Source: https://patents.justia.com/patent/9669180
Timestamp: 2020-02-18 08:36:21
Document Index: 316525293

Matched Legal Cases: ['art\n20020005198', 'Application No. 2010', 'Application No. 2012', 'Application No. 10184931', 'Application No. 201301315', 'Application No. 600484', 'Application No. 2003', 'Application No. 600484', 'Application No. 10184921', 'Application No. 10184931', 'Application No. 2010', 'Application No. 2010', 'Application No. 2010', '§311', '§42', '§311', '§42', 'Application No. 201010287077', 'Application No. 10', 'Application No. 10', 'Application No. 10', 'Application No. 2014', 'Application No. 03252554', 'Application No. 14168092', 'Application No. 14168092', 'Application No. 14188910', 'Application No. 03252554', 'Application No. 707821', 'Application No. 201310491654', 'Application No. 2015', 'Application No. 2014', 'Application No. 2015', 'Application No. 201310491654', 'Application No. 2015203513', 'Application No. 03252554', 'Application No. 14168092', 'Application No. 2016']

US Patent for Ergonomic and adjustable respiratory mask assembly with elbow assembly Patent (Patent # 9,669,180 issued June 6, 2017) - Justia Patents Search
Justia Patents Coil Spring ContactUS Patent for Ergonomic and adjustable respiratory mask assembly with elbow assembly Patent (Patent # 9,669,180)
Mar 4, 2013 - ResMed Limited
This application is a continuation of U.S. application Ser. No. 13/183,889, now U.S. Pat. No. 8,387,616, which is a continuation of U.S. application Ser. No. 12/368,545, filed Feb. 10, 2009, now U.S. Pat. No. 7,997,267, which is a continuation of U.S. application Ser. No. 10/390,720, filed Mar. 19, 2003, now U.S. Pat. No. 7,487,772, which claims priority from Australian Application PS 1926, filed Apr. 23, 2002 and U.S. Provisional Applications 60/377,254, filed May 3, 2002, 60/397,195, filed Jul. 22, 2002 and 60/402,509, filed Aug. 12, 2002, each of which is incorporated herein by reference in their entirety.
FIG. 1b shows a headgear assembly according to a sample embodiment;
FIG. 6a is a top view of an elbow assembly and frame according to another sample embodiment;
FIG. 8a is an enlarged view of a right side yoke according to another sample embodiment;
FIG. 10a is a side view of a clip and frame in a nearly fully connected condition according to a sample embodiment;
FIGS. 10e-10g illustrate the clip and yoke in various connected positions;
FIG. 18b is a side view of another sample embodiment of a swivel elbow;
FIG. 22b is a perspective view of another sample embodiment of a vent cover for connection with the swivel elbow of FIG. 18b;
FIG. 24g shows a mask cushion in accordance with a sample embodiment incorporating a septum notch;
FIG. 25i is an enlarged view of FIG. 25d showing typical (TYP) dimensions of a sample embodiment (R-radius);
FIGS. 29a-29d show alternative sealing configurations of the cushion of FIGS. 27a-27e;
FIGS. 32a-1-32c-2 illustrate an additional sample embodiment for engagement between the frame and cushion, the cushion showing CAD construction lines;
FIG. 32e illustrates an additional sample embodiment for engagement between the frame and cushion;
Based on the curved design of the frame 20, and other features, the center of gravity CG1 (FIG. 5b) of the mask assembly 10 can be formed closer to the face of the patient. As such, rotative torque or moment created in the vertical plane due, for example, to the weight of the mask assembly can be reduced. For example, if the patient is sitting in the upright position as shown in FIG. 5b, the weight of the mask assembly 10 can produce torque about an axis A (into the page) that is transverse to the patient's nose in the horizontal plane. That torque can produce forces tending to rotate the mask assembly 10 in the direction of arrow B about the axis A which is generally positioned along the upper lip region of the cushion. Such torque may result in patient discomfort along the upper lip region and/or reduced sealing around the lower bridge region of the nose and/or at the cheek region. Specifically, a center of gravity CG1 located close to the face can produce less torque than a mask having a center of gravity CG2 that is further away from the face. This is because the distance d1, d2 between the center of gravity CG1, CG2 and the face defines the lever arm used to measure torque (torque=force×lever arm distance). Accordingly, torque can be reduced if the force or the lever arm distance is reduced. Similar torques can be created if the patient is lying on his or her side as well. The torque is affected by the geometry of the elbow, including such features as its length and height in relation to the cushion. It is desirable to minimize the effective lever arm length of the assembly which depends amongst other things on the configuration of the elbow.
