interface can be fabricated, at least partially, from a malleable material such as medical putty or flexible plastic. The patient or caregiver can mold the malleable interface to substantially correspond to the contour of the patient's face and provide a stable fit with the patient's face.

[0217] In other examples, an anatomically formed interface may have a malleable frame extending through the interface that can be bent to substantially match the contour of the patient's face and provide a structural shape to the interface. In some embodiments, a post-annealing process can be applied to the malleable frame so that the interface maintains its shape after molding.

[0218] Other types of formable interface materials include one or more of silicone, rubber (synthetic or natural), thermoplastic polymers, and thermosetting polymers. Composite materials can be manufactured by commolding or overmolding. These materials may initially be malleable, thereby allowing them to be molded to the shape of a patient's face, and then such materials can become rigid after a period of time or through active curing processes such as UV treatment or heat treatment.

[0219] Dynamic Interface The dynamic interface incorporates one or more hinges along the device that respond to both natural and forced facial movements, as well as external forces applied to the interface. The hinges can minimize the influence of facial movements and external forces on the fit of the interface on the patient's face, and in particular on the placement of the prongs within the patient's nostrils. As used herein, a hinge generally refers to a portion of the interface configured to bend in one or more directions. The hinges can be configured to bend in one or more predefined directions, and in some embodiments, the bending of the hinge can be restricted to certain directions.

[0220] Figures 4A and 4B show examples of the shape of a relaxed infant face, and Figure 4C shows a schematic diagram of the geometric shape of the dynamic interface 200 on the relaxed face. Figure 4A is a front view of the infant's face, and Figure 4B is a bottom view of the infant's face. Figure 4C is a bottom view of the dynamic interface. The dynamic interface 200 may have one or more hinges 210. Preferably, the dynamic interface has a central hinge 212 positioned between the prongs 230. As can be noted by comparing Figures 4B and 4C, the multiple hinges 210 on the interface allow the interface 200 to conform to the overall contour of the patient's face.

[0221] Figures 5A and 5B are front and bottom views, respectively, of examples of the shape of a patient's face under stress or crushing. Figure 5C shows a schematic bottom view of the geometric shape of the dynamic interface on the crushed face. The crushed face approximates, for example, the facial distortion that occurs when a patient lies face down. As shown in Figure 5C, the hinge 310 helps to conform the interface 300 to the shape of the distorted face and maintain the position of the prongs 330 within the patient's nostrils. The dynamic interface 300 is particularly useful in infants who tend to exhibit exaggerated cheek movements.

[0222] Each hinge 310 can be configured to respond to applied forces in a predetermined manner, and different hinges can respond differently depending on their position on the interface. For example, a hinge 312 located in the region between the prongs 330 can bend downward toward the lips and / or inward toward the face to form a concave shape when viewed from the front, and a hinge 314 adjacent to the patient's cheek can bend outward to form a convex shape around the cheek. The hinge 312 can resist outward movement perpendicular to the face and minimize movement of the prongs 330 out of the nostrils due to lateral forces applied to the device. In some situations, the bending of the hinge 312 can be limited by the patient's anatomical structure. For example, the inward bending of the hinge 312 can be limited by the patient's philtrum, which can favorably limit the displacement of the prongs 330. When a force applied to the interface reaches its limit, it can act on other hinges (e.g., the hinge 314 adjacent to the cheek). The combination of hinge type and position allows designers to control how the interface responds in various situations. Depending on its desired function, the hinge can be designed to allow 1, 2, or 3 degrees of movement in any predefined direction. Advantageously, this allows for the development of an inherently stable interface that maintains the prongs within the patient's nostrils under various loading conditions.

[0223] Figures 6A and 6B illustrate an example of how the dynamic interface 400 can respond to an external force 460. As shown in Figure 6A, an extension 450 can be attached to the dynamic interface 400 by a hinge 416. The extension 450 can be part of the dynamic interface 400 connected to an external device, or the extension 450 can be part of an external device connected to the dynamic interface 400. For example, the extension 450 can be part of the dynamic interface 400 and connectable to a tube, or it can be part of a tube connected to the interface 400. The hinge 416 can be positioned at the connection point between the extension 450 and the interface 400. Referring to Figure 6B, any external force 460, such as pushing or pulling the tube, is suppressed by the response of the hinge 416, reducing the force transmitted to the dynamic interface 400. The external force 460 can be at least partially isolated so as not to affect the positioning of the prongs 430 in the patient's nostrils. Preferably, another hinge 418 is provided on the extension 450 to improve the restraining capacity of the extension 450. In some embodiments, further additional hinges may be provided on the extension 450 for even greater restraining capacity.

[0224] The hinges and their positions on the interface can be customized to work effectively depending on the specific method of retention of the interface. For example, referring to Figures 5A to 5C, if the interface is configured to be secured to the cheek with tape or some similar retention method, one or more hinges can be positioned between the cheek portion and the prongs to accommodate facial movement. Similarly, referring to Figures 6A and 6B, if a head strap is connected to the extension 450, at least one hinge can be positioned between the head strap and the interface to accommodate external forces.

[0225] Figures 7A and 7B show examples of dynamic nasal interfaces 500. A gull-wing shaped dynamic interface 500 may have an overall curvature that substantially corresponds to the contours of the patient's face. The dynamic interface 500 may include one or more nasal prongs 502, a bridge 504 extending between the prongs 502 that is configured to follow the patient's upper lip below the nose when in use, a pair of wings or face pads 506, and an integrated tube 508, all of which are spaced substantially symmetrically around the sagittal plane. The dynamic interface 500 is formed as an integrated or standalone component of the prongs 502 and the tube 508 that fluidly communicates with them. The open end of each integrated tube 508 is configured to receive a suitable breathing tube connected to a gas supply source. The breathing tube can be attached to the interface tube 508 or otherwise coupled (or connected). Preferably, the tube 508 includes two separate sides having independent flow paths. However, in some embodiments, the two sides can be in fluid communication through a tube or the like that extends across the bridge to connect the two sides of the pipe.

[0226] The face pad 506 is anatomically molded to a size, shape, and curvature that reflects the intended shape of the patient's face. The anatomical shape of the face pad 506 provides a secure engagement with the patient's face in a predetermined position relative to the interface, with the contour of the face pad 506 matching the contour of the patient's face. The pre-molded face pad 506 enhances the nasal prongs 502 by improving the precision and speed at which the prongs 502 can be positioned and held within the patient's nostrils.

[0227] By pre-molding or conforming the face pad 506 to the patient's facial features, the pressure applied to the patient's face by any retention mechanism (adhesive tape, headgear, or other means) is reduced. This reduces the likelihood of pressure ulcers on the user. The secure engagement facilitated by the anatomical shape of the face pad 506 improves the stability of the interface 500 and prongs 502, and therefore improves comfort and the efficacy of the treatment being administered. In some embodiments, the face pad 506 can be tapered, being wider at the outer portion and narrowing towards the middle. Further examples of nasal interfaces may be those described in International Publication No. 2012 / 053910, which are incorporated herein by reference as a whole.

[0228] Referring to Figures 4A and 4B, the bridge 504 of the nasal interface 500 may have a bridge hinge 510 configured to curve inward toward the patient. As best shown in Figure 7B, the bridge 504 is curved in the opposite direction to the rest of the nasal interface, so that the interface has a gull-wing-like shape. The bridge hinge 510 is curved toward the rear of the interface 500, thereby making the bridge 504 convex when viewed from the front. The curvature of the bridge 504 causes the hinge 510 to be pre-positioned to curve inward toward the patient, as opposed to outward as in the case of conventional nasal interfaces.

