A THERAPY SYSTEM FOR RESPIRATORY-RELATED DISORDERS, AND PATIENT INTERFACE AND HEADGEAR FOR USE IN SAME
20220379061 · 2022-12-01
Inventors
- Michiel Kooij (Sydney, AU)
- Adam Francis Barlow (Sydney, AU)
- Iain McNicol FINLAY (Sydney, AU)
- Robin Yew (Singapore, SG)
- Muhammad Adil BIN ABDUL HALIM (Singapore, SG)
Cpc classification
A61M2039/1077
HUMAN NECESSITIES
A61M16/208
HUMAN NECESSITIES
International classification
Abstract
The present technology relates to a patient interface for delivery of a flow of pressurised air to an entrance of a patient's airways, the patient interface comprising a mask with a seal-forming structure and one or more positioning and stabilising structures configured to provide a force to hold the mask in a therapeutically effective position on a patient's head in use. The mask and one or more of the positioning and stabilising structures includes a connection port to receive an end of the air circuit. The pressurised air is delivered from the air circuit to the seal-forming structure. In use, the patient connects the air circuit to the connection port of choice, depending on whether they prefer the patient interface to be arranged such that the end of the air circuit is superior to the patient's otobasion superior or inferior to the patient's otobasion superior.
Claims
1. A patient interface for delivery of a flow of pressurised air from an air circuit to an entrance of a patient's airways, the patient interface comprising: a plenum chamber; a seal-forming structure provided to the plenum chamber; a plurality of connection ports configured to receive the flow of air from the air circuit and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, the plurality of connection ports comprising a first connection port and a second connection port; and one or more positioning and stabilising structures configured to provide a force to hold the seal-forming structure in a therapeutically effective position on a patient's head in use, wherein the patient interface is structured and arranged to be worn by the patient in a first use configuration and a second use configuration, wherein in the first use configuration, the air circuit is connected to the first connection port that is positioned superior to the patient's otobasion superior and that is connected to ports on sides of the plenum chamber via a first and second gas delivery tubes being constructed and arranged to contact at least a region of the patient's head superior to the otobasion superior of the patient's head and position and stabilise the seal-forming structure of the patient interface in the therapeutically effective position, wherein in the second use configuration, the air circuit is connected to the second connection port that is positioned on an anterior side of the plenum chamber inferior to the patient's otobasion superior, and wherein, when the air circuit is connected to the first connection port in the first use configuration, the second connection port receives a vent structure or a stop.
2. The patient interface as claimed in claim 1, wherein the one or more positioning and stabilising structures comprises first and second positioning and stabilising structures configured to be interchangeably provided as part of the patient interface.
3. T The patient interface as claimed in claim 2, wherein the first positioning and stabilising structure is configured for use with the patient interface in the first use configuration.
4. The patient interface as claimed in claim 2, wherein the first positioning and stabilising structure comprises the first and second gas delivery tubes being constructed and arranged to contact at least a region of the patient's head superior to an otobasion superior of the patient's in use, wherein a portion of the gas delivery tube superior to the otobasion superior of the patient's head is provided to the connection port.
5. The patient interface as claimed in claim 2, wherein the second positioning and stabilising structure comprises one or more straps, constructed and arranged to contact at least a region of the patient's head superior to an otobasion superior of the patient's head, wherein the second positioning and stabilising structure is configured for use with the patient interface in the second use configuration.
6. (canceled)
7. The patient interface as claimed in claim 1, wherein the first connection port is provided to the first positioning and stabilising structure, wherein the portion of the first and second gas delivery tubes superior to the otobasion superior of the patient's head is provided with the first connection port.
8. (canceled)
9. (canceled)
10. (canceled)
11. The patient interface as claimed in claim 1, wherein the first connection port is provided to a portion of the gas delivery tube superior to the otobasion superior of the patient's head.
12. The patient interface as claimed in claim 1, wherein the patient interface further comprises one or more vent structures or stops.
13. The patient interface as claimed in claim 12, wherein each vent structure or stop is configured to connect to the first and/or second connection port.
14. The patient interface as claimed in claim 13, wherein, in the first use configuration, the air circuit is connected to the first connection port and one of the vent structures or stops is connected to the second connection port, and, in the second use configuration, the air circuit is connected to the second connection port and one of the vent structures or stops is connected to the first connection port.
15. The patient interface as claimed in claim 11, wherein the first and second connection ports are provided with a closure.
16. The patient interface as claimed in claim 15, wherein the closure is configured to be moveable from a closed condition to an open condition.
17. The patient interface as claimed in claim 16, wherein the closure comprises an opening and at least one closure lid covering at least a portion of the opening when in the closed condition.
18. The patient interface as claimed in claim 17, wherein the closure comprises a ring structure circumscribing the opening.
19. The patient interface as claimed in claim 18, wherein the closure lid is pivotally hinged by an outer edge to the ring structure.
20. The patient interface as claimed in claim 18, wherein the closure lid is slideably mounted to the ring structure, wherein the ring structure is provided with a track along which the closure lid is configured to slide.
21. The patient interface as claimed in claim 16, wherein the closure comprises an opening and at least one closure flap covering at least a portion of the opening when in the closed condition and arranged to be biased from the closed condition to the open condition by an end portion of the air circuit.
22. The patient interface as claimed in claim 21, wherein the closure comprises a ring structure circumscribing the opening.
23. The patient interface as claimed in claim 22, wherein the at least one closure flap is pivotally hinged by an outer edge to the ring structure.
24. The patient interface as claimed in claim 22, wherein the at least one closure flap is pivotally hinged to a strut spanning the opening of the ring.
25. The patient interface as claimed in claim 22, wherein the at least one closure flap spans the opening or ring structure and is provided with a central aperture which increases in size as the closure is biased from the closed condition to the open condition by the end portion of the air circuit.
26. The patient interface as claimed in claim 21, wherein the end portion of the air circuit includes an activation mechanism arranged to act against the closure.
27. The patient interface as claimed in claim 17, wherein the closure includes a vent.
28. The patient interface as claimed in claim 27, wherein the vent is in the form of one or more apertures provided to the closure lid or closure flap.
29. The patient interface as claimed in claim 27, wherein the closure comprises two or more closure flaps, and wherein the vent is in the form of a slit formed by a distance between adjacent closure flaps.
30. The patient interface as claimed in claim 27, wherein the closure comprises four closure flaps attached to an inside surface of the closure, and wherein the vent is in the form of two intersecting slits formed by a distance between adjacent closure flaps.
31. The patient interface as claimed in claim 15, wherein, when in the open condition the closure allows delivery of the flow of air to the entrance of the patient's airways, and wherein, when in the first use configuration, the closure of the first connection port is in an open condition and the closure of the second connection port is in a closed condition, and wherein, when in the second use configuration, the closure of the first connection port is in a closed condition and the closure of the second connection port is in an open condition.
32. The patient interface as claimed in claim 1, wherein the patient interface comprises more than one plenum chamber, wherein each plenum chamber is configured to be interchangeably comprised as part of the patient interface.
33. The patient interface as claimed in claim 1, wherein the patient interface comprises more than one seal-forming structure, wherein each seal-forming structure is configured to be interchangeably comprised as part of the patient interface.
34. The patient interface as claimed in claim 33, wherein the plenum chamber(s) and/or seal-forming structure(s) are configured as one or more of: a nasal mask, nasal cushion, nasal pillows or a full-face mask.
35. The patient interface as claimed in claim 1, wherein the one or more positioning and stabilising structures comprises first and second positioning and stabilising structures configured to be provided as part of the patient interface.
