ORO-NASAL PATIENT INTERFACE
A patient interface to provide breathable gas to a patient, comprising: a plenum chamber assembly, comprising: a nasal plenum chamber at least partly defining an upper gas chamber; an oral plenum chamber at least partly defining a lower gas chamber; and a decoupling structure at least partly connecting the nasal plenum chamber and the oral plenum chamber and at least party defining a flow path; a top plate including at least one connection feature configured to releasably retain a first portion of a positioning and stabilising structure; and a faceplate configured to releasably retain a second portion of a positioning and stabilising structure.
This application claims the benefit of U.S. Provisional Application No. 61/823,353, filed May 14, 2013, and U.S. Provisional Application No. 61/954,201, filed Mar. 18, 2014, each of which is incorporated by reference herein in its entirety.
2 BACKGROUND OF THE TECHNOLOGY2.1 Field of the Technology
The present technology relates to one or more of the diagnosis, treatment and amelioration of respiratory disorders, and to procedures to prevent respiratory disorders. In particular, the present technology relates to medical devices, and their use for treating respiratory disorders and for preventing respiratory disorders.
2.2 Description of the Related Art
The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.
The airways consist of a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lung. The prime function of the lung is gas exchange, allowing oxygen to move from the air into the venous blood and carbon dioxide to move out. The trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli. The alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory zone. See West, Respiratory Physiology—the essentials.
A range of respiratory disorders exist.
Obstructive Sleep Apnoea (OSA), a form of Sleep Disordered Breathing (SDB), is characterized by occlusion of the upper air passage during sleep. It results from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes the affected patient to stop breathing for periods typically of 30 to 120 seconds duration, sometimes 200 to 300 times per night. It often causes excessive daytime somnolence, and it may cause cardiovascular disease and brain damage. The syndrome is a common disorder, particularly in middle aged overweight males, although a person affected may have no awareness of the problem. See U.S. Pat. No. 4,944,310 (Sullivan).
Cheyne-Stokes Respiration (CSR) is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation, causing repetitive de-oxygenation and re-oxygenation of the arterial blood. It is possible that CSR is harmful because of the repetitive hypoxia. In some patients CSR is associated with repetitive arousal from sleep, which causes severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Pat. No. 6,532,959 (Berthon-Jones).
Obesity Hyperventilation Syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hyperventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness.
Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a group of lower airway diseases that have certain characteristics in common. These include increased resistance to air movement, extended expiratory phase of respiration, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (primary risk factor), occupational exposures, air pollution and genetic factors. Symptoms include: dyspnea on exertion, chronic cough and sputum production.
Neuromuscular Disease (NMD) is a broad term that encompasses many diseases and ailments that impair the functioning of the muscles either directly via intrinsic muscle pathology, or indirectly via nerve pathology. Some NMD patients are characterised by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, swallowing difficulties, respiratory muscle weakness and, eventually, death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterised by muscle impairment that worsens over months and results in death within a few years (e.g. Amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: Characterised by muscle impairment that worsens over years and only mildly reduces life expectancy (e.g. Limb girdle, Facioscapulohumeral and Myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing generalised weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, morning headache, and difficulties with concentration and mood changes.
Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thoracic cage. The disorders are usually characterised by a restrictive defect and share the potential of long term hypercapnic respiratory failure. Scoliosis and/or kyphoscoliosis may cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral oedema, orthopnoea, repeated chest infections, morning headaches, fatigue, poor sleep quality and loss of appetite.
Otherwise healthy individuals may take advantage of systems and devices to prevent respiratory disorders from arising.
2.2.1 SystemsOne known product used for treating sleep disordered breathing is the S9 Sleep Therapy System, manufactured by ResMed.
2.2.2 TherapyNasal Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA). The hypothesis is that continuous positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall.
Non-invasive ventilation (NIV) has been used to treat OHS, COPD, MD and Chest Wall disorders.
2.2.3 Patient InterfaceThe application of a supply of air at positive pressure to the entrance of the airways of a patient is facilitated by the use of a patient interface, such as a nasal mask, full-face mask or nasal pillows. A range of patient interface devices are known, however a number of them suffer from being one or more of obtrusive, aesthetically undesirable, poorly fitting, difficult to use and uncomfortable especially when worn for long periods of time or when a patient is unfamiliar with a system. Masks designed solely for aviators, as part of personal protection equipment or for the administration of anaesthetics may be tolerable for their original application, but nevertheless be undesirably uncomfortable to be worn for extended periods, for example, while sleeping.
Traditional oro-nasal masks include full face masks or ResMed LIBERTY full-face mask. Due to their size and bulk, they may less comfortable and more intrusive than other masks due to physiological reasons including claustrophobia or clithrophobia. Oro-nasal masks are typically bulky and heavy and can interfere with patient comfort and prevent wearing of eyeglasses.
2.2.3.1 Seal-Forming PortionPatient interfaces typically include a seal-forming portion.
One type of seal-forming portion extends around the periphery of the patient interface, and is intended to seal against the user's face when force is applied to the patient interface with the seal-forming portion in confronting engagement with the user's face. The seal-forming portion may consist of an air or fluid filled cushion, or a moulded or formed surface of a resilient seal element made of an elastomer such as a rubber. With this type of seal-forming portion, if the fit is not adequate, there will be gaps between the seal-forming portion and the face, and additional force will be required to force the patient interface against the face in order to achieve a seal.
Another type of seal-forming portion incorporates a flap seal of thin material so positioned about the periphery of the mask so as to provide a self-sealing action against the face of the user when positive pressure is applied within the mask. Like the previous style of seal forming portion, if the match between the face and the mask is not good, additional force may be required to effect a seal, or the mask may leak. Furthermore, if the shape of the seal-forming portion does not match that of the patient, it may crease or buckle in use, giving rise to leaks.
Another form of seal-forming portion may use adhesive to effect a seal. Some patients may find it inconvenient to constantly apply and remove an adhesive to their face.
A range of patient interface seal-forming portion technologies are disclosed in the following patent applications, assigned to ResMed Limited: WO 1998/004,310; WO 2006/074,513; WO 2010/135,785.
2.2.3.2 Positioning and StabilisingA seal-forming portion of a patient interface used for positive air pressure therapy is subject to the corresponding force of the air pressure to disrupt a seal. Thus a variety of techniques have been used to position the seal-forming portion, and to maintain it in scaling relation with the appropriate portion of the face.
One technique is the use of adhesives. See for example US Patent publication US 2010/0000534.
Another technique is the use of one or more straps and stabilising harnesses. Many such harnesses suffer from being one or more of ill-fitting, bulky, uncomfortable and awkward to use.
2.2.3.3 Vent TechnologiesSome forms of patient interface systems may include a vent to allow the washout of exhaled carbon dioxide. Many such vents are noisy. Others may block in use and provide insufficient washout. Some vents may be disruptive of the sleep of a bed-partner 1100 of the patient 1000, e.g. through noise or focussed airflow.
ResMed Limited has developed a number of improved mask vent technologies. See WO 1998/034,665; WO 2000/078,381; U.S. Pat. No. 6,581,594; US Patent Application; US 2009/0050156; US Patent Application 2009/0044808.
Sound pressure values of a variety of objects are listed below
One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow, or nasal puff is the subject of U.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.
ResMed Limited has manufactured the following products that incorporate nasal pillows: SWIFT nasal pillows mask, SWIFT II nasal pillows mask, SWIFT LT nasal pillows mask, SWIFT FX nasal pillows mask and LIBERTY full-face mask. The following patent applications, assigned to ResMed Limited, describe nasal pillows masks: International Patent Application WO2004/073,778 (describing amongst other things aspects of ResMed SWIFT nasal pillows), US Patent Application 2009/0044808 (describing amongst other things aspects of ResMed SWIFT LT nasal pillows); International Patent Applications WO 2005/063,328 and WO 2006/130,903 (describing amongst other things aspects of ResMed LIBERTY full-face mask): International Patent Application WO 2009/052,560 (describing amongst other things aspects of ResMed SWIFT FX nasal pillows).
3 BRIEF SUMMARY OF THE TECHNOLOGYThe present technology is directed towards providing medical devices used in the diagnosis, amelioration, treatment, or prevention of respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.
An aspect of the present technology may be directed to a patient interface to provide breathable gas to a patient. The patient interface may comprise: a plenum chamber assembly, comprising: a nasal plenum chamber at least partly defining a first gas chamber, the nasal plenum chamber structured to contact the patient's nose below the bridge of the nose and around the lower periphery of the nose; an oral plenum chamber at least partly defining a second gas chamber, the oral plenum chamber structured to seal around the patient's mouth; and a decoupling structure at least partly connecting the nasal plenum chamber and the oral plenum chamber and at least partly defining a flow path between the nasal plenum chamber and the oral plenum chamber, the decoupling structure configured to decouple relative movement between the nasal plenum chamber and the oral plenum chamber; a top plate operatively connected to the plenum chamber assembly at the nasal plenum chamber, including at least one connection feature configured to releasably retain a first portion of a positioning and stabilising structure; and a faceplate operatively connected to the plenum chamber assembly at the oral plenum chamber, and configured to releasably retain a second portion of the positioning and stabilising structure, wherein the top plate and faceplate are more rigid than the plenum chamber assembly.
