Abstract: Nasal cannula assemblies for providing respiratory therapy to patients are provided. A nasal cannula assembly can include a cannula, an optional manifold which may be removable, a gas supply tube, and a securement mechanism. Securement mechanisms can include headgear straps, cheek pads, or an adhesive nose strip. A nasal cannula assembly can also include a lanyard, lanyard clip, and/or lanyard connector to help support the weight of a main gas delivery conduit.
NASAL CANNULA ASSEMBLIES AND RELATED PARTS
FIELD OF THE INVENTION
[0001] The present disclosure relates to devices and systems for providing gases to patients for respiratory therapy. More specifically, the present disclosure relates to nasal cannula interfaces for providing gases to patients via the nasal passages.
BACKGROUND OF THE INVENTION
[0002] Medical professionals may wish to provide patients with respiratory assistance in the form of supplemental oxygen or airflow for many reasons in ICU (intensive care unit), other hospital, or home environments. Different types of interfaces for supplying gases to patients are available. For example, various nasal masks, full face masks, oral interfaces, nasal pillows, and nasal cannula interfaces exist. Nasal cannula interfaces typically include two nasal prongs that are placed in the patient's nostrils to deliver gases to the patient.
[0003] Nasal cannula assemblies generally consist of entry tubing, either symmetric or single sided that lies across the upper lip. Protruding from this tubing are open ended prongs which extend into the nares of the patient to deliver oxygen. Nasal cannula have the advantage of being more comfortable and acceptable than a face mask to most patients. A single flow entry nasal cannula has the advantage of being unobtrusive, and may be more relevant to delivering humidity than a dual flow entry style of nasal cannula, due to the advantage of flow rates and surface area for heat loss. A single flow entry however is provided at one side of the cannula, the left or the right side. If the tube is on the left side for example, the user has difficulty in use if the flow source is on the opposite or right side of the user requiring longer lengths of tubing and causing the tube to cross the body.
[0004] When providing humidified gases to a patient it is common to use a heated breathing circuit (tubing). This circuit is heavy and can drag and pull on the patient interface. It is common to use a short flexible tube between the heated circuit and patient interface to reduce any torque or twisting. In order to stop the weight pulling on the patient interface, circuit hangers are occasionally used. This is a large extendable metal arm to take the weight. It also has been known in the art to clip part of the tubing to the patient's clothes or bedclothes. Both of these solutions have been found to be quite unsuitable for mobile patients especially when sleeping and turning in bed.
[0005] With patient interfaces such as nasal cannula the stability of the nasal prongs on the face is very important, as movement of the prongs within the nares can cause severe irritation. Current methods employed to retain a single entry nasal cannula on the face use a simple elastic band of material around the back of the patients head. This is prone to rotating the nasal cannula relative to the patient's head especially when
turning ones head on a pillow. This rotation causes the prongs move within the nares, irritating this sensitive area.
[0006] In this specification where reference has been made 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 specifically stated otherwise, reference to such external documents is not to be construed as an admission that such documents, or such sources of information, in any jurisdiction, are prior art, or form part of the common general knowledge in the art.
[0007] It is an object of the present invention to provide an improved nasal cannula assembly or patient interface headgear, or to at least provide the public with a useful choice.
SUMMARY OF THE INVENTION
[0008] The nasal cannula interfaces described herein can advantageously be used to deliver gases to patients over a wide range of concentrations and flow rates. The nasal cannula interfaces described herein also include various features designed to improve patient comfort, safety, ease of use, and/or efficiency, reduce costs, and/or provide other benefits.
[0009] In some embodiments, a nasal cannula system includes a cannula and a manifold. The cannula includes a central body portion, first and second side portions that extend in opposite lateral directions from the central body portion and contact a cheek of a user when the system is in use, and first and second nasal prongs extending from the central body portion . The central body portion includes a patient facing side and at least one retention strap that cooperate to define a cavity. The first and second nasal prongs communicate with the cavity. The manifold receives a supply of gas from a gas source and includes a gas inlet and a gas outlet. The manifold is receivable within the cavity of the cannula such that the gas outlet is aligned with the first and second nasal prongs. The at least one retention strap defines first and second lateral edges, and the first and second nasal prongs are located between the first and second lateral edges.
[0010] In some embodiments, a nasal cannula system includes a cannula and a supply tube. The cannula includes a central body portion, first and second side portions that extend in opposite lateral directions from the central body portion and contact a cheek of a user when the system is in use, and first and second nasal prongs extending from the central body portion . The cannula defines a cavity having an inlet at a first end and a second end communicating with first and second gas paths. The first and second gas paths communicate with the first and second nasal prongs, respectively. The inlet is located at one of the first and second side portions, and the first and second gas paths extend in a lateral direction toward the first and second nasal prongs. The supply tube has a first end connectable to a supply of gas from a gas source and a second end coupled to the inlet of the cavity of the cannula.
[0011] In some embodiments, a nasal cannula system includes a cannula, a manifold, and a supply tube. The cannula includes a central body portion, first and second side portions that extend in opposite lateral directions from the central body portion, and first and second nasal prongs extending from the central body portion. The central body portion defines a cavity and a forward-facing inlet to the cavity. The first and second nasal prongs communicate with the cavity. The manifold receives a supply of gas from a gas source and includes a gas inlet and a gas outlet. The manifold is connectable with the cannula such that the gas outlet is aligned with the forward-facing inlet of the cannula and the gas inlet faces a lateral direction. The supply tube is connected to the gas inlet of the manifold and positioned forward of the forward-facing inlet of the cannula.
[0012] In some embodiments, a nasal cannula patient interface includes first and second nasal prongs, each including an inlet end and an outlet end, and at least one support portion configured to rest upon the nose of a patient at a point at or above the tip of the nose. In use, no portion of the patient interface contacts an upper lip of the patient to provide any substantial support to the patient interface.