[0229] For example, Figure 7C shows a nasal interface 500 having, for example, a roughly gull-wing shape, with a force 550 applied to the side of the interface. The force 550 may be applied to the interface, for example, when the patient is lying face down or when the patient's face is compressed. In Figure 7C, the nasal interface 500 in a relaxed state is shown by a dotted line. Figure 7C also shows the nasal interface in a stressed state with a force 550 applied to it. When a force 550 is applied to the side of the nasal interface, the bridge 504 tilts to bend inward at the bridge hinge 510, as shown by the central arrow in Figure 7C. The inward bending of the bridge 504 causes the prongs 502 to displace inward toward the patient, as opposed to outward toward the patient, as in the case of a conventional nasal interface, where the prongs 502 may pop out of the nostrils. As described above, the bending of the bridge hinge 510 can be limited by the patient's anatomical structure. For example, the inward bending of the bridge hinge 510 can be limited by the patient's philtrum, thereby favorably limiting the displacement of the prong 502. The nasal interface design helps reduce the risk of the prong 502 protruding from or rubbing against the sides of the patient's nostrils.

[0230] Typically, the displacement distance of the prong 502 can be reduced compared to a conventional nasal interface. Figure 7C shows the prong 502 displaced from its normal relaxed position by a displacement of Z, which is in the opposite direction and a smaller distance compared to the Y displacement shown in Figure 2 for a conventional nasal interface. The nasal cannula moves hinged in at least three positions, namely the bridge hinge 510 and the lateral hinges 512, 514 on either side of the prong, whereas a conventional nasal interface bends primarily in a single position at the bridge. The additional hinges of the nasal interface help stabilize the position of the prong 502 when the cannula is under stress, reducing the displacement distance, keeping the prong in the patient's nostril, and reducing nasal irritation caused by the prong.

[0231] Figures 8A to 8C show another example of the dynamic nasal interface 600. For example, a dynamic interface 600 having a substantially wavy shape includes one or more nasal prongs 602, a bridge 604 extending between the prongs 602, a pair of wings or face pads 606, and a tube 608 coupled to the face pads 606, all of which are arranged substantially symmetrically spaced around the midline. The dynamic interface 600 can be formed as an integrated or standalone component of the prongs 602 and the tube 608 that fluidly communicates with them. The open end of each integrated tube 608 is configured to receive a suitable breathing tube connected to a gas supply source. The breathing tube can be attached to or otherwise coupled (or connected) to the interface tube 608. Preferably, the tube 608 includes two separate sides having independent flow paths. However, in some embodiments, the two sides can be fluidly communicated through a tube or the like extending across the bridge to connect the two sides of the tube.

[0232] The face pad 606 is molded to substantially match the geometric shape of the intended patient's face. As shown in Figure 8B, the face pad 606 may have a wavy shape that substantially matches the shape of the patient's outline, for example, as shown in Figure 4B. The face pad 606 may have an outer concave portion 612 configured to be positioned over the patient's protruding cheek and an inner convex portion 614 configured to be positioned over the crease between the cheek and the upper lip. The bridge 604 may have a concave shape to accommodate the protrusions of the upper lip and philtrum. The tube 608 may follow the contour of the nasal interface 600.

[0233] The anatomical shape of the face pad 606 provides a secure engagement with the patient's face at a predetermined position, with the contour of the face pad 606 matching the contour of the patient's face. The pre-molded face pad 606 enhances the nasal prongs 602 by improving the precision and speed at which the prongs 602 can be positioned and held within the patient's nostrils.

[0234] Figure 8C shows a front view of the nasal interface 600. The face pad 606 can be tapered, being wider on the outer side and narrowing towards the middle. The bridge 604 can be integrated with the face pad 606 and, in some embodiments, connects two face pads 606. In some embodiments, the bridge 604 can bend downward and have a hinge 610. The hinge 610 can be pre-oriented to bend downward so that the bridge 604 can bend downward when the nasal interface 600 is subjected to facial movement or force from an external force. Bending downward can help stabilize the prongs 602 and minimize their movement in the sagittal (i.e., anterior / posterior) and coronal (i.e., superior / inferior) planes. The downward bending of the bridge 604 causes the prongs 602 to displace toward each other, but not outward away from the nostrils, as in conventional nasal interfaces. The nasal interface design helps reduce the risk of the prongs 602 popping out of the patient's nostrils or rubbing against the sides of the nostrils.

[0235] Figures 9A to 9D show another, non-limiting example of the dynamic nasal interface 700. The dynamic interface 700 includes one or more nasal prongs 702, a curved space frame support structure 703 on which a bridge 704 extends between the prongs 702, a pair of wings or face pads 706, and a tube 708 coupled to the face pads 706, all arranged substantially symmetrically and spaced apart with respect to the sagittal plane. The dynamic interface 700 can be formed as an integrated or standalone component of the prongs 702 and the tube 708 that fluid-communicates with them. The open end of each integrated tube 708 is configured to receive a suitable breathing tube connected to a gas supply source. The breathing tube can be attached to the interface tube 708 or otherwise coupled. Preferably, the tube 708 includes two separate sides having independent flow paths. However, in some embodiments, the two sides can be fluid-communicated through a tube or the like extending across the bridge to connect the two sides of the tube.

[0236] The face pad 706 is shaped to substantially conform to the anatomical shape of the intended patient's face. As shown in FIG. 9B, the face pad 706 can be positioned toward the outer portion of the dynamic interface 700 and curved to conform to the shape of the patient's cheek. In some embodiments, the face pad can extend further toward the middle of the dynamic interface and / or can be connected as a continuous pad that extends across the entire dynamic interface. The face pad 706 can have a concave portion 712 configured to be positioned over the patient's protruding cheek.

[0237] Due to the anatomical shape of the face pad 706, a secure engagement with the patient's face is provided at a predetermined position where the contour of the face pad 706 matches the contour of the patient's face with respect to the interface. The pre-formed face pad 706 commends the nasal prong 702 by improving the accuracy and speed with which the prong 702 can be positioned and held within the patient's nostrils.

[0238] Continuing to refer to FIGS. 9A and 9B, the nasal prongs 702 and tubes 708 can be at least partially supported by a support structure 703. The support structure 703 can be coupled to the face pad 706 and can include a bridge 704 between the prongs 702. The dynamic interface 700 with the space frame-like support structure 703 helps to stabilize the interface from three-dimensional changes in the shape of the patient's face and helps to maintain the prongs 702 within the patient's nostrils. In some embodiments, the support structure 703 is hollow and can be in fluid communication with the prongs 702, whereby the prongs 702 are in fluid communication with each other. In other embodiments, the prongs 702 are separate and may not be fluidly connected to each other, at least not via the support structure 703. In these embodiments, the support structure 703 can be solid, hollow, or filled with a material such as, for example, foam or a malleable wire frame.

[0239] In some embodiments, the bridge 704 can be curved downward and have a hinge 710. As shown in FIGS. 9C and 9D, the hinge 710 can be pre-oriented to curve downward so that the bridge 704 can curve downward when the dynamic interface 700 receives a facial movement or a force from an external force. FIGS. 9C and 9D show the crushing of the dynamic interface 700 on the patient's face to simulate excessive facial deformation or external force. Curving downward can help to stabilize the prong 702 and minimize the movement of the prong 702 in the sagittal plane (i.e., front / back) and the coronal plane (i.e., up / down). When the bridge 704 curves downward, the prongs 702 are displaced so as to approach each other, but do not displace outwardly away from the nostrils as in the case of a conventional nasal interface. The design of the dynamic interface 700 can help to reduce the risk that the prongs 702 pop out of the patient's nostrils or rub against the sides of the nostrils.

[0240] Continuing to refer to FIGS. 9C and 9D, the support structure 703 can further include one or more inner hinges 716 and / or one or more outer hinges 718, whereby the support structure 703 has a zigzag shape. As shown in FIGS. 9C and 9D, the inner hinge 716 can be pre-oriented to curve downward so that the inner hinge 716 can curve upward when the dynamic interface 700 receives a force. As shown in FIGS. 9C and 9D, the outer hinge 718 can be pre-oriented to curve downward so that the outer hinge 718 can curve downward when the dynamic interface 700 receives a force. The hinges 710, 716, 718 all act together to deform and at least partially absorb the force in order to stabilize the nasal prong 702 and prevent the prong 702 from popping out of the patient's nostrils or rubbing against the sides of the nostrils when the dynamic interface 700 receives a facial movement or an external force.

