Source: http://patents.com/us-9889266.html
Timestamp: 2018-08-22 04:24:24
Document Index: 221091120

Matched Legal Cases: ['artz\n2033448', 'art\n4354488', 'art\n6513206', 'art\n7207335', 'Application No. 102', 'Application No. 09178736', 'Application No. 101', 'Application No. 102']

US Patent # 9,889,266. Breathing mask arrangement as well as an application device and a forehead support device for same - Patents.com
United States Patent 9,889,266
Lang , et al. February 13, 2018
A breathing mask arrangement includes an arch body, a sealing lip means for bearing against the surface of the face of a mask user, a respiratory gas conduit means for feeding respiratory gas to a mask internal space which is defined by the arch body and which is in communication with the nose and/or mouth opening of the user of the mask, and an application structure for application of the sealing lip means jointly with the arch body, wherein the application structure has a carrier portion on which a respiratory gas conduit member is releasably coupled.
Lang; Bernd Christoph (Graefelfing, DE), Biener; Achim (Aufkirchen, DE), Heidmann; Dieter (Geretsried, DE), Madaus; Stefan Rolf (Graefelfing, DE), Vogele; Harald Wolfgang (Gauting, DE)
ResMed R&D Germany GmbH (Martinsried, DE)
Family ID: 1000003113684
15/665,558
US 20170326322 A1 Nov 16, 2017
14829864 Aug 19, 2015 9757534
13923671 Sep 29, 2015 9144656
13067282 Jul 9, 2013 8479738
11987164 Aug 9, 2011 7992559
10493424 Jan 22, 2008 7320323
PCT/EP02/11798 Oct 22, 2002
Oct 22, 2001 [DE] 101 51 984
Jan 17, 2002 [DE] 102 01 682
Mar 14, 2002 [WO] PCT/EP02/02877
Current CPC Class: A61M 16/0633 (20140204); A61M 16/06 (20130101); A61M 16/065 (20140204); A61M 16/0616 (20140204); A61M 16/0875 (20130101); A61M 16/0644 (20140204); A61M 16/0655 (20140204); A61M 16/0683 (20130101); A61M 16/0825 (20140204); A61M 16/0638 (20140204)
Current International Class: A61M 16/06 (20060101); A61M 16/08 (20060101)
Field of Search: ;128/201.22,201.23,205.25,206.12,206.21,206.24,206.26-206.28,207.13
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This application is a continuation of U.S. application Ser. No. 14/829,864, filed Aug. 19, 2015, now allowed, which is a continuation of U.S. application Ser. No. 13/923,671, filed Jun. 21, 2013, now U.S. Pat. No. 9,144,656, which is a continuation of U.S. application Ser. No. 13/067,282, filed May 20, 2011, now U.S. Pat. No. 8,479,738, which is a continuation of U.S. application Ser. No. 11/987,164, filed Nov. 28, 2007, now U.S. Pat. No. 7,992,559, which is a continuation of U.S. application Ser. No. 10/493,424, filed Apr. 22, 2004, now U.S. Pat. No. 7,320,323, which is the US National Phase of International Application No. PCT/EP02/011798, filed Oct. 22, 2002, which designated the US. PCT/EP02/011798 claims priority to DE Application No. 101 51 984.2, filed Oct. 22, 2001, DE Application No. 102 01 682.8, filed Jan. 17, 2002, and International Application No. PCT/EP02/02877, filed Mar. 14, 2002. Each of these applications are incorporated herein by reference in their entirety.
1. A respiratory mask assembly for providing respiratory therapy to a patient, the respiratory mask assembly comprising: a frame including headgear holding members, and the frame further including a conduit carrier portion having an insert opening; a mask releasably coupled with the frame, the mask including a body portion and a sealing portion, the mask forming a mask internal space pressurizable to a therapeutic pressure above ambient pressure, wherein the body portion includes a circular inlet opening structured to receive a flow of air at the therapeutic pressure for breathing by the patient, wherein the mask includes an inside surface exposed to said therapeutic pressure in use and an outside surface exposed to ambient pressure, and the frame includes a wall arranged outside the mask internal space, the sealing portion is constructed and arranged to form a seal with a patient's nose, the sealing portion including an upper lip region adapted to pass along an upper lip of the patient, wherein the sealing portion comprises an elastomer material and the body portion does not comprise an elastomer material; a positioning and retaining arrangement structured and arranged to releasably couple the mask to the frame, the positioning and retaining arrangement comprising at least one positioning member provided to the frame, wherein the at least one positioning member is structured and arranged to extend posteriorly from the frame and into the body portion of the mask such that the body portion covers the at least one positioning member when the mask and the frame are coupled to one another, and the positioning and retaining arrangement further comprising a mask retainer part provided to the body portion of the mask, wherein the mask retainer part is structured and arranged to engage over and behind a frame retainer part of the frame to releasably retain the mask to the frame; a respiratory gas conduit member structured to connect to a respiratory gas conduit to deliver the flow of air at the therapeutic pressure to the internal space, and the respiratory gas conduit member having an end portion mounted within the insert opening of the conduit carrier portion of the frame; headgear to maintain the respiratory mask assembly in position on a patient's head, the headgear including bands adapted to connect to the headgear holding members of the frame; and a plurality of outlet openings for discharge of gas from the mask internal space to ambient atmosphere.