[0013] In some embodiments, a nasal cannula system comprises a cannula having a central body portion, a first nasal prong and a second nasal prong extending from the central body portion . The cannula defines a cavity in communication with the first and second nasal prongs. An integrated head strap includes a first section and a second section, wherein the first and second sections extend in opposite lateral directions from the central body portion. The first section defines a rear portion of the head strap. An adjustable coupling arrangement permits coupling of the first and section sections in an adjustable manner such that a circumference of the head strap is adjustable. A supply tube has a first end connectable to a supply of gas from a gas source and a second end coupled to the cavity of the cannula.
[0014] In some embodiments, a nasal cannula system includes a cannula comprising a central body portion, a first nasal prong and a second nasal prong extending from the central body portion. The cannula defines a cavity in communication with the first and second nasal prongs. The cannula defines a lateral slot. A head gear strap extends through the lateral slot of the cannula. A supply tube has a first end connectable to a supply of gas from a gas source and a second end coupled to the cavity of the cannula.
[0015] In some embodiments, a nasal cannula system comprises a cannula comprising a central body portion, a first nasal prong and a second nasal prong extending from the central body portion. The cannula defines a cavity in communication with the
first and second nasal prongs. The cannula defines a first opening at a first location of the cavity and a second opening at a second location of the cavity spaced from the first location. A valve body is movable within the cavity. A supply tube has a first end connectable to either one of the first opening or the second opening of the cannula and a second end connectable to a supply of gas from a gas source. When the first end of the supply tube is connected to the first opening of the cannula, the valve body moves in response to a flow of gas in the cavity from the gas source to block the second opening such that the flow of gas is directed to the first and second nasal prongs and, when the first end of the supply tube is connected to the second opening of the cannula, the valve body moves in response to the flow of gas in the cavity from the gas source to block the first opening such that the flow of gas is directed to the first and second nasal prongs.
[0016] In some embodiments, a nasal cannula system comprises a cannula comprising a central body portion, a first nasal prong and a second nasal prong extending from the central body portion. The cannula defines a cavity in communication with the first and second nasal prongs. The cannula defines a first opening at a first location of the cavity and a second opening at a second location of the cavity spaced from the first location. The cannula comprises a first valve that selectively closes the first opening and a second valve that selectively closes the second opening. A supply tube has a first end connectable to either one of the first opening or the second opening of the cannula and a second end connectable to a supply of gas from a gas source. When the first end of the supply tube is connected to the first opening of the cannula, the second valve blocks the second opening such that a flow of gas from the gas source is directed to the first and second nasal prongs and, when the first end of the supply tube is connected to the second opening of the cannula, the first valve blocks the first opening such that the flow of gas is directed to the first and second nasal prongs.
[0017] In some embodiments, a nasal cannula system comprises a cannula comprising a central body portion, a first nasal prong and a second nasal prong extending from the central body portion. The cannula defines a cavity in communication with the first and second nasal prongs. The cannula defines a first opening at a first end of the cavity and a second opening at a second end of the cavity. A supply tube has a first end comprising a first insert and a second end comprising a second insert. Each of the first insert and the second insert is positionable within the cavity to seal the first opening and the second opening and deliver a flow of gas from the gas source to the first and second nasal prongs. When the first end of the supply tube is connected to the cannula, the second end is connectable to the gas source and, when the second end of the supply tube is connected to the cannula, the first end is connectable to the gas source.
[0018] In some embodiments, a nasal cannula system comprises a cannula comprising a central body portion, a first nasal prong and a second nasal prong extending from the central body portion. The cannula defines a cavity in communication with the first and second nasal prongs. A supply tube has a first end coupled to the cavity of the cannula and a second end connectable to a supply of gas from a gas source. The first end of the supply tube defines a connection axis relative to the cannula. The supply tube comprises a flexible portion at or adjacent the first end that can be bent at least about 90 degrees to either the left or right side without significant occlusion of an internal passage of the supply tube.
[0019] In some embodiments, a nasal cannula system comprises a cannula comprising a cavity and a first nasal prong and a second nasal prong in communication with the cavity. A supply tube receives a flow of gas from a gas source. The supply tube is connected to the cannula to supply the flow of gas to the cavity of the cannula. A clip removably receives the cannula. A retention arrangement secures the clip to the head of a patient. The cannula is positionable within the clip in a first orientation such that the supply tube extends in a first direction from the clip, and the cannula is positionable within the clip in a second orientation such that the supply tube extends in a second direction from the clip.
[0020] In some embodiments, a nasal cannula system comprises a cannula comprising a first nasal prong and a second nasal prong. The cannula defines a cavity in communication with the first and second nasal prongs. The cannula defines a first opening at a first location of the cavity and a second opening at a second location of the cavity spaced from the first location. A supply tube assembly comprises a clip that can be releasably coupled to the cannula in either of a first orientation and a second orientation . The supply tube assembly further comprises a supply tube connectable to a supply of gas from a gas source. The clip supports the supply tube and comprises a sealing portion. When the clip is connected to the cannula in the first orientation, the supply tube is connected to the first opening of the cannula and extends in a first direction from the cannula and the sealing portion at least substantially seals the second opening and, when the clip is connected to the cannula in the second orientation, the supply tube is connected to the second opening of the cannula and extends in a second direction from the cannula and the sealing portion at least substantially seals the first opening.
[0021] In some embodiments, a nasal cannula system comprises a cannula clip comprising a first nasal prong and a second nasal prong. The cannula defines a cavity in communication with the first and second nasal prongs. A supply tube assembly comprises a manifold having at least one manifold opening and a supply tube connectable to a supply of gas from a gas source. The cannula clip is capable of being releasably coupled to the manifold in either of a first orientation and a second orientation in which the manifold is received within the cavity of the cannula clip and the first and second prongs are aligned with the at least one manifold opening such that a flow of gas is provided to the first and second prongs. When the cannula clip is connected to the manifold in the first orientation, the supply tube extends in a first direction relative to the first and second prongs and, when the cannula clip is connected to the manifold in the second orientation, the supply tube extends in a second direction relative to the first and second prongs.