In examples, (a) said flow path may pneumatically connect the first gas chamber and the second gas chamber, (b) said top plate and said faceplate may be releasably attachable to the plenum chamber assembly, (c) said positioning and stabilising structure may comprise a rigidiser arm assembly having a pair of rigidiser arms, the rigidiser arm assembly may be connected to the top plate, (d) each of the pair of rigidiser arms may be permitted to flex in a plane parallel to the patient's transverse plane, and each of the pair of rigidiser arms may be structured to resist flexing in a plane perpendicular to the patient's transverse plane, resist twisting, and/or resist stretching, (e) each of the rigidiser arms may have an ellipsoidal profile to conform with the curvature of a patient's cheek, (f) said nasal plenum chamber may comprise a nasal flange defining a nasal opening, and said nasal flange may be configured to form a seal with at least the nose of the patient, (g) said nasal flange may include a recessed portion to receive the tip of the nose of the patient, (h) said oral plenum chamber may comprise an oral flange defining an oral opening, and said oral flange may be configured to form a seal with at least the mouth of the patient, (i) said oral flange may be formed around the entire perimeter of the oral plenum chamber, or around two opposing sides of the perimeter of the oral plenum chamber, or the majority of the perimeter of the oral plenum chamber, (j) said oral plenum chamber may comprise a pair of oral undercushion portions each disposed on a respective side of said oral plenum chamber to support said oral flange, (k) said oral plenum chamber may comprise an oral undercushion portion disposed circumferentially about said oral plenum chamber and extending radially from each end of the decoupling structure to support said oral flange, (j) said decoupling structure may connect the nasal flange and the oral flange, (k) the decoupling structure may comprise an upper surface, a lower surface, and a connecting surface, the connecting surface having a greater stiffness than the upper surface and the lower surface, (l) said decoupling structure may be stiffer at a portion opposite the face of the patient than at a portion adjacent to the face of the patient, (m) said decoupling structure may have a stiffness that increases radially from a portion adjacent to the face of the patient to a portion opposite the face of the patient, (n) a nose-contacting portion of said nasal flange may be stiffer at a portion that does not contact the nose of the patient than at a portion of said nasal flange that does not contact the nose of the patient, (o) said nasal flange may increase in stiffness outwardly from said nasal opening, (p) said nasal flange may have a varied stiffness around said nasal opening at predetermined positions, (q) a lower portion of said nasal flange proximal to said decoupling structure may be concave to seal against the upper lip of the patient, (r) said nasal flange may comprise a pair of protruding ends extending symmetrically about the nasal opening, each protruding end configured to seal against a corresponding alae of the nose of the patient, (s) said nasal plenum chamber may comprise a pair of nasal undercushion sections, each of the pair of nasal undercushion sections supporting one of the pair of protruding ends, (t) each said nasal undercushion section may be disposed on an upper portion of said oral plenum chamber, (u) the patient interface may comprise headgear to releasably secure said patient interface to the patient, said headgear including a pair of upper straps configured to connect to the nasal plenum chamber and a pair of lower straps configured to connect to the oral plenum chamber, (v) the top plate may be permanently connected to the nasal plenum chamber, (w) the top plate may be removably attachable to a soft connection region of the nasal plenum chamber, (x) the top plate may be removably attachable to a hard connection region of the nasal plenum chamber, and/or (y) the top plate and the rigidiser arms may comprise one piece and the rigidiser arms are flexible relative to the top plate in a plane parallel to the patient's transverse plane.
Another aspect of the present technology may be directed to a patient interface to provide breathable gas to a patient. The patient interface may comprise: a nasal cushion to at least partially define a nasal gas chamber; an oral cushion to at least partially define an oral gas chamber distinct from said nasal gas chamber; a decoupling structure disposed between said nasal cushion and said oral cushion; a top plate fixed to the nasal cushion and a pair of upper attachment features configured to releasably attach a pair of upper side straps of a positioning and stabilizing structure to the top plate; and a faceplate fixed to the oral cushion and a pair of lower attachment features configured to releasably attach a pair of lower side straps of the positioning and stabilizing structure.
In examples, (a) said decoupling structure may be adapted to form a pneumatic connection between said nasal gas chamber and said oral gas chamber, (b) the decoupling structure may comprise an upper surface, a lower surface, and a connecting surface, the connecting surface having a greater stiffness than the upper surface and the lower surface, (c) said decoupling structure may have a stiffness that is radially variable about its perimeter such that a portion distal to the face of the patient is stiffer than a portion proximal to the face of the patient, and the nasal cushion may be structured to move independently of the oral cushion, (d) a nose-contacting portion of the nasal cushion may be less stiff than a portion of the nasal cushion that does not contact the patient's nose, (e) said decoupling structure may be structured to support the nasal cushion against the nose of the patient, (f) said nasal cushion may be stiffer at a portion of said nasal cushion that does not contact the nose of the patient than at a nose-contacting portion, (g) said nasal cushion may comprise a concave portion to seal against the upper lip of the patient, (h) said nasal cushion may comprise a pair of protruding ends that are each configured to form a seal between respective alae and nasolabial sulci of the face of the patient, (i) said nasal cushion may comprise a pair of nasal undercushion portions each disposed under each respective protruding end to support each respective protruding end against the face of the patient, (j) said nasal cushion may comprise a wing on each side of the nasal cushion to seal against respective alae of the nose of the patient, (k) said oral cushion may comprise an oral undercushion portion extending radially about said oral cushion from either side end said of decoupling structure to support said oral cushion against the face of the patient, (l) said oral cushion may comprise a pair of oral undercushion portions each disposed on a respective side of said oral cushion to support said oral cushion against the face of the patient, (m) said nasal cushion may be shaped to include a recessed portion configured to receive the tip of the nose of the patient, (n) said nasal cushion may be configured to contact the inferior periphery of the nose of the patient below the bridge of the nose, (o) said nasal cushion, said oral cushion, and said decoupling structure may comprise one piece, (p) the top plate may be permanently connected to the nasal plenum chamber, (q) the top plate may be removably attachable to a soft connection region of the nasal plenum chamber, (r) the top plate may be removably attachable to a hard connection region of the nasal plenum chamber, (s) the top plate and a rigidiser arm assembly may comprise one piece and a pair of rigidiser arms of the rigidiser arm assembly are flexible relative to the top plate in a plane parallel to the patient's transverse plane, (t) the positioning and stabilising structure may comprise a rigidiser arm assembly releasably attachable to the top plate at the upper attachment features, (u) the patient interface may comprising a frame releasably attachable to the faceplate and the lower attachment features may be disposed on the frame, (v) each of the lower attachment features may comprise a mating portion having a mating portion magnet to releasably connect to corresponding clips of the positioning and stabilising structure and each of the corresponding clips may include a clip magnet oriented such that when each clip magnet is magnetically attracted to each mating portion magnet the mating portion is joined to the corresponding clip, (w) the patient interface may comprise a top plate buffer to dampen the connection between the top plate and the rigidiser arm assembly and a faceplate buffer to dampen the connection between the faceplate and the frame, and/or (x) the frame may be shaped to join around the periphery of the faceplate, the frame may comprise catches and the faceplate comprises cutouts, and engagement between the catches and the cutouts may join the frame to the faceplate.
Another aspect of the present technology may be directed to a patient interface to provide breathable gas to a patient. The patient interface may comprising: a plenum chamber assembly, comprising: a nasal plenum chamber at least partly defining an first gas chamber, the nasal plenum chamber is adapted to seal against the patient below the bridge of the nose and around the inferior periphery of the patient's nose; and an oral plenum chamber at least partly defining a second gas chamber operatively connected to the nasal plenum chamber; and a unitary plate member having an upper portion releasably attachable to the nasal plenum chamber and a lower portion releasably attachable to the oral plenum chamber; wherein the upper portion of the plate member includes at least one connection feature configured to releasably retain a first portion of a positioning and stabilising structure having a pair of rigidiser arms, and the lower portion of the plate member is configured to releasably retain a second portion of the positioning and stabilising structure.
In examples, (a) the plenum chamber assembly may comprise a decoupling structure at least partly connecting the nasal plenum chamber and the oral plenum chamber, the decoupling structure at least partly defining a flow path between the nasal plenum chamber and the oral plenum chamber, (b) each of the pair of rigidiser arms may be permitted to flex in a plane parallel to the patient's transverse plane, and each of the pair of rigidiser arms may be structured to resist flexing in a plane perpendicular to the patient's transverse plane, resist twisting, and/or resist stretching, (c) each said at least one connection feature may comprise a hinge to allow a corresponding one of the pair of rigidiser arms to rotate relative to the rigid top plate upper portion of the unitary plate member in a plane parallel to the patient's transverse plane, (d) the first portion of a positioning and stabilising structure may include a hook to pivotably connect with the connection feature of the upper portion of the unitary plate member, (e) said nasal plenum chamber may comprise a nasal flange defining a nasal opening, and said nasal flange may be configured to form a seal with at least the nose of the patient, (e) said nasal flange may include a recessed portion to receive the tip of the nose of the patient, (f) said oral plenum chamber may comprise an oral flange defining an oral opening, and said oral flange may be configured to form a seal with at least the mouth of the patient, (g) said oral flange may be formed around the entire perimeter of the oral plenum chamber, or around two opposing sides of the perimeter of the oral plenum chamber, or the majority of the perimeter of the oral plenum chamber, (f) said oral plenum chamber may comprise a pair of oral undercushion portions each disposed on a respective side of said oral plenum chamber to support said oral flange, (g) said oral plenum chamber may comprise an oral undercushion portion disposed circumferentially about said oral plenum chamber and extending radially from each end of the decoupling structure to support said oral flange, (h) said decoupling structure may connect the nasal flange and the oral flange, (i) said decoupling structure may be stiffer at a portion opposite the face of the patient than at a portion adjacent to the face of the patient, (j) said decoupling structure may have a stiffness that increases radially from a portion adjacent to the face of the patient to a portion opposite the face of the patient, (k) a nose-contacting portion of said nasal flange may be stiffer at a portion that does not contact the nose of the patient than at a portion of said nasal flange that does not contact the nose of the patient, (l) said nasal flange may increase in stiffness outwardly from said nasal opening, (m) said nasal flange may have a varied stiffness around said nasal opening at predetermined positions, (n) a lower portion of said nasal flange proximal to said decoupling structure may be concave to seal against the upper lip of the patient, (o) said nasal flange may comprise a pair of protruding ends extending symmetrically about the nasal opening, each protruding end configured to seal against a corresponding alae of the nose of the patient, (p) said nasal plenum chamber may comprise a pair of nasal undercushion sections each corresponding to each protruding end to support each protruding end, (q) each said nasal undercushion section may be disposed on an upper portion of said oral plenum chamber, and/or (r) each of said pair of rigidiser arms may have an ellipsoidal curvature between the first end and the second end.
Another aspect of the present technology may be directed to a cushion assembly for a patient interface for treatment of sleep disordered breathing of a patient, comprising: a nasal cushion joined to a nasal plenum chamber, the nasal cushion structured to seal around the lower periphery of the patient's nose; an oral cushion joined to an oral plenum chamber, the oral cushion structured to seal around the patient's mouth; a decoupling structure connecting the nasal cushion and the nasal plenum chamber to the oral cushion and the oral plenum chamber, the decoupling structure configured to allow the nasal cushion and the nasal plenum chamber to move relative to the oral cushion and the oral plenum chamber; a pair of side supports, each of the pair of side supports located on opposite sides of the nasal cushion and joining respective lateral sides of the nasal cushion to the oral cushion; a pair of undercushion support walls provided to support protruding ends positioned posteriorly on the nasal cushion; and a pair of pockets, each of the pair of pockets located on opposite sides of the nasal cushion, each of the pair of pockets including an upper surface defined by the nasal cushion and the nasal plenum chamber, each of the pair of pockets including a lower surface defined by the oral cushion and the oral plenum chamber, and each of the pair of pockets including side surfaces defined by the decoupling structure and respective ones of the pair of side supports, wherein an opening of each of the pair of pockets is positioned opposite the face of the patient when the patient interface is donned by the patient.