36. The patient interface as claimed in claim 35, wherein the first positioning and stabilising structure is configured to provide a force to hold the seal-forming structure in a therapeutically effective position on a patient's head in use, wherein the first positioning and stabilising structure includes the first and second gas delivery tubes being constructed and arranged to contact, in a first use configuration, at least a region of the patient's head superior to an otobasion superior of the patient's head, wherein a portion of the first and second gas delivery tubes superior to the otobasion superior of the patient's head in the first use configuration is provided with a connection port to receive the flow of air from the air circuit and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, and wherein the first and second gas delivery tubes have an inferior end configured to be connected to a side of the plenum chamber.
37. The patient interface as claimed in claim 35, wherein the second positioning and stabilising structure is configured to provide a force to hold the seal-forming structure in a therapeutically effective position on a patient's head in use, the second positioning and stabilising structure including at least one strap being constructed and arranged to contact, in a second use configuration, at least a region of the patient's head superior to an otobasion superior of the patient's head.
38. The patient interface as claimed in claim 36, wherein the inferior ends of the first and second gas delivery tubes are connected to the sides of the plenum chamber in a manner such that the first positioning and stabilising structure is moveable between the first use configuration and the second use configuration, wherein in the second use configuration, the connection port is inferior to the otobasion superior.
39. The patient interface as claimed in claim 36, wherein, in the first use configuration, the first positioning and stabilising structure is donned to contact at least a region of the patient's head superior to an otobasion superior of the patient's head and the connection port receives the flow of air from the air circuit.
40. The patient interface as claimed in claim 36, wherein, in the second use configuration, the second positioning and stabilising structure is donned to contact at least a region of the patient's head superior to an otobasion superior of the patient's head, and the connection port of the first positioning and stabilising structure receives the flow of air from the air circuit.
41. A patient interface for delivery of a flow of pressurised air from an air circuit to an entrance of a patient's airways, the patient interface comprising: a plenum chamber; a seal-forming structure provided to the plenum chamber; a first positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on a patient's head in use, wherein the first positioning and stabilising structure comprises at least one gas delivery tube being constructed and arranged to contact, in a first use configuration, at least a region of the patient's head superior to an otobasion superior of the patient's head, wherein a portion of the gas delivery tube superior to the otobasion superior of the patient's head is provided with a first connection port to receive the flow of air from the air circuit and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure in the first use configuration, wherein the gas delivery tube is connected, in the first use configuration, to a port on a side of the plenum chamber and is constructed and arranged to position and stabilise the seal-forming structure of the patient interface in the therapeutically effective position; and a second positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on a patient's head in use, wherein, in a second use configuration, the second positioning and stabilising structure is constructed and arranged to contact at least a region of the patient's head superior to an otobasion superior of the patient's head; a second connection port to receive the flow of air from the air circuit, wherein the second connection port is provided to an anterior side of the plenum chamber, wherein, in the second use configuration, the second connection port receives the flow of air from the air circuit to deliver the flow of air to the seal-forming structure; and a vent structure or stop configured to connect to the second connection port in the first use configuration.
42. A patient interface for delivery of a flow of pressurised air to an entrance of a patient's airways, the patient interface comprising: a plenum chamber; a seal-forming structure provided to the plenum chamber; and a positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on a patient's head in use, wherein the positioning and stabilising structure includes at least one gas delivery tube being constructed and arranged to contact at least a region of the patient's head superior to an otobasion superior of the patient's head, wherein a portion of the gas delivery tube superior to the otobasion superior of the patient's head is provided with a first connection port to, in a first use configuration, receive the flow of air from an air circuit and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, and wherein the gas delivery tube is connected, in the first use configuration, to a port on a side of the plenum chamber and is constructed and arranged to position and stabilise the seal-forming structure of the patient interface in the therapeutically effective position, wherein an anterior side of the plenum chamber is provided with a second connection port to, in a second use configuration, receive the flow of air from the air circuit and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, and wherein the patient interface further comprises one or more vent structures or stops, each vent structure or stop configured to connect to the first and/or second connection port, and wherein, in the first use configuration, the air circuit is connected to the first connection port and one of the vent structures or stops is connected to the second connection port, and, in the second use configuration, the air circuit is connected to the second connection port and one of the vent structures or stops is connected to the first connection port.
43. A patient interface for delivery of a flow of pressurised air from an air circuit to an entrance of a patient's airways, the patient interface comprising: a plenum chamber; a seal-forming structure provided to the plenum chamber; and a first positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on a patient's head in use, wherein the first positioning and stabilising structure includes at least one gas delivery tube being constructed and arranged to contact, in a first use configuration, at least a region of the patient's head superior to an otobasion superior of the patient's head, wherein a portion of the gas delivery tube superior to the otobasion superior of the patient's head in the first use configuration is provided with a connection port to receive the flow of air from the air circuit and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, and wherein the gas delivery tube has an inferior end configured to be connected to a side of the plenum chamber and is constructed and arranged to position and stabilise the seal-forming structure of the patient interface in the therapeutically effective position in the first use configuration; and a second positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on a patient's head in use, the second positioning and stabilising structure including at least one strap being constructed and arranged be connected to headgear attachment points of the plenum chamber and to contact, in a second use configuration, at least a region of the patient's head superior to an otobasion superior of the patient's head, wherein the inferior end of the gas delivery tube is connected to the side of the plenum chamber in a manner such that the first positioning and stabilising structure is moveable between the first use configuration and the second use configuration, and wherein in the second use configuration, the connection port is inferior to the otobasion superior.
44. A patient interface for delivery of a flow of pressurised air to an entrance of a patient's airways, the patient interface comprising: a plenum chamber; a seal-forming structure provided to the plenum chamber; and a positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on a patient's head in use, wherein the positioning and stabilising structure includes at least one gas delivery tube being constructed and arranged to contact at least a region of the patient's head superior to an otobasion superior of the patient's head, wherein a portion of the gas delivery tube superior to the otobasion superior of the patient's head is provided with a first connection port to, in a first use configuration, receive the flow of air from an air circuit and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, and wherein the gas delivery tube is connected, in the first use configuration, to a port on a side of the plenum chamber and is constructed and arranged to position and stabilise the seal-forming structure of the patient interface in the therapeutically effective position, wherein an anterior side of the plenum chamber is provided with a second connection port to, in a second use configuration, receive the flow of air from the air circuit and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, and wherein the first and second connection ports are each configured with a closure, wherein the closure is arranged to be moveable from a closed condition to an open condition, wherein, when in the open condition the closure allows delivery of the flow of air to the entrance of the patient's airways, and wherein, when in the first use configuration, the closure of the first connection port is in an open condition and the closure of the second connection port is in a closed condition, and wherein, when in the second use configuration, the closure of the first connection port is in a closed condition and the closure of the second connection port is in an open condition.
45. The patient interface as claimed in claim 41, wherein the patient interface comprises more than one plenum chamber, wherein each plenum chamber is configured to be interchangeably comprised as part of the patient interface.
46. The patient interface as claimed in claim 41, wherein the patient interface comprises more than one seal-forming structure, wherein each seal-forming structure is configured to be interchangeably comprised as part of the patient interface.
47. The patient interface as claimed in claim 46, wherein the plenum chamber(s) and/or seal-forming structure(s) are configured as one or more of: a nasal mask, nasal cushion, nasal pillows or a full-face mask.
