Patient Interface
By designing a patient interface with a variable flexible pathway and a predefined compensation area, the problem of existing interfaces being instable due to facial changes and external force application is solved, achieving higher stability and gas delivery effects.
Patent Information
- Application Number
- CN202110100908.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2015-07-30
- Filing Date
- 2015-09-18
- Publication Date
- 2025-03-11
- Estimated Expiration
- 2035-09-18
AI Technical Summary
During use, existing patient interfaces are prone to instability due to changes in facial geometry and external forces, affecting the comfort and integrity of gas delivery.
A patient interface including a body portion, a side arm and a bridge portion is designed, the body portion has a fluid path of varying flexibility, the side arm includes a predefined point or a localized compensation area to adjust the stability of the interface, and the bridge portion is isolated from the applied force.
By adjusting the flexure or bending of the side arms, it can effectively resist external forces, maintain a stable position of the interface, and improve the comfort and integrity of gas delivery.
Smart Images

Figure CN113144364B_ABST
Abstract
Description
[0001] This application is a divisional application of invention patent application No. 201580060077.0, entitled “PATIENT INTERFACE”, filed on September 18, 2015. Technical Field
[0002] The present disclosure relates to a patient interface for delivering gas to a user, and more specifically, but not exclusively, to patient interfaces for delivering a flow of gas to a user that compensate for or adjust movement or forces applied or translated to the interface during use to avoid destabilizing the interface from a therapeutic delivery position on the user, or alternatively to patient interfaces that deliver gas to the nostrils or nasal passages of a user. Background Art
[0003] There are many forms of patient interfaces for delivering gases to a user, such as full-face masks, oronasal masks, nasal masks, and nasal cannulas. It would be desirable to provide a patient interface in a manner that conforms to the varying facial geometry of a user, or that is constructed in a manner that maintains a stable position on a user or at least helps improve the maintenance of stability when external forces are applied to such a patient interface.
[0004] There are a variety of patient interfaces available to users, each of which may have their own stability issues.
[0005] The stability of the interface used on the user is important at least for reasons of comfort and maintenance of the desired therapeutic delivery to the user. To achieve one or both of these results, or other results, it would be useful to provide an alternative patient interface with improved stability and / or performance located on the user's face.
[0006] Instability of the interface may result in movement of the interface or components of the interface, which may affect the desired delivery or integrity of therapy for the user.
[0007] Instability of the interface used on a user in different modes may be the result of, for example, loads caused by the user speaking and changing the geometry of the user's face where the interface is positioned. Facial geometry, such as that of humans, varies greatly due to a large number of factors. These factors may include, but are not limited to, gender, age, or specific medical symptoms. Incorrect size estimates and geometry of the interface for a particular user may also adversely affect the stability and usability of the interface for a particular patient.
[0008] With respect to facial movement, when a user speaks, eats, cries, or their facial features are distorted or exaggerated, such movement may affect the stability of the patient interface or components of the interface on the user, such as a nasal prong like a nasal cannula or a pair of such prongs, which may inadvertently disengage from a gas delivery position for delivering gas to the nostrils of the user's nose. Longer term changes in facial features may also be caused by aspects such as the user's posture (e.g., while sleeping). Long term changes in geometry may also occur as a result of user growth and injury recovery.
[0009] In conjunction with the above, it will be appreciated that forces or movements may be transmitted to the interface and its components, whether due to changes in the geometry of the user to which the patient interface is positioned, or due to other forces, such as due to the user pulling on tubing or other components of the interface or attached thereto, for example. The application of such forces may cause issues with stability, comfort, and operational use of the patient interface for the user.
[0010] Further aspects and advantages of the invention will become apparent from the following description which is given by way of example only. Summary of the invention
[0011] It is therefore an object of certain embodiments disclosed herein to provide a patient interface or at least a portion of a patient interface that, when implemented as a patient interface, will go to at least some length to address the aforementioned problems or will at least provide the industry / public with a useful choice.
[0012] According to at least one of the aspects disclosed herein, there is provided a patient interface, such as a nasal cannula, comprising:
[0013] a. a main body portion which, in use, is to be positioned on the face of a user, the main body portion having a side arm or preferably a pair of said side arms extending laterally from a substantially central bridge portion which, in use, is to be positioned in or around the septum region of a user,
[0014] b. at least one and preferably a pair of nasal prongs extending from the bridge portion to be inserted into or direct a flow of gas into one or more nostrils of the user's nose in an operating position,
[0015] c. the main body portion having at least one fluid passage connected to the one or more nasal prongs for supplying gas to the one or more nostrils of the user's nose,
[0016] d. wherein the cross-section of the passageway varies along the length of the body portion so as to provide a region of varying flexibility along the body portion.
[0017] In some embodiments, the or each said side arm comprises one or more predefined or prearranged points or localised compensation areas (or parts) positioned along the side arm so as to adjust or assist in compensation of the patient interface in or at one or more of these compensation areas (or parts), and wherein when a force applied to the patient interface may be experienced by one or more side arms of the interface, these compensation areas (or parts) of the side arm or the side arm elements or both adjust the force by flexing or bending or articulating or other displacement of the side arm or the side arm elements or both.
[0018] In some embodiments, one or more of these compensation regions (or areas) are regions or areas that pass through or surround a bending region or an articulation region that passes through at least two different (non-parallel) planes of the interface.
[0019] In some embodiments, the bridge portion includes a bridge portion element, and the bridge portion, the bridge portion element, or both the bridge portion and the bridge portion element are substantially isolated from forces applied to or experienced by the patient interface.
[0020] In some embodiments, the bridge portion element and the one or more side arm elements are separate parts that can be assembled to form a unitary structure.
[0021] In some embodiments, the bridging portion element is sized to span the width of the user's septum region, or is sized to be the distance or width between air outlets, or is sized to be defined by the maximum distance spanned from one nasolabial groove to another nasolabial groove of the user, and the side arm element is sized to extend away at least partially along the length of the side arm.
[0022] In some embodiments, the bridging portion element includes one or a pair of cutouts or shaped portions to locate, position or accommodate at least one or a pair of outlets of a gas delivery system for supplying gas to the airway of a user.
[0023] In some embodiments, the bridge portion element is or includes a textile material and is positioned on an outer surface of the bridge portion, wherein the bridge portion element adds stiffness to the bridge portion so as to maintain the distance between the nose prongs.
[0024] In some embodiments, the or each said side arm comprises at least one substantially elastic or relatively more rigid side arm element which at least partially defines the form or curvature of the or each side arm and has one or more predefined or prearranged points or localized compensation areas (or locations) positioned along the or each side arm and / or the or each side arm element so as to adjust the compensation of the patient interface in one or more of the compensation areas (or locations) or at one or more of the compensation areas (or locations), and wherein the one or more side arms are patient interface stabilizers.
[0025] In some embodiments, the side arm element includes one or more cutouts to allow flexure of the side arm element, such that the side arm portion can flex in response to the application of a force.
[0026] In some embodiments, the interface is overmolded onto the bridging portion element and the side arm element.
[0027] According to at least one of the aspects disclosed herein, there is provided a patient interface comprising:
[0028] a. a main body portion which, in use, will be positioned on the user's face, the main body portion having a left arm and a right arm and a bridge portion located between the left arm and the right arm,
[0029] b. at least one nasal prong extending from the bridge portion to be inserted into or direct a gas flow into one or more nostrils of the user's nose in an operating position,
[0030] c. the main body portion having at least one fluid passage connected to the one or more nasal prongs for supplying gas to the one or more nostrils of the user's nose,
[0031] d. wherein the cross-section of the passageway varies along the length of the body portion so as to provide a region of varying flexibility along the body portion.
[0032] In some embodiments, the shape of the cross-section of the passageway varies along at least a portion of the length of the main body portion and changes from a substantially circular cross-section at or near an outer end for connection with a breathing tube or conduit (releasably or permanently) to an elongated cross-section having a longer axis arranged substantially vertically (parallel to the user's face).
[0033] In some embodiments, the elongated section is disposed in or forms a bending region or hinged portion of the main body portion, the elongated section providing greater flexibility for bending of the main body portion toward or away from the user's face in the direction of the shorter axis of the elongated section.
[0034] In some embodiments, the at least one nose fork includes a pair of nose forks, and the bridging region includes a solid section located between these nose forks, so that the bridging region is more rigid than these curved regions, and the bridging region has a height or vertical dimension sufficient to provide torsional stability and prevent the bridging region from twisting during use.
[0035] In some embodiments, the bridge portion comprises thicker wall sections than wall sections of the bending regions, such that the bridge portion is more rigid than the bending regions.
[0036] In some embodiments, the bridging portion comprises a further more rigid material so as to provide rigidity to the bridging region, the bridging portion being formed from a different rigid material to the material forming the remainder of the patient interface.
[0037] In some embodiments, the side arms comprise one or more side arm elements provided to or within the side arms of the interface, the side arm elements being formed of a rigid material so as to provide stiffness to the side arms / portions, the side arm elements further comprising one or more cutouts or notches to allow the side arms to flex / articulate in response to forces applied to or experienced by the side arms.
[0038] In some embodiments, the bridge portion transitions to the left arm and the right arm by extending outwardly away from the user's facial side of the bridge portion in an abducted or bent manner, the left arm and the right arm bend backward away from the bridge portion from the front extension of the main body portion, and the one or more curvatures of the user's facial side of the bridge portion and / or the transition area between the bridge portion and the left arm and the right arm have a relatively large radius (or multiple radii), so that pressure from the bridge and / or these transition areas on the user's face is spread over the philtrum or upper lip area of the user.
[0039] In some embodiments, the main body portion includes a U-shaped area located between the at least one nose fork and the adjacent left arm and right arm when the main body portion is viewed from above, the inner side of the U-shaped area faces the user's face during use, and each U-shaped area is formed or arranged in a bending area where the main body portion preferentially bends when the left portion or the right portion of the main body portion is flexed toward or away from the user's face, and the bending area tends to bend in the recess of the U-shaped area.
[0040] In some embodiments, the interior angle of the U-shaped region is less than about 130 degrees, or 120 degrees, or 110 degrees, or 105 degrees.
[0041] In some embodiments, the patient interface is a single integrally formed component formed from a single material in a single molding operation, wherein the patient interface is formed from a thermoplastic or silicone material having a Shore A durometer of approximately 5 to 60.
[0042] In some embodiments, the cross-section of the passage at the base of at least one nasal fork is an asymmetric cross-section, one side of the cross-section is flatter than the opposite side of the cross-section, and the shape of the passage extending along at least one nasal fork changes from the asymmetric cross-section at or near the base of at least one nasal fork to a circular cross-section at or near the tip of at least one nasal fork.
[0043] In some embodiments, the cross-sectional area of at least one nasal prong decreases from the base to the tip of the nasal prong, and the flatter side of at least one nasal prong is positioned toward the forward side of the patient interface (away from the user's face).
[0044] In some embodiments, at least one nasal prong has a base integrally formed with the bridging portion of the main body portion of the patient interface, and wherein the base of at least one nasal prong includes a fillet located between a wall of the nasal prong and the bridging portion, the fillet extending around the periphery of at least one nasal prong, and wherein the radius of the fillet varies around the periphery of at least one nasal prong.
[0045] In some embodiments, the patient interface includes at least one pad of a retention system for holding the interface in an appropriate position, and when worn by a user in use, these pads are attached to at least one of the left arm and the right arm of the main body portion, and the pads are substantially symmetrical about a central approximately vertical axis, and the vertical axis divides the pads into a left side and a right side, so that pads of the same shape can be applied to both the left arm and the right arm of the main body portion. Optionally, each of the at least one pad is attached to the corresponding left part or right side part by overmolding with an overmolding material, whether by integrally molding the interface with the pad or the at least one pad or subsequently attached to the interface by overmolding the interface with the pad.
[0046] In some embodiments, the retention system comprises a two-part releasable attachment (or connection) device comprising:
[0047] a. Skin patches and user interface patches,
[0048] b. The skin patch has a patient side and an interface side,
[0049] c. The patient side of the skin patch can be attached to the user's skin, (e.g., by an adhesive, typically a skin-sensitive adhesive such as a hydrocolloid),
[0050] d. the interface side of the skin patch is provided with a first part of a two-part releasable attachment or connection system, and
[0051] e. the user interface patch having an interface side and a patient side,
[0052] f. the patient side of the user interface patch is provided with a complementary second part of the two-part releasable attachment or connection system,
[0053] g. The interface side of the user interface patch is attachable (or connectable) to the user interface and / or components associated with the user interface (eg, a tube or conduit).
[0054] In some embodiments, the body portion or at least the left side arm or the right side arm is co-molded or over-molded with the retention system such that the cushion is retained on or within the side arm portions of the interface.
[0055] In some embodiments, each of the left arm and the right arm includes one or more predefined or prearranged points or localized compensation areas (or parts), and the one or more predefined or prearranged points or localized compensation areas (or parts) are positioned along the or each side arm to adjust the compensation of the patient interface in one or more of the compensation areas (or parts) or at one or more of the compensation areas (or parts), and the one or more predefined or prearranged points or localized compensation areas (or parts) are constructed to adjust forces by flexure or bending or articulation or other displacement.
[0056] In some embodiments, one or more of these compensation regions (or areas) are regions or areas that pass through or surround a bending region or an articulation region that passes through at least two different (non-parallel) planes of the interface.
[0057] In some embodiments, the bridge portion includes a bridge portion element, and the bridge portion, the bridge portion element, or both the bridge portion and the bridge portion element are substantially isolated from forces applied to or experienced by the patient interface.
[0058] According to at least one of the aspects disclosed herein, there is provided a patient interface comprising:
[0059] a. a side arm or preferably a pair of said side arms, the side arm or side arms extending laterally from a substantially central bridge portion which, in use, will be positioned in or around the septum region of a user,
[0060] b. wherein the or each said side arm is connected to a substantially elastic or relatively more rigid bridging portion element which defines a substantially predetermined spatial relationship for one or more outlets of a gas delivery system having the or each said side arm.
[0061] According to at least one of the aspects disclosed herein, there is provided a patient interface comprising:
[0062] a. a side arm or preferably a pair of said side arms, the side arm or side arms extending laterally from a substantially central bridge portion which, in use, will be positioned in or around the septum region of a user,
[0063] b. the or each said side-arm comprises one or more predefined or pre-arranged points or localised compensation areas (or sites) positioned along the side-arm so as to adjust or facilitate compensation of the patient interface in or at one or more of these compensation areas (or sites), and
[0064] c. wherein the or each said side arm is connected to a substantially elastic or relatively more rigid bridging portion element which defines a substantially predetermined spatial relationship for one or more outlets of a gas delivery system having the or each said side arm.
[0065] According to at least one of the aspects disclosed herein, there is provided a patient interface comprising:
[0066] a. a side arm or preferably a pair of said side arms, the side arm or side arms extending laterally from a substantially central bridge portion which, in use, will be positioned in or around the septum region of a user,
[0067] b. the or each said side arm comprises at least one substantially elastic or relatively more rigid side arm element which at least partially defines the form or curvature of the or each side arm and has one or more predefined or prearranged points or localised compensation areas (or locations) positioned along the or each side arm and / or the or each side arm element so as to adjust the compensation of the patient interface in or at one or more of the compensation areas (or locations), and
[0068] c. wherein the or each said side arm element is connected or interconnected via a connecting material to a substantially elastic or relatively more rigid bridging portion element which defines a substantially predetermined spatial relationship for one or more outlets of a gas delivery system having the or each said side arm.
[0069] According to one or more of the above aspects, one or more of the following additional embodiments may be provided.
[0070] In some embodiments, the bridge portion or the bridge portion elements (or both) are substantially isolated from forces such as may be applied to or may be experienced by the patient interface.
[0071] In some embodiments, the force applied to the patient interface can be experienced by one or more side arms of the interface, and these compensation areas (or portions) of the side arm or the side arm elements or both adjust the force through flexure or bending or articulation or other displacement of the side arm or the side arm elements or both.
[0072] In some embodiments, the one or more side arms are patient interface stabilizers.
[0073] In some embodiments, the bridge portion element and the one or more side arm elements are separate parts that are assembled to form a single component.
[0074] In some embodiments, the bridge portion element and the one or more side arm elements are a single component, or at least the bridge portion and the at least one side arm element are a single component.
[0075] In some embodiments, the bridge portion element and the one or more side arm elements are integrally formed as a single component, or at least the bridge portion and at least one side arm element are integrally formed as a single component.
[0076] In some embodiments, the bridging portion element and the one or more side arm elements are formed as an integral component.
[0077] In some embodiments, the bridging portion element and at least one of the one or more side arm elements are separate components, and each of the bridging portion element and at least one of the one or more side arm elements can be substantially interconnected or provided by the material of the patient interface, such as one or more side arms, in an interconnected relationship with each other.
[0078] In some embodiments, the bridging portion element is a discontinuous component from one or more side arm elements.
[0079] In some embodiments, the side arm comprises one or more individual side arm elements, each of which passes through or is spaced apart along the length of the side arm.
[0080] In some embodiments, each of the one or more individual side arm elements are spaced apart as an array across or along the length of one or each of the side arms.
[0081] In some embodiments, the bridging portion element and the one or more side arm elements are separate parts connected or interconnected to each other via one or a pair of associated side arms and optionally the bridging portion, the associated side arm being composed of one or more associated side arm elements.
[0082] In some embodiments, each individual side arm element provides a relatively elastic portion, and the material of the side arm is inserted between or adjacent to each individual side arm element, and the material of the side arm provides a compensation area (or region).
[0083] In some embodiments, the patient interface comprises a bridge portion and at least one separate side-arm element located in each of one or a pair of side-arms.
[0084] In some embodiments, the bridging portion is disposed in the middle of a pair of side arms.
[0085] In some embodiments, the bridging portion element is arranged in the middle of these side arm elements of a pair of side arms.
[0086] In some embodiments, the bridging portion element has a size that is (sufficient) for spanning the width of the user's septum region, or has a size that is the distance or width between the air outlets, or has a size defined by the maximum distance spanned from one nasolabial groove to another nasolabial groove of the user.
[0087] In some embodiments, the bridging portion element includes one or a pair of cutouts or shaped portions to locate, position or accommodate at least one or a pair of outlets of a gas delivery system for supplying gas to the airway of a user.
[0088] In some embodiments, the bridging portion element includes one or a pair of cutouts or molded portions to position, place or accommodate a nasal prong or a pair of nasal prongs as the one or more outlets of the gas delivery system for supplying gas to one or more nostrils of the user.
[0089] In some embodiments, one or more of these compensation regions (or areas) facilitate flexure or bending or articulation or localized displacement and / or elastic deformation.
[0090] In some embodiments, one or more of these compensation regions (or areas) are regions or areas that pass through or surround a bending region or an articulation region that passes through at least one plane of the interface.
[0091] In some embodiments, one or more of these compensation regions (or areas) are regions or areas that pass through or surround bending regions or articulation regions that pass through multiple parallel planes of the interface.
[0092] In some embodiments, one or more of these compensation regions (or areas) are regions or areas that pass through or surround a bending region or an articulation region that passes through at least two different (non-parallel) planes of the interface.
[0093] In some embodiments, one or more of the compensation regions (or areas) are regions or areas that pass through or surround a bending region or an articulation region that passes through at least two different (orthogonal) planes of the interface.
[0094] In some embodiments, the one or more compensation regions (or parts) flex or bend (or articulate or can be locally displaced or elastically deformed or moved), more preferably in one or more first directions, or a first group of directions, and less preferably in another direction or another group of directions.
[0095] In some embodiments, the one or more compensation regions (or areas) are constructed or adapted to substantially resist flexing or bending (or articulation or local displacement or elastic deformation) in a less preferred direction or set of directions.
[0096] In some embodiments, the first direction or first set of directions is in a substantially transverse plane.
[0097] In some embodiments, the first direction or first set of directions is in a substantially transverse plane, in a ventral direction or a dorsal direction, or can be in both the ventral direction and the dorsal direction.
[0098] In some embodiments, the first direction or first set of directions is in one or more of: a substantially transverse plane, a substantially sagittal plane, and / or in a substantially coronal plane.
[0099] In some embodiments, the first direction or the first set of directions is in one or more directions that substantially facilitate movement or bending of the side arm element relative to the bridging portion element.
[0100] In some embodiments, the side arm elements are formed of a substantially elastic material, or are constructed or adapted to provide substantial elasticity in these side arm element regions for flexing or bending (or for articulation or local displacement or elastic deformation), these side arm element regions are selected from one or more of the following:
[0101] a. disposed between a single compensation region (or portion) positioned laterally outwardly from the bridging portion element and the outer end of the side arm element,
[0102] b. disposed between the outer compensation region (or portion) of the side arm member and the outer end of the side arm member,
[0103] c. disposed between each of a series of compensation regions (or locations) of the side arm element,
[0104] d. It is arranged between two compensation areas (or parts) located laterally outward from the bridging portion element, and is located between the outer compensation area (or part) of the side arm element and the outer end of the side arm element.
[0105] In some embodiments, each side arm element includes a single compensation region (or site).
[0106] In some embodiments, each side arm element includes two compensation regions (or areas).
[0107] In some embodiments, each side arm element includes three compensation regions (or sites).
[0108] In some embodiments, each side arm element includes multiple compensation areas (or regions).
[0109] In some embodiments, at least one compensation region (or location) is located at the more inner end of the side arm element that is connected to the bridge portion element.
[0110] In some embodiments, at least one of these compensation areas (or locations) is located at the junction or connection between the side arm element and the bridge portion element.
[0111] In some embodiments, at least one of these compensation areas (or locations) is located in an area of the bridging portion element that is substantially defined by the periphery, lateral exterior, or edges of the user's septum area or is located at an area of the bridging portion element that is substantially defined by the periphery, lateral exterior, or edges of the user's septum area.
[0112] In some embodiments, the or each side arm element is configured to flex or bend (or articulate or partially displace or be elastically deformable or movable) relative to the bridging portion element.
[0113] In some embodiments, the side arm element further comprises one or more small protrusions.
[0114] In some embodiments, wherein the one or more tabs are engageable, or are configured to be in a shape or configuration to associate with the material of the side arm.
[0115] In some embodiments, the interaction or engagement of the tab with the material of the side arm provides resistance to flexing or bending (or articulation or elastic deformation) of the side arm element.
[0116] In some embodiments, wherein the material of the side arm is at least partially compressible (or may be substantially incompressible or partially compressible), the one or more protrusions can translate the force or movement experienced by the side arm element into compression of the material of the side arm (or can translate the force or movement experienced by the side arm element into extension of the material when the material is placed under tension due to the one or more protrusions).
[0117] In some embodiments, the material of the side arm encapsulates or encapsulates the at least one side arm element.
[0118] In some embodiments, the side arm partially encapsulates or partially encloses at least one side arm element.
[0119] In some embodiments, the side arm completely encapsulates or encloses at least one side arm element.
[0120] In some embodiments, the material of the side arm fills one or more gaps between the side arm element and the side arm.
[0121] In some embodiments, the material of the side arm surrounds the side arm element, thereby positioning the side arm element at or in or adjacent to the one or more predefined or prearranged points or localized compensation areas (or locations).
[0122] In some embodiments, when a pair of side arms are provided, each of the side arms extends laterally from the bridging portion, one side arm of the pair of side arms is provided to extend substantially around the left side of the user's face, and the other side arm of the pair of side arms is provided to extend substantially around the right side of the user's face.
[0123] In some embodiments, the or each side arm extends substantially around the user's face, optionally extending along at least a portion of the user's cheek.
[0124] In some embodiments, the or each side arm extends substantially laterally away from or outwardly from the sagittal plane of the user.
[0125] In some embodiments, the or each side arm element extends along at least a portion of the length or the entire length of or along or through each such side arm that includes said side arm element.
[0126] In some embodiments, the or each side arm element is comprised of a plurality of side arm element branches.
[0127] In some embodiments, the side arm element branches contain or include one or more small protrusions.
[0128] In some embodiments, the or each side arm or side arm element or both are formed or formed so as to provide at least a portion of a passageway for receiving a supply of gas to be delivered to a user via the one or more outlets or for receiving a conduit for delivering gas to a user via the one or more outlets.
[0129] In some embodiments, the side arm forms the passageway.
[0130] In some embodiments, the one or more side arm elements form the passageway.
[0131] In some embodiments, the portion of the passageway at least partially formed by the one or more side arm elements is at least 50% of the wall circumference or wall perimeter (eg per unit length segment) of the passageway so formed.
[0132] In some embodiments, the portion of the passageway at least partially formed by the side arm is the remainder of a wall circumference or wall perimeter (eg, of a unit length segment) otherwise formed by the one or more side arm elements.
[0133] In some embodiments, the passage is a void space or cavity or recess in or through the one or more side arms or side arm elements or both, through which gas can be directed or supplied for delivery to the one or more outlets.
[0134] In some embodiments, the passageway is at least partially defined by the sidearm and at least partially by the sidearm element.
[0135] In some embodiments, the side arm includes a port for accessing a passageway extending to the one or more gas outlets for delivering gas to the one or more gas outlets.
[0136] In some embodiments, each side arm of a pair of side arms includes a port for accessing a passage extending through each side arm to an associated air outlet.
[0137] In some embodiments, each side arm provides a separate passageway for delivering gas separately to an associated gas outlet.
[0138] In some embodiments, the one or more side arms will be positioned on the user's face during use.
[0139] In some embodiments, the one or more side arms will be positioned on the cheeks of the user's face during use.
[0140] In some embodiments, the interface is a nasal cannula comprising a pair of nasal prongs as the outlets, and wherein a head cap or retention system is attachable to a pair of side arms for holding the nasal cannula in place when worn by a user in use.
[0141] In some embodiments, the retention system includes a releasable connection system for releasably connecting the patient interface, such as at least the rear portion of each side arm, to the user's face (e.g., the releasable connection system may be comprised of a hook and loop or hook and hook type connector for such a releasable system).
[0142] In some embodiments, the releasable connection system includes at least one cushion attached to the user's face, and the patient interface is releasably engageable to the at least one cushion on the user's face.
[0143] In some embodiments, the bridging portion element is or includes a polymer material.
[0144] In some embodiments, the or each side arm element is or comprises a polymer material.
[0145] In some embodiments, the polymer material is one or a combination of any one or more of the following: one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, more preferably the polymer may be those, such as but not limited to: polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, for example, a thermoplastic elastomer series, such as styrene block copolymers, copolyester elastomers, or thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, more preferably a polymer having a Shore A hardness of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80 or about 90.
[0146] The nasal prongs can be used as a patient interface in a high flow therapy system. When assembled, gas is directed through the nasal delivery elements (e.g., tubular prongs) of the nasal cannula, which rest in the patient's nostrils. In some patients, and particularly for newborn or infant patients, when the face is distorted due to compressive forces applied by another object (e.g., when resting the face against a pillow or bed frame) or due to the expression of emotion (e.g., when crying or frowning), the force applied to the nasal cannula can cause the nasal delivery elements to be pushed out of the nostrils. Although the nasal cannula can be constructed so that many such forces will have a reduced tendency to cause the nasal delivery elements to be dislodged from the nostrils (see, e.g., co-owned PCT / NZ2014 / 000217, co-owned US61 / 891697, co-owned US61 / 919579, co-owned US62 / 052980, or co-owned US62 / 064106, the disclosures of each of which are incorporated herein by reference in their entirety), in some cases, the nasal delivery elements may still deploy from one another when such forces are applied. Solutions to these above difficulties have been found.
[0147] In some embodiments, the patient interface includes: a first side arm, which is adapted to be located on or adjacent to a first portion of a user's face; a second side arm, which is adapted to be located on or adjacent to a second portion of the user's face; a bridge, which extends between the first side arm and the second side arm and links the first side arm and the second side arm; and a support structure, which is positioned on at least a portion of the bridge.
[0148] In some embodiments, the support structure extends over the entire bridge. In some constructions, the support structure is positioned on at least a portion of the user-facing portion of the bridge. In some constructions, the support structure is positioned on a portion of the non-user-facing portion of the bridge. In some constructions, the support structure is positioned over the entire non-user-facing portion of the bridge. In some constructions, the user-facing portion of the bridge is adapted to rest on or adjacent to the philtrum of the user. In some constructions, the support structure is configured to resist tension. In some constructions, the support structure is configured to resist compression. In some constructions, the support structure is configured to resist shear forces. In some constructions, the support structure changes the neutral axis of the bridge in use in order to reduce or resist bending within the bridging section.