2. The respiratory mask assembly according to claim 1, wherein the positioning and retaining arrangement further comprises a recessed region in the frame adapted to receive a protrusion provided to the body portion of the mask to facilitate positioning of the mask with respect to the frame, wherein the mask retainer part and the frame retainer part are structured and arranged to at least partly align with one another along a direction of assembly, and the mask retainer part is structured and arranged to engage over and behind the frame retainer part to positively and releasably interlock the mask and the frame in an assembled position, wherein the respiratory gas conduit member is substantially circular when viewed in cross-section, further comprising a connector sleeve rotatably coupled to the respiratory gas conduit member to allow rotatable movement between the respiratory gas conduit member and the respiratory gas conduit, wherein the headgear holding members comprise a pair of through openings structured to removably receive respective ones of the bands of the headgear, wherein each of the plurality of outlet openings includes a cross-section that enlarges in an outlet direction, wherein the frame and the carrier portion comprise a one-piece structure, and wherein the respiratory gas conduit member comprises a bend to change a direction of the flow of air therethrough.
3. The respiratory mask assembly according to claim 2, wherein the mask retainer part and the frame retainer part are structured and arranged to allow deflection into the assembled position.
4. A respiratory mask assembly for providing respiratory therapy to a patient, the respiratory mask assembly comprising: a frame assembly including a frame and a respiratory gas conduit member provided to the frame, the frame including a pair of upper headgear holding members and a pair of lower headgear holding members, and the frame further including a conduit carrier portion having an insert opening, the respiratory gas conduit member structured to connect to a respiratory gas conduit, and the respiratory gas conduit member is mounted within the insert opening of the conduit carrier portion of the frame; a mask releasably coupled with the frame assembly, the mask including a body portion and a sealing portion, the body portion forming a mask internal space pressurizable to a therapeutic pressure above ambient pressure, and the body portion including a circular inlet opening structured to receive a flow of air at the therapeutic pressure from the respiratory gas conduit member for breathing by the patient, wherein the body portion includes an inside surface exposed to said therapeutic pressure in use and an outside surface exposed to ambient pressure, and the frame includes a wall arranged outside the mask internal space and arranged to cover a portion of the mask when the mask and the frame assembly are coupled to one another, wherein the body portion includes a plurality of outlet openings for discharge of gas from the mask internal space to ambient atmosphere, and the frame includes a portion that is adjacent and passes below the plurality of outlet openings when the mask and the frame assembly are coupled to one another, the sealing portion is constructed and arranged to form a seal with a patient's nose and mouth, wherein the sealing portion comprises an elastomer material and the body portion does not comprise an elastomer material; a positioning and retaining arrangement structured and arranged to releasably couple the mask to the frame assembly, the positioning and retaining arrangement comprising a recessed region in the frame adapted to receive a protrusion provided to the body portion of the mask to facilitate positioning of the mask with respect to the frame assembly, and the positioning and retaining arrangement further comprising a frame retainer part provided to the respiratory gas conduit member and a mask retainer part provided to the body portion of the mask, wherein the frame retainer part projects beyond the conduit carrier portion of the frame, and when the mask and the frame assembly are coupled to one another, the frame retainer part extends through the circular inlet opening of the body portion and the mask retainer part engages over and behind the frame retainer part to releasably retain the mask to the frame assembly, and wherein the frame retainer part comprises a bead adjacent a distal end of the respiratory gas conduit member and the mask retainer part comprises an internal surface of the body portion of the mask arranged to engage behind the bead when the mask and the frame assembly are coupled to one another; and headgear to maintain the respiratory mask assembly in position on a patient's head, the headgear including upper bands adapted to connect to the upper headgear holding members of the frame and lower bands adapted to connect to the lower headgear holding members of the frame, and the upper bands adapted to be routed over respective ones of a patient's ears and the lower bands adapted to be routed under respective ones of the patient's ears.
5. The respiratory mask assembly according to claim 4, wherein the respiratory gas conduit member is substantially circular when viewed in cross-section, wherein the upper headgear holding members comprise holding loops integral with the frame, wherein the upper headgear holding members comprise a pair of through openings structured to removably receive respective ones of the upper bands of the headgear and the lower headgear holding members comprise a pair of through openings structured to removably receive respective ones of the lower bands of the headgear, wherein each of the plurality of outlet openings includes a cross-section that enlarges along its length, wherein the frame and the carrier portion comprise a one-piece structure, and wherein the respiratory gas conduit member comprises a bend to change a direction of the flow of air therethrough.