[0241] Figures 10A to 10F show another, non-limiting example of a dynamic nasal interface 800 having hinges that bend in two or more dimensions. The multidimensional dynamic interface 800 may include one or more nasal prongs 802, a pair of wings or face pads 806, and a tube 808 coupled to the face pad 806, all arranged substantially symmetrically and spaced apart with respect to the sagittal plane. The tube 808 may be configured to receive a suitable breathing tube connected to a gas supply source. The breathing tube may be attached to the interface tube 808 or otherwise coupled.

[0242] The face pad 806 can be molded to substantially match the anatomical shape of the intended patient's face. As shown in Figure 10A, the face pad 806 can be positioned toward the outer portion of the dynamic interface 800 and curved to match the shape of the patient's cheek. In some embodiments, the face pad can extend further toward the middle of the dynamic interface and / or be connected as a continuous pad extending across the entire dynamic interface. The face pad 706 may have a concave portion configured to be positioned over the patient's protruding cheek.

[0243] The anatomical shape of the face pad 806 provides a secure engagement with the patient's face at a predetermined position, with the contour of the face pad 806 matching the contour of the patient's face. The pre-molded face pad 806 enhances the nasal prongs 802 by improving the precision and speed at which the prongs 802 can be positioned and held within the patient's nostrils.

[0244] In some embodiments, the dynamic nasal interface 800 includes a structural member 803 that defines the shape and bending characteristics of the dynamic nasal interface 800, as shown, for example, in Figure 10B. The structural member 803 can be overmolded onto the dynamic nasal interface 800 or attached by other means, such as adhesive, ultrasonic welding, fasteners, etc. The structural member 803 shown in Figure 10B includes a bridge hinge 810 configured to be positioned between the prongs 802 and pre-oriented to bend downward. The illustrated structural member 803 also includes an inner hinge 812 pre-oriented to bend upward and an outer hinge 814 pre-oriented to bend inward toward the patient. The bending hinges can occupy grooves or cavities that naturally occur in the anatomical structure of most patients' faces, such as creases between the cheeks and the edges of the nose 820 and spaces within the philtrum 822, as shown in Figure 10C. In some embodiments, as will be described later, stress can be applied to the multi-directional dynamic interface 800 before it is attached to the patient's face to facilitate the hinge bending in a predetermined direction and stabilizing the nasal prongs.

[0245] Figure 10D shows a front view of the multi-directional dynamic interface 800 on the patient's face. Figure 10E shows a front view of the multi-directional dynamic interface 800 when stress is applied to the patient's face. When stress, such as a crushing force, is applied to the patient's face, the multi-directional dynamic interface 800 bends as predetermined. As shown in Figure 10E, the bridge hinge 810 can bend downward and inward toward the space of the philtrum 822. The inner hinge 812 can bend upward. As shown in Figure 10F, the outer hinge 814 bends inward toward the patient into the crease between the cheek and the nose 820. Some of the bending of the hinges can be limited by the patient's anatomical structure. For example, the inward bending of the bridge hinge 810 can be limited by the patient's philtrum 822, thereby favorably limiting the displacement of the prong 802. The bending of the outer hinge 814 can be limited by the crease 820, which in turn can favorably limit the displacement of the prong 802. When the multi-directional dynamic interface 800 is subjected to facial movement or external force, the hinges 810, 812, and 814 work together to deform in multiple dimensions and absorb forces at least partially in order to stabilize the nasal prong 802 and help prevent the prong 802 from popping out of the patient's nostril or rubbing against the sides of the nostril.

[0246] Figures 11A–11C show another, non-limiting example of the dynamic nasal interface 900. The dynamic nasal interface 900 may have an overall curvature that substantially corresponds to the contour of the patient's face and may include two distinct sides, each comprising a nasal prong 902, a face pad 906, and a tube 908 coupled to the face pad 906. The tube 908 can be in fluid communication with the prong 902. An overstrap bridge 904 may extend between the two sides of the overstrap dynamic interface 900 and connect them. The open end of the tube 908 is configured to receive a suitable breathing tube connected to a gas supply source. The breathing tube may be attached to the interface tube 908 or otherwise coupled.

[0247] The face pad 906 can be molded to substantially match the anatomical shape of the intended patient's face. As shown in the top view of Figure 11B, the face pad 906 can be positioned toward the outer portion of the dynamic interface 906 and can be curved to match the shape of the patient's cheek. The face pad 906 may have a concave portion configured to sit on the patient's protruding cheek.

[0248] The anatomical shape of the face pad 906 provides a secure engagement with the patient's face at a predetermined position, with the contour of the face pad 906 matching the contour of the patient's face. The pre-molded face pad 906 enhances the nasal prongs 902 by improving the precision and speed at which the prongs 902 can be positioned and held within the patient's nostrils.

[0249] Referring to Figures 11A and 11B, an overstrap bridge 904 can extend between the two sides of the overstrap dynamic interface 900. The overstrap bridge 904 can be coupled to the interface tube 908 or to the face pad 906, as shown in the figures, and can be attached at any location along each side of the dynamic interface 900. In the illustrated example, the overstrap bridge 904 is generally connected toward the middle of the interface tube 908. In other embodiments, the overstrap bridge 904 can be connected toward the prongs 902 or toward the outer edge of the dynamic interface 900. The connection portion 912 between the overstrap bridge 904 and the side of the dynamic interface 900 may be a rigid connection. In some embodiments, the connection portion 912 may be adjustable by a hinge or the like, or it may be flexible.

[0250] The overstrap bridge 904 can be made from an elastic material that can be stretched or adjusted to conform to the shape and size of the patient's face. For example, the overstrap bridge 904 can be adjusted so that the prongs 902 can be spaced out according to the anatomical structure of the individual patient's nose, providing a wide range of patient sizes that can be accommodated by a particular overstrap dynamic interface 900. The overstrap bridge 904 has a bridge hinge 910 that is pre-directed to bend inward toward the patient, so that the overstrap bridge 904 bends inward when the dynamic interface 900 is subjected to facial movement or force from an external force.

[0251] As shown in Figure 11B, the bridge hinge 910 is curved in the opposite direction compared to the rest of the nasal interface. The bridge hinge 910 is curved towards the rear of the dynamic interface 900, thereby making the bridge hinge 910 convex when viewed from the front. The inward curvature can help stabilize the prongs 902 and minimize their movement in the sagittal (i.e., anterior / posterior) and coronal (i.e., superior / inferior) planes. The inward curvature of the bridge hinge 910 allows the prongs 902 to displace toward each other, but not outward away from the nostrils, as in conventional nasal interfaces. The design of the dynamic interface 900 can help reduce the risk of the prongs 902 popping out of the patient's nostrils or rubbing against the sides of the nostrils.

[0252] In some embodiments, the bridge 904 may be configured with a bridge hinge 910 so that it is preloaded during installation, allowing the overstrap dynamic interface 900 to absorb force when the patient's face moves or when an external force is applied to the dynamic interface 900.

[0253] The dynamic interface described above can be fabricated, at least partially, from an elastic material that can return to its original shape after being deformed by the patient's facial movements or external forces. These materials also preferably have high compliance to conform to the shape of the patient's face. Examples of dynamic interface materials include silicone, rubber (synthetic or natural), thermoplastic polymers, and thermosetting polymers. Composite materials can be manufactured by commolding or overmolding.

[0254] Hinge Various hinge types can be used in dynamic interfaces. The hinges can bend in a limited number of predictable directions to define the mechanical behavior of the dynamic interface. The following paragraphs describe several hinge types and how they can be implemented. The hinges described are not an exhaustive list of all hinge types that can be used, and the scope of the invention should not be limited by the specific embodiments described. Hinge types, but not limited to, include notched, cross-sectional, variable-thickness, composite, elastic, barrel and pin, and ball and socket hinges.