[0149] In some embodiments, the support structure is at least partially formed of a textile material. In some such configurations, the textile material is a woven, non-woven or knitted textile material.
[0150] In some embodiments, the support structure is a sheet of material. In some configurations, the support structure comprises a rigid material. In some configurations, the support structure comprises a semi-rigid material.
[0151] In some embodiments, the support structure is formed of a polymer material. In some configurations, the support structure and the bridge are at least partially formed of the same polymer material. In some configurations, the polymer material comprises a tough and flexible polymer. In some configurations, the polymer material comprises a rigid polymer. In some configurations, the support structure is formed of a material that is more rigid than the material forming the bridge.
[0152] In some configurations, the first body is adapted to rest on the cheek of the user.
[0153] In some embodiments, the first side-arm and the second side-arm are adapted to rest on opposite cheeks of the user.
[0154] In some embodiments, the first side arm and / or the second side arm include one or more nasal delivery elements or nasal prongs adapted to rest in one or more nostrils of the user. In some such structures, the one or more nasal delivery elements are configured to allow ambient gas outside the patient interface to pass through the nostrils. In other words, the nasal delivery elements can be positioned in the nostrils in a non-sealed manner. In some such structures, the one or more nasal delivery elements are shaped or angled so that they extend inwardly toward the septum of the user. In some such structures, the one or more nasal delivery elements are shaped or angled so that the tip of the one or more nasal delivery elements points to the back of the user's head during use. In some such structures, the first side arm and / or the second side arm include one or more gas delivery lumens pneumatically connected to the one or more nasal delivery elements. In some such structures, one or more gas delivery conduits can be pneumatically connected to the one or more gas delivery lumens. In other structures, the one or more nasal delivery elements can be configured to be positioned in the nostrils in a sealed manner.
[0155] In some embodiments, the support structure extends along the first side arm and / or the second side arm. In some such configurations, the support structure extends along the user-facing portion of the first side arm and / or the second side arm. In some such configurations, the support structure extends only along the user-facing portion of the first side arm and / or the second side arm. In some such configurations, at least a portion of the support structure present on these user-facing portions of the first side arm and / or the second side arm is adapted to dock with one or more fixed structures fastened to the face so as to reinforce the patient interface to the face. In some configurations, the support structure extends along the non-user-facing portion of the first side arm and / or the second side arm.
[0156] In some embodiments, the patient interface is shaped to match the contour of the face of the user. In some configurations, the first side arm and / or the second side arm include one or more hinged or pivot joints, allowing the first side arm and / or the second side arm to move relative to each other and / or relative to the bridge.
[0157] In some embodiments, the first side arm and / or the second side arm comprises one or more areas of reduced thickness relative to adjacent areas of the first side arm and / or the second side arm. In some such configurations, the one or more areas of reduced thickness are positioned on portions of the first side arm and / or the second side arm that rest on one or more cheeks of the user. In some such configurations, the one or more areas of reduced thickness are positioned on the outer edges of the first side arm and / or the second side arm. In some configurations, the one or more areas of reduced thickness are positioned only on the outer edges of the first side arm and / or the second side arm.
[0158] In some constructions, the patient interface includes one or more attachment structures secured to the user-facing portion of the first side arm and / or the second side arm, the one or more attachment structures being adapted to interface with one or more fixing structures secured to the face so as to secure the patient interface to the face.
[0159] According to at least one of the aspects disclosed herein, a nasal cannula is provided, comprising: a first side arm and a second side arm adapted to be located on or adjacent to opposite cheeks of a user; at least one nasal delivery element extending from the first side arm and / or the second side arm and adapted to be non-sealedly resting in one or more nostrils of the user; a bridge linking the first side arm and the second side arm; and a reinforcement structure positioned on at least a portion of the bridge.
[0160] In other embodiments, the at least one nasal delivery element may be adapted to sealingly rest in one or more nostrils of the user.
[0161] In some embodiments, the reinforcing structure is positioned on only a portion of the bridge. In some configurations, the reinforcing structure is positioned on at least a portion of the user-facing portion of the bridge. In some such configurations, the reinforcing structure is positioned on only a portion or all of the user-facing portion of the bridge. In some configurations, the reinforcing structure is configured to resist compressive forces. In some configurations, the reinforcing structure is configured to resist tensile forces. In some configurations, the reinforcing structure is configured to resist shear forces. In some configurations, the reinforcing portion is configured to resist bending in use by offsetting the neutral axis of the bridge.
[0162] In some embodiments, the reinforcement structure is at least partially formed of a textile material. In some such configurations, the textile material is a woven, non-woven or knitted textile material.
[0163] In some embodiments, the reinforcing structure is a sheet. In some configurations, the reinforcing structure comprises a rigid material. In some configurations, the reinforcing structure comprises a semi-rigid material.
[0164] In some embodiments, the reinforcing structure and the bridge are at least partially formed of the same polymer material. In some configurations, the polymer material comprises a tough and flexible polymer. In some configurations, the polymer material comprises a rigid polymer. In some configurations, the reinforcing structure comprises a material that is more rigid than the material forming the bridge.
[0165] In some embodiments, the at least one nasal delivery element is shaped or angled so that it extends inwardly toward the septum of the user.
[0166] In some embodiments, the at least one nasal delivery element is shaped or angled such that, in use, the tip of the at least one nasal delivery element is directed toward the back of the user's head.
[0167] In some embodiments, the first side arm and / or the second side arm comprises one or more gas delivery lumens in pneumatic communication with the at least one nasal delivery element. In some such configurations, the nasal cannula further comprises one or more gas delivery conduits in pneumatic communication with the one or more gas delivery lumens.
[0168] In some embodiments, the reinforcing structure extends along the first side arm and / or the second side arm. In some such structures, the reinforcing structure extends along the user-facing portion of the first side arm and / or the second side arm. In some such structures, the reinforcing structure extends only along the user-facing portion of the first side arm and / or the second side arm. In some such structures, at least a portion of the reinforcing structure present on these user-facing portions of the first side arm and / or the second side arm is adapted to dock with one or more fixed structures fastened to the face so as to reinforce the patient interface to the face. In some structures, the reinforcing structure extends across the non-user-facing portion of the first side arm and / or the second side arm. In some structures, the reinforcing structure is positioned on the non-user-facing portion of the bridge. In some structures, the user-facing portion of the bridge is adapted to rest on the philtrum of the user or adjacent to the philtrum of the user.
[0169] In some embodiments, the nasal cannula is shaped to match the contours of the face of the user.
[0170] In some embodiments, the first side arm and / or the second side arm include one or more areas of reduced thickness relative to adjacent areas of the first side arm and / or the second side arm. In some such configurations, the areas of reduced thickness are positioned on the outer edges of the first side arm and / or the second side arm. In some such configurations, the areas of reduced thickness are positioned only on the outer edges of the first side arm and / or the second side arm.
[0171] In some constructions, the nasal cannula further includes one or more attachment structures fastened to the user-facing portion of the first side arm and / or the second side arm, the one or more attachment structures being adapted to dock with one or more fixing structures fastened to the face so as to secure the nasal cannula to the face.
[0172] According to at least one of the aspects disclosed herein, a nasal cannula is disclosed. The nasal cannula includes: a first side arm adapted to rest on a first portion of a user's face; a second side arm adapted to rest on a second portion of the user's face; and at least one nasal delivery element extending from the first side arm and / or the second side arm and adapted to rest in one or more nostrils of the user in a non-sealing manner; wherein the first side arm and / or the second side arm includes one or more regions of reduced thickness relative to adjacent regions of the first side arm and / or the second side arm.
[0173] In some embodiments, the first side-arm and the second side-arm are adapted to rest on opposite cheeks of the user.
[0174] In some embodiments, the one or more areas of reduced thickness are positioned on a portion of the first side-arm and / or the second side-arm that rests on one or more cheeks of the user.
[0175] In some embodiments, the one or more regions with reduced thickness are positioned only on the outer edges of the first side arm and / or the second side arm. In some such configurations, the one or more regions with reduced thickness are positioned only on the outer edges of the first side arm and / or the second side arm.
[0176] In some embodiments, the nasal cannula further comprises a bridge linking the first side arm and the second side arm.
[0177] According to at least one of the aspects disclosed herein, a patient interface, such as a nasal cannula, comprises:
[0178] a. a pair of corresponding left and right arms which, in use, will be positioned on the user's face,
[0179] b. at least one and preferably a pair of nasal prongs to be inserted into or direct the flow of gas into one or more nostrils of a user's nose, and
[0180] c. a bridge member attached to or extending from a point of connection with the left side arm to a point of connection with the right side arm, one or each of these corresponding connection points including a primary movable joint, such as a hinged or pivotal joint, thereby allowing primary movement of the bridge member relative to the corresponding side arm.
[0181] In some embodiments, the primary movable joint allows relative rotation between the end of the bridge and the corresponding side arm about at least one axis.
[0182] In some embodiments, the primary movement joint is one or a combination of: an articulated joint, a pin and barrel type joint, a ball and socket joint.
[0183] In some embodiments, each side-arm includes a facial pad that is contoured to engage an area of the user's face.
[0184] In some embodiments, at least one and preferably the pair of nose forks extend from one or each of the more inward ends of the corresponding left and / or right arms, or from an area substantially adjacent to these more inward ends of one or both of the corresponding side arms, and wherein the bridging member is a rod extending on or adjacent to the one or more nose forks.
[0185] In some embodiments, the patient interface further includes a mounting member attached to the corresponding side arm to facilitate a connection point for the rod, the mounting member including a secondary movable joint, such as a hinged or pivot joint, thereby allowing secondary movement of the mounting member relative to the corresponding side arm, the mounting member being attached to the corresponding side arm, and the rod being attached to the mounting member via a primary movable joint.
[0186] In some embodiments, the mounting member is slidably attached to the corresponding side arm to allow adjustment of the relative position along the side arm to adjust the distance between the nose prongs.
[0187] In some embodiments, when the patient interface is in position on the user's face, shifts in the position of one or both of the left and / or right arms are transmitted to the stem via one or more connection points or one or more mounting members and corresponding primary and / or secondary movable joints in a manner that minimizes movement of one or more nasal prongs relative to the user's nostrils.
[0188] In some embodiments, the primary and secondary movable joints are aligned to allow movement of the attachment components in substantially the same orientation.
[0189] In some embodiments, the primary and secondary movable joints are misaligned to allow movement in different orientations.
[0190] In some embodiments, the rod includes one or more additional movable joints.
[0191] In some embodiments, the left and right arms, including the nose prongs, are relatively flexible or uniformly covered relative to the pole and / or the one or more mounting members.
[0192] In some embodiments, the connection point or one or more mounting members include fingers extending outwardly therefrom on which the primary movable joint is located for connection to the pole.
[0193] In some embodiments, the rod is an over-center component of the patient interface, with the connection point or one or more mounts symmetrically located on each of one or more corresponding side arms.
[0194] In some embodiments, the secondary movable joint is one or a combination of: an articulated joint, a pin and barrel type joint, and a ball and socket joint.
[0195] In some embodiments, the bridge comprises at least one, and preferably a pair of nose prongs.
[0196] In some embodiments, each primary movable joint is disposed between a distal end of the bridge member and an inner end of a corresponding side arm.
[0197] In some embodiments, the primary movable joint allows relative rotation between the ends of the bridge and the corresponding side arms about three substantially orthogonal axes.
[0198] In some embodiments, the primary movable joint comprises a ball and socket joint.
[0199] In some embodiments, a pair of primary movable joints are provided between each end of the bridge and the inner ends of the corresponding left and right arms.
[0200] In some embodiments, when the patient interface is in position on the user's face, shifts in the position of one or both of the left and / or right arms are transmitted to one or each primary movable joint in a manner that minimizes shifts of the bridge and one or more nasal prongs relative to the user's nostrils.
[0201] According to at least one of the aspects disclosed herein, a patient interface, such as a nasal cannula, comprises:
[0202] a. a main body portion which, in use, will be positioned on the user's face, and
[0203] b. at least one and preferably a pair of nasal prongs extending from the body portion to be inserted into or direct a flow of gas into one or more nostrils of the user's nose in an operating position,
[0204] c. the body has at least one hollow area having a fluid channel connected to the one or more nasal prongs for supplying gas to the one or more nostrils of the user's nose, and
[0205] d. wherein, during the supply of fluid through the fluid channel, the hollow region substantially resists the transmission of displacement forces from one or more regions of the main body portion to one or more nasal prongs and maintains the operating position of these nasal prongs.
[0206] In some embodiments, the body portion includes a substantially rigid frame and at least one relatively flexible hollow region extending from the rigid frame.
[0207] In some embodiments, the at least one hollow region is expandable to expand in the extension direction of the one or more nose prongs.
[0208] In some embodiments, the hollow region is connected to the one or more nasal prongs and is expandable during gas supply to the one or more nostrils of the user's nose, the hollow region being positioned against the philtrum or upper lip region of the user in at least the expanded state so as to substantially maintain the one or more nasal prongs in the operating position.
[0209] In some embodiments, in the expanded state, the hollow region is substantially deeper than a depth of the frame of the body adjacent to the hollow region.
[0210] In some embodiments, either end of the body portion comprises a user face contacting surface contoured to engage a cheek region of a user's face in use.
[0211] In some embodiments, the body portion, or at least either end of the body portion, is shaped or curved to substantially complement the facial structure of a user in use.
[0212] In some embodiments, the body portion includes a pair of corresponding left and right body sections or side arms.
[0213] In some embodiments, the left and right body sections or side arms are substantially flexible.
[0214] In some embodiments, the one or more nose prongs extend from one or each of the more inward ends of these corresponding left body segments or side arms and / or right body segments or side arms, or from an area of one or both of these corresponding body portions or side arms that is substantially adjacent to these more inward ends.
[0215] In some embodiments, a bridge portion connects the more inner ends of the respective left and right arms.
[0216] In some embodiments, the bridge portion is substantially rigid relative to the left and right body sections.
[0217] In some embodiments, at least one and preferably both left and / or right body sections include a hollow region, each hollow region having a fluid passage for delivering a gas supply to the corresponding nasal prong.
[0218] In some embodiments, the patient interface further comprises one or more internal support struts extending between opposing interior surfaces of the hollow region to maintain an open fluid passageway.
[0219] In some embodiments, the one or more internal support columns include a plurality of support columns spatially distributed within the hollow region.
[0220] According to at least one of the aspects disclosed herein, a patient interface, such as a nasal cannula, comprises:
[0221] a. a main body part which will be positioned on the user's face during use,
[0222] b. a bridging portion extending away from the main body portion, and
[0223] c. at least one and preferably a pair of nasal prongs extending from the bridge portion to be inserted into or direct a flow of gas into one or more nostrils of the user's nose in an operating position,
[0224] d. Wherein the body portion is actively regulated using electrical potential from the system or stored in the cannula.
[0225] In some embodiments, the main body portion is located on one facial cheek of the user during use, and the other facial cheek of the user will not have an interface.
[0226] According to at least one of the aspects disclosed herein, a patient interface, such as a nasal cannula, comprises:
[0227] a. a main body portion which, in use, will be positioned on the user's face, and
[0228] b. at least one and preferably a pair of nasal prongs extending from the body portion to be inserted into or direct a flow of gas into one or more nostrils of the user's nose in an operating position,
[0229] c. the patient interface has a non-use configuration in which the body portion is substantially planar or at least either end of the body portion is substantially planar and coplanar with the other end of the body portion, and the at least one and preferably a pair of nasal prongs extend in a direction outwardly away from a central plane of the body portion,
[0230] d. and a configuration for use wherein the main body portion or at least any end of the main body portion is shaped or bent to substantially complement the facial structure of the user during use, and the one or more nose prongs extend in a direction substantially parallel to a central plane of the main body portion.
[0231] In some embodiments, the body portion is a single integrally formed component.
[0232] In some embodiments, the body portion and the at least one and preferably a pair of nasal prongs are a single integrally formed component.
[0233] In some embodiments, the ends of the body portion will be positioned on the user's face during use.
[0234] In some embodiments, the ends of the body portion will be positioned on the cheeks of a user's face in use.
[0235] In some embodiments, the interface further comprises a bridging portion having a cavity that is concave when viewed in a direction away from the user.
[0236] In some embodiments, the or each cavity is filled or at least partially filled with a relatively soft and / or flexible material, or with a relatively harder or reinforcing material.
[0237] In some embodiments, the interface further includes an arcuate transition portion between the bridge and an adjacent portion of the body.
[0238] In some embodiments, these arcuate transition portions are spaced outwardly from these nose prongs.
[0239] In some embodiments, the center of each of these arcuate transition portions is positioned outward relative to the midline or longitudinal axis of the adjacent nasal prong to reduce movement of the nasal prongs during use.
[0240] In some embodiments, the thickness of the body portion is relatively thin so as to reduce the elastic / spring force experienced by the user on their philtrum.
[0241] In some embodiments, the flexed portion of the patient interface may have ridges, corrugations, or cutouts to minimize or eliminate kinking of the patient interface.
[0242] In some embodiments, the nose prongs in the non-use configuration may be angled outwardly from each other at an angle of approximately 32°.
[0243] In some embodiments, the area of the patient interface intended to come into contact with the philtrum of a user has a comfort-enhanced surface finish.
[0244] In some embodiments, the interface further comprises a loop material for releasably connecting the patient interface to the face of a user.
[0245] In some embodiments, the interface is a nasal cannula comprising a pair of nasal prongs as the outlets, and wherein a head cap or retention system is attachable to the cannula for holding the nasal cannula in place when worn by a user in use.
[0246] In some embodiments, the retention system includes a releasable connection system for releasably connecting the patient interface to the user's face (e.g., the releasable connection system may be comprised of a hook and loop or hook and hook type connector for such a releasable system).
[0247] In some embodiments, a portion of the releasable connection system is disposed on the patient interface.
[0248] In some embodiments, the portion of the releasable connection system disposed on the patient interface is configured to be connected to the interface by an overmolding or overmolding connection of the interface to the portion or the interface around the portion. By overmolding a portion of the interface to the portion of the releasable connection system, a more durable or robust attachment or engagement of the portion to the interface can be achieved. The material used to form or be molded into the interface can be simultaneously allowed to flow around or onto a portion of the releasable connection system, such as a pad or patch (or alternatively hook) comprising a ring. This can allow for a more integral portion including such a ring or hook to the patient interface.
[0249] In some embodiments, the overmolded or overmolded connection of the interface to or around the portion extends at least around the periphery of the portion and may optionally extend partially or fully across the face of the portion from which components of the releasable connection system may extend.
[0250] For example, in some embodiments, where the portion provides a hook and loop or another type of two-part releasable connection system, the overmolding may extend around the periphery of such portion or may extend partially or fully across the face from which the hook or loop or another type of two-part releasable connection system may extend.
[0251] Alternative embodiments are also provided in which attachment of the portion to the patient interface can be accomplished in a form once the interface has first been molded or formed (or manufactured). For example, with the interface molded or formed (or manufactured), a subsequent or additional overmolding step or stage can be performed to provide an overmolding that connects or attaches the portion and the interface together via an overmolded connection. As described above, the molding material can be allowed to flow so as to extend around the periphery of such portion, or can extend partially or completely across the face of the portion.
[0252] In some embodiments, the releasable connection system includes at least one cushion attached to the user's face, and the patient interface is releasably engageable to the at least one cushion on the user's face.
[0253] In some embodiments, the body portion or at least either end of the body portion comprises an elastic material.
[0254] In some embodiments, the body portion or at least either end of the body portion comprises a flexible material.
[0255] In some embodiments, the interface is or includes a polymer material.
[0256] In some embodiments, the polymer material is one or a combination of any one or more of the following: one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, more preferably the polymer may be those, such as but not limited to: polyolefins, thermoplastic elastomers or breathable thermoplastic elastomers, for example, a thermoplastic elastomer series, such as styrene block copolymers, copolyester elastomers or thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, more preferably a polymer having a Shore A hardness of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80 or about 90.
[0257] In accordance with at least one of the aspects disclosed herein, a patient interface, such as a nasal cannula, comprises: an elongated body that, in use, is to be positioned on the face of a user, the body comprising at least one and preferably a pair of nasal prongs that are to be inserted into or direct a flow of gas into one or more nostrils of the user's nose, and at least one and preferably a pair of facial contact surfaces that are movably coupled to the body so as to respond to one or more forces or movements experienced by the one or more facial contact surfaces and to at least partially mitigate transfer of one or more such forces and / or movements to the body and the one or more nasal prongs.
[0258] In some embodiments, each face contacting surface is movably coupled to an end portion of the body.
[0259] In some embodiments, each face contacting surface is slidably coupled to the body.
[0260] In some embodiments, each face contacting surface has a hollow waveguide associated therewith for slidably receiving a portion of the body therethrough.
[0261] In some embodiments, the patient interface further comprises a resilient member associated with each face contacting surface.
[0262] In some embodiments, the resilient member is coupled between the face contacting portion and the body.
[0263] In some embodiments, the resilient member biases the face contacting surface toward the center of the body.
[0264] In some embodiments, the resilient member comprises a compression spring.
[0265] In some embodiments, the body includes a bridge portion from which the one or more nasal prongs extend. In some embodiments, the bridge portion bends inwardly so as to extend into position toward the septum of the user.
[0266] In some embodiments, the body is substantially rigid.
[0267] In some embodiments, the body is substantially hollow and fluidly coupled to one or more nose prongs to allow gas flow through the body.
[0268] In some embodiments, at least one end, and preferably both ends, of the body are configured to fluidly couple to a flow path of a breathing circuit.
[0269] In some embodiments, each face contact surface is shaped to engage a cheek of the user's face.
[0270] In accordance with at least one of the aspects disclosed herein, a patient interface, such as a nasal cannula, comprises: a body that is to be positioned on the face of a user during use, the body including at least one and preferably a pair of nasal prongs that are to be inserted into one or more nostrils of the user's nose or that direct a flow of gas into one or more nostrils of the user's nose in an operating position, and at least one and preferably a pair of active elements, each of the at least one or a pair of active elements being configured to be activated in response to input energy to move at least one other area of the body so as to maintain the one or more nasal prongs in the operating position.
[0271] In some embodiments, the input energy is non-mechanical energy.
[0272] In some embodiments, at least one active element is configured to convert input energy into mechanical energy to move at least one other region of the body.
[0273] In some embodiments, each active element includes at least one and preferably a pair of expansion elements, which are configured to expand in response to input energy so as to move at least one other region adjacent to one or more nasal prongs to maintain the one or more nasal prongs in an operating position.
[0274] In some embodiments, the one or more expansion elements are positioned on the user engagement side of the body.
[0275] In some embodiments, the one or more expansion elements are configured to be positioned adjacent to a cheek of the user's face.
[0276] In some embodiments, the patient interface further comprises one or more hinges, pivots or articulations, or any combination thereof, operable in response to activation of one or more of the one or more active elements.
[0277] In some embodiments, there are one or more hinges at the bridging portion of the body, and the one or more nose prongs extend from the one or more hinges.
[0278] In some embodiments, wherein the one or more expansion elements are configured to expand in response to input energy so as to move the bridge portion of the body, the one or more nasal prongs extend from the bridge portion toward the philtrum of the user and / or against the philtrum of the user into position.
[0279] In some embodiments, the body is flexible in at least one or more regions so as to deform in response to expansion of the one or more expansion elements and cause the bridge portion to move into position toward the philtrum.
[0280] In some embodiments, the bridging portion includes the one or more hinges.
[0281] In some embodiments, the at least one active element is an electromechanical element configured to receive electrically activated energy to move at least one other region of the body.
[0282] In some embodiments, the electromechanical element is coupled to an electrical circuit and is activated in response to an electrical activation signal generated by a change in voltage, resistance, or current, or any combination, in the electrical circuit.
[0283] In some embodiments, the electrical activation signal is generated by movement or force, or both, experienced by one or more regions of the body.
[0284] In some embodiments, movement of the one or more regions of the body causes electrical contacts of the circuit to engage and generate the electrical activation signal.
[0285] In some embodiments, movement of the one or more regions of the body causes a change in resistance in the circuit to generate the electrical activation signal.
[0286] In some embodiments, the electromechanical element comprises a conductive polymer or a bimetallic strip or any combination thereof.
[0287] In some embodiments, the electromechanical element includes a pair of electromagnets.
[0288] In some embodiments, the input energy is manifested by a change in humidity at one or more regions of the body, and at least one active element is configured to activate in response to a threshold humidity or a change in humidity, or both, to move at least one other region of the body to maintain one or more nasal prongs in an operating position.
[0289] In some embodiments, the active element is configured to absorb water and expand in response to a threshold humidity or a change in humidity, or both, to thereby move at least one other region of the body.
[0290] In some embodiments, the active element or at least a portion of the active element is positioned adjacent to the base of the associated nasal prong and is configured to engage the philtrum in place, and wherein expansion of the active element or a portion of the active element causes the nasal prong to pivot toward the back of the corresponding nostril of the user so as to maintain the nasal prong in an operating position.
[0291] In some embodiments, the at least one active element comprises a polymer material configured to expand with increasing humidity.
[0292] In some embodiments, the at least one active component forms at least a portion of the body.
[0293] In some embodiments, the body includes a left body portion or side arm and a separate right body portion or side arm, each of the left body portion or side arm and the right body portion or side arm having an active element and a nose fork associated therewith.
[0294] In some embodiments, the patient interface further comprises a bridge portion that bridges over the active elements of the left and right arms, respectively, to hold these elements in place against the philtrum of the user.
[0295] In some embodiments, the patient interface further includes at least one and preferably a pair of facial contact pads, which are configured to engage the user's face during use, wherein the end or either end of the bridging portion is correspondingly connected to one or more facial contact pads.
[0296] According to at least one of the embodiments disclosed herein, a patient interface, such as a nasal cannula, comprises:
[0297] a. a main body portion which, in use, will be positioned on the user's face, the main body portion having a left arm and a right arm and a bridge portion located between the left arm and the right arm,
[0298] b. at least one and preferably a pair of nasal prongs extending from the bridge portion to be inserted into or direct a flow of gas into one or more nostrils of the user's nose in an operating position,
[0299] c. the main body portion having at least one fluid passage connected to the one or more nasal prongs for supplying gas to the one or more nostrils of the user's nose,
[0300] d. wherein the cross-section of the passageway varies along the length of the body portion so as to provide a region of varying flexibility along the body portion.
[0301] In some embodiments, the shape of the cross-section of the passageway varies along at least a portion of the length of the body portion.
[0302] In some embodiments, the cross-section changes from a substantially circular cross-section at or near the outer end for connection with a breathing tube or conduit (releasably or permanently) to an elongated cross-section having a longer axis arranged substantially vertically (parallel to the user's face).
[0303] In some embodiments, the elongated section is disposed in or forms a bending region or hinged portion of the main body portion, the elongated section providing greater flexibility for bending of the main body portion toward or away from the user's face in the direction of the shorter axis of the elongated section.
[0304] In some embodiments, the elongated section is adjacent to the bridging portion of the main body portion between the nasal prong and an entrance to the passageway to which a breathing tube or conduit is attached.
[0305] In some embodiments, the body portion preferably curves toward and away from the user's face in the curved regions of the body portion.
[0306] In some embodiments, the cross-sectional area of the passageway is substantially constant along a portion of the length of the body portion.
[0307] In some embodiments, the bridge portion is relatively rigid compared to other portions of the patient interface.
[0308] In some embodiments, the bridge portion transitions to the left and right arms by extending outwardly away from the user's facial side of the bridge portion in an abducted or curved manner, and the left and right arms bend rearwardly away from the bridge portion from a front extension of the main body portion.
[0309] In some embodiments, the curvature or curvatures of the user's facial side of the bridge portion and / or the transition area between the bridge portion and the left arm and the right arm have a relatively large radius (or multiple radii) so that pressure from the bridge and / or these transition areas on the user's face is spread over the user's philtrum or upper lip area.
[0310] In some embodiments, the main body portion extends forward from each side of the bridging portion to a position in front of the bridging portion and then extends rearwardly so that the distal ends of the left arm and the right arm are positioned rearward of the bridging portion in at least the in-use position.
[0311] In some embodiments, the main body portion includes a U-shaped area located between each nose prong and the left arm and the right arm, and when the main body portion is viewed from above, the inner side of the U-shaped area faces the user's face during use.
[0312] In some embodiments, each U-shaped region is formed or disposed in a bending region where the main body portion preferentially bends when the left portion or the right portion of the main body portion is flexed toward or away from the user's face.
