Source: http://www.google.com/patents/US7942148?dq=6,073,142
Timestamp: 2015-08-04 11:19:53
Document Index: 184879324

Matched Legal Cases: ['Application No. 60', 'application No. 60', 'Application No. 07784697', 'Application No. 2003275762', 'Application No. 09161984', 'Application No. 2006', 'Application No. 200710000902', 'Application No. 03810331']

Patent US7942148 - Compact oronasal patient interface - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA breathing arrangement includes a patient interface, at least one inlet conduit, and a headgear assembly. The patient interface includes a mouth covering assembly including a cushion structured to sealingly engage around exterior of a patient's mouth in use, a nozzle assembly including a pair of nozzles...http://www.google.com/patents/US7942148?utm_source=gb-gplus-sharePatent US7942148 - Compact oronasal patient interfaceAdvanced Patent SearchPublication numberUS7942148 B2Publication typeGrantApplication numberUS 10/584,711PCT numberPCT/AU2004/001832Publication dateMay 17, 2011Filing dateDec 24, 2004Priority dateDec 31, 2003Fee statusPaidAlso published asCN1901961A, CN1901961B, CN1973914A, CN1973914B, CN101214402A, CN101214402B, CN101628142A, CN101628142B, CN103785090A, EP1701759A1, EP1701759A4, EP1701759B1, EP2510968A1, US7658189, US7708017, US9067033, US20060237017, US20070144525, US20070186930, US20100132717, US20110209709, WO2005063328A1Publication number10584711, 584711, PCT/2004/1832, PCT/AU/2004/001832, PCT/AU/2004/01832, PCT/AU/4/001832, PCT/AU/4/01832, PCT/AU2004/001832, PCT/AU2004/01832, PCT/AU2004001832, PCT/AU200401832, PCT/AU4/001832, PCT/AU4/01832, PCT/AU4001832, PCT/AU401832, US 7942148 B2, US 7942148B2, US-B2-7942148, US7942148 B2, US7942148B2InventorsAaron Davidson, Michael Gunaratnam, Susan Lynch, Milind Raje, Gary Robinson, Steven Lubke, Gregory Smart, Philip Kwok, Rupert ScheinerOriginal AssigneeResmed LimitedExport CitationBiBTeX, EndNote, RefManPatent Citations (101), Non-Patent Citations (97), Referenced by (9), Classifications (14), Legal Events (2) External Links: USPTO, USPTO Assignment, EspacenetCompact oronasal patient interface
US 7942148 B2Abstract
A breathing arrangement includes a patient interface, at least one inlet conduit, and a headgear assembly. The patient interface includes a mouth covering assembly including a cushion structured to sealingly engage around exterior of a patient's mouth in use, a nozzle assembly including a pair of nozzles structured to sealingly engage within nasal passages of a patient's nose in use, and a flexible element connecting the mouth covering assembly and the nozzle assembly. The at least one inlet conduit is structured to deliver breathable gas into at least one of the mouth covering assembly and the nozzle assembly for breathing by the patient. The headgear assembly is removably connected to at least one of the mouth covering assembly and the nozzle assembly so as to maintain the mouth covering assembly and the nozzle assembly in a desired position on the patient's face.
Images(59) Claims(48)
a patient interface including
a mouth covering assembly including a cushion structured to sealingly engage around an exterior of a patient's mouth in use,
a nozzle assembly including a pair of nozzles structured to sealingly engage within nasal passages of a patient's nose in use, and
a flexible element connecting the mouth covering assembly and the nozzle assembly;
at least one inlet conduit structured to deliver breathable gas into at least one of the mouth covering assembly and the nozzle assembly for breathing by the patient; and
a headgear assembly directly and removably connected to the mouth covering assembly that, in use, follows two vectors, so as to maintain the mouth covering assembly and the nozzle assembly in a sealed position on the patient's face.
2. The breathing arrangement according to claim 1, wherein the mouth covering assembly provides a first chamber and the nozzle assembly provides a second chamber.
3. The breathing arrangement according to claim 2, wherein the flexible element includes a conduit that allows gas to pass between the first and second chambers.
4. The breathing arrangement according to claim 1, wherein the nozzle assembly is adapted to connect to an inlet conduit to deliver breathable gas to the patient's nose.
