AUTO-ADJUSTING MASK STABILIZER

Abstract

A forehead support for a facial mask is adapted to be moveable between a first position with respect to a frame of the mask and a second position with respect to the frame. The forehead support includes a biasing mechanism that urges the forehead support in the second position. A method of positioning a forehead support with respect to a frame of a patient interface includes positioning the forehead support and patient interface assembly on a face; disengaging a forehead support locking mechanism; allowing the forehead support to move from a first position to a second position; and engaging a forehead support locking mechanism.

Claims

1-18. (canceled)

19. A forehead support for a facial mask, the facial mask having a mask frame, the forehead support comprising: a frame extension provided on top of the mask frame, the frame extension having a cylindrical extension; a cushion frame including a shaft received in a bore of the cylindrical extension, the cushion frame being adapted to be moveable between a first position with respect to the mask frame and a second position with respect to the mask frame, the second position being towards a wearer's forehead; and a compressible biasing element provided inside the shaft, the compressible biasing element being configured to urge the forehead support towards the second position.

20. The forehead support according to claim 19, further comprising headgear configured to support the facial mask on a wearer's head.

21. The forehead support according to claim 20, wherein the cushion frame further includes slotted connectors configured to be connected to ends of an upper head strap of the headgear.

22. The forehead support according to claim 19, wherein the shaft is translatably supported in the cylindrical extension.

23. The forehead support according to claim 19, wherein the compressible biasing element is configured to bias the shaft away from the cylindrical extension.

24. The forehead support according to claim 19, further comprising at least one forehead pad supported by the cushion frame.

25. The forehead support according to claim 19, wherein the compressible biasing element comprises a compression spring.

26. The forehead support according to claim 19, wherein the compressible biasing element comprises an elastomeric spring element.

27. The forehead support according to claim 19, wherein an inclination angle between the forehead support and the mask frame remains constant as the forehead support moves with respect to the mask frame.

28. The forehead support according to claim 19, wherein the forehead support is configured to be adjacent and above a wearer's nose.

29. The forehead support according to claim 19, wherein an axis of the cylindrical extension intersects the wearer's forehead.

30. The forehead support according to claim 19 further comprising a lock mechanism configured to lock the cushion frame in a position relative to the frame extension.

31. The forehead support according to claim 19 further comprising: headgear configured to support the facial mask on a wearer's head; at least one forehead pad supported by the cushion frame; and a lock mechanism configured to lock the cushion frame in a position relative to the frame extension, wherein the cushion frame further includes slotted connectors configured to be connected to ends of an upper head strap of the headgear, wherein the shaft is translatably supported in the cylindrical extension, wherein the compressible biasing element is configured to bias the shaft away from the cylindrical extension, wherein the compressible biasing element comprises a compression spring, wherein the compressible biasing element comprises an elastomeric spring element, wherein an inclination angle between the forehead support and the mask frame remains constant as the forehead support moves with respect to the mask frame wherein the forehead support is configured to be adjacent and above a wearer's nose, and wherein an axis of the cylindrical extension intersects the wearer's forehead.

32. A mask for positive airway pressure therapy comprising: a frame; and the forehead support of claim 19, the forehead support extending from the frame.

33. A mask for positive airway pressure therapy comprising: a mask frame; a frame extension provided on top of the mask frame, the frame extension having a cylindrical extension; and a forehead support moveable between a first position with respect to the mask frame and a second position with respect to the mask frame, the second position being towards a wearer's forehead, the forehead support comprising: a cushion frame including a shaft received in a bore of the cylindrical extension; and a compressible biasing element provided inside the shaft, the compressible biasing element being configured to urge the forehead support towards the second position.

34. The mask according to claim 33, wherein the mask further comprises: a mask cushion supported by the mask frame; an angled connector with a distal end configured to connect to a gas supply hose and a proximal end configured to connect to the mask; and headgear configured to secure the mask to a wearer's head.

35. The mask according to claim 34, wherein the angled connector comprises a swivel elbow.

36. The mask according to claim 34, wherein the mask frame includes a pair of connectors configured to connect to a lower strap of the headgear.

37. A forehead support for a facial mask, the facial mask having a mask frame, the forehead support comprising: a frame extension with a proximal end adjacent the mask frame and a distal end opposite the proximal end; a bore positioned at the distal end of the frame extension; a shaft that is received through the bore and is movable through the bore, the shaft being oriented so that a longitudinal axis of the shaft is transverse to the longitudinal axis of the frame extension; and a cushion frame positioned at an end of the shaft so that the cushion frame is movable with the shaft toward and away from the bore along the longitudinal axis of the shaft, wherein the cushion frame is configured to be selectively fixed at a plurality of discrete distances from the bore.