[0313] In some embodiments, the curved region tends to curve within the concave portion of the U-shaped region.
[0314] In some embodiments, the interior angle of the U-shaped region is less than about 130 degrees, or 120 degrees, or 110 degrees, or 105 degrees.
[0315] In some embodiments, the bend regions are positioned outward and forward from the nasal prongs relative to the facial side of the body portion.
[0316] In some embodiments, the patient interface is a single, integrally formed component formed from a single material.
[0317] In some embodiments, the patient interface is formed from a single molding operation.
[0318] In some embodiments, the patient interface is formed from a thermoplastic or silicone material having a Shore A durometer of approximately 5 to 60.
[0319] In some embodiments, the patient interface includes at least one pad of a retention system for holding the interface in place when worn by a user in use, these pads being attached to at least one of the left and right arms of the main body portion, the pads being substantially symmetrical about a central, generally vertical axis that divides the pads into left and right sides such that pads of the same shape can be applied to both the left and right arms of the main body portion.
[0320] In some embodiments, the one or more pads include a hook portion for connecting to a complementary hook and loop portion of a corresponding pad located on the user's face.
[0321] In some embodiments, the cross-section of the passage at the base of these nose prongs is an asymmetric cross-section, with one side of the cross-section being flatter than the opposite side of the cross-section.
[0322] In some embodiments, the shape of the passage extending along the nasal fork changes from the asymmetric cross-section at the base of the nasal fork to a circular cross-section at the tip of the nasal fork.
[0323] In some embodiments, the cross-sectional area of the nasal fork decreases from the base to the tip of the nasal fork.
[0324] In some embodiments, the flat side of the nasal prong is positioned toward the forward side of the patient interface (away from the user's face).
[0325] In some embodiments, the main body portion includes more material (larger cross-sectional area) per length in the bridge portion than in other portions of the main body portion.
[0326] In some embodiments, the bridging region includes a solid section located between these nose prongs, so that the bridging region is more rigid than these curved regions.
[0327] In some embodiments, the bridge portion comprises thicker wall sections than wall sections of the bending regions, such that the bridge portion is more rigid than the bending regions.
[0328] In some embodiments, the bridge portion comprises a still more rigid material to provide stiffness to the bridge portion.
[0329] In some embodiments, the bridge region has a height or vertical dimension sufficient to provide torsional stability and prevent twisting of the bridge region during use.
[0330] In some embodiments, the passageway is vertically positioned generally centrally on the left side portion and / or the right side portion of the body portion.
[0331] In some embodiments, the passageway is positioned generally centrally on a cushion of a retention system on each of the left and right arms for holding the interface in place when worn by a user.
[0332] In some embodiments, the horizontal neutral bending axis of the main body portion is positioned approximately centrally in the vertical direction on the fastening system for fastening the interface to the user's face.
[0333] In some embodiments, the body portion includes varying geometries to achieve regions with more flexibility and regions with less flexibility.
[0334] In some embodiments, the thickness of the body portion is varied to provide regions of varying flexibility.
[0335] In some embodiments, the body portion has a thinner thickness wall or section surrounding the passageway in a curved region of the body portion than in other regions of the body portion.
[0336] In some embodiments, the cross-sectional area of the main body portion at the recessed portion of the U-shaped region of the main body portion is smaller than the cross-sectional area in an adjacent region of the main body portion.
[0337] In some embodiments, the main body portion has a left passage and a right passage, and the left passage and the right passage are separated by a dividing section in the bridge area.
[0338] In some embodiments, the dividing section is a central area of the bridge located between the two nose prongs.
[0339] In some embodiments, the central region of the bridging region is solid.
[0340] In some embodiments, each nasal prong has a base integrally formed with the bridging portion of the main body portion of the patient interface, and wherein the base of each nasal prong includes a fillet located between a wall of the nasal prong and the bridging portion, the fillet extending around the periphery of the nasal prong, and wherein the radius of the fillet varies around the periphery of the nasal prong.
[0341] In some embodiments, the radius of the fillet varies around the perimeter of the nasal fork so as to change the wall thickness of the nasal fork at the base of the nasal fork.
[0342] In some embodiments, the thickness of the nasal fork base varies around the periphery of the nasal fork.
[0343] In some embodiments, the radius of the fillet on the non-facial side of the main body portion is smaller than the radius of the fillet on the inner side of the nasal fork (located between the two nasal forks) and the radius of the fillet on the outer side of the nasal fork.
[0344] In some embodiments, the radius of the fillet on the inner side of the nasal fork is greater than the radius of the fillet on the outer side of the nasal fork.
[0345] In some embodiments, the radius of the fillet on the facial side of the main body portion is larger than the radius on the inner and outer sides of the nasal prong.
[0346] In some embodiments, each nasal prong has a base that is integrally formed with the bridging portion of the main body portion of the patient interface, and the thickness of the nasal prong base varies around the periphery of the nasal prong.
[0347] According to at least one of the embodiments disclosed herein, a patient interface, such as a nasal cannula, comprises:
[0348] a. a main body portion which, in use, will be positioned on the user's face, the main body portion having a left arm and a right arm and a bridge portion located between the left arm and the right arm,
[0349] b. at least one and preferably a pair of nasal prongs extending from the bridge portion to be inserted into or direct a flow of gas into one or more nostrils of the user's nose in an operating position,
[0350] c. the main body portion having at least one fluid passage connected to the one or more nasal prongs for supplying gas to the one or more nostrils of the user's nose, and
[0351] d. at least one pad of a retention system for holding the interface in position on the user's face, the pad being attached to at least one of the left and right arms of the main body portion, the pad being substantially symmetrical about a central axis dividing the pad into left and right sides such that pads of the same shape can be applied to both the left and right arms of the main body portion.
[0352] According to at least one of the embodiments disclosed herein, a patient interface, such as a nasal cannula, comprises:
[0353] a. a main body portion which, in use, will be positioned on the user's face, the main body portion having a left arm and a right arm and a bridge portion located between the left arm and the right arm,
[0354] b. at least one and preferably a pair of nasal prongs extending from the bridge portion to be inserted into or direct a flow of gas into one or more nostrils of the user's nose in an operating position,
[0355] c. the main body portion having at least one fluid passage connected to the one or more nasal prongs for supplying gas to the one or more nostrils of the user's nose,
[0356] d. The passage has an asymmetric cross-section at the base of the nasal prongs, one side of the asymmetric cross-section being flatter than the opposite side of the asymmetric cross-section.
[0357] In some embodiments, the shape of the passage extending along the nasal fork changes from the asymmetric cross-section at the base of the nasal fork to a circular cross-section at the tip of the nasal fork.
[0358] In some embodiments, the cross-sectional area of the nasal fork decreases from the base to the tip of the nasal fork.
[0359] In some embodiments, the flat side of the nasal prong is positioned toward the forward side of the patient interface (away from the user's face).
[0360] According to at least one of the aspects disclosed herein, a patient interface, such as a nasal cannula, comprises:
[0361] a. a main body portion which, in use, will be positioned on the user's face, the main body portion having a left arm and a right arm and a bridge portion located between the left arm and the right arm,
[0362] b. at least one and preferably a pair of nasal prongs extending from the bridge portion to be inserted into or direct a flow of gas into one or more nostrils of the user's nose in an operating position,
[0363] c. the main body portion having at least one fluid passage connected to the one or more nasal prongs for supplying gas to the one or more nostrils of the user's nose,
[0364] d. wherein the patient interface is a single integrally formed component formed from a single material, and the bridging portion is relatively rigid compared to other portions of the patient interface including the left arm and the right arm.
[0365] In some embodiments, the patient interface is formed from a thermoplastic or silicone material having a Shore A durometer of approximately 5 to 60.
[0366] In some embodiments, the main body portion includes more material (larger cross-sectional area) per length in the bridge portion than in other portions of the main body portion.
[0367] In some embodiments, the bridging region comprises a solid section between the nose prongs.
[0368] In some embodiments, the bridge region has a height or vertical dimension sufficient to provide torsional stability and prevent twisting of the bridge region during use.
[0369] In some embodiments, the body portion includes varying geometries to achieve regions with more flexibility and regions with less flexibility.
[0370] In some embodiments, the thickness of the body portion is varied to provide regions of varying flexibility.
[0371] In some embodiments, the body portion has a thinner thickness wall or section surrounding the passageway in a curved region of the body portion than in other regions of the body portion.
[0372] In some embodiments, the cross-sectional area of the main body portion at the recessed portion of the U-shaped region of the main body portion is smaller than the cross-sectional area in an adjacent region of the main body portion.
[0373] In some embodiments, the main body portion has a left passage and a right passage, and the left passage and the right passage are separated by a dividing section in the bridge area.
[0374] In some embodiments, the dividing section is a central area of the bridge located between the two nose prongs.
[0375] In some embodiments, the central region of the bridging region is solid.
[0376] According to at least one of the aspects disclosed herein, a patient interface, such as a nasal cannula, comprises:
[0377] a. a main body portion which, in use, will be positioned on the user's face, the main body portion having a left arm and a right arm and a bridge portion located between the left arm and the right arm,
[0378] b. at least one and preferably a pair of nasal prongs extending from the bridge portion to be inserted into or direct a flow of gas into one or more nostrils of the user's nose in an operating position,
[0379] c. The main body portion has at least one fluid passage connected to the one or more nasal prongs for supplying gas to the one or more nostrils of the user's nose, wherein the passage is roughly centered in the vertical direction on the left arm and / or right arm of the main body portion.
[0380] According to at least one of the aspects disclosed herein, a patient interface, such as a nasal cannula, comprises:
[0381] a. a main body portion which, in use, will be positioned on the user's face, the main body portion having a left arm and a right arm and a bridge portion located between the left arm and the right arm,
[0382] b. at least one and preferably a pair of nasal prongs extending from the bridge portion to be inserted into or direct a flow of gas into one or more nostrils of the user's nose in an operating position,
[0383] c. the main body portion having at least one fluid passage connected to the one or more nasal prongs for supplying gas to the one or more nostrils of the user's nose, and
[0384] d. A pad of a retention system on each of the left and right arms for holding the interface in place on the user's face, with the passageway positioned generally centrally on the pad.
[0385] According to at least one of the aspects disclosed herein, a patient interface, such as a nasal cannula, comprises:
[0386] a. a main body portion which, in use, will be positioned on the user's face, the main body portion having a left arm and a right arm and a bridge portion located between the left arm and the right arm,
[0387] b. at least one and preferably a pair of nasal prongs extending from the bridge portion to be inserted into or direct a flow of gas into one or more nostrils of the user's nose in an operating position,
[0388] c. The main body portion has at least one fluid passage connected to the one or more nasal prongs for supplying gas to the one or more nostrils of the user's nose, and a pad of a retention system on each of the left arm and the right arm for maintaining the interface in a proper position on the user's face, wherein the horizontal neutral bending axis of the main body portion is positioned approximately centrally on the pads in the vertical direction.
[0389] According to at least one of the aspects disclosed herein, a patient interface, such as a nasal cannula, comprises:
[0390] a. a main body portion which, in use, will be positioned on the user's face, the main body portion having a left arm and a right arm and a bridge portion located between the left arm and the right arm,
[0391] b. at least one and preferably a pair of nasal prongs extending from the bridge portion to be inserted into or direct a flow of gas into one or more nostrils of the user's nose in an operating position,
[0392] c. The main body portion has at least one fluid passage connected to the one or more nasal prongs for supplying gas to the one or more nostrils of the user's nose, wherein
[0393] d. Each nasal prong has a base integrally formed with the bridging portion of the main body portion of the patient interface, and wherein the base of each nasal prong includes a fillet located between the wall of the nasal prong and the bridging portion, the fillet extending around the periphery of the nasal prong, and wherein the radius of the fillet varies around the periphery of the nasal prong.
[0394] In some embodiments, the radius of the fillet varies around the perimeter of the nasal fork so as to change the wall thickness of the nasal fork at the base of the nasal fork.
[0395] In some embodiments, the thickness of the nasal fork base varies around the periphery of the nasal fork.
[0396] In some embodiments, the radius of the fillet on the non-facial side of the main body portion is smaller than the radius of the fillet on the inner side of the nasal fork (located between the two nasal forks) and the radius of the fillet on the outer side of the nasal fork.
[0397] In some embodiments, the radius of the fillet on the inner side of the nasal fork is greater than the radius of the fillet on the outer side of the nasal fork.
[0398] In some embodiments, the radius of the fillet on the facial side of the main body portion is larger than the radius on the inner and outer sides of the nasal prong.
[0399] According to at least one of the aspects disclosed herein, a patient interface, such as a nasal cannula, comprises:
[0400] a. a main body portion which, in use, will be positioned on the user's face, the main body portion having a left arm and a right arm and a bridge portion located between the left arm and the right arm,
[0401] b. at least one and preferably a pair of nasal prongs extending from the bridge portion to be inserted into or direct a flow of gas into one or more nostrils of the user's nose in an operating position,
[0402] c. The main body portion has at least one fluid passage connected to the one or more nasal prongs for supplying gas to the one or more nostrils of the user's nose, wherein
[0403] d. Each nasal prong has a base that is integrally formed with the bridging portion of the main body portion of the patient interface, and the thickness of the nasal prong base varies around the periphery of the nasal prong.
[0404] In accordance with at least one of the aspects disclosed herein, a patient interface includes a single integrally formed component formed from a single material having one or more flex or articulation regions.
[0405] In some embodiments, the patient interface includes a bridge portion, and a nasal prong extending from the bridge portion, wherein the bridge portion is more rigid than the bending or articulation regions.
[0406] In some embodiments, these bending or articulation regions may be formed by or include at least one bending or articulation element, such as a mechanical hinge.
[0407] The term "cheek" as used in this specification and claims means any area on the user's face at or adjacent to the cheekbone, and may include any area on the side and / or below the cheekbone and / or may include any other area between the user's respective eyes, ears, and the periphery of the nose.
[0408] The term "compensation" as used in this specification and claims, and specifically with respect to one or more distinct areas or locations so identified, means an area or location that is capable of at least one or more of: changing shape, or flexing, or bending, or twisting, twisting, shearing or shear-like movement, or localized displacement, or at least some other form of dynamic behavior, or a response resulting from the application of a force or applied movement, or a response resulting from a force or movement experienced by at least a portion of the patient interface.
[0409] The term "comprising" as used in this specification means "consisting at least in part of..." When interpreting each statement in this specification containing the term "comprising", there may also be features other than the one or those features following the term. Related terms such as "comprise" and "comprises" are to be interpreted in the same way.
[0410] The present invention may also be broadly described as consisting of the parts, elements and features individually or collectively referred to or specified in the specification of the present application, and any or all combinations of any two or more of said parts, elements or features, and, when specific integers having known equivalents in the art to which the present invention relates are mentioned herein, such known equivalents are deemed to be incorporated herein as if individually listed.
[0411] The present invention resides in the foregoing, and also contemplates a variety of configurations, only examples of which are given below. BRIEF DESCRIPTION OF THE DRAWINGS
[0412] These and other features, aspects and advantages of the present disclosure will be described with reference to the following drawings, which are illustrative and should not be limiting of the present disclosure.
[0413] Figure 1 A general assembly of a humidification system for delivering a flow of humidified gas to a patient interface being worn by a user is shown.
[0414] Figure 2A-2E A patient interface is shown from different angles, particularly where a bridging portion element will be incorporated into the interface; more particularly,
[0415] Figure 2A shows a front perspective view of the interface, Figure 2B shows a rear perspective view of the interface, Figure 2C A partial cross section through the side arm of the interface is shown, Figure 2D A front perspective view showing a bridge section element, Figure 2E Shows Figure 2D Rear perspective view of Figure 2F The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Figure 2A A line drawing of the shape of the interface, and Figure 2G A line graph is shown once one or more compensation regions (or areas) are activated in response to an applied force.
[0416] Figures 3A-3C A patient interface is shown from different angles, particularly where a bridging portion element will be incorporated into the interface; more particularly,
[0417] Figure 3A shows a front perspective view of the interface, Figure 3B Shows Figure 3A Rear perspective view of Figure 3C A partial cross section through the side arm of the interface is shown, Figure 3D The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Figure 3AA line drawing of the shape of the interface, and Figure 3E A line graph is shown once one or more compensation regions (or areas) are activated in response to an applied force.
[0418] Figures 4A-4C A patient interface is shown from different angles, particularly where a bridging portion element will be incorporated into the interface; more particularly,
[0419] Figure 4A shows a front perspective view of the interface, Figure 4B Shows Figure 4A Rear perspective view of Figure 4C A partial cross section through the side arm of the interface is shown, Figure 4D The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Figure 4A A line drawing of the shape of the interface, and Figure 4E A line graph is shown once one or more compensation regions (or areas) are activated in response to an applied force.
[0420] Figures 5A-5E A patient interface is shown from different angles, particularly where the bridge portion element and the side arm element will be incorporated into the interface; more particularly,
[0421] Figure 5A shows a front perspective view of the interface, Figure 5B Shows Figure 5A Rear perspective view of Figure 5C A partial cross section through the side arm and side arm elements of the interface is shown, Figure 5D A front perspective view showing the bridge portion element and the side arm element, Figure 5E Shows Figure 5D Rear perspective view of Fig. 5F The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Figure 5A A line drawing of the shape of the interface, and Figure 5G A line graph is shown once one or more compensation regions (or areas) are activated in response to an applied force.
[0422] Figures 6A-6E A patient interface is shown from different angles, particularly where the bridge portion element and the side arm element will be incorporated into the interface; more particularly,
[0423] Fig. 6A shows a front perspective view of the interface, Figure 6B Shows Fig. 6A Rear perspective view of Figure 6C A partial cross section through the side arm and side arm elements of the interface is shown, Fig.6D A rear perspective view showing the bridge portion element and the side arm element, Fig. 6EShows Fig.6D Front perspective view of Fig. 6F The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Fig. 6A A line drawing of the shape of the interface, and Figure 6G A line graph is shown once one or more compensation regions (or areas) are activated in response to an applied force.
[0424] Figures 7A-7E A patient interface is shown from different angles, particularly where the bridge portion element and the side arm element will be incorporated into the interface; more particularly,
[0425] Fig. 7A shows a front perspective view of the interface, Figure 7B Shows Fig. 7A Rear perspective view of Figure 7C A partial cross section through the side arm and side arm elements of the interface is shown, Fig.7D A front perspective view showing the bridge portion element and the side arm element, Fig. 7E Shows Fig.7D Rear perspective view of Figure 7F The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Fig. 7A A line drawing of the shape of the interface, and Figure 7G A line graph is shown once one or more compensation regions (or areas) are activated in response to an applied force.
[0426] Figures 8A-8E A patient interface is shown from different angles, particularly where the bridge portion element and the side arm element will be incorporated into the interface; more particularly,
[0427] Fig. 8A shows a front perspective view of the interface, Figure 8B Shows Fig. 8A Rear perspective view of Figure 8C A partial cross section through the side arm and side arm elements of the interface is shown, Fig.8D A front perspective view showing the bridge portion element and the side arm element, Fig. 8E Shows Fig.8D Rear perspective view of Fig.8F The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Fig. 8A A line drawing of the shape of the interface, and Figure 8G A line graph is shown once one or more compensation regions (or areas) are activated in response to an applied force.
[0428] Figures 9A-9E A patient interface is shown from different angles, particularly where the bridge portion element and the side arm element will be incorporated into the interface; more particularly,
[0429] Fig.9A shows a front perspective view of the interface, Fig. 9B Shows Fig.9A Rear perspective view of Fig. 9C A partial cross section through the side arm and side arm elements of the interface is shown, Fig.9D A front perspective view showing the bridge portion element and the side arm element, Fig.9E Shows Fig.9D Rear perspective view of Fig.9F The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Fig.9A A line drawing of the shape of the interface, and Figure 9G A line graph is shown once one or more compensation regions (or areas) are activated in response to an applied force.
[0430] Figures 10A-10E A patient interface is shown from different angles, particularly where the bridge portion element and the side arm element will be incorporated into the interface; more particularly,
[0431] Fig. 10A shows a front perspective view of the interface, Fig. 10B Shows Fig. 10A Rear perspective view of Fig. 10C A partial cross section through the side arm and side arm elements of the interface is shown, Fig. 10D A front perspective view showing the bridge portion element and the side arm element, Fig.10E Shows Fig. 10D Rear perspective view of Fig.10F The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Fig. 10A A line drawing of the shape of the interface, and Figure 10G A line graph showing once one or more compensation regions (or areas) are activated in response to an applied force, and Fig. 10H As a front view, it is shown to illustrate that before one or more compensation areas (or parts) become effective Fig. 10A A line drawing of the shape of the interface, and Fig.10I A line graph is shown once one or more compensation areas (or regions) have been activated.
[0432] Figures 11A-11E A patient interface is shown from different angles, particularly where the bridge portion element and the side arm element will be incorporated into the interface; more particularly,
[0433] Fig.11A shows a front perspective view of the interface, Fig. 11B Shows Fig.11A Rear perspective view of Fig. 11C A partial cross section through the side arm and side arm elements of the interface is shown, Fig.11D A front perspective view showing the bridge portion element and the side arm element, Fig.11E Shows Fig.11D Rear perspective view of Fig.11F The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Fig.11A a first line drawing of the shape of the interface, and Fig.11G A line graph showing once one or more compensation regions (or areas) are activated in response to an applied force, and Fig.11H The plan view shows the process before one or more compensation areas (or locations) become effective. Fig.11A a second line diagram of the shape of the interface, and Fig.11I A line graph is shown once one or more compensation areas (or regions) have been activated.
[0434] Figures 12A-12E A patient interface is shown from different angles, particularly where the bridge portion element and the side arm element will be incorporated into the interface; more particularly,
[0435] Fig. 12A shows a front perspective view of the interface, Fig. 12B Shows Fig. 12A Rear perspective view of Fig. 12C A partial cross section through the side arm and side arm elements of the interface is shown, Fig.12D A front perspective view showing the bridge portion element and the side arm element, Fig.12E Shows Fig.12D Rear perspective view of Fig.12F The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Fig. 12A A line drawing of the shape of the interface, and Figure 12G A line graph is shown once one or more compensation regions (or areas) are activated in response to an applied force.
[0436] Figures 13A-13E A patient interface is shown from different angles, particularly where the bridge portion element and the side arm element will be incorporated into the interface; more particularly,
[0437] Fig.13A shows a front perspective view of the interface, Fig. 13B Shows Fig.13A Rear perspective view of Fig. 13C A partial cross section through the side arm and side arm elements of the interface is shown, Fig.13D A front perspective view showing the bridge portion element and the side arm element, Fig.13E Shows Fig.13D Rear perspective view of Fig.13F The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Fig.13A A line drawing of the shape of the interface, and Figure 13G A line graph is shown once one or more compensation regions (or areas) are activated in response to an applied force.
[0438] Figures 14A-14E A patient interface is shown from different angles, particularly where the bridge portion element and the side arm element will be incorporated into the interface; more particularly,
[0439] Fig.14A shows a front perspective view of the interface, Fig. 14B Shows Fig.14A Rear perspective view of Fig. 14C A partial cross section through the side arm and side arm elements of the interface is shown, Fig.14D A front perspective view showing the bridge portion element and the side arm element, Fig.14E Shows Fig.14D Rear perspective view of Fig.14F The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Fig.14A A line drawing of the shape of the interface, and Figure 14G A line graph is shown once one or more compensation regions (or areas) are activated in response to an applied force.
[0440] Figures 15A-15E A patient interface is shown from different angles, particularly where the bridge portion element and the side arm element will be incorporated into the interface; more particularly,
[0441] Fig.15A shows a front perspective view of the interface, Fig. 15B Shows Fig.15A Rear perspective view of Fig. 15C A partial cross section through the side arm and side arm elements of the interface is shown, Fig.15D A front perspective view showing the bridge portion element and the side arm element, Fig.15E Shows Fig.15D Rear perspective view of Fig.15F The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Fig.15A A line drawing of the shape of the interface, and Figure 15G A line graph is shown once one or more compensation regions (or areas) are activated in response to an applied force.
[0442] Figures 16A-16E A patient interface is shown from different angles, particularly where the bridge portion element and the side arm element will be incorporated into the interface; more particularly,
[0443] Fig.16A shows a front perspective view of the interface, Fig. 16B Shows Fig.16A Rear perspective view of Fig. 16C A partial cross section through the side arm and side arm elements of the interface is shown, Fig.16D A front perspective view showing the bridge portion element and the side arm element, Fig.16E Shows Fig.16D Rear perspective view of Fig.16F The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Fig.16A A line drawing of the shape of the interface, and Figure 16G A line graph is shown once one or more compensation regions (or areas) are activated in response to an applied force.
[0444] Figures 17A-17E A patient interface is shown from different angles, specifically where the bridging portion element and separate side arm elements will be incorporated into the side arms of the interface; more specifically,
[0445] Fig.17A shows a front view of the interface, Fig. 17B Shows Fig.17A The rear view of Fig. 17C showing a front perspective view of the bridging portion element and the separate side arm elements in their relative spatial arrangement when embedded in the interface, Fig.17D yes Fig. 17C Rear perspective view of Fig.17E yes Fig.17A A front perspective view of the interface, Fig.17F The plan view shows the structure of the compensation area before one or more compensation areas (or regions) become effective. Fig.17A A line drawing of the shape of the interface, and Figure 17G A line graph is shown once one or more compensation regions (or areas) are activated in response to an applied force.
[0446] Fig.18 A front view of the patient interface is shown.
[0447] Fig.19 Shows Fig.18 Rear view of the patient interface shown in .
[0448] Fig. 20 Shows Fig.18 Side perspective view of the patient interface shown in .
[0449] Fig.21A Shows Fig.18 Close-up of the front to rear view of the patient interface shown in .
[0450] Fig.21B Shows the application of Fig.21A Schematic diagram of the forces on the patient interface shown in .
[0451] Fig.22A A close-up of a portion of the patient interface is shown.
[0452] Fig. 22B Shows the application of Fig.22A Schematic diagram of the forces on the patient interface shown in .
[0453] Fig.23 A front rear view of the patient interface is shown.
[0454] Fig.24 A front rear view of the patient interface is shown.
[0455] FIG. 25A to FIG. 25C Embodiments of a patient interface are shown from different angles.
[0456] FIG. 26A to FIG. 26C Another embodiment of a patient interface is shown from a different angle.
[0457] FIG. 27A to FIG. 27C Another embodiment of a patient interface is shown from a different angle.
[0458] FIG. 28A to FIG. 28B Another embodiment of a patient interface is shown from a different angle.
[0459] FIG. 29A to FIG. 29C Another embodiment of a patient interface is shown from a different angle.
[0460] FIG. 30A to FIG. 30F Another embodiment of a patient interface is shown from different angles in a non-use configuration.
[0461] Fig.31 yes FIG. 30A to FIG. 30F The illustrated embodiment includes a modification of a portion of a releasable connection system, such as a fastening system, in one example a loop material, for releasably connecting the patient interface to the face of a user.
[0462] Fig.32 Another embodiment of a patient interface is shown.
[0463] Fig.33 Another embodiment of a patient interface is shown.
[0464] Figures 34A-34C Another embodiment of an interface is shown from a different angle.
[0465] Fig.35 Another embodiment of a patient interface is shown.
[0466] Fig.36 yes Fig.35 A floor plan of the interface.
[0467] Fig.37 Shows Fig.35 of the interface and half of another interface for comparison.
[0468] Fig.38A A symmetrical cushion of a patient interface system is shown.
[0469] Fig.38B Shown from another angle Fig.35 interface.
[0470] Fig.39A Shows Fig.35 part of the interface, and Fig.39B Shows Fig.39A The segment of line AA in .
[0471] Fig.40A Shows Fig.35 part of the interface, and Fig.40B Shows Fig.40A The segment of line BB in .
[0472] Fig.41A Shows Fig.35 part of the interface, and Fig.41B Shows Fig.41A Segment of line CC in .
[0473] Fig.42A Shows Fig.35 part of the interface, and Fig.42B Shows Fig.42A The segment of line DD in .
[0474] Fig.43A Shows Fig.35 part of the interface, and Fig.43B Shows Fig.43A The section of line EE in .
[0475] Fig.44 yes Fig.35 Front view of the interface.
[0476] Fig.45 Shows Fig.35 A portion of the interface showing the base of the nose prongs.