[0022] In some embodiments, a nasal cannula system comprises a cannula comprising a main body defining a cavity and a first nasal prong and a second nasal prong extending from the main body and in communication with the cavity. A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. The first and second nasal prongs are tiltable relative to the main body of the cannula between at least a first position in which the first and second nasal prongs are tilted in a first direction relative to the main body and a second position in which the first and second nasal prongs are tilted in a second direction relative to the main body. A first surface of the main body defines a patient-facing surface of the cannula in the first position and a second surface of the main body defines the patient-facing surface of the cannula in the second position to effectively switch the side from which the supply tube extends from the cannula between the first and second positions.
[0023] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. The first and second nasal prongs are directionally-oriented relative to the cannula and are movable between at least a first position in which the first and second nasal prongs are oriented such that openings of the prongs generally face in a first direction relative to the cannula and a second position in which the first and second nasal prongs are oriented such that the openings of the prongs generally face in a second direction relative to the cannula. A first surface of the cannula defines a patient-facing surface in the first position and a second surface of the cannula defines the patient-facing surface in the second position to effectively switch the side from which the supply tube extends from the cannula between the first and second positions.
[0024] In some embodiments, a nasal cannula system comprises a cannula defining a patient-facing surface and a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A
manifold supports the cannula for rotation about at least one axis between at least a first position and a second position opposite the first position. A supply tube is coupled to the manifold and in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. When the cannula is in the first position, the supply tube is positioned on a first side of the first and second nasal prongs and, when the cannula is in the second position, the supply tube is positioned on a second side of the first and second nasal prongs to effectively switch the side from which the supply tube extends from the cannula between the first and second positions.
[0025] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. A pressure line is in communication with the cavity and is configured to be connectable to a control unit of the gas source or a display unit to provide a signal to the control unit or display unit indicative of a pressure within the cavity.
[0026] In some embodiments, a nasal cannula comprises a cannula body defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. The cannula defines a patient-facing surface having one or more comfort features selected from a plurality of through-holes, a plurality of raised bumps, a plurality of grooves and a gel pad.
[0027] In some embodiments, a nasal cannula comprises a cannula body defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. The cannula body comprises a central portion containing the first and second nasal prongs and first and second side portions extending from each side of the central portion. The cannula body defines a patient-facing surface. The central portion is spaced forwardly of adjacent portions of the first and second side portions such that, in use, the patient-facing surface of the central portion is spaced from the upper lip of the patient.
[0028] In some embodiments, a supply tube for a nasal cannula comprises a tube body having a first end a second end. The tube body comprises a malleable section that permits the section to be shaped by an external force and that substantially retains the shape after the external force is removed.
[0029] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A supply tube is coupled to the
cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. A support arrangement supports the supply tube at a spaced location from the cannula. The support arrangement comprises a fastener having a first portion coupled to the supply tube and a second portion located at the spaced location.
[0030] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. A retention arrangement secures the cannula to the patient. A support arrangement supports the supply tube at a spaced location from the cannula, which is located on the retention arrangement.
[0031] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. A support arrangement supports the supply tube at a spaced location from the cannula. The support arrangement comprises a fastener that engages a piece of fabric at the spaced location.
[0032] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. A support arrangement supports the supply tube at a spaced location from the cannula. The support arrangement comprises at least one of an armband that engages the supply tube, an adhesive pad comprising a fastener for releasably fastening the supply tube to the adhesive pad, a generally U-shaped support that sits on the patient's shoulder and engages the supply tube, and a headgear strap comprising a strap extending over the top of the patient's head and engages the supply tube.
[0033] In some embodiments, a retention arrangement for a nasal cannula assembly comprises a headgear strap comprising a first ear loop and a second ear loop, each of which at least partially surround an ear of the patient. A connection portion connects the retention arrangement to the nasal cannula assembly. A strap portion extends around the back of the patient's head between the first and second ear loops. [0034] In some embodiments, a retention arrangement for a nasal cannula comprises a headgear strap comprising a strap portion. A first pad and a second pad, in use, contact first and second cheeks of the patient. A connection portion connects the retention arrangement to the nasal cannula. The strap portion extends around the patient's head and extends from the first and second pads at an angle relative to the nasal cannula.
[0035] In some embodiments, a retention arrangement for a nasal cannula comprises a frame comprising a connection portion that connects the retention arrangement to the nasal cannula. A first ear stem portion and a second ear stem portion extend rearwardly from opposite sides of the connection portion. The ear stem portions are configured to be positioned above the ears of the patient.
[0036] In some embodiments, a nasal cannula system comprises a cannula having a central portion defining a cavity and comprising a first nasal prong and a second nasal prong extending from the central portion and in communication with the cavity. A first side portion and a second side portion extend in a lateral direction from opposing sides of the central portion . A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. A first adhesive pad and a second adhesive pad are configured to be adhesively secured to the face of the patient and connectable to a respective one of the first and second side portions of the cannula through an adjustable fastening arrangement.
[0037] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A modular retention arrangement secures the cannula to the patient. The cannula is configured to be used with any one of the retention arrangements selected from a set of adhesive pads that attach to the patient's face, a headgear strap and a halo-style headgear strap that has a strap portion extending over the top of the patient's head.
[0038] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A modular retention arrangement secures the cannula to the patient. The retention arrangement comprises a nose strip coupled to the cannula and attachable to the nose of a patient and a headgear strap comprising a clip configured to receive the cannula. The cannula can be secured to the patient using either the nose strip or the headgear strap.
[0039] In some embodiments, a retention arrangement for a nasal cannula comprises a headgear strap that is connectable to a nasal cannula and capable of being tensioned around the head of a patient. The headgear strap comprises a tension indicator that provides a first indication when the tension is at an incorrect value and a second indication when the tension is at a correct value.