6. The respiratory mask assembly according to claim 5, wherein the mask retainer part and the frame retainer part are structured and arranged to allow deflection into an assembled position.
7. A respiratory mask assembly for providing respiratory therapy to a patient, the respiratory mask assembly comprising: a frame including a main body and a forehead support extending from the main body, the forehead support including a pair of upper headgear holding members and the main body including a pair of lower headgear holding members; a mask releasably coupled with the frame, the mask including a body portion and a sealing portion, the body portion forming a mask internal space pressurizable to a therapeutic pressure above ambient pressure, and the body portion including a circular inlet opening structured to receive a flow of air at the therapeutic pressure for breathing by the patient, wherein the body portion includes an inside surface exposed to said therapeutic pressure in use and an outside surface exposed to ambient pressure, and the main body of the frame includes a side wall arranged along the outside surface of the body portion so that the side wall is outside the mask internal space, the sealing portion is constructed and arranged to form a seal with a patient's nose and mouth, the sealing portion including a hole therein adapted to receive the patient's nose and mouth such that the flow of air at the therapeutic pressure is delivered to the patient's nose and mouth, wherein the sealing portion comprises an elastomer material and the body portion does not comprise an elastomer material; a positioning and retaining arrangement structured and arranged to releasably couple the body portion of the mask to the main body of the frame in a substantially fixed, substantially non-adjustable position to resist adjustable movement between the body portion of the mask and the main body of the frame, the positioning and retaining arrangement comprising a pair of positioning members provided to the frame, wherein the pair of positioning members are structured and arranged to protrude from the main body of the frame and into respective receiving portions provided in the body portion of the mask when the mask and the frame are coupled to one another, and the positioning and retaining arrangement further comprising a mask retainer part provided to the body portion of the mask, wherein the mask retainer part is structured and arranged to engage behind a frame retainer part of the frame to releasably retain the mask to the frame; a respiratory gas conduit member structured to connect to a respiratory gas conduit to deliver the flow of air at the therapeutic pressure to the internal space, and the respiratory gas conduit member is configured to communicate with the mask through the circular inlet opening of the body portion; and headgear to maintain the respiratory mask assembly in position on a patient's head, the headgear including upper bands adapted to connect to the upper headgear holding members of the frame and lower bands adapted to connect to the lower headgear holding members of the frame, and the upper bands adapted to be routed over respective ones of a patient's ears and the lower bands adapted to be routed under respective ones of the patient's ears.
8. The respiratory mask assembly according to claim 7, wherein the body portion includes a plurality of outlet openings for discharge of gas from the mask internal space to ambient atmosphere, wherein the main body of the frame includes a closed ring or closed loop configuration structured and arranged to embrace the body portion of the mask when the mask and the frame are coupled to one another, further comprising a connector sleeve rotatably coupled to the respiratory gas conduit member to allow rotatable movement between the respiratory gas conduit member and the respiratory gas conduit, wherein the upper and lower headgear holding members are integral with the frame, wherein the upper headgear holding members comprise a pair of through openings structured to removably receive respective ones of the upper bands of the headgear, wherein the frame has a front side and a rear side, and the frame includes an opening through which at least a portion of the body portion is exposed towards the front side of the frame, and the plurality of outlet openings are exposed towards the front side of the frame, and wherein the respiratory gas conduit member comprises a bend to change a direction of the flow of air therethrough.
9. The respiratory mask assembly according to claim 8, wherein the mask retainer part and the frame retainer part are structured and arranged to allow deflection into an assembled position.