[0255] Figure 12A shows a nose interface 1000 in which a hinge 1010 is located on a bridge 1004 between prongs 1002. The hinge 1010 may be solid and may include one or more notches 1012. In the embodiment shown in Figure 12B, the hinge 1010 includes three notches 1012 located on the side 1014 of the hinge 1010 facing away from the desired bending direction. The notches 1012 facilitate the bending of the hinge 1010 in the direction M of the moment shown, as this helps to reduce tensile stress on the side 1014 when the notches 1012 are opened. The hinge 1010 is pre-oriented to bend in direction M.

[0256] Figure 13A shows another embodiment of the nose interface 1100, which has a bridge 1104 between the prongs 1102. The bridge 1104 is hollow and allows gas to flow, thereby enabling the prongs 1102 to fluidly communicate with each other through the bridge 1104. The bridge 1104 may have a notch and act as a hinge 1110. Figures 13B to 13D show several non-limiting notch examples. Figure 13B shows a triangular notch 1116, Figure 13C shows a channel notch 1118, and Figure 13D shows a trapezoidal notch 1120. The notch design can be modified to allow different amounts of bending at the hinge, and the designer can select the appropriate type of notch design to achieve the desired amount of bending.

[0257] Hinges can be designed into structures through variations in their cross-sectional shape. Under applied loads, the design's cross-sectional area can pre-direct the structure to deflect in several directions. For example, the structure could be a bridge located between the prongs of a nasal interface. As shown for hinge 1210 in Figure 14A, we assume the load force F is lateral and simulate the exaggerated facial movement or external force described above. The illustrated triangular cross-sectional shape promotes a downward bend toward the mouth in the example of a bridge. This downward bend reduces the effect of load F on the position of the prongs within the nostrils, as described above.

[0258] Figure 14B shows the triangular cross-sectional shape of a hinge 1210 having a bending neutral axis 1212 located closer to the tensile region 1214 of the structure while in a bent state. Pre-orienting the structure to bend in a desired direction can be achieved by making the tensile region 1214 (i.e., the region that is preferably in a tensile state) larger than the cross-sectional area of ​​the compressive region 1216 (i.e., the region that is preferably subjected to compression). Since materials tend to have a greater compressive modulus than tensile modulus, when a load force F is applied to the hinge 1210, the force required to compress the compressive region 1216 and extend the tensile region 1214 is smaller, in contrast to the force required to stretch the compressive region 1216 and compress the tensile region 1214. Thus, the hinge 1210 can bend in a predictable downward direction.

[0259] Figures 15A and 15B show examples of design features, such as cutouts, that can reduce compressive stress. Figure 15A shows a lateral load force F on the nose interface 1300. The nose interface 1300 has one or more prongs 1302 and a hinge 1310 positioned between the prongs 1302. Figure 15B is an enlarged cross-section of the hinge region. As shown in the figure, the hinge 1310 includes a tension region 1314 and a compression region 1316. As described above, by making the cross-sectional area of ​​the tension region 1314 larger than the cross-sectional area of ​​the compression region 1316, the structure can be pre-oriented to bend in a desired direction. In the example shown in Figure 15B, the compression region 1316 consists of a hollow channel 1320 between flanges 1318. The hollow channel 1320 gives the compression region 1316 a smaller cross-sectional area than the tension region 1314, allowing the hinge 1310 to bend in a predictable downward direction.

[0260] Figures 16A and 16B show an example of a hinge 1410 with variable thickness. Similar to that shown in Figure 15A, a lateral loading force F can be applied to the nose interface 1400. Referring to Figure 16A, the nose interface 1400 has one or more prongs 1402 and a hinge 1410 disposed between the prongs 1402. The hinge 1410 can be made thinner in a specific direction compared to other directions so that it is pre-oriented to bend in the direction of the thinnest material. For example, in the illustrated embodiment, the hinge 1410 is thinner in the extending direction of the prongs, that is, in the vertical direction in the figure of Figure 16A. Figure 16B is an enlarged cross-section of the hinge region showing an elliptical cross-section. Since the hinge 1410 is thinnest in the vertical direction, it bends predictably downward.

[0261] Figures 17A and 17B show a hinge 1510 including two materials with different measurements, such as a rigid material and a flexible material overlapping each other, that functions to bend in a predetermined direction. Figure 17A shows an embodiment having a flexible portion 1514 and a rigid portion 1516 in an unbent state. As shown in Figure 17B, when a force is applied to the flexible portion 1514, bending is pre-oriented in a direction opposite to that of the rigid portion 1516. The rigid portion 1516 prevents the flexible portion 1514 from bending toward the rigid portion 1516, and the flexible portion 1514 can only bend in one or more pre-oriented directions. The two material types can be fixed using an overmolding technique or the like to bond the materials at the central position 1518 of the hinge 150. In some embodiments, the two material types can be removably fixed at one or more positions of the hinge. The outer portion of the flexible material 1514 preferably has unrestricted movement.

[0262] Elastic hinges can be used to facilitate the fixation of the interface onto the patient's face. Elastic hinges can store elastic energy by pre-stressing the nasal interface before it is applied to the patient. When the nasal interface is placed on the patient, the stored elastic energy of the elastic hinge acts on the patient's face to facilitate fixation. Elastic hinges can have a relaxed state in which virtually no elastic energy is stored in the hinge, and a pre-stressed state in which some external force bends the hinge, allowing it to store some elastic energy.

[0263] For example, a patient's face may be in a relaxed state as shown in Figure 4A, or in a stressed state as shown in Figure 5A. The nasal interface can be formed such that its relaxed state substantially corresponds to the stressed shape of the patient's face. Figure 18A shows an example of an elastic hinge nasal interface 1600 in a relaxed state. As shown in Figure 18B, the nasal interface 1600 in a relaxed state can substantially correspond to the stressed shape of the patient's face, and in this configuration, the nasal interface 1600 may not exert force on the patient's stressed face.

[0264] When the elastic hinge nasal interface 1600 is attached to the patient's face, the user can pre-stress the nasal interface by, for example, extending it as shown in Figure 18C. When the pre-stressed nasal interface is placed on the patient's relaxed face, as shown by the cross-hatching in Figure 18D, the curved portion of the nasal interface acts as an elastic hinge 1610. When stress is applied to the patient's face, the elastic hinge nasal interface 1600 is pre-configured to bend back to its relaxed state, as shown in Figure 18B. The elastic hinge nasal interface 1600 can conform to the shape of the patient's face as the face changes from a relaxed shape to a stressed shape, thereby helping to stabilize the nasal prongs and prevent them from popping out of the patient's nostrils or rubbing against the sides of the nostrils.

[0265] For example, the nasal interface can be attached to the patient's face through several different types of retention methods, such as adhesives and straps. Preferably, the method of retaining the nasal interface on the patient's face has at least enough strength to withstand the pre-stress energy accumulated in the elastic hinge.

[0266] Elastic hinge nose interfaces can be fabricated from resilient materials that can store energy when they extend from their relaxed state. Some, but not limited to, examples of such materials include rubber, plastics, composites, and steel.

[0267] Another hinge design that can be used in a dynamic interface is a pin and barrel design. Figure 19A shows a dynamic interface 1700 in which a pin and barrel hinge design is positioned on a bridge 1704 between nasal prongs 1702. When the shape of the patient's face changes, for example, due to external forces or facial movements, the angle of the pin and barrel hinge can be adjusted to accommodate the facial movements or external forces. The adjustment by the pin and barrel hinge helps to stabilize the prongs within the patient's nostrils.

[0268] Figure 19B shows an example of a pin and barrel hinge 1710. The first side of the hinge may have a pin 1712 attached to or integrally formed with the first side. The second side may have a barrel 1714 (e.g., a through hole) attached to or integrally formed with the second side. The pin 1712 can be inserted into the barrel 1714 and held by a functional connection. The pin 1712 can rotate relative to the barrel 1714 to form the hinge 1710.