[0477] Fig.46 Shows Fig.35 Rear view of a portion of the patient interface shown in .
[0478] Fig.47 Shows Fig.35 Another angle of the patient interface shown.
[0479] Fig.48 Shows Fig.35 Front to rear view of a portion of the patient interface shown in . DETAILED DESCRIPTION
[0480] The present disclosure relates to a patient interface that, in use, is positioned on the face of a user and compensates for movement.
[0481] By compensating for movement, the patient interface may have improved or greater stability on the user.
[0482] Improvements in stability can result in greater comfort for the user when the interface is worn and in use and / or improved or more consistent delivery of therapy to the user. For example, minimizing or at least somewhat mitigating the transfer or translation of forces or movement to the gas outlet of the patient interface (i.e., the portion of the interface most closely associated with the delivery of gases to the user) can provide specific benefits in terms of uninterrupted, or at least minimized, delivery of therapy, and maintaining user comfort.
[0483] As such, it would be desirable to have a patient interface that operates as an effectively self-compensating device in response to forces or movements applied to the patient interface.
[0484] In those patient interfaces (such as nasal cannulae), the nasal prongs are typically associated with the air outlet of the interface. Nasal prong flicking is a problem associated with movement of the patient interface where the nasal prongs move from their intended position and can irritate the user's nostrils or can even be sufficiently disturbed that they are no longer properly positioned within the nostrils. Such interference with the air outlet or nasal prongs will be avoided where possible.
[0485] The patient interface of the present invention advantageously provides improvements in the delivery of respiratory care utilizing a ventilator or gas supply device, or in conjunction with a gas humidification system or other gas supply system for supplying gas to a patient, or for the delivery of any other gas to a patient.
[0486] Different preferred forms of patient interfaces will be described with reference to in-hospital respiratory care systems such as may be used by adults and / or for pediatric and / or neonatal use. It will be understood that the described patient interface embodiments are used in delivering different respiratory therapies, such as but not exclusively high flow therapy, PAP therapy (e.g., CPAP or BIPAP), and ventilation therapy; and such patient interfaces may be of the sealing or non-sealing type, depending on the desired therapy.
[0487] Because relatively high gas delivery flow rates can be used with the embodiments or configurations described herein, the gas supplied or delivered to a user or patient can be delivered to different portions of the airway of the user or patient. It will be understood that these relatively high gas delivery flow rates can be used with any of adults, children, or infants (e.g., neonates or pediatric patients) and the flow rates will be selected or adjusted accordingly. The embodiments of the patient interface described herein include flow ranges suitable for use with adults as well as flow ranges suitable for neonates or pediatric patients.
[0488] For example, according to the various embodiments and configurations described herein, the flow rate of a gas supplied or provided to an interface or via a system, such as through a flow path, may include, but is not limited to, a flow rate of at least about 2, 3, 4, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 L / min or more, and the usable range may be selected to be between any of these values (e.g., about 40 to about 80, about 50 to about 80, about 60 to about 80, about 70 to about 100 L / min, about 70 to 80 L / min).
[0489] Such relatively high flow rates of gas can help provide the supplied gas into the user's airway, or to different parts of the user's airway, for example, such flow rates can allow delivery of such gas to the upper airway region or the lower airway region. The upper airway region typically includes the nasal cavity, pharynx, and larynx, while the lower airway region typically includes the trachea, mainstem bronchi, and lungs.
[0490] As used in the present disclosure, "high flow therapy" may refer to the delivery of gas to an adult patient at a flow rate greater than or equal to about 5 or 10 liters per minute (5 LPM or 10 LPM). In some configurations, "high flow therapy" may refer to the delivery of gas to an adult patient at a flow rate between about 5 or 10 LPM and about 100 LPM, or between about 15 LPM and about 95 LPM, or between about 20 LPM and about 90 LPM, or between about 25 LPM and about 85 LPM, or between about 30 LPM and about 80 LPM, or between about 35 LPM and about 75 LPM, or between about 40 LPM and about 70 LPM, or between about 45 LPM and about 65 LPM, or between about 50 LPM and about 60 LPM. For example, according to the various embodiments and configurations described herein, the flow rate of a gas supplied or provided to an interface or via a system, such as through a flow path, may include, but is not limited to, a flow rate of at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 L / min or more, and the usable range may be selected to be between any of these values (e.g., about 40 to about 80, about 50 to about 80, about 60 to about 80, about 70 to about 1000 L / min, about 70 to 80 L / min).
[0491] For newborns and premature infants, "high flow therapy" can refer to the delivery of gas at a flow rate between about 0 LPM and 40 LPM, that is, more than 0.1 LPM, or between about 5 LPM and 35 LPM, or about 10 LPM to about 30 LPM, or about 15 LPM to about 25 LPM. For example, according to the various embodiments and configurations described herein, the flow rate of gas supplied or provided to an interface or via a system, such as through a flow path, can include, but is not limited to: at least about 0.1, 5, 10, 15, 20, 25, 30, 35 or 40 LPM or more, and the available range can be selected to be between any of these values (e.g., about 5 to about 15, about 20 to about 40, about 30 to about 40). Typically, the delivery of gas at a flow rate between 8 LPM and 10 LPM is suitable for newborns.
[0492] For pediatric patients, "high flow therapy" can refer to the delivery of gas at a flow rate between about 2 or 5 LPM and about 100 LPM, or between about 15 LPM and about 95 LPM, or between about 20 LPM and about 90 LPM, or between about 25 LPM and about 85 LPM, or between about 30 LPM and about 80 LPM, or between about 35 LPM and about 75 LPM, or between about 40 LPM and about 70 LPM, or between about 45 LPM and about 65 LPM, or between about 50 LPM and about 60 LPM. For example, according to the various embodiments and configurations described herein, the flow rate of the gas supplied or provided to the interface or via the system, such as through the flow path, can include, but is not limited to, at least about 2, 3, 4, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 L / min or more, and the usable range can be selected to be between any of these values (e.g., about 40 to about 80, about 50 to about 80, about 60 to about 80, about 70 to about 1000 L / min, about 70 to 80 L / min). In general, for pediatric patients, the flow rate is supplied at 2 L / kg body weight.
[0493] The delivered gas may include a percentage of oxygen. In some configurations, the percentage of oxygen in the delivered gas may be between about 20% and about 100%, or between about 30% and about 100%, or between about 40% and about 100%, or between about 50% and about 100%, or between about 60% and about 100%, or between about 70% and about 100%, or between about 80% and about 100%, or between about 90% and about 100%, or about 100%, or 100%.
[0494] High flow therapy has been found to be effective in meeting or exceeding the patient's normal peak inspiratory demand in order to increase the patient's oxygenation and / or reduce the work of breathing. Additionally, high flow therapy can produce effective irrigation in the nasopharynx so that the anatomical dead space of the upper airway is flushed by the high inlet gas flow. This creates a reservoir of fresh gas available for each and every breath while minimizing rebreathing of carbon dioxide, nitrogen, etc. It will also be understood that various aspects of the present invention can be applied to any form of patient interface, including but not limited to an indirect nasal mask (which covers the nose), a direct nasal mask (including a nozzle or pillow that enters or engages the wearer's nostrils), a mouth mask (which covers the mouth), or a full face mask (which covers the nose and mouth), and a mouthpiece, but will be described with reference to a nasal cannula.
[0495] Similarly, it will also be appreciated that the various aspects of the present invention may be used with any form of patient interface application, in combination with any suitable form of headgear or retention system or fastening system for securing the patient interface to a user, suitable for retaining the patient interface to be maintained on a user for delivery of the desired treatment, such as, for example, a fastening system such as that described in PCT / NZ2011 / 000218 (published as WO 2012 / 053910, the contents of which are incorporated herein by reference).
[0496] In a particularly preferred embodiment, the interface is a nasal cannula of a non-sealing nasal prong type delivery system.Such a nasal cannula can be utilized to deliver high flow, low pressure therapy to a user.
[0497] Therapeutic delivery at high flow and low pressure can be provided, for example but not exclusively, at: from just over 9 L / min to 120 L / min, about 20 L / min to about 50 L / min (e.g., for adult users), about 5 L / min to about 30 L / min (e.g., for pediatric users), about just over 0 L / min to about 8 L / min (e.g., for neonatal users).
[0498] A patient interface according to the present invention may be used in a respiratory care system, such as a humidified CPAP or an in-hospital respiratory care system.
[0499] Figure 1 A typical humidified respiratory system is shown. A patient 1 receives humidified and pressurized gas through a patient interface 100, shown in this example as a nasal cannula assembly, which is connected to a humidified gas transport path or inspiratory duct 3, which in turn is connected to a humidifier 8 (including a humidification chamber 5), which is supplied with gas from a blower 15 or other suitable gas supply device. A head cap 20 is provided to support the patient's face against and maintain the patient interface. The inspiratory duct 3 is connected to an outlet 4 of a humidification chamber 5, which includes a certain amount of water 6. The humidification chamber 5 is preferably formed of a plastic material and may have a high thermal conductivity substrate (e.g., an aluminum substrate) in direct contact with a heater plate 7 of the humidifier 8. The humidifier 8 is equipped with a control device or electronic controller 9, which may include a microprocessor-based controller that executes computer software commands stored in an associated memory. The gas flowing through the respiratory duct 3 is delivered to the patient through the patient interface 100.
[0500] The controller 9 receives input from a source, such as a user input device or a dial 10, by which a user of the device can, for example, set a predetermined desired value (preset value) of the humidity or temperature of the gas supplied to the patient 1. In response to the user setting the humidity or temperature value input via the dial 10 and other possible inputs (such as internal sensors sensing gas flow or temperature), or through parameters calculated in the controller, the controller 9 determines when (or to what level) to energize the heater plate 7 to heat the water 6 in the humidification chamber 5. When a certain amount of water 6 in the humidification chamber 5 is heated, water vapor begins to fill the volume of the chamber above the surface of the water and is transferred out of the humidification chamber 5 outlet 4 along with the flow of gas (e.g., air) provided from the gas supply device or blower 15, which enters the chamber through the inlet 16. It should be noted that it is possible to obtain a relationship between the humidity of the gas in the humidification chamber 5 and the temperature of the heater plate 7. Therefore, it is possible to use the heater plate temperature in an algorithm or lookup table in order to determine the humidity of the gas.
[0501] The blower 15 may be provided with a variable speed pump or fan 2 that draws air or other gas through a blower inlet 17. The speed of the variable speed pump or fan 2 may be controlled by another control device or electrical controller 18 in response to input from the controller 9 and a predetermined desired value (preset value) of pressure or fan speed set by the user via a dial 19 (or alternatively the functions of this controller 18 may be performed by another controller 9).
[0502] The heating element 11 may be provided with the conduit or pipe 3 to help prevent condensation of the humidified gas within the conduit. Such condensation is due to the temperature of the conduit wall being close to the ambient temperature (the temperature of the surrounding atmosphere), which is generally lower than the temperature of the humidified gas within the conduit. The heater element effectively replaces energy lost from the gas by conduction and convection during transmission through the conduit. Thus, the conduit heater element ensures that the delivered gas is at an optimal temperature and humidity.
[0503] Figure 1The use of the patient interface 200 in the respiratory therapy system 100 is shown. The respiratory therapy system 100 includes a flow generator 104. The flow generator 104 receives gas from the air inlet 102 and propels it to the humidifier 106. The humidifier 106 heats and humidifies the gases. The heated and humidified gas passes through the air outlet 108. The gas moves from the air outlet 108 to the gas conduit 110. The gas conduit 110 includes a heater 112 that reduces or prevents condensation of moisture along the walls of the gas conduit 110. The heater 112 may include a resistive heating wire. The respiratory therapy system 100 includes a controller 114 that controls the operation of the flow generator 104. The controller 114 also controls the operation of the humidifier 106. The respiratory therapy system 100 includes an input / output module 116. The input / output module (I / O) 116 includes a device that allows a user to interact with and set parameters of the flow generator 104 and / or the humidifier 106, and receive information about the operation of the respiratory therapy system 100 and its components. The I / O module 116 may include, for example, buttons, knobs, dials, switches, levers, touch screens, speakers, displays, and / or other input or output elements. In some configurations, the humidifier 106 may not be present. In some configurations, the gas conduit 110 may not have a heater 112.
[0504] A preferred embodiment of the present invention will now be described with respect to a patient interface 200 with reference to FIGS. 2 to 17 .
[0505] 2-17, various alternative configurations and preferred forms of patient interfaces are shown.
[0506] In a first embodiment, a patient interface 200 is provided that includes at least one side arm 201 (and preferably a pair of side arms, each side arm being labeled item 201) that extends laterally from a substantially central bridging portion 202 that, in use, will be positioned in or around the septum region of a user.
[0507] The or each side arm 201 is connected to a substantially resilient or relatively more rigid bridging portion element 203. The bridging portion element 203 defines a substantially predetermined spatial relationship of one or more outlets 204 for a gas delivery system having the or each side arm 201. In this way, the spatial relationship of the outlets 204 (and for example a nasal prong 208 which may be arranged in fluid connection with such outlets 204) may be maintained in a constant reference relationship to each other.
[0508] It may be useful to provide the nasal prongs 208, or other form of gas delivery system as may be suitable fluidly connected to the gas outlet 204 as the patient interface may be, in a constantly referenced spatial relationship while the nasal prongs are maintained in a substantially predetermined position for the user. This may allow minimization of nasal prong flicking or other nasal prong irritation of the user's nares.
[0509] In a second embodiment, a patient interface 200 is provided that includes at least one side arm 201 (and preferably a pair of side arms, each side arm being labeled item 201) that extends laterally from a substantially central bridging portion 202 that, in use, will be positioned in or around the septum region of a user.
[0510] The or each side arm 201 comprises one or more predefined or prearranged points or localised compensation areas (or sites) 205 positioned along the side arm 201. When the interface is subjected to or has forces applied thereto, the different one or more compensation areas (or sites) may adjust or contribute to the compensation of the patient, may act or take effect so as to adjust or contribute to the compensation of the patient interface in or at one or more of these compensation areas (or sites).
[0511] The or each side arm 201 is connected to a substantially resilient or relatively more rigid bridging section element 203. The bridging section element 203 defines a substantially predetermined spatial relationship for one or more outlets 204 of a gas delivery system having the or each side arm 201 .
[0512] In a third embodiment, a patient interface 200 is provided that includes at least one side arm 201 (and preferably a pair of side arms, each side arm being labeled item 201) that extends laterally from a substantially central bridging portion 202 that, in use, will be positioned in or around the septum region of a user.
[0513] The or each side arm 201 comprises at least one substantially elastic or relatively more rigid side arm element 206. The or each side arm element 206 at least partially defines the form or curvature of the or each side arm 201, and each side arm 201 and / or side arm element may comprise one or more predefined or prearranged points or localised compensation areas (or sites) 205. Different one or more compensation areas (or sites) may be positioned along the or each side arm and / or the or each side arm element 206 in order to adjust the compensation of the patient interface in one or more of these compensation areas (or sites) 205 or at one or more of these compensation areas (or sites).
[0514] The or each side arm element 206 is connected or interconnected via a connecting material to a substantially resilient or relatively more rigid bridge section element 203. The bridge section element 203 defines a substantially predetermined spatial relationship for one or more outlets 204 of a gas delivery system having the or each side arm 201.
[0515] The connecting material may be the material forming the side arm 201 or a portion thereof and may, for example, consist of a thermoplastic elastomer.
[0516] Reference is made to the accompanying description. Those areas or portions marked as 205 or 205s in the drawings indicate compensation areas (or portions) of either the side arm 201 or the side arm element 206 .
[0517] The following additional description is provided with reference to the above embodiments and with reference to the accompanying drawings.It will be understood that different iterations and alternative embodiments are provided through the description herein and the accompanying drawings are provided for illustrative purposes.
[0518] In various forms of the invention, it may be particularly advantageous to provide a bridging portion 202 or bridging portion element 203, or the bridging portion via which is or can be substantially isolated from forces such as may be applied to or experienced by the patient interface 200.
[0519] Forces applied to or experienced by the patient interface 200 may be experienced by one or more side arms 201 , or side arm elements 206 , or any other portion of the interface 200 , of the interface.
[0520] For example, such forces may be the result of impingement of a tube or conduit that is part of a breathing circuit or gas supply system for patient interface 200 (i.e., so-called "tube drag" or pulling or tugging on the tube or conduit, whether intentionally or unintentionally, by the user or anyone else, which in turn applies force to the interface that is otherwise maintained in a desired operating position on the user).
[0521] Forces may, for example, include movement or flexing or bending or twisting or distortion or compression or extension (such as tension) of the patient interface 200 (or portions of the interface). These may be the result of the user changing the shape of their face (whether directly or indirectly) on which the patient interface is located. The change in shape means that the patient interface 200 moves or receives these forces (i.e., some form of dynamic behavior is experienced by the patient interface).
[0522] Therefore, each side arm 201 or those side arms 201 that may additionally incorporate a side arm element 206 may be equipped with one or more predefined or prearranged points or localized compensation areas (or locations) 205 at different positions or locations along the side arm element 206.
[0523] The different compensation regions (or locations) may adjust or assist in compensating for the applied forces so as to at least somewhat isolate or absorb or attenuate the forces, or at least minimize the transfer or translation of any such forces to prevent interference with one or more outlets from the desired treatment delivery location. For example, where the nasal prongs 208 may be fluidly connected to those outlets 204, it may be desirable to minimize or avoid movement of the nasal prongs 208 in the user's nostrils.
[0524] One or more of the side arms 201 or the or each side arm element 206 may respond to (be activated in response to) forces applied to the patient interface. Specifically, one or more of the compensation regions (or sites) 205 may respond (or be activated) to adjust such forces, or at least some of these forces. Compensation by the regions (or sites) 205 may be performed by flexion or bending (or other responses as described above) of the side arm 201 or the side arm element 206 (or both of these).
[0525] Thus, the or each side arm 201 and / or the or each side arm element 206 which may be provided as part of the side arm 201 may contribute to a self compensating system for mitigating forces or movements experienced by the patient interface from being imparted to the bridge portion 202 or bridge portion element 203. This in turn may, for example, affect the dimensional stability of the air outlet 204 in the nostril of the user's nose and optionally any nasal prongs 208.
[0526] Similarly, the side arm 201 or side arm element 206, which may be configured as part of the side arm 201, may facilitate a self-compensating system for mitigating forces or movements experienced by the patient interface from being imparted to other parts or portions of the patient interface 200 itself. In this way, forces or movements experienced by one portion or area of the patient interface may be at least somewhat isolated from being transferred or translated to the remainder of the patient interface 200. Those forces or movements that are transferred or translated to other portions of the patient interface 200 may preferably be at a reduced force or reduced level / amount of movement, or may be transferred or translated such that other portions of the patient interface 200 may in turn be isolated or absorb the forces or movements.
[0527] From the above, it will be appreciated that one or more side-arms 201 and optionally in combination with side-arm elements 206 can function as a patient interface stabilizer or patient interface stabilization system, or at least a portion of such a stabilizer or stabilization system.
[0528] Bridge and side arms are single piece or assembled from multiple pieces
[0529] The bridge portion 202 and the side arm 201 can be configured as a single piece or unitary component. The patient interface is advantageously a unitary component that is easy to manufacture because the tooling and assembly process are relatively simple. However, in some embodiments, the bridge portion 202 and the side arm 201 may be assembled together from separate or multiple parts.
[0530] Similarly, the bridging portion element 203 and the one or more side arm elements 206 can be configured as a single piece or unitary component, or can be assembled together from separate or multiple parts. For example, the bridging portion element 203 and the one or more side arm elements 206 can be integrally formed as a single component.
[0531] As shown in the various figures of this specification, the bridge portion 202 is typically disposed in the middle of a pair of side arms 201. Thus, the bridge portion element 203 is typically disposed in the middle of the side arm elements 206 of the pair of side arms 201.
[0532] According to e.g. Fig.17A -E, it is possible to provide a patient interface 200 having a bridge portion element 203 and at least one of the one or more side arm elements 206, each of which is a separate component. Each of these separate components can be substantially interconnected, or set in an interconnected relationship with each other by a connecting material, such as the material of the side arm 201.
[0533] From the above, it will be appreciated that the bridging portion element 203 may in certain embodiments be provided as a component that is discontinuous from or with one or more side arm elements 206 .
[0534] In yet another embodiment, the side arm 201 may include one or more separate side arm elements 206 (see, e.g. Fig.17A -E), each of those one or more individual side arm elements 206 may be spaced apart across or along the length of the side arm 201 in which the one or more individual side arm elements are located. Various other arrangements may be considered for providing multiple compensation regions (or locations) 205, depending on the complexity or sophistication of the side arm 201 and the side arm elements 206. For example, multiple side arm elements 206 may be spaced apart as an array across or along the length of one or each side arm 201 in which the multiple side arm elements are located.
[0535] Where a separate bridging portion element 203 and one or more separate side arm elements 206 are provided, these may be connected or interconnected to one another via one or a pair of associated side arms 201. It will be appreciated that the bridging portion element 203 may optionally be associated with the side arm element 206 as a single component, but another of the side arm elements 206 provided as a separate component may be located in or along the side arm element. In this way, a plurality of alternative compensation regions (or locations) 205 may be provided.
[0536] For example, although not shown, additional side arm members may be provided along the Fig.17A - The length positioning of these side arms of the interface 200 shown in -E. In such embodiments, additional compensation areas (or locations) 205 will be provided along the length of the side arm 201, depending on the location and structure of such additional side arm elements 206.
[0537] Each side arm element 206 can provide a relatively resilient portion of the material of the side arm inserted between, or adjacent to, each individual side arm element, either alone or as part of a continuous component including other side arm elements 206. In other words, the material of the side arm 201 inserted between the side arm elements can itself provide a compensation area (or region) 205 that helps compensate in response to force.
[0538] As shown in the various figures of this specification, the bridge portion 202 is typically disposed in the middle of a pair of side arms 201. Thus, the bridge portion element 203 is typically disposed in the middle of the side arm elements 206 of the pair of side arms 201.
[0539] The bridge defines the nose fork / air outlet spacing / spatial relationship
[0540] The bridging portion element 203 is advantageously sized (sufficient) to span the width of the user's septum region, or is configured to establish or define a distance or width between the air outlets 204, or is defined by a maximum distance spanning substantially from one nasolabial groove to another nasolabial groove of the user.
[0541] The bridging portion element 203 may include one or a pair of cutouts or shaped portions 207 to locate, position or accommodate an outlet or a pair of outlets of a gas delivery system for supplying gas to the airway of a user.
[0542] The bridging portion element 203 having the cutout or molded portion 207 advantageously allows the air outlets 204 to be maintained in a constant reference relationship to each other, more preferably such that when the nasal prong 208 is configured to be fluidly connected to the outlet 204, the nasal prong 208 is maintained in a constant reference relationship so as to minimize movement of the nasal prong in the user's nostrils, or problems with nasal prong flicking.
[0543] The bridging portion element 203 may include one or a pair of cutouts or molded portions 207 for positioning, placing or accommodating a nasal prong or a pair of nasal prongs, such as those marked as item 208, or for connection to the one or more outlets 204, or as one or more outlets themselves, for a gas delivery system for supplying gas to one or more nostrils of a user.
[0544] It will be appreciated that different types and styles of gas delivery system outlets for patient interfaces may be provided. In the figure, nasal prongs 208 are shown, typically these are non-sealing style nasal prongs. However, it will be appreciated that different forms of outlets may be provided, as may be appropriate depending on the treatment being delivered and the style or type of patient interface. For example, a sealed style nasal prong (e.g., a "nasal pillow" or other nasal sealing system for the nasal prongs may be utilized), or a nasal mask system or full face mask such as may often be used to deliver positive airway pressure therapy, or a patient interface more commonly used for high flow (but not sealed type) therapy delivery may be utilized.
[0545] It will be appreciated that the patient interface may be constructed of any suitable material, although medical grade materials are preferred.For example, the bridge portion element and the side arm elements may be or consist of a polymeric material.
[0546] Different polymer materials may be utilized, either alone or in combination with others. In particular, medical grade polymers are preferred.
[0547] The polymer material can be any one or more of the following combinations: one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers or one or more breathable thermoplastic polyurethanes, more preferably the polymer can be those, such as but not limited to: polyolefins, thermoplastic elastomers or breathable thermoplastic elastomers, for example, a thermoplastic elastomer series, such as styrene block copolymers, copolyester elastomers or thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, more preferably a polymer having a Shore A hardness of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80 or about 90.
[0548] Bending direction
[0549] Each one or more of the predefined or prearranged points or localized areas (or locations) 205 preferably facilitates flexure or bending or articulation and / or elastic deformation in response to a force or movement input.
[0550] The one or more compensation regions (or areas) 205 may provide areas or areas of bending or articulation through or around the following planes:
[0551] At least one plane passing through the interface
[0552] Multiple parallel planes passing through the interface
[0553] At least two different (non-parallel) planes passing through the interface
[0554] At least two different (orthogonal) planes passing through the interface.
[0555] For example, Figure 5A-5G , 6A-6G, 7A-7G, 8A-8G, 9A-9G embodiments generally show a side arm element 206 having a compensation region (or portion) 205, wherein there is at least one or a series of articulation or bending or flexing regions or portions (i.e., these compensation regions (or portions)), wherein the articulation or bending or flexing (preferably primarily) passes through a plane that passes through the interface 200, wherein those planes are parallel to each other.
[0556] It will be understood that the compensation regions (or portions) 205 can be constructed so as to each provide a different bending or articulation or flexure plane, such as an offset plane, whether orthogonal or not, parallel or not, allowing compensation in multiple planes to operate effectively in combination to isolate or absorb or attenuate the forces experienced by the interface to prevent them from being transferred or translated to the bridging portion or bridging portion elements.
[0557] Figures 10A-10E For example, an embodiment is shown in which the compensation region (or area) allows articulation or bending or flexing through multiple planes, such as by Figures 10F-10I As shown in the line graph.
[0558] The compensation area (or area) can be molded or formed as a cut-out portion or a wedge-shaped (thinned or thickened) portion of the side arm 201 or side arm element 206 to provide multiple planes through which articulation or bending or flexure can be preferably facilitated.
[0559] The compensation area (or area) may preferably be positioned or placed more toward the rear of the side arm 201 or side arm element 206, or may be positioned or placed more toward the front of the side arm or side arm element (or may be more centrally located).
[0560] In some embodiments, one or more of the compensation regions (or locations) 205 can flex or bend (or articulate or be partially displaceable or can elastically deform or move or respond) to a force or movement input, more preferably in a first direction or a first set of directions, and less preferably in another direction or set of directions. For example, each one or more of the different compensation regions (or locations) 205 can be adapted or configured to substantially resist or be more resistant to flexing or bending (or articulating or elastically deforming) in a less preferred direction or set of directions than in a more preferred direction of flexing or bending (or any of other articulating or elastic deformation responses).
[0561] In a particular preferred mode, the first direction or the first set of directions is in a substantially transverse plane (e.g., the XY plane of the user's body). More specifically, the first direction or the first set of directions can be in a substantially transverse plane, in an abdominal direction or a dorsal direction, or in both an abdominal direction and a dorsal direction.
[0562] In other preferred modes, an additional preferred direction or a set of directions (eg, an additional first direction or a set of directions) may be one or more of the following: a substantially transverse plane, a substantially sagittal plane, a substantially coronal plane.
[0563] In yet another preferred mode, the first direction or first group of directions is in one or more directions that substantially facilitate movement or bending of the side arm 201 or side arm element 206 relative to the bridge portion 202 or bridge portion element 203.
[0564] For example, the compensation area (or area) 205 may allow bending or flexing in the front direction or the back direction of the user's body, etc. In this way, each of the different areas (or areas) 205 is adapted or constructed to be more easily or with less resistance to bending or flexing in such a direction, etc., but more resistant to bending or flexing in another direction.
[0565] Thus, it will be appreciated that one or more or a series of such compensation regions (or locations) 205 may be provided along the side arm 201 or side arm element 206 so as to provide a custom arrangement that preferably enables the region or location 205 to bend or flex, etc. in response to a force or movement experienced by the patient interface 200. In this way, at least some degree of absorption or isolation or mitigation of the force or movement may be achieved to prevent translation or transfer of such force or movement to other portions of the interface. Specifically, it is preferably desirable to avoid or minimize transfer or translation of force or movement to the air outlet 204 and, for example, the nasal prong 208.