In FIGS. 6a and 6b, the elbow assembly 60 is attached to the mask 20 using a C-clip 23 (FIG. 6b) that can be expanded and contracted to fit within a circumferential groove 25 provided on a portion of the elbow assembly 60 that protrudes into the frame 20 using a mechanism similar to that provided on ResMed's ULTRA MIRAGE® mask and as described in U.S. Pat. No. 6,691,707 (Drew et al.). An exploded view of the cushion 40, the frame 20, the elbow assembly 60 and the gas delivery tube is shown in FIG. 6b. The C-clip 23 has a surface that engages the inside surface of the frame 20 to prevent unwanted disconnection between elbow assembly 60 from the frame 20. The elbow assembly 60 may also include one or more vent openings 61 open to atmosphere, for example, for gas washout of exhaled carbon dioxide, among other things. The vent openings 61 are structured so that treatment pressure will be maintained within the nasal cavity. The vent openings 61 may be covered with a shell member 65 which is resiliently and removably clipped onto an outer surface of the elbow assembly 60. The vent openings 61 in FIG. 6a are visible through the clear shell member 65. Details of the shell member 65 and the C-clip are described in the ResMed's U.S. Pat. Nos. 6,532,961, 6,691,707 or WO 00/78384, all of which are incorporated herein by reference.
The swivel elbow assembly 60 of FIG. 6a may be the same as is currently used in ResMed's ULTRA MIRAGE® mask, which employs an internal C-clip member, as described above. The elbow assembly 60 of FIG. 6a is intended to be used with a connector tube 300 (FIG. 23). The connector tube 300 is provided between the elbow assembly 60 and the gas delivery tube 310 (FIG. 26).
The frame 20 includes a flange 21 provided at a distal end of a wall 25 defining the aperture 24. FIGS. 5 and 5a show the flange 21, while the embodiment of FIG. 6a does not show or include such a flange since a different elbow assembly 160 is employed. As the flange 21 is inserted within the space 183, it engages protrusions 181 formed in the inside surface of the collar 173. In this embodiment, only two protrusions 181 are provided. The protrusions 181 are ramped or inclined such that engagement with the flange 21 causes outward flexure (FIGS. 19b-1-19b-2) of each end of the cross portion of the T-shaped collar 173, until the flange 21 aligns with and is received within the groove portion 167b (FIGS. 19c-1-19c-2). In this state, with the elbow 160 secured to the frame 20, the collar 173 returns to its unflexed state. Portions of the flange 21 rest against lugs 165 provided within the space 183.
In the connected state, the inside surface of the wall 25 of the frame 20 sealingly engages the outside surface of the end portion 169 of the conduit as shown in FIGS. 19a-1-19c-2. These surfaces engage one another for a distance of approximately 1-10 mm, preferably 6 mm, which helps to seal as well as to provide stability to the connection between the elbow 160 and the frame 20. As seen in FIGS. 19c-1-19c-2, a portion of the wall 25 extends inside the mask 20 to further increase the area of contact between the elbow 160 and the frame 20. In the connected state, an end portion 173a of the collar 173 is flush with the outside surface 20c of the frame 20, as shown in FIGS. 19c-1-19c-2. The wall 25 includes a flange 25a (FIG. 19c-2) to form a stop for the insertion of the end portions 169, and to permit a controlled leak between the elbow 160 and frame 20. In one embodiment, the leak between the elbow 160 and frame 20 is minimal. In another embodiment, a seal is provided between the elbow 160 and frame 20 to prevent a leak.
The curved portion 186 of the vent cover fits adjacent apron 170 of the swivel joint 160 to provide a generally air-tight seal between an interior of the vent cover 180 and the swivel joint 160. In this manner, exhalation gases from an interior of the mask can flow through exhaust port 164 of swivel joint 160, through the interior of the vent cover 180 and to the atmosphere through vents 190. FIG. 19c-1 includes an arrow B that approximates the path exhaust gas follows when the vent cover is in position. This arrangement has an additional advantage in that the vent direction reduces or prevents irritation of a bed partner of the patient by gas flow from the mask. FIGS. 1-4 show the elbow 160 and vent cover 180 in the connected position. A spacer 163 is provided to ensure that the vent cover 180 is spaced sufficiently away from the exterior surface of the elbow 160, which especially helps prevent the air gap from collapsing since the vent cover is preferably made of a resilient flexible material. Of course, the vent cover could be made of a plastic member somewhat like the cover used in the Ultra Mirage™, if desired. In addition, this vent arrangement can be replaced or supplemented using ResMed's vent assembly disclosed, for example, in U.S. Pat. No. 6,561,190, incorporated herein by reference in its entirety.