10. A respiratory mask assembly for providing respiratory therapy to a patient, the respiratory mask assembly comprising: a frame including a pair of upper headgear holding members and a pair of lower headgear holding members; a mask releasably coupled with the frame, the mask including a body portion and a sealing portion, the body portion forming a mask internal space pressurizable to a therapeutic pressure above ambient pressure, and the body portion including a circular inlet opening structured to receive a flow of air at the therapeutic pressure for breathing by the patient, wherein the body portion includes an inside surface exposed to said therapeutic pressure in use and an outside surface exposed to ambient pressure, and the frame includes a side wall arranged along the outside surface of the body portion so that the side wall is outside the mask internal space, the sealing portion is constructed and arranged to form a seal with a patient's nose and mouth, the sealing portion including a hole therein adapted to receive the patient's nose and mouth such that the flow of air at the therapeutic pressure is delivered to the patient's nose and mouth, wherein the sealing portion comprises an elastomer material and the body portion does not comprise an elastomer material; a positioning and retaining arrangement structured and arranged to releasably couple the mask to the frame in a substantially fixed, substantially non-adjustable position to resist adjustable movement between the mask and the frame, the positioning and retaining arrangement comprising a pair of positioning members provided to the frame, wherein the pair of positioning members are structured and arranged to protrude from the frame and into respective receiving portions provided in the body portion of the mask when the mask and the frame are coupled to one another, and the positioning and retaining arrangement further comprising a mask retainer part provided to the body portion of the mask, wherein the mask retainer part is structured and arranged to engage behind a frame retainer part of the frame to releasably retain the mask to the frame; a respiratory gas conduit member structured to connect to a respiratory gas conduit to deliver the flow of air at the therapeutic pressure to the internal space, and the respiratory gas conduit member is configured to communicate with the mask through the circular inlet opening of the body portion; and headgear to maintain the respiratory mask assembly in position on a patient's head, the headgear including upper bands adapted to connect to the upper headgear holding members of the frame and lower bands adapted to connect to the lower headgear holding members of the frame, and the upper bands adapted to be routed over respective ones of a patient's ears and the lower bands adapted to be routed under respective ones of the patient's ears.
11. The respiratory mask assembly according to claim 10, wherein the body portion includes a plurality of outlet openings for discharge of gas from the mask internal space to ambient atmosphere, wherein the frame includes a closed ring or closed loop configuration structured and arranged to embrace the body portion of the mask when the mask and the frame are coupled to one another, further comprising a connector sleeve rotatably coupled to the respiratory gas conduit member to allow rotatable movement between the respiratory gas conduit member and the respiratory gas conduit, wherein the upper and lower headgear holding members are integral with the frame, wherein the upper headgear holding memebrs comprise a pair of through openings structured to removably receive respective ones of the upper bands of the headgear, wherein the frame has a front side and a rear side, and the frame includes an opening through which at least a portion of the body portion is exposed towards the front side of the frame, and the plurality of outlet openings are exposed towards the front side of the frame, and wherein the respiratory gas conduit member comprises a bend to change a direction of the flow of air therethrough.
12. The respiratory mask assembly according to claim 11, wherein the mask retainer part and the frame retainer part are structured and arranged to allow deflection into an assembled position.
13. A CPAP system used for treatment of sleep disordered breathing, the CPAP system comprising: the respiratory mask assembly according to claim 1; a CPAP device structured to supply the flow of air at the therapeutic pressure; and the respiratory gas conduit connected between the CPAP device and the respiratory mask assembly to deliver the flow of air at the therapeutic pressure from the CPAP device to the respiratory mask assembly.
14. A CPAP system used for treatment of sleep disordered breathing, the CPAP system comprising: the respiratory mask assembly according to claim 4; a CPAP device structured to supply the flow of air at the therapeutic pressure; and the respiratory gas conduit connected between the CPAP device and the respiratory mask assembly to deliver the flow of air at the therapeutic pressure from the CPAP device to the respiratory mask assembly.
15. A CPAP system used for treatment of sleep disordered breathing, the CPAP system comprising: the respiratory mask assembly according to claim 7; a CPAP device structured to supply the flow of air at the therapeutic pressure; and the respiratory gas conduit connected between the CPAP device and the respiratory mask assembly to deliver the flow of air at the therapeutic pressure from the CPAP device to the respiratory mask assembly.
16. A CPAP system used for treatment of sleep disordered breathing, the CPAP system comprising: the respiratory mask assembly according to claim 10; a CPAP device structured to supply the flow of air at the therapeutic pressure; and the respiratory gas conduit connected between the CPAP device and the respiratory mask assembly to deliver the flow of air at the therapeutic pressure from the CPAP device to the respiratory mask assembly.
In accordance with a particularly preferred embodiment of the invention the respiratory gas conduit member is in the form of a tube connection. Such a tube connection is preferably made from dishwasher-resistant plastic material so that the respiratory gas conduit member can be cleaned at comparatively high temperatures and in the process sterilised. The tube connection is preferably of such a configuration that its inside diameter is in the range of 12 to 34 mm. The tube connection can be of a substantially circular or preferably polygonal cross-section. The tube connection can be in the form of a conduit bend which provides for a slight change in direction of the flow of respiratory gas through an angle in the range of from 0 to 45.degree..
In accordance with a particularly preferred embodiment, particularly reliable discharge of respiratory gas loaded with CO.sub.2 to the ambient atmosphere is attained in that the arch body is provided with openings through which the respiratory gas which is under pressure in the internal region of the arch body can escape to the ambient atmosphere. The openings are preferably such that the cross-section thereof enlarges in the outlet direction. Those outlet openings are preferably arranged in such a way that they are disposed as closely as possible to the region which, in the position of application of the breathing mask arrangement, is adjacent to the nasal openings of a user of the mask.