[0566] According to this embodiment, the side arm 201 or side arm element 206 (or both) may be formed of a substantially elastic material or may be configured to provide substantial elasticity to flex or bend (or articulate or elastically deform) in a side arm 201 or side arm element 206 compensation region (or area) 205 selected from one or more of the following:
[0567] is disposed between a single compensation region (or portion) 205 located laterally outward from the bridge portion 202 or the bridge portion element 203 and an outer end 209 of the side arm 201 or the side arm element 206,
[0568] The outer compensation region (or part) 205 of the side arm 201 or the side arm element 206 is arranged between the outer end of the side arm 201 or the side arm element 206,
[0569] Between each of a series of compensation regions (or locations) 205 disposed on the side arm 201 or side arm element 206,
[0570] It is arranged between two compensation areas (or parts) 205 positioned laterally outward from the bridging portion 202 or the bridging portion element 203, and is located between the more outer compensation area (or part) 205 of the side arm 201 or the side arm element 206 and the outer end 209 of the side arm element 206.
[0571] In one embodiment, Figure 2A -G shows a patient interface 200 including a bridging portion element 203 connected to a pair of side arms 201 via the connecting material of each side arm. Compensation areas (or locations) 205 are indicated at the junction or connection between the bridging portion element 203 and the side arm 201 material. Additional compensation areas (or locations) 205s are indicated on the side arm 201, which is formed or shaped to provide such compensation areas (or locations) 205s. Specifically, Figure 2F The shape of the patient interface before the interface and the compensation area (or region) 205, 205s respond to the force applied or experienced by the interface are shown, and Figure 2G The shape of the interface 200 is shown as the compensation region (or area) reacts to compensate for the applied or experienced force.
[0572] In another embodiment, Figure 3A -C and Figure 4A -C each shows something like Figure 2A -E patient interface 200. The gas supply conduit is shown as being contained or positioned by item 213 for delivery of gas to the outlet 204 and the nasal prongs 208. The compensation areas (or portions) are shown as 205, 205s. The compensation areas (or portions) 205, 205s allow the patient interface to respond to the applied forces so as to minimize or isolate the transfer or translation to the bridge portion and thus to the outlet 204 and the nasal prongs 208. Note that Figure 3D and Figure 4D shows the shape of the patient interface before the interface acts to compensate for the force, and Figure 3E and Figure 4E The shape of the interface is shown when the compensation area (or region) 205, 205s operates in response to the force.
[0573] In one embodiment, one or each side arm 201 or one or each side arm element 206 may be comprised of a single compensation region (or area) 205, 205s configured for such flexure or bending (or any of other responses, such as articulation or local displacement or elastic deformation or movement). See, for example, Figures 5A-5E, one such embodiment is shown in which a compensation region (or location) 205 is located proximate to the bridging portion and is a portion of the side arm element 206 where some material has been removed (e.g. may be a slot or notch or crack or cut, or may be formed or molded in this manner) The compensation region (or location) 205 is provided to the rear side of the side arm element and allows articulation or preferably bending or flexing of the side arm element in this region. It will be appreciated that there may be an optional further compensation region (or location) 205, 205s at the outer end 209 of the or each side arm element 206 where the side arm 201 is attached or connected (i.e. interconnected) to the side arm element. At such region (or location) 205, 205s, the difference in material properties may create an effective further region (or location) 205, 205s for flexing or bending etc. However, this may be an optional feature. Fig. 5F , Figure 5G Different nodes are shown for preferred compensation regions 205, 205s as may be provided by side arms or side arm elements. Fig. 5F is the shape of the interface 200 before application (or response by the compensation region (or site)), and Figure 5G It is the shape of the interface once the compensation area (or part) is in effect.
[0574] In another embodiment, for example Fig. 6A -E embodiment, the side arm element 206 is provided with at least two points or localized compensation areas (or sites) 205, 205s, and there may also be an optional compensation area (or site) at the outer end of the side arm element 206, at the junction with the side arm 201 material, for example, the different material properties of the side arm and the side arm element can interact or intersect to provide such additional compensation areas (or sites). Further, another compensation area (or site) can be provided by the side arm 201 itself (for example, as the side arm material bows in response to forces, such as changes in the shape of the user's face / cheek, and the side arm can be releasably connected to the user's face / cheek by a retention system or a fastening system). As seen, the side arm element 206 has a first compensation area (or site 205) located at the more internal end of the side arm element (close to or adjacent to the bridging portion element), and this first area (or site) 205 is a narrow groove or notch or crack or cut or molded cavity or void from the front side or face of the side arm element 206. A second compensation area (or region 205) is then disposed more laterally outward from the first area or region and is shown as a depression or recess formed in the top and bottom surfaces of the side arm element.
[0575] Fig. 6F -G's line graph shows that when the region (or part) 205 bends or articulates or flexes, Fig. 6A At least one embodiment of how an interface can respond to an applied force.
[0576] In each of the different embodiments shown, it will be appreciated that at the outer end 209 of the or each side-arm element 206, there may be a region 205, or optionally 205s, where the side-arm 201 is attached or connected to the side-arm element 206. At such regions (or locations) 205, 205s, differences in material properties, or other shapes or formations of the side-arm 201 or side-arm element 206, or their joints, may create effective additional regions (or locations) 205 or 205s for flexing or bending or the like.
[0577] A line diagram showing the location and operation of the compensation regions (or locations) 205, 205s for each of these embodiments for a node is shown by Fig. 6F -G, Figure 7F -G, Fig.8F -G, Fig.9F -G, Fig.10F -G (as Fig. 10D The top view of these nodes is shown above), Fig. 10H -I (as Fig. 10D A front view of these nodes shown in Fig.11F -G, Fig.11H -I (as an example of an additional compensation area (or location) provided externally or provided at the joint of the side arm 201 with the side arm element 206), Fig.12F -G, Fig.13F -G, Fig.14F -G, Fig.15F -G, Fig.16F Again, the operating shapes of the interface 200 before a force is applied (or compensation regions (or sites) are those of the first reference figure above, and the second reference figure is once the compensation regions (or sites) 205, 205s have been activated or operated / responsive to an applied force.
[0578] Considering the different embodiments discussed above, it will be appreciated that in different modes, configurations or adaptations, one or more of the following may be provided:
[0579] At least one point or localized compensation area (or location) 205 can be located at the more internal end 210 of the side arm 201 or side arm element 206 that is connected to the bridging portion 202 or the bridging portion element 203 (for example, the or each side arm element 206 can be configured to flex or bend (or hinge or locally displace or can elastically deform or move) relative to the bridging portion element 203).
[0580] At least one of the points or localized regions (or sites) 205 may be located at a junction or connection between the side arm 201 or side arm element 205 and the bridge portion 202 or bridge portion element 203.
[0581] At least one of these points or localized areas (or locations) 205 can be located in an area of the bridging portion 202 or the bridging portion element 203 that is substantially defined by the periphery or lateral outer edges of the user's septum area or in an area of the bridging portion element that is substantially defined by the periphery or lateral outer edges of the user's septum area.
[0582] The side arm element or side arm allows the provision of space / gap for gas supply to one or more outlets
[0583] In yet another embodiment, either the side arm 201 or the side arm element 206, either individually or in combination, can be shaped or constructed or adapted to provide a passage 213. Such a passage 213 is formed by one or more of a lumen or void space or cavity or other recess through the side arm 201 and / or the side arm element 206.
[0584] Such passageway 213 permits receipt of a supply of gas (from a source) and directing delivery of that gas to a user via one or more outlets 204; or alternatively, permits receipt of a gas supply conduit (not shown, but which may be received or fitted into such article 213) for then delivering the gas to a user via one or more outlets 204.
[0585] Such a passage 213 in or through the side arm 201 or the side arm element 206 or both allows for the formation of a conduit or lumen through which gas can be directed or supplied for delivery to one or more outlets 204 .
[0586] The passage 213 or conduit or lumen (or channel) thus formed by a lumen or void space or cavity or other recess through the side arm 201 and / or side arm element 206 can be at least partially defined by the side arm 201 and at least partially by the side arm element 206 (i.e., the side arm element 206 can itself form a portion of the wall of such article 213 and the side arm 201 can itself form another portion of the remainder of the article 213).
[0587] Each side arm 201 may include a port for access to the passageway 213. Such a port may be located on the front face of each side arm, at the more external end of the side arm. The port is preferably located below the horizontal midline of the patient interface, and is more preferably oriented to accept a gas supply conduit or other gas connection from a direction below or under the side arm.
[0588] At least a portion of the passage 213 formed by one or more side arm elements can be at least 10%, or at least 20%, or at least 30%, or at least 40%, or at least 50%, or at least 60%, or at least 70%, or at least 80%, or at least 90% of the wall circumference or wall perimeter (e.g., unit length segment) of the passage so formed, or can be in the range of about 1-99%, or about 5-95%, or about 10-90%, or about 15-85%, or about 20-80%, or about 30-70%, or about 40-60%, or about 30-50%.
[0589] Since the wall of the passageway can be formed by the combination of the side arm 201 and the side arm element 206, the side arm 201 can provide the remaining portion of the wall circumference or wall perimeter that is otherwise formed by the side arm element.
[0590] Small protrusion
[0591] Where a side arm element 206 is utilized, one or more tabs 211 may be provided around or along such element 206. These various tabs 211 may be engageable or configured in a shape or configuration that will associate with the material of the side arm 201. See, for example, Fig.15A -E, shows such a small protrusion 211.
[0592] The tabs 211 provide extension of the side arm element 206 in a variety of directions or planes, and in some embodiments may provide structural details of the side arm element 206, onto which the side arm 201 may be engaged, such as in an overmolding arrangement, or the material for the side arm 201 may be provided to otherwise engage with the tabs 211. In this manner, such tabs 211 may be effectively implanted into the side arm 201. Such implantation may provide yet another area (or location) 205, or additional reinforcement or enhancement of the side arm 201 or side arm element 206, or a combination thereof. For example, the interaction of the tabs 211 with the material of the side arm 201 may provide a particular resistance to flexing or bending (or articulation or elastic deformation) of the side arm element 206 of the side arm 201, or a combination thereof.
[0593] According to e.g. Fig.15A -E, the material of the side arm 201 can surround the tab 211. The material of the side arm 201 can be at least partially compressible (or can be at least partially incompressible), or have desired properties such that the tab 211 can translate flexure or bending (or articulation or elastic deformation) of the side arm element 206 into compression of the material of the side arm 201 (or as an extension or stretching of the side arm material in response to a force, such as tension).
[0594] In this way, the side arm material operates to resist articulation or flexure or bending due to its material properties when compressed by a tab or other portion of a side arm element, such as the wall of a notch or crack or slot or other cutout in which the side arm material may be located. Similarly, the side arm material may resist extension or stretching, for example, due to the notch or crack or slot or other cutout changing shape or increasing its angle in response to an applied force.
[0595] Different iterations of the patient interface 200 are shown in the accompanying drawings - however, these illustrations should not be viewed as limiting to a particular arrangement. Where the patient interface 200 utilizes a side arm 201 in conjunction with a side arm element 206, the material of the side arm 201 may, for example, in some forms encapsulate or substantially envelop the side arm element 206 (e.g., may be completely or entirely encapsulated or encapsulated); but in other alternative forms, the side arm element 206 may only be partially encapsulated or encapsulated.
[0596] The one or more materials of the side arm 201 can be used to fill any voids or gaps that may otherwise be present between the side arm 201 and the side arm element 206. In this way, the one or more side arm materials can provide a material that is inserted into voids or gaps of the side arm element 206 or around other shapes, such as the region (or area) 205. As described above, the one or more materials of the side arm 201 can encapsulate or encapsulate the side arm element 206 in whole or in part.
[0597] The material or materials of the side arm 201 may be selected based on specific preferred properties. The interaction of the region (or site) 205 or the tab 211 (or both) with the material or materials of the side arm 201 may work in conjunction with one or more of the predefined or prearranged points or localized regions (or sites) 205 to allow force or movement input more preferably in a first direction or first set of directions, and less preferably flexure or bending (or articulation or elastic deformation or movement or response) in another direction or another set of directions, but also provide some resistance to such flexure or bending.
[0598] Side arms extend around each side of the face
[0599] In certain embodiments, and for example when a pair of side arms 201 are provided for a patient interface, each of the side arms 201 is adapted to extend laterally from the bridging portion 202, and one of the side arms 201 of the pair of side arms can extend substantially around the left side of the user's face and the other side arm can extend substantially around the right side of the user's face.
[0600] The or each side arm 201 may extend substantially laterally away from or outwardly from the sagittal plane of the user.The or each side arm element 206 may extend along the actual length of each such side arm 201 comprising such side arm element or along or through each such side arm element.
[0601] Thus, a pair of side arms 201 may be provided wherein the patient interface 200 can be positioned on the face of a user, each of the side arms 201 providing a portion of a retention system or fastening system to which the headgear may be coupled or associated. In this way, the patient interface 200 may be held or fastened on the face of the user in a desired operating position.
[0602] Each of the side-arms 201 or side-arm elements 206 may in turn be responsive to forces or movements experienced by the patient interface so as to isolate or absorb or attenuate or at least somewhat mitigate the likelihood of such forces or movements being transferred or translated to other portions of the patient interface.
[0603] In a preferred embodiment, there is a minimization of forces or movement that is not transferred or translated to the bridging portion 202 or the bridging portion element 203 (or both). This can allow for a more stable position or positioning of the air outlet 204 and any such nasal prongs 208 associated with the bridging portion 202 or the bridging portion element 203. In turn, this can help reduce the movement of such air outlets or nasal prongs to prevent movement close to the user's nose or their nostrils, thereby helping to avoid nasal prong flicking. Nasal prong flicking is an undesirable result of movement of the air outlet 204 or nasal prongs 208. Nasal prong flicking can irritate the user and can interrupt the delivery of therapy.
[0604] As shown in certain figures, the or each side arm element 206 may be constructed as a plurality of element branches 212 (i.e., the side arm element 206 may be bifurcated or otherwise split or branched into a series of element branches 212). One or more of these side arm element branches 212 may themselves include one or more of the tabs 211 previously described.
[0605] refer to Figure 2A-2E , an embodiment is provided wherein the bridge portion 202 includes a bridge portion element 203 that defines a pair of notched cutouts or molded portions 207. Portions 207 provide a predefined outlet 204 path or port to which a nasal prong 208 may be fluidly connected to direct the gas flow to the nostrils of the user's nose. Figure 2C As seen in the figure, there is a passage 213 in or through the side arm 201. Similarly, the bridging portion element 203 is shaped or formed to allow gas to be supplied through the lumen or void space or cavity or recess 213 to be guided or supplied for delivery to one or more outlets 204.
[0606] exist Figure 2A -E embodiment, the side arms 201 include their own regions (or areas) 205s, which may be, for example, the general bowing of the side arms in response to forces through the side arm material.
[0607] refer to Figure 3A -C and Figure 4A -C, an embodiment is provided in which the bridging portion 202 includes a bridging portion element 203, which defines a pair of cutouts or molded portions, which define a spatial arrangement for the outlet 204 and a pair of nose forks 208 extending out of the pair of cutouts or molded portions. In addition, on each side arm 201 is a gas supply conduit locator 214, which is used to locate or accommodate the gas supply conduit as part of the passage 213. The gas supply conduit can be fixed in an appropriate position using a locator or in the passage 213 (for example, it can be glued in an appropriate position). The bridging portion element 203 also includes such an article 213 for receiving a delivery of a gas supply and then for directing such gas to the outlet 204 and the nose fork 208.
[0608] exist Figure 3A In the embodiment of -C, the gas supply conduit provides some resistance or at least some constraint to the extension of the side arm laterally outward from the side arm 201.
[0609] exist Figure 4A In the -C embodiment, the gas supply conduit is provided with an even shorter length between fixed positions, is fixed to one or each of the positioners 214, and in doing so provides even greater resistance to extension of the side arms laterally outward from the bridging portion.
[0610] refer to Figure 5A-E, an embodiment is provided in which the bridging portion 202 includes a bridging portion element 203 having a pair of left and right arm elements 206. The bridging portion element 203 defines a pair of cutouts or formed portions 207 that define a spatial arrangement for the outlet 204 and a pair of nose prongs extending from the pair of cutouts or formed portions. The side arm element 206 includes at least one area (or portion) 205 around which articulation capability is provided. The articulation capability allows the side arm elements 206 to bend or flex or articulate so as to absorb or at least somewhat mitigate the transfer or translation of forces or movements applied to these side arm elements 206 from reaching the bridging portion 202 and the bridging portion element 203, which defines the spatial arrangement of the outlet 204 and the nose prong 208. As shown, the area (or portion) 205 can be a notch or crack or slot or cutout from the side arm element 206. Additionally, the joint or connection of the material between the side arm 201 and the side arm element 206 may provide an additional region (or area) 205 around which some flexing or bending, etc. may occur. The level of flexing or bending, etc. that may occur may depend at least in part on the materials used for the side arm 201 and the side arm element 206 and their relative properties. Figure 5C As shown in FIG. 1 , the side arm 201 is shaped or formed to include a passage 213 for positioning or accommodating a gas supply conduit, or at least forming a portion of such a lumen or passage. The bridging portion element 203 is also shaped to facilitate such a passage 213 when combined with the side arm 201, for example, see Figure 5E .
[0611] refer to Fig. 6A -E, an embodiment is provided wherein the bridge portion 202 includes a bridge portion element 203 having a pair of left and right arm elements 203. The bridge portion element 203 defines a pair of cutouts or formed portions 207 that define a spatial arrangement for the outlet 204 and a pair of nose prongs extending out of the pair of cutouts or formed portions. The side arm element 206 includes at least two regions (or portions) 205. The first of the regions (or portions) 205 is located at a more interior end 210 of the side arm element 206, proximate to the junction between the bridge portion element 203 and the side arm element 206. The second of the regions or portions (205) is located toward a more exterior end 209 of the side arm element 206. The first region (or portion) allows for providing a preferred first direction or a first set of directions in which the side arm elements can bend or flex or move outward from the user's face (i.e., in the transverse abdominal direction), while the second region (or portion) allows for providing a preferred first direction or a first set of directions in which the side arm elements can bend or flex or move inward toward the user's face (i.e., in the transverse dorsal direction).
[0612] Additionally, the joint or connection of the material between the side arm 201 and the side arm element 206 may provide an optional additional region (or location) 205. The level of flexure or bending that may occur may depend at least in part on the materials used for the side arm 201 and the side arm element 206 and their relative properties. Figure 6C As shown in , the side arm 201 is shaped or formed to include a lumen or void space or cavity or other recess 213 for positioning or accommodating a gas supply conduit, or at least forming a portion of such a lumen or channel. The bridging portion element 203 is also shaped to facilitate such an item 213 when combined with the side arm 201, for example, see Fig.6D .
[0613] exist Fig. 6A In the embodiment of -E, the side arms 201 include their own regions (or areas) 205s.
[0614] As reference Fig. 6A -E describes the example, Figure 7A-16G Each of the embodiments shows another alternative arrangement utilizing multiple areas or locations (205) and multiple more preferred first directions for a patient interface 200 equipped with a self-compensating capability to minimize forces or movements applied or experienced by the patient interface to prevent transfer or translation to the bridge portion 202 or bridge portion element 203, and thereby the air outlet 204 and a nasal prong that can, for example, be fluidly connected thereto.
[0615] Fig. 7A -E embodiment shows at least three regions (or portions) 205, and optionally additional regions (or portions) 205, such as may be implemented at the junction of the outer end of the side arm element 206 with the side arm 201. The first of the regions (or portions) 205 is located at the more inward end 210 of the side arm element 206, while the second and third regions (or portions) 205 are located more outward along the length of the side arm element 206. It should be noted that the second and third (i.e., more outwardly located) regions (or portions) 205 are constructed for more preferred bending or flexing in a different direction than the first region (or portion) which is more inward. This can allow for multiple bending or flexing directions to be provided along the side arm element 206. As Figure 7C As shown in , the side arm 201 is shaped or formed to include a lumen or void space or cavity or other recess 213 for positioning or accommodating a gas supply conduit, or at least forming a portion of such a lumen or channel. The bridging portion element 203 is also shaped to facilitate such an item 213 when combined with the side arm 201, for example, see Fig. 7E .
[0616] At least Fig. 7A-E embodiment, the side arms 201 may include their own regions (or locations) 205s as indicated. Such side arm regions (or locations) 205s may be implemented by thinner and thicker sections or side arm materials or other shapes of side arms to allow articulation or bending or flexing in a preferred direction or plane.
[0617] Fig. 8A -E embodiment shows at least two regions (or locations) 205, and optionally additional regions (or locations) 205, such as can be implemented at the junction of the outer end of the side arm element 206 with the side arm 201. The first region (or location) 205 is located further inward (i.e., closer to the bridge portion element 203) than the second region (or location) 205. The different geometry of each region (or location) 205 allows for different types or levels of bending or flexing of each region (or location) 205. Figure 8C As shown in , the side arm 201 is shaped or formed to include a lumen or void space or cavity or other recess 213 for positioning or accommodating a gas supply conduit, or at least forming a portion of such a lumen or channel. The bridging portion element 203 is also shaped to facilitate such an item 213 when combined with the side arm 201, for example, see Fig. 8E .
[0618] Fig. 9A -E embodiment shows at least two regions (or parts) 205, and optionally additional regions (or parts) 205, such as can be implemented at the junction of the outer end of the side arm element 206 and the side arm 201. In this embodiment, a series of regions (or parts) 205 can be arranged or arranged sequentially along the length or body of the side arm element 206. The first of the regions (or parts) 205 is positioned more inwardly and closest to the bridging portion element 203. This first region (or part) 205 can allow a first preferred direction or a first set of directions that is different from the preferred direction or a set of directions provided by the sequentially arranged regions (or parts) 205 that are positioned more outwardly than this first region (or part 205). As Fig. 9C As shown in , the side arm 201 is shaped or formed to include a lumen or void space or cavity or other recess 213 for positioning or accommodating a gas supply conduit, or at least forming a portion of such a lumen or channel. The bridging portion element 203 is also shaped to facilitate such an item 213 when combined with the side arm 201, for example, see Fig.9E .
[0619] Fig. 10A-E embodiment shows at least two regions (or parts) 205, and optionally additional regions (or parts) 205, such as can be implemented at the junction of the outer end of the side arm element 206 and the side arm 201. In this embodiment, the first region (or part) 205 can allow a first preferred direction or a first set of directions, which is different from the preferred direction or a set of directions provided by the sequentially arranged regions (or parts) 205 positioned more outwardly than this first region (or part 205). For example, the region (or part) 205 located at a more inward position 210 of the side arm element 206 provides complex or multiple flexure or bending facilities, for example in multiple (different) planes. As Fig. 10C As shown in , the side arm 201 is shaped or formed to include a lumen or void space or cavity or other recess 213 for positioning or accommodating a gas supply conduit, or at least forming a portion of such a lumen or channel. The bridging portion element 203 is also shaped to facilitate such an item 213 when combined with the side arm 201, for example, see Fig. 10E .
[0620] Figures 11A-16G Each of the figures shows yet another arrangement of the side arm element 206 utilized in conjunction with the bridging portion 202, the bridging portion element 203 and the side arm 201. In each of these embodiments, the side arm 201 is molded or formed to include a lumen or void space or cavity or other recess 213 for positioning or accommodating a gas supply conduit, or at least forming a portion of such a lumen or passage. The bridging portion element 203 is also molded to facilitate such item 213 when combined with the side arm 201. Further, each of these figures shows different and multiple arrangements of regions (or parts) 205, whether the same or different or other combinations, which provide a set or array of bending or flexing or articulation, etc. in a first direction or a first set of directions that is more preferred than another direction or another set of directions. Therefore, the patient interface 200 can be equipped with any one or more of these configurations provided herein, or alternative combinations thereof.
[0621] As shown in the various figures, the material used for the side arm 201 can form part of the dynamic capabilities of the side arm element 206 or the side arm 201 itself. For example, the side arm 201 material can surround or encapsulate or encapsulate (whether partially or completely) the side arm element 206. The side arm 201 material can then be inserted between or around the tabs 211 or side arm element branches 212. In this way, the side arm 201 material can provide resilience or resistance to flexing or bending or articulation, or can act to provide such resistance, but absorb these forces or movements experienced by the patient interface.
[0622] In use, one or more side arms 201 will be positioned on the user's face, such as on or around the cheeks of the face. Suitable types of headgear (such as headbands and harnesses or other variations) can be connected to the side arms 201 to provide a retention system to hold or retain the patient interface 200 on the user. In a particularly preferred embodiment of the present invention, the patient interface 200 is a nasal cannula including a pair of side arms 201 and a pair of nasal prongs 208 fluidly connected to the air outlet 204.
[0623] refer to Fig.18 , a non-limiting exemplary embodiment shown in FIG. 4 shows a patient interface 4200. In the illustrated configuration, the patient interface 4200 includes a nasal cannula. In some alternative configurations, the patient interface 4200 may include a sealed interface or a non-sealed interface. For example, the patient interface 4200 may include a nasal mask, a mouth mask, an oronasal mask, a full face mask, a nasal cannula, a non-sealed oronasal interface, a nasal pillow mask, an endotracheal tube, a combination of the above or some other gas delivery system or device. Certain features, aspects, and advantages of the illustrated nasal cannula may be envisioned in other patient interfaces.
[0624] Further references Figure 18-23 , the patient interface 4200 includes a first nasal delivery element 4202A and a second nasal delivery element 4202B adapted to rest in the patient's nostrils. The nasal delivery elements 4202A and 4202B shown are substantially tubular and guide the gas passing through the patient interface 4200 to the patient. The nasal delivery elements 4202A and 4202B are shaped and angled so that they extend generally inwardly toward the septum of the patient in use. The nasal delivery elements 4202A and 4202B end at the tip pointing to the back of the patient's head in use. It should be understood that in some configurations, the nasal delivery elements 4202A and 4202B can have different shapes. For example, although the average cross-section of the nasal delivery elements 4202A and 4202B in the shown configuration is substantially circular, in some configurations, the cross-sections of the nasal delivery elements 4202A and 4202B can be substantially elliptical, substantially square, or substantially rectangular. In some configurations, the cross-section of the nasal delivery elements 4202A, 4202B can vary along the length of the nasal delivery elements 4202A, 4202B. In some configurations, the first nasal delivery element 4202A and the second nasal delivery element 4202B can have different characteristics. For example, the first nasal delivery element 4202A can be smaller or shorter than the second nasal delivery element 4202B. Some examples of nasal delivery elements with different characteristics are shown in the co-owned WO2015 / 020540, the disclosure of which is incorporated herein by reference in its entirety. In some configurations, only one nasal delivery element can be used. In some configurations, more than two (e.g., three or four) nasal delivery elements can be used.
[0625] The first nasal delivery element 4202A and the second nasal delivery element 4202B extend from the first side arm 4206A and the second side arm 4206B (also referred to as the first arm and the second arm) of the patient interface 4200. The first side arm 4206A and the second side arm 4206B include internal gas delivery lumens 4210A, 4210B that receive gas from the gas inlets 4208A, 4208B of the first side arm 4206A and the second side arm 4206B and direct the gas to the first nasal delivery element 4202A and the second nasal delivery element 4202B. The gas inlets 4208A, 4208B interface with a pair of gas delivery conduits 4218A, 4218B (see Figure 1 ). In the illustrated construction, the gas delivery conduits 4218A, 4218B are integrally formed or non-detachably connected to the gas inlets 4208A, 4208B. The gas delivery conduits 4218A, 4218B are in turn integrally formed or non-detachably connected to the gas conduit connector 222. The gas conduit connector 222 is configured to releasably dock with a complementary connector 118, which is in pneumatic communication with the gas conduit 110 (referenced elsewhere in this disclosure). Figure 1 Description). Other configurations are contemplated. For example, in some configurations, the patient interface 4200 can be configured such that the first nasal delivery element 4202A and the second nasal delivery element 4202B receive gas from a single internal gas delivery lumen positioned in either the first side arm 4206A or the second side arm 4206B, and the single internal gas delivery lumen in turn receives gas from a single gas delivery conduit. In some configurations, such gas delivery conduits 4218A, 4218B are unnecessary, and one or more gas inlets 4208A, 4208B can be directly docked with the gas conduit 110 (or indirectly docked via a complementary connector 118 and / or a gas conduit connector 222). In some such configurations, the first side arm 4206A or the second side arm 4206B can be integrally formed or in the form of a single continuous piece with the gas conduit 110. In some configurations, one or more of the gas delivery conduits 4218A, 4218B are removably coupled to one or more of the gas inlets 4208A, 4208B. In some configurations, one or more of the gas delivery conduits 4218A, 4218B are removably coupled to the gas conduit connector 222.