In examples, (a) each of the pair of side supports may include a notch to provide a pivot point for relative movement between the nasal cushion and the oral cushion, (b) the notch of each of the pair of side supports may be open in a direction opposite the face of the patient when the patient interface is donned by the patient, (c) the nasal cushion may comprise a pair of stiffened sections, each of the pair of stiffened sections may be located at opposite lateral sides of the nasal cushion, and the stiffened sections may be stiffer than the remainder of the nasal cushion, (d) the pair of stiffened sections may comprise a thickness greater than other portions of the nasal cushion, (e) the pair of stiffened sections may extend internally relative to the nasal cushion and the nasal plenum chamber such that an external surface of the nasal cushion is not raised, (f) the nasal cushion may comprises a nasal sling, the nasal sling being formed in-plane with the nasal cushion, and the nasal sling being structured to contact the patient's columella, (g) the nasal cushion and the nasal sling may define a pair of nare ports, each of the pair of nare ports structured to pneumatically communicate with a respective one of the patient's nares, and/or (h) the nasal sling may be structured to prevent the tip of the patient's nose from extending into a nasal gas chamber, the nasal gas chamber defined at least in part by the nasal cushion and the nasal plenum chamber.
Another aspect of the present technology is directed to a patient interface system to provide breathable gas to a patient. The patient interface may comprise: a cushion assembly, the cushion assembly may comprise: a nasal cushion to at least partially define a nasal gas chamber; an oral cushion to at least partially define an oral gas chamber distinct from said nasal gas chamber; and a decoupling structure disposed between said nasal cushion and said oral cushion; a positioning and stabilizing structure with a pair of lower side straps; and a pair of lower attachment features configured to releasably attach a corresponding one of the pair of lower side straps of the positioning and stabilizing structure to the cushion assembly, wherein each of the pair of lower attachment features comprises a thermoplastic elastomer and each of the pair of lower attachment features has a first magnet embedded therein.
In examples, (a) the patient interface system may comprise: a faceplate fixed to the oral cushion; and a frame releasably attachable to the faceplate, wherein the pair of lower attachment features are fixed to the frame, (b) the frame may comprise a material more rigid than thermoplastic elastomer, (c) the pair of lower attachment features may be molded onto the frame, (d) the positioning and stabilizing structure may comprise a pair of clips to attach a corresponding one of the pair of lower side straps to corresponding one of the pair of lower attachment features, (e) each of the pair of clips may comprise a second magnet to attach each of the pair of clips to a corresponding one of the pair of lower attachment features, (f) each of the pair of clips may comprise a notch and each of the pair of lower attachment features may comprise a protrusion, and the protrusion may engage with the notch when each of the pair of clips are engaged with a corresponding one of the pair of lower attachment features, (g) each of the pair of lower attachment features may comprise a flex point, each of the pair of the pair of lower attachment features structured to flex at said flex point, and/or (h) each of the pair of lower attachment features may include a region of reduced thickness at the flex point.
Another aspect of the present technology is directed to a patient interface to provide breathable gas to a patient. The patient interface may comprise: a nasal cushion to at least partially define a nasal gas chamber; an oral cushion to at least partially define an oral gas chamber distinct from said nasal gas chamber a decoupling structure disposed between said nasal cushion and said oral cushion; a top plate fixed to the nasal cushion; and a rigidiser arm assembly releasably attachable to the top plate, wherein the rigidiser arm assembly and the top plate engage at at least three points of contact.
In examples, (a) the top plate may comprise a pair of upper attachment features and the rigidiser arm assembly may comprise a pair of connection features, each of the pair of connection features may be structured to engage with a corresponding one of the pair of upper attachment features, (b) the rigidiser arm assembly may comprise a rib to engage with the top plate when the rigidiser arm assembly is engaged with the top plate, (c) the patient interface may comprise a top plate buffer to dampen engagement between the rigidiser arm assembly and the top plate, the top plate buffer may be positioned on an anterior side of the top plate to contact a posterior side of the rigidiser arm assembly, (d) the top plate buffer and the nasal cushion may comprise one piece, the top plate buffer extending through the top plate from the nasal cushion, (e) the rigidiser arm assembly may comprise a pair of rigidiser arms, each of the pair of rigidiser arms may be structured to a receive an upper side strap of a positioning and stabilizing structure, and/or (f) each of the pair of rigidiser arms may comprise a pad to cushion the pair of rigidiser arms against the patient's face.
Another aspect of the present technology is directed to a patient interface to provide breathable gas to a patient. The patient interface may comprise: a nasal cushion to at least partially define a nasal gas chamber; an oral cushion to at least partially define an oral gas chamber distinct from said nasal gas chamber; and a decoupling structure disposed between said nasal cushion and said oral cushion, wherein the decoupling structure comprises an upper surface joining the decoupling structure to the nasal cushion, a lower surface joining the decoupling structure to the oral cushion, and a connecting surface joining the upper surface and the lower surface, wherein the upper surface and the lower surface are substantially equal in thickness, and wherein the connecting surface is thicker than the upper surface and the lower surface.
In examples, (a) the connecting surface may be about twice as thick as the upper surface and the lower surface, (b) the decoupling structure may be structured to be flexible such that the upper surface and the lower surface can be positioned at up to 50° relative to one another, and/or (c) the upper surface and the lower surface may be about 0.5 mm thick and the connecting surface is about 1.2 mm thick.
Another aspect of one form of the present technology is a patient interface that is moulded or otherwise constructed with a clearly defined perimeter shape which is intended to match that of an intended wearer. The patient interface system may have a reduced part count compared to currently available patient interface systems. The patient interface system may provide a visible mouth region of the patient if the faceplate is semi-transparent or transparent. The patient interface system is an oro-nasal mask meaning it covers the nasal airways and the mouth. It may not obstruct the patient's line of sight, and may be considered physiologically non-threatening and may increase patient selection of the system and adherence to therapy. The patient interface system may flex to adapt to changes in jaw movement and head position throughout the night. The patient interface system may provide a supply of pressurised air or breathable gas to a patient's nasal passages and may prevent or reduce mouth leak by providing an effective seal with both the patient's mouth and the patient's nasal passages.
Another aspect of one form of the present technology is a patient interface that may have a reduced skin contact area and less total points of contact with the face, when compared to most known full face masks. This may allow a far reduced headgear tension to be applied, significantly improving patient comfort. Patient comfort may be further enhanced since the patient is less likely to feel claustrophobic, particularly with the removal of any mass that is close to the eyes.
Another aspect of one form of the present technology is a patient interface that may be quick and easy to fit by all customer segments including patient, home medical equipment dealers and clinicians. It may simplify mask selection for clinicians and dealers due to its superior ease of use (fitting, sealing, size selection, sometimes remotely) and intuitiveness to assemble and fit allowing greater success in remote setups done in an unassisted environment without instruction. The patient interface may have one primary size fitting the majority of the general adult patient population, and no more than two additional sizes. It is envisaged that three sizes of the patient interface will fit at least 90% of the general adult population.
Of course, portions of the aspects may form sub-aspects of the present technology. Also, various ones of the sub-aspects and/or aspects may be combined in various manners and also constitute additional aspects or sub-aspects of the present technology.
Other features of the technology will be apparent from consideration of the information contained in the following detailed description, abstract, drawings and claims.
The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference numerals refer to similar elements including:
4.1 Treatment SystemsBefore the present technology is described in further detail, it is to be understood that the technology is not limited to the particular examples described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting.
The following description is provided in relation to various examples which may share one or more common characteristics and/or features. It is to be understood that one or more features of any one example may be combinable with one or more features of another example or other examples. In addition, any single feature or combination of features in any of the examples may constitute a further example.
5.1 Treatment SystemsIn one form, the present technology comprises apparatus for treating a respiratory disorder. In an example, the apparatus comprises a flow generator or blower for supplying pressurised respiratory gas, such as air, to the patient 1000 via an air delivery tube leading to a patient interface 3000.
5.2 TherapyIn one form, the present technology comprises a method for treating a respiratory disorder comprising the step of applying positive pressure to the entrance of the airways of a patient 1000.
5.2.1 Nasal CPAP for OSAIn one form, the present technology comprises a method of treating Obstructive Sleep Apnea in a patient by applying nasal continuous positive airway pressure to the patient.
5.3 Patient InterfaceA non-invasive patient interface in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure, a plenum chamber, a positioning and stabilising structure and a connection port for connection to an air circuit. In some forms a functional aspect may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use the seal-forming structure is arranged to surround an entrance to the airways of the patient so as to facilitate the supply of air at positive pressure to the airways.
Also shown in
The rear view in
In
In
This view also shows the nasal cushion 3112 surrounding a portion of the nose, specifically the nose tip, of the patient 1000. The nasal gas chamber 3104 is thus formed by the nasal cushion 3112 and the face of the patient. In this example, breathable gas from the air circuit 4170 may pass through the oral gas chamber 3102, then through the opening defined by the decoupling structure 3106 and into the nasal gas chamber 3104. The line B-B shown in
The patient interface 3000, according to an example of the present technology, has a 4896 mm2 surface area footprint on the face which is less obtrusive than a conventional full face mask (for example, the ResMed Quattro FX full face mask has a 7007.89 mm2 surface area footprint on the face) by about 30%. For some patients, it may also feel less claustrophobic. Also, the specific areas of reduced obstruction are important because these areas are found to have significant beneficial psychological impact on a bed partner when looking at the mask because it looks less medical and “opens up” the face. From the patient's perspective, the exemplary patient interface 3000 is not in, or significantly reduced from, their field of vision because the nasal cushion 3112 seals below the bridge of the nose. This allows the patient to wear spectacles when reading a book or watching television after donning the patient interface 3000 before they fall asleep. By sealing below the nose bridge, irritation may be avoided in an area that has thin skin, is pressure sensitive, and/or has high chance of skin breakdown due to blood flow constriction. Another advantage may be that anthropometric variations between patients above the nose bridge do not need to be considered and focus for the mask fit range can be directed towards anthropometric variations around the upper lip area. Also, unlike some other full face masks, the patient interface 3000 may not require a forehead support which is required for providing pressure point relief. This may also avoid the problem of the forehead support being a source of a pressure point and/or skin break down.
Anatomically,
A sealing feature described above that may be seen in
Another sealing feature of the depicted exemplary patient interface 3000 can be seen in
The nasal gas chamber 3104 may be seen defined, at least in part, by the nasal cushion 3112, nasal plenum chamber 3202, and the patient's nose to provide a sealed path for breathable gas to enter the patient's airways via the naris or nostril. A gap 3106.1 can also be seen between the oral plenum chamber 3200 and the nasal plenum chamber 3202. The gap 3106.1 will be discussed in greater detail below, however, it should be understood that the gap 3106.1 may facilitate, in part, maintenance of the seals against the nose and mouth in spite of independent movement of the nasal cushion 3112 and the oral cushion 3110. It may be advantageous to maintain the seal of the nasal cushion 3112 against the nose, the connection region 3106.2 against the lip superior, and the oral cushion 3110 around the mouth while allowing these components to move independently of one another and also to accommodate anthropometric variance and a large range of patients.
As shown in
In one form of the present technology, a seal-forming structure 3100 provides a sealing-forming surface, and may additionally provide a cushioning function.
