Source: https://patents.google.com/patent/EP1701759B1/en
Timestamp: 2018-05-22 10:38:25
Document Index: 246217798

Matched Legal Cases: ['Application No. 60', 'Application No. 10', 'application No. 60', 'Application No. 10', 'application No. 10', 'Application No. 10', 'Application No. 10', 'Application No. 10', 'application No. 10']

EP1701759B1 - Nozzle for an oronasal patient interface - Google Patents
Nozzle for an oronasal patient interface Download PDF
EP1701759B1
EP1701759B1 EP20040802133 EP04802133A EP1701759B1 EP 1701759 B1 EP1701759 B1 EP 1701759B1 EP 20040802133 EP20040802133 EP 20040802133 EP 04802133 A EP04802133 A EP 04802133A EP 1701759 B1 EP1701759 B1 EP 1701759B1
EP20040802133
EP1701759A1 (en )
EP1701759A4 (en )
Aaron c/o ResMed Ltd DAVIDSON
Michael c/o ResMed Ltd GUNARATNAM
Susan c/o ResMed Ltd LYNCH
Milind c/o ResMed Ltd RAJE
Gary c/o ResMed Ltd ROBINSON
Steven c/o ResMed Ltd LUBKE
Gregory c/o ResMed Ltd SMART
Philip c/o ResMed Ltd KWOK
Rupert c/o ResMed Ltd SCHEINER
This application claims the benefit of U.S. Provisional Application No. 60/533,214, filed December 31, 2003 .
One form of nasal assembly known as a nasal puff is described in U.S. Patent No. 4,782,832 (Trimble et al. ). This device has a pair of nasal puffs together with a plenum chamber held in place with a harness assembly adapted to be worn over the head of the patient. The device does not provide a mouth seal.
Another form of known nozzle assembly is described in U.S. Patent No. 6,431,172 (Bordewick et al. ). The patent discloses a device with nares elements mounted on an inflatable plenum chamber. Again this does not provide any structure for sealing the mouth.
One typical example of a known nasal mask is described in U.S. Patent No. 5,243,971 (Sullivan et al. ). This has a ballooning seal in order to fit the patient's nose and facial contours but does not provide a mouth seal. The contents of this patent are hereby referred to.
International publication number WO 01/97893 A1 (Frater et al. ) describes a mask system for delivering air to a user including a suspension mechanism. This suspension mechanism allows relative movement between a face-contacting portion and a mask shell.
A known example of a full face mask is described in U.S. Patent No. 6,513,526 B2 (Kwok et al. ), which is hereby referred to. Whilst providing a facial contour and sealing mechanism that incorporates both the nasal and mouth, this mask cannot flex to adapt to changes in jaw movement and head position throughout the night.
A known example of a nose and mouth mask is described in U.S. Patent No. 5,560,354 (Berthon-Jones et al. ), the content of which is hereby referred to.
U.S. Patent Publication No. 2002/0069872 A1 (Gradon et al. ) describes a mouthpiece which seals the oral cavity against 'mouth leak'. This mouthpiece includes both intra-oral and extra-oral sealing means and can be kept in place without the need for straps. International patent WO 01/95965 (Gradon et al. ) describes a similar mouthpiece for supplying humidified gases to a user.
U.S. Patent No. 6,571,798 B1 (Thornton ) describes an oral device for improving a patient's breathing together with a connecting post that provides a standard interface to a CPAP patient interface. The oral device is said to extend the lower jaw of the patient and thus open the breathing passage. The oral device is clenched between the teeth which may lead to discomfort and if mask pressures are high can lead to the slow creep of gums around the teeth due to the sustained load..
U.S. Patent No. 1,873,160 (Sturtevant ) describes a cylindrical air chamber held in position by a mouth portion that extends between the lips and teeth. The mouth portion may prove irritating and lead to discomfort when used for long periods.
WO92/20392 describes a nasal cannula.
The scope to the invention is as defined by the claims and an embodiment of the invention can be seen in figures 56a and 56b.
In accordance with another aspect of the invention there is provided a patient interface that provides an effective seal with the patient's nasal passages.
Figs. 1a-d show a dual chamber patient interface;
Figs. 1e-1h illustrate various connections between the upper and lower chambers;
Figs. 2a-c show a dual chamber patient interface;
Figs. 3a-c show a dual chamber patient interface;
Figs. 4a-c show a single chamber patient interface;
Figs. 5a-d show front and rear views.
Figs. 6a-b show a single chamber patient interface with mouth gusset portion ;
Figs. 7a-b show views of a single chamber patient interface with mouth gusset portion ;
Figs. 7c-f show views of a single chamber patient interface;
Fig. 8 shows a patient interface connected to a headgear routed around the top of the ears;
Fig. 9 shows a patient interface connected to different forms of headgear routed around the top of the ears;
Figs. 10-12 illustrate various headgear arrangements ;
Figs. 13-18d illustrate a single chamber patient interface;
Figs. 19-24d illustrate a single chamber patient interface;
Figs. 25a-25e illustrate a single chamber patient interface;
Figs. 26-28 illustrate a single chamber patient interface with no nozzles;
Figs. 29 and 30 illustrate a single chamber patient interface with blocked nozzles;
Figs. 31-33c illustrate a single chamber patient interface with a. gusset portion;
Figs. 34-38 illustrate a single chamber patient interface with insertable nozzles;
Figs. 39-40 illustrate a patient interface with a mouth appliance;
Figs. 41-42 illustrate a patient interface with a corrugated frame;
Figs. 43-56b illustrate nozzle arrangements;
Figs. 57-62 illustrate support members for nozzles;
Figs. 63-64 illustrate a patient interface with a boomerang-shaped cushion;
Fig. 65a-65c illustrates a patient interface with an extended frame;
Figs. 66a-67 illustrate a patient interface with an insertable anti-asphyxia valve; and
Figs. 68-80 illustrate headgear assemblies.