The nasal bridge region 43 is designed to contact the patient's nose, for example, as shown in FIG. 1, where it can be seen that the lower portion of the bridge is selected for contact. Note that FIG. 1 shows the cushion 40 spaced away from the frame. However, pictures in Appendix C of incorporated U.S. Application 60/402,509 of Moore et al., show the nasal mask assembly attached to two model noses (A & B), described further below. More specifically, the nose includes relatively bony sections at the upper portion of the bridge, and flexible cartilage at the tip of the nose. Reference may be had to Gray's Anatomy, Thirty-Eighth Edition (1995), FIGS. 6.133A, B, 6.135A and 11.3A, B, incorporated herein by reference for drawings showing these regions. It is desirable to avoid localized pressure points along the bony region of the nose, to increase comfort to the patient. Conversely, it is desirable to avoid mask contact with only the cartilage portion of the nose, because its flexibility may allow too much unwanted movement of the cushion in use, may occlude the nasal passages of the patient, and may not provide a stable fit. In addition, positioning on the tip of the nose may increase the distance between the center of gravity of the mask assembly of the face of the patient—an undesirable consequence.
As seen in FIGS. 24a-c, an inner edge 230 of the membrane 205 defines an aperture 235 of the membrane 205. In this preferred form, the shape of the aperture 235 is generally trapezoidal and has a base width w of about 31-45 mm, sides with a length s of 20-22 mm, and a top portion t, generally parallel to the base portion with a length of about 5-10 mm. See FIG. 24c. The included angle α is in the range of 45°-55°, and preferably 50°. The height h between the base portion and the top portion of the membrane 205 is in the range of 19-22 mm. Further, the overall height h0 of the cushion 40 is in the range of 45-55 mm, preferably 50-51 mm and the overall width wo of the cushion 40 is in the range of 65-75 mm, preferably 69-71 mm. Also, as shown in FIG. 24f, the dimension d2 of the cushion is in the range of 29-31 mm and the dimension d3 of the cushion is in the range of 41-43 mm. In one embodiment of a cushion 40 that has a “standard size”, the membrane 205 of the cushion 40 has a width w in the range of 31-34 mm, preferably 33 mm, a height h in the range of 19-28 mm, preferably 22 mm, and the notch 255 has a depth d1 in the range of 19-23 mm, preferably 21.5 mm. In another embodiment of a cushion 40 that has a “deep” size, the membrane 205 of the cushion 40 has a width w in the range of 31-34 mm, preferably 33 mm, a height h in the range of 19-28 mm, preferably 22 mm, and the notch 255 has a depth d1 in the range of 22-27 mm, preferably 24 mm. In yet another embodiment of a cushion 40 that is wider and/or shallower in depth (“wide/shallow”), the membrane 205 of the cushion 40 has a width w in the range of 35-45 mm, preferably 41 mm, a height h in the range of 19-28 mm, preferably 22 mm, and the notch 255 has a depth d1 in the range of 12-20 mm, preferably 16 mm. It is to be understood that these dimensions refer to a particular embodiment of the invention, and a differently sized mask (for example, a “small” size versus a “large” size) while having the same shape would have different dimensions and nevertheless be within the scope of the invention. Further, while the “standard” size cushion, “deep” size cushion, and “wide/shallow” size cushion may be provided individually, these cushions may be provided together as a set of cushions. This set of three cushions provides a good fit in a wide range of patients without having an excessive inventory.
1. A patient interface for delivering breathable gas to a patient comprising:
a frame comprising a left first connector portion and a right first connector portion;
a cushion attached to the frame; and
a headgear assembly comprising a left second connector portion and a right second connector portion adapted for interconnection with the left and right first connector portions of the frame, respectively, wherein
the frame and the headgear assembly are configured to prevent the left first connector portion from being magnetically attached to the right second connector portion, and prevent the right first connector portion from being magnetically attached to the left second connector portion.
2. A patient interface according to claim 1, wherein each of the first and second connector portions includes a magnet.
3. A patient interface according to claim 2, wherein the magnets of the left first connector portion and the right second connector portion are oriented to repulse each other, and the magnets of the right first connector portion and the left second connector portion are oriented to repulse each other.