38. The forehead support according to claim 37, wherein the bore is oriented relative to the frame extension so that a longitudinal axis of the frame extension is transverse to a central axis of the bore.

39. The forehead support according to claim 37, wherein the shaft is translatably supported in the bore.

40. The forehead support according to claim 37 further comprising at least one forehead pad supported by the cushion frame.

41. The forehead support according to claim 37, wherein an inclination angle between the shaft and the mask frame remains constant as the shaft moves through the bore.

42. The forehead support of claim 37, wherein the shaft is biased to urge the cushion frame away from the bore.

43. The forehead support of claim 38, wherein the shaft is biased by a compressible biasing element inside the shaft.

44. A mask for positive airway pressure therapy comprising: a cushion configured to sealingly engage a patient's face; a frame that forms a chamber with the cushion; the forehead support of claim 37, the forehead support extending from the frame; and headgear that is attachable to the forehead support and the frame.

45. The mask of claim 44, wherein posterior opening in the cushion and an anterior opening in the frame are coaxial along a longitudinal axis that is transverse to the longitudinal axis of the frame extension of the forehead support.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The accompanying drawings facilitate an understanding of the various embodiments of this invention. In such drawings:

[0032] FIG. 1 is a perspective view of a mask including an auto-adjusting mask stabilizer according to one embodiment of the invention;

[0033] FIG. 2 is a perspective view of an auto-adjusting mask stabilizer of FIG. 1;

[0034] FIG. 3 is a perspective view of a cushion frame of an auto-adjusting mask stabilizer of FIG. 1;

[0035] FIG. 4 is a perspective view of a mask extension of an auto-adjusting mask stabilizer of FIG. 1;

[0036] FIG. 5 is a perspective assembly view of the mask extension and cushion frame of the auto-adjusting mask stabilizer of FIG. 1;

[0037] FIG. 6 is a front side perspective view of the mask extension and cushion frame of the auto-adjusting mask stabilizer of FIG. 1;

[0038] FIG. 7 is a rear side perspective view of the mask extension and cushion frame of the auto-adjusting mask stabilizer of FIG. 1;

[0039] FIG. 8 is a perspective view of an auto-adjusting mask stabilizer according to another embodiment of the invention;

[0040] FIG. 9 is an elevation view of an auto-adjusting mask stabilizer according to another embodiment of the invention;

[0041] FIG. 10 is an elevation view of an lock release mechanism for the auto-adjusting mask stabilizer of FIG. 9;

[0042] FIGS. 11 and 12 are elevation views of an embodiment of a lock release mechanism for an auto-adjusting mask stabilizer according to the invention;

[0043] FIG. 13 is an illustration of an auto-adjusting mask stabilizer according to another embodiment of the invention; and

[0044] FIGS. 14 and 15 are sectional views of an auto-adjusting mask stabilizer according to another embodiment of the invention.

DETAILED DESCRIPTION

[0045] The following description is provided in relation to several embodiments which may share common characteristics and features. It is to be understood that one or more features of any one embodiment may be combinable with one or more features of the other embodiments. In addition, any single feature or combination of features in any of the embodiments may constitute additional embodiments.

[0046] In this specification, the word comprising is to be understood in its open sense, that is, in the sense of including, and thus not limited to its closed sense, that is the sense of consisting only of. A corresponding meaning is to be attributed to the corresponding words comprise, comprised and comprises where they appear.

[0047] The term air will be taken to include breathable gases, for example air with supplemental oxygen. It is also acknowledged that the blowers described herein may be designed to pump fluids other than air.

FIRST EMBODIMENT

[0048] Referring to FIG. 1, an auto-adjusting mask stabilizer, e.g., forehead support, 10 according to one embodiment of the invention includes a cushion frame 12 mounted to a frame extension 14. The frame extension 14 is connected to, or formed integrally with, a mask 16 used to supply breathable gas to a patient. A separate frame extension allows the auto-adjusting mask stabilizer of the present invention to be adapted to existing mask frames.