Figs. 1a-1d illustrate a first example. As shown in Fig. 1a, a headgear assembly 1 includes a patient interface having a dual chamber assembly 10 including an upper chamber 12 and a lower chamber 14. As shown in Fig. 1a, the lower chamber 14 is in a disconnected position, while Figs. 1b-1d shown the upper and lower chambers in a connected position.
Referring to Fig. 1a, 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. Patent Application No. 10/781,929, filed February 20, 2004 . 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. 1c and 1d).
As best shown in Fig. 1a, where the upper and lower chambers are disassembled, a first portion 36 of the lower chamber 14 maybe connected to a second portion 37 of the upper chamber 12. Connection may be achieved via a conduit 41 (See Fig. 1e), or preferably a flexible element that connects the upper chamber 12 to the lower chamber 14. The flexible element may comprise one or more thin silicone conduits through which air can pass. It may take the form of any other flexible element through which air can pass however, examples including a spring 43 (Fig. 1f), bellows 45 (Fig. 1g) or piston mechanism 47 (Fig. 1h). The flexible element provides a range of adjustment to adapt to the different geometry of a wide range of patients and in addition allow for any movement of their jaw and head position during sleep. The conduit need not be flexible if adjustment can occur via flexibility of the cushions of the upper and lower chambers.
As shown in figures 1a-1d, the lower chamber 14 includes a rigid polycarbonate frame 38 which defines a mouth covering chamber 40 (see Fig. 1c) 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. Patent No. 5,560,354 , the contents of which are hereby referred to. However it may take a variety of forms, such as described in U.S. Provisional Patent application No. 60/483,622 filed 1 July 2003 . The cushion 42 maybe 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.
The inlet conduit 35 is structured to deliver breathable gas.into the lower chamber 14. The inlet conduit 35 may be inserted into an aperture of the frame 38, in which case the tube 35 may be held in place by friction alone, as best shown in Figs. 1b and 1d. Alternatively, the inlet conduit 35 may be connected to a swivel assembly (not shown) which in turn is connected to the frame 38. In another alternative, one or more suitable headgear straps (not shown) can be used to support the lower chamber 14 such that it can move or pivot relative to the upper chamber without the need for connection thereto or a flexible element.
Figures 2a and 2b show a second example. In this example, the lower chamber 14 does not have a direct inlet conduit, like the inlet conduit 35 in Fig. 1a, but instead the air is directed to the upper chamber 12 via the inlet conduits 22 only. Air travels through the flexible element, i.e., through first and second surfaces 36 and 37, from the upper chamber 12 to the lower chamber 14, for example, thus allowing both nose and mouth breathing. Fig. 2b best showed the position where the flexible element would be located between the first and second surfaces 36, 37.
In a third example, as shown in Figs. 3a and 3b, 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. 1a. Instead, a pair of plugs 54 may be placed into each end of the nozzle assembly 16, as described in U.S. Patent Application No. 10/781,929, filed February 20, 2004 and entitled "Nasal Assembly", incorporated herein by reference in its entirety.
Figures 4a-c schematically show a fourth example. In this example, the mouth covering chamber 40 and the nozzle assembly 16 form one chamber with inherent flexibility of the soft silicone cushion 42 upon which the nozzles 17 are mounted providing for movement and changes in alignment between the two. This example achieves the advantage of minimizing the volume of the patient interface which is positioned between the nares and the upper lip.
Figs. 5a-5d illustrate yet another example. As can be seen from Fig. 5a, 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. 5b). 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. 5b, 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 example describes nozzles 17 of a similar form to those disclosed in US Patent application No. 10/781,929 filed 20 February 2004 , , they may take the form of any nasal prongs insertable into each nare. As shown in Fig. 5d, 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 No. 10/655,603, filed September 5, 2003 .
Figures 6a-b schematically illustrate a fifth example. In this example, the patient interface includes a mouth covering chamber 40 incorporating a rigid frame 38, a gusset portion 62 and a soft cushion 42. The nozzles 17 are connected directly to the outer face contacting portion of the cushion 42 which takes the form of a thin silicone membrane 58. The gusset portion 62 includes a flexible membrane and has a first side attached to the frame 38 and a second side attached to the cushion 42, as shown in Fig. 6b. Pressure within the patient interface acts upon the increased surface area of the gusset portion 62 projected on the patient's face so as to provide a sealing force for the soft cushion 42 against the patient's face. In addition the gusset portion 62 acts to effectively isolate or decouple the rigid frame 38 from the soft cushion 42. In these respects, the gusset portion 62 acts in a similar manner to that described in International publication number WO 01/97893 A1 (Frater et al :), the content of which is hereby referred to
Due to its location between the cushion 42 and the frame 38, the gusset portion 62 also acts to decouple the nozzles 17 mounted upon the soft cushion 42 from the rigid frame 38. This provides further flexibility within the patient interface which has the advantages previously described of allowing the interface to adjust to the geometry of different patients and allowing for any jaw or head movement during sleep. A further advantage of the gusset portion 62 is that it allows the face contacting portion, e.g., membrane 58, of the cushion 42: increased freedom to deform in accordance with the contours of the mouth region than does a direct connection between the cushion 42 and rigid frame 38. Thus the cushion 42 may "wrap around" the mouth region as required.