Description
4 BRIEF DESCRIPTION OF DRAWINGS
[0150] 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 Respiratory Therapy Systems
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4.2 Facial Anatomy
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4.3 Patient Interface
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5 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY
[0178] Before 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.
[0179] 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 Therapy
[0180] In one form, the present technology comprises a method for treating a respiratory disorder comprising applying positive pressure to the entrance of the airways of a patient 1000.
[0181] In certain examples of the present technology, a supply of air at positive pressure is provided to the nasal passages of the patient via one or both nares.
[0182] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.
5.2 Respiratory Therapy Systems
[0183] In one form, the present technology comprises a respiratory therapy system for treating a respiratory disorder. As shown in
5.2.1 Air Circuit
[0184] The air circuit comprises the conduit that delivers the flow of pressurised air to the patient interface. It is typically a length of tubing of biocompatible plastics material fluidly connected at an upstream end to the RPT device 4000 and to the patient interface 3000 at a downstream end. In some examples, the downstream end portion of the air circuit 4170 is configured as a connector that engages with the patient interface 3000. This engagement may be by way of snap-lock fittings, complementary threads or similar arrangements.
5.2.2 Patient Interface
[0185] A non-invasive patient interface 3000 in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilising structure 3300, a vent structure 3400, and one form of connection port, either 3600A or 3600B, for connection to the downstream end of the air circuit 4170.
[0186] 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 3100 is arranged to surround an entrance to the airways of the patient so as to maintain positive pressure at the entrance(s) to the airways of the patient 1000. The sealed patient interface 3000 is therefore suitable for delivery of positive pressure therapy.
[0187] If a patient interface is unable to comfortably deliver a minimum level of positive pressure to the airways, the patient interface may be unsuitable for respiratory pressure therapy.
[0188] The patient interface 3000 in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 6 cmH.sub.2O with respect to ambient. In another form of the present technology, the patient interface is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 10 cmH.sub.2O with respect to ambient. In yet another form of the present technology, the patient interface 3000 is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 20 cmH.sub.2O with respect to ambient.
5.2.3 Seal-Forming Structure
[0189] In one form of the present technology, the patient interface includes a seal-forming structure 3100 that provides a target seal-forming region and may additionally provide a cushioning function. The target seal-forming region is a region on the seal-forming structure 3100 where sealing may occur. The region where sealing actually occurs—the actual sealing surface—may change within a given treatment session, from day to day, and from patient to patient, depending on a range of factors including for example, where the patient interface was placed on the face, tension in the positioning and stabilising structure and the shape of a patient's face.
[0190] In one form the target seal-forming region is located on an outside surface of the seal-forming structure 3100.
[0191] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material, e.g. silicone rubber.
[0192] A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, resilient material such as silicone.
[0193] In certain forms of the present technology, a system is provided comprising more than one a seal-forming structure 3100, each being configured to correspond to a different size and/or shape range. For example, the system may comprise one form of a seal-forming structure 3100 suitable for a large sized head, but not a small sized head and another suitable for a small sized head, but not a large sized head.
5.2.3.1 Sealing Mechanisms
[0194] In one form, the seal-forming structure includes a sealing flange utilizing a pressure assisted sealing mechanism. In use, the sealing flange can readily respond to a system positive pressure in the interior of the plenum chamber 3200 acting on its underside to urge it into tight sealing engagement with the face. The pressure assisted mechanism may act in conjunction with elastic tension in the positioning and stabilising structure.
[0195] In one form, the seal-forming structure 3100 comprises a sealing flange and a support flange. The sealing flange comprises a relatively thin member with a thickness of less than about 1 mm, for example about 0.25 mm to about 0.45 mm, which extends around the perimeter of the plenum chamber 3200. Support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the marginal edge of the plenum chamber 3200, and extends at least part of the way around the perimeter. The support flange is or includes a spring-like element and functions to support the sealing flange from buckling in use.
[0196] In one form, the seal-forming structure may comprise a compression sealing portion or a gasket sealing portion. In use the compression sealing portion, or the gasket sealing portion is constructed and arranged to be in compression, e.g. as a result of elastic tension in the positioning and stabilising structure.
[0197] In one form, the seal-forming structure comprises a tension portion. In use, the tension portion is held in tension, e.g. by adjacent regions of the sealing flange.
[0198] In one form, the seal-forming structure comprises a region having a tacky or adhesive surface.
[0199] In certain forms of the present technology, a seal-forming structure may comprise one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having a tacky or adhesive surface.
5.2.4 Plenum Chamber
[0200] The patient interface 3000 includes a plenum chamber 3200 that has a perimeter 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 one form of the present technology, the plenum chamber may be part of a full-face mask, ora-nasal, nasal mask, nasal pillows or nasal cushion.
[0201] 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 of the plenum chamber 3200. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material.
[0202] The plenum chamber has an anterior side, which should be understood to be the external surface of the plenum chamber facing away from the patient in use. In some forms of the present technology, the plenum chamber may be comprised of two or more components. In one example, the anterior surface may comprise part of a rigid shell to which other portions of the plenum chamber are connected or mounted, either permanently, through the use of appropriate bonding or over-moulding techniques, or temporarily, through the use of complementary or snap lock fasteners.
[0203] In some examples, the plenum chamber and/or seal-forming structure may be configured to be removed from the patient interface and replaced with another plenum chamber and/or seal-forming structure, for example ones that differ structurally in some way, for examples ones of different size, type or shape. In this way, the patient may, for example, swap between a plenum chamber and seal-forming structure configured as a nasal mask, a full-face mask, a nasal cushion, and nasal pillows, or between small, medium and large masks of the same type. The plenum chamber and seal-forming structure may form a sub-assembly or module to make such interchanging more convenient for a patient.
[0204] The plenum chamber has a posterior side, which should be understood to be the internal surface of the plenum chamber. The posterior side of the plenum chamber has provided to it the seal-forming structure which, in use, receives the nose and/or mouth of the patient.
[0205] In certain forms of the present technology, the plenum chamber 3200 does not cover the eyes of the patient in use. In other words, the eyes are outside the pressurised volume defined by the plenum chamber. Such forms tend to be less obtrusive and/or more comfortable for the wearer, which can improve compliance with therapy.
[0206] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material, e.g. a transparent polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy. The use of a transparent material can aid a clinician to observe how the patient interface is located and functioning.
[0207] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.
5.2.5 Positioning and Stabilising Structure
[0208] The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealing position when being worn by the patient through the use of the positioning and stabilising structure 3300. Positioning and stabilising structure 3300 may be referred to as “headgear” since it contacts and engages with the patient's head in order to hold the patient interface 3000 in a sealing position.
[0209] In one form the positioning and stabilising structure 3300 provides a retention force at least sufficient to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.
[0210] In one form the positioning and stabilising structure 3300 provides a retention force to overcome the effect of the gravitational force on the patient interface 3000.
[0211] In one form the positioning and stabilising structure 3300 provides a retention force as a safety margin to overcome the potential effect of disrupting forces on the patient interface 3000, such as from tube drag, or accidental interference with the patient interface.
[0212] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured in a manner consistent with being worn by a patient while sleeping. In one example the positioning and stabilising structure 3300 has a low profile, or cross-sectional thickness, to reduce the perceived or actual bulk of the apparatus.
[0213] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a supine sleeping position with a back region of the patient's head on a pillow.
[0214] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a side sleeping position with a side region of the patient's head on a pillow.