[0626] The first side arm 4206A and the second side arm 4206B of the patient interface 4200 are adapted to rest on the patient's face. In the illustrated configuration, the first side arm 4206A and the second side arm 4206B are adapted to rest on opposite cheeks of the patient. In order to fix the first side arm 4206A and the second side arm 4206B in position on the patient's face, the first side arm 4206A and the second side arm 4206B are provided with attachment structures 4216A, 4216B on the side facing the patient, which are adapted to maintain the patient interface 4200 in the desired alignment with the face (e.g., in this configuration, so that the nasal delivery elements 4202A, 4202B are comfortably and non-sealedly positioned in the nostrils). The attachment structures 4216A, 4216B are configured so that they can dock with a fixed structure attached to the face. In some configurations, the attachment structures 4216A, 4216B and the fixed structures can be structured so that they complement each other. For example, the attachment structures 4216A, 4216B can include a "loop" portion (e.g., made of textiles or plastics), which are bonded or otherwise fastened to the first side arm 4206A and the second side arm 4206B on the patient-facing side, and the fixed structure can include a "hook" pad, which is bonded or otherwise fastened to the face (e.g., for a "hook and loop" style connection). Some examples of hook and loop style connections are shown in co-owned WO2012 / 053910, the disclosure of which is incorporated herein by reference in its entirety. Other configurations are considered. For example, in some configurations, the attachment structures 4216A, 4216B can be directly docked with the face (e.g., by using an adhesive pad or other structure). In some configurations, only a single attachment structure can be used, or more than two (e.g., three or four) attachment structures can be used. In some constructions, the attachment structures 4216A, 4216B may include features other than the "loop" portion. For example, the attachment structures 4216A, 4216B may include a "hook" portion that docks with a complementary "loop" portion on the fixed structure. As another example, the attachment structures 4216A, 4216B may include snap-fit features or other mechanical interlocking features that dock with features on the fixed structure. In some constructions, the patient interface 4200 may not include an attachment structure. In some constructions, the patient interface 4200 may include a head cap adapted to hold the patient interface 4200 in a desired orientation or alignment on the face. The head cap may include, for example, one or more straps configured to extend around the patient's head, buckles for adjusting the tightness of the straps by modifying the effective length of the straps, brimless caps, headscarves, brimmed caps, helmets, and / or one or more other features.
[0627] The bridge 4204 connects the first side arm 4206A and the second side arm 4206B. The bridge 4204 is an extension of the first side arm 4206A and / or the second side arm 4206B that does not include an internal gas lumen, and acts to help keep the nasal delivery elements 4202A, 4202B in a desired orientation relative to each other. Other configurations are contemplated. For example, in some configurations, the bridge 4204 can be made of a second material or a material different from the rest of the interface, such as the first arm and the second arm. In some such configurations, only one of the first side arm 4206A and / or the second side arm 4206B includes an internal gas lumen and / or an air inlet. In some configurations, the bridge 4204 extends between a first connection point on the first side arm 4206A and a second connection point on the second side arm 4206B. In some such configurations, the first connection point and / or the second connection point may include one or more movable joints. In some such configurations, one or more joints may include one or more articulation regions. As part of the articulation region, there may be an articulated joint. In some such configurations, one or more joints may include one or more pivot joints. One or more joints may allow the bridge 4204 to move relative to the first side arm 4206A and / or the second side arm 4206B.
[0628] like Fig.19 As seen in the drawings, the first and second side arms 4206A, 4206B decrease in width as they extend toward the nasal delivery elements 4202A, 4202B and / or the bridge 4204. The attachment structures 4216A, 4216B are positioned on relatively wider portions of the first and second side arms 4206A, 4206B, adjacent to the outer edges of the first and second side arms 4206A, 4206B, to improve the stability of the patient interface 4200 on the face when the attachment structures 4216A, 4216B are used with a fixation structure. Additionally, as shown Fig.23 As seen in FIG. 4 , the patient interface 4200 is generally shaped or configured so that it substantially matches the contours of the face. The patient interface 4200 is also configured so that when a force F1 is applied to the first side arm 4206A and the second side arm 4206B, thereby pushing the outer edges of the side arms 4206A, 4206B inwardly toward the bridge 4204 (this force may be applied, for example, due to compression of the face against the pillow or due to facial expressions of an emotional state), the inner portions of the side arms 4206A, 4206B and / or the bridge 4204 act as hinge regions to cause a force F2 to be applied to the nasal delivery elements 4202A, 4202B, thereby causing the nasal delivery elements 4202A, 4202B to move toward the patient. This movement of the nasal delivery elements 4202A, 4202B toward the patient can help keep the nasal delivery elements 4202A, 4202B in the patient's nostrils.
[0629] Further references Fig.18 , the outer edges of the first side arm 4206A and the second side arm 4206B include breakaway structures 4212A, 4212B. The breakaway structures 4212A, 4212B are positioned on the outer portions of the side arms 4206A, 4206B, spaced apart from the air inlets 4208A, 4208B. In the illustrated configuration, the breakaway structures 4212A, 4212B are tabs that include an inner region with reduced thickness relative to adjacent portions of the side arms 4206A, 4206B. Outside of the inner region of the tab and toward the outer edges of the side arms 4206A, 4206B, the tabs additionally include an outer region with normal thickness or increased thickness relative to the same adjacent portions of the side arms 4206A, 4206B. The tabs are configured so that the outer region can be grasped and pulled by the patient or another person (e.g., a healthcare professional, such as, but not limited to, a nurse or physician). When pulled, the outer area can rotate around the inner area and sufficient force can be applied to the patient interface 4200 so that the attachment structures 4216A, 4216B are disengaged from the fixed structure present on the face. The disengagement structures 4212A, 4212B can therefore be used to more easily disengage the patient interface 4200 from the face. Other constructions are considered. For example, in some constructions, only a single disengagement structure can be positioned on a single body of the interface 4200. In some constructions, the patient interface 4200 may include more than two (e.g., three or four) disengagement structures. In some constructions, the disengagement structures 4212A, 4212B may be positioned on other parts of the side arms 4206A, 4206B or on other parts of the patient interface 4200. In some constructions, the disengagement structures 4212A, 4212B may include structures other than the tabs. For example, the detachment structure 4212A, 4212B may include a flat extension of the first side arm 4206A and / or the second side arm 4206B that can be pulled or otherwise manipulated to separate the patient interface 4200 from the face.
[0630] refer to Fig.21A and Fig. 21B , showing a close-up view of the patient interface 4200. Fig. 21B Specifically, a schematic diagram of the bridge 4204 and nasal delivery elements 4202A, 4202B is shown, and the bridge 4204 is shown as a beam, showing the neutral axis N, the compression side C, and the tension side (e.g., the patient-facing side) T of the bridge 4204. As described elsewhere in this disclosure Fig.23As described, when a force is applied to the first side arm 4206A and the second side arm 4206B so as to push these side arms inwardly toward the bridge 4204, the shape of the patient interface 4200 causes the nasal delivery elements 4202A, 4202B to move toward the patient, so that the nasal delivery elements 4202A, 4202B are retained in the patient's nostrils. However, some of the force F that acts to push the nasal delivery elements 4202A, 4202B can also act to push the nasal delivery elements 4202A, 4202B apart, thereby causing them to shift relative to each other. In some cases, the nasal delivery elements 4202A, 4202B are caused to open, thereby rotating the displacement angle D1 in directions substantially opposite to each other. As shown in FIG. Fig. 21B As shown in FIG. , force F causes the patient-facing side of the bridge 4204 to be placed under tension, thereby effectively stretching and bending the patient-facing side of the bridge 4204 and causing the nasal delivery elements 4202A, 4202B to flex (see FIG. Fig. 21B , indicating an undeployed position of the nasal delivery elements 4202A, 4202B). The opposite side of the bridge 4204 similarly becomes compressed and generally does not maintain its curvature or shape due to the force F. When the nasal delivery elements 4202A, 4202B are deployed from one another, in some instances the nasal delivery elements 4202A, 4202B deform against the inside of the nostrils and may "pop out" or be displaced so as to be located on the outside of the nostrils, which may be inconvenient for the patient or another person serving the patient.
[0631] Fig.22A and 22B A modified patient interface 4200 is shown. The modified patient interface 4200 includes a support structure 4220 positioned on the patient-facing side of the bridge 4204. In the illustrated configuration, the support structure 4220 is configured to reinforce the bridge 4204 so as to resist the tendency of the nasal delivery elements 4202A, 4202B to flex when a force F is applied to the bridge 4204 (e.g., the support structure 4220 acts as a reinforcement structure 4204). Effectively, as Fig. 22B , the presence of the support structure 4220 on the patient-facing side of the bridge 4204 causes the neutral axis N to shift from approximately in the center or middle of the bridge 4204 to closer to the tension side T of the bridge 4204. The tensile strength of the bridge 4204 can be improved. Then, for the same force F, the nasal delivery elements 4202A, 4202B will only shift a smaller displacement angle D2 and may be less likely to deform against the inside of the nostril, or shift to be located on the outside of the nostril.
[0632] In some configurations, the support structure 4220 is at least partially made of a textile material. For example, the support structure 4220 can be made of a woven, non-woven or knitted textile material. In the illustrated configuration, the support structure 4220 is made of a polymer (e.g., polypropylene) sheet. Constructing the support structure 4220 from a textile material gives the support structure 4220 enough strength to move the neutral axis and resist the flexure of the nasal delivery elements 4202A, 4202B. Additionally, the use of a textile material on the patient-facing side of the bridge 4204 can maintain or improve the comfort of the patient interface 4200 on the face and help reduce or prevent pressure sores caused by the extended use of the patient interface 4200 on the face. However, in other configurations, other forms of the support structure include, but are not limited to, sheets, films, plates, panels, flat plates, and other blocks of different shapes and sizes, and other materials include, but are not limited to, polymers, plastics, metals, ceramics, cloth, wax, and other materials of different qualities that can be used for the support structure 4220. Although in the illustrated construction the support structure 4220 has a substantially constant thickness across the length and width of the support structure 4220, in some constructions the support structure 4220 may have a non-uniform thickness along the length and / or width of the support structure 4220 (e.g., in some cases the support structure 4220 may have a “bumpy” or “wavy” patient-facing surface).
[0633] In some configurations, the support structure 4220 is bonded to the patient-facing side of the bridge 4204. In some configurations, the support structure 4220 and / or the bridge 4204 are configured to rest against the philtrum of the user. In some configurations, the support structure 4220 can be attached to the patient-facing side of the bridge 4204 according to other engagement structures or devices. For example, in some configurations, the support structure 4220 can be overmolded onto the patient-facing side of the bridge 4204, bonded to the patient-facing side of the bridge 4204 (e.g., via the use of one or more adhesives or glues), melt-bonded to the patient-facing side of the bridge 4204, welded via the use of ultrasonic or high-frequency welding, sutured, stapled, screwed, and / or bolted. In some configurations, the support structure 4220 can be chemically bonded to the bridge 4204. In some such configurations, the support structure 4220 may be constructed of the same material (e.g., the same plastic, e.g., polypropylene) as the bridge 4204 (and potentially the same material as other portions of the patient interface 4200). For example, if both the support structure 4220 and the bridge 4204 are constructed of polypropylene (in this example, the support structure 4220 is a polypropylene textile and the bridge 4204 is another block of polypropylene), the chemical bond may be more easily facilitated and may allow for a more seamless and aesthetically acceptable join between the support structure 4220 and the bridge 4204.
[0634] It should be understood that the support structure 4220 need not be located only on the patient-facing side of the bridge 4024. In some configurations, and as Fig.24 As seen in , the support structure 4220 can extend across at least a portion of the first side arm 4206A and / or the second side arm 4206B. The support structure 4220 can be in the form of a strip having substantially the same width as the bridge 4204 over the length of the support structure 4220. In other constructions, the support structure 4220 can decrease in width over the length of the support structure 4220. In yet another construction, the support structure 4220 can increase in width over the length of the support structure 4220. In some such constructions, the width of the support structure 4220 increases so that it approaches or matches the width of the first side arm 4206A and / or the second side arm 4206B (in the construction shown, the width increases as they extend outward from the bridge 4204 and / or the nasal delivery elements 4202A, 4202B). In some constructions, and as shown Fig.23 , the support structure 4220 can extend the entire length of the patient interface 4200, including over the bridge 4204 and over the first and second side arms 4206A, 4206B. In one configuration, the support structure 4220 can be discontinuous over the length of the support structure 4220 (e.g., the support structure 4220 can be in the form of three non-adjacent sections).
[0635] In some configurations, if the support structure 4220 extends into a section of the patient-facing portion of the side arms 4206A, 4206B that typically holds one or more of the attachment structures 4216A, 4216B, the support structure 4220 can be configured to function as one or more of the attachment structures 4216A, 4216B. In some such configurations, one or more of the attachment structures 4216A, 4216B need not be present, and the support structure 4220 can be configured to fulfill the function of one or more of the attachment structures 4216A, 4216B. For example, the support structure 4220 can include a "loop" section that can dock with a complementary "hook" section on a fixed structure fastened to the face. As another example, the support structure 4220 can be bonded directly to the face.
[0636] It should be understood that the support structure 4220 need not be located on the patient-facing side of the patient interface 4200 (including but not limited to the first side arm 4206A, the second side arm 4206B, and / or the bridge 4204). In some configurations, the support structure 4220 can be positioned on other sides of the patient interface 4200 (including but not limited to: the side of the bridge 4204, the first side arm 4206A, and / or the second side arm 4206B that is away from the face and / or the side opposite to one or more patient-facing sides), provided that the material and / or structure and / or construction of the support structure 4220 shifts the neutral axis in an appropriate manner such that the nasal prongs resist flexion after the first side arm and / or the second side arm are pushed inwardly toward the bridge 4204 and / or the first nasal delivery element 4202A and / or the second nasal delivery element 4202B. In some configurations, the support structure 4220 rests on the non-user-facing side of the bridge 4204. In some configurations, the support structure 4220 rests on the non-user-facing side of the first side arm 4206A and / or the second side arm 4206B. In the illustrated configuration, the support structure 4220 is configured to resist tension. The support structure 4220 provides resistance to bending of the bridge 4204 by displacing the neutral axis. In some configurations, the support structure 4220 can resist compression in order to displace the neutral axis. In further alternative configurations, the support structure 4220 is configured to resist shear forces.
[0637] The patient interface of the present disclosure advantageously provides improvements in the delivery of respiratory care utilizing a ventilator or gas supply device, or in conjunction with a gas humidification system or other gas supply system for supplying gas to a patient, or for the delivery of any other gas to a patient.
[0638] refer to FIG. 25A to FIG. 26C In the embodiment shown in FIG. 1 , a patient interface 2201 / 2301 (such as a nasal cannula) has a pair of corresponding left and right arms 2201 / 2301 and 2203 / 2303 (also referred to as a main body portion) to be positioned on the face of a user in use, and at least one and preferably a pair of nasal prongs 2205 / 2305, 2207 / 2307 to be inserted into or direct the flow of gas to one or more nostrils of the user's nose. The patient interface 2201 / 2301 also has a bridge 2209 / 2309 attached to and extending from the connection point with the left arm or main body portion to the connection point with the right arm or main body portion. The bridge 2209 / 2309 includes a substantially inelastic component.
[0639] One or each of the corresponding connection points has a primary movable joint 2211 / 2311, 2213 / 2313, such as a hinged or pivot joint, allowing primary movement of the bridge relative to the corresponding side arm or main body portion. The primary movable joint allows relative rotation between the end of the bridge 2209 / 2309 and the corresponding side arm or main body portion about at least one axis. The primary movable joint is one or a combination of the following: an articulated joint, a needle and barrel type joint, a ball joint. The interface also has a facial pad 2215 / 2315, 2217 / 2317 associated with each side arm. Each facial pad is contoured to engage an area of the user's face.
[0640] refer to FIG. 25A to FIG. 25C In the embodiment shown in , the bridge 2209 includes at least one and preferably a pair of nasal prongs 2205, 2207. Each primary movable joint is arranged between the end of the bridge 2209 and the inner end of the corresponding side arm. The primary movable joint allows relative rotation between the end of the bridge and the corresponding side arm around three substantially orthogonal axes. The primary movable joints include ball joints 2211, 2213. A pair of primary movable joints are arranged between each end of the bridge 2209 and the inner ends of the corresponding left arm 2201 and right arm 2203. When the patient interface is in place on the user's face, the displacement of the position of one or both of the left body part 2201 and / or the right body part 2203 is transmitted to one or each primary movable joint in a manner that minimizes the displacement of the bridge and one or more nasal prongs relative to the user's nostrils.
[0641] refer to FIG. 26A to FIG. 26C , at least one and preferably the pair of nose forks 2305, 2307 extend from one or each of the more inward ends of the corresponding left arm 2301 and / or right arm 2303, or from an area of one or both of the corresponding side arms substantially adjacent to these more inward ends, and wherein the bridge member 2309 is a rod extending on or adjacent to the one or more nose forks.
[0642] In this embodiment, the patient interface further includes a mounting member 2319, 2321 attached to the corresponding side arm to facilitate a connection point for the rod 2309, the mounting member including a secondary movable joint, such as a hinged or pivot joint 2311, 2313, thereby allowing secondary movement of the mounting member relative to the corresponding side arm, the mounting member is attached to the corresponding side arm, and the rod is attached to the mounting member via a primary movable joint.
[0643] The mountings 2319, 2321 are slidably attached to the corresponding side arms to allow adjustment of the relative position along the side arms, thereby adjusting the distance between the nasal prongs. When the patient interface is in place on the user's face, displacement of the position of one or both of the left arm 2301 and / or the right arm 2303 is transmitted to the stem via one or more connection points or one or more mountings and corresponding primary and / or secondary movable joints in a manner that minimizes movement of the one or more nasal prongs relative to the user's nostrils.
[0644] The primary and secondary movable joints are aligned to allow movement of the attachment member in substantially the same orientation. In an alternative embodiment, the primary and secondary movable joints may be misaligned to allow movement in different orientations. In another alternative embodiment, the rod may have one or more additional movable joints.
[0645] The side arms, including the nose prongs, are relatively flexible or comfortable relative to the relatively inflexible or uncomfortable stem and / or one or more mounting members. The connection point or one or more mounting members include a finger extending outwardly therefrom on which the primary movable joint is located for connection to the stem. The stem is an over-center component of the patient interface, wherein the connection point or one or more mounting members are symmetrically located on each of the one or more corresponding side arms. The secondary movable joint is one or a combination of: an articulated joint, a pin and barrel type joint, and a ball and socket joint.
[0646] refer to FIG. 27A to FIG. 28B In the embodiment shown in , a patient interface (such as a nasal cannula) has a main body portion 2601 to be positioned on the user's face during use. The patient interface has at least one and preferably a pair of nasal prongs 2605 / 2705, 2607 / 2707, which extend from the main body portion and are inserted into one or more nostrils of the user's nose or direct the gas flow to one or more nostrils of the user's nose in an operating position. The main body 2601 has at least one hollow area 2619 / 2719, 2721, which has a fluid channel connected to one or more nasal prongs for supplying gas to one or more nostrils of the user's nose. During the supply of fluid through the fluid channel, the hollow areas 2619 / 2719, 2721 substantially resist the transmission of displacement forces from one or more areas of the main body portion to one or more nasal prongs 2605 / 2705, 2607 / 2707, and maintain the operating position of these nasal prongs.
[0647] refer to FIG. 27A to FIG. 27CIn the embodiment shown in , the main body portion 2601 includes a substantially rigid frame 2601a and at least one relatively soft hollow area 2619 extending from the rigid frame. At least one hollow area 2619 is expandable to expand in the extension direction of one or more nasal prongs. The hollow area 2619 is connected to the one or more nasal prongs and is expandable during the supply of gas to one or more nostrils of the user's nose. The hollow area 2619 is positioned against the philtrum or upper lip area of the user in at least an expanded state so as to substantially maintain the one or more nasal prongs in an operating position.
[0648] In the expanded state, the hollow region 2619 is substantially deeper than the depth of the frame of the body adjacent the hollow region. Either end of the body portion 2601 includes a user face contacting surface 2615, 2617 that is contoured to engage the cheek region of the user's face in use. The body portion 2601 or at least either end of the body portion is shaped or curved to substantially complement the facial structure of the user in use.
[0649] refer to FIG. 28A to FIG. 28B In the embodiment shown in , the main body portion includes a pair of corresponding left arms 2701 and right arms 2703. The left arm 2701 and the right arm 2703 are substantially flexible. One or more nose forks 2705, 2707 extend from one or each of the ends closer to the interior of the corresponding left arm and / or right arm, or extend from an area substantially adjacent to the ends closer to the interior of one or both of the corresponding side arms. The bridging portion 2709 connects the ends closer to the interior of the corresponding left and right arms. The bridging portion 2709 is substantially rigid relative to the left and right arms.
[0650] At least one and preferably both left side body section 2701 and / or right side body section 2703 include hollow regions 2719, 2721, each hollow region having a fluid channel for delivering a gas supply to a corresponding nasal prong.
[0651] The patient interface 2700 includes one or more internal support posts extending between opposing inner surfaces of the hollow region to maintain an open fluid passageway. The one or more internal support posts include a plurality of support posts spatially distributed within the hollow region.
[0652] refer to FIG. 29A to FIG. 29CIn the embodiment shown in FIG. 1 , a patient interface 3100 (such as a nasal cannula) has a main body portion 3103 to be positioned on the user's face in use, a bridge portion 3102 extending away from the main body portion, and at least one and preferably a pair of nasal prongs 3105, 3107 to be inserted into one or more nostrils of the user's nose or to direct the flow of gas to one or more nostrils of the user's nose in an operating position. The main body portion is actively regulated using an electrical potential from the system or stored in the cannula. The main body portion is located on one of the user's facial cheeks in use, and the user's other facial cheek will not have an interface.
[0653] refer to Figures 34A-34C In the embodiment shown in FIG. 1 , a patient interface 3400 (such as a nasal cannula) has an elongated body 3402 to be positioned on the face of a user in use. The body 3402 has at least one and preferably a pair of nasal prongs 3405, 3407 to be inserted into or direct the flow of gas to one or more nostrils of the user's nose, and at least one and preferably a pair of facial contact surfaces 3415, 3417 movably coupled to the body 3402 so as to respond to one or more forces or movements experienced by the one or more facial contact surfaces and at least partially mitigate the transfer of one or more such forces and / or movements to the body and one or more nasal prongs.
[0654] Each face contact surface 3415, 3417 is contoured to engage the cheek of the user's face. Each face contact surface 3415, 3417 is movably coupled to the end portion of the body, preferably slidably coupled to the body. Each face contact surface 3415, 3417 has a hollow waveguide 3409, 3411 associated therewith for slidably receiving a portion of the body 3402 therethrough.
[0655] The patient interface 3400 further includes a resilient member (not visible) associated with each face contacting surface 3415, 3417. The resilient member is coupled between the face contacting surface 3415, 3417 and the body and biases one or more of the face contacting surfaces 3415, 3417 toward the center of the body 3402. In the preferred embodiment shown, the resilient member comprises a compression spring.
[0656] The body 3402 includes a bridge portion 3409 from which one or more nasal prongs 3405, 3407 extend. The bridge portion 3409 is bent inwardly so as to extend into position toward the septum of the user. The body (preferably the entire body) 3402 is substantially rigid and substantially hollow, and is fluidly coupled to one or more nasal prongs to allow gas flow through the body. At least one end of the body, and preferably both ends, is configured to fluidly couple the flow path of the breathing circuit.
[0657] refer to Fig.32 and Fig.33 In the embodiment shown in, the patient interface 3500 / 3600 (such as a nasal cannula) has a body 3501 / 3601 to be positioned on the face of the user in use. The body 3501 / 3601 includes at least one and preferably a pair of nasal prongs 3605, 3607, which are inserted into one or more nostrils or direct the flow of gas into one or more nostrils of the user's nose in an operating position. The patient interface 3500 / 3600 also has at least one active element 3501 and preferably a pair of active elements 3601, 3603, each of which is configured to be activated in response to input energy to move at least one other area of the body to keep one or more nasal prongs in an operating position.
[0658] The input energy is non-mechanical energy. At least one active element 3501 / 3601, 3603 is configured to convert the input energy into mechanical energy to move at least one other area of the body. Each active element 3501 / 3601, 3603 includes at least one and preferably a pair of expansion elements, which are configured to expand in response to the input energy to move at least one other area adjacent to one or more nasal prongs to maintain the one or more nasal prongs in an operating position.
[0659] One or more expansion elements are positioned on the user engagement side of the body. The one or more expansion elements are configured to be positioned adjacent to a cheek of the user's face.
[0660] The patient interface also has one or more hinges, pivots or articulations, or any combination thereof, operable in response to activation of one or more of the one or more active elements. The patient interface has one or more hinges at the bridging portion of the body, with one or more nasal prongs extending from the one or more hinges.
[0661] refer to Fig.32 In the embodiment shown in , one or more expansion elements form the body 3501 and are configured to expand in response to input energy so as to move a bridge portion 3509 of the body 3501, with one or more nasal prongs extending from the bridge portion toward the philtrum of the user and / or against the philtrum of the user into position.
[0662] At least one active element 3501 is an electromechanical element configured to receive electrical activation energy to move at least one other area of the body. The electromechanical element is coupled to an electrical circuit and is activated in response to an electrical activation signal generated by a change in voltage, resistance, or current, or any combination, in the circuit.
[0663] The electrical activation signal is generated by the movement or force or both experienced by one or more regions of the body. The movement of the one or more regions of the body causes the electrical contacts of the circuit to engage and generate the electrical activation signal. The movement of the one or more regions of the body causes a change in resistance in the circuit to generate the electrical activation signal.
[0664] The electromechanical element is or comprises a conductive polymer or a bimetallic strip or any combination thereof.Alternatively, the electromechanical element may be or comprise a pair of electromagnets.
[0665] The patient interface further comprises at least one and preferably a pair of facial contact pads 3515, 3517, which are configured to engage the user's face in use, wherein the end or either end of the bridging portion is correspondingly connected to one or more facial contact pads.
[0666] refer to Fig.33 In the embodiment shown in , input energy is manifested by changes in humidity at one or more regions of the body, and at least one active element 3601, 3603 is configured to activate in response to threshold humidity or changes in humidity, or both, so as to move at least one other region of the body to maintain one or more nasal prongs in an operating position.
[0667] The body 3501 is flexible in at least one or more areas so as to deform in response to the expansion of the one or more expansion elements and cause the bridge portion 3609 to move into position toward the philtrum. The bridge portion 3609 includes one or more hinges 3621, 3623. The bridge portion 3609 is preferably a rigid component so as to prevent or at least substantially inhibit the one or more expansion elements from moving upward and to encourage the one or more expansion elements to move downwardly above the philtrum of the user.
[0668] The active element 3601, 3603 is configured to absorb water and expand in response to a threshold humidity or a change in humidity or both, so as to thereby move at least one other area of the body. The active element 3601, 3603 or at least a portion of the active element 3601, 3603 is positioned adjacent to the base of the associated nasal prong and is configured to engage the philtrum in place, and wherein the expansion of the active element or a portion of the active element causes the nasal prong to pivot toward the back of the corresponding nostril of the user so as to maintain the nasal prong in an operating position. At least one active element 3601, 3603 is or includes a polymer material configured to expand as humidity increases. At least one active element forms at least a portion of the body.
[0669] The body includes a left side arm and a separate right side arm, each of which has an active element and a nasal prong associated therewith. The patient interface further includes a bridge portion 3609 that bridges over the active elements of the left and right arms, respectively, to hold these elements in place against the philtrum of the user.
[0670] The patient interface further comprises at least one and preferably a pair of facial contact pads 3615, 3617 configured to engage the face of a user in use, wherein the end or either end of the bridge portion is correspondingly coupled to one or more facial contact pads. The patient interface further comprises another facial contact pad 3625 configured to engage the face of a user in use, in particular their philtrum.