[0040] In some embodiments, a retention arrangement for a nasal cannula comprises a headgear strap that is connectable to a nasal cannula. At least one strap extends around the head of a patient from one side to the other of the cannula. A tension adjuster tensions the headgear strap by varying an effective length of the at least one strap by winding up a portion of the at least one strap.
[0041] In some embodiments, a headgear strap for a nasal cannula comprises a first portion that is connectable to a nasal cannula and a second, elastic portion that is positioned at a back of a head of a patient in use. A pad extends at least partially along the second, elastic portion.
[0042] In some embodiments, a nasal cannula assembly comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A head strap is positioned around the head and above the ears of the patient in use. A first arm is coupled to a first side of the cannula and a second arm is coupled to a second side of the cannula. Upper end portions of each of the first and second arms are attached to the head strap.
[0043] In some embodiments, a nasal cannula system comprises a cannula defining an open cavity and comprises a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A manifold is configured to be removably coupled to the cannula and a portion of the manifold received into the cavity of the cannula. The manifold includes first and second holes that align with the first and second nasal prongs when the manifold is coupled to the cannula, and the manifold also includes a side opening configured to be coupled to a tube. An inner surface of the cavity of the cannula includes a first attachment portion and an outer surface of the portion of the manifold includes a second attachment portion. The first and second attachment portions can be configured to engage one another to secure the manifold to the cannula.
[0044] In some embodiments of a nasal cannula system, the first and second attachment portions comprise cooperating portions of a hook and loop material fastener. The nasal cannula system can also include an arrangement in which the cavity and the portion of the manifold have corresponding symmetrical shapes so that the portion of the outer surface of the manifold can be positioned within the cavity in multiple orientations. In some embodiments, the cavity and the portion of the manifold are circular or oval shaped. In some embodiments, the first and second attachment portions are substantially planar.
[0045] In some embodiments, a nasal cannula assembly comprises a cannula defining a cavity and a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. The cannula includes a first outer surface and a second outer surface that are substantially planar and extending along the length of the cannula. The cannula also includes a first end and a second end. A retention arrangement is coupled to the cannula and configured to support the cannula on the face of a patient. A tube can be coupled to the cannula adjacent either the first end or the second end of the cannula and configured to be in communication with the cavity. The cannula has a first position in which the first outer surface contacts the face of the patient and the first and second nasal prongs extend into the nostrils of the patient. The cannula has a second position in which the second outer surface contacts the face of a patient and the first and second nasal prongs extend into the nostrils of the patient.
[0046] In some embodiments of a nasal cannula assembly, the cannula has a substantially triangular cross-sectional shape. The nasal cannula assembly can be arranged so that an angle between the first and second nasal prongs and the first outer surface is substantially the same as an angle between the first and second nasal prongs and the second outer surface. In some embodiments, the first and second nasal prongs extend outward from the cannula at a corner of the substantially triangular cross-sectional shape between the first and second outer surfaces.
[0047] In some embodiments, a nasal cannula assembly comprises a cannula body defining a cavity and comprises a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. The first and second nasal prongs can have a relaxed position in the absence of any substantial external force. An outer portion is configured to be movably coupled to the cannula body and configured to surround at least a portion of the cannula body. The outer portion defines at least one opening through which the first nasal prong extends and the outer portion includes at least one edge defining the at least one opening. The outer portion can move relative to the cannula body and the first and second nasal prongs, and the at least one edge is configured to engage the first and second prongs and deflect the first and second prongs from their relaxed positions.
[0048] In some embodiment of a nasal cannula assembly, the cannula body and the outer portion are substantially cylindrical and the outer portion extends around the circumference of the cannula body, and the outer portion can be rotated about the cannula body. Each of the first and second nasal prongs can include a flexible base portion configured to allow the angle at which the prong extends from the cannula body to change. The at least one opening can comprise a first opening and a second opening and the at least one edge can comprise a first edge and a second edge, the first opening defining the first edge and the second opening defining the second edge. The first nasal prong can extend through the first opening and the second nasal prong extends through the second opening. In some embodiments of a nasal cannula assembly, the outer portion includes a slot and the cannula body includes a protrusion that extends into the slot. The protrusion can be configured to move within the slot and the slot can have side walls configured to engage the protrusion and limit the amount of movement of the outer portion relative to the cannula body.
[0049] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprises at least one nasal prong extending from the cannula and in communication with the cavity. A frame portion is configured to support the cannula and at least one head strap is coupled to the frame portion and positioned around the head of the patient in use. The cannula is slidably supported by the frame portion and can move relative to the frame portion, the cannula including an opening through which the frame portion extends. The cannula system can comprise a tube support member supported by the frame portion or the head strap and the tube support member can be configured to support and selectively release a tube.
[0050] In some embodiments of a nasal cannula system, the tube support member is configured to loosely support the tube so that the tube can slide within the support member. The tube support member can comprise a strap configured to wrap around a tube and a clip configured to couple the strap to the head strap or frame portion. The frame portion can have a circular or rounded cross-section and the cannula can move laterally relative to the frame portion and can rotate relative to the frame portion. In some embodiments of a nasal cannula system, the interface between the cannula and the frame portion is a friction fit that allows the cannula to retain its position relative to the frame portion when not being moved by a user. The frame portion can include a plurality of notches configured to interact with the cannula and provide discrete locations along the frame portion at which the cannula can be supported.
[0051] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprises a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. The cannula includes an opening extending through a portion of the cannula and a head strap is positioned around the head of the patient in use. The opening on the cannula is configured to receive the head strap so that the head strap extends through the opening and supports the cannula and the cannula is configured to slide relative to the head strap and change positions along the head strap.
[0052] In some embodiments of a nasal cannula system, the cannula comprises a planar outer surface configured to contact the face of a patient when the first and second prongs are inserted into the nostrils of a patient. The head strap can be made of an elastic material and configured to hold the cannula against the face of a patient.