[0215] In one form of the present technology, a positioning and stabilising structure 3300 is provided with a decoupling portion located between an anterior portion of the positioning and stabilising structure 3300, and a posterior portion of the positioning and stabilising structure 3300. The decoupling portion does not resist compression and may be, e.g. a flexible or floppy strap. The decoupling portion is constructed and arranged so that when the patient lies with their head on a pillow, the presence of the decoupling portion prevents a force on the posterior portion from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.
5.2.5.1 Headgear Strap(s)
[0216] In one form of the present technology, the positioning and stabilising structure 3300 is in the form of a headstrap arrangement 3300B, as shown in
[0217] The strap(s) 3330 may be constructed from a laminate of a fabric patient-contacting layer, a foam inner layer and a fabric outer layer. In one form, the foam is porous to allow moisture, (e.g., sweat), to pass through the strap(s) 3330. The strap(s) 3330 may be breathable to allow moisture vapour to be transmitted through the strap. In one form, the fabric outer layer comprises loop material to engage with a hook material portion.
[0218] In certain forms of the present technology, the strap(s) 3330 of the positioning and stabilising structure 3300B are configured to be extensible, e.g. resiliently extensible. For example the strap may be configured in use to be in tension, and to direct a force to draw a seal-forming structure into sealing contact with a portion of a patient's face. In an example the strap may be configured as a tie.
[0219] In certain forms of the present technology, the strap(s) 3330 of the positioning and stabilising structure 3300B is comprised to be bendable and e.g. non-rigid. An advantage of this aspect is that the strap is more comfortable for a patient to lie upon while the patient is sleeping. The strap(s) 3330 is sufficiently flexible to pass around the back of the patient's head and lie comfortably against the patient's head, even when under tension in use.
[0220] In certain examples of the present technology, the positioning and stabilising structures 3300B are configured to receive the strap 3330 at the locations superior to and proximate the patient's ears. If the strap 3330 connects to the positioning and stabilising structures too high with respect to the patient's head, the strap 3330 may have a tendency to ride up the back of the patient's head. Additionally, the strap 3330 could form too large of an angle with respect to the superior portions of the positioning and stabilising structure 3300B, resulting in the necessity for the patient to tighten the strap 3330 excessively, which could result in both excessive tension in the positioning and stabilising structure 3300B and make the strap 3330 more likely to ride up the back of the patient's head. Accordingly, it is advantageous for the connection between the strap 3330 and the positioning and stabilising structures 3300B to be provided as low as possible but spaced from the top of the patient's ear sufficiently that upon tightening of the strap 3330, the positioning and stabilising structures are not pulled into contact with the patient's ears as this may cause discomfort.
[0221] In certain forms of the present technology, a system is provided comprising more than one positioning and stabilizing structure 3300B, each being configured to provide a retaining force to correspond to a different size and/or shape range. For example, the system may comprise one form of positioning and stabilizing structure 3300B suitable for a large sized head, but not a small sized head, and another, suitable for a small sized head, but not a large sized head.
5.2.5.2 Gas Delivery Tube(s)
[0222] In some forms of the present technology, for example that of
[0223] In one example, the tubes 3310, 3320 may be substantially cylindrical. However, in other examples, the tubes may be formed with a variety of cross-sectional shapes. For example, a substantially D-shaped cross-sectional profile may be used; the flat side of this profile may contact the patient's face when being worn and may be more comfortable than a semi-circular profile.
[0224] In some forms of the present technology, the conduit headgear comprises a pair of tubes 3310, 3320 that deliver pressurised air from the downstream end of the air circuit to the seal-forming structure. As an example, in
[0225] In some forms of the present technology, as shown in
[0226] In the examples illustrated in
[0227] In certain examples of the present technology, the conduit headgear 3300A is formed from a suitably sprung material that provides sufficient stabilising forces that correctly locates the patient interface in a sealing arrangement on the patient's head. In certain other examples, the positioning and stabilising structure comprises a mechanism for connecting a headgear strap 3390 or other stabilising component to the headgear tubes. The headgear strap may supplement the stabilising forces provided by the conduit headgear and help correctly locate the patient interface in a sealing arrangement on the patient's head.
[0228] In these examples, the headgear strap may be connected directly or indirectly to the headgear tubes 3310, 3320. In the case of the patient interface shown in
[0229] The back strap 3390 may be secured to itself after passing through the slits in the tabs 3380, for example, with hook-and-loop fastening material. The back strap 3390 therefore is able to be adjusted to fit around different head sizes. In some forms of the technology, more than one tab may be provided to the tubes 3310, 3320 to provide the patient a range of alternative placement options for the back strap 3390. This may be helpful for ensuring appropriate application of sealing forces to the face.
[0230] The tubes 3310, 3320 of the conduit headgear 3300A may be formed from textile, spacer fabric and/or foam materials, in some examples. Portions of the tubes 3310, 3320 that contact the patient may be formed with textiles or fabrics for greater patient comfort. In some examples, the tubes may be formed of a semi-rigid material such as an elastomeric material, e.g. silicone. In these examples, the tubes may comprise thin sleeves of fabric or textiles wrapped around them. The sleeves may be more comfortable against the patient's face than the tubes without any covering.
[0231] As shown in
[0232] Since air can be contained and passed through the tubes 3310, 3320 of the conduit headgear 3300A in order to deliver pressurised air from the air circuit 4170 to the patient's airways, the conduit headgear may be described as being inflatable. It will be understood that an inflatable conduit headgear does not require all its components to be inflatable. For example, when the positioning and stabilising structure comprises the headgear tubes 3310, 3320 and back strap 3390, the headgear tubes are inflatable and the back strap is not inflatable.
5.2.6 Vent Structure
[0233] In one form, the patient interface 3000 includes a vent structure 3400 constructed and arranged to allow for the washout of exhaled gases, e.g. carbon dioxide. An example is shown in
[0234] In certain forms the vent structure 3400 is configured to allow a continuous vent flow from an interior of the plenum chamber 3200 to ambient whilst the pressure within the plenum chamber is positive with respect to ambient. The vent structure 3400 is configured such that the vent flow rate has a magnitude sufficient to reduce rebreathing of exhaled CO.sub.2 by the patient while maintaining the therapeutic pressure in the plenum chamber in use.
[0235] One form of the vent structure 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.
[0236] In one form of the technology the vent structure 3400 may be configured to be an integral part of the plenum chamber and/or the seal-forming structure. In a further form, the vent structure may be an integral part of the connection port 3600A, 3600B. In yet another form, the vent structure may be an integral part of the positioning and stabilising structure. In other forms of the technology the vent structure 3400 may be a separate component to the plenum chamber, seal-forming structure, connection port and/or positioning and stabilising structure, but may be provided to one of those components. The vent structure may be detachable for cleaning and replacing. In some forms of the present technology, the patient interface may be provided with more than one vent structure.
[0237] In one form of the technology the vent structure 3400 is formed from rigid medical grade plastics material. In alternative forms, the vent structure is formed from a soft woven mesh. In these forms, the mesh may be bounded by a rigid or semi-rigid frame to confer some structural integrity to the vent structure. In other forms, it may be formed as a moulding from a rigid plastics material.
[0238] As shown in
[0239] In one form, one or more additional vent structure 3400A may be provided in the nasal cushion 3020 (see
5.2.7 Connection Port
[0240] The connection ports 3600A, 3600B allow for connection of the patient interface 3000 to the downstream end portion of the air circuit 4170.
[0241] In some examples, such as that shown in
[0242] When the present technology is in use, the location of the connection port 3600A, 3600B, and therefore the location at which the downstream end portion of the air circuit 4170 connects to the patient interface 3000, depends on whether the patient has selected to wear the patient interface in a first use configuration or a second use configuration.