The gusset portion 62 of the example shown in figures 6a and 6b is a partial gusset portion in that it is arranged at the chin portion of the mouth covering chamber 40. Alternatively the gusset portion 62 may fit around the entire circumference of the rigid frame 38. An example of this is shown in figures 7a-c. As can be seen from Fig. 7a, the example includes an inlet swivel assembly 50, a frame 38, a gusset portion 62 and a soft cushion 42 with nozzles 17 mounted thereon.
Fig. 7b shows the components disassembled, although the swivel assembly 50 and frame 38 are shown in an assembled state that could be disassembled in an alternative example. The headgear clips 60, cushion clip 56 and cushion 42 with gusset portion 62 can also be seen in Fig. 7b. The clip 56 may include one or more resilient tabs 57 that engage with corresponding recesses 59, one of which is shown on frame 38.
Two alternative cushions, 42A and 42B without gussets are displayed in Fig. 7b. 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. Patent 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. Application No. 10/781,929, filed February 20,2004 and entitled "Nasal Assembly."
Figures 7c-7f show an alternative example of a patient interface assembled to a headgear assembly 31 via clip 60 that is selectively adjustable in a rotational sense with respect to yoke 31 attached to strap 30, as described in U.S. Patent Application No. 10/391,440, filed March 19, 2003 , which is herein referred to. Each clip 60 includes opposed arms 64 that may resiliently flex towards one another to allow engagement and disengagement of claws 66 formed on arms 64. The claws 66 may lockingly engage with corresponding structure or a receptacle 68 formed on or as part of frame 38. In this example, the receptacle 68 may be moved, flexed or pivoted with respect to a portion 38a of the frame 38, e.g., along pivot axis 70. Fig. 7d shows the clips 60 in different angular positions.
Fig. 7e is an exploded view of clip 60, receptacle 68 and portion 38a of frame 38. The portion 38a may be attached to (e.g., via glue) or formed as an integral part of the frame 38. The receptacle 68 includes side chambers 68a for receiving claws 66 and a central chamber 68b for receiving central tab 61 of clip 60. The receptacle 68 maybe attached to portion 38a, e.g., via a pin and slot assembly. For example, the receptacle 68 may include opposed arms 69 each including a pin 71. Each pin 71 can be received within an end 73 of a C-shaped channel 75. At least one of the arms 69 or the C-shaped channel 75 may flex to allow assembly and disassembly. Of course, other arrangements for allowing relative movement are possible.
Alternative headgear may be used, i.e., this example is not limited to the headgear assembly shown in Fig. 7c. Vents 72 for the removal of excess carbon dioxide are shown in Fig. 7c. The vents 72 may be formed on an elastic insert, as described in U.S. Patent No. 6,561,190 , which is herein referred to. Fig. 7f shows an enlarged patient-side view of the cushion 42 in isolation.
Fig. 8 shows an alternative form of headgear with an occipital strap 74, a coronal strap 76 and a depending strap 78 that is routed to the top of the ears. The headgear straps 74, 76, 78 may be rigid or may be constructed from a laminated foam material such as Breath-O-Prene™. In one form the headgear straps may be constructed from a combination of a soft comfortable material, such as Breath-O-Prene and a stiffening yoke 28 constructed from a polymer, such as nylon, as described in International Patent Application PCT/AU03/00458 . Angular adjustment between the rigid frame 38 and the headgear, such as that may be achieved via the arrangement shown in Fig. 7c.
Figures 9-12 show the patient interface supported by spectacles-type headgear 80. One strap 82 is used as a hook mechanism behind the ear. The strap 82 may be extended to wrap around the head and apply a force inwards towards the head, as shown in Fig. 9, or the wrap around portion may be eliminated as shown in Fig. 10. Fig. 11 shows an additional stabilizing band 84 around the neck. The headgear straps may be formed of any suitable material such as textile, plastic or semi-rigid assemblies. The headgear assembly has the advantage that it covers the minimum head area and therefore is more comfortable than many traditional designs. In order to improve patient comfort, the headgear may also require adjustment to suit the head circumference and ear height. It may also be applied to alternative forms of patient interface such as nasal prongs or nose masks.
Figs. 13-18d illustrate another patient interface. As illustrated, the patient interface includes a cushion 42 and a pair of nozzles 17 flexibly mounted to the cushion 42. The patient interface is formed as a one-piece structure such that the cushion 42 is integrally formed in one-piece along with the nozzles 17. For example, the cushion 42 and nozzles 17 may be formed in an injection molding process as is known in the art. Also, the cushion 42 and nozzles 17 form one chamber with flexibility between the cushion 42 and nozzles 17 to provide for movement and changes in alignment between the two.
