US20100071700A2 - Forehead supports for facial masks - Google Patents
Forehead supports for facial masks Download PDFInfo
- Publication number
- US20100071700A2 US20100071700A2 US11/793,055 US79305506A US2010071700A2 US 20100071700 A2 US20100071700 A2 US 20100071700A2 US 79305506 A US79305506 A US 79305506A US 2010071700 A2 US2010071700 A2 US 2010071700A2
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- US
- United States
- Prior art keywords
- forehead
- support
- cushion
- adjustment knob
- face mask
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0683—Holding devices therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0611—Means for improving the adaptation of the mask to the patient with a gusset portion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0633—Means for improving the adaptation of the mask to the patient with forehead support
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0633—Means for improving the adaptation of the mask to the patient with forehead support
- A61M16/0638—Means for improving the adaptation of the mask to the patient with forehead support in the form of a pivot
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0633—Means for improving the adaptation of the mask to the patient with forehead support
- A61M16/0644—Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position
- A61M16/0655—Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position in the form of a linear or curvilinear slide
Abstract
Description
- This application is the US national phase of international application PCT/AU2006/000037, filed 12 Jan. 2006, which designated the U.S. and claims the benefit of U.S. Provisional Application Nos. 60/643,113, filed Jan. 12, 2005, 60/696,502, filed Jul. 6, 2005, 60/715,173, filed Sep. 9, 2005, and 60/735,823, filed Nov. 14, 2005, each of which is incorporated herein by reference in its entirety.
- The present invention relates generally to the field of forehead supports for facial masks used to supply breathable gas to a wearer's airways.
- Facial masks are well known for use in continuous positive airway pressure (CPAP) treatment of various respiratory ailments and sleep disordered breathing (SDB), such as, for example, obstructive sleep apnea (OSA) and/or other ventilatory assistance treatments such as noninvasive positive pressure ventilation (NPPV). See, for example, U.S. Pat. No. 4,944,210, the entire content of which is expressly incorporated hereinto by reference. While the present invention will be described below with reference to a full facial mask for use in CPAP treatment, it will be understood that such a reference is non-limiting and is directed toward a particularly preferred embodiment of the present invention. Thus, the various characteristics and advantages of the present invention could equivalently be embodied in another type of mask, such as a nasal mask, or in another type of non-invasive ventilation treatment.
- Apparatus for the treatment of SDB generally involves a blower which delivers a supply of air at positive pressure to a patient interface via a conduit. The patient interface may take several forms, such as a nasal mask assembly and a nasal and mouth mask assembly (i.e., a full face mask). Patients typically wear a mask assembly while sleeping to receive the NPPV therapy.
- Mask assemblies typically include a rigid shell or frame and a soft face-contacting cushion. The cushion cushions the rigid frame from the patient's face, and provides a seal with the patient's face. The frame and cushion define a cavity which receives the nose or nose and mouth. The frame and cushion are held in position on the patient's face by a headgear assembly. The headgear assembly typically comprises an arrangement of straps which pass along both sides of the patient's face to the back or crown of the patient's head.
- One problem that arises with existing masks used for CPAP treatments is that tightening of the mask straps results in compression of the mask against the wearer's face which may therefore apply undue force against certain of the wearer's facial features, such as the wearer's nose. A poorly fitting mask can leak when pressurized which encourages a patient to tighten the headgear straps excessively which, in turn leads to discomfort, marks on the face and in some cases facial sores.
- Thus, conventional masks have been provided with a forehead support, which provides a support and stability mechanism between the mask and the forehead. The forehead support prevents both the mask from pushing too strongly against the wearer's facial region as well as minimizing movement of the mask with the addition of a contact point between the mask and the wearer's head thereby reducing uncomfortable pressure points. Furthermore, in facial masks having a gusseted facial cushion such as described in co-pending U.S. Provisional Patent Application Ser. No. 60/643,113, filed Jan. 12, 2005, the entire content of which is expressly incorporated hereinto by reference, a forehead support may be employed to control the amount of gusset opening and/or closing thereby assisting in the applied force to the wearer's face, for example, the patient's nasal region.