[0269] Figures 19C and 19D show a pin and barrel hinge 1710 with directional movement. The pin and barrel hinge 1710 includes a stopper 1716 that prevents the hinge from bending in a predetermined direction, thereby pre-directing the hinge 1710 to bend in a desired direction, for example, downward away from the patient's nostrils. Directional hinge designs can be strategically placed on specific portions of the nasal interface to control how the interface bends when force is applied to the interface. Although directional hinge designs are shown herein in combination with pin and barrel designs, directional hinge designs can also be used with other types of hinges, such as those described herein.

[0270] Figure 20 shows an example of a nasal interface 1800 having a ball-and-socket hinge 1810 between nasal prongs 1802. The first side of the hinge 1810 may have a ball 1812 attached to or integrally formed with the first side. The second side may have a barrel 1814 (e.g., a cavity) attached to or integrally formed with the second side. The ball 1812 can move and rotate inside the barrel 1814 to provide three degrees of mobility around the center of the hinge. As the shape of the patient's face changes, for example, due to external forces or facial movements, the three degrees of mobility of the ball-and-socket hinge 1810 can adjust to the facial movements or external forces, helping to stabilize the prongs 1802 within the patient's nostrils.

[0271] Referring to the embodiments shown in Figures 21A to 21C, the patient interface 2100, such as a nasal cannula, has a pair of left and right body portions 2101 and 2103, each body portion positioned on the user's face during use, and each body portion is separated from the others. At least one, preferably both, of the body portions includes nasal prongs 2105, 2107 that are inserted into one or both nostrils of the user's nose or that direct the gas flow. A bar 2109 extends from a connection point 2109a with the left body portion to a connection point 2109b with the right body portion. The bar has a substantially elastically deformable region 2111.

[0272] Displacements of either or both of the left body portion 2101 and / or the right body portion 2103 when they are in their original positions are transmitted to the bar 2109 via the connection point, and the substantially elastically deformable region 2111 is deformable as a reaction response to the displacement.

[0273] The substantially elastically deformable region 2111 of the bar 2109 is a substantially flexible portion that can be deformed to substantially absorb displacement. The substantially elastically deformable region 2111 of the bar reduces the transmission of displacement from one part of the body to the other part of the body.

[0274] The connection points 2109a and 2109b of the main body portion of the bar 2109 are via anchors in the form of engagement projections 2121. The engagement projections 2121 are received by a region 2123 of the main body portion that is substantially distal to each prong, thereby enabling fluid communication between the engagement projections and the prongs.

[0275] The elastically deformable region 2111 is substantially aligned with the prongs 2105, 2107 in at least one plane. Each connection point 3209a, 2109b of the bar 2109 is in fluid communication with the prong of the respective body section and is configured to connect the gas flow path of the breathing circuit. The interface also has face pads 2115, 2117 associated with each body section. Each face pad 2115, 2117 is contoured to engage with the area of ​​the user's face.

[0276] Referring to the embodiments shown in Figures 22-23C, the patient interface 2400 / 2500, such as a nasal cannula, has a pair of left body portions 2401 / 2501 and right body portions 2403 / 2503, respectively, which are positioned over the user's face when in use. A bridge portion 2509 extends between each of the left and right body portions. Nasal prongs 2405 / 2505, 2407 / 2507 extend from one or each of the inner ends of the respective left and / or right body portions, or from one or both of the areas of the respective body portions substantially adjacent to the inner ends. The nasal prongs 2405 / 2505, 2407 / 2507 are inserted into one or both nostrils of the user's nose or directed to direct the gas flow.

[0277] The bridge portion 2409 / 2509 allows movement of each body portion 2401 / 2501, 2403 / 2503 so that their inner ends face each other, but resists movement of each body portion so that their inner ends face each other. When the patient interface is in its original position on the user's face, displacement of the position of one or both of the left and / or right body portions is transmitted to the bridge portion 2409 / 2509 to minimize movement of its prongs or multiple prongs relative to the user's nostrils.

[0278] Referring to the embodiment shown in Figure 22, the bridge portion 2409 extends and connects the inner ends of the respective body portions 2401 and 2403. The bridge portion 2409 is a material that can be subjected to compression in the direction extending between the inner ends of the respective body portions and that resists or withstands applied tension. The direction extending between the inner ends of the respective body portions is the longitudinal direction extending along each body portion. The bridge portion preferably includes a fabric material, which may be a woven fabric, knitted fabric, or nonwoven fabric.

[0279] Referring to the embodiments shown in Figures 23A to 23C, the bridge portion 2509 is axially expandable / extendable but elastic so as to resist the movement of each body portion as their inner ends move away from each other. The length of the bridge portion between the connection points 2509a, 2509b of the left body portion and the connection point of the right body portion is greater than the distance between the nasal prongs 2505, 2507. The bridge portion 2509 preferably comprises a flexible polymer material.

[0280] Referring to the embodiments shown in Figures 24A to 24C, the patient interface 2800 / 2900, such as a nasal cannula, has a pair of left and right body portions 2801 / 2901 and 2803 / 2903, which are positioned over the user's face when in use. A bridge portion 2809, 2909 extends between the left and right body portions, respectively. Nasal prongs 2805 / 2905, 2807 / 2907 extend from one or each of the inner ends of the left and / or right body portions, or from one or both of the areas of the respective body portions substantially adjacent to the inner ends. The nasal prongs 2805 / 2905, 2807 / 2907 are inserted into one or both nostrils of the user's nose or directed to direct the gas flow. Each body portion, preferably both, includes user face contact surfaces 2815 / 2915, 2817 / 2917 oriented relative to the respective nasal prongs, thereby holding the nasal prongs in a position where the torsional force applied to the left and / or right body portions, when in their original position, directs the gas flow into or into the nostrils of the user's nose.

[0281] The rotation of the main body portion toward the user's face, preferably the rotation of both main body portions, maximizes the contact surface area between the face contact surface and the user's face, positioning the nasal prongs to direct the gas flow towards or into the nostrils of the user's nose.

[0282] The bridge section 2809 / 2909 has a relatively smaller diameter than the left and right main body sections. Each main body section is equipped with a channel, which has one end fluidly connected to the respective nasal prong and the other end open to fluidly connect to the gas flow path of the breathing circuit.

[0283] Referring to the embodiments shown in Figures 24A to 24C, at least one of the left body portion and the right body portion, preferably each, includes axially twisted face contact surfaces 2909, 2911 that are movable between a relaxed position and a twisted position, thereby increasing the surface area located adjacent to the user's face.

[0284] The facial contact surfaces 2909 and 2911 twist axially along the length of the main body, from the inner end to the outer end of the main body. The facial contact surfaces 2909 and 2911 extend spirally along the length of the main body. In the relaxed position, the facial contact surfaces face away from the direction of extension of the nasal prongs at their distal ends, and in the twisted position, they face the direction of extension of the nasal prongs and are substantially planar along the substantial length of the main body.

[0285] Referring to the embodiments shown in Figures 25A to 25C, the nasal prongs 2905 and 2907 are angled relative to the left and right body portions, respectively, to apply a torsional force to the body portion when the nasal prongs are inserted into the nostrils of the user's nose. The facial contact surfaces of the left and / or right body portions are contoured to engage with the cheeks of the user's face.

[0286] Referring to the embodiment shown in Figure 26, the patient interface, such as a nasal cannula, has a pair of left and right body portions that are positioned over the user's face when in use. A bridge portion extends between each of the left and right body portions. Nasal prongs extend from one or each of the inner ends of the left and / or right body portions, or from one or both of the areas of the respective body portions substantially adjacent to the inner ends. The nasal prongs are inserted into one or both nostrils of the user's nose, or direct a gas flow into them. The interface has a series of discontinuous, separate face contact surfaces that are movable relative to each other to respond to forces and / or movements experienced by the face contact surfaces, and to at least partially mitigate the transmission of such forces and / or movements to the nasal prongs.