The membrane 58 is structured to form a seal around the lips of a patient. In the illustrated example, 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. 18b).
For example, Figs. 19-24d illustrate another patient interface. Similar elements are indicated with similar reference numerals. As illustrated, the upper edge of the aperture 55 has an arcuate protruding portion. Also, as shown in Figs. 20 and 21, the upper side of the side wall has an arcuate configuration that corresponds with the arcuate configuration of the upper edge of the aperture 55. Thus, the plan profile of the cushion 42 shown in Figs. 20 and 21 is curved and has a shape similar to a smile. This configuration helps stability by more closely following the patient's facial geometry and prevents roll since the cushion 42 is higher at the sides. That is, the cushion shown in Fig. 20 has a greater height than the cushion shown in Fig. 14, which helps with stability. However, the shorter height of the cushion shown in Fig. 14 has a shorter profile and is therefore less obtrusive to the patient. For example, the cushion in Fig. 20 may have a height of about 60 mm and the cushion in Fig. 14 may have a height of about 50 mm. However, the cushion may have any other suitable height. The cushion 42 also has a membrane 58 with a substantially flat profile (e.g., see Figs. 24a-24c), which provides an enhanced seal as described above.
As best shown in Fig. 15, the rims 53 are preferably provided on lateral sides of the side wall only 51. The rims 53 add rigidity to the membrane 58 at the sides of the patient's mouth or cheeks. As illustrated, each rim 53 has a general C-shape and extends inwardly into the cavity of the cushion 42. While it is preferable that the membrane 58 be thinner than the rim 53, they could have the same thickness. For example, in Figs. 18a, 18c, 24a, and 24c, the side wall thickness maybe about 3.20 mm, which tapers to about 0.50 mm at the edges of the membrane. In Figs. 18b and 24b, the side wall thickness may be about 3.20 mm, which tapers to about 0.50 mm at the edges of both the rim and the membrane. However, the side wall, rim, and membrane may have any other suitable thicknesses.
In the illustrated example, the face-contacting portion of the cushion 42 has a double-walled construction, i.e., membrane and rim, in the region of the cheeks and a single-walled construction, i.e., membrane, under the nozzles 17 and in the region of the chin and/or lower lip. The single wall construction at the top and bottom of the cushion 42 helps to accommodate high landmarks, e.g., pointed chin, by allowing the center of the cushion 42 to flex. This flexibility accommodates more patients with the same cushion 42. Also, the single wall construction under the nozzles 17 alleviates space constraints and potential occlusion of the nasal air path by a rim. However, the cushion 42 may have any other suitable construction, e.g., single walled, triple walled or more walled construction, in any suitable region of the cushion 42, e.g., cheek, chin, under nozzles. For example, Fig. 25a illustrates a patient interface substantially similar to the patient interface shown in Figs. 13-18d. In contrast, the patient interface includes a rim 53 that extends around the entire perimeter of the cushion 42 as indicated by the dashed line. Also, the rim 53 could be completely removed. Figs. 25b-25e illustrates a patient interface substantially similar to the patient interface shown in Figs. 13-18d (nozzles omitted for clarity purpose). In contrast, the side wall 51 of the cushion 42 has a slightly different perimeter geometry. The cushion 42 also has a membrane 58 with a substantially flat profile (e.g., see Figs. 25c-25e), which provides an enhanced seal as described above.
The side wall of the cushion 42 supports the pair of nozzles 17. Similar to the above examples, the nozzles 17 may have a similar form to those disclosed in U.S. Patent application No. 10/781,929 filed 20 February 2004 , the contents of which are hereby incorporated by cross-reference, however they may take the form of any nasal prongs insertable into each nare.
Also, the conduits 19 may have different lengths to accommodate different patients. For example, the conduits 19 illustrated in Figs. 13-17 are longer than the conduits 19 illustrated in Figs. 19-23. The longer conduits of Figs. 13-17 provide more nozzle flexibility, whereas the shorter conduits of Figs. 19-23 allow more direct transfer of forces from the side wall support to the nozzles. The conduits 19 may have any suitable length and may be suitably varied to accommodate various patients, e.g., with varying length between the patient's nose and upper lip. For example, the nozzles 17 are about 8 mm long, which allows good flexibility and articulation while still allowing the nozzles 17 to be loaded adequately to effect seal.
Figs. 26-28 illustrate a patient interface wherein the nozzles have been removed so that the patient interface includes a cushion 42 only. The cushion 42 may have a structure similar to the cushions described above, e.g., side wall 51, a pair of rims 53 extending away from the side wall 51 in the cheek regions, and a membrane 58. However, the cushion 42 may have any other suitable structure to seal around a patient's mouth.
Figs. 29 and 30 illustrate a patient interface that include a cushion 42 and a pair of nozzles 17 that are blocked from fluid communication with the chamber defined by the cushion 42. In Fig. 29, the nozzles 17 are blocked at entrance to the cushion 42. That is, the upper portion of the side wall 51 is not provided with any openings that communicate with the nozzles 17. In Fig. 30, the nozzles 17 are blocked at the nozzle tips. That is, the nasal opening of the nozzle 17 is blocked so that gas cannot pass through the nozzles 17. The pressure within the nozzles 17 aids the seal within the nasal passages of the patient. In another example, a set of plugs maybe inserted into the nozzles 17, e.g., at the top or bottom of the nozzles, to block nasal flow. In these examples, the nozzles 17 simply seal the patient's nasal passages, and gas is delivered to the patient's mouth only. The blocked nozzles may also serve to stabilize the cushion and help with alignment.