- Typically, a mask forehead support is adjustable so that a standard mask may be capable of adjustment suitable for a number of patients with different anthropometric features. Conventional masks having adjustable forehead supports are evidenced by U.S. Pat. Nos. 6,119,693; 6,463,931; 6,557,556; and 6,691,708, the entire content of each such prior-issued patent being incorporated expressly hereinto by reference. To facilitate adjustability, conventional forehead supports may also be capable of displacement relative to the mask as shown, for example, in U.S. Pat. No. 6,532,961 (the entire content of which is expressly incorporated hereinto by reference), so as to provide a means by which the relative angle between the mask and the forehead support can be varied to accommodate the facial features of a particular wearer.
- A problem with conventional forehead supports for masks, however, is that the range of adjustment is relatively limited which therefore does not in fact provide a universal fit for a relatively large number of wearers. That is, due to the anthropometric features of a particular user's head, the adjustability of conventional forehead supports may not be sufficient to allow for a comfortable fit. Thus, while the forehead supports described above perform in a satisfactory manner, improvements to forehead supports for masks are needed.
- In one embodiment, a mask forehead support provides for greater universality of fit as compared to conventional forehead support structures. More specifically, according to embodiments of the present invention, forehead supports are provided which are capable of a more useful and beneficial range of adjustment as compared to conventional forehead support structures thereby allowing the forehead supports of the present invention to more universally fit a much larger number of patients.
- According to a particularly preferred aspect of the present invention, there is provided a face mask assembly for supplying breathable gas to a wearer, said face mask assembly comprising a mask frame; a facial cushion attached to the mask frame; and a forehead support. Advantageously, the forehead support includes a receiver attached to the mask frame and defining an arcuately shaped channel, an arcuately shaped elongate bar which is received within said channel of the receiver and configurable between retracted and extended positions, and a forehead cushion assembly adjustably (e.g., pivotally) attached to a distal end of the bar.
- Preferably, the forehead cushion assembly comprises a pair of cushion support plates.
- In another aspect of the invention, the forehead support assembly comprises a central support adjustably (e.g., pivotally) connected to a distal end of the slider bar, and wherein said support plates extend outwardly from said central support.
- A further aspect of the invention is embodied in the central support plates being connected to the central support so as to be substantially V-shaped or substantially T-shaped relative to the slider bar.
- The cushion support assembly most preferably comprises a convex or concave forehead cushion. Specifically, in accordance with an aspect of the present invention, the cushion support plates comprise apertures, and the forehead cushion assembly comprises a pair of cushions having concave interior surfaces, and an attachment head protruding rearwardly therefrom which is inserted into and through a respective one of the apertures in the support plates so as to physically attach the cushions thereto.
- According to another aspect of the invention, the receiver comprises a pair of opposed openings, and the slider bar comprises a series of apertures spaced apart from one another in a general lengthwise direction of the slider bar and capable of respective alignment with the opposed openings of the receiver upon sliding movement of the slider bar between said retracted and extended positions thereof. A position pin may be provided which is insertable through said opposed openings and a respective one of said apertures of the slider bar when said at least one aperture is aligned with said openings to positionally maintain the slider bar relative to the receiver.
- According to another aspect of the present invention, the slider bar comprises a gear rack, and the receiver comprises an adjustment knob having a pinion gear meshed with said gear rack. As such, turning movement of the adjustment knob causes the slider bar to be moved between the retracted and extended positions thereof.
- The slider bar may comprise a resilient detent button, while the receiver comprises a series of longitudinally spaced apart position apertures. The detent button may thus be resiliently engageable with the position apertures as the slider bar is moved between the retracted and extended positions thereof.
- In one aspect of the invention, the slider bar comprises an elongate slot, and the adjustment knob comprises a head portion and a cylindrical post which connects the head portion to the pinion gear thereof. The cylindrical post is thus received within the elongate slot to allow for movement of the slider bar between the retracted and extended positions thereof. The receiver may also comprise a circular bearing surface against which the underside of the adjustment knob bears.