[0049] The mask 16 includes a mask frame 17 and a mask cushion 19. The mask frame 17 includes an angled connector 18 (e.g., in the form of a swivel elbow) which has a distal end 20 for connection to a gas supply hose (not shown) and a proximal end 22 for connection to the mask 16. The connector 18 communicates the supplied gas from the gas supply hose to the interior of the mask 16. The mask frame 17 also includes a pair of slotted connectors 24 to which are respectively connected ends of a lower head strap (not shown) for securing the mask 16 to the patient's head.

[0050] The frame extension 14 is provided on top of the mask frame 17 generally adjacent and above the patient's nose. It should be appreciated that the mask 16 shown in FIG. 1 is just one example of a respiratory mask that may be supported by the mask stabilizer 10. For example, the mask stabilizer 10 may also be used in supporting a nasal mask, a full-face (i.e. nose and mouth) mask, or nasal prongs, puffs, nozzles or the like.

[0051] The mask stabilizer 10 may also be used with facial masks in which the angled connector 18 is incorporated into the mask in the general position of the frame extension 14. In this type of mask, the supplied gas flows through or past the mask stabilizer 10.

[0052] The cushion frame 12 includes a pair of cushions (e.g., forehead cushions) 25 mounted at each end of the upper portion of the frame 12 on the side adapted to contact the face of the patient (e.g., the patient's forehead). Examples of cushions 25 include open or closed cell foam, silicone, dual durometer foams, single pads or multiple pads joined together. The cushions 25 may be integrally molded with the cushion frame 12 or attached thereto by clips or adhesives or the like. The cushion frame 12 also includes slotted connectors 26 adjacent each of the cushions 25 to which are respectively connected ends of an upper head strap (not shown) for securing the mask 16, including the mask stabilizer 10, to the patient's head.

[0053] Referring to FIGS. 2 and 4, the frame extension 14 includes a frame extension cylinder 30. As shown in FIG. 4, the frame extension cylinder 30 includes a bore 36. A cantilevered lever 34 is formed in an outer peripheral surface of the frame extension cylinder 30. A lock mechanism release button 32 is provided on the free end of the lever 34.

[0054] As shown in FIGS. 2 and 4, the cushion frame 12 includes a shaft 40 that is received in the bore 36 of the frame extension cylinder 30.

[0055] Referring to FIG. 3, the shaft 40 is also in the form of a cylinder. A biasing element 42, e.g. a compression coil spring, is provided inside the shaft 40. The biasing element 42 may be secured to the cushion frame 12 at the end of the shaft, i.e., on the portion of the cushion frame 12 that supports the cushions 25. Referring again to FIG. 1, it should also be appreciated that the mask stabilizer 10 may be adjusted to control the deflection of the mask cushion 19, for example in the region of the patient's nasal bridge.

[0056] Referring to FIG. 4, the frame extension cylinder 30 includes radial projections 38 on the inner cylindrical surface of the cylinder 30. The radial projections 38 extend axially along the cylinder 30. As shown in FIG. 5, the radial projections 38 are received in radial grooves 44 formed in the outer circumferential surface of the shaft 40 of the cushion frame 12. Although the frame extension cylinder 30 and the shaft 40 of the cushion frame 12 are shown having circular cross-sections, it should be appreciated that the cylinder and shaft may have a polygonal cross-section, for example.

[0057] As shown in FIG. 4, the lock mechanism release button 32 has a pawl 50 which extends from the release button 32 radially inward of the frame extension cylinder 30. The pawl 50 has ratchet teeth 52 provided on opposite sides. The pawl 50 and the release button 32 are resiliently supported at the end of the cantilevered lever 34.

[0058] Referring to FIG. 5, the shaft 40 of the cushion frame 12 includes an axial slot 45. The slot 45 includes ratchet teeth 46 on each side. When the shaft 40 of the cushion frame 12 is inserted into the bore 36 of the frame extension cylinder 30, the pawl 50 of the lock release button 32 is received in the axial slot 45 of the shaft 40 so that the ratchet teeth 52 of the pawl 50 engage the ratchet teeth 46 of the axial slot 45. The engagement of the radial projections 38 of the frame extension cylinder 30 into the radial grooves 44 of the shaft 40 of the cushion frame 12 ensure that the cushion frame 12 and the frame extension cylinder 30 are properly aligned for assembly of the mask stabilizer 10.

[0059] The position shown in FIG. 5 is the locked position of the auto-adjusting mask stabilizer 10 and relative movement between the cushion frame 12 and the mask extension 14 is prevented, or locked, by the engagement of the ratchet teeth 52 of the pawl 50 with the ratchet teeth 46 of the slot 45 or by high friction coefficient material on the pawl 50 and/or the ratchet teeth 52 to lock the movement, e.g. a clutch.