[0053] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising at least one nasal prong extending from the cannula and in communication with the cavity. The cannula includes a first slot and a second slot. A first frame portion is configured to be slidably received by the first slot of the cannula and a second frame portion is configured to be slidably received by the second slot. At least one head strap is coupled to the first and second frame portions and positioned around the head of the patient in use. The cannula is slidably supported by the first and second frame portions and can be selectively moved relative to the first and second frame portions.
[0054] In some embodiments of a nasal cannula system, the cannula includes a side opening configured to receive a supply tube, and the first and second frame portions are configured to allow a tube to pass between them. A nasal cannula system can also comprise a tube support member supported by the first and second frame portions and configured to slide relative to the first and second frame portions to position the supply tube relative to the first and second frame portions. The first and second frame portions can have circular cross-sections and the first and second slots can be configured to retain the first and second frame portions. In some embodiments of a nasal cannula system, the first frame portion is positioned above the second frame portion and the first and second slots are located on the outer side of the cannula facing away from the patient. The cannula can include a planar surface facing the face of the patient.
[0055] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising at least one nasal prong extending from the cannula and in communication with the cavity. The cannula includes a slot and a first frame portion is configured to be slidably received by the slot of the cannula. A second frame portion is fixedly coupled to the cannula. A first dial and a second dial are each coupled to both the first frame portion and the second frame portion. At least one head strap is coupled to the first and second frame portions and positioned around the head of the patient in use. The cannula is slidably supported by the first frame portion and the dials can be configured to rotate to move a section of the second frame portion and the cannula relative to the first frame portion. The first and second frame portions can be wires coated with a soft material. In some embodiments, the second frame portion is located above the first frame portion when the cannula system is worn by a patient.
[0056] In some embodiments, a retention arrangement for a nasal cannula comprises a band configured to extend around the head of a patient and a first arm pivotally coupled to the band at a first joint. A second arm is pivotally coupled to the first arm at a second joint and the second arm can be connectable to a nasal cannula at a third joint. The first, second and third joints are configured to allow three dimensional movement and are configured to retain the relative position of the band, first arm, second arm, and cannula unless moved by a user.
[0057] In some embodiments of a retention arrangement, the band includes a stabilizing portion that is wider than the band and configured to contact the head of a patient. The third joint can be coupled to the side of a cannula. In some embodiments, the first, second and third joints are ball joints.
[0058] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprises at least one nasal prong extending from the cannula and in communication with the cavity. The cannula includes a slot and has a clip portion extending from the cannula. A frame is configured to support the cannula and be coupled to a head strap. The frame includes an opening configured to receive the clip portion of the cannula and the clip portion can be movable within the opening so that the cannula can assume different positions relative to the frame while being supported by the frame.
[0059] In some embodiments of a nasal cannula system, the cannula is positioned between the frame and the face of a patient when in use. The frame can include at least one pad member arranged to contact the face of a patient when in use. In some embodiments, the interface between the clip portion and the frame opening allows the cannula to be moved laterally and rotated relative to the frame. A cannula system can also include a head strap coupled to the frame and a tube support member supported by the head strap or frame.
[0060] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprises at least one nasal prong extending from the cannula and in communication with the cavity. The cannula has a first end portion and a second end portion. A first corrugated tube section is coupled to the first end portion of the cannula and a second corrugated tube section is coupled to the second end portion of the cannula. The position of the cannula relative to a patient's face can be adjusted by expanding and compressing the first and second corrugated tube sections. In some embodiments, the cannula system also comprises a first non-corrugated tube coupled to the first corrugated tube section and a second non-corrugated tube coupled to the second corrugated tube section. The first and second corrugated tube sections can be backed by a head strap.
[0061] In some embodiments, a prong arrangement for a nasal cannula comprises a prong comprising a first prong portion comprising a first slot and a second prong portion comprising a first flange. The second prong portion is coupled to the first prong portion and the first flange extends longitudinally within the first slot. The first and second prong portions are configured to extend away from a cannula and define a passageway and the first flange is movable within the first slot so that the first prong portion and second prong portion can be moved toward and away from one another to adjust an outer dimension of the prong.
[0062] In some embodiments of a prong arrangement, the first and second prong portions each include a sealing member adjacent the cannula and the sealing members overlap each other and are configured to slide relative to one another. The prong can further comprise a size indicator configured to indicate the relative outer dimensions of the prong. In some embodiments, the prong includes a second slot and a second flange, the second flange extending longitudinally within the second slot. The first slot can comprises two side walls configured to limit the extent to which the first flange can move within the first slot.
[0063] In some embodiments, a prong arrangement for a nasal cannula comprises a prong comprising a first collapsible portion configured to be coupled to a cannula. The first collapsible portion includes a first passageway. A second collapsible portion is coupled to the first collapsible portion and has a second passageway. A third collapsible portion is coupled to the second collapsible portion and has a third passageway. The first, second and third collapsible portions are configured to collapse and expand telescopically relative to one another so that the height of the prong can be adjusted.
[0064] In some embodiments of a prong arrangement, the third collapsible portion includes a top edge that is configured to form a seal with a patient's nostril . The outer dimensions of the third collapsible portion can be larger than the outer dimensions of the second collapsible portion, and the outer dimensions of the second collapsible portion can be larger than the outer dimensions of the first collapsible portion. The first, second and third passageways can be coaxial .
[0065] In some embodiments, a prong arrangement for a nasal cannula comprises a cannula defining a cavity and the cannula includes a slot. A first prong extends from the cannula and is fixed relative to the cannula. A second prong extends from the cannula through the slot and is movable relative to the cannula. The second prong can be moved within the slot in order to adjust a distance between the first prong and the second prong.