An embodiment of the forehead support device, which is preferred in accordance with a particular aspect of the present invention, is afforded in that the holder is in the form of a pivotal holder. That pivotal holder advantageously permits a tilting movement of the contact element about at least one axis substantially parallel to the usual contact orientation. That pivotal holder can preferably be formed by a pivot or hinge device which in accordance with a particularly preferred embodiment includes a ball joint. As an alternative thereto or also in combination with that configuration, it is possible for the pivot device to be formed by an elastomer structure. The range of movement of the holder of the contact element is preferably in the range of 10-30.degree.. It is possible to take sufficient account of all possible forehead architectures within that angular range.
The ball joint structures advantageously provide for good adaptability to the horizontal and vertical configuration of the forehead of the user of the mask. The pivot device--in particular the ball joint means--can also be designed to be lockable. The pivot device can also preferably be tiltable in a particularly advantageous manner about given axes--in particular about a horizontal axis. The curvature of the contact element can be so selected that different radii of curvature are afforded in the horizontal and vertical directions. The radii of curvature are preferably smaller than the usual radii of curvature of a forehead.
Advantageously the mounting position of the contact element is adjustably variable. As an alternative thereto--or also in combination with this feature--it is also possible to provide a plurality of coupling options so that it is possible to achieve varying spacings on the forehead, by suitable selective coupling. It is possible to implement coarse adjustment by for example two, preferably three or also more coupling options, and to implement preferably stepless fine adjustment within a limited fine adjustment range. It is possible to permit a plurality of permutation options, in which case the individual coupling permutations result in respectively different settings in terms of the spacing relative to the forehead. It is also possible to provide clamping structures, by means of which stepless adjustment of the spacing relative to the forehead is possible. The coupling means can be so designed that a defined adhesive location is achieved, so that a setting which is individually steplessly adapted is durably maintained by adhesive means.
In accordance with a further aspect of the present invention, adaptability, which is still further increased in comparison with the above-described embodiment, of the forehead support device to the individual curvature of the forehead of the user of the mask, is achieved if the pivot axes of the arm members are inclined relative to each other through an angle .alpha. in the range of between 8 and 45.degree. relative to each other. It is advantageously possible for the structure defining the pivot axes to be designed in such a way that the angle .alpha. of the pivot axes relative to each other is adjustably variable.
FIG. 25 is a plan view of the forehead support device shown in FIG. 24,
FIG. 30 is a sectional view through a connecting region formed in the region of the forehead support, between the connecting portion of a breathing mask and a conduit portion (here the mask-side socket of a washing-out adaptor--AEROCLICK (registered trade mark of MAP Medizin-Technologie GmbH); Wisper-Swivel (Respironics));
FIG. 35 shows an embodiment of a breathing mask arrangement with a tube portion which is steplessly variable in curvature--and a forehead support device coupled thereto,
The frame portion 3 is made from a plastic material and has holding clips or loops 4 which are produced integrally therewith. In the application position of the breathing mask arrangement the holding loops 4 are disposed at cheek level or at the level of the sides of the nose of the user of the mask and permit coupling of a lower web band arrangement. For reliably coupling the arch body 2 to the frame portion 3, there is a retaining structure 5, by way of which the arch body 2 can be fixed to the frame portion 3 in the joining position by latching engagement therein. The retaining structure 5 includes a retaining nose 5a which engages over a top side of the frame portion 3.
A respiratory gas conduit member which here is in the form of a docking port 8 is releasably fixed to the carrier portion 7. The docking port 8 includes an annular flange (not visible here) on to which a hose connecting sleeve 9 is rotatably movably fitted. The hose connecting sleeve 9 includes a hose connecting portion 9a on to which an end portion of a respiratory gas hose can be fitted.
The forehead cushion elements 14 are made from an elastomer material and, on their underside 14a which in the application position faces towards the user of the mask, form a contact surface involving a predetermined distribution in terms of surface pressure. The forehead cushion elements 14 are each coupled to the loop portion 12 by way of a respective push-in foot 16. The push-in foot 16 is provided eccentrically on the respective forehead cushion element 14 in such a way that pivoting the forehead cushion elements 14 about the axis 17 of the push-in foot, as indicated by the arrow P, makes it possible to achieve different contact positions for the underside 14a of the forehead cushion elements 14 on the surface of the forehead of the user of the mask. Different contact positions can be achieved by virtue of selection of the pivotal position of the forehead cushion element 14 and by virtue of selection of the receiving opening 18 provided to receive the push-in foot 16. In the embodiment illustrated here, two mutually spaced receiving openings 18 are provided in the loop portion 12, for each of the left and the right forehead cushion elements 14.