In an example, a seal-forming structure 3100 in accordance with the present technology is constructed from a soft, flexible, resilient material such as silicone. In another example of the present technology, the seal-forming structure 3100, e.g., the oral cushion 3110, the nasal cushion 3112 and/or their respective undercushions, may be formed from foam.
In an example, the plenum chamber 3200 has a perimeter 3210 that is shaped to be complementary to the surface contour of the face of an average person in the region where a seal will form in use. In use, a marginal edge of the plenum chamber 3200 is positioned in close proximity to an adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend in use about the entire perimeter 3210 of the plenum chamber 3200.
The oral cushion 3110 and the oral plenum chamber 3200 can be seen partially defining the oral gas chamber 3102. The opening 3101 to the oral gas chamber 3102 defined by the oral cushion 3110 can also be seen.
Also visible in
The seal-forming structure 3100 and the plenum chamber 3200 according to this example includes pockets 3208.1 on either side of the nasal cushion 3112 near the side portions 3106.3 and under the protruding ends 3114.
The side supports 3207 shown in the examples depicted by
The side supports 3207 may each include a notch 3209. The notches 3209 of the side supports 3207 may provide a pivot point between the nasal cushion 3112 and the oral cushion 3110. The pockets 3208.1 may also serve to control the location of the pivot point.
The side supports 3207 may also provide attachment points for the top plate 3206. The top plate 3206 may be integrally and/or chemically bonded with the seal-forming structure 3100 and the plenum chamber 3200. In an example, the silicone of the seal-forming structure 3100 and the plenum chamber 3200 may be formed and/or molded around the top plate 3206. No mechanical interlock may be necessary, according to an example of the present technology, between the top plate 3206 and the seal-forming structure 3100 and the plenum chamber 3200. Alternatively, there may be no chemical and/or integral bond, such that a mechanical interlock between the top plate 3206 and the seal-forming structure 3100 and the plenum chamber 3200 would be necessary. The top plate 3206 may also define, at least in part, the pivot point between the nasal cushion 3112 and the oral cushion 3110.
It may also be desirable to strengthen or stiffen the nasal cushion 3112 to provide localized support so as to reduce or control deformation in particular regions of the nasal cushion relative other regions. Examples of stiffening may include increasing the relative thickness of the nasal cushion 3112 that are desired to be strengthened. Alternatively, reinforcement ribs or other reinforcement structures may be formed on the nasal cushion 3112 to provide the desired level and position of localized support.
In alternative examples of the present technology, the thickened nasal cushion sections 3124 not be provided and other structures may be provided to increase stiffness in these regions. For examples, ribs or other reinforcing structures may be provided to the nasal cushion 3112 in the regions where the thickened nasal cushion sections 3124 are shown to accomplish the function of stiffening the nasal cushion 3112 in these areas.
Also,
The seal-forming structure 3100 may include a compliant region. The compliant region is not shown in these examples. Description and depiction of further examples of the compliant region is provided in PCT Application No. PCT/AU2014/000026. The compliant region may be relatively soft, flexible, and/or compliant relative to other portions of the seal-forming structure 3100. The compliant region's relative flexibility may be advantageous in that it may help to relieve discomfort to the patient in the regions of the tip of the nose and the septum. The compliant region may be relatively thin as compared to other portions of the seal-forming structure 3100 and, as such, may function like a mechanical spring to maintain an effective seal at the tip of the nose by wrapping against and/or contacting the tip of the nose. The compliant region may be located on the seal-forming structure 3100 at the upper apex where the seal-forming structure 3100 transitions to the plenum chambers 3200, 3202. The compliant region may be located on the seal-forming structure 3100 above the recessed portion 3116. The compliant region may also blend into the recessed portion 3116. The compliant region may also be located substantially centrally on the seal-forming structure 3100 in horizontal direction. The seal-forming structure 3100 may have a thickness at the compliant region that is about 0.35 mm according to an example of the present technology and may be one of the thinnest regions of the seal-forming structure 3100.
5.3.1.1 Exemplary Nasal CushionsFurthermore, it should also be understood that the exemplary nasal cushions 3112 depicted in
It should also be understood that the nasal cushion 3112 may have a cross-section of variable thickness. Thus, the region of the nasal cushion 3112 proximate to the opening 3103 to the nasal gas chamber 3104 may be thinner than the region where the nasal cushion 3112 attaches to the nasal plenum chamber 3202. Advantageously, this may afford more comfort for the patient by providing a thinner and, thus, more compliant region of cushion material at the area where a large amount of contact is made with the patient's nose.
The decoupling structure 3106 shown in
As to the decoupling structure 3106 depicted in
The decoupling structure 3106 may be used to connect the oral cushion 3110 and the nasal cushion 3112 to facilitate this independent movement. Allowing independent movement of the cushions 3110, 3112 may allow for better sealing against a wider variety of patient facial shapes and it may also aid in maintaining a seal against the patient's face in spite of movement in different regions of the face, movement of the air circuit 4170 or external forces. Moreover, due to the fact that the patient interface 3000 may seal against two separate regions of the face, the nose and the mouth, two separate openings must be provided to supply the breathable gas to the patient. By allowing the sealing structures (e.g., the oral cushion 3110 and the nasal cushion 3112) to move independently a seal may be maintained around the nose independently of the seal around the mouth to prevent undesired leakage and therefore, pressure loss through one or both openings.
The decoupling structure 3106 may also form part of a wall of the oral plenum chamber 3200 and the nasal plenum chamber 3202 in an anterior direction. The decoupling structure 3106 may also be resiliently flexible to allow for relative movement and/or length extension between the structures that define the oral gas chamber 3102 and the nasal gas chamber 3104. Thus, the oral plenum chamber 3200 and the nasal plenum chamber 3202 may be extended away from one another or compressed together, while a pneumatic connection is maintained between the oral gas chamber 3102 and the nasal gas chamber 3104. Moreover, the decoupling structure 3106 may also allow these structures (e.g., the oral plenum chamber 3200 and the nasal plenum chamber 3202) to be tilted relative to one another, while a pneumatic connection is maintained between the oral gas chamber 3102 and the nasal gas chamber 3104 and a seal is maintained with the patient's face.
The decoupling structure 3106 may also comprise an upper surface 3106.4, a connecting surface 3106.5, and a lower surface 3106.6. The connecting surface 3106.5 may be relatively stiffer than the upper surface 3106.4 and the lower surface 3106.6. The lower surface 3106.6 may be understood to be a separate surface from the oral cushion 3110. The upper surface 3106.4 may be understood to be a separate surface from the nasal cushion 3112. The greater stiffness of the connecting surface 3106.5 may be produced by reinforcement ribs or other reinforcement structures or by making the connecting surface 3106.5 thicker than the upper surface 3106.4 and the lower surface 3106.6. According to one example, the upper surface 3106.4 and the lower surface 3106.6 may each have a thickness of 0.5 mm and the connecting surface 3106.5 may have a thickness of 1.2 mm. According to further examples of the present technology, the specific numerical value of the thicknesses may be varied while maintaining the same ratio of thickness as between the upper surface 3106.4, the connecting surface 3106.5, and the lower surface 3106.6.
According to a further example of the present technology, the relative thicknesses of the upper surface 3106.4, the connecting surface 3106.5, and the lower surface 3106.6 may be chosen to allow for a desired amount of flexibility of the decoupling structure 3106. In examples, the decoupling structure 3106 may be able to flex such that the upper surface 3106.4 and the lower surface 3106.6 are positioned at up to about 45° to about 50° relative to each other.
Also, according to further examples of the present technology, the angle between the upper surface 3106.4 and the connecting surface 3106.5 may be between about 80° and about 140°. According to a still further example of the present technology, the angle between the upper surface 3106.4 and the connecting surface 3106.5 may be about 90°. It should be understood that the angle between the upper surface 3106.4 and the connecting surface 3106.5 may vary across the length of the decoupling structure 3106 due to its curved shape. If the angle between the upper surface 3106.4 and the connecting surface 3106.5 is greater than 90° in a given example, then it may be easier to stretch or separate the nasal structures and the oral structures from one another. If the angle between the upper surface 3106.4 and the connecting surface 3106.5 is less than 90° in a given example, then it may be easier to compress the nasal structures and the oral structures toward one another.
According to further examples of the present technology, the angle between the lower surface 3106.6 and the connecting surface 3106.5 may be between about 80° and about 140°. According to a still further example of the present technology, the angle between the lower surface 3106.6 and the connecting surface 3106.5 may be about 90°. If the angle between the lower surface 3106.6 and the connecting surface 3106.5 is greater than 90° in a given example, then it may be easier to stretch or separate the nasal structures and the oral structures from one another. If the angle between the lower surface 3106.6 and the connecting surface 3106.5 is less than 90° in a given example, then it may be easier to compress the nasal structures and the oral structures toward one another.
Another advantageous feature of this exemplary patient interface 3000 may also be seen in
It should be understood that each respective pair of straps, upper 3310 and lower 3312, represent a separate pair of vectors along which tension forces that are directed to retain respective portions of the patient interface 3000 against the face of the patient. In other words, the upper straps 3310 serve to retain the nasal cushion 3112 against the nose and the lower straps 3312 serve to retain the oral cushion 3110 against the mouth. The decoupling structure 3106 allows for a pneumatic connection between the two cushions 3110, 3112 although these cushions may be moved independently of one another. Thus, a variety of different patient head and face shapes may be accommodated by the patient interface 3000. Also, it should be understood that the ability to form separate seals independently may allow the patient interface 3000 to maintain these seals in spite of movement by the patient.
By providing a gap 3106.1 between respective anterior portions of the oral plenum chamber 3200 and the nasal plenum chamber 3202, as shown in this view, it may be possible to allow the components of the oral plenum chamber 3200 and the nasal plenum chamber 3202 to move independently of one another with some amount of freedom before coming into contact with one another. It should also be understood that the ability of the nasal cushion 3112 and the oral cushion 3110 to move independently of one another while maintaining an effective seal may be furthered by providing the decoupling structure 3106 with a radially variable thickness or varied stiffness. Thus, the decoupling structure 3106 may be thinnest, or least stiff, at the portion that contacts the upper lip of the patient and its thickness/stiffness may increase radially to the anterior portion of the decoupling structure 3106. By this arrangement an effective seal against the upper lip may be maintained while also providing sufficient support and structure to the cushions 3110, 3112. The decoupling structure 3106 may be thicker at its vertex at the closed end of the gap 3106.1 compared to regions proximal to the open end of the gap 3106.1. This variation may prevent distortion and to improve hinging because the thicker portion of the decoupling structure 3106 at the closed end of the gap 3106.1 may serve as a pivot point.