5. The breathing arrangement according to claim 1, wherein the mouth covering assembly is adapted to connect to an inlet conduit to deliver breathable gas to the patient's mouth.
6. The breathing arrangement according to claim 1, wherein the mouth covering assembly and the nozzle assembly form a single chamber.
7. The breathing arrangement according to claim 1, wherein the cushion, nozzles, and flexible element are integrally formed as a one-piece structure.
8. The breathing arrangement according to claim 1, wherein the cushion includes a non-face-contacting portion and a face-contacting portion, the non-face-contacting portion being structured to be removably attached to a substantially rigid frame and the face-contacting portion having a resilient membrane structured to provide a seal.
9. The breathing arrangement according to claim 8, wherein the cushion includes a gusset portion between the non-face-contacting portion and the face-contacting portion.
10. The breathing arrangement according to claim 8, wherein the cushion has a side wall, a rim extending away from the side wall, and a membrane that substantially surrounds the rim.
11. The breathing arrangement according to claim 10, wherein the nozzles are mounted upon the side wall.
12. The breathing arrangement according to claim 11, wherein the nozzles are angled with respect to the side wall.
13. The breathing arrangement according to claim 8, wherein an inner edge of the membrane defines an aperture, the aperture having a general oval shape.
14. The breathing arrangement according to claim 13, wherein the aperture includes an arcuate protruding portion along an upper and/or lower edge thereof.
15. The breathing arrangement according to claim 10, wherein a rim is provided on lateral sides of the side wall.
16. The breathing arrangement according to claim 8, wherein the membrane has a thickness that is less than a thickness of the rim.
17. The breathing arrangement according to claim 1, wherein the headgear assembly includes a strap routed around the top of the patient's ears.
18. The breathing arrangement according to claim 1, wherein the headgear assembly may be rotated with respect to the patient interface so as to adjust a position of the headgear assembly with respect to the patient interface in use, without detaching the headgear assembly and the patient interface.
19. The breathing arrangement according to claim 1, wherein the headgear assembly is connected to the patient interface with a snap-fit.
20. The breathing arrangement according to claim 1, wherein the patient interface includes a frame, the frame including an inlet conduit coupled to one side thereof and an anti-asphyxia valve module coupled to an opposite side thereof.
21. The breathing arrangement according to claim 1, wherein the nozzles are blocked from fluid communication with the cushion.
22. The breathing arrangement according to claim 1, wherein the cushion and nozzles are formed from one of a gel-like material or foam-like material.
23. The breathing arrangement according to claim 1, wherein the nozzles are formed separately from the cushion and selectively mounted thereto.
24. The breathing arrangement according to claim 1, wherein the patient interface includes a frame, the frame having corrugations that add flexibility to the frame.
25. The breathing arrangement according to claim 1, wherein each nozzle includes a conduit having a concertina configuration that adds flexibility to the nozzle.
26. The breathing arrangement according to claim 1, wherein the nozzles are mounted within rounded recesses to add flexibility to the nozzles.
27. The breathing arrangement according to claim 1, wherein each nozzles includes a conduit having a varying cross-sectional configuration.
28. The breathing arrangement according to claim 1, wherein each nozzle includes a gusset portion that changes the sealing force in accordance with the treatment pressure.
29. The breathing arrangement according to claim 1, wherein each nozzle includes a thin membrane that surrounds each nozzle.
30. The breathing arrangement according to claim 1, further comprising a nozzle support member that engages the nozzles to support the nozzles in a rigid configuration for alignment.
31. The breathing arrangement according to claim 1, wherein the cushion has a boomerang shape.
32. A patient interface for a breathing arrangement that delivers breathable gas to a patient, the patient interface comprising:
a cushion structured to sealingly engage around an exterior of a patient's mouth in use, the cushion including
a flexible side wall structured to be removably attached to a frame,
a rim extending away from the side wall, and
a membrane provided to substantially surround the rim; and
a pair of nozzles structured to sealingly engage within nasal passages of a patient's nose in use, each of nozzles including a conduit that extends from the side wall of the cushion and supports each nozzle,
wherein each conduit allows gas to pass between each of the nozzles and the cushion.