[0066] In some embodiments of a prong arrangement, the second prong includes a pin and the slot includes multiple notches, and the notches are configured to receive the pin when the second prong is moved to discrete locations within the slot. The second prong can include a rib that extends from the base of the prong and the slot can include multiple grooves configured to receive the rib. In some embodiments, the second prong includes a tab having multiple notches that are configured to engage an edge of the slot so that the second prong can be held in multiple discrete positions relative to the slot.
[0067] In some embodiments, a prong for a nasal cannula comprises a film having a substantially cylindrical shape and a plurality of ribs coupled to the film around the circumference of the film. The film and ribs expand outward as gas flow increases through the prong, and the outer diameter of the prong increases to form a seal with a patient's nostril. In some embodiments, the ribs are substantially fixed and do not bend or move relative to one another.
[0068] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprises at least one nasal prong extending from the cannula and in communication with the cavity. A support member is coupled to the cannula and configured to support the cannula. The support member is configured to extend upward from the cannula and around a patient's nose when in use. The support member contacts a portion above a tip of the patient's nose and the support member comprises a bendable material that can be shaped to correspond to the shape of the face of a patient.
[0069] In some embodiments, a nasal cannula system, also includes a head strap configured to wrap around the head of a patient and the head strap is removably coupled at one end to the support member and adjustably coupled to the support member at the other end. In some embodiments, the bendable material is a metal material and is located at the upper portion of the support member. The support member can include an attachment portion having multiple notches and the cannula can include an opening configured to receive the attachment portion. The notches can be configured to interact with the opening to couple the support member to the cannula and allow for adjustment of the support member relative to the cannula. In some embodiments, the cannula includes a first tube extending from one side of the cannula and a second tube extending from the other side of the cannula, and the support member is coupled to the first and second tubes of the cannula. The first tube can be supported by a first padded member and the second tube can be supported by a second padded member, and the first and second padded members can be configured to rest against a patient's face. In some embodiments, a nasal cannula system also includes a head strap coupled to the first and second padded members and configured to extend around the head of a patient. The first tube and the second tube can be removable from the cannula so that the cannula can be removed and rotated relative to the rest of the system.
[0070] In some embodiments, a tube arrangement for a nasal cannula system comprises a cannula tube comprising an outer wall and an opening. The tube includes a longitudinal axis and the outer wall comprises a thin material that has been folded or rolled and sealed at an edge.
[0071] In some embodiments of a tube arrangement, the outer wall is made of a fabric that provides insulation. Embodiments of a tube arrangement can also include a
spring extending within the outer wall. The cannula tube can also be coupled to a connector at its opening and the connector can include a valve. In some embodiments, the cannula tube further comprises an extruded tube extending within the outer wall. The outer wall can include a tab having one or more holes configured to be coupled to a head strap. In some embodiments, the outer wall is made of an insulating material, a spring extends within the outer wall, and a breathing tube extends within the spring.
[0072] In some embodiments of a tube arrangement, the outer wall is made of an insulating material, a breathing tube extends within the outer wall, a spring extends within the breathing tube, and at least a pressure line tube extends within the outer wall in addition to the breathing tube. Some embodiments can also include a breathing tube within the outer wall, the breathing tube having a cannula portion from which at least one prong extends, the cannula tube being flexible so that it can curve around the face of a patient. Each end of the cannula tube can include a tab with holes configured to receive a pin located on a head strap. Each end of the cannula tube can include a connector configured to receive an inspiratory tube connector, each connector including a valve. In some embodiments, the outer wall is made of a breathable material .
[0073] In some embodiments, a tube arrangement for a nasal cannula system comprises a tube comprising an outer wall and an opening . The tube includes a longitudinal axis and the outer wall comprises a thin material that has been folded or rolled, and the outer wall includes one or more cut portions that extend through the material. In some embodiments, the one or more cut portions comprise a tab that can be pulled away from the tube, and the tab is configured to engage a support device in order to hang the tube.
[0074] In some embodiments of a tube arrangement, the tab includes a hole configured to receive a hook or hanger. The cut portions can comprise slots defining a portion of the material that can be pulled away from the tube while remaining connected at two sides, and the pulled away material can form a hook portion that can engage a hanger. In some embodiments, the cut portions can comprise two tabs that can be pulled away from the tube, the ends of the tabs being configured to be coupled together or to another structure. The tube can also comprise an inner tube and a spring within the inner tube.
[0075] In some embodiments, a cannula tube arrangement for a nasal cannula system comprises a tube comprising an outer wall and the outer wall comprises a thin film having a first edge and a second edge. The film is folded or rolled and the first and second edges are sealed together. A bead is located on the outer wall and configured to provide structural support to the tube.
[0076] In some embodiments of a cannula tube arrangement, the bead includes a cannula portion configured to receive a cannula with prongs, and the cannula portion includes two holes that extend through the film. The tube can include a first end and a second end, and the first end and second end can be coupled to connectors having valves. The first and second ends can each include a tab having a hole configured to be coupled to a head strap. In some embodiments, the first and second edges of the film are heat-sealed to form the tube. The bead can be printed or extruded onto the outer wall. The bead can have a pattern that is configured to create bend areas along the tube length. In some embodiments, the bead is on the inside of the tube. The bead can comprise thermal and structural elements printed on the film. In some embodiments, the first edge overlaps the second edge and the first and second edges can extend into the tube.
[0077] In some embodiments, a cannula tube arrangement for a nasal cannula system comprises a tube comprising an outer wall. The outer wall comprises a thin plastic film having a first edge and a second edge. A substantially planar side wall is coupled to the outer wall and a bead is located on the other wall and configured to provide structural support to the tube. The first edge is coupled to the side wall and the second edge is also coupled to the side wall so that a cavity exists between the outer wall and the side wall. In some embodiments, the first edge and second edge are heat-sealed to the side wall, and the side wall is made of a fabric material.
[0078] In some embodiments, a cannula tube arrangement comprises a spring having a length and a cross-section having at least one substantially planar side. A tube surrounds the spring and the tube defines a passageway through which gas can pass. At least one nasal prong is coupled to the tube and communicates with the passageway.