Figs. 31-33c illustrate a patient interface that includes a cushion 42 and a pair of nozzles flexibly mounted to the cushion 42 (nozzles omitted for clarity purposes). As illustrated, the cushion 42 includes a side wall 51 incorporating a gusset portion 62, a pair of rims 53 extending away from the side wall 51, and a membrane 58 to substantially surround the rims 53 and provide a sealing structure for engagement with the patient's face.
Similar to the examples in Figs. 13-24d, the rims 53 are provided on the lateral sides of the side wall 51 only (e.g., see Figs. 31 and 33b). However, a rim may be provided around the entire perimeter of the side wall, or at any other suitable portion of the side wall, e.g., chin portion of the cushion. Also, similar to the example in Figs. 13-24d, the side wall thickness may be about 3.20 mm, which tapers to about 0.50 mm at the edges of both the rim and the membrane. The thickened side wall helps to support the nozzles in proper position.
Figs. 34-38 illustrate a patient interface that include a cushion 42 and a pair of nozzles 17 that are selectively mounted to the cushion 42. Specifically, the nozzles 17 are formed separately from the cushion 42, and then secured to the cushion 42 to construct a patient interface with both cushion 42 and nozzles 17. This arrangement provides a greater scope of patient fitting by being able to select cushion size and nozzle size independently. Also, the nozzles 17 may be independently aligned with respect to the cushion 42 for optimal fit.
In each of the examples, each nozzle 17 includes a nozzle portion 21 that seals within a respective patient nasal passage and a base portion 23 that is mountable to the cushion 42. The side wall of the cushion 42 includes nozzle mounting portions 25 structured to mount a respective nozzle 17.
The nozzles 17 maybe mounted to the cushion 42 in any suitable manner. For example, Fig. 34 illustrates an arrangement wherein the nozzle mounting portions 25 are in the form of inclined platforms 104 structured to support a respective nozzle 17 thereon. The base portion 23 of the nozzles 17 may be secured to respective platforms 104 in any suitable manner, e.g., adhesive, male/female connection, etc.
As shown in Figs. 35 and 36, the nozzles 17 are mounted to the cushion 42 such that the nozzles 17 can rotate independently to align each nozzle 17 with a respective one of the patient's nares. As shown in Fig. 36b, a ball-jointed insert 106 maybe incorporated into the nozzles 17 to allow greater rotational and angular freedom and allow alignment in all directions. As shown in Fig. 38, the cushion 42 may include angular alignment marks 27 to align the nozzles 17 with respect to the cushion 42, which assists the patient in consistent setup. The marks 27 may have any suitable configuration, e.g., detented.
The examples of Figs. 34-37 allow nozzles 17 to be interchanged for different size patient nares, which improves seal and patient comfort. Also, it should be understood that the nozzles 17 could be interchanged individually, or a single insert could be provided that contains both nozzles 17.
Figs. 39-40 illustrate a patient interface that include a pair of nozzles 17 that are mounted to a mouth appliance 110, e.g., an appliance that sits within a patient's mouth. In the illustrated example, the mouth appliance 110 provides a mouth seal by sandwiching the inside and outside of the patient's mouth. Specifically, the mouth appliance 110 includes a tongue depressor 112, a soft seal 114 that abuts against the inner surface of the patient's mouth, and a snap flap 116 that abuts against the outer surface of the patient's mouth to provide an endstop against the appliance being swallowed. An example of such mouth appliance is disclosed in WO200195965 , the contents of which are hereby referred to. The nozzles 17 are mounted to the mouth appliance 110 by a conduit 19 that allows gas to pass between the mouth appliance 110 and nozzles 17. The conduit 19 may have a flexible or rigid construction. As shown in the example of Fig. 40, a mask system 118, e.g., similar to a diving mask, may be incorporated into the patient interface to improve seal and to help locate the nozzles 17 with respect to the patient's nasal passages. Also, the tongue depressor 112 is optional and may be removed.
Figs. 41 and 42 illustrate a patient interface having a corrugated frame 38 and a cushion (not visible) with nozzles 17 mounted to the frame 38, or to the cushion. The corrugations in the frame 38 add flexibility to the frame 38 to allow the frame 38 to adjust to the facial geometry of different patients and to allow for any jaw or head movement during sleep. For example, the frame 38 may move downwardly for jaw dropping during sleep, and may move rearwardly for receding jaw (see arrows in Fig. 42). As illustrated, the corrugations are provided along a lower portion of the frame 38. However, the corrugations may extend across the entire frame 38. The movement maybe accomplished via pivoting and/or sliding action of the corrugated frame about the sides of the frame. In this arrangement, the seal in the lower lip region is thus not compromised even if the jaw moves. Also, frame flexibility may be provided by other suitable structures, e.g., gusset portion provided in the frame. The frame 38 may be adjusted, e.g., by adjusting the tension in the lower straps of a headgear assembly 31. Further, the corrugated configuration may be incorporated into a full-face mask.