In another example of the present technology, a portion of the decoupling structure 3106 proximal to the gap 3106.1 may be eliminated such that only the undercushion support walls 3208 and/or the connection region 3106.2 connect the oral and nasal plenum chambers 3200, 3202 and the oral and nasal cushions 3110, 3112. In such an example, the connection portion 3205 may also perform a sealing function to provide a pneumatically sealed connection between the oral gas chamber 3102 and the nasal gas chamber 3104. In other words, the connection portion 3205 may effectively replace the eliminated portion of the decoupling structure 3106 when the unitary member of the top plate 3206, connection portion 3205, and faceplate 3204 are attached to the oral and nasal plenum chambers 3200, 3202. Again, in this example it may be desirable to form the connection portion 3205 from silicone or any other like material.
5.3.3 Top Plate and Faceplate Connection Features, Rigidiser Arms, and Positioning and Stabilising StructureOn a anterior side of the nasal cushion 3112, which would be opposite the face of the patient in use, a rigid top plate 3206 may be attached to a nasal plenum chamber 3202. The top plate 3206 may be made from a rigid material such as EMS-Grivory Grilamid® TR 90. The top plate 3206 may include at least one upper attachment feature 3252. In one example, a pair of upper attachment features 3252 may be disposed at either side of the top plate 3206 to releasably and rotatably connect respective rigidiser arms 3302 of the positioning and stabilising structure 3300. UBE America Inc.'s Ubesta® nylon, Hytrel® from DuPont™, TPE and polypropylene and other flexible polymers and materials are possible materials for the rigidiser arms 3302. Other materials may also be used for the rigidiser arms 3302 that are substantially inextensible, while allowing the rigidiser arms 3302 to flex. The rigidiser arms 3302 may be flexible in a direction parallel to the patient's coronal plane (see
On an opposite side of the oral cushion 3110, a faceplate or lower plate 3204 may be attached to the oral plenum chamber 3200. The means of attachment may include being overmolded, push fit with soft material to hard material, or a cushion clip to rely on the hoop stress of silicone. The faceplate 3204 may include a port 3600 that facilitates connection to a air circuit 4170 (not pictured in this view). Also, the faceplate 3204 may include at least one lower attachment feature 3250 to attach respective headgear straps of the positioning and stabilising structure 3300 to be discussed in greater detail below. The lower attachment features 3250 shown in this example may be female clip receiving structures to receive male clips attached to headgear straps 3306. Alternatively, the configuration may include male structures to receive female clips.
The exemplary patient interface 3000, shown in a front view in
In an example, the seal-forming structure 3100 of the patient interface 3000 of the present technology is held in sealing position in use by the positioning and stabilising structure 3300.
In one form of the present technology, the rigidiser arms 3302 discussed above may be comprised as a component of the positioning and stabilising structure 3300. Alternatively, the rigidiser arms 3302 may be comprised as a component of the patient interface 3000.
The positioning and stabilising structure 3300 may comprise headgear straps 3306. The headgear may include at least upper side straps 3310, lower side straps 3312, and a rear portion. Also, the headgear straps 3306 may comprise a one-piece composite of soft, flexible material. One layer of the headgear, e.g., an outer layer that does not contact the skin of the patient when donned, may connect to tabs of material fixed to respective ends of the upper and lower side straps 3310, 3312. This connection may include a hook-and-loop connection and the outer layer may comprise the loop material. This connection may allow the side straps 3310, 3312 to loop through attachment features of the patient interface 3000 to releasably and/or adjustably retain the patient interface to the patient's head via the headgear straps 3306. Other connections may include a ladder lock or sliders that are not hook-and-loop.
By including the rigidiser arms 3302 on the patient interface 3000 and attaching them to the nasal plenum chamber 3202 by the top plate 3206, it may be possible to advantageously locate the upper straps 3310 of the positioning and stabilising structure 3300. To effectively seal the nose of the patient, as described above, it may be desirable to urge the nasal cushion 3112 in a generally upward direction against the underside of the nose. The rigidiser arms 3302 may allow for the proper direction of the tension force vectors generated by the upper straps 3310 of the positioning and stabilising structure 3300 while decoupling these straps 3310 from the nasal plenum chamber 3202 such that the straps 3310 do not pass across the eyes of the patient. In other words, sufficiently stiff rigidiser arms 3302 will allow the upper straps 3310 of the positioning and stabilising structure 3300 to effectively pull the nasal cushion 3112 against the nose of the patient while locating the straps 3310 away from the patient's face so that the patient may be more comfortable, wear glasses, see more easily, etc.
It should be understood that the top plate 3206 may be joined to the nasal plenum chamber 3202 and/or the faceplate 3204 may be joined to the oral plenum chamber 3200 by a permanent connection. A permanent connection may be facilitated by molding to form a mechanical interlock or the components may be joined by a chemical bond. A permanent connection may be understood to mean a connection where disconnecting the components is irreversible such that the components cannot be returned to their connected state. Disconnection of such a permanent connection may, for example, entail tearing, damaging, or breaking one or more of the components such that it cannot reconnected in an operative fashion.
Alternatively, the top plate 3206 may be joined to the nasal plenum chamber 3202 and/or the faceplate 3204 may be joined to the oral plenum chamber 3200 by a non-permanent connection. A non-permanent connection may comprise a connection where the components can be detached from one another and reattached in a manner that is reversible. In other words, the separation of the components does not necessitate, for example, tearing, damaging, or breaking one or more of the components such that it cannot reconnected in an operative fashion. In a non-permanent connection, when detached components are reattached, the device is returned to an operable state.
Another example of the present technology may include lower attachment features 3250 that are magnetic and provided to a living hinge, such as examples described in PCT Application No. PCT/AU2014/000021. The living hinge allows for movement of the lower attachment features 3250 in one plane (e.g., a plane parallel to the patient's transverse plane) and the direction of movement may be about an axis. Such an arrangement may provide for more control of the attachment of the positioning and stabilising structure 3300 to the lower attachment features 3250 and may provide for more stability for the seal of the oral cushion 3110 against the patient's face.
The rigidiser arm assembly 3301 may comprise two components. The rigidiser arms 3302 and a top plate cover 3303 may be formed in one piece, with the connection features 3304 and the openings 3308 being molded thereon as well. Nylon or Hytrel® may be used to form the rigidiser arms 3302 and the top plate cover 3303. A pad 3305 may be overmolded onto each rigidiser arm 3302 as well. The pads 3305 may be formed from a thermoplastic elastomer. The pads 3305 may cushion the patient's face (e.g., the cheeks) against the rigidiser arms 3302 and prevent marking of the patient's skin when the patient interface 3000 is worn for several hours (e.g., during therapy).
The rigidiser arms 3302 may also be formed with an ellipsoidal curvature, as can be seen in
According to examples of the present technology, it may be advantageous to ensure that the rigidiser arm assembly 3301 is secured to the top plate 3206 so as to minimize relative movement between the top plate 3206 and the rigidiser arm assembly 3301 when engaged with one another. To ensure that relative movement between the top plate 3206 and the rigidiser arm assembly 3301 is adequately controlled, these components may be structured to engage one another at at least three points. The connection features 3304 may provide two of the points of contact and another structure positioned on the rigidiser arm assembly 3301 between the connection features 3304 may provide a third point of contact.
According to further examples of the present technology, structures other than the rib 3307 may be provided for a third point of contact, in addition to the connection features. For example, the top plate 3206 and the rigidiser arm assembly 3301 may engage at a third point of contact with a rod inserted into a hole.
As to the faceplate 3204 and the top plate 3206 described above, it may be advantageous to choose a material that is relatively more rigid than the nasal cushion 3112, for example, which may be formed from a flexible material such as silicone. Choosing a relatively rigid material may provide for an effective anchor point for the positioning and stabilising structure 3300 (e.g., the rigidiser arms 3302) so that the positioning and stabilising structure 3300 may attach to the seal-forming structure 3100 at fixed positions. Were the positioning and stabilising structure 3300 to be connected directly to the seal-forming structure 3100, which may be made of a relatively flexible material such as silicone, this arrangement may cause undesirable deformation of the oral and nasal cushions 3110, 3112 when donned by the patient and tension is applied by the positioning and stabilising structure 3300. Tension may be particularly applied in the anterior/posterior directions. Examples of the positioning and stabilising structure 3300 may be made from Breathe-O-Prene™, Soft Edge™, and/or elastic cloth.
Also, by forming the faceplate 3204 and the top plate 3206 from relatively a rigid material, these components may be shaped to have approximately the same curvature as the face of the patient, which may in turn ensure a better seal by properly supporting the seal-forming structure 3100. This may also ensure an effective seal against the airways of the patient when the positioning and stabilising structure 3300 generates a tension force vector V substantially parallel to the Frankfort horizontal as indicated in
Forming the faceplate 3204 and the top plate 3206 from a relatively rigid material may also be beneficial in that such a relatively rigid material may prevent the outer portions of the seal-forming structure 3100 from deforming to the point that the periphery folds inward to the face. This arrangement may also help to ensure that sealing pressure is evenly applied over the face of the patient by the seal-forming structure 3100. The headgear strap 3306 of the positioning and stabilising structure 3300 may generate tension force vectors to seal the seal-forming structure 3100 against the patient's face, however, the faceplate 3204 and the top plate 3206 may help to spread these sealing forces out over the oral cushion 3110 and the nasal cushion 3112. By spreading these sealing forces over a broader area, pressure and/or deformation may not be localized to particular regions of the oral cushion 3110 and the nasal cushion 3112, for example near where the headgear straps 3306 are connected.
Additionally, by forming the top plate 3206 from a relatively rigid material this may prevent undesirable vertical flexing of the rigidiser arms 3302 when the patient interface 3000 is donned, but still allow pivoting of the rigidiser arms 3302 in a plane parallel to the patient's coronal plane. It should be understood that a small amount of vertical flexing may be tolerable.
Also, by making the faceplate 3204 from a relatively rigid material it may be easier for the patient to attach the lower straps 3312 of the positioning and stabilising structure 3100. This is so because the lower attachment features 3250 may be held in a relatively fixed position when the patient interface 3000 is donned by the patient.
Furthermore, disassembly and assembly of the patient interface 3000 and positioning and stabilising structure 3300 (e.g., for cleaning purposes) may be easier for the patient if the positioning and stabilising structure 3300 is not directly connected to the seal-forming structure 3100.
By providing separate attachment points for the upper straps 3310 and the lower straps 3312 through the top plate 3206 and the faceplate 3204, respectively, it may be possible to better control the sealing of the nasal cushion 3112 against the nose. For example, decoupling the nasal cushion 3112 may allow the upper straps 3310 to provide targeted pressure upward against the underside of the nose and/or inward against the face. It may also be possible to control the height of the nasal cushion 3112 relative to the nose as well as its lateral position (e.g., left vs. right). Additionally, it may be possible to control the rotation of the nasal cushion 3112 relative to the nose and about an axis parallel to a longitudinal axis of the top plate 3206. These features may provide these benefits which may not be possible when all of the straps of a positioning and stabilising structure 3300 are connected to one common front plate. Thus, the examples disclosed herein may provide for a more effective and stable seal around the nose of the patient. It should also be understood that by virtue of the connection of the nasal plenum chamber 3202 to the oral plenum chamber 3200 by the decoupling structure 3106, the relative height of the oral cushion 3110 may also be controlled by the upper straps 3310 of the positioning and stabilising structure 3300.