[0079] In some embodiments of a cannula tube arrangement, the spring has a V-shaped or triangular cross-section. The spring can comprise a thin folded sheet of metal having cut-out portions along the length of the spring. The spring can include a middle section and first and second ends, and the cross-section of the middle section can be smaller than the cross-section at the first and second ends. In some embodiments, the spring is a helical spring having a triangular cross-section. The spring can be a helical wire having bent ends that extend in the direction of a third side. The spring can also have a substantially triangular cross-section with curved sides. In some embodiments, the spring has a cross-section shaped like a half-circle.
[0080] In some embodiments, a cannula breathing tube arrangement comprises a tube made at least in part from a foam material. The tube has a length and a substantially planar side extending along the length of the tube and the tube defines a passageway. A spring extends through the passageway of the tube and along the length of the tube, and the spring is configured to impede kinking of the tube.
[0081] In some embodiments of a cannula breathing tube arrangement, the tube includes a cavity extending along the length of the tube and a shapeable rod extending through the cavity. In some embodiments, the foam material is a closed cell foam material. The tube can include a slot extending along the length of the tube, the slot being configured to receive a coupling member. In some embodiments, the coupling member is a mushroom head member configured to slide into the slot.
[0082] In some embodiments, a cannula tube arrangement comprises a tube having a length and a substantially planar side extending along the length of the tube. The tube defines a passageway and has an inner surface. The tube includes at least one rib located on the inner surface and extending along the length of the tube, and the at least one rib is configured to provide structural support and impede kinking of the tube.
[0083] In some embodiments of a cannula tube arrangement, the at least one rib comprises multiple ribs on the inner surface. The tube can comprise a rectangular cross-section and include a fabric material surrounding the tube. In some embodiments, the tube has a substantially triangular cross-section and in other embodiments, the tube has a substantially half-circle cross-section.
CLAIMS
1. A nasal cannula for administering a breathable gas to a patient (or user), the nasal cannula comprising :
a first section formed from a first material; and
a second section formed from a second material;
wherein the first section is relatively softer than the second section.
2. The nasal cannula as claimed in claim 1, where the second material that is the same as the first material.
3. The nasal cannula as claimed in claim 1, where the second material that is different from the first material.
4. The nasal cannula as claimed in any one of claims 1-3, where the sections are assembled through the use of one or more mechanical fasteners.
5. The cannula as claimed in any one of claims 1-4, wherein the sections are assembled to each other through the use of one or more fastening systems.
6. The cannula as claimed in any one of claims 1-5, wherein the first section provides for a user-friendly or comfort contacting component part of a nasal cannula.
7. The cannula as claimed in any one of claims 1-6, wherein the second section provides for a structural or support or shape-defining, component part, of a nasal cannula.
8. The cannula as claimed in any one of claims 1-7, wherein the configuration or shape of the first section is at least in part defined by parts or portions of the second section.
9. The cannula as claimed in any one of claims 1-8, wherein the first section forms a patient contacting surface, and the second section forms a frame upon which the first section is attached.
10. The cannula as claimed in any one of claims 1-9, wherein the first section encapsulates at least a part of the second section.
11. The cannula as claimed in any one of claims 1-10, wherein the second section is at least in part over-moulded by the first section.
12. The cannula as claimed in any one of claims 1-11, wherein the first section is at least an arm or a pair of arms extending outwards from a central body portion that comprises at least one (or preferably a pair of) nasal prong(s).
13. The cannula as claimed in any one of claims 1-12, wherein the first section is adapted to receive a manifold connection for delivery of a source of gases to the nasal cannula or a body of the nasal cannula in fluid communication with a delivery system for delivery of gases to the user, such as via at least one nasal prong (or preferably a pair of nasal prongs) to, in-use, the nare or nares of the user.
14. The cannula as claimed in any one of claims 1-13, wherein the second section is adapted to receive a manifold connection for delivery of a source of gases to the nasal cannula or a body of the nasal cannula in fluid communication with a delivery system for delivery of gases to the user, such as via at least one nasal prong (or preferably a pair of nasal prongs) to, in-use, the nare or nares of the user.
15. The cannula as claimed in any one of claims 1-14, wherein a manifold is a component of a relatively rigid material, relative to the first material, the manifold connectable with an associated region of the nasal cannula or a body of the nasal cannula.
16. The cannula as claimed in any one of claims 1-15, wherein the first section comprises one or more surface relief portions, the surface relief portion(s) of the first section engageable with an associated one or more commensurately or complimentarily shaped or configured surface relief portions of the second section.
17. The cannula as claimed in any one of claims 1-16, wherein the first section comprises at least one raised region receivable by an associated aperture or detent region of the second section.
18. The cannula as claimed in any one of claims 1-17, wherein the first section comprises a cannula body portion defining at least in part an open cavity receivable of a supply of gases directed thereto via a manifold, the open cavity in fluid communication with one or a pair of nasal prongs.
19. The cannula as claimed in any one of claims 1-18, wherein the first section and second section are commensurately or complimentarily shaped or configured to communally receive a manifold connection for delivery of a source of gases to be delivered to a user.
20. The cannula as claimed in any one of claims 1-19, wherein the first section is at least in part a nasal cannula body defining an open cavity.
21. The cannula as claimed in any one of claims 1-20, wherein the second section at least in part surrounds a nasal cannula body defining an open cavity.
22. The cannula as claimed in any one of claims 1-21, wherein the second section supports the first section in a predetermined configuration.
23. The cannula as claimed in any one of claims 1-22, wherein the second section extends: substantially about the length of a nasal cannula defined by a first section, or substantially to a longer length than the nasal cannula defined by a first section, or wherein the second section extends to a shorter length than the nasal cannula defined by a first section.
24. The cannula as claimed in any one of claims 1-23, wherein a nasal cannula includes a pair of side arms extending outwardly from a cannula body defining at least in part an open cavity receivable of a source of gases, such as via a manifold connection.