Figs. 43-46 illustrate 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 a radial notch 122 is provided in the conduit 19 that interconnects each nozzle 17 with the cushion 42. The notch 122 adds flexibility to the conduit 19 which facilitates movement of the nozzle 17 with respect to the cushion 42.
Figs. 47-51 illustrate nozzles 17 having a nozzle portion 21 and a conduit 19 that interconnects the nozzle portion 21 with the side wall of the cushion 42. As illustrated, the cross-sectional configuration of the conduit 19 may be varied to vary the flexibility of the nozzle 17. For example, Figs. 47 and 48 illustrate that the conduit 19 has a substantially constant cylindrical cross-sectional configuration along its length. Figs. 49-51 illustrate that the cross-sectional configuration of the conduit 19 varies along its length. As illustrated, the conduit 19 has an elliptical cross-sectional configuration near the nozzle portion 21 which continuously varies to a cylindrical cross-sectional configuration near the side wall of the cushion 42. Thus, the conduit has a "swept" cross-sectional configuration. In other examples, the nozzles 17 may include anatomically-shaped nozzle portions, and the nozzle portions may include openings that are off-center from the conduit opening. Preferably, the cross-sectional shape of the conduit and the nozzle opening are similar or the same, although dissimilar shapes are also possible. Also, the nozzles 17 may be structured to dilate the patient's nose similar to the structure shown in Fig. 18 of U.S. Patent No. 4,782,832 , which is herein referred to.
Figs. 52-54 illustrate a patient interfaces including a cushion 42 and a pair of nozzles 17 mounted to the cushion 42. As illustrated, the nozzle conduits 19 have a concertina configuration, e.g., accordion-like, which adds flexibility to the nozzles 17 with respect to the cushion 42. Specifically, the concertina configuration allows both rotational and vertical adjustment of the nozzles 17 with respect to the cushion 42. For example, Fig. 53 shows a nozzle 17 in a neutral position, and Fig. 54 shows a nozzle 17 stretched and rotated with respect to the cushion 42. The concertina configured conduit 19 may be constructed from a soft silicone material or a stiffer material, e.g., drinking straw material, to allow articulation and extension. This configuration allows the conduits to be adjustably positioned in a number of different positions, and maintained in position during use. Also, the nozzles 17 may be integrally formed in one-piece along with the cushion 42, or the nozzles 17 may be formed separately from the cushion 42 and mounted thereto.
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 maybe 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.
Figs. 63 and 64 illustrate a patient interface having a cushion 42 and a pair of nozzles 17 mounted to the cushion 42. As illustrated, the cushion 42 is shaped as a boomerang, and may include rims 53 extending from the side wall of the cushion 42.
Figs. 65a-65c illustrate a patient interface wherein the frame 38 includes extended portions 144 to cover the cheek regions of the patient's face. This arrangement is structured to prevent or at least control cheek blowout. Also, as illustrated, the frame 38 is structured such that inlet conduits 22 are coupled to opposing sides of the frame 38 for delivering breathable gas into the patient interface. However, one or more inlet conduits 22 may be coupled to the frame 38 in any other suitable manner, e.g., to the front of the frame.
Figs. 66a-67 illustrate a patient interface wherein the frame 38 includes an inlet conduit 22 coupled to one side thereof and an anti-asphyxia valve module 150 coupled to the opposite side thereof. It should be understood that the inlet conduit 22 and module 150 can be interchanged.
As shown in Fig. 66b, the anti-asphyxia module 150 includes an anti-asphyxia valve 154 that is housed within an anti-asphyxia cap 156 secured to the frame 38. As illustrated, the anti-asphyxia cap 156 includes a plurality of openings 157, and the anti-asphyxia valve 154 includes a flexible membrane 155 that is movable between operative and inoperative positions. In the inoperative position (shown in solid line in Figs. 66c and 66d), the membrane 155 is spaced from the cap 156 so that atmospheric air can pass through the openings 157. The membrane 155 is moved into the operative position (shown in dotted lines in Figs. 66c and 66d) by mask pressure and closes the openings 157 so that atmospheric air cannot pass through the openings 157. Embodiments of such anti-asphyxia valve and anti-asphyxia cap are disclosed in WO200038772 , the contents of which are hereby referred to.
The anti-asphyxia valve module 150 has the advantage of being in close proximity to the patient's mouth. The close proximity to the mouth improves CO2 washout, is good for the stability of the system (i.e., there is not a heavy weight located at a distance from the patient interface), and is fail safe if the anti-asphyxia valve module 150 is not attached to the device. As illustrated, the frame and/or cushion may include an exhaust vent 152. Also, headgear 31 is attached to frame 38 in any suitable manner to maintain the cushion and nozzles in a desired adjusted position on the patient's face. In the illustrate example, the headgear 31 includes a strap that extends below the ears and around the upper portion of the patient's neck, and a strap that extends in front of the ears and over the top of the patient's head. However, the headgear 31 may include any other suitable strap arrangement.
Figs. 68-70 illustrate a headgear assembly 160 removably coupled to the frame 38 of a patient interface so as to maintain the cushion and nozzles in a desired adjusted position on the patient's face. As illustrated, the headgear assembly 160 includes two straps each having an independent attachment to the frame 38. Specifically, the headgear assembly 160 includes an upper strap 161, a lower strap 162, and a connecting strap 163 that interconnects the upper and lower straps 161,162. Each end of the upper and lower straps 161, 162 includes an attachment member 164 adjustably secured thereto. Each attachment member 164 is interlockable with a respective anchor 165a, 165b provided on the frame 38 as discussed in greater detail below.