4. A patient interface according to claim 3, wherein the left second connector portion comprises a first bore configured to receive the magnet of the left first connector portion, and the right second connector portion comprises a second bore configured to receive the magnet of the right first connector portion.
5. A patient interface according to claim 4, wherein the magnet of the left first connector portion is configured to move axially into and out of the first bore during assembly of the headgear assembly to the frame and disassembly of the headgear assembly from the frame, and the magnet of the right first connector portion is configured to move axially into and out of the second bore during assembly of the headgear assembly to the frame and disassembly of the headgear assembly from the frame.
6. A patient interface according to claim 5, wherein each magnet of the first connector portions is configured to automatically locate itself in a predetermined position when the headgear assembly is connected to the frame.
7. A patient interface according to claim 6, wherein each magnet of the first connector portions is cylindrically shaped.
8. A patient interface according to claim 7, wherein the first and second connector portions are configured to permit rotation relative to each other during assembly of the headgear assembly to the frame and disassembly of the headgear assembly from the frame, and
the first and second connector portions are configured to be locked or constrained against rotation such that they may not rotate relative to one another when the left and right second connector portions are connected with the left and right first connector portions, respectively.
9. A patient interface according to claim 8, wherein at least one of the magnets includes neodymium.
10. A patient interface for delivering breathable gas to a patient comprising:
the first and second connector portions are configured to permit rotation relative to each other during assembly of the headgear assembly to the frame and disassembly of the headgear assembly from the frame,
the first and second connector portions are configured to be locked or constrained against rotation such that they may not rotate relative to one another when the left and right second connector portions are connected with the left and right first connector portions, respectively, and
the left first connector portion is incompatible with the right second connector portion and the right first connector portion is incompatible with the left second connector portion.
11. A patient interface according to claim 10, wherein each of the first and second connector portions includes a magnet.
12. A patient interface according to claim 11, wherein the magnets of the left first connector portion and the left second connector portion are oriented to attract each other, and the magnets of the right first connector portion and the right second connector portion are oriented to attract each other.
13. A patient interface according to claim 12, wherein the left second connector portion comprises a first bore configured to receive the magnet of the left first connector portion, and the right second connector portion comprises a second bore configured to receive the magnet of the right first connector portion.
14. A patient interface according to claim 13, wherein the magnet of the left first connector portion is configured to move axially into and out of the first bore during assembly of the headgear assembly to the frame and disassembly of the headgear assembly from the frame, and the magnet of the right first connector portion is configured to move axially into and out of the second bore during assembly of the headgear assembly to the frame and disassembly of the headgear assembly from the frame.
15. A patient interface according to claim 14, wherein each magnet of the first connector portions is cylindrically shaped.
16. A patient interface according to claim 15, wherein at least one of the magnets includes neodymium.
17. A patient interface for delivering breathable gas to a patient comprising:
a frame comprising a left first connector portion and a right first connector portion, each of the first connector portions comprising a magnet;
a headgear assembly comprising a left second connector portion and a right second connector portion adapted for interconnection with the left and right first connector portions of the frame, respectively, each of the second connector portions comprising a magnet,
wherein each magnet of the first connector portions comprises a distal surface facing away from the frame, the distal surfaces of the first connector portion magnets having different polarities from each other.
18. A patient interface according to claim 17, wherein the magnet of the left first connector portion is oriented to repulse the magnet of the right second connector portion, and the magnet of the right first connector portion is oriented to repulse the left second connector portion.
19. A patient interface according to claim 18, wherein each magnet of the first connector portions is configured to automatically locate itself in a predetermined position when the headgear assembly is connected to the frame.
20. A patient interface according to claim 19, wherein the first and second connector portions are configured to permit rotation relative to each other during assembly of the headgear assembly to the frame and disassembly of the headgear assembly from the frame, and
21. A patient interface according to claim 1, wherein:
the left first connector portion and the right second connector portion are prevented from being secured to each other, and
the right first connector portion and the left second connector portion are prevented from being secured to each other.
22. A patient interface according to claim 1, wherein the left first connector portion and the right first connector portion are independently connectable to the headgear assembly.
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Patent number: 9669180
Patent Publication Number: 20130174839
Inventors: Anthony Michael Ging (Christchurch), Saad Nasr (Oatley), Rachael Elizabeth Moore (North Bondi), Andrew Martin Price (Baulkham Hills)
Application Number: 13/784,213
Current U.S. Class: Coil Spring Contact (200/276)
International Classification: A62B 18/08 (20060101); A61M 16/08 (20060101); A61M 16/06 (20060101); A61M 16/00 (20060101);