5.2.8 Closure
[0243] In one form, the connection ports 3600A, 3600B of the patient interface 3000 and conduit headgear 3300A comprise a closure 3786. The closure is arranged to be moveable between a closed condition, where the connection port is substantially sealed, and an open condition, where pressurised air from the air circuit is able to flow into the connection port. The closure allows the patient to seal or substantially close off the connection port when the air circuit is not connected. The closure may be a separate component, inserted by the patient as required, or formed integrally as part of the connection ports.
[0244] In one form of the technology the closure 3786 is formed from rigid medical grade plastics material. In alternative forms, the closure is formed from a softer, semi-rigid material such as silicone or the like. In these forms, the closure may be bounded by a rigid or semi-rigid frame or ring to confer some structural integrity to the closure.
[0245] In some examples, the closure 3786 may be constructed and arranged to allow for the washout of exhaled gases, e.g. carbon dioxide. Non-limiting examples of closures for use in these forms of technology are shown in
5.2.9 First Use Configuration/Second Use Configuration
[0246] In the present technology, the patient is able to select between a first use configuration and a second use configuration when wearing the patient interface.
[0247] The first use configuration should be understood to be an arrangement where, when the patient interface 3000 is being worn with a positioning and stabilising structure 3300 in the form of conduit headgear 3300A, the air circuit 4170 engages with the patient interface at a point superior to the patient's otobasion superior, i.e. the connection port is superior to the patient's otobasion superior. In this configuration, examples of which are shown in
[0248] This first use configuration places the connection port 3600A and downstream end of the air circuit 4170 generally away from the patient's face. Instead, the downstream end of the air circuit is located proximate the superior side of the patient's head before the remainder of the air circuit extends or falls away down the sides or back of the patient. An informal term for this configuration may be “tube up”.
[0249] The second use configuration should be understood to be an arrangement where, when the patient interface 3000 is being worn, the downstream end of the air circuit 4170 engages with the patient interface 3000 at a point inferior to the patient's otobasion superior, i.e. the connection port 3600A is inferior to the patient's otobasion superior. Examples of a patient interface 3000 in the second use configuration are shown in
[0250] In this second use configuration, the connection port 3600B may be provided to, or configured as part of, the anterior side of the plenum chamber 3200 as shown in
[0251] In these examples, the second use configuration places the connection port (3600A when part of the conduit headgear, 3600B when part of the plenum chamber) and downstream end of the air circuit 4170 proximate the patient's face or neck. The downstream end of the air circuit is located anterior or inferior to the patient's head, in front of the face or around the chin or neck, before the remainder of the air circuit extends or falls away. An informal term for this configuration may be “tube down”.
[0252] Patient interfaces in which the connection port is not positioned in front of the patient's face may be advantageous for patients who find an air circuit connecting to a patient interface in front of the face to be unsightly and/or obtrusive. For example, an air circuit connecting to a patient interface in front of the face may be prone to being tangled up in bedclothes or bed linen, particularly if the air circuit extends inferiorly from the patient interface in use. Forms of the technology with a patient interface with a connection port positioned proximate the top of the patient's head in use may make it easier or more comfortable for a patient to lie or sleep in one or more of the following positions: in a side or lateral position; in a supine position (i.e. on their back, facing generally upwards); and in a prone position (i.e. on their front, facing generally downwards). Moreover, connecting a conduit to the front of a patient interface may exacerbate a problem known as tube drag, wherein the conduit may provide an undesired drag force upon the patient interface thereby causing dislodgement of the patient interface away from the face while the patient is sleeping and jeopardising therapy.
[0253] Conversely, patient interfaces in which the connection port is positioned in front of the patient's face may be advantageous for some patients, particularly those who do not mind the presence of the air circuit in their sightline and are used to patient interfaces of this type. Some patients may wear the patient interface while awake and when their upper body is generally upright. The presence of the air circuit to the front of their body may be less obtrusive and/or more easily managed.
[0254] The present technology is directed towards a patient interface (e.g., a modular patient interface) that allows the patient to select between the first use and second use configurations, i.e. between “tube up” and “tube down” configurations. In some instances, there may be a trade-off between these tube up and tube down configurations.
[0255] For example, a tube up configuration when wearing conduit headgear may provide added freedom of movement and less obtrusiveness. It may afford the patient more freedom of choice by avoiding the need for having an air circuit connecting to the front of the patient. This may allow the patient to move more freely or face bed partners easily during therapy. However, a tube up configuration be not as stable when holding the patient interface in sealing contact with the face of the patient as there may be relatively more restrictions in designing conduit headgear that functions dually as both a headgear and a tube that delivers pressurised air, when compared to the design of headgear straps. In the instance where conduit headgear is less stable, it may be provided with a patient interface with a more robust seal forming structure to compensate for a reduction in system stability. In this case, the seal forming structure may be slightly more obtrusive to effect a more robust seal, when compared to a relatively less robust seal forming structure.
[0256] During the course of therapy, a patient may choose to alternate between a tube up or tube down configuration depending on their choice between the added freedom of movement and less obtrusiveness that conduit headgear provides versus the added stability of a headgear having straps and buckles. Other benefits include the ability to easily switch between the two configurations. For example, the patient may try the first, “tube up” configuration initially as it provides more freedom and only switch out the conduit headgear for conventional headgear straps if there is inadequate seal formation. Another benefit of a modular patient interface system where the connection ports for the air circuit are either in the patient interface or up the top of the conduit headgear may be a reduction in stock keeping units and therefore less cost to manufacture and reduced choices between systems.
[0257] In certain forms of the present technology, the patient interface 3000 may be provided to the patient as a therapy system comprising a plurality of components, to be assembled, connected to each other and interchanged according to personal preference. The patient selects the desired patient interface 3000 and the positioning and stabilising structure 3300 depending on their preference for a “tube up” or a “tube down” use configuration. In these forms, the therapy system may include at least: a patient interface 3000, comprising one or more of the following mask types: full face 3010, nasal mask, and nasal cushion 3020; and positioning and stabilising structure 3300, compromising conduit headgear 3300A and optionally a headstrap arrangement 3300B.
[0258] In certain forms of the present technology, the therapy system may include, in addition to the components mentioned above, one or more of the following: connection port 3600; vent structure 3400; plug structure 3500; and adaptors/connectors to facilitate the engagement of respective components to assemble a complete therapy system according to the patient's personal preference.
[0259] In some forms of the present technology, additional vents may be provided. In one example, if present, the conduit headgear 3300A may include a series of small openings which serve as vents. In another example, the seal forming structure 3100 may include a series of small openings which serve as vents.
[0260] The present technology shall now be described in respect of certain, non-limiting examples.
5.2.9.1 First Example
[0261] One example of the present technology is shown in
[0262] The patient interface includes a plenum chamber and seal-forming structure in the form of a full-face mask 3010 that, when worn by the patient, covers and forms a seal around the nose and mouth, and a positioning and stabilising structure 3300 in the form of conduit headgear 3300A, having left and right tubes 3310, 3320. The two tubes are fluidly connected at their upper ends to each other and to a connection port 3600.