[0287] Referring to the embodiments shown in Figures 27A to 27C, the patient interface 3200 / 3300, such as a nasal cannula, has a pair of left and right body portions 3201 / 3301 and 3203 / 3303, each body portion positioned on the user's face during use. The patient interface 3200 / 3300 also has a bridge portion 3209 / 3309 extending between the left and right body portions. Nasal prongs extend from one or each of the inner ends of the left and / or right body portions, or from one or both of the areas of the respective body portions substantially adjacent to the inner ends. The nasal prongs 3205 / 3305, 3207 / 3307 are inserted into one or both nostrils of the user's nose, or direct a gas flow into them. The cannula includes at least one hinge region, which will be described in detail later. At least one hinge region is pivotable relative to another region of the cannula, either around at least two substantially orthogonal axes, or along two substantially orthogonal planes, or both, in response to forces or movements, or both, on the other region, and at least partially mitigates the transmission of such forces and / or movements to the nasal prongs. At least one hinge region may be pivotable about three substantially orthogonal axes, or along three substantially orthogonal planes, or both.

[0288] The bridge 3209 / 3309 also includes a bridge hinge 3219 adjacent to or between a pair of nasal prongs. The bridge hinge 3219 is pre-oriented to have a sharp curve. The bridge hinge 3219 is pre-oriented to bend inward toward the user and downward toward the nostrils in its original position.

[0289] The bridge 3209 / 3309 further comprises a second hinge on one side of the bridge hinge, or a pair of opposing second hinges 3216, 3220 adjacent to one or more nasal prongs on either side of the bridge hinge 3219. Each hinge of the second hinge or the pair of second hinges 3216, 3220 is pre-oriented to have a sharp curve. Each hinge of the second hinge or the pair of second hinges 3216, 3220 is pre-oriented to bend upward toward the user's nostrils and outward away from the user in its original position.

[0290] The bridge features a third hinge adjacent to the left or right body section, or a pair of third hinges 3214, 3221 positioned adjacent to the left and right body sections, respectively. Each of the third hinges or the pair of third hinges 3214, 3221 is pre-oriented to have a sharp curve. Each of the third hinges or the pair of third hinges 3214, 3221 is pre-oriented to bend downward away from the nostrils and outward away from the user in its original position.

[0291] Referring to the embodiments shown in Figures 27A to 27C, one end of the bridge portion extends substantially perpendicularly from the third hinge, or either end 3222, 3223 of the bridge portion extends substantially perpendicularly from either one of the pair of third hinges and inward toward the cheek of the user's face in its original position. Each body portion has face pads 3224, 3225 contoured to engage with the area of ​​the user's face. Either end of the bridge portion extends along at least a portion of the face pad.

[0292] The bridge portion 3209 is substantially hollow at at least one end of the bridge portion, through which a gas flow is transported. Either end of the bridge portion is configured to connect with the gas flow path of the breathing circuit. The bridge portion 3209 has an annular cross-section along at least a substantially portion of the length of the bridge portion.

[0293] The nasal prongs 3205 and 3207 extend from each end of the bridge section and are fluidly coupled to each end.

[0294] Referring to the embodiment shown in Figure 28, the bridge further comprises a fourth hinge adjacent to the third hinge, or pairs of fourth hinges 3326, 3327 adjacent to each pair of third hinges. Each of the fourth hinges, or pairs of fourth hinges, is pre-oriented to have a sharp curve. Each of the fourth hinges, or pairs of fourth hinges, is pre-oriented to curve downward away from the user's nostrils and inward toward the user's cheeks in its original position. Each body portion includes face pads 3324, 3325 contoured to engage over the user's facial area.

[0295] While several embodiments, features, and examples have been described herein, those skilled in the art will understand that many aspects of the methods and apparatus illustrated and described herein can be combined and / or modified in different ways to form further embodiments. For example, any one component of the nasal interface illustrated and described herein can be used alone or in combination with other components without departing from the spirit of the invention. Furthermore, it will be understood that the methods described herein can be carried out in different orders and / or with additional apparatus as required. Such alternative embodiments and / or uses of the methods and apparatus described herein, as well as obvious modifications and equivalents thereof, are intended to be within the scope of the invention. Accordingly, the scope of the invention should not be limited by the specific embodiments described herein, but should be determined solely by a fair interpretation of the following claims.

[0296] Further embodiments Item 1: Patient interfaces such as nasal cannulas, Each device consists of a left and a right body section, with each section positioned over the user's face during use, and each section being separate from the others. A pair of left and right body parts, at least one, preferably both, of the main body parts, each including nasal prongs that are inserted into or direct a gas flow into one or both nostrils of the user's nose, A bar extending from the connection point with the left main body to the connection point with the right main body, and including a substantially elastically deformable region. Equipped with, A patient interface in which the displacement of one or both of the left and / or right main body portions during use can be transmitted to a bar via a connection point, and a substantially elastically deformable region can be deformed as a reaction response to that displacement.

[0297] Item 2. A patient interface as defined in Item 1, wherein a substantially elastically deformable region of the bar includes a substantially flexible portion.

[0298] Item 3. A patient interface as defined in Item 1 or 2, wherein a substantially elastically deformable region of the bar is deformable to substantially absorb displacement.

[0299] Item 4. A patient interface defined as any one of items 1-3, wherein a substantially elastically deformable region of the bar reduces the transmission of displacement from one part of the body to the other part of the body.

[0300] Item 5. A patient interface defined as one of items 1-4, where the connection point of the bar to the main body is via an anchor.

[0301] Item 6. A patient interface as defined in Item 5, where the anchor is an anchoring projection that is received by a region of the main body located substantially distal to each prong.

[0302] Item 7. A patient interface as defined in Item 6, in which the protruding projections and prongs are in fluid communication.

[0303] Item 8. A patient interface defined in any one of items 1-7, wherein an elastically deformable region is substantially aligned with the prongs of at least one plane, or both.

[0304] Item 9. A patient interface defined in any one of Items 1-8, wherein each connection point of the bar is configured to be in fluid communication with the prongs of the respective main body and to connect with the gas flow path of the breathing circuit.

[0305] Item 10. A patient interface defined in any one of items 1-9, further comprising a face pad associated with each main body part, the face pad being contoured to engage with an area of ​​the user's face.

[0306] Item 1a. Patient interfaces such as nasal cannulas, A pair of left and right main body parts that are positioned over the user's face when in use, and a bridge portion extending between each of the left and right main body parts, Nasal prongs extending from one or each of the inner ends of the left and / or right body portions, or from one or both of the portions substantially adjacent to the inner ends, which are inserted into one or both nostrils of the user's nose or directed thereto. Equipped with, A patient interface in which the bridge portion allows the inner ends of the main body portions to move toward each other, but resists the movement of the main body portions so that their inner ends move toward each other.

[0307] Item 2a. A patient interface as defined in Item 1a, wherein when the patient interface is in its original position on the user's face, displacement of one or both of the left and / or right body parts is transmitted to the bridge in such a way that movement of one or more prongs relative to the user's nostrils is minimized.

[0308] Item 3a. A patient interface as defined in Item 1a or 2a, in which the bridge portion extends and connects the inner ends of each main body portion.

[0309] Item 4a. A patient interface defined in any one of items 1a to 3a, wherein the bridge portion is made of a material that can be subjected to compression and resists or withstands applied tension in a direction extending between the respective inner ends of the main body portion.

[0310] Item 5a. A patient interface as defined in Item 4a, wherein the direction extending between each inner end of the main body portion is the longitudinal direction extending along each main body portion.

[0311] Item 6a. A patient interface defined as any one of items 1a-5a, with the bridge portion containing fabric material.

[0312] Item 7a. A patient interface as defined in Item 1a or 2a, wherein the bridge portion is axially expandable / extendable, but is elastic enough to withstand the movement of each body portion so that its inner ends move away from each other.

[0313] Item 8a. A patient interface as defined in Item 7a, where the length of the bridge between the connection point of the left main body and the connection point of the right main body is greater than the distance between the nasal prongs.

[0314] Item 9a. A patient interface as defined in Item 7a or 8a, wherein the bridge portion includes a flexible polymer material.