33. The patient interface according to claim 32, wherein the membrane has a substantially flat profile.
34. The patient interface according to claim 32, wherein the inner edge of the membrane defines an aperture having a generally oval shape.
35. The patient interface according to claim 34, wherein the upper and/or lower edge of the aperture includes an arcuate protruding portion.
36. The patient interface according to claim 32, wherein the side wall supporting the nozzles includes an arcuate configuration.
37. The patient interface according to claim 32, wherein the rim is provided on lateral sides of the side wall only.
38. The patient interface according to claim 32, wherein the nozzles are angled with respect to the side wall.
39. The patient interface according to claim 32, wherein the side wall includes a gusset portion.
40. A breathing arrangement that delivers breathable gas to a patient, the breathing arrangement comprising:
a substantially rigid frame; and
a flexible side wall structured to be removably attached to the frame,
a pair of nozzles structured to sealingly engage within nasal passages of a patient's nose in use, each of nozzles including a conduit that extends from the side wall of the cushion and supports each nozzle;
41. The breathing arrangement according to claim 40, wherein the membrane has a substantially flat profile.
42. The breathing arrangement according to claim 40, wherein the inner edge of the membrane defines an aperture having a generally oval shape.
43. The breathing arrangement according to claim 42, wherein the upper and/or lower edge of the aperture includes an arcuate protruding portion.
44. The breathing arrangement according to claim 40, wherein the side wall supporting the nozzles includes an arcuate configuration.
45. The breathing arrangement according to claim 40, wherein the rim is provided on lateral sides of the side wall only.
46. The breathing arrangement according to claim 40, wherein the nozzles are angled with respect to the side wall.
47. The patient interface according to claim 40, wherein the side wall includes a gusset portion.
48. The breathing arrangement according to claim 40, wherein the frame is adapted to connect to an inlet conduit for delivering breathable gas. Description
This national phase application claims the benefit of PCT Application No. PCT/AU2004/001832, filed Dec. 24, 2004, which claims the benefit of U.S. Provisional Application No. 60/533,214 filed Dec. 31, 2003, each of which is incorporated herein in its entirety.
Referring to FIG. 1 a, the upper chamber 12 includes a nozzle assembly 16 supported by a frame including a first connector on each lateral end thereof, as described in U.S. Pat. No. 7,318,437 and incorporated herein by reference in its entirety. The nozzle assembly 16 is secured to the frame via a clip 18 which in this embodiment supports a pressure measurement port 20. The nozzle assembly 16 may include a pair of nozzles 17 (see FIGS. 1 c and 1 d).
As shown in FIGS. 1 a-10 d, the lower chamber 14 includes a rigid polycarbonate frame 38 which defines a mouth covering chamber 40 (see FIG. 1 c) and a soft (e.g., compliant, resilient) silicone cushion 42 which contacts the patient and forms a seal. The lower chamber 14 closely resembles the mouth chamber and mouth cushion described in U.S. Pat. No. 5,560,354, the contents of which are hereby incorporated by cross-reference. However it may take a variety of forms, such as described in U.S. Provisional Patent application No. 60/483,622 filed 1 Jul. 2003. The cushion 42 may be attached to the frame 38 by connecting a base edge of the cushion 42 to the frame 38, e.g., via adhesives and/or a tongue and groove arrangement. In another form, connection may be achieved by stretching the cushion 42 over the outer edge of the frame 38.
In a third embodiment of the invention, as shown in FIGS. 3 a and 3 b, inlet air is directed directly to the lower chamber 14 through a swivel assembly 50. The upper chamber 12 does not have any inlet conduits but instead the air is directed to the upper chamber 12 by traveling through a conduit extending from the first surface 36 to the second surface 37. The use of a swivel assembly 50 has the advantage that the inlet conduit (not shown, but connected to end 52 of swivel assembly 50) can be routed from any direction. Further, nozzle assembly 16 need not be provided with second connectors 34 and elbow connectors 26 as shown in FIG. 1 a. Instead, a pair of plugs 54 may be placed into each end of the nozzle assembly 16, as described in U.S. Pat. No. 7,318,437 and entitled “Nasal Assembly”, incorporated herein by reference in its entirety.