In examples of the technology various headgear configurations may be used with the exemplary patient interfaces 3000 described herein. One example of the technology may utilize headgear similar to that disclosed in US Patent Application Publication 2012/0138061. A further variation may include upper straps 3310 that are shorter than those disclosed in the aforementioned publication by virtue of their connection to the rigidiser arms 3302.
In further examples of the technology, the positioning and stabilising structure 3300 may include the features disclosed in PCT Application No. PCT/AU2013/000830 or in US Patent Application Publication No. 2014/0026890. The positioning and stabilising structure 3300 disclosed in that reference may be used as the upper straps 3310. The lower straps 3312 may be neoprene CommonLine headgear straps.
According to a further example of the present technology, one size of the top plate 3206 and the faceplate 3204 may be used for a variety of sizes of seal-forming structure 3100 and plenum chamber 3200. This may be advantageous to reduce the number of parts needed to be produced to manufacture patient interfaces 3000 to accommodate various patient head/face sizes. Thus, only the seal-forming structure 3100 and the plenum chamber 3200 may need to be molded in different sizes according to this example of the technology.
The top plate buffer 3214 being formed in one piece with the nasal plenum chamber 3202 and connecting through the hole 3217 in the top plate 3206 may also provide a retaining function to retain the top plate 3206 in position against the nasal plenum chamber 3206.
The rib 3307 may also work in conjunction with the top plate buffer 3214 to provide dampening and/or retention of the engagement between the top plate 3206 and the rigidiser arm assembly 3301. The engagement of the rib 3307 with the top plate buffer 3215 and the top plate 3206 may provide the dampening and/or retention and the relative dimensions of these components may be selected to ensure the desired level of dampening and/or retention.
The faceplate buffer 3215 may extend from the periphery of the oral plenum chamber 3200 in an anterior direction. The faceplate buffer 3215 may be formed in one piece with the oral plenum chamber 3200. The faceplate buffer 3215 may be formed from silicone. The faceplate buffer 3215 may also dampen the hard-to-hard connection between the faceplate 3204 and the frame 3251 to reduce or eliminate rattling that may result from the connection.
The upper attachment features 3252 of the top plate 3206 may connect the rigidiser arm assembly 3301 at the connection features 3304, as shown in
The faceplate 3204 may also include a cutout 3213 on each side to connect a frame 3251 to the faceplate. Each cutout 3213 may extend laterally from the faceplate 3204. The cutouts 3213 may facilitate a hard-to-hard connection (e.g., between two relatively rigid components) between the faceplate 3204 and the frame 3251. The hard-to-hard connection may take the form of a snap-fit and may produce an audible click when the frame 3251 is attached to the faceplate 3204. Also, the connection port 3600 can be seen formed in the faceplate 3204. In
In a further alternative example, the extension 3218 may be formed in one piece with the top plate 3206. In this example, the barb shape of the extension 3218 may serve the retaining function but due to being made from the same, relatively rigid material of the top plate 3206 it may not serve the cushioning and/or dampening functions. As such, the overmolded silicone of the seal-forming structure 3100 that substantially surrounds the top plate 3206 may serve the cushioning and/or dampening functions.
The frame 3251 may also include a catch 3253 on each side to engage with respective ones of the cutouts 3213 to facilitate attachment to the faceplate 3204. The engagement of the catches 3253 with the cutouts 3213 may generate a hoop stress in the frame 3251 that holds the frame onto the faceplate 3204. The lower attachment features 3250 may also be formed on the frame 3251. As shown in
The wing portions 3257 may be joined to the frame 3251 by overmolding the wing portions 3257 onto frame extensions 3259 of the frame such that a mechanical interlock is formed. The frame extensions 3259 may then extend into respective recesses 3258 of the wing portions 3257. The mating portions 3255 may also be joined to the wing portions 3257 by simultaneous overmolding such that a mechanical interlock is also formed between the wing portions 3257 and the mating portions 3255. Thus, mating portion extensions 3256 may also extend into the recesses 3258 of the wing portions 3257.
The wing portions 3257 may be formed from thermoplastic elastomer. The wing portions 3257 may also be flexible such that the lower attachment features 3250 function as living hinges. In other words, the lower attachment features 3250 may be able to move in an anterior/posterior direction due to their flexibility so that the tension of the straps 3306 causes them to flex and retain the patient interface 3000 on the patient when donned. The mating portions 3255 may also be formed from a thermoplastic elastomer.
The clip 3314 may include a bar 3315 around which the lower strap 3312 is looped to attach the clip 3314 to the lower strap 3312.
To join the clips 3314 to the lower attachment features 3250 a magnetic connection may be provided. A clip magnet 3260 may be provided to each of the clips 3314 in a clip pocket 3317 and a mating portion magnet 3261 may be provided to each of the mating portions 3255 of the lower attachment features 3250 within a mating portion pocket 3262. The poles of each clip magnet 3260 and each mating portion magnet 3261 may be aligned such that a magnetic attraction is generated between these magnets to draw and retain the clips 3314 to the lower attachment features 3250. Further examples of these attachment arrangements are disclosed in PCT Application No. PCT/AU2014/000021, which is incorporated herein by reference in its entirety.
The mating portions 3255 of these examples may also include a guide surface 3263 and a protrusion 3264 to position the clip 3314 as it is attached. Also, each of the clips 3314 may include a receiving surface 3319 to engage with a respective guide surface 3263 and a notch 3318 to engage with a respective protrusion 3264. When the clips 3314 are attached to respective mating portions 3255 of the lower attachment features 3250, the engagement of the notch 3318 and the protrusion 3264 may prevent rotation of the clip 3314 relative to the mating portion 3255 of the lower attachment feature 3250. This may help ensure that the direction of the tension force vectors of the lower straps 3312 become and remain properly aligned when the patient interface 3000 is donned by the patient.
The guide surface 3263 may have a curved profile. The guide surface 3263 may also be shaped to form an overhang. The receiving surface 3319 may be shaped to correspond to the shape of the guide surface 3263. The shape of the guide surface 3263 may also have a guiding and/or retaining function. The curved profile and slope of the guide surface 3263 may allow the receiving surface 3319 to slide along the guide surface 3263 and into position such that the protrusion 3264 engages with the notch 3318. This may be advantageous because it may be difficult for the patient to align the clips 3314 with the lower attachment features 3250 when the patient interface 3000 is being donned. Also, the patient may be in a darkened environment, may have limited tactile ability, and/or may have limited vision to align the clips 3314 with the lower attachment features 3250. Thus, structuring the guide surface 3263 such that it guides the receiving surface 3315 and, therefore, the clip 3314 into place may be helpful to ensure a proper and secure fit of the patient interface 3000.
In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the washout of exhaled carbon dioxide.
One form of vent 3400 in accordance with the present technology comprises a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes. More than 80 holes is also envisaged.
In an example, the vent 3400 is located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a tube decoupling structure 3500. e.g. a swivel 3510.
In another example of the present technology the vent 3400 may be located on the top plate 3206 and/or the faceplate 3204. In such an example, the tube decoupling structure 3500 may not include a vent.
The vent 3400 may be laser cut or made from a mesh material or a linear array. The vent 3400 may also be made from a material or textile of interlacing plastic fibers. The material of the interlacing plastic fibers is a thermoplastic polymer including polycarbonate, nylon, polyethylene and preferably polypropylene. Specifically, the textile may be SEFAR material Tetex Mono 05-1010-K 080 woven polypropylene material. The textile is typically provided in the form of a roll or ribbon. The weave of the textile is preferably a satin weave. However, other weaves are envisaged including plain weave, plain reverse dutch weave and twill weave. The voids or holes defined by the weave of fibers through the textile do not necessarily have a uniform dimension since there is some variation between the positioning, spacing and compression of the fibers in the weave of the textile. The voids are preferably not straight through holes but rather define a tortuous air flow path between adjacent fibers through the thickness of the textile. A tortuous air flow path significantly diffuses the air flow and thereby reduces noise. If the voids are straight through holes, then the fibers of the textile may be arranged in the form of a mesh grid.
In one example, the airflow rate of the vent portion of the textile is first measured by an airflow meter. A determination is made on whether there is a difference between the measured airflow rate and a desired airflow rate. If the airflow rate through the vent portion exceeds a predetermined range, the amount of porosity of the vent portion is selectively reduced. The desired predetermined range is about 42 to about 59 litres per minute at 20 cm H2O pressure, preferably, about 47 to about 53 litres per minute at 20 cm H2O pressure. For example, the airflow rate through the SEFAR material Tetex Mono 05-1010-K 080 woven polypropylene material may be about 37 to about 64 litres at 20 cm H2O pressure, preferably, about 42 to about 58 litres at 20 cm H2O pressure. The variance over the length of the SEFAR textile may be sinusoidal over the length of the textile ribbon. Different areas of the SEFAR textile when first received from a textile manufacturer exhibit different air flow rates. After the porosity has been reduced, the airflow rate is measured again for verification to confirm it is now within the predetermined range. The average diameter of the opening of the voids is preferably less than 0.1 mm, and preferably provide a total open area of approximately 1% to 10% of the superficial area of the vent. For example, the total open area may be 22 mm2 where the superficial area of the vent is 240 mm2.
If the desired air flow rate exists in the textile, optionally, the holes in a peripheral edge region of a desired vent portion are occluded. The peripheral edge region of the vent portion is overmolded to the top plate 3206 and/or the faceplate 3204. Since the holes that existed at the peripheral edge region have been occluded, the airflow rate of the vent portion should not differ after overmolding.
In some examples, the airflow rate may be measured after the vent portion is cut from the textile, and also the vents may be measured after being overmolded to the top plate 3206 and/or the faceplate 3204. This enables the airflow rate to be known and determined to be within the desired predetermined range after each step. This may prevent wastage so that the part may be discarded as soon as it is known that it is not within the desired predetermined range.
The porosity of the vent portion can be reduced by several ways, including: heat staking, plastic deformation by compression, ultrasonic welding, applying a sealant (e.g. hot melt adhesive) and applying a thin film. Preferably, heat staking by a staking punch is used to reduce porosity due to increased precision, greater certainty of occlusion of holes in the textile, manufacturing speed, good visual appeal after heat staking, and no additional material is required. Some material shrinkage occurs when heating a thermoplastic which is accounted for by having excess material surrounding the specific physical dimension for the shape of the vent. The porosity of the vent portion is reduced by partially occluding or by fully occluding holes in the vent portion.