Figs. 71-73 illustrate another headgear assembly 170 removably coupled to the frame 38 of a patient interface. As illustrated, the headgear assembly 170 includes two straps each having an independent attachment to the frame 38. Specifically, the headgear assembly 170 includes an upper strap 171 and a lower strap 172. Each end of the upper strap 171 includes an upper locking clip 173a secured thereto and each end of the lower strap includes a lower locking clip 173b secured thereto. Each locking clip 173a, 173b is interlockable with a respective clip receiver 174a, 174b provided on the frame 38 as discussed in greater detail below.
As illustrated, each upper clip 173a includes a crossbar 175 that enables respective end portions of the upper straps 171 to be wrapped around, in a known manner. In the illustrated example, each free end of the upper strap 171 is secured to the remainder of the strap, e.g., by stitching, to secure the clip in place. Also, an intermediate portion of the upper strap 171 includes an adjustable ladder lock arrangement 176 for adjustment purposes. Each lower clip 173b includes an adjustable ladder lock arrangement 177 that enables respective end portions of the lower strap 172 to be engaged, in a known manner. Each free end of the lower strap 172 is held in place to the remainder of the strap by a watch strap style retainer 178. However, the straps may be secured to the clips 173a, 173b in any other suitable manner, e.g., Velcro®. Further, each clip 173a, 173b includes a side wall having a longitudinally extending slot 180 that leads into a transversely extending slot 181.
The frame 38 includes upper and lower clip receivers 174a, 174b on each side thereof As best shown in Fig. 73, each clip receiver 174a, 174b 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 173a, 173b is interlocked with a respective clip receiver 174a, 174b by first moving the clip receiver 174a, 174b into the respective clip 173a, 173b 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 173a, 173b may be released from the respective clip receiver 174a, 174b 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 173b on the ends of the lower strap 172 are adapted to releasably interlock with respective lower clip receivers 174b on the frame 38, and the upper clips 173a on the ends of the upper strap 171 are adapted to releasably interlock with respective upper clip receivers 174a on the frame 38. The clip arrangement may provide audible feedback when the clip 173a, 173b is attached to the respective clip receiver 174a, 174b.
Figs. 74-76 illustrate another headgear assembly 190 removably coupled to the frame 38 of a patient interface. As illustrated, the headgear assembly 190 includes two straps with a single point of attachment to the frame 38. Specifically, the headgear assembly 190 includes an upper strap 191 and a lower strap 192. One end of the upper and lower straps 191, 192 is adjustably secured to one attachment member 193, and the other end of the upper and lower straps 191, 192 is adjustably secured to another attachment member 193. Each attachment member 193 is interlockable with a respective anchor 194 provided on the frame 38 as discussed in greater detail below.
As best shown in Fig. 76, each attachment member 193 is generally V-shaped and includes a upper and lower crossbars 195a, 195b that enable respective end portions of the straps 191, 192 to be wrapped around, in a known manner. The free ends of the straps 191, 192 include a strip of hook material attached thereto by stitching, for example, that engages the loop material of the remainder of the strap to secure the attachment member in place. The hook/loop arrangement, e.g., Velcro®, allows adjustment of the straps 191,192 with respect to the attachment member 193. However, the straps 191, 192 maybe secured to the attachment member 193 in any other suitable manner, e.g., adjustable ladder-lock arrangement. Each attachment member 193 includes a relatively large lead-in into a relatively smaller attachment opening 196.
Figs. 77 and 78 illustrate another headgear assembly 210 removably coupled to the frame 38 of a patient interface. As illustrated, the headgear assembly 210 includes two straps with a single point of attachment to the frame 38. Specifically, the headgear assembly 210 includes an upper strap 211 and a lower chin strap 212. One end of the upper and lower straps 211, 212 is adjustably secured to one attachment member 213, and the other end of the upper and lower straps 211, 212 is adjustably secured to another attachment member 213. Each attachment member 213 is interlockable with a respective anchor 214 provided on the frame 38 as discussed in greater detail below.
Figs. 79-80 illustrate another headgear assembly 230 removably coupled to the frame 38 of a patient interface. As shown in Fig. 79, the headgear assembly 230 includes an upper strap 232 and a lower strap 234. However, the lower strap 234 is optional. Also, the strap may have two-strap configuration wherein upper and lower straps 232, 234 are incorporated into a single structure as shown in Fig. 80. Each end of the straps includes an attachment member 236 adjustably secured thereto. Each attachment member 236 is interlockable with a respective anchor 238a, 238b provided on the frame 38 as discussed in greater detail below.
The frame 38 includes upper and lower anchors 238a, 238b on each side thereof Each anchor 238a, 238b is in the form of a protruding knob. In use, each attachment member 236 is interlocked with a respective anchor 238a, 238b by moving the attachment member 236 adjacent the respective anchor 238a, 238b such that the respective anchor 238a, 238b extends through the attachment opening.
It should be understood that the cushion 42 and nozzles 17 described above may be formed from any suitable material. For example, the cushion 42 and nozzles 17 maybe formed from a gel-like material, or they may be formed from a foam-like material. Also, the cushion 42 and nozzles 17 may be formed separately from one another, or may be integrally formed as a one-piece structure.