[0671] refer to FIG. 30A to FIG. 30F In the embodiment shown in , a patient interface 3700 (such as a nasal cannula) has a main body portion to be positioned on the user's face in use, the main body portion having a left arm 3701 and a right arm 3703. The patient interface 3700 has at least one and preferably a pair of nasal prongs 3705, 3707 extending from the left and right arms to be inserted into one or more nostrils of the user's nose or direct the flow of gas into one or more nostrils of the user's nose in the operating position. In the operating position, the left and right arms are positioned on the cheeks of the user's face in a substantially curved manner, which will be described in more detail below.
[0672] Patient interface 3700 has a non-use configuration. FIG. 30A to FIG. 30C , wherein the main body portion is substantially planar or at least either end of the main body portion is substantially planar and substantially coplanar with the other end of the main body portion. Fig. 30C As shown in, in this configuration, the face contact surfaces 3715, 3717 at each end are substantially planar surfaces that are substantially coplanar with each other. At least one and preferably a pair of nose prongs extend in a direction away from the center plane of the main body portion.
[0673] In alternative embodiments, either or both ends 3701, 3703 of the body portion are substantially coplanar; that is, they may be offset relative to each other. Additionally or alternatively, when in the non-use configuration, either or both ends 3701, 3703 of the body portion, the face contact surface 3715, 3717 may have a slight curve or other shape. Either or both ends 3701, 3703 of the body portion are preloaded / prestressed so that they are urged back toward a coplanar arrangement.
[0674] The patient interface 3700 has a bridging portion 3710 having a cavity that is concave when viewed in a direction opposite to the user. The cavity can be filled or at least partially filled with a soft and / or flexible material. Alternatively, the cavity can be filled or at least partially filled with a relatively harder material. The benefit of filling the cavity with a suitable material is that the cavity will not attract and / or retain dirt. As described above, either or both ends 3701, 3703 of the main body portion are pre-loaded. This pre-loading causes the bridging portion to move toward and contact the philtrum of the user when the facial contact portion is stretched, bent, and placed on the user's face.
[0675] The cavity, whether empty, partially filled or filled, reduces the elastic / spring force experienced by the user on their philtrum compared to a bridge without a cavity. One or more other sections of the patient interface may have cavities that may or may not be filled, or at least partially filled, with a soft and / or flexible material or a relatively more rigid material. In a preferred embodiment, the bridge has been shown and described as being relatively flexible and / or elastic. In an alternative embodiment, the bridge may include a relatively rigid bridging portion so as to define at least the initial orientation and / or spatial position of the nasal prongs. The relatively rigid portion may be a filled or partially filled cavity as described above, or may be a co-molded or overmolded portion of the patient interface.
[0676] When viewed from above, the left and right arms initially extend outward from the bridge in an unfolded manner before transitioning into a substantially planar section. The transition portions 3719, 3721 located between the bridge and the left and right arms are smooth arcuate transition portions. The transition portions 3719, 3721 have a relatively large radius, so the pressure from the bridge and transition portions 3719, 3721 on the user's face is evenly distributed on their philtrum. The transition portions 3719, 3721 are spaced outward from the nasal prongs. Specifically, the center of the bend 3720 in each transition portion is positioned outward relative to the midline or longitudinal axis A of the adjacent nasal prongs so as to reduce the movement of the nasal prongs during use. The thickness between the surfaces 3721 and 3725 of the patient interface is relatively thin so as to reduce the elastic force / spring force experienced by the user on their philtrum.
[0677] When viewed in the direction opposite to the user, the outer surfaces 3727, 3729 of the left and right arms opposite the face contact surfaces 3715, 3717 are slightly curved and convex; however, when in the non-use configuration, the overall shape of the left and right arms is substantially planar. The outer surfaces 3727, 3729 have a relatively low profile and relatively less material, which makes the patient interface flexible. The face contact surfaces 3715, 3717 are spaced a relatively small distance from adjacent portions of the left and right arms. The profile of the flexure of the patient interface can be designed to minimize kinking in use or in the non-use configuration. For example, the flexure of the patient interface can have ridges, folds or cuts to minimize or eliminate kinking of the patient interface.
[0678] The left and right arms are to be positioned on the face of the user in use. Preferably, the left and right arms of the main body portion are to be positioned on the cheeks of the user's face in use. The patient interface has an in-use configuration. FIG. 30D to FIG. 30F , wherein the main body portion, or at least the left and right arms, are shaped or curved to substantially complement the facial structure of the user in use, and one or more nose prongs extend in a direction substantially parallel to the central plane of the main body portion, or at least at an angle less than in the non-use configuration. Specifically, when viewed from the user's position, the face contact surfaces 3715, 3717 are arcuate concave surfaces. When ... Fig.30F When the position shown in is observed, left side arm and right side arm are arc-shaped basically.In this structure, the transition portion between bridge piece and left side arm and right side arm is also a smooth arc-shaped transition portion.
[0679] The main body is a single integrally formed component. FIG. 30A to FIG. 30F As shown in , the main body portion and at least one and preferably a pair of nasal prongs are a single integrally formed component; that is, the patient interface 3700 is a single integrally formed component.
[0680] The nasal prongs in the non-use configuration can be angled outwardly from each other at an angle greater than 0° and less than 180°. For example, the angle between the nasal prongs can be greater than 0° and up to about 60°, between about 5° and about 55°, between about 10° and about 50°, between about 15° and about 45°, between about 20° and about 40°, about 5°, about 10°, about 30°, about 32°, about 45°, about 60°, about 80°, about 90°, about 100°, about 120°, about 140°, about 160°, or about 170°. When the interface is stretched and / or applied to the user's face, the interface 3700 straightens the nasal prongs into a substantially parallel configuration.
[0681] The interface is a nasal cannula including a pair of nasal prongs as outlets for the cannula, and wherein a head cap or retention system is attachable to the cannula for holding the nasal cannula in place when worn by a user in use. The retention system (or fastening system) may include a releasable connection system for releasably connecting or fastening the patient interface to the user's face (e.g., the releasable connection system may include a hook and loop or a hook and hook-type connector for such a system). Such a releasable connection or fastening system may include at least one cushion (including a material such as a hydrocolloid) attached to the user's face, on which the patient interface is releasably engageable to the at least one cushion.
[0682] Similarly, it will also be appreciated that various aspects of the present disclosure may be used with any form of patient interface application, in combination with any suitable form of headgear or retention system or fastening system for securing the patient interface to a user, suitable for retaining the patient interface to be retained on a user for delivery of the desired treatment, such as, for example, that fastening system described in PCT / NZ2011 / 000218 (published as WO 2012 / 053910, the contents of which are incorporated herein by reference). Thus, one or a pair of side arms may be provided in which the patient interface can be positioned on the face of a user, each or both of the side arms providing a portion of a retention system or fastening system to which a headgear may be attached or associated. In this way, the patient interface may be retained or secured to the face of a user in a desired operating position.
[0683] The body portion or at least either end of the body portion comprises an elastic and / or flexible material.
[0684] The patient interface 3700 is or includes a polymer material. The polymer material is one or a combination of any one or more of the following: one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, more preferably the polymer may be those such as, but not limited to: polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, for example, thermoplastic elastomer series, such as styrene block copolymers, copolyester elastomers, or thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, more preferably a polymer having a Shore A hardness of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80 or about 90. In embodiments where the cavity is filled with a material, that material preferably has a Shore A hardness of about 0 to about 30, or about 10 to about 20, or about 10, or about 15, or about 20, or about 30.
[0685] The area of the patient interface intended to contact the philtrum of the user may have a comfort enhancing surface modification, such as a light pattern, a sandblasted surface modification, a shot peened surface modification, a roughened or patterned surface modification, dots, channels or grooves or other surface relief features.
[0686] The body portion may be shaped or constructed or adapted to provide passageways 3711, 3713. Such passageways 3711, 3713 are formed by one or more of a lumen or void space or cavity or other recess through the body portion.
[0687] Such passages 3711, 3713 allow for receiving a supply of gas (from a source) and directing the delivery of that gas to a user via the nasal prongs 3705, 3707; or alternatively, allow for receiving a gas supply conduit (not shown, but which may be received or fitted into such articles 3711, 3713) for then delivering the gas to a user via one or more nasal prongs. Such passages 3711, 3713 in or through the sidearm 201 or sidearm element 206 or both allow for the formation of a conduit or lumen through which gas may be directed or supplied for delivery to the nasal prongs 3705, 3707.
[0688] Fig.31 An alternative embodiment 3800 is shown, which is FIG. 30A to FIG. 30F A modification of the embodiment shown in , including loop material 3816 for releasably connecting a patient interface to a user's face. The loop material 3816 is preferably part of a hook and loop connector for a releasable connection system, which is used to releasably connect the patient interface to the user's face. In the illustrated embodiment, the loop material 3816 is in sections with spaces between the sections so that the loop material does not bunch or concentrate when the patient interface is placed on the user's face. Alternatively, the loop material 3816 can be a single piece of material extending from the end of the or each side arm toward the center of the patient interface. In this embodiment, the loop material is flexible so that it does not bunch or concentrate when the patient interface is in use. In another alternative embodiment, the loop material can be in adjacent or adjacent sections with full or partial cutouts between the sections so that the sections are allowed to move relative to each other and do not bunch or concentrate when the patient interface is in use.
[0689] refer to FIG. 30A to FIG. 30F and Fig.31 The embodiments shown in FIG. 1 and in particular Fig.30F and Fig.31, each of the nasal prongs 3705 / 3805, 3707 / 3807 extends at an angle θ relative to the center plane P of the patient interface. The angle is defined by the angle between the center axis extending through each of the nasal prongs and the center plane. As described above, the nasal prongs in the non-use configuration can be angled outwardly from each other. Fig.31 In the in-use configuration, the properties of the material forming the patient interface and the shape of the patient interface allow the nasal prongs to extend at least at a lesser angle than in the non-use configuration.
[0690] refer to Figure 35 to Figure 45 In the embodiment shown in , the patient interface 4700 (such as a nasal cannula) has a main body portion to be positioned on the user's face in use, the main body portion having a left arm 4701 and a right arm 4703. The patient interface 4700 has at least one and preferably a pair of nasal prongs 4705, 4707, which are to be inserted into one or more nostrils or direct the gas flow into one or more nostrils of the user's nose. In use, the left arm and the right arm will be positioned on the cheeks of the user's face.
[0691] The patient interface 4700 has a bridging portion 4710. One or more nasal prongs 4705, 4707 extend from the bridging portion. In some embodiments, the bridging portion is relatively rigid so as to define at least an initial orientation and / or spatial position of the nasal prongs. By "relatively rigid" is meant that the bridging portion is more rigid than the rest of the body portion, such that the rest of the body portion bends or otherwise deforms before the bridging portion bends or deforms during use. The bridging portion is more rigid, either because it is thicker in width and / or height. Alternatively, the bridge may be more rigid by including a bridging portion element.
[0692] When viewed from above, the bridging portion transitions to the left and right arms by extending outwardly away from the user's facial side of the bridging portion in an abduction or bending manner. The left and right arms 4701, 4703 are bent backward away from the bridging portion from the front extension of the main body portion of the interface. The curvature of the user's facial side 4720 of the bridging portion and / or the transition area 4719, 4721 between the bridging piece and the left and right arms is smooth. The facial side of the bridging portion and / or the transition area 4719, 4721 have a relatively large radius, so the pressure from the bridging piece and the transition area 4719, 4721 on the user's face is evenly distributed on their philtrum or the upper lip area between the upper lip and the nose of the user. The transition area 4719, 4721 is spaced outward from the nose fork.
[0693] In some embodiments, as described above, the main body portion extends forward from each side of the bridge portion 4710 to a position in front of the bridge portion, and then extends rearwardly so that the end of the main body portion is positioned behind the bridge portion. When viewed from above, this arrangement provides a generally "U" shape between each nose fork 4705, 4707 and the left or right arm 4701, 4703 of the main body portion, as shown in FIG. Fig.36 4723, 4725. Each of the U-shaped regions 4723, 4725 provides an articulation or bending region, wherein the body portion tends to bend when the left or right arm of the body portion flexes inwardly to conform to the user's face. In some embodiments, the U-shaped region tends to bend at the base or bottom of the recess 4730 of the U-shaped region. However, in some embodiments, the bending region can bend in an area extending a distance along the body portion. The bending region can bend not only at discrete points on the body portion, but also over a zone or region of the body portion.
[0694] The flex or articulation regions 4723, 4725 isolate the left and right portions of the interface from flexing of the bridge portion and therefore the nasal prongs. This results in facial movements that may be transmitted to the left and right sides of the interface being at least partially isolated from the nasal prongs, such that the position of the nasal prongs in the user's nostrils is not disturbed by movement of the user's face during use.
[0695] The U-shape of the body portion in the bend region positions the bend region outwardly and forwardly from the nasal prongs relative to the facial side of the body portion. This arrangement further aids in the flexibility of the bend portion because it causes the general planes of the left and right sides of the body portion to be spaced further away from the nasal prongs than an interface without a U-shaped region, for example, as indicated by Fig.37 The movement of the user's face is generally in the general plane 4750 of the left and right parts and makes this plane coincide with the plane formed by Fig.37 The nasal prongs indicated by arrows 4751 in the figure are further spaced to further isolate facial movement from the nasal prongs so as to help reduce the effect of facial movement on the position of the nasal prongs in the user's nostrils. The flexibility of the flexure region can determine how large this distance between the general plane of each of the left and right sides of the body portion and the corresponding nasal prong should be.
[0696] In some embodiments, the bending or articulation region may be formed by or include at least one bending or articulation element, such as a mechanical hinge. For example, the mechanical hinge may be molded into the articulation or bending region of the main body portion.
[0697] Figure 35 to Figure 45The main body of the interface is a single integrally formed component. As shown, the left and right arms, the curved portion, the bridge portion, and at least one and preferably a pair of nasal prongs are a single integrally formed component; that is, the patient interface 4700 is a single integrally formed component. In some embodiments, the patient interface is formed by a single molding operation.
[0698] The patient interface 4700 is formed of a polymer material. The polymer material is one or a combination of any one or more of the following: one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, or breathable polyamides, more preferably the polymers may be those such as, but not limited to: polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, for example, a thermoplastic elastomer series such as styrene block copolymers, copolyester elastomers, or thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers. In a preferred embodiment, the patient interface has a main body portion formed of a thermoplastic or silicone material having a Shore A hardness of approximately 5 to 60. In some embodiments, the main body portion has a Shore A hardness of about 10 to about 50, or about 10 to about 40, or about 20 to 40, or about 10 to 30. In some embodiments, the main body portion is Made of K.
[0699] Figure 35 to Figure 45 The interface may include a retention system for keeping the interface in place when worn by the user in use, as described in earlier embodiments. As previously described, the retention system (or fixation system) may include a releasable connection system for releasably connecting or fastening the patient interface to the user's face, such as a shackle or hook and hook type connector. This releasable connection or fastening system may include at least one pad (including materials such as hydrocolloids) attached to the user's face, and the patient interface can be releasably engaged to at least one pad on the user's face. For example, a pad may be attached to each of the left-hand side and right-hand side of the main body portion of the interface, the pad including half of a shackle or hook and hook connector. And a corresponding pad including a second half of a shackle or hook and hook connection may be attached to the user's face.
[0700] In some embodiments, the cushion to be attached to the body portion is substantially symmetrical about a central upright (e.g., vertical or substantially vertical) axis that divides the cushion into a left side and a right side, such as Fig.38A In this way, the same shape of pads can be applied to both the left and right hand sides 4701, 4703 of the main body portion. In some embodiments, the pads can be symmetrical around the horizontal axis. In some embodiments, the pads can be symmetrical around both the vertical axis and the horizontal axis.
[0701] Symmetrical retention pads simplify the manufacturing process because the same ring pad can be applied to either side of the interface, thereby increasing production speed and reducing operator error. This also means that only one type of pad needs to be stocked for both the left and right sides of the interface. The pads can be asymmetrical along the horizontal. The pads can be attached to a recessed area in each of the left and right arms of the main body portion of the interface. The recessed area 4760 is Fig.38B The recess in which the pad is located may also be symmetrical, such that the left and right hand sides of the recess have the same or similar shape, so as to match the shape of the pad.
[0702] In various embodiments or configurations described herein, the use of a two-part connection system allows attachment, removal, and reattachment of the interface to the user's face. This can allow for suitable repositioning of the interface, such as for improved comfort or delivery of therapy (or both).
[0703] In addition, in different embodiments of the construction as described herein, a part of the releasable connection system is arranged on the patient interface. The part of the releasable connection system that is arranged on the patient interface itself is arranged to be connected to the interface in different ways, one of which can be connected by overmolding or overmolding of the interface to the part or the interface around the part. By overmolding a part of the interface to the part of the releasable connection system, a more durable or robust attachment or engagement of the part to the interface can be achieved. The material used to form or be molded into the interface can be allowed to flow around a part of the releasable connection system or flow to a part of the releasable connection system at the same time, such as a pad or patch (or alternatively hook) including a ring. This can allow a more integral part of the patient interface to be hooked after including such a ring. Optionally, for example, the overmolding or overmolding connection can extend at least around the periphery of the part (so as to provide the connection / attachment of the part to the interface), and the material of this overmolding can optionally extend partially or completely across the face of the part, and the components of the releasable connection system can extend from the part. For example, where the portion provides a hook and loop or another type of two-part releasable connection system, the overmolding may extend around the periphery of such portion or may extend partially or fully across the face, from which the hook and loop or another type of two-part releasable connection system may extend.
[0704] The portion that may be overmolded to the interface may be the loop portion or the hook portion of a two-part connection system.
[0705] Fig.38A, B shows a situation where a hook or loop cushion section or portion can be positioned into a recessed section 4760. It is contemplated that the loop portion can be specifically disposed in such a section 4760, while the hook portion can be disposed on another portion of the two-part connection system (e.g., a cushion or patch that can be disposed on the user's face).
[0706] Such overmolding of a portion is advantageous because it can allow the loop or hook pad portion to be more accurately positioned and retained than a gluing operation typically performed by a person. The overmolding can provide a stronger bond between the loop or hook pad portion segment and the patient interface. The molded arrangement of the loop or hook pad portion and the patient interface can be more robust, and the loop or hook pad portion segment is less likely to peel off or tear or debond the segment of the interface to which it is attached. More specifically, because the patient interface is itself overmolded over the portion, the inclusion of the hook or loop portion or other portions of the two-part connection system allows for a more integrated arrangement of the interface and releasable connection system, and therefore a more robust and permanent or durable connection of the interface to the portion.
[0707] In alternative configurations, arrangements may also be provided in which attachment of the portion to the patient interface may be accomplished once the interface has first been molded or formed (or manufactured). For example, with the interface molded or formed (or manufactured), a subsequent or additional overmolding step or stage may be performed to provide an overmolding that connects or attaches the portion and the interface together via an overmolded connection. As described below, the molding material may be allowed to flow so as to extend around the periphery of such portion, or may extend partially or completely across the face of the portion.
[0708] The overmold material of the loop or hook pad portion section can be controlled to ensure that the polymer or plastic in the overmold flows so as to cover some but not all of the loop or hook pad portion. The overmold section still maintains enough loop or hook exposure of the portion to allow connection to the opposing portion of the two-part connection system, such as the hook portion of a pad or a patch placed on the user's face.
[0709] In some alternative embodiments, the overmold material may be controlled to extend or flow through some of the loop or hook portions so as to integrally bond the portion to the interface to which it will be attached.
[0710] The overmolding may be performed as part of the interface (e.g., nasal cannula) molding process itself, or may be performed as a subsequent step. Alternatively, the overmolding may be performed once the interface body (e.g., nasal cannula body) is formed.
[0711] In other embodiments or constructions, the loop or hook portion is overmolded as part of the interface manufacturing process and therefore uses the same material as the remainder of the interface body (e.g., nasal cannula body) to ensure a secure bond (i.e., material compatibility is not compromised between the interface and the overmolded material).
[0712] will understand, as Fig.38A The cushion shown in may be the "portion" that may be attached to the patient interface via an overmolding process or by an overmolding material used to connect or attach the cushion or "portion" to the interface as described above. Fig.38B A recessed area 4760 is shown which may preferably receive the "portion" or pad. It will be appreciated that as discussed herein, a "portion" of one part of a two-part releasable connection system may be disposed at other portions of the interface, for example, as shown in other figures, the two-part connection system may utilize pads or portions disposed at other areas of the interface. Overmolding of such portions or pads to the interface is provided as another means in which these may be attached or connected to the interface, for example, to provide a more secure or robust connection or attachment. Such overmolding may avoid the use of adhesives or glues which may otherwise be required for such attachment or connection of the pad or portion to the interface.
[0713] In a particularly preferred embodiment, the nasal cannula is formed or molded, and in doing so is simultaneously overmolded onto the portion, such as a cushion consisting of a ring (forming one part of a two-part releasable connection system). Such a portion with a ring can be held in place and the plastic or polymer used to form the cannula is allowed to flow over or around the ring, which includes the cushion which then becomes formed as an integral ring with the cannula itself.
[0714] As such, it will be appreciated that in one embodiment, a patient interface may be formed, such as by a molding process, and during that process, a portion comprised of one of the two-part connection systems (e.g., loops or hooks) may be integrated into the interface as such (i.e., the portion is formed as an integral part of the interface during the formation of the interface itself). In an alternative embodiment, a patient interface may be formed, such as by a molding process, and after that process, a portion comprising a two-part connection system (e.g., loops or hooks) may be integrated by an overmolded connection to form a portion of the interface (i.e., the interface and portion are attached or connected to each other by an overmolded material).
[0715] As described above, the main body portion includes curved regions 4723, 4725 between the left and right arms 4701, 4703 of the main body portion and the bridge portion 4710. Preferably, the padding area 4760 of the main body portion for receiving the padding of the retention system is located outward from the curved regions 4723, 4725. In other words, the retention system does not bridge or cover the curved regions, such that the fixation system is separated or isolated from the bridge portion by the curved regions.
[0716] The body portion may be shaped or constructed or adapted to provide passageways 4711, 4713. Such passageways 4711, 4713 may be formed by one or more of a lumen or void space or cavity or other recess through the body portion.
[0717] Such passageways 4711, 4713 allow for receipt of a supply of gas (from a source) and the directing of that gas for delivery to a user via the nasal prongs 4705, 4707; or alternatively, allow for receipt of a gas supply conduit (not shown, but which may be received or fitted into such articles 4711, 4713) for then delivering the gas to a user via the one or more nasal prongs. Such passageways 4711, 4713 in or through the side arms 4701, 4703 allow for the formation of a conduit or lumen through which gas may be directed or supplied for delivery to the nasal prongs 4705, 4707.
[0718] In some embodiments, the cross-section of passages 4711, 4713 varies along their length to provide or impart different structural features or characteristics to the main body portion of the interface, such that the main body portion has regions of different flexibility. Unless the context otherwise indicates, the term "cross-section" is intended to mean a cross-section of the passage that passes through the passage and is not along the length of the passage. The passage may pass through a cross-sectional transition point along the length of the passage.
[0719] FIG. 38A to FIG. 41B The cross-section along the length of the flow path is shown. Fig.39B As shown in , the cross-section of the passageway at or near the location where the breathing tube or catheter is connected to the passageway is substantially circular to fit a circular tube or catheter.
[0720] Moving along the passage from the breathing tube or conduit toward the nasal prongs, the cross-section of the passage changes from circular to oval or elongated with a longer axis arranged in a vertical or upright direction (generally parallel to the user's face in use) compared to the direction of entry into the user's face, such as Fig.40B as shown in .
[0721] The elongated cross-section provides a low-profile interface, meaning that the interface is at a distance from the user's face because the passageway is flatter for a given cross-sectional area of the passageway. Also, the elongated cross-section provides greater flexibility for bending in a lateral direction, such as a direction into the user's face, which is along the shorter axis of the elongated cross-section. In other words, a flatter or elongated cross-section is easier to bend about an axis that is generally parallel to the user's face than a circular cross-section of the same or similar area. For example, Fig.36 As shown, the cross-section of the above-described bending regions 4723, 4724 is preferably elongated, having a longer axis arranged generally parallel to the user's face and a shorter axis arranged generally perpendicular to the user's face. The elongated cross-section of the body and the U-shape combine to create bending regions that preferably bend laterally toward and away from the user's face compared to other areas of the body portion. These bending regions reduce the likelihood of the nasal prongs popping out of the user's nostrils (e.g., forward) due to facial movement. These described bending regions are manufactured without the use of any type of mechanical hinge structure, but instead due to the air passage allowing the body portion to more easily buckle or bend in these flatter areas. Elongated or oval shapes.
[0722] refer to Figure 35 to Figure 45 In the embodiments of the present invention, it will be appreciated that the patient interface may include one or more of the side arm or bridging elements described above. These elements will be or include a relatively more rigid material than the remainder of the interface, and will have suitable features and functions, as described above with respect to earlier embodiments. These side arm elements and / or bridging portion elements will add stability and structure to the patient interface while still maintaining the flexibility provided by the other features of the patient interface.
[0723] The bending regions allow for more flexible movement at the cheek of the user. The bending regions are wider than they could be if the passage was circular. The longer longitudinal axis of the elongated cross-section helps ensure that the body portion flexes predominantly in a substantially horizontal or transverse direction (i.e., the left or right portion bends inwardly toward the bridge of the body portion) and without twisting or flexing in other directions (i.e., bending across the user's face).
[0724] The cross section of the passage transitions to an asymmetric shape at the base of the nasal prong, wherein one side of the cross section is flatter than the opposite side of the cross section, such as Fig.41B This asymmetric shape can be loosely described as having a "D" shape. The benefits of this "D" shape are discussed below.
[0725] In some embodiments, one or both nasal prongs include a "D" shaped or asymmetrically shaped passageway along a portion of the length of the passageway or may include a "D" shaped / asymmetrically shaped passageway along the entire length of the nasal prong. FIG. 39A to FIG. 43B In the embodiment shown, continuing along the nose fork, the cross-section of the passage moves from a D-shape toward a circle, so that the passage is generally circular at the outlet or tip of the nose fork, as shown in FIG. Fig.43B as shown in . Fig.42B A cross section roughly along the middle of the nasal fork is shown. The cross-sectional area may decrease slightly from the base of the nasal fork toward the tip of the nasal fork.
[0726] The different cross-sectional areas of the passage from the end of the tube or duct to the base of the nasal prongs are preferably substantially constant so as to maintain similar flow resistance along the passage. Thus, flow resistance due to a change in shape from a circular to a flat shape is substantially avoided. As described above, the passage may taper slightly along the nasal prongs towards the nasal prong tips.
[0727] refer to Fig.41B In some embodiments, the nasal prong includes an asymmetric cross-section of at least the base region or end of the nasal prong. The asymmetric shape includes one side 4771 that is flatter than the opposite side 4772 of the cross-section. The asymmetric shape can be loosely described as having a "D" shape.
[0728] The flat side of the nasal prong is positioned toward the forward side or non-face contact side (away from the user's face) of the patient interface. The asymmetric shape is particularly beneficial from a manufacturing perspective. The shape allows for an improved separation line and allows the separation line to be moved away from the sensitive portion of the nose. The separation line is formed where the molding tool moves apart to allow the molded part to be formed. The separation line can typically be a rough / sharp line. Therefore, it is desirable to move these separation lines away from the face, and having the flat side nasal prong makes it easy to manufacture because tool design becomes easier. In the flat side or asymmetric shape, the flat side of the tool remains stationary and the curved side of the tool moves toward and away from the flat portion. For nasal prongs that are typically more rounded, a more complex arrangement is required with two moving tools that move toward and away from each other. In addition, the shape can cause sharp edges on these separation lines to be avoided or reduced, which helps the user's comfort during use.
[0729] No sharp edges are formed at the separation line on the nasal prongs. This makes it more comfortable for the patient because no sharp edges come into contact with the patient. The more rounded side of the nasal prongs is positioned on the user's facial side of the nasal prongs and maintains comfort at the base of the nostrils. The backward rounded shape also maintains structural stability at the base of the nasal prongs; the flatter side of the "D" shape is more likely to flex in response to an applied force than the rounded side. In addition, the asymmetric shape does not significantly change the air flow resistance of the passage along the nasal prongs. In some embodiments, the radius of the fillet located between the nasal prongs and the bridging portion can be increased to provide additional rigidity at the base of the nasal prongs. Further discussion of this arrangement is provided below.
[0730] In some embodiments, the bridge portion 4710 between the two curved portions 4723, 4725 can be reinforced to prevent outward movement of the nose prongs relative to each other. Reinforcement can be achieved by including more material in the bridge area (e.g., thicker wall sections) without using reinforcing members embedded in the body portion.