The forehead cushion elements 14 can be removed from the loop portion 12 by pulling the push-in feet 16 out of the receiving openings 18, as is shown in FIG. 2. In this embodiment, the centre lines of the receiving openings 18 are spaced from each other by approximately 10 mm. The eccentricity of the push-in foot 16 on the respective forehead cushion element 14 (see in that respect FIG. 1) is also about 10 mm. As a result of the eccentric arrangement of the push-in foot 16 and the spaced arrangement of the receiving opening 18, heightwise variability of the forehead cushion elements in a range of about 30 mm is achieved substantially perpendicularly to a line joining the eyebrows of the user of the mask. A variation in the contact position over a range of 20 mm is also possible in a lateral direction, that is to say in the direction of the above-mentioned line which joins the eyebrows. The holding loop 15 provided for coupling an upper web band arrangement is arranged in the proximity of the receiving openings 18 in such a way that the through opening 15a defined by the holding loop is covered over towards the user of the mask by the forehead cushion element 14.
In the view shown in FIG. 2 the hose connecting sleeve 9 shown in FIG. 1 has been removed from the docking port 8. It is possible in this view to see an annular flange 19 which is formed integrally with the docking port 8 and which has a plurality of tongue elements 19a which are elastically deflectable towards the centre of the through passage formed by the docking port 8. Provided on the tongue elements 19a is a retaining bead or ridge 20 which can be brought into engagement with an internal peripheral groove provided in complementary relationship on the hose connecting sleeve 9. The geometry of the retaining bead 20, the internal peripheral groove in the rotational sleeve 9 and the elasticity of the tongue elements 19a are so matched that the hose connecting sleeve 9 can be withdrawn from the annular flange 19 without involving the use of a tool, when a given pulling force is exceeded. The annular flange 19 and the hose connecting sleeve 9 are also designed to fit in such a way that the hose connecting sleeve 9 is easily rotatably carried on the annular flange 19.
FIG. 4 shows the application structure of the breathing mask arrangement according to the invention, in an assembly condition in which the docking port 8 according to the invention is inserted into the insert opening formed in the carrier portion 7 and correctly fixed in position by way of the bayonet closure device provided in the region of the insert opening. In this embodiment, the docking port 8 forms a conduit member which is in the nature of a pipe bend and by which the flow of respiratory gas flowing by way of the hose connecting sleeve 9 (FIG. 1) is diverted through an angle of about 30.degree. towards the tip of the nose of the user of the mask. Feeding the respiratory gas in that way to the internal space in the mask, which is defined by the arch body 2 (FIG. 1), provides that the gas advantageously flows over the bridge of the nose of the user of the mask.
FIG. 7 shows the breathing mask arrangement according to the invention--with the exception of the forehead cushion elements 14 (FIG. 1)--in the completely assembled condition, from the direction of the pivot axis X. As can be seen in that view the docking port 8 which in accordance with the invention can be releasably inserted into the carrier portion 7 forms a coupling element for coupling the elastomer arch body 2 to a rotatably supported hose connecting sleeve 9, by which the feed flow of respiratory gas is deflected through an angle .alpha. which in this embodiment is 32.degree..
The breathing mask arrangement is supported on the forehead region of the mask user by way of a forehead support device which will be described in greater detail hereinafter. Preferably support on the forehead region is implemented by way of two contact zones 207, 208 which are disposed above a transverse line 206 which joins the eyebrows 205. In the view illustrated here support for the breathing mask arrangement in the forehead region is implemented at two contact zones 207, 208, wherein the spacing of the centroids S1, S2 of the contact zones 207, 208 preferably approximately corresponds to the spacing between the eyes of the mask user. The contact pressure of the sealing lip device of the breathing mask arrangement in the region of the sealing lip contact zone 201 is adjustably variable insofar as contact elements provided for affording contact in the contact zones 207, 208 are pivotable about pivot axes X0, X1, X1', X2, X2' and preferably also about a transverse axis Y0.
The pivot axes X0, X1, X1', X2, X2' which permit adjustment of the support configuration of the forehead support device preferably extend directed away from the forehead region towards the upper lip region 202 of the user of the mask. The axes X1, X2 which are shown here are oriented in mutually parallel relationship and spaced from each other by a spacing a which substantially corresponds to the width of the bridge of the nose, in particular the width of the bridge of the nose in the region of the tear duct openings of the mask user.
The pivot axes X1', X2' which are inclined relative to each other here are also preferably spaced in the region of the width a of the bridge of the nose, at the level of the contact zones 207 and 208. The axes X1', X2' are inclined relative to each other at an angle .alpha. which is preferably so selected that the two axes intersect in the region between the base of the nose and the chin 211 of the mask user.