25. The cannula as claimed in any one of claims 1-24, wherein located substantially toward each end of the side arms is a connection system for connecting a headgear, the headgear in-use, to be worn by a user.
26. The cannula as claimed in any one of claims 1-25, wherein the connection system is a part of the second section.
27. The cannula as claimed in any one of claims 1-26, wherein the first section provides for a gasket-type seal for a manifold connection or a manifold receivable by at least a part of the first section, such as that defining an open cavity of a cannula body.
28. The cannula as claimed in any one of claims 1-27, wherein the second section provides for a structure to which a manifold connection may be made, and the first section provides for a sealing, such as a fluid-type seal, of a manifold in making such a manifold connection.
29. The cannula as claimed in any one of claims 1-28, wherein a nasal cannula comprises a body defining an open cavity engageable by a manifold, a rear portion of said body being, in-use, substantially adjacent to a user's septum region, the rear portion being substantially compliant or deformable in response to a pressure applied by a user to said rear portion.
30. The cannula as claimed in claim 29, wherein the rear portion is a substantially thinned wall section of the body.
31. The cannula as claimed in claim 29 or 30, wherein the rear portion is defined by a hollow section of the body, with the open cavity being a separate distinct region of the body.
32. The cannula as claimed in any one of claims 29-31, wherein the rear portion defines at least a part of a wall of the open cavity.
33. The cannula as claimed in any one of claims 29-32, wherein the rear portion is substantially elasticised.
34. The cannula as claimed in any one of claims 29-33, wherein the rear portion is elastically deformable.
35. The cannula as claimed in any one of claims 29-34, wherein the body comprises a hollowed enclosure substantially adjacent to the user's septum region,
36. The cannula as claimed in any one of claims 29-35, wherein the body comprises a pillow section substantially adjacent to the user's septum region.
37. The cannula as claimed in claim 36, wherein the pillow section is a hollow region, the hollow region bounded by walls of the body, and separate to an open chamber, and having a relatively thin wall or elasticised section in the region substantially adjacent to, in use, the user's septum.
38. The cannula as claimed in claim 36 or 37, wherein the pillow section is formed by a rear wall of such an open cavity, the rear wall being a relatively thin wall or elasticised section in the region substantially adjacent to, in use, the user's septum.
39. The cannula as claimed in any one of claims 36-38, wherein the pillow section is formed of a material capable of deforming under application of a pressure by a user during use.
40. A headgear comprising :
a strap, each end of the strap adapted to be attached to a patient interface and extend around a patient's head to hold the patient interface in place on a patients face, wherein
at least a portion of the strap is configured to bifurcate into more than one band to extend around the patients head.
41. The headgear as claimed in claim 40, wherein the strap comprises a longitudinal frangible section extending along a portion of the strap to be torn by a user to separate the portion of the strap into more than one band.
42. The headgear as claimed in claim 41, wherein the frangible section comprises a relatively thin section.
43. The headgear as claimed in claim 42, wherein the frangible section is a perforated section.
44. The headgear as claimed in any one of claims 41-43, wherein the bands are separated by the frangible section.
45. The headgear as claimed in any one of claims 41-44, wherein the strap comprises a hole at an end of the frangible section, the hole comprising a rounded portion defining an end of the frangible section to prevent tearing the strap beyond the frangible section.
46. The headgear as claimed in any one of claims 41-45, wherein at least the portion of the strap is formed from fabric forming the bands, and the fabric is coated with a polymer with the bands arranged together, the coating providing the frangible section between the bands, the coating adapted to be torn to separate the bands.
47. The headgear as claimed in claim 46, wherein the bands are formed by a longitudinal cut in the fabric along the portion of the strap, the polymer coating bridging the cut to hold the bands together in a non-bifurcating configuration.
| # | Name | Date |
|---|---|---|
| 1 | 202238021257-TRANSLATIOIN OF PRIOIRTY DOCUMENTS ETC. [08-04-2022(online)].pdf | 2022-04-08 |
| 2 | 202238021257-STATEMENT OF UNDERTAKING (FORM 3) [08-04-2022(online)].pdf | 2022-04-08 |
| 3 | 202238021257-REQUEST FOR EXAMINATION (FORM-18) [08-04-2022(online)].pdf | 2022-04-08 |
| 4 | 202238021257-POWER OF AUTHORITY [08-04-2022(online)].pdf | 2022-04-08 |
| 5 | 202238021257-FORM 18 [08-04-2022(online)].pdf | 2022-04-08 |
| 6 | 202238021257-FORM 1 [08-04-2022(online)].pdf | 2022-04-08 |
| 7 | 202238021257-FIGURE OF ABSTRACT [08-04-2022(online)].pdf | 2022-04-08 |
| 8 | 202238021257-DRAWINGS [08-04-2022(online)].pdf | 2022-04-08 |
| 9 | 202238021257-DECLARATION OF INVENTORSHIP (FORM 5) [08-04-2022(online)].pdf | 2022-04-08 |
| 10 | 202238021257-COMPLETE SPECIFICATION [08-04-2022(online)].pdf | 2022-04-08 |
| 11 | 202238021257-Proof of Right [07-06-2022(online)].pdf | 2022-06-07 |
| 12 | 202238021257-Correspondence-Letter [07-06-2022(online)].pdf | 2022-06-07 |
| 13 | 202238021257-FER.pdf | 2022-11-29 |
| 14 | 202238021257-OTHERS [24-05-2023(online)].pdf | 2023-05-24 |
| 15 | 202238021257-FER_SER_REPLY [24-05-2023(online)].pdf | 2023-05-24 |
| 16 | 202238021257-CORRESPONDENCE [24-05-2023(online)].pdf | 2023-05-24 |
| 17 | 202238021257-CLAIMS [24-05-2023(online)].pdf | 2023-05-24 |
| 1 | Search11E_28-11-2022.pdf |