Further, although the above examples are described in relation to nozzles, nasal prongs (which are inserted into the nose) and/or nasal dilators are also contemplated.
Advantages of illustrated examples may include:
Numerous modifications may be made and other arrangements maybe devised without departing from the scope of the invention.
A nozzle (17) for use in a patient interface for delivering breathable gas to a patient and for sealingly engaging within the nasal passage of a patient's nose in use, wherein
the nozzle comprises:
an upper nozzle portion (21) adapted to extend inside the patient's nasal passage and a thin membrane (124) that surrounds the upper nozzle portion (21) to enhance the seal of the nozzle with the patient's nasal passage; and
a conduit (19) for interconnecting the upper nozzle portion (21) with the patient interface;
characterized in that each of the upper nozzle portion and the membrane have a concave shape.
A nozzle (17) according to claim 1, wherein the nozzle (17) comprises a dual wall construction with the one membrane (124) that surrounds the upper nozzle portion (21).
A nozzle (17) according to claim 1, wherein the nozzle (17) comprises a three or more wall construction with more than one membrane (124).
A nozzle (17) according to any one of the preceding claims, wherein the upper nozzle portion (21) comprises one or more openings (126) for air communication to improve inflation of the membrane (124).
A nozzle (17) according to any one of the preceding claims, wherein each of the upper nozzle portion (21) and the membrane (124) comprise a truncated, hollow cone shape.
A nozzle (17) according to any one of the preceding claims, wherein the nozzle (17) comprises a gusset portion (29) in the conduit (19).
A nozzle (17) according to claim 6, wherein the gusset portion (29) is structured to allow articulation of the nozzle (17) and provide upward pressure of the nozzle (17) into the patient's nasal passage.
A nozzle (17) according to any one of claims 1 to 5, wherein said conduit (19) has a substantially constant cylindrical, cross-sectional configuration along its length.
A nozzle (17) according to any one of claims 1 to 5, wherein said conduit (19) has a varying cross-sectional configuration along its length.
A nozzle (17) according to any one of claims 1 to 5, wherein said conduit (19) has a concertina configuration to add flexibility to the nozzle (17).
A patient interface for a breathing arrangement that delivers breathable gas to the patient, the patient interface comprising:
a cushion (42) structured to sealingly engage around an exterior of a patient's mouth in use, the cushion (42) including
a side wall (51) structured to be removably attached to a frame (38),
a rim (53) extending away from the side wall (51), and
a membrane (58) provided to substantially surround the rim (53); and
a pair of nozzles (17) each according to any one of claims 1 to 10, wherein the conduit (19) supports each nozzle (17) on the side wall (51) of the cushion (42), and allows gas to pass between each of the nozzles (17) and the cushion (42).
The patient interface according to claim 11, wherein
the nozzles (17) are formed from a gel-like material or a foam-like material.
A breathing arrangement that delivers breathable gas to a patient, the breathing arrangement comprising:
an interface according to claim 11 or 12; and
a substantially rigid frame (38), wherein the cushion's side wall (51) is removably attached to the frame.
EP20040802133 2003-12-31 2004-12-24 Nozzle for an oronasal patient interface Active EP1701759B1 (en)
US53321403 true 2003-12-31 2003-12-31
EP20170154818 EP3228347A1 (en) 2003-12-31 2004-12-24 Nozzle for a nasal patient interface
EP20110195610 EP2510968B1 (en) 2003-12-31 2004-12-24 Compact oronasal patient interface
EP20170154818 Division EP3228347A1 (en) 2003-12-31 2004-12-24 Nozzle for a nasal patient interface
EP20110195610 Division EP2510968B1 (en) 2003-12-31 2004-12-24 Compact oronasal patient interface
EP20110195610 Division-Into EP2510968B1 (en) 2003-12-31 2004-12-24 Compact oronasal patient interface
EP1701759A1 true EP1701759A1 (en) 2006-09-20
EP1701759A4 true EP1701759A4 (en) 2009-11-11
EP1701759B1 true EP1701759B1 (en) 2015-01-21
EP20040802133 Active EP1701759B1 (en) 2003-12-31 2004-12-24 Nozzle for an oronasal patient interface
EP20110195610 Active EP2510968B1 (en) 2003-12-31 2004-12-24 Compact oronasal patient interface
EP20170154818 Pending EP3228347A1 (en) 2003-12-31 2004-12-24 Nozzle for a nasal patient interface
US (6) US7942148B2 (en)
CN (5) CN1901961B (en)
DE2331240A1 (en) 1972-06-20 1974-01-24 Lennartsfors Ab Pillow for sound insulation and airtight seal
DE59908562D1 (en) * 1998-08-04 2004-03-25 Hygrama Ag Zug Pressure cylinder, switch valve and fluid-actuated working unit
EP1857129B8 (en) 2006-05-19 2009-09-02 Boehringer Mannheim Gmbh Adapter device for sticking a medical instrument to the skin surface
CN103785090B (en) 2017-09-05 grant
US20070144525A1 (en) 2007-06-28 application
CN1973914A (en) 2007-06-06 application
CN101628142B (en) 2014-03-26 grant
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US20110209709A1 (en) 2011-09-01 application
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