[0263] The connection port 3600A is provided in use with an elbow 3610 which receives the downstream end of the air circuit 4170. When the conduit headgear is worn by the patient, the connection port is located superior to the patient's otobasion superior (refer to
[0264] In this example of the present technology, the sides of the plenum chamber 3200 of the full-face mask 3010 are configured with left and right air entry ports 3210, 3220. The left and right air entry ports 3210, 3220 are configured to be in fluid communication with the inferior ends 3310A, 3320A of the tubes of the conduit headgear 3300A. This allows delivery of pressurised air from the air circuit 4170 to the seal-forming structure (not visible in
[0265] The air entry ports 3210, 3220 and portions of the tubes 3310A, 3320A that engage with same are configured with appropriate attachment mechanisms, for example in the form of complementary male and female fittings, such as interlocking grooves and pegs.
[0266] One example of the attachment mechanism used to connect the tubes to the air entry ports is shown in respect of the left tube 3310 in
[0267] In a hard-to-hard type engagement between the tubes 3310, 3320 and the air entry ports 3210, 3220 of the patient interface 3000, a pressure activated seal such as a peripheral sealing flange may be used. When pressurised gas is supplied through the tubes 3310, 3320 the sealing flange is urged against the join between the tubes and the inner circumferential surface of air entry ports of the plenum chamber to enhance the seal between them. If the air entry ports are soft and a rigid connector is provided to the tube the pressure activated seal as described earlier may also be used to ensure the connection is air-tight, although it may also not be necessary.
[0268] The anterior side of the plenum chamber of the full-face mask 3010 is also provided with a connection port 3600B. In a first use configuration of the patient interface as shown in
[0269] The vent structure 3400 may be configured as a vent module to be inserted or otherwise engaged into an appropriately configured opening, such as the connection port 3600B in the patient interface 3000. In this form, the vent structure may include flanges or similar structures, which engage in an interlocking manner with complementary structures in the patient interface or connection port. To encourage an adequate seal, a pressure activated seal such as a peripheral sealing flange may also be used. It should be understood that additional vent structures may be present; these may also be configured to be removable or alternatively are integrally formed with other components of the patient interface 3000.
[0270] To convert the patient interface 3000 to the second use configuration, shown in
[0271] In the second use configuration, the air entry ports 3210, 3220 in the patient interface are closed to prevent leaking of pressurised air. The air entry ports 3210, 3220 may be closed with a vent structure 3400 as previously described or sealed off with a plug structure 3500 or stop. This plug structure 3500 may be formed from medical grade plastics material and may be configured with flanges or similar structures, which engage in an interlocking manner with complementary structures in the air entry ports 3210, 3220. As with the vent structure, the plug module may be provided with a pressure activated seal such as a peripheral sealing flange or the like. In forms incorporating a plug module or stop, air exhaled by the patient may be vented by vent structures provided, for example integrally formed, in another part of the patient interface 3000.
[0272] In this example of the present technology, the full-face mask 3010 is configured with headgear attachment points 3350 for the headstrap 3300B. The attachment points may take a variety of forms including loops, as shown in
[0273] Another example of the present technology is shown in
[0274] In some examples, the patient interface 3000 may be provided with a pair of headgear attachment points 3350; these may be masks with a two-point headgear attachment arrangement. In other examples, the patient interface 3000 may be provided with two opposing pairs of headgear attachment points 3350; these may be masks with a four-point headgear attachment arrangement as shown in
[0275] An alternative example is shown in
[0276] The attachment points 3350 are in the form of push-fit buttons in
[0277] In the example of
[0278] In the second use configuration, the downstream end of the air circuit 4170 is inserted into the connection port 3600B on the anterior side of the plenum chamber 3200 of the full-face mask 3010 of
[0279] This arrangement places the connection port 3600B inferior to the otobasion superior, proximate the face and chin of the patient. In some examples, the straps 3330 of the positioning and stabilising structure 3300B worn in the second use configuration may be used to close off the air entry ports. In these examples, a portion of the straps may comprise integrated plugs complementary to the air entry ports, and configured to connect to the air entry ports in use.
[0280] The patient is able to change the patient interface 3000 shown in
[0281] The patient interface may also be swapped out if desired. An advantage of the present form of the technology is its relative modularity; by using common connectors and fittings for the tubes of the conduit headgear, air entry ports, and connection ports, the patient interface may be readily interchanged between full-face masks, nasal cushions, nasal pillows and nasal masks, for example.
[0282] For some examples of the patient interface 3000, such as full-face or nasal masks, when in the first use configuration, the inferior ends of the tubes 3310, 3320 of the conduit headgear may engage directly with the plenum chamber 3200 as shown in
[0283] However, in some other examples of the patient interface, such as nasal cushions which usually have a plenum chamber with an overall smaller surface area, connectors or adaptors may be required to allow connection of the tubes to facilitate delivery of pressurised air to the plenum chamber and seal-forming structure. In such example, the tubes engage with air entry ports in the adaptors, and the adaptors in turn engage with the air entry ports of the plenum chamber 3200.
5.2.9.2 Second Example
[0284] Rather than swapping out the positioning and stabilising structure, as with the first example, some patients may prefer to simply swap the placement of the air circuit relative to the patient interface.
[0285] In a second example of the present technology, shown in
[0286] The tubes 3310, 3320, are each provided with a tab 3380, configured to be engaged with a backstrap 3390. The backstrap 3390 is sufficiently flexible to pass around the back of the patient's head and lie comfortably against the patient's head, even when under tension in use.
[0287] The tabs 3380 project away from the tubes in a generally posterior direction. The tabs have slits in them to receive the ends of the backstrap. The strap may be secured to itself after passing through the slits in the tabs, for example, with hook-and-loop fastening material. The strap therefore is able to be adjusted to fit around different head sizes. In some forms of the technology, more than one tab may be provided to provide the patient a range of alternative placement options for the backstrap. This may be helpful for ensuring appropriate application of sealing forces to the face.
[0288] In the example of
[0289] The nasal mask 3020 is also provided with a connection port 3600B on its anterior side as shown in a close up view in
[0290] When one of the two connection ports 3600A, 3600B receives the air circuit 4170, the other connection port is open. This may compromise the delivery of pressurised air to the patient. To prevent this, a vent structure 3400 or plug 3500 is inserted into the open connection port. In one form, the when one of the two connection ports 3600A, 3600B receives the air circuit 4170, the other connection port is substantially sealed with a closure.
[0291] In the first use configuration, when the air circuit delivers pressurised air to the patient interface via the elbow 3610 and tubes 3310, 3320, the vent structure 3400 or plug 3500 is inserted into the connection port 3600B in the plenum chamber 3200 of the nasal mask 3020 to ensure minimal or no loss of pressurised air from the patient interface (other than that exiting through the vent structure).
[0292] In the second use configuration, when the air circuit is delivering pressurised air to the patient interface via the nasal mask, the vent structure 3400 or plug 3500 is inserted into the connection port 3600A at the crown connector 3360.
[0293] As previously described, the respective connection ports 3600A, 3600B may be configured and arranged with identical engagement mechanisms to facilitate the connection to the air circuit. In some examples, the vent structure or plug is provided with complementary engagement mechanisms. This allows the same vent structure 3400 or plug 3500 to be interchangeable between the connection ports 3600A, 3600B, advantageously reducing the number of components that need to be manufactured and supplied as part of the patient interface 3000.
[0294] To convert the patient interface 3000 to the second use configuration shown in
5.2.9.3 Third Example
[0295] In a third example, shown in
[0296] In this example, while the conduit headgear 3300A is worn in the first use configuration as per
[0297] In this example, the manner of engagement of the tubes 3310, 3320 of the conduit headgear 3300A with the plenum chamber 3200 is such that the tubes may swivel or otherwise rotate relative to the nasal cushion 3020.