In the illustrated embodiment the coupling members 217, 218 are coupled movably to the left and right arm elements 214, 215 respectively associated therewith. In the illustrated embodiment coupling of the coupling members 217, 218 to the arm elements 214, 215 associated therewith is effected in each case by way of a hinge portion 227 and 228 respectively which permits a pivotal movement of the coupling member 217, 218 with respect to the arm element 214, 215 associated therewith. The arm elements 214, 215 are coupled to the base portion 216 by way of a hinge connection 229, 230. The hinge connections 229, 230 are here in the form of film hinges. In this case the arm elements 214, 215 are formed integrally with the base portion 216. The hinge connections 229, 230 define the pivot axes X1, X1' and X2, X2' respectively referred to hereinbefore in connection with FIG. 1. As a consequence of the pair of forces applied to the respective arm element in the region of the hinge portions 227, 228 and the hinge connections 229, 230, the respective arm element can be moved with respect to the base portion 216 into a pivotal position which is defined by the radial spacing of the engagement portion 219, 221 from the axis of rotation 224. The maximum radial stroke movement of the engagement portions 219, 221 and the spatial position of the hinge portions and the hinge connections 227, 228, 229, 230 are so selected that, for example in a range of rotary movement of the adjusting wheel 222 through an angle of rotation of 540.degree., it is possible to adjust a pivot angle .beta. of the arm elements 214, 215 in the range of from 0 to 40.degree..
FIG. 16 sets out a further embodiment of the adjusting drive 212. In this case also the adjusting drive 212 includes an adjusting wheel 222 coupled rotatably to the base portion 216 by way of a rotary trunnion or projection 240. Provided on the underside of the adjusting wheel 222, which faces towards the base portion 216, is a spiral structure 241 which is directly in engagement with an engagement portion 219' provided on the arm element 214. The arm element 214 is pivotably movably coupled to the base portion 216 by way of a hinge connection 229 which in this case also is in the form of a film hinge. Rotation of the adjusting wheel 222 about the axis of rotation 224 defined by the rotary trunnion 214 makes it possible to set different spacings of the engagement portion 219' from the axis of rotation 224, whereby the arm element 214 is pivotable with respect to the base portion 216 into respectively desired pivotal positions.
Mounted to the arm elements 214, 215 there are also forehead pads 249' which are provided to bear against the surface of the forehead of the mask user, the forehead pads 249' being suspended tiltably on trunnions or projections 262 which are formed integrally with the respective arm element 215, 214. Disposed between the trunnions 262 there is again an eye portion 250 for passing therethrough an end portion of an upper band arrangement. It is possible for the base portion 216 to be guided displaceably on an arm portion 253a which extends from the holding portion 234 to the holding foot 253. That makes it possible for the vertical spacing of the forehead support device from the sealing lip device 246 also to be variably altered.
FIG. 24 shows a further embodiment of a forehead support device. This forehead support device also includes a forehead support portion 201 which is made from a sufficiently elastically deformable material, preferably silicone rubber. A conduit passage element 204a is supported displaceably by way of an adjusting device 214 on the forehead support portion 201. The conduit passage element 204a can be of a configuration similar to that described hereinbefore with reference to FIG. 23 as a connecting element by way of which coupling of a connecting portion on the mask side to a respiratory gas conduit is permitted. As an alternative thereto it is also possible for the conduit passage element 204a to be of such a design configuration that it merely embraces a respiratory gas conduit portion and in so doing couples it adjustably in respect of height to the forehead support portion 201.
In this embodiment the adjusting device 214 includes two adjusting drive devices 215 by way of which the spacing of the central axis Z of the conduit passage element 204a with respect to the support surface 205 of the forehead support portion 201 is steplessly adjustable. In this embodiment the adjusting drive devices 215, 216 are provided with internally threaded sleeves which are manually rotatable by way of a knurling provided on the external periphery thereof. The internally threaded sleeves are in engagement with screwthread portions (not shown) of adjusting screws 217, 218 so that manual rotation of the respective internally threaded sleeve causes the effective length of a strut formed by the internally threaded sleeve and the adjusting screw in engagement therewith to be steplessly adjustable. The spacing of the conduit connecting element 204a can also be individually adjusted by the user of the mask by varying the effective length of those struts.
As can be seen from FIG. 25 the forehead support portion 201 is provided with support locations 222, 223 in which the two adjusting drive devices 215, 216 are respectively anchored on one side. Also provided on the conduit passage element 204a are support locations 224 in which the end portions of the adjusting screws 217, 218 are sufficiently non-rotatably anchored.
The arrangement is here such that the operative length of the structure coupling the conduit passage element 204a to the respective support locations 222, 223 is steplessly variable by actuation of the two adjusting drive devices 215, 216. By rotation of the internally threaded sleeves which are indicated here and which are knurled on the outside periphery (see the arrow symbols in FIG. 24), it is possible to adjust the position of the conduit passage element 204a relative to the forehead support portion 201 both in the direction of the axes X, Y indicated here. It is further possible for the conduit passage element 204a also to be pivoted slightly in respect of the longitudinal axis Z thereof.