[0060] The biasing element 42 operates to bias the shaft 40 of the cushion frame 12 away from the cylinder 30 of the frame extension 14. When the lock mechanism is in the position shown in FIG. 5, movement of the cushion frame 12 caused by the biasing force of the biasing element 42 away from the frame extension 14 is prevented by the engagement of the ratchet teeth 52 with the ratchet teeth 46. In order to release the lock mechanism, the release button 32 is pressed downwardly to release the engagement of the ratchet teeth 52 from the ratchet teeth 46. When the ratchet teeth are disengaged, the biasing element 42 biases the cushion frame 12 in a direction away from the frame extension 14 toward the forehead of the patient.

[0061] The engagement of the shaft 40 of the cushion frame 12 into the bore 36 of the mask extension cylinder 30 allows the cushion frame 12 to translate with respect to the mask frame 17. Thus, the inclination between the cushion pads 25 and the patient's forehead does not change during adjustment, i.e., movement of the cushion frame 12 with respect to frame extension 14. The mask stabilizer 10 of the present invention thus provides the ability to stabilize the vertical angle of the position of the mask 16 relative to the patient's forehead and also stabilizes the relative set position of the mask 16 throughout the patient's sleep session.

[0062] Referring to FIG. 6, when the mask system is initially fitted, the shaft 40 of the cushion frame 12 is fully inserted into the mask extension cylinder 30. In this position, the biasing element 42 is under compression and the forehead pads 25 are in the most outward set position so that the compression of the biasing element 42 is at a maximum and the forehead pads 25 are at their closest position to the frame extension 14. In order to determine the ideal position of the mask 16 on the patient's face, the mask 16 is placed in contact with the patient's face and adjusted so that a good seal and comfortable fit are obtained. The lock mechanism release button 32 is then pressed down and the engagement between the ratchet teeth 52 and the ratchet teeth 46 is released. The biasing element 42 then acts to bias the cushion frame 12 toward the patient's forehead and into contact with the patient's forehead. Once the forehead pads 25 are in contact with the patient's forehead, the lock mechanism release button 32 is released and the lock mechanism returns to the locked position (i.e. the ratchet teeth 52 of the pawl 50 return to engagement with the ratchet teeth 46 of the slot 45). Fine tuning of the fit may be achieved by repressing the release button 32, which releases the lock mechanism, and moving the mask 16 relative to the patient's face. Once the fine tuning is complete, the release button 32 is again released and the lock mechanism returns to the locked position to lock the cushion frame 12 into position.

[0063] The adjustment may be performed with one hand. The patient, or clinic worker, simply presses the release button 32 and adjusts the position of the mask 16 with the same hand used to depress the release button 32. This allows adjustment of the fit of the mask 16 according to the present invention in a quicker manner than mask systems of the prior art. A mask system including the auto-adjusting stabilizer according to the invention may be initially fit in under one second, almost instantaneously, as opposed to up to five seconds as may be required for forehead supports according to the prior art. As the mask adjustment may be performed with one hand, the mask system of the present invention requires less dexterity to adjust than masks of the prior art.

[0064] As shown in FIG. 3, the biasing element 42 may be a coiled compression spring. For example, the spring could be a stainless steel or nickel-plated spring. It should be appreciated, however, that the biasing element 42 may take other forms. For example, the biasing element 42 may be a compressible open cell foam or silicone rubber elastic band. As another example shown in FIG. 13, the biasing element 42 may be an air spring having a reservoir, or an air bladder or integrally spring-loaded bellows 42a with an elastic memory so as the air is compressed the bladder can stretch and provide a spring force. The air bladder could be in communication with the air being delivered to the mask so that an air line 60 is provided between the inside of the mask frame and the air bladder or bellows 42a so that the air bladder or bellows 42a is under the influence of air pressure which influences or biases the movement of the cushion frame 12 toward the patient's face. It should also be appreciated that the air bladder may be provided with a valve 62 allowing the deflation of the air bladder. In operation, the air bladder or bellows 42a is normally in an extended position. Prior to fitting the mask to the patient, the valve 60 is opened and the air bladder or bellows 42 as is compressed during fitting. The valve 60 is then closed to fix the support in position.