[0298] For example, in
[0299] In another example, in
[0300] It will be understood that, in this example, the conduit headgear 3300A is the first positioning and stabilising structure. However, when in the second use configuration a force is still required to be applied to ensure the seal-forming structure 3100 remains in place on the patient's face. Therefore, when the conduit headgear 3300 is in the inverted state of
[0301] The headstrap arrangement 3300B includes one or more straps 3330 that are worn about the head of the patient above the otobasion superior. In contrast to the embodiment of the headstrap arrangement of
[0302] In this second use configuration, the connection port 3600A has been moved from its original position superior to the otobasion superior to a position where it is inferior to the otobasion superior. In the second use configuration, the connection port 3600A and air circuit 4170 is proximate the chin and neck of the patient.
5.2.9.4 Closure Examples
[0303] In the first use configuration, when the air circuit delivers pressurised air to the patient interface via the elbow 3610 and tubes 3310, 3320, the connection port 3600B in the plenum chamber 3200 of the nasal mask 3020 is closed (e.g., using a vent structure 3400, plug structure 3500 or a closure 3786) to ensure minimal or no loss of pressurised air from the patient interface (other than that exiting through the vent structure, if present).
[0304] In the second use configuration, when the air circuit is delivering pressurised air to the patient interface via the nasal mask, the connection port 3600A at the crown connector 3360 is closed (e.g., using a vent structure 3400, plug structure 3500 or a closure 3786) to ensure minimal or no loss of pressurised air from the patient interface (other than that exiting through the vent structure, if present).
[0305] As previously described, the respective connection ports 3600A, 3600B may be configured and arranged with identical or similar engagement mechanisms to facilitate the connection to the air circuit.
[0306] The engagement mechanisms, such as snap-lock or push-fit fittings, are complementary to the fittings provided to the downstream end of the air circuit 4170, allowing the air circuit to be inserted and sealingly engage with one or the other of the two connection ports 3600A, 3600B. In the illustrated examples of
[0307] The connection ports 3600A and 3600B may comprise a closure 3786 covering an opening into which the downstream end of the air circuit may be inserted. The closure is moveable, either by the patient or by the downstream end (or elbow) of the air circuit such that it can change from a closed condition, where the connection port is substantially sealed (in some examples, there may be some functionality for venting exhaled carbon dioxide) to an open condition, where pressurised air is delivered to the tubes of the conduit headgear and into the patient's airways. The closure may be configured in a number of ways.
[0308] In a first example of the closure 3786, shown in an open condition in
[0309] Circumscribing the rigid ring 3788 is a loop 3716 to which a lid closure 3720 is connected by a hinge portion 3789. The hinge portion 3789 may be formed of a soft, deformable plastics material allowing the closure to be placed in a closed condition. The patient may simply mate the inner surface 3721 of the lid with the rigid ring 3788 of the closure 3786. In some examples, the lid may be a separate structure, not connected to the ring. In this example, the ring 3788 may be provided without the hinge portion 3789. In some examples, the hinge portion 3789 may be removably coupled to the lid closure 3720 and/or the ring 3788.
[0310] The lid is provided with a plurality of apertures; these serve as vent holes 3799 to vent carbon dioxide exhaled by the patient but without allowing undue volumes of pressurised air to be lost. The number of apertures and their dimensions may vary according to the desired volume of exhaled gases to be vented. They need to be sufficient to reduce rebreathing of exhaled CO.sub.2 by the patient while maintaining the therapeutic pressure in the plenum chamber in use.
[0311]
[0312] Although shown in
[0313] In some examples, the ends of the track 3750 may include a stop in the form of a moulded peg or the like to ensure the lid 3720 does not become disengaged from the body should it move too far along the track 3750.
[0314] In some examples, the lid 3720 may be provided with a plurality of apertures arranged and dimensioned for venting purposes. In other examples, the raised mouth of the ring may be formed with a series of notches extending posterior of the top surface of the mouth. In this example, while the lid may be able to form a seal with the top surface of the mouth, the notches serve to allow exhaled gases to be vented. It will be appreciated that the flanges of the lid may be arranged to ensure sufficient clearance of the lid as it is moved from the closed and open conditions. The dimensions of the notches need to be sufficient to reduce rebreathing of exhaled CO.sub.2 by the patient while maintaining the therapeutic pressure in the plenum chamber in use.
[0315] In the examples of
[0316] In this example, the closure 3786 is in the form of a ring 3788, best seen in
[0317] However, in other examples, the closure flaps 3760 may be pivotally hinged or otherwise mounted to the perimeter of the ring 3788 as shown in
[0318] In an example, in the closed condition as shown in
[0319] In an open condition as shown in
[0320] In
[0321] In
[0322] In examples where the closure flaps are mounted by an outer edge to the ring such as that of
[0323] While the ring 3788 itself may be formed from polypropylene, polycarbonate, nylon or the like, in some examples, the closure flaps may be formed from a less rigid plastics material, such as liquid silicone rubber of an appropriate shore hardness. The manner in which the closure flaps are connected to the strut (or perimeter of the ring) are such that the connected portion of the closure flap functions as a living hinge. In alternative forms, the closure flaps may be more rigid but connected via specific hinge structure to the strut (or perimeter of the ring).
[0324] An alternative example in which the action of inserting the downstream end portion of the air circuit into the connection ports may place the closure into an open condition from a closed condition is shown in
[0325]
[0326] In the examples of
[0327] It should be appreciated that the connection ports of the patient interface may be provided such that each has a different type of closure. For example, the connection port 3600A provided to the conduit headgear may be provided with a closure such as that described in
6 GLOSSARY
[0328] For the purposes of the present technology disclosure, 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.
6.1 General
[0329] Air: In certain forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology air may be taken to mean some other combination of breathable gases, e.g. atmospheric air enriched with oxygen.
[0330] Ambient: In certain forms of the present technology, the term ambient will be taken to mean (i) external of the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.
[0331] Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjustable, e.g. from breath to breath, between minimum and maximum limits, depending on the presence or absence of indications of SDB events.
[0332] Continuous Positive Airway Pressure (CPAP) therapy: Respiratory pressure therapy in which the treatment pressure is approximately constant through a respiratory cycle of a patient. 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.
[0333] Flow therapy: Respiratory therapy comprising the delivery of a flow of air to an entrance to the airways at a controlled flow rate referred to as the treatment flow rate that is typically positive throughout the patient's breathing cycle.
[0334] Patient: A person, whether or not they are suffering from a respiratory condition.
[0335] Pressure: Force per unit area. Pressure may be expressed in a range of units, including cmH.sub.2O, g-f/cm.sup.2 and hectopascal. 1 cmH.sub.2O is equal to 1 g-f/cm.sup.2 and is approximately 0.98 hectopascal (1 hectopascal=100 Pa=100 N/m2=1 millibar-0.001 atm). In this specification, unless otherwise stated, pressure is given in units of cmH.sub.2O.
[0336] The pressure in the patient interface is given the symbol Pm, while the treatment pressure, which represents a target value to be achieved by the interface pressure Pm at the current instant of time, is given the symbol Pt.
[0337] Respiratory Pressure Therapy (RPT): The application of a supply of air to an entrance to the airways at a treatment pressure that is typically positive with respect to atmosphere.
[0338] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.
6.2 Materials
[0339] Silicone or Silicone Elastomer: A synthetic rubber. In this specification, a reference to silicone is a reference to liquid silicone rubber (LSR) or a compression moulded 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, an exemplary 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.
[0340] Polycarbonate: a thermoplastic polymer of Bisphenol-A Carbonate.