FIGS. 5 a-5 d illustrate yet another embodiment of the invention. As can be seen from FIG. 5 a, a swivel assembly 50 provides air from an air delivery tube (not shown) and supplies it to the mouth covering chamber 40 (best shown in FIG. 5 b). The cushion 42 is connected to the rigid frame 38 of the mouth covering chamber 40 via a cushion clip 56. As best shown in FIG. 5 b, the nozzles 17 are connected or provided directly to the outer face contacting portion of the cushion 42 which takes the form of a thin silicone membrane 58. The membrane 58 performs the dual function of forming a seal around the lips of a patient and additionally supporting the nozzles 17. The inherent flexibility of the membrane 58 provides a range of adjustment to adapt to the different geometry of a wide range of patients and in addition allows for any movement of their jaw and head position during sleep. It should be noted that whilst this embodiment describes nozzles (which may be in the form of nasal pillows, nasal prongs, cannula, or nasal puffs) 17 of a similar form to those disclosed in U.S. Pat. No. 7,318,437, the contents of which are hereby incorporated by cross-reference, they may take the form of any nasal prongs insertable into each nare. As shown in FIG. 5 d, the patient interface can easily be attached via clips 60 to a headgear assembly 31 in order to secure the patient interface to the patient. The headgear 31 includes an intermediate strap 31 a extending between clip 60 and connector 33. The clip 60 and its connection to frame 30 resemble the clip/frame described in U.S. Patent Application Publication 2004/0112384 A1, incorporated herein by reference in its entirety.
Two alternative cushions, 42A and 42B without gussets are displayed in FIG. 7 b. It should be noted that each of the nozzles 17 on cushion 42B includes a simple mound rather than containing a single flexible pleat as do the nozzles on cushion 42 and cushion 42A. The nozzles 17 may also include a plurality of corrugations and in general the nozzles may take the form of a nasal puff as described in U.S. Pat. No. 4,782,832 (Trimble et al), or as in other known nasal cannulae, such as prongs that extend into the nares. Further nozzle alternatives are described in U.S. Pat. No. 7,318,437 and entitled “Nasal Assembly.”
The membrane 58 is structured to form a seal around the lips of a patient. In the illustrated embodiment, the membrane 58 has a substantially flat profile. In use, the edge 61 of the flat-profiled membrane 58 is the first point of contact with the patient's face. As the membrane 58 comes more into contact with the patient's face, the membrane 58 conforms to the patient's face with good contact at the inner edge 61 thereof, which reduces the possibility of pressurized air coming between the skin and the edge 61, thereby improving the integrity of the seal. Also, the edge 61 of the membrane 58 contacts the face and fully extends or stretches the membrane 58, thereby eliminating any wrinkles. A more rounded membrane profile provides a tangential contact with the patient, potentially providing a leak path under the membrane when air pressure is applied. Further, the membrane 58 extends further than the edges of the rims 53 to prevent the rims 53 from being a source of irritation (e.g., see FIG. 18 b).
The side wall of the cushion 42 supports the pair of nozzles 17. Similar to the above embodiments, the nozzles 17 may have a similar form to those disclosed in U.S. Pat. No. 7,318,437, the contents of which are hereby incorporated by cross-reference, however they may take the form of any nasal prongs insertable into each nare.
FIGS. 43-46 illustrate embodiments of patient interfaces including a cushion 42 and a pair of nozzles 17 mounted to the cushion 42. The nozzles 17 are mounted to the cushion 42 to add flexibility to the nozzles 17 with respect to the cushion 42. For example, FIG. 43 illustrates nozzles 17 mounted within respective rounded recesses 120 or scalloped reliefs provided in the side wall of the cushion 42. The depth of the recess 120 may be suitably modified to provide desired variations of flexibility. For example, the recesses 120 may be relatively deep for greater flexibility as shown in FIG. 44, or the recesses 120 may be relatively shallow for moderate flexibility as shown in FIG. 45. FIG. 46 illustrates an embodiment wherein a radial notch 22 is provided in the conduit 19 that interconnects each nozzle 17 with the cushion 42. The notch 22 adds flexibility to the conduit 19 which facilitates movement of the nozzle 17 with respect to the cushion 42.