[0315] Item 1b. Patient interfaces such as nasal cannulas, A pair of left and right main body parts that are positioned over the user's face when in use, and a bridge portion extending between each of the left and right main body parts, Nasal prongs extending from one or each of the inner ends of the left and / or right body portions, or from one or both of the areas of the respective body portions substantially adjacent to the inner ends, which are inserted into or directed into the nostrils of the user's nose. Equipped with, A patient interface in which one, preferably both, of the respective body parts includes a user face contact surface oriented with respect to the respective nasal prongs, thereby substantially holding the nasal prongs in a position that directs the gas flow into or within the nostrils of the user's nose when in its original position.

[0316] Item 2b. A patient interface as defined in Item 1b, wherein the rotation of the main body portion toward the user's face, preferably both main body portions, maximizes the contact area between the face contact surface and the user's face, and the nasal prongs are positioned to direct the gas flow into or into the nostrils of the user's nose.

[0317] Item 3b. A patient interface as defined in Item 1b or 2b, in which the bridge portion has a diameter that is relatively smaller than the left and right main body portions.

[0318] Item 4b. A patient interface defined in any one of items 1b to 3b, wherein each main body section has a channel at one end that is fluidly connected to its respective nasal prongs and at the other end that is open to fluidly connect to the gas flow path of the breathing circuit.

[0319] Item 5b. A patient interface as defined in any one of items 1b to 4b, wherein at least one of the left body portion and the right body portion, preferably each, includes an axially twisted face contact surface that is movable between a relaxed position and a twisted position, thereby increasing the surface area located adjacent to the user's face.

[0320] Item 6b. A patient interface as defined in Item 5b, wherein the face contact surface is twisted axially along the length of the main body from the inner end to the outer end of the main body.

[0321] Item 7b. A patient interface as defined in Item 5b, wherein the face contact surface extends spirally along the length of the main body.

[0322] Item 8b. A patient interface as defined in Item 5b or 6b, wherein, in the relaxed position, the facial contact surface faces away from the direction of extension of the nasal prongs at the distal end, and in the twisted position, faces the direction of extension of the nasal prongs and is substantially planar along the substantial length of the main body portion.

[0323] Item 9b. A patient interface defined in any one of items 1b to 4b, wherein one or more nasal prongs are angled relative to the left and right main body sections, respectively, to apply a twisting force to the main body section when the nasal prongs are inserted into the nostrils of the user's nose.

[0324] Item 10b. A patient interface as defined in Item 9b, wherein the facial contact surfaces of each left and / or right body portion are contoured to engage with the cheeks of the user's face.

[0325] Item 1c. Patient interfaces such as nasal cannulas, A pair of left and right main body parts that are positioned over the user's face when in use, and a bridge portion extending between each of the left and right main body parts, Nasal prongs extending from one or each of the inner ends of the left and / or right main body portions, or from one or both of the areas of the respective main body portions substantially adjacent to the inner ends, which are inserted into or directed into the nostrils of the user's nose, A series of discontinuous, separate facial contact surfaces that are movable relative to each other, responding to the forces and / or movements or both that the facial contact surfaces experience, and at least partially reducing the transmission of such forces and / or movements to the nasal prongs. A patient interface equipped with a

[0326] Item 1d. Patient interfaces such as nasal cannulas, A pair of left and right main body parts that are positioned over the user's face when in use, and a bridge portion extending between each of the left and right main body parts, Nasal prongs extending from one or each of the inner ends of the left and / or right body portions, or from one or both of the areas of the respective body portions substantially adjacent to the inner ends, which are inserted into or directed into the nostrils of the user's nose. Equipped with, A patient interface comprising at least one hinge region, the cannula being pivotable relative to another region of the cannula, at least about substantially orthogonal axes of a pair, or along substantially orthogonal planes of a pair, or both, thereby responding to forces and / or movements experienced by the other region, and at least partially mitigating the transmission of such forces and / or movements to the nasal prongs.

[0327] Item 2d. An interface as defined in Item 1d, in which at least one hinge region is pivotable about three substantially orthogonal axes, or along three substantially orthogonal planes, or both.

[0328] Item 3d. An interface as defined in Item 1d or 2, wherein the bridge has a bridge hinge adjacent to or between a pair of nasal prongs.

[0329] Item 4d. The interface defined in Item 3d, where the bridge hinge is pre-configured to have a sharp curve.

[0330] Item 5d. An interface as defined in item 3d or 4d, in which the bridge hinge is pre-oriented to bend inward toward the user and downward away from the nostrils in its original position.

[0331] Item 6d. An interface defined in any one of items 3d to 5d, wherein the bridge further comprises a second hinge on one side of the bridge hinge, or a pair of opposing second hinges on either side of the bridge hinge and adjacent to one or more nasal prongs.

[0332] Item 7d. An interface defined in Item 6d, in which each hinge of a pair of second hinges is pre-oriented to have a sharp curve.

[0333] Item 8d. An interface as defined in Item 6d or 7d, in which each hinge of a pair of second hinges is pre-oriented to bend outward in its original position, upward toward the user's nostrils and away from the user.

[0334] Item 9d. An interface defined in any one of items 6d-8d, wherein the bridge comprises a third hinge adjacent to the left body portion or the right body portion, or a pair of third hinges positioned adjacent to the left body portion and the right body portion, respectively.

[0335] Item 10d. An interface as defined in Item 9d, in which each of the third hinges, or a pair of third hinges, is pre-oriented to have a sharp curve.

[0336] Item 11d. An interface as defined in Item 9d or 10d, in which each of the third hinges, or a pair of third hinges, is pre-oriented to bend downward away from the nostrils and outward away from the user in its original position.

[0337] Item 12d. An interface defined in any one of items 9d-11d, wherein one end of the bridge portion extends substantially perpendicularly from the third hinge, or either end of the bridge portion extends substantially perpendicularly from one of the pair of third hinges and inward toward the cheek of the user's face in its original position.

[0338] Item 13d. An interface as defined in Item 12d, in which each main body portion has a face pad contoured to engage with the user's facial area.

[0339] Item 14d. An interface as defined in Item 13d, wherein one end of the bridge portion extends along at least a portion of the face pad.

[0340] Item 15d. An interface defined in any one of items 12d-14d, wherein the bridge portion is substantially hollow at at least one end of the bridge portion so as to transport a gas flow through its interior.

[0341] Item 16d. An interface as defined in Item 15d, in which either end of the bridge portion is configured to connect to the gas flow path of the breathing circuit.

[0342] Item 17d. The interface defined in Item 15d or 16d, where the nasal prongs or each nasal prong extends from and is fluidly coupled to each end of the bridge portion.

[0343] Item 18d. An interface defined in any one of items 1d to 17d, wherein the bridge portion has an annular cross-section along at least substantially a portion of the length of the bridge portion.

[0344] Item 19d. An interface defined in any one of items 9d-18d, wherein the bridge further comprises a fourth hinge adjacent to a third hinge, or a pair of fourth hinges adjacent to each pair of third hinges.

[0345] Item 20d. An interface as defined in Item 19d, in which each hinge of a fourth hinge, or a pair of fourth hinges, is pre-oriented to have a sharp curve.

[0346] Item 21d. An interface as defined in Item 19d or 20d, in which each hinge of a fourth hinge, or a pair of fourth hinges, is pre-oriented to curve downward away from the user's nostrils and inward toward the user's cheeks in its original position.

[0347] Item 22d. An interface defined in any one of items 19d-21d, wherein each main body part has a face pad contoured to engage over the user's face.

[0348] Item 1f. A nasal interface configured to stabilize prongs on the patient's face when force is applied to the interface, An elongated body having an overall curvature that substantially corresponds to the external shape of the patient's face, configured to be connected to a gas source, and comprising an elongated body having at least one lumen that extends at least partially through the body, A pair of prongs extending from the main body and in fluid communication with at least one lumen, One or more hinges, wherein at least one hinge is positioned between a pair of prongs and is pre-directed to bend in a predefined direction. A nasal interface equipped with a nasal interface.