- According to yet another aspect of the invention, a face mask assembly is provided with a forehead cushion support having a slider bar which includes a resilient central tongue member, a push button and a fixed pawl carried by the tongue member. The receiver comprises an elongate slot through which the push button extends, and a series of ratchet teeth engageable with said pawl. Thus, the pawl is disengaged from a respective one of said ratchet teeth upon pressing the push button so as to allow the slider bar to be moved slidably within the receiver between the retracted and extended positions thereof. Preferably, a fixed pawl is provided on each side of said push button.
- One aspect of the invention is embodied in a forehead cushion pad having a generally concave cushion flange, a cushion body portion supporting the cushion flange, and a pair of rearwardly protruding elongate foot pads. According to this aspect of the invention, the cushion body portion comprises an open channel, while cushion support plates have retaining clips which extend into said open channel and thereby retain the cushion pads to said support plates.
- Another aspect of the invention relates to a face mask assembly for supplying breathable gas to a wearer. The face mask assembly includes a mask frame, facial cushion attached to the mask frame, and a forehead support. The forehead support includes a receiver attached to the mask frame including spaced-apart arcuately shaped channels that define an elongated central finger and outer guide rails. An arcuately shaped elongate slider bar is slidably received within the channels of the receiver for movements between retracted and extended positions. The slider bar is supported on the central finger and guided by the outer guide rails. A forehead cushion assembly is attached to a distal end of the slider bar.
- Yet another aspect of the invention relates to a face mask assembly for supplying breathable gas to a wearer. The face mask assembly includes a mask frame, a facial cushion attached to the mask frame, and a forehead support. The forehead support includes a forehead cushion assembly and an adjustment knob operatively coupled to the forehead cushion assembly such that turning movement of the adjustment knob causes the forehead cushion assembly to be moved between retracted and extended positions.
- Still another aspect of the invention relates to a face mask assembly for supplying breathable gas to a wearer. The face mask assembly includes a mask frame including a support, a facial cushion attached to the mask frame, and a forehead support. The forehead support includes a forehead cushion assembly and an adjustment knob operatively coupled to the forehead cushion assembly. The adjustment knob is threadably engaged with the forehead cushion assembly such that turning movement of the adjustment knob causes the mask frame to be moved between retracted and extended positions with respect to the forehead cushion assembly.
- Still another aspect of the invention relates to a face mask assembly for supplying breathable gas to a wearer. The face mask assembly includes a mask frame, a facial cushion attached to the mask frame, and a forehead support. The forehead support includes a forehead cushion support movably mounted to the mask frame for movements between retracted and extended positions and a forehead cushion attached to the forehead cushion support. The forehead cushion support includes a first connector that engages a second connector provided by the forehead cushion, and the first and second connectors each include a connector side wall with one or more slots through the connector side wall that allows the first and second connectors to compress in use.
- Still another aspect of the invention relates to a forehead cushion support for a forehead support of a mask assembly. The forehead cushion support includes forehead cushion support plates to support forehead cushions and a slider provided to the support plates. The slider includes a resilient tab to provide quick-release assembly to a mask frame.
- Still another aspect of the invention relates to a forehead support for a mask assembly. The forehead support includes a support provided to a mask frame, a forehead cushion support movably mounted to the support for generally linear movement between retracted and extended positions with respect to the support, and an adjustment knob threadably engaged with the forehead cushion support such that turning movement of the adjustment knob causes the forehead cushion support to be moved between the retracted and extended positions.
- Still another aspect of the invention relates to a face mask assembly for supplying breathable gas to a wearer. The face mask assembly includes a mask frame, a facial cushion attached to the mask frame, and a forehead support. The forehead support includes a receiver attached to the mask frame and defining an arcuately shaped channel, an arcuately shaped elongate slider bar which is slidably received within the channel of the receiver for movement between retracted and extended positions, and a forehead cushion assembly rigidly connected to a distal end of the slider bar.