SECOND EMBODIMENT

[0065] Referring to FIG. 8, according to another embodiment of the invention, a bushing 61 may be provided between the release button 32 and the outer surface of the mask extension cylinder 30. The bushing 61 serves to adjust the force required to depress the release button 32. The bushing 61 may also serve to prevent accidental release of the locking mechanism, for example during movement of the patient during the sleep session. The bushing 61 may also bias the locking mechanism into the locked position.

ALTERNATE EMBODIMENTS

[0066] Although the lock mechanism release button 32 is shown in the attached drawings as being provided on top of the mask frame extension cylinder 30, it should be appreciated that the release button could also be provided anywhere along the circumference of the mask frame extension cylinder 30, with a corresponding movement of the slot 45 and ratchet teeth 46 of the shaft 40 of the cushion frame 12. It should also be appreciated that the release button could be provided at the closed end of the mask frame extension cylinder 30. However, positioning the release button 32 on top of the frame extension cylinder 30 allows the patient to activate the release button in a natural way and the force that is required to activate the release button is in a plane normal to the direction along which the patient or fitter is positioning the mask. This minimizes the chance of moving the mask while adjusting the position of the cushion frame 12.

[0067] Spacing of the ratchet teeth 46 in the slot 45 of the shaft 40 of the cushion frame 12 may be, for example, 1 mm The position of the cushion frame 12 may thus be adjusted in 1 mm increments. It should be appreciated, however, that other spacings of the ratchet teeth 46 are within the spirit and scope of the invention.

THIRD EMBODIMENT

[0068] Referring to FIG. 9, an auto-adjusting stabilizer according to another embodiment of the invention includes a frame extension 14a having a frame extension cylinder 30a. A shaft 40a of a cushion frame (not shown) is received in the frame extension cylinder 30a. A biasing element (not shown) is provided between the cylinder 30a and the shaft 40a to bias the shaft 40a relative to the frame 30a.

[0069] Radial projections 38a of the frame extension cylinder 30a frictionally engage the outer surface of the shaft 40a to retain the shaft 40a against movement relative to the cylinder 30a caused by the biasing element. A lock mechanism release button 32a is provided for releasing the engagement of the radial projections 38a from the shaft 40a to permit relative movement between the shaft 40a and the cylinder 30a by the biasing element. Depressing the release button 32a causes the cylinder 30a to deform, thus disengaging the projections 38a from the cylinder 40a.

FOURTH EMBODIMENT

[0070] As shown in FIG. 10, a lock mechanism 32j according to an embodiment of the invention includes a lock mechanism release button 32b engagable by the patient or clinician. The release button 32b is supported by a release button support 32c. The release button support 32c includes a cylindrical portion 32d that receives a release mechanism sleeve 32e. The sleeve 32e is concentrically supported by the cylindrical portion 32d to permit relative movement between the release button support 32c and the sleeve 32e. Resilient, curved legs 32f couple the support 32c to the sleeve 32e and a cylindrical plug 32g connected to the release button 32b couples the release button 32b to the support 32c. A biasing element 32k, e.g., a spring, is provided between the cylindrical plug 32g and a cross element 32i in the sleeve 32e to bias the lock mechanism 32 into the position shown in FIG. 10. Depressing the release button 32b causes the plug 32g to compress the biasing element 32k. The biasing element 32k is initially compressed by movement of the release button 32b, and then transfers further depression of the release button 32b to the sleeve 32e through engagement of the biasing element and the cross element 32i.

FIFTH EMBODIMENT

[0071] The ratchet teeth of the lock mechanism shown in FIGS. 1-7 may be replaced by a friction lock. Referring to FIGS. 11 and 12, the release button 32b of the lock release mechanism includes a pawl 50b. The pawl 50b includes an engagement surface 53 on each side that engages a corresponding engagement surface 47 of the slot 45b of the shaft 40b of the cushion frame to lock the cushion frame in position. The engagement surfaces 53 of the pawl 50b and the engagement surfaces 47 of the slot 45b may be textured, such as by knurling, to increase the friction between the pawl 50b and the sides of the slot 45b. The use of a friction lock would provide for continuous, or infinite, variability of the position of the cushion frame 12 with respect to the mask 16. In contrast to prior art forehead supports which provide a large number of discrete set points for the support and which may be complicated to use and fit, the provision of an infinite number of set points simplifies using and fitting masks incorporating an auto-adjusting stabilizer according to the invention. Although FIGS. 11 and 12 include a space between the engagement surfaces 47 and 53 for illustrative purposes, it should be appreciated that the surfaces are in contact.