[0349] Item 2f. A nasal interface as defined in Item 1f, further comprising one or more facial pads configured to rest on the patient's face.

[0350] Item 3f. A nasal interface as defined in Item 1f or 2f, having at least one hinge positioned between a pair of prongs, having a curve that is substantially inverted from the overall curve of the elongated body.

[0351] Item 4f. A nasal interface as defined in Item 3f, wherein at least one hinge positioned between a pair of prongs is configured to bend inward toward the patient's face.

[0352] Item 5f. A nasal interface having a roughly gull-wing shape, as defined in any one of items 1f to 4f.

[0353] Item 6f. A nasal interface having a wavy shape, as defined in any one of items 1f to 4f.

[0354] Item 7f. A nasal interface defined in any one of items 1f to 4f, having a curved space frame-like support structure.

[0355] Item 8f. A nose interface defined in any one of items 1f-7f that bends in two or more dimensions.

[0356] Item 9f. A nose interface defined in any one of items 1f to 8f, wherein one or more hinges have notches.

[0357] Item 10f. A nasal interface defined in any one of items 1f to 9f, wherein one or more hinges have a variable cross-sectional area.

[0358] Item 11f. A nasal interface defined in any one of items 1f to 10f, wherein one or more hinges have a variable thickness.

[0359] Item 12f. A nasal interface defined in any one of items 1f to 11f, wherein one or more hinges include two or more materials with different flexibility.

[0360] Item 13f. A nasal interface defined in any one of items 1f to 12f, including one or more hinges, which are elastic hinges configured to be pre-stressed before being applied to a patient.

[0361] Item 14f. A nose interface defined in any one of items 1f to 13f, wherein one or more hinges include a barrel and a pin.

[0362] Item 15f. A nose interface defined in any one of items 1f to 13f, wherein one or more hinges include a ball and a socket.

[0363] Item 16f. Nasal interface, An elongated body comprising at least one lumen extending at least partially through the body, and configured to be coupled to a gas source, One or more prongs extending from the main body and in fluid communication with at least one lumen, One or more hinges pre-directed to bend in a predefined direction Equipped with, A nasal interface in which one or more hinges are configured to stabilize the position of one or more prongs on the patient's face when force is applied to the nasal interface.

[0364] Item 17f. A nasal interface as defined in Item 16f, further comprising one or more facial pads configured to rest on the patient's face.

[0365] Item 18f. A nasal interface as defined in item 16f or 17f, wherein at least one of one or more hinges is located adjacent to or between one or more prongs.

[0366] Item 19f. A nasal interface as defined in any one of items 16f-18f, wherein at least one of one or more hinges is configured to bend inward toward the patient's face.

[0367] Item 20f. A nasal interface defined in any one of items 16f-18f, wherein at least one of one or more hinges is configured to bend downward.

[0368] Item 21f. A nasal interface having a roughly gull-wing shape, as defined in any one of items 16f to 20f.

[0369] Item 22f. A nasal interface having a wavy shape, as defined in any one of items 16f to 20f.

[0370] Item 23f. A nasal interface defined in any one of items 16f-20f, having a curved space frame-like support structure.

[0371] Item 24f. A nose interface defined in any one of items 16f-23f that bends in two or more dimensions.

[0372] Item 25f. A nasal interface defined in any one of items 16f-24f, comprising two separate lateral sections joined by an overstrap bridge.

[0373] Item 26f. A nose interface defined in any one of items 16f to 25f, wherein one or more hinges have notches.

[0374] Item 27f. A nasal interface defined in any one of items 16f to 26f, wherein one or more hinges have a variable cross-sectional area.

[0375] Item 28f. A nose interface defined in any one of items 16f to 27f, wherein one or more hinges have a variable thickness.

[0376] Item 29f. A nasal interface defined in any one of items 16f to 28f, wherein one or more hinges include two or more materials with different flexibility.

[0377] Item 30f. A nasal interface defined in any one of items 16f to 29f, including one or more hinges, which are elastic hinges configured to be pre-stressed before being applied to a patient.

[0378] Item 31f. A nose interface defined in any one of items 16f to 30f, comprising one or more hinges including a barrel and a pin.

[0379] Item 32f. A nose interface defined in any one of items 16f to 30f, wherein one or more hinges include a ball and a socket.

[0380] Item 33f. Nasal interface, An elongated body comprising at least one lumen extending at least partially through the body, and configured to be coupled to a gas source, One or more prongs connected to the main body and in fluid communication with at least one lumen Equipped with, A nasal interface having a slender body whose shape roughly corresponds to the anatomical contours of the facial features of a patient or group of patients.

[0381] Item 34f. A nasal interface as defined in Item 33f, where the patient group is one of the following: premature infant, neonatal, infant, child, or adult.

[0382] Item 35f. A nasal interface as defined in item 33f or 34f, in which the tubular body is initially malleable.

[0383] Item 36f. A nasal interface defined in any one of items 33f-35f, in which the shape of the tubular body is fixed through a hardening process.

[0384] Item 37f. A nasal interface defined in any one of items 1f to 36f, wherein at least one of one or more hinges is pre-directed to bend in a pre-defined direction.

Claims

1. A nasal interface for delivering respiratory gas to a patient, wherein the nasal interface is The main body, A first side having a first nasal prong and a first tubular portion that defines a first flow path to the first nasal prong, A second side having a second nasal prong and a second tubular portion that defines a second flow path to the second nasal prong, A main unit equipped with, A bar is provided that extends between the first side and the second side and connects the first side and the second side. A nasal interface in which the length of the bar between the first connection point on the first side and the second connection point on the second side is greater than the distance between the first nasal prong and the second nasal prong.

2. The nasal interface according to claim 1, wherein the open end of the first tubular portion and the open end of the second tubular portion are configured to receive a breathing tube connected to a gas supply source.

3. The nose interface according to claim 1 or 2, wherein the first connection point between the bar and the first side of the nose interface and the second connection point between the bar and the second side of the nose interface are rigid connection points.

4. The nasal interface according to claim 1 or 2, wherein the first connection point between the bar and the first side of the nasal interface and the second connection point between the bar and the second side of the nasal interface are flexible connection points.

5. The nasal interface according to any one of claims 1 to 4, wherein the bar is made of at least partially an elastic material.

6. The nasal interface according to any one of claims 1 to 5, wherein the bar comprises an elastically deformable region.

7. The nasal interface according to any one of claims 1 to 6, wherein the first connection point of the bar to the first side and / or the second connection point of the bar to the second side are via an anchor.

8. The nasal interface according to claim 7, wherein the anchor is a hooked projection that is received by the first side and / or the second side of the main body.

9. The nasal interface according to any one of claims 1 to 8, wherein the first nasal prong and the second nasal prong extend from the respective inner ends of the first and second sides, and these inner ends are contained within the length between the first connection point and the second connection point.

10. The nose interface according to any one of claims 1 to 9, wherein the first side and the second side of the main body each include a face contact surface.

11. The nasal interface according to any one of claims 1 to 10, wherein the bar comprises a flexible polymer material.

12. The nasal interface according to any one of claims 1 to 11, wherein the bars are elastic to resist movement of the first and second sides of the body, respectively, moving away from each other.

13. The nasal interface according to any one of claims 1 to 12, wherein the bar is connected to the first tubular portion at a first end and to the second tubular portion at a second end.

14. The nasal interface according to any one of claims 1 to 13, wherein the bar is connected to the first side of the nasal interface and the second side of the nasal interface at points laterally outward from each of the nasal prongs.

15. The nasal interface according to any one of claims 2 to 14, wherein the breathing tube extends laterally at least in part from each of the first and second sides of the nasal interface.

16. The nasal interface according to any one of claims 1 to 15, further comprising a fixing system for fixing the nasal interface onto the patient's face.

17. The nose interface according to any one of claims 1 to 16, wherein each end of the bar is attached to the front surface of the first side and the second side of the main body, respectively.

18. The nasal interface according to any one of claims 10 to 17, wherein each face contact surface is coupled to the first tubular portion and the second tubular portion, respectively.

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