Any area or region of the vent portion may be selected to reduce porosity. Preferably, the porosity of a continuous peripheral edge region of the vent portion is reduced. This provides good visual appeal because this is adjacent to or at the location where the vent portion is overmolded to the top plate 3206 and/or the faceplate 3204. Any visual differences between the continuous peripheral edge region and the rest of the vent portion may be less noticeable to the human eye at this location since it may appear to be a defined edge of the top plate 3206 and/or the faceplate 3204 for receiving the vent 3400. Alternatively, the area for porosity reduction may be in the form of a character/letter or logo in a central region of the vent portion to enhance visual impact and improve brand awareness.
Sound caused by exhaled carbon dioxide passing through the vent 3400 is minimised because of greater air diffusion as it passes through the textile, in particular, for nasal pillows when a patient exhales out of their nose and the carbon dioxide flows out through the vent. Diffusion of the exhaled carbon dioxide avoids direct or focused airflow to a bed partner or the patient depending on vent orientation and sleeping position.
The vent of the patient interface is easy to clean. A mild cleaning solution or soapy water can be used for cleaning the vent. Hot water can also be used to flow through the vent for cleaning. The vent can be hand washed and rinsed without disassembly from the top plate 3206 and/or the faceplate 3204 because it may be permanently connected, for example, overmolded, to the top plate 3206 and/or the faceplate 3204. Less detachable parts for the patient interface avoids the possibility of losing individual parts and also reduces cleaning time by not having to detach and re-attach each part from each other. Since the vent is formed with plastic fibers, durability of the vent is maintained even after repeated cleaning in contrast to a vent made from another less durable material, for example, a cloth textile.
The vent is quiet. Sound energy generated by exhaled carbon dioxide is spread evenly. Vibrations caused by the exhaled carbon dioxide coming in contact with the top plate 3206 and/or the faceplate 3204 may produce vibrations in the top plate 3206 and/or the faceplate 3204. Such vibrations may be dampened by the vent.
In one form the patient interface 3000 includes at least one tube decoupling structure 3500, for example a swivel or a ball and socket. The tube decoupling structure 3500 may also include an elbow feature. The tube decoupling structure 3500 may be divided between the hose and mouth.
A connection port 3600 may allow for connection to the air circuit 4170. The air circuit 4170 may include a short tube connected to a longer tube. Examples of the tubes may include the tube features disclosed in PCT Application No. PCT/AU2013/000830. A rotatable adapter may also be included to connect the short tube and long tube.
In one form, the patient interface 3000 includes an anti-asphyxia valve 3800.
According to the examples shown in
In certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, alternative definitions may apply.
5.4.1 GeneralAir: Air will be taken to include breathable gases, for example air with supplemental oxygen.
Continuous Positive Airway Pressure (CPAP): CPAP treatment will be taken to mean the application of a supply of air or breathable gas to the entrance to the airways at a pressure that is continuously positive with respect to atmosphere, and preferably approximately constant through a respiratory cycle of a patient. In some forms, the pressure at the entrance to the airways will vary by a few centimeters of water within a single respiratory cycle, for example being higher during inhalation and lower during exhalation. In some forms, the pressure at the entrance to the airways will be slightly higher during exhalation, and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example being increased in response to detection of indications of partial upper airway obstruction, and decreased in the absence of indications of partial upper airway obstruction.
5.4.2 Aspects of PAP DevicesAir circuit: A conduit or tube constructed and arranged in use to deliver a supply of air or breathable gas between a PAP device and a patient interface. In particular, the air circuit may be in fluid connection with the outlet of the pneumatic block and the patient interface. The air circuit may be referred to as air delivery tube. In some cases there may be separate limbs of the circuit for inhalation and exhalation. In other cases a single limb is used.
APAP: Automatic Positive Airway Pressure.
Blower or flow generator: A device that delivers a flow of air at a pressure above ambient pressure.
Controller: A device, or portion of a device that adjusts an output based on an input. For example one form of controller has a variable that is under control—the control variable—that constitutes the input to the device. The output of the device is a function of the current value of the control variable, and a set point for the variable. A servo-ventilator may include a controller that has ventilation as an input, a target ventilation as the set point, and level of pressure support as an output. Other forms of input may be one or more of oxygen saturation (SaO2), partial pressure of carbon dioxide (PCO2), movement, a signal from a photoplethysmogram, and peak flow. The set point of the controller may be one or more of fixed, variable or learned. For example, the set point in a ventilator may be a long term average of the measured ventilation of a patient. Another ventilator may have a ventilation set point that changes with time. A pressure controller may be configured to control a blower or pump to deliver air at a particular pressure.
Therapy: Therapy in the present context may be one or more of positive pressure therapy, oxygen therapy, carbon dioxide therapy, control of dead space, and the administration of a drug.
Positive Airway Pressure (PAP) device: A device for providing a supply of air at positive pressure to the airways.
5.4.3 Anatomy of the FaceAla: The external outer wall or “wing” of each nostril (plural: alae)
Alar angle: The angle defined between the ala, from an inferior view.
Alare: The most lateral point on the nasal ala.
Alar curvature (or alar crest) point: The most posterior point in the curved base line of each ala, found in the crease formed by the union of the ala with the cheek.
Auricula or Pinna: The whole external visible part of the ear.
(nose) Bony framework: The bony framework of the nose comprises the nasal bones, the frontal process of the maxillac and the nasal part of the frontal bone.
(nose) Cartilaginous framework: The cartilaginous framework of the nose comprises the septal, lateral, major and minor cartilages.
Columella: the strip of skin that separates the nares and which runs from the pronasale to the upper lip.
Columella angle: The angle between the line drawn through the midpoint of the nostril aperture and a line drawn perpendicular to the Frankfurt horizontal while intersecting subnasale.
Frankfort horizontal plane: A line extending from the most inferior point of the orbital margin to the left tragion. The tragion is the deepest point in the notch superior to the tragus of the auricle.
Glabella: Located on the soft tissue, the most prominent point in the midsagittal plane of the forehead.
Lateral nasal cartilage: A generally triangular plate of cartilage. Its superior margin is attached to the nasal bone and frontal process of the maxilla, and its inferior margin is connected to the major alar cartilage.
Lip, lower (labrale inferius): A point where the boundary of the vermilion border of the lower lip and the skin is intersected by the median sagittal plane.
Lip, upper (labrale superius): The point on the upper lip lying in the median sagittal plane on a line drawn across the boundary of the vermilion border and skin.
Major alar cartilage: A plate of cartilage lying below the lateral nasal cartilage. It is curved around the anterior part of the naris. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four minor cartilages of the ala.
Nares (Nostrils): Approximately ellipsoidal apertures forming the entrance to the nasal cavity. The singular form of nares is naris (nostril). The nares are separated by the nasal septum.
Naso-labial sulcus or Naso-labial fold: The skin fold or groove that runs from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.
Naso-labial angle: The angle between the columella and the upper lip, while intersecting subnasale.
Otobasion inferior: The lowest point of attachment of the auricle to the skin of the face.
Otobasion superior: The highest point of attachment of the auricle to the skin of the face.
Pronasale: the most protruded point or tip of the nose, which can be identified in lateral view of the rest of the portion of the head.
Philtrum: the midline groove that runs from lower border of the nasal septum to the top of the lip in the upper lip region.
Pogonion: Located on the soft tissue, the most anterior midpoint of the chin.
Ridge (nasal): The nasal ridge is the midline prominence of the nose, extending from the Sellion to the Pronasale.
Sagittal plane: A vertical plane that passes from anterior (front) to posterior (rear) dividing the body into right and left halves.
Sellion: Located on the soft tissue, the most concave point overlying the area of the frontonasal suture.
Septal cartilage (nasal): The nasal septal cartilage forms part of the septum and divides the front part of the nasal cavity.
Subalare: The point at the lower margin of the alar base, where the alar base joins with the skin of the superior (upper) lip.
Subnasal point. Located on the soft tissue, the point at which the columella merges with the upper lip in the midsagittal plane.
Supramentale: The point of greatest concavity in the midline of the lower lip between labrale inferius and soft tissue pogonion
5.4.4 Anatomy of the SkullFrontal bone: The frontal bone includes a large vertical portion, the squama frontalis, corresponding to the region known as the forehead.
Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.
Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbits. The frontal process of the maxilla projects upwards by the side of the nose, and forms part of its lateral boundary.
Nasal bones: The nasal bones are two small oblong bones, varying in size and form in different individuals; they are placed side by side at the middle and upper part of the face, and form, by their junction, the “bridge” of the nose.
Nasion: The intersection of the frontal bone and the two nasal bones, a depressed area directly between the eyes and superior to the bridge of the nose.
Occipital bone: The occipital bone is situated at the back and lower part of the cranium. It includes an oval aperture, the foramen magnum, through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.
Parietal bones: The parietal bones are the bones that, when joined together, form the roof and sides of the cranium.
Temporal bones: The temporal bones are situated on the bases and sides of the skull, and support that part of the face known as the temple.
Zygomatic bones: The face includes two zygomatic bones, located in the upper and lateral parts of the face and forming the prominence of the cheek.
5.4.5 Anatomy of the Respiratory SystemDiaphragm: A sheet of muscle that extends across the bottom of the rib cage. The diaphragm separates the thoracic cavity, containing the heart, lungs and ribs, from the abdominal cavity. As the diaphragm contracts the volume of the thoracic cavity increases and air is drawn into the lungs.
Larynx: The larynx, or voice box houses the vocal folds and connects the inferior part of the pharynx (hypopharynx) with the trachea.
Lungs: The organs of respiration in humans. The conducting zone of the lungs contains the trachea, the bronchi, the bronchioles, and the terminal bronchioles. The respiratory zone contains the respiratory bronchioles, the alveolar ducts, and the alveoli.
Nasal cavity: The nasal cavity (or nasal fossa) is a large air filled space above and behind the nose in the middle of the face. The nasal cavity is divided in two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal outgrowths called nasal conchae (singular “concha”) or turbinates. To the front of the nasal cavity is the nose, while the back blends, via the choanae, into the nasopharynx.
Pharynx: The part of the throat situated immediately inferior to (below) the nasal cavity, and superior to the oesophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (epipharynx), the oropharynx (mesopharynx), and the laryngopharynx (hypopharynx).
5.4.6 MaterialsSilicone or Silicone Elastomer: A synthetic rubber. In this specification, a reference to silicone is a reference to liquid silicone rubber (LSR) or a compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, a preferred form of LSR has a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.
Polycarbonate: a typically transparent thermoplastic polymer of Bisphenol-A Carbonate.
5.4.7 Aspects of a Patient InterfaceAnti-asphyxia valve (AAV): The component or sub-assembly of a mask system that, by opening to atmosphere in a failsafe manner, reduces the risk of excessive CO2 rebreathing by a patient.
Elbow: A conduit that directs an axis of flow or air to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be less than 90 degrees. The conduit may have an approximately circular cross-section. In another form the conduit may have an oval or rectangular cross-section.