[0731] In some embodiments, the height or vertical dimension of the bridge region 4710 is greater than that of the other patient interfaces. Fig.44 The increased vertical dimension helps improve torsional stability and prevents the body and nasal prongs from twisting away from the nostrils when flexed, and also helps spread load or contact to the area above the user's philtrum. The height of the bridge area should be less than the philtrum to maintain patient comfort. The required height of the bridge area can depend on how flexible the curved areas of the body portion are in order to isolate movement of the left and right arms from the bridge and prevent or reduce the occurrence of the nasal prongs popping out of the user's nostrils.
[0732] As described above, the radii of curvature of the bridge region and the regions of the body portion between the curved regions 4723, 4725 and the bridge region 4710 are relatively large. This arrangement helps ensure that no sharp edges come into contact with the patient. In some embodiments, the nasal prongs are Fig.44 Angled slightly inward as shown in .
[0733] In some embodiments, the passages 4711, 4713 are positioned approximately in the middle of the cheek pad in the vertical direction. This arrangement can provide more predictable behavior in the way the body portion deforms, and when force is applied to the breathing tube or conduit, the nasal prongs can be encouraged to move in a substantially horizontal direction rather than a substantially vertical direction, which helps prevent the nasal prongs from popping or flicking out of the user's nostrils.
[0734] By arranging the passageway generally centrally vertically on the body portion, the horizontal neutral bending axis 4780 of the body portion is also generally centrally located vertically. This can place the neutral axis generally centrally on the securing system for securing the interface to the user's face, which helps reduce forces acting to pull or tear the interface from the user's face than if the neutral axis were closer to the upper or lower edge of the body portion.
[0735] Also, having a tube or conduit extending centrally from the interface and the passageway being centrally located on the body portion helps maintain the nasal prongs in the correct position in the user's nostrils. For example, an upward force on a tube located closer to the base of the body portion can cause the middle of the body portion to move outward and the nasal prongs to rotate outward from the user's nose, which is less preferred.
[0736] As described above, the interface 4700 includes features for ensuring that the body has the necessary flexibility in the desired area for improved fit with the user's face. For example, as described, the body portion can include a passageway having a changing shape cross-section and / or shape area to provide an area that is easily flexed to, for example, isolate movement of the user's face (e.g., cheeks) from the nasal prongs. The flexibility of the body portion can be enhanced by changing the material, geometry, or thickness of sections (including hinge points), and changing the shape of tubular portions, such as the passageway along the body portion and along the nasal prongs, as described above.
[0737] As described above, in a preferred embodiment, the patient interface 4700 is a single, integrally formed component made of a thermoplastic or silicone material. A single, unitary component is easier to manufacture than an interface comprising many parts and / or different materials (e.g., some materials overmolded with other materials). The varying geometry of the body portion is selected to achieve areas with more flexibility and areas with less flexibility in a single, unitary component formed of a single material.
[0738] As described above, in a preferred embodiment, the bending areas 4723 and 4725 are more flexible than the bridging portion of the main body portion and the left and right arms. At least a portion of the passage extends through these bending areas and is molded to assist flexibility. The passage extends into the bridging area 4710 and extends along these nasal forks, however, the bridging area preferably includes a solid section with more material than the adjacent bending areas 4723, 4715, so that the bridging area is more rigid. These nasal forks should not be so flexible that they fold or are too easy to be compressed in the nose. Therefore, the purpose of the changed geometry of the main body portion is to cause any flexion and bending or deflection to occur at these bending areas rather than in the bridging portion.
[0739] The thickness of the main body material can be changed to assist in maintaining different flexible and less flexible areas. The main body can have thinner walls or sections around the passage in the curved area than in other areas of the main body. In some embodiments, the cross-sectional area of the main body material at the recess 4730 of the U-shaped area 4723, 4725 is smaller than that in the adjacent area of the main body. In a preferred embodiment, the main body provides a left passage and a right passage, wherein the left passage 4711 and the right passage 4713 are separated by a dividing section in the bridging area. The dividing section is the central area of the bridge between the two nose forks. The central area of the bridging area can be solid in order to provide relative rigidity to the bridging portion. In some embodiments, the bridging portion includes a wall section thicker than these curved areas, so that the bridging portion is more rigid than these curved portions. These thicker walls of the bridging portion provide more material to the bridging portion than in these hinged or curved areas in order to give more rigidity to the bridging portion. In some embodiments, the bridge portion comprises a yet more rigid material to provide stiffness to the bridge portion.For example, a more rigid or hard material may be molded into the bridge portion, such as by 2-shot overmolding or a multiple molding process.
[0740] In some embodiments, the left and right arms or areas of the main body portion are soft so as to flex easily on the user's face. The left and right areas are preferably more flexible than the bridge area. In some embodiments, the left and right areas are preferably more flexible than the nasal prongs. In some embodiments, the bending areas are more flexible than the nasal prongs, the bridge area, and the left and right arms in at least one plane.
[0741] Each nasal prong has a base 4715, 4717 integrally formed with the bridge portion 4710 of the main body portion of the patient interface. In some embodiments, the base of each nasal prong includes a fillet located between the arm of the nasal prong and the bridge portion. The fillet extends around the perimeter of the nasal prong. The fillet bends the outer surface of the nasal prong into the outer surface of the bridge portion.
[0742] In some embodiments, the radius of the fillet at the base of each nasal prong changes around the perimeter of the nasal prong to improve the stability of the nasal prong and reduce buckling or bending of the nasal prong at the base of the nasal prong. The larger the radius of the fillet, the smoother the transition from the outer surface of the bridge portion to the outer surface of the nasal prong, which can reduce the likelihood of the nasal prong bending or wrinkling at the base.
[0743] In some embodiments, the radius of the fillet at the base of each prong changes around the perimeter of the prong so as to change the wall thickness of the prong at the base 4715, 4717 of the prongs 4705, 4707. The larger the radius of the fillet, the thicker the material can be at the base of the prong, and thus the base becomes more rigid. Changing the fillet radius around the prong base to change the thickness of the base can be used to change the rigidity of the prong base around the perimeter of the prong.
[0744] The thickness of the base of the prong can be varied in other ways, for example the geometry of the passage can be varied so as to vary the wall thickness of the prong at the base of the prong, with a constant fillet radius on the outside of the main body portion between the prong and the bridge portion. However, this arrangement for varying the thickness of the prong wall may be less preferred, since increasing the wall thickness in this way may reduce the cross-sectional area of the passage, resulting in an increase in flow resistance.
[0745] The fillet radius can be varied according to the size constraints of the particular patient interface. Fig.45 , in some embodiments, it may be desirable to have a fillet with a smaller radius between the bridge and the bridge portion on the non-facial side of the main body portion, and a fillet with a larger radius on the inside of the nasal prongs (between the two nasal prongs) and the outside of the nasal prongs. The radius of the fillet on the inside of the nasal prongs can be larger than the radius of the fillet on the outside of the nasal prongs. The fillet on the facial side of the main body portion can have a radius between the radii on the inside and outside of the nasal prongs. Example dimensions are Fig.45 , but other arrangements may also be useful.
[0746] In an alternative embodiment, the patient interface includes a reference Figure 35 to Figure 45 Features of the described embodiments as well as side arm elements and or bridging portion elements.
[0747] Specifically, such an embodiment includes a main body portion that is to be positioned on the user's face during use, the main body portion having a left arm and a right arm and a bridging portion located between the left arm and the right arm. The patient interface has at least one nasal prong extending from the bridging portion that is to be inserted into one or more nostrils of the user's nose in an operating position or that directs the flow of gas into one or more nostrils of the user's nose. The main body portion has at least one fluid passage that is connected to the one or more nasal prongs for supplying gas to the one or more nostrils of the user's nose. The cross-section of the passage changes along the length of the main body portion so as to provide an area of varying flexibility along the main body portion. In this embodiment, each of the left and right arms includes one or more predetermined or pre-arranged points or localized compensation areas (or parts), which are positioned along the or each side arm to adjust the compensation of the patient interface in one or more of the compensation areas (or parts) or at one or more of the compensation areas (or parts), and one or more predetermined or pre-arranged points or localized compensation areas (or parts) are constructed to adjust the force through flexure or bending or articulation or other displacement. One or more of these compensation areas (or parts) can be areas or parts of the bending area or articulation area through or around at least two different (non-parallel) planes passing through the interface. In this embodiment, these side arms can include one or more side arm elements provided to the side arms of the interface or within these side arms, which are formed of a rigid material to provide rigidity to these side arms / parts. The side arm element can further include one or more cutouts or notches to allow these side arms to flex / articulate in response to forces applied to these side arms or experienced by these side arms. In addition to or in lieu of one or more side arm elements, the bridge portion may include a bridge portion element, and the bridge portion, the bridge portion element, or both the bridge portion and the bridge portion element are substantially isolated from forces applied to or experienced by the patient interface.
[0748] In addition or in lieu of the embodiments described above, further attention is paid to the first side arm 4206A and the second side arm 4206B. Fig.46 and Fig.47 , the second side arm 4206B is shown. It should be understood that in the illustrated configuration, the patient interface 4200 is substantially symmetrical. In other configurations, the patient interface 4200 may be asymmetrical. Fig.46 and 474, the second side arm 4206B includes regions 4214B1, 4214B2, 4214B3, 4214B4 with reduced thickness positioned on the outer edge of the second side arm 4206B (except for one region 4214B1 positioned on the outer edge of the inward facing portion of the flange defining the patient facing portion of the body 4206B adapted to hold a section of the second attachment structure 4216B). The regions 4214B1, 4214B2, 4214B3, 4214B4 with reduced thickness can be, for example, notches or cutouts along the second side arm 4206B. The regions 4214B1, 4214B2, 4214B3, 4214B4 with reduced thickness are configured to increase the flexibility of the portion of the second side arm 4206B configured to rest over the cheek of the patient. The use of regions 4214B1, 4214B2, 4214B3, 4214B4 having thickness in this region to improve the flexibility of the patient interface 4200 can improve the conformity of the patient interface 4200 to the contours of the face, particularly when a force F1 is applied to the side arms 4206A, 4206B (see Fig.48 ). Other configurations are contemplated. For example, in some configurations, an area with reduced thickness may be positioned elsewhere on the second side arm 4206 or the bridge 4204 to improve the adaptability of the patient interface 4200. As disclosed, it should be understood that similar areas with reduced thickness are positioned on the first side arm 4206A. However, in some configurations, only one body may include an area with reduced thickness. Although four areas 4214B1, 4214B2, 4214B3, 4214B4 with reduced thickness are used on the second side arm 4206B in the illustrated configuration, it should be understood that less than or more than four areas (e.g., one, two, three, five, or six areas) may be used. In some configurations, the second side arm 4206B may not include an area with reduced thickness. In some configurations (not shown), the first side arm 4206A and / or the second side arm 4206B may include one or more hinge points associated with each corresponding body to allow each body to pivot or move relative to the bridge 4204 or another corresponding body. In some configurations, at least a portion of one of the side arms can be pivotable relative to the bridge 4204 and / or another corresponding body.
[0749] The specific embodiments of the interface described herein can be suitable for infants, newborns or children and provide flow therapy to these patients. It is particularly useful for use with infants, newborns or children because their faces move frequently. However, it will be understood that the specific embodiments of the interface described herein can also be used to treat adults using high flow therapy.
[0750] Unless the context clearly requires otherwise, throughout the specification and claims, the words "comprising," "including," and the like should be construed in an inclusive sense (as opposed to an exclusive or exhaustive sense), that is, in the sense of "including but not limited to."
[0751] Although the present disclosure has been described with respect to specific embodiments, other embodiments that are clear to those of ordinary skill in the art are also within the scope of the present disclosure. Therefore, various changes and modifications may be made without departing from the spirit and scope of the present disclosure. For example, different components may be repositioned as needed. In addition, not all of these features, aspects, and advantages are necessary to practice the present disclosure. Therefore, the scope of the present disclosure is intended to be limited only by the following claims.
[0752] Different embodiments have been described by way of example. In some embodiments, any one or more of the features of one or more of the described embodiments may be combined with one or more features of other embodiments.
[0753] Language of degree used herein, such as the terms "substantially," "about," "generally," and "substantially" as used herein, refers to a value, amount, or characteristic that is close to the stated value, amount, or characteristic and still performs the desired function or achieves the desired result. For example, the terms "generally parallel" and "substantially parallel" refer to values, amounts, or characteristics that may deviate from exact parallelism by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degrees, or another value, amount, or characteristic.
[0754] In this specification and claims, unless the context indicates otherwise, terms such as top, bottom, above, below, vertically, and horizontally are intended to refer to a user having a patient interface positioned on the user's face, the user being in an upright standing position. Unless the context indicates otherwise, the terms inside or inwardly and outside or outwardly and similar such terms are intended to refer to the central vertical plane of the patient interface (i.e., the sagittal plane of the user) that is positioned on the user's face. Unless the context indicates otherwise, the terms forward, rearward, posteriorly are intended to refer to the user having a patient interface positioned on the user's face.
[0755] Where reference is made in this specification to patent specifications, other external documents, or other sources of information, this is generally for the purpose of providing a context for discussing the features of the invention. Unless expressly stated otherwise, reference to these external documents should not be construed as an admission that these documents, or these sources of information, are prior art or form part of the common general knowledge in the art in any jurisdiction.
[0756] The foregoing description of the invention includes preferred forms of the invention. Modifications may be made to the invention without departing from the scope of the invention.
[0757] Additional Features
[0758] Clause A1. A patient interface comprising:
[0759] a. a first body adapted to rest on a first portion of a user's face;
[0760] b. a second body (hereinafter the first body and the second body are referred to as a pair of side arms), the second body being adapted to rest on a second portion of the face of the user;
[0761] c. a bridge member linking the first body and the second body; and
[0762] d. A support structure positioned on at least a portion of the bridge.
[0763] Clause A2. A patient interface as described in Clause A1, wherein the support structure is positioned on at least a portion of the user-facing portion of the bridge.
[0764] Clause A3. A patient interface as described in any of Clauses A1-2, wherein the support structure is at least partially formed from a textile material.
[0765] Clause A4. A patient interface as described in Clause A3, wherein the textile material is a woven, non-woven or knitted textile material.
[0766] Clause A5. A patient interface as described in any of Clauses A1-2, wherein the support structure is at least partially formed from a molded polymer.
[0767] Clause A6. A patient interface as described in Clause A5, wherein the support structure is formed from a molded polymer sheet.
[0768] Clause A7. A patient interface as described in any of Clauses A1-6, wherein the support structure and the bridge are formed at least in part from the same polymer.
[0769] Clause A8. A patient interface as described in any of clauses A1-7, wherein the first body is adapted to rest on the cheek of the user.
[0770] Clause A9. A patient interface as described in any of clauses A1-8, wherein the first body and the second body are adapted to rest on opposite cheeks of the user.
[0771] Clause A10. A patient interface as described in any of clauses A1-9, wherein the first body and / or the second body includes one or more nasal delivery elements adapted to rest in one or more nostrils of the user.
[0772] Clause A11. A patient interface as described in Clause A10, wherein the one or more nasal delivery elements are configured to allow ambient gas external to the patient interface to pass through the nostrils.
[0773] Clause A12. A patient interface as described in any of clauses A10-11, wherein the one or more nasal delivery elements are shaped or angled so that they extend inwardly toward the septum of the user.
[0774] Clause A13. A patient interface as described in any of clauses A10-12, wherein the one or more nasal delivery elements are shaped or angled so that in use the tips of the one or more nasal delivery elements are pointed towards the back of the user's head.
[0775] Clause A14. A patient interface as described in any of Clauses A10-13, wherein the first body and / or the second body includes one or more gas delivery tube lumens in pneumatic communication with the one or more nasal delivery elements.
[0776] Clause A15. The patient interface of Clause A14, further comprising one or more gas delivery conduits in pneumatic communication with the one or more gas delivery lumens.
[0777] Clause A16. A patient interface as described in any of Clauses A1-15, wherein the support structure extends along the first body and / or the second body.
[0778] Clause A17. A patient interface as described in clause A16, wherein the support structure extends along a user-facing portion of the first body and / or the second body.
[0779] Item A18. A patient interface as described in Item A17, wherein at least a portion of the support structure present on these user-facing portions of the first body and / or the second body is adapted to interface with one or more fixed structures secured to the face so as to reinforce the patient interface to the face.
[0780] Clause A19. A patient interface as described in any of clauses A1-18, wherein the patient interface is shaped to match the contour of the face of the user.
[0781] Clause 20. A patient interface as described in any of Clauses A1-19, wherein the first body and / or the second body includes one or more regions of reduced thickness relative to adjacent regions of the first body and / or the second body.
[0782] Clause A21. A patient interface as described in clause A20, wherein the one or more regions of reduced thickness are positioned on portions of the first body and / or the second body that rest on one or more cheeks of the user.
[0783] Clause A22. A patient interface as described in any of clauses A20-21, wherein the one or more regions of reduced thickness are positioned on an outer edge of the first body and / or the second body.
[0784] Item A23. A patient interface as described in any of Items A1-22, further comprising one or more attachment structures fastened to the user-facing portion of the first body and / or the second body, the one or more attachment structures being adapted to dock with one or more fixed structures fastened to the face so as to reinforce the patient interface to the face.
[0785] Clause A24. A nasal cannula comprising:
[0786] a. a first body and a second body, the first body and the second body being adapted to rest on opposite cheeks of a user;
[0787] b. at least one nasal delivery element extending from the first body and / or the second body and adapted to be non-sealingly resting in one or more nostrils of the user;
[0788] c. a bridge member linking the first body and the second body; and
[0789] d. A reinforcing structure positioned on at least a portion of the bridge.
[0790] Clause A25. The nasal cannula of clause A24, wherein the reinforcement structure is positioned on at least a portion of the user-facing portion of the bridge.
[0791] Clause A26. The nasal cannula of any of Clauses A24-25, wherein the reinforcement structure is at least partially formed from a molded polymer.
[0792] Clause A27. The nasal cannula of Clause A26, wherein the reinforcement structure is formed from a molded polymer sheet.
[0793] Clause A28. The nasal cannula of any of Clauses A24-25, wherein the reinforcement structure is at least partially formed from a textile material.
[0794] Clause A29. The nasal cannula of Clause A28, wherein the textile material is a woven, non-woven, or knitted textile material.
[0795] Clause A30. The nasal cannula of any of Clauses A24-29, wherein the reinforcing structure and the bridge are formed at least in part from the same polymer.
[0796] Clause A31. The nasal cannula of any of Clauses A24-30, wherein the at least one nasal delivery element is shaped or angled so that it extends inwardly toward the septum of the user.
[0797] Clause A32. The nasal cannula of any of Clauses A24-31, wherein the at least one nasal delivery element is shaped or angled such that, in use, the tip of the at least one nasal delivery element points toward the back of the user's head.
[0798] Clause A33. The nasal cannula as described in any of Clauses A24-32, wherein the first body and / or the second body comprises one or more gas delivery lumens in pneumatic communication with the at least one nasal delivery element.
[0799] Clause A34. The nasal cannula as described in Clause A33, further comprising one or more gas delivery conduits pneumatically connected to the one or more gas delivery lumens.
[0800] Clause A35. The nasal cannula of any of Clauses A24-34, wherein the reinforcement structure extends along the first body and / or the second body.
[0801] Clause A36. The nasal cannula of clause A35, wherein the reinforcement structure extends along a user-facing portion of the first body and / or the second body.
[0802] Item A37. A nasal cannula as described in Item A36, wherein at least a portion of the reinforcing structure present on these user-facing portions of the first body and / or the second body is adapted to dock with one or more fixed structures fastened to the face so as to reinforce the nasal cannula to the face.
[0803] Clause A38. The nasal cannula of any of Clauses A24-37, wherein the nasal cannula is shaped to match the contour of the face of the user.
[0804] Clause A39. The nasal cannula as described in any of clauses A24-38, wherein the first body and / or the second body includes one or more regions of reduced thickness relative to adjacent regions of the first body and / or the second body.
[0805] Clause A40. The nasal cannula of Clause A39, wherein the one or more regions of reduced thickness are positioned on an outer edge of the first body and / or the second body.
[0806] Clause A41. A nasal cannula as described in any of clauses A24-40, further comprising one or more attachment structures fastened to the user-facing portion of the first body and / or the second body, the one or more attachment structures being adapted to dock with one or more fixing structures fastened to the face so as to reinforce the nasal cannula to the face.
[0807] Clause A42. A nasal cannula comprising:
[0808] a. a first body adapted to rest on a first portion of a user's face;
[0809] b. a second body adapted to rest on a second portion of the face of the user; and
[0810] c. at least one nasal delivery element extending from the first body and / or the second body and adapted to be non-sealingly resting in one or more nostrils of the user;
[0811] d. Wherein the first body and / or the second body comprises one or more regions having a reduced thickness relative to adjacent regions of the first body and / or the second body.
[0812] Clause A43. The nasal cannula of clause A42, wherein the first body and the second body are adapted to rest on opposite cheeks of the user.
[0813] Clause A44. The nasal cannula as described in any of clauses A42-43, wherein the one or more regions of reduced thickness are positioned on portions of the first body and / or the second body that rest on one or more cheeks of the user.
[0814] Clause A45. The nasal cannula of any of clauses A42-44, wherein the one or more regions of reduced thickness are positioned on an outer edge of the first body and / or the second body.
[0815] Clause A46. The nasal cannula as described in any of Clauses A42-45, further comprising a bridge member connecting the first body and the second body.
[0816] Clause B1. A patient interface comprising:
[0817] a. a side arm or preferably a pair of said side arms, the side arm or side arms extending laterally from a substantially central bridge portion which, in use, will be positioned in or around the septum region of a user,
[0818] b. wherein the or each said side arm is connected to a substantially elastic or relatively more rigid bridging portion element which defines a substantially predetermined spatial relationship for one or more outlets of a gas delivery system having the or each said side arm.
[0819] Clause B2. A patient interface comprising:
[0820] a. a side arm or preferably a pair of said side arms, the side arm or side arms extending laterally from a substantially central bridge portion which, in use, will be positioned in or around the septum region of a user,
[0821] b. the or each said side-arm comprises one or more predefined or pre-arranged points or localised compensation areas (or sites) positioned along the side-arm so as to adjust or facilitate compensation of the patient interface in or at one or more of these compensation areas (or sites), and
[0822] c. wherein the or each said side arm is connected to a substantially elastic or relatively more rigid bridging portion element which defines a substantially predetermined spatial relationship for one or more outlets of a gas delivery system having the or each said side arm.
[0823] Clause B3. A patient interface comprising:
[0824] a. a side arm or preferably a pair of said side arms, the side arm or side arms extending laterally from a substantially central bridge portion which, in use, will be positioned in or around the septum region of a user,
[0825] b. the or each said side arm comprises at least one substantially elastic or relatively more rigid side arm element which at least partially defines the form or curvature of the or each side arm and has one or more predefined or prearranged points or localised compensation areas (or locations) positioned along the or each side arm and / or the or each side arm element so as to adjust the compensation of the patient interface in or at one or more of the compensation areas (or locations), and
[0826] c. wherein the or each said side arm element is connected or interconnected via a connecting material to a substantially elastic or relatively more rigid bridging portion element which defines a substantially predetermined spatial relationship for one or more outlets of a gas delivery system having the or each said side arm.
[0827] Clause B4. An interface as described in any of clauses B1-3, wherein the bridging portion or the bridging portion elements (or both) are substantially isolated from forces such as may be applied to or may be experienced by the patient interface.
[0828] Clause B5. An interface as described in any of Clauses B1-4, wherein forces applied to the patient interface can be experienced by one or more side arms of the interface, wherein the compensation regions (or portions) of the side arms or side arm elements or both adjust the forces by flexing or bending or articulating or other displacement of the side arms or side arm elements or both.
[0829] Clause B6. The interface of any of clauses B1-5, wherein the one or more side arms are patient interface stabilizers.
[0830] Clause B7. The interface of any of clauses B1-6, wherein the bridging portion element and the one or more side arm elements are separate parts assembled to form a single component.
[0831] Clause B8. An interface as described in any of clauses B1-7, wherein the bridging portion element and the one or more side arm elements are a single component, or at least the bridging portion and the at least one side arm element are a single component.
[0832] Clause B9. An interface as described in any of clauses B1-8, wherein the bridging portion element and the one or more side arm elements are formed integrally as a single component, or at least the bridging portion and the at least one side arm element are formed integrally as a single component.
[0833] Clause B10. An interface as described in any of clauses B1-9, wherein the bridging portion elemen...
Claims
1. A patient interface, comprising: a. a left side arm and a right side arm, each extending laterally from a bridge portion which, in use, will be positioned around the septum region of a user, b. A pair of nasal prongs for directing the gas flow into the user's nostrils, c. wherein the bridging portion is more rigid than the left and right arms, the bridging portion being attached to and extending between the left and right arm connection points, the bridging portion defining a predetermined spatial arrangement of the pair of nose prongs, d. wherein, when the patient interface is in place on the user's face, displacement of the position of the left arm and / or the right arm is transmitted to the bridge portion via the corresponding connection points in a manner that minimizes movement of the pair of nasal prongs relative to the user's nostrils.
2. A patient interface according to claim 1, wherein: The bridge portion is isolated from forces that may be applied to the left or right arms of the patient interface.
3. A patient interface according to claim 1, wherein: The left and right arms each include a localized compensation region to facilitate compensation of the patient interface; when force is applied to the left and / or right arms of the patient interface, the localized compensation region adjusts the force by bending of the side arms.
4. A patient interface according to claim 1, wherein: The left and right side arms each include separate side arm elements that are spaced apart along the length of the left and right side arms.
5. The patient interface of claim 1, wherein: The patient interface includes: a bridging portion element including a stem extending over the pair of nasal prongs; and at least one separate side arm element located in each of the left arm and the right arm.
6. A patient interface according to claim 3, wherein: The localized compensation area is the curved area.
7. A patient interface according to claim 3, wherein: Each localized compensation region is more preferentially curved in the first direction.
8. A patient interface according to claim 7, wherein: The first direction is in a direction that facilitates movement or flexure of the side arm member relative to the bridge portion.
9. A patient interface according to claim 4, wherein: Each side arm element is formed of a resilient material or is configured to provide substantial resiliency to flex in one or more regions selected from: a. disposed between a single compensation region positioned laterally outwardly from the bridging portion and the outer end of the side arm member, b. disposed between the outer compensation region of the side arm member and the outer end of the side arm member, c. disposed between each of a series of compensation regions of the side arm element, d. is arranged between two compensation areas located laterally outward from the bridging portion and between the outermost compensation area of the side arm element and the outer end of the side arm element.
10. The patient interface of claim 4, wherein: Each side arm element comprises two compensation regions.
11. A patient interface according to claim 4, wherein: At least one compensation region is located at a more inner end of one of the side arm elements connected to the bridge portion.
12. A patient interface according to claim 4, wherein: The side arm elements are configured to bend relative to the bridging portion element.
13. A patient interface according to claim 4, wherein: The side arm element also includes a tab that is engageable with the material of the side arm to provide resistance to bending of the side arm element.
14. A patient interface according to claim 1, wherein: The left arm and the right arm each extend outwardly from the sagittal plane of the user.
15. A patient interface according to claim 4, wherein: The side arm elements extend along at least a portion of the length of each side arm.
16. A patient interface according to claim 1, wherein: The left and right arms each form at least a portion of a passageway for receiving a supply of gas to be delivered to a user via the pair of nasal prongs.
17. A patient interface according to claim 1, wherein: The left and right arms each provide a separate passage for delivering gas to the associated nasal prongs.
18. A patient interface according to claim 1, wherein: The patient interface further comprises a two-part releasable attachment arrangement comprising: a. Skin patches and patient interface patches, b. The skin patch has a patient side and an interface side, c. The patient side of the skin patch can be attached to the user's skin, d. The interface side of the skin patch is provided with a first part of a two-part releasable attachment means, and e. The patient interface patch has an interface side and a patient side, f. the patient side of the patient interface patch is provided with a complementary second part of a two-part releasable attachment means, g. The interface side of the patient interface patch is attachable to a patient interface.
Citation Information
Patent Citations
A nasal cannula, conduit and securement system
WO2012053910A1
Asymmetrical nasal delivery elements and fittings for nasal interfaces
WO2015020540A1
Methods and devices for improving efficacy of non-invasive ventilation
CN101977656A