[0072] The release button 32b is biased into the locked position shown in FIGS. 11 and 12 by a biasing element 32k, e.g., a spring. A projecting rim 41b in the slot 45b of the shaft 40b engages a shoulder 33b of the release button 32b to maintain the release button 32b in the locked position shown in FIG. 11 When the release button 32b is depressed, as shown in FIG. 12, the amount of engagement between the engagement surfaces 47 and 53 is reduced and the amount of friction is correspondingly reduced. The shaft 40b of the cushion frame is then movable relative to the mask extension cylinder that supports the release button 32b to permit adjustment of the position of the cushion frame.

SIXTH EMBODIMENT

[0073] Referring to FIGS. 14 and 15, according to another embodiment, the cushion frame 12 may include a flexible member 72 which has two side by side spaced apart tongues 74 and a middle protruding button 76 on its distal end. The frame extension 14 may include two generally arcuate shaped portions 78 that each have a pair of four grooves 80. It should be appreciated that the pair of four grooves is merely an example and that only two or more grooves are required. It should also be appreciated that the flexible member 72 can be on the frame extension 14 and the grooves 40 can be on the cushion frame 12. The tongue 74 and the grooves 80 extend in a direction substantially parallel to a line extending radially from the axis 70. The cushion frame 12 may be constructed from a plastic material, such as polypropylene or polycarbonate, which allows the member 72 to be flexed relative to the cushion frame 12 upon which is mounted when pressure is applied to the button 76 in the direction of arrow 82. The corresponding movement of the tongues 74 releases them from engagement with one of the pairs of grooves 80 (as shown in FIG. 15) to allow angular adjustment between the cushion frame 12 and the joining member 14 about the axis 30. Releasing the button 76 allows the tongue 74 to resiliently flex back towards the grooves 80. When the tongues 74 and one of the pairs of grooves 80 are aligned (as shown in FIG. 14) the tongues 74 engage one of the pair of grooves 80. When the tongues 74 are engaged with one of the pair of grooves, the cushion frame 12 and joining member 14 are locked against pivotal movement therebetween at a predetermined angle.

[0074] A biasing member, such as a torsion spring (not shown), may be provided between the cushion frame 12 and the mask extension 14 to bias the cushion frame 12 into a position when the button 76 is released. For example, the biasing member may be configured to bias the cushion frame 12 toward the face of the patient when the button 76 is pressed. Alternatively, the biasing member may be configured to bias the cushion frame 12 away from the face of the patient when the button 76 is pressed.

[0075] The cushions 25 may be supported on the cushion frame 12 by a resilient member 90. For example, the resilient member 90 may be a silicone rubber stem-like member. As the cushion frame 12 rotates about the axis 70, the resilient member 90 is able to flex or bend to maintain the contact face of the cushion 25 flush against the face of the patient, e.g. against the patient's forehead.

[0076] It should be appreciated that the auto-adjusting mask stabilizer may be incorporated into any mask system where the fitting and correct adjustment of the mask relative to the wearer's head or face can be achieved. For example, the auto-adjusting mask stabilizer of the invention may be used in mask systems that are not provided with a forehead support, but instead utilize, for example, a cheek support or upper lip support. It should further be appreciated that the auto-adjusting mask stabilizer of the invention may be utilized in a mask system in which the forehead support is located or otherwise attached to a headgear system. It should be even further appreciated that the auto-adjusting mask stabilizer may not include a lock mechanism. In such case, the cushion frame would be biased against the patient's head, e.g., forehead, by the biasing element and its position would self-adjust to the patient.

[0077] While the invention has been described in connection with what are presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the invention. Also, the various embodiments described above may be implemented in conjunction with other embodiments, e.g., aspects of one embodiment may be combined with aspects of another embodiment to realize yet other embodiments. Further, each independent feature or component of any given assembly may constitute an additional embodiment. Furthermore, each individual component of any given assembly, one or more portions of an individual component of any given assembly, and various combinations of components from one or more embodiments may include one or more ornamental design features. In addition, while the invention has particular application to patients who suffer from OSA, it is to be appreciated that patients who suffer from other illnesses (e.g., congestive heart failure, diabetes, morbid obesity, stroke, barriatric surgery, etc.) can derive benefit from the above teachings. Moreover, the above teachings have applicability with patients and non-patients alike in non-medical applications.