Frame: Frame will be taken to mean a mask structure that bears the load of tension between two or more points of connection with a headgear. A mask frame may be a non-airtight load bearing structure in the mask. However, some forms of mask frame may also be air-tight.
Functional dead space: The functional dead space refers to at least one region within a breathing circuit where a patient's exhalate may collect such that the normal flow of gas within the breathing circuit cannot effectively flush the exhalate from the breathing circuit.
Headgear: Headgear will be taken to mean a form of positioning and stabilizing structure designed for use on a head. Preferably the headgear comprises a collection of one or more struts, ties and stiffeners configured to locate and retain a patient interface in position on a patient's face for delivery of respiratory therapy. Some ties are formed of a soft, flexible, elastic material such as a laminated composite of foam and fabric.
Membrane: Membrane will be taken to mean a typically thin element that has, preferably, substantially no resistance to bending, but has resistance to being stretched.
Plenum chamber: a mask plenum chamber will be taken to a mean portion of a patient interface having walls enclosing a volume of space, the volume having air therein pressurized above atmospheric pressure in use. A shell may form part of the walls of a mask plenum chamber. In one form, a region of the patient's face forms one of the walls of the plenum chamber.
Seal: The noun form (“a seal”) will be taken to mean a structure or barrier that intentionally resists the flow of air through the interface of two surfaces. The verb form (“to seal”) will be taken to mean to resist a flow of air.
Shell: A shell will preferably be taken to mean a curved structure having bending, tensile and compressive stiffness, for example, a portion of a mask that forms a curved structural wall of the mask. Preferably, compared to its overall dimensions it is relatively thin. In some forms, a shell may be faceted. Preferably such walls are airtight, although in some forms they may not be airtight.
Stiffener. A stiffener will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.
Strut: A strut will be taken to be a structural component designed to increase the compression resistance of another component in at least one direction.
Swivel: (noun) A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be constructed to rotate through an angle of at least 360 degrees. In another form, the swivel may be constructed to rotate through an angle less than 360 degrees. When used in the context of an air circuit, the sub-assembly of components preferably comprises a matched pair of cylindrical conduits. Preferably there is little or no leak flow of air from the swivel in use.
Tie: A tie will be taken to be a structural component designed to resist tension.
Vent: (noun) the structure that allows a deliberate controlled rate leak of air from an interior of the mask, or conduit to ambient air, to allow washout of exhaled carbon dioxide (CO2) and supply of oxygen (O2).
5.4.8 Terms Used in Relation to Patient InterfaceCurvature (of a surface): A region of a surface having a saddle shape, which curves up in one direction and curves down in a different direction, will be taken to have a negative curvature. A region of a surface having a dome shape, which curves the same way in two principle directions, will be taken to have a positive curvature. A flat surface will be taken to have zero curvature.
Floppy: A quality of a material, structure or composite that is the combination of features of:
-
- Readily conforming to finger pressure.
- Unable to retain its shape when caused to support its own weight.
- Not rigid.
- Able to be stretched or bent elastically with little effort.
The quality of being floppy may have an associated direction, hence a particular material, structure or composite may be floppy in a first direction, but stiff or rigid in a second direction, for example a second direction that is orthogonal to the first direction.
Resilient: Able to deform substantially elastically, and to release substantially all of the energy upon unloading, within a relatively short period of time such as 1 second.
Rigid: Not readily deforming to finger pressure, and/or the tensions or loads typically encountered when setting up and maintaining a patient interface in scaling relationship with an entrance to a patient's airways.
Semi-rigid: means being sufficiently rigid to not substantially distort under the effects of mechanical forces typically applied during positive airway pressure therapy.
5.5 Other RemarksUnless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include their plural equivalents, unless the context clearly dictates otherwise.
Moreover, in interpreting the disclosure, all terms should be interpreted in the broadest reasonable manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.
Although the technology herein has been described with reference to particular examples, it is to be understood that these examples are merely illustrative of the principles and applications of the technology. In some instances, the terminology and symbols may imply specific details that are not required to practice the technology. For example, although the terms “first” and “second” may be used, unless otherwise specified, they are not intended to indicate any order but may be utilised to distinguish between distinct elements. Furthermore, although process steps in the methodologies may be described or illustrated in an order, such an ordering is not required. Those skilled in the art will recognize that such ordering may be modified and/or aspects thereof may be conducted concurrently or even synchronously.
It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the technology.
Claims
1.-104. (canceled)
105. A cushion assembly for a patient interface for treatment of sleep disordered breathing of a patient, comprising:
- a nasal cushion joined to a nasal plenum chamber, the nasal cushion structured to seal around the lower periphery of the patient's nose;
- an oral cushion joined to an oral plenum chamber, the oral cushion structured to seal around the patient's mouth;
- a decoupling structure connecting the nasal cushion and the nasal plenum chamber to the oral cushion and the oral plenum chamber, the decoupling structure configured to allow the nasal cushion and the nasal plenum chamber to move relative to the oral cushion and the oral plenum chamber;
- a pair of side supports, each of the pair of side supports located on opposite sides of the nasal cushion and joining respective lateral sides of the nasal cushion to the oral cushion;
- a pair of undercushion support walls provided to support protruding ends positioned posteriorly on the nasal cushion; and
- a pair of pockets, each of the pair of pockets located on opposite sides of the nasal cushion, each of the pair of pockets including an upper surface defined by the nasal cushion and the nasal plenum chamber, each of the pair of pockets including a lower surface defined by the oral cushion and the oral plenum chamber, and each of the pair of pockets including side surfaces defined by the decoupling structure and respective ones of the pair of side supports,
- wherein each of the pair of pockets is open in an anterior direction of the cushion assembly when the patient interface is donned by the patient.
106. The cushion assembly according to claim 105, wherein each of the pair of side supports includes a notch to provide a pivot point for relative movement between the nasal cushion and the oral cushion.
107. The cushion assembly according to claim 106, wherein the notch of each of the pair of side supports is open in a direction opposite the face of the patient when the patient interface is donned by the patient.
108. The cushion assembly according to claim 105, wherein the nasal cushion comprises a pair of stiffened sections, each of the pair of stiffened sections located at opposite lateral sides of the nasal cushion,
- wherein the stiffened sections are stiffer than the remainder of the nasal cushion.
109. The cushion assembly according to claim 108, wherein the pair of stiffened sections comprise a thickness greater than other portions of the nasal cushion.
110. The cushion assembly according to claim 108, wherein the pair of stiffened sections extend internally relative to the nasal cushion and the nasal plenum chamber such that an external surface of the nasal cushion is not raised.
111. The cushion assembly according to claim 105, wherein the nasal cushion comprises a nasal sling, the nasal sling being formed in-plane with the nasal cushion, and the nasal sling being structured to contact the patient's columella.
112. The cushion assembly according to claim 111, wherein the nasal cushion and the nasal sling define a pair of nare ports, each of the pair of nare ports structured to pneumatically communicate with a respective one of the patient's nares.
113. The cushion assembly according to claim 111, wherein the nasal sling is structured to prevent the tip of the patient's nose from extending into a nasal gas chamber, the nasal gas chamber defined at least in part by the nasal cushion and the nasal plenum chamber.
114. The cushion assembly according to claim 105, wherein the cushion assembly is formed from one piece of liquid silicone rubber.
115. The cushion assembly according to claim 105, wherein each of the protruding ends is structured to seal within the gap between the respective alae and nasolabial sulci of the patient.
116. The cushion assembly according to claim 105, wherein each of the pockets is structured to support a corresponding one of the protruding ends in use.
117. The cushion assembly according to claim 105, wherein the nasal cushion further comprises a recessed portion to receive the tip of the patient's nose in use.
118. A patient interface system for treatment of sleep disordered breathing of a patient, the patient interface system comprising:
- the cushion assembly of claim 105;
- a positioning and stabilizing structure to secure the patient interface system on the patient during use; and
- a frame to attach the positioning and stabilizing structure to the cushion assembly.
119. A cushion assembly for a patient interface for treatment of sleep disordered breathing of a patient, comprising:
- a nasal cushion joined to a nasal plenum chamber, the nasal cushion structured to seal around the lower periphery of the patient's nose;
- a pair of undercushion support walls provided to support protruding ends positioned posteriorly on the nasal cushion; and
- a pair of pockets, each of the pair of pockets located on opposite sides of the nasal cushion, each of the pair of pockets including an upper surface defined by the nasal cushion and the nasal plenum chamber, each of the pair of pockets including a lower surface, and each of the pair of pockets including side surfaces,
- wherein each of the pair of pockets is open in an anterior direction of the cushion assembly when the patient interface is donned by the patient.
120. The cushion assembly according to claim 119, wherein the nasal cushion comprises a pair of stiffened sections, each of the pair of stiffened sections located at opposite lateral sides of the nasal cushion,
- wherein the stiffened sections are stiffer than the remainder of the nasal cushion.
121. The cushion assembly according to claim 120, wherein the pair of stiffened sections comprise a thickness greater than other portions of the nasal cushion.
122. The cushion assembly according to claim 120, wherein the pair of stiffened sections extend internally relative to the nasal cushion and the nasal plenum chamber such that an external surface of the nasal cushion is not raised.
123. The cushion assembly according to claim 119, wherein the nasal cushion comprises a nasal sling, the nasal sling being formed in-plane with the nasal cushion, and the nasal sling being structured to contact the patient's columella.
124. The cushion assembly according to claim 123, wherein the nasal cushion and the nasal sling define a pair of nare ports, each of the pair of nare ports structured to pneumatically communicate with a respective one of the patient's nares.
125. The cushion assembly according to claim 123, wherein the nasal sling is structured to prevent the tip of the patient's nose from extending into a nasal gas chamber, the nasal gas chamber defined at least in part by the nasal cushion and the nasal plenum chamber.
126. The cushion assembly according to claim 119, wherein the cushion assembly is formed from one piece of liquid silicone rubber.
127. The cushion assembly according to claim 119, wherein each of the protruding ends is structured to seal within the gap between the respective alae and nasolabial sulci of the patient.
128. The cushion assembly according to claim 119, wherein each of the pockets is structured to support a corresponding one of the protruding ends in use.
129. The cushion assembly according to claim 119, wherein the nasal cushion further comprises a recessed portion to receive the tip of the patient's nose in use.
130. A patient interface system for treatment of sleep disordered breathing of a patient, the patient interface system comprising:
- the cushion assembly of claim 119;
- a positioning and stabilizing structure to secure the patient interface system on the patient during use; and
- a frame to attach the positioning and stabilizing structure to the cushion assembly.
Type: Application
Filed: May 14, 2014
Publication Date: Mar 24, 2016
Inventors: Adam Francis BARLOW (Sydney), Rupert Christian SCHEINER (Sydney), Lachlan Richard GOLDSPINK (Sydney), Lemmy NGA (Sydney)
Application Number: 14/889,034