As shown in FIGS. 56 a and 56 b, each nozzle 17 may include a dual wall construction. Specifically, the nozzle 17 includes a thin membrane 124 that surrounds the upper nozzle portion 21 to enhance the seal of the nozzle 17 with the patient's nasal passage. As illustrated, the upper nozzle portion 21 may include one or more openings 126 for air communication to improve inflation of the membrane 124. The openings 126 may have any suitable shape, e.g., ring-like, and may have any suitable size. Also, as shown in FIG. 56 b, each nozzle 17 may include a gusset portion 29 in the conduit 19 that interconnects the nozzle portion 21 with a cushion. Further, both embodiments may include more than one membrane 124, thereby providing a nozzle having a three or more wall construction.
FIGS. 57-62 illustrate-embodiments of support members for supporting nozzles 17 of a patient interface and properly aligning them with the patient's nasal passages. For example, FIGS. 57 and 58 illustrate a support member in the form of a C-shaped spring 130 having openings 132 for receiving nozzle conduits therein. The spring 130 is positioned between the side wall 51 of the cushion 42 and the nozzle portions 21 of the nozzles 17, and provides a biasing force to extend the nozzles 17 and maintain a substantially rigid configuration to facilitate proper alignment and seal with the patient's nasal passages. The spring 130 may be constructed of any suitable material, e.g., metal or polymer. Also, additional adjustment may, be added to the spring, e.g., additional bending axis 131 that allows lateral adjustment of the nozzles.
The frame 38 includes upper and lower clip receivers 174 a, 174 b on each side thereof. As best shown in FIG. 73, each clip receiver 174 a, 174 b includes a resiliently flexible tab 182 having a ramped surface leading to a locking shoulder 183 and a release projection 184. In use, each clip 173 a, 173 b is interlocked with a respective clip receiver 174 a, 174 b by first moving the clip receiver 174 a, 174 b into the respective clip 173 a, 173 b such that the release projection 184 extends through the longitudinally extending slot 180 until the locking shoulder 183 interlocks with the transversely extending slot 181 with a snap fit. The clip 173 a, 173 b may be released from the respective clip receiver 174 a, 174 b by depressing the release projection 184 until the locking shoulder 183 releases from the transversely extending slot 181. As shown in FIG. 71, the lower clips 173 b on the ends of the lower strap 172 are adapted to releasably interlock with respective lower clip receivers 174 b on the frame 38, and the upper clips 173 a on the ends of the upper strap 171 are adapted to releasably interlock with respective upper clip receivers 174 a on the frame 38. The clip arrangement may provide audible feedback when the clip 173 a, 173 b is attached to the respective clip receiver 174 a, 174 b. Also, as shown in FIG. 73, each clip 173 a, 173 b may be rotatably engaged with the respective strap such that the clip 173 l, 173 b may be freely rotated with respect to the strap to allow the patient interface to self-align on the patient's face.
Also, all the headgear assemblies described above may incorporate rigidizing elements (via insertion of rigid panels, stitiching, lamination, or other means) to add rigidity to the headgear assemblies to aid in mask stability.
reducing significantly the bulk required to form an effective nasal and oral seal. This has the advantage of creating a less intrusive patient interface that significantly reduces the problems of patient claustrophobia. The removal of the requirement to seal around the nasal bridge provides the opportunity for the patient to wear spectacles. In addition this removes the danger of leaks affecting the sensitive eye region, thereby reducing the possibility of creating conjunctivitis style problems.
reducing the force (headgear tension) required to maintain the seal as compared to current full face masks in the prior art. The force is reduced due to the reduction in the effective area of the cushion on to the face. As a result, there is less area over which the pressure inside the patient interface acts and the resultant headgear tension is reduced.
improving seal as it avoids the nose bridge region where leak commonly occurs, thus the force required to deform the cushion and effect a seal is also reduced. The reduction in the headgear tension and cushion to face force would substantially reduce the discomfort to a patient.
The reduction in the area of the face across which a seal must be formed allows a single size or shape to fit a wider range of patient geometry. This is particularly advantageous for a clinician since the patient interface is both easier to fit to a new patient and potentially more forgiving of fitting errors. The independent nature of the chambers due to the flexible connection, also allows for some movement of the face during the night without loss of seal. This leads to far more stability than conventional single chamber full face masks.
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