6.3 Mechanical Properties
[0341] Resilience: Ability of a material to absorb energy when deformed elastically and to release the energy upon unloading.
[0342] Resilient: Will release substantially all of the energy when unloaded. Includes e.g. certain silicones, and thermoplastic elastomers.
[0343] Hardness: The ability of a material per se to resist deformation (e.g. described by a Young's Modulus, or an indentation hardness scale measured on a standardised sample size).
[0344] ‘Soft’ materials may include silicone or thermo-plastic elastomer (TPE), and may, e.g. readily deform under finger pressure.
[0345] ‘Hard’ materials may include polycarbonate, polypropylene, steel or aluminium, and may not e.g. readily deform under finger pressure.
[0346] Stiffness (or rigidity) of a structure or component: The ability of the structure or component to resist deformation in response to an applied load. The load may be a force or a moment, e.g. compression, tension, bending or torsion. The structure or component may offer different resistances in different directions. The inverse of stiffness is flexibility.
[0347] Floppy structure or component: A structure or component that will change shape, e.g. bend, when caused to support its own weight, within a relatively short period of time such as 1 second.
[0348] Rigid structure or component: A structure or component that will not substantially change shape when subject to the loads typically encountered in use. An example of such a use may be setting up and maintaining a patient interface in sealing relationship with an entrance to a patient's airways, e.g. at a load of approximately 20 to 30 cmH.sub.2O pressure.
[0349] As an example, an I-beam may comprise a different bending stiffness (resistance to a bending load) in a first direction in comparison to a second, orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.
6.4 Anatomy of the Face
[0350] Auricle: The whole external visible part of the ear.
[0351] (nose) Bony framework: The bony framework of the nose comprises the nasal bones, the frontal process of the maxillae and the nasal part of the frontal bone.
[0352] (nose) Cartilaginous framework: The cartilaginous framework of the nose comprises the septal, lateral, major and minor cartilages.
[0353] 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.
[0354] Lip, lower (labrale inferius):
[0355] Lip, upper (labrale superius):
[0356] 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.
[0357] Otobasion inferior: The lowest point of attachment of the auricle to the skin of the face.
[0358] Otobasion superior: The highest point of attachment of the auricle to the skin of the face.
[0359] Sagittal plane: A vertical plane that passes from anterior (front) to posterior (rear). The midsagittal plane is a sagittal plane that divides the body into right and left halves.
6.5 Anatomy of the Skull
[0360] Frontal bone: The frontal bone includes a large vertical portion, the squama frontalis, corresponding to the region known as the forehead.
[0361] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.
[0362] 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.
[0363] 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.
[0364] 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.
[0365] 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.
[0366] Orbit: The bony cavity in the skull to contain the eyeball.
[0367] Parietal bones: The parietal bones are the bones that, when joined together, form the roof and sides of the cranium.
[0368] 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.
[0369] 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.
6.6 Patient Interface
[0370] Anti-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 CO.sub.2 rebreathing by a patient.
[0371] Elbow: An elbow is an example of a structure that directs an axis of flow of air travelling therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be more, or less than 90 degrees. The elbow may have an approximately circular cross-section. In another form the elbow may have an oval or a rectangular cross-section. In certain forms an elbow may be rotatable with respect to a mating component, e.g. about 360 degrees. In certain forms an elbow may be removable from a mating component, e.g. via a snap connection. In certain forms, an elbow may be assembled to a mating component via a one-time snap during manufacture, but not removable by a patient.
[0372] 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.
[0373] Headgear: Headgear will be taken to mean a form of positioning and stabilizing structure designed for use on a head. For example the headgear may comprise 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. Alternatively, the headgear may be in the form of one or two gas delivery tubes which may conform somewhat to the shape of the head.
[0374] 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.
[0375] Plenum chamber: a mask plenum chamber will be taken to mean a portion of a patient interface having walls at least partially enclosing a volume of space, the volume having air therein pressurised above atmospheric pressure in use. A shell may form part of the walls of a mask plenum chamber.
[0376] Seal: May be a noun form (“a seal”) which refers to a structure, or a verb form (“to seal”) which refers to the effect. Two elements may be constructed and/or arranged to ‘seal’ or to effect ‘sealing’ therebetween without requiring a separate ‘seal’ element per se.
[0377] Shell: A shell will be taken to mean a curved, relatively thin structure having bending, tensile and compressive stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, a shell may be faceted. In some forms a shell may be airtight. In some forms a shell may not be airtight.
[0378] 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 delivery conduit, the sub-assembly of components preferably comprises a matched pair of cylindrical conduits. There may be little or no leak flow of air from the swivel in use.
[0379] Tie (noun): A structure designed to resist tension.
[0380] Vent: (noun): A structure that allows a flow of air from an interior of the mask, or conduit, to ambient air for clinically effective washout of exhaled gases. For example, a clinically effective washout may involve a flow rate of about 10 litres per minute to about 100 litres per minute, depending on the mask design and treatment pressure.
7 OTHER REMARKS
[0381] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in Patent Office patent files or records, but otherwise reserves all copyright rights whatsoever.
[0382] Unless the context clearly dictates otherwise and where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range, and any other stated or intervening value in that stated range is encompassed within the technology. The upper and lower limits of these intervening ranges, which may be independently included in the intervening ranges, are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.
[0383] Furthermore, where a value or values are stated herein as being implemented as part of the technology, it is understood that such values may be approximated, unless otherwise stated, and such values may be utilized to any suitable significant digit to the extent that a practical technical implementation may permit or require it.
[0384] Unless 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.
[0385] When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as a substitute. Furthermore, unless specified to the contrary, any and all components herein described are understood to be capable of being manufactured and, as such, may be manufactured together or separately.
[0386] 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.
[0387] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and/or materials which are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.
[0388] 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.
[0389] The subject headings used in the detailed description are included only for the ease of reference of the reader and should not be used to limit the subject matter found throughout the disclosure or the claims. The subject headings should not be used in construing the scope of the claims or the claim limitations.
[0390] 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.
[0391] 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.
8 REFERENCE SIGNS LIST
[0392]
TABLE-US-00004 patient 1000 bed partner 1100 patient interface 3000 full face mask 3010 nasal cushion 3020 nasal pillows 3030 oro - nasal mask 3040 seal - forming structure 3100 elbow 3160 plenum chamber 3200 air entry port 3210 air entry port 3220 positioning and stabilising 3300 structure/conduit headgear left tube of conduit headgear 3310 right tube of conduit headgear 3320 strap 3330 attachment point 3350 crown connector 3360 rigid connector 3370 tab 3380 back strap 3390 vent structure 3400 plug structure 3500 connection port 3600 elbow 3610 adaptor 3700 adaptor swivel ring 3710 portion 3715 loop 3716 lid 3720 lid closure 3720 one - piece elbow 3720 adaptor elbow 3722 lid enclosure 3720 inner surface 3721 portion 3730 body 3740 slots 3742 opening 3745 raised mouth (or body) 3746 flanges 3747 track 3750 closure flap 3760 gap 3765 channels 3766 strut 3770 wedges 3780 closure 3786 ring 3788 hinge portion 3789 seal 3790 central aperture 3795 additional vent holes 3799 vent holes 3799 frame extension 3800 arms 3810 RPT device 4000 air circuit 4170 humidifier 5000 conduit headgear 3300A headstrap 3300B headstrap 3300B tubes 3310A inferior end of left tube 3310A inferior end of right tube 3320A vent structure 3400A connection port - conduit headgear 3600A connection port - patient interface 3600B