The conduit passage element 204a provided in the embodiment of FIGS. 24 and 25 can also be of such a configuration that it forms part of the respiratory gas conduit itself. Such a configuration for the conduit passage element 204a is shown in FIG. 28. The conduit passage element 204a includes the support portion 238 co-operating with the adjusting drive devices and a flexible hose conduit portion 239 which is provided in this embodiment. Provided on the hose conduit portion 239 is a push-in sleeve, by way of which a further hose conduit can be rotatably connected.
FIG. 30 is a view in the form of a simplified section showing how the conduit connecting element 204 or also the conduit passage element 204a can be used for coupling a connecting portion 200a provided on the breathing mask 200 to a further respiratory gas conduit member 200b. In this embodiment the respiratory gas conduit member 200b forms part of a washing-out valve as is described in particular in German patent application DE 198 . . . . Provided on the breathing mask 200 are loop portions 200c, by way of which the breathing mask 200 can be fixed by means of a lower headband arrangement in the region of the nose of the mask user.
FIG. 31 shows a forehead support device which has substantial points in common with the embodiment already described hereinbefore with reference to FIG. 23. The conduit connecting element 204 (also 204a) is coupled by way of loop elements 243 to the forehead support portion 201. Adjustment of the spacing of the central axis Z of the conduit connecting element 204 relative to the underside (contact surface 205) of the forehead support portion is achieved in this case in that the loop elements 243 can be fitted into suitably selected bores 244. Depending on which bores 244 are selected for anchoring the loop elements 243 at the forehead support portion, that affords different spacings of the central axis Z relative to the contact surface 205. The forehead support portion 201 can be fixed by way of fixing straps 245 to an upper headband arrangement 246. In this embodiment the upper headband arrangement 246 includes a band portion 247 which extends between the two fixing straps 245 under the forehead support portion 201 and in that case additionally cushions the forehead support portion against the forehead of the mask user.
FIG. 32 shows a forehead support device for supporting a breathing mask arrangement against the forehead, which also permits stepless adjustment of the support height. In this embodiment a conduit connecting element 204 which can be fitted on to a connecting portion of a breathing mask is pivotably coupled to the coupling structure 203. In this embodiment the coupling structure 203 is in the form of a bent wire member as is shown by way of example in FIG. 33. The coupling structure 203 in conjunction with an adjusting drive device 215 forms the strut triangle indicated in the diagrammatic view at K1. The strut S1 is in this case formed by the coupling structure 203, the strut S2 is formed by the conduit connecting element 204 and the strut S3 by the adjusting drive 215. A preferred structure of the adjusting drive 215 is illustrated in FIG. 34. The adjusting drive in FIG. 34 includes a screwthreaded spindle 250 which is pivotably but non-rotatably coupled to the coupling structure 203 by way of a pivot head 251 as can be seen in FIG. 32. The screwthreaded spindle 250 is in engagement with an internally threaded sleeve 231 which in turn is anchored rotatably by way of a seat element 233 in a radially projecting portion 252 of the conduit connecting element 204. Rotation of the sleeve 231 makes it possible to alter the effective spacing between the pivot head 251 and the seat element 233 and thus to pivot the coupling structure 203 relative to the conduit connecting element 204. In that way it is possible to implement different relative positions of the lower limbs 203a relative to a breathing mask connected to the conduit connecting element 204, and thus different forehead spacings.
FIG. 36 shows a forehead support device having a conduit passage element 204a which can be fitted on to a breathing mask 200. Provided on that conduit passage element 204a is a ball joint trunnion which permits rotatable and pivotable mounting of a tube sleeve element 270. The tube sleeve element 270 here includes a spherical portion 271 which is of such a configuration that it is carried on the trunnion portion of the conduit passage element 204a in substantially sealing relationship but sufficiently easily movably thereon. Provided on the tube sleeve element 270 is a male screwthread portion 272 which is in threaded engagement with a coupling structure 203. The coupling structure 203 includes limb portions 203a which can be coupled to a preferably cushioned upper headband arrangement 246. By rotation of the tube sleeve element 270 about the central axis Z, it is possible, by virtue of the screwthread engagement between the male threaded portion 272 and the coupling structure 203, to steplessly vary the spacing between the points E1 and E2. In the region of the points E1, E2 an adjusting loop element 262 is pivotably coupled to the coupling structure 203 and the conduit passage element 204 respectively. In this embodiment the tube sleeve element 270 jointly with the coupling structure 203 forms a strut S1 in the sketch K2 illustrated here. The conduit passage element 204a, with its portion which can be fitted directly on to the breathing mask, forms the strut S2, while in this triangle the pivotal loop element 262 forms the strut S3. By altering the operative length of the strut S1 it is then possible for the tube sleeve element 270 and jointly therewith the coupling structure 203 to be steplessly pivoted about the axis Y indicated here.
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