- It will of course be understood that, while the present invention will be described in connection with a full facial mask, those in this art will recognize that such a description represents one preferred embodiment and is thus non-limiting. Thus, the structural and/or functional features of the present invention may, for example, also be usefully employed in nasal masks or nasal prongs, nozzles, nare seals, and/or cannulae.
- These and other aspects and advantages will become more apparent after careful consideration is given to the following detailed description of preferred exemplary embodiments thereof.
- Reference will hereinafter be made to the accompanying drawings, wherein like reference numerals throughout the various FIGURES denote like structural elements, and wherein;
-
FIGS. 1-1 to 1-4 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with an embodiment of the invention, including front and rear perspective views (FIGS. 1-1 and 1-2, respectively), a front plan view (FIG. 1-3 ) and a cross-sectional left side elevational view (FIG. 1-4 ) as taken along line A-A inFIG. 1-3 but shown without the face cushion for ease of depiction; -
FIG. 2 shows a side view of a “standard” facial profile superimposed onto a grid of vertical and horizontal distances centered substantially on the nasion region, together with superimposed circular ranges of movement of forehead supports according to a prior art mask and a facial mask in accordance with an aspect of the invention; -
FIGS. 3-1 to 3-8 show various views of an alternative embodiment of a slider bar subassembly that may be employed in the facial mask assembly of the present invention depicted inFIGS. 1-1 to 1-4, including a left and right side elevation views (FIGS. 3-1 and 3-5, respectively), top and bottom elevation views (FIGS. 3-2 and 3-4, respectively), a front elevation view (FIG. 3-3 ) and front, bottom and rear perspective views (FIGS. 3-6 , 3-7 and 3-8, respectively); -
FIGS. 4-1 to 4-6 show various views of an embodiment of a facial mask frame that may be employed with the facial mask assembly of the present invention depicted inFIGS. 1-1 to 1-4 including front and side elevation views (FIGS. 4-1 and 4-2, respectively), a bottom elevation view (FIG. 4-6 ), and front, side and rear perspective views (FIGS. 4-3 , 4-4 and 4-5, respectively); -
FIG. 5 shows a detailed plan view of the forehead cushion sub-assembly that may be employed in accordance with the forehead support shown inFIGS. 1-1 to 1-4 according to the present invention; -
FIGS. 6-1 to 6-3 are various views of an alternative forehead cushion that may be employed in combination with the cushion support plate shown inFIG. 5 ; -
FIGS. 7-1 to 7-3 are side views of various alternative slider bars that may be employed in the forehead supports according to the present invention; -
FIGS. 8-1 to 8-5 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with another embodiment of the invention, including front and side elevation views (FIGS. 8-1 and 8-2, respectively), a top view (FIG. 8-3 ) and rear and top perspective views (FIG. 8-4 and 8-5, respectively); -
FIGS. 9-1 to 9-6 show various views of an embodiment of a slider bar subassembly that may be employed in the facial mask assembly depicted inFIGS. 8-1 to 8-4, including a front elevation view (FIG. 9-1 ), a top view (FIG. 9-2 ), right and left side elevation views (FIGS. 9-3 and 9-4, respectively), and bottom and top perspective views (FIGS. 9-5 and 9-6, respectively); -
FIGS. 10-1 to 10-5 show various views of an embodiment of a facial mask frame that may be employed with the slider bar subassembly depicted inFIGS. 9-1 to 9-6 including front and side elevation views (FIGS. 10-1 and 10-2, respectively), a top view (FIG. 10-3 ), and top and rear perspective views (FIGS. 10-4 and 10-5, respectively); -
FIGS. 11-1 to 11-3 show various views of a position adjustment knob that may be employed operatively with the slider bar subassembly depicted inFIGS. 9-1 to 9-6, including a side perspective view (FIG. 11-1 ), a front elevation view (FIG. 11-2 ), and a bottom plan view (FIG. 11 -3); -
FIGS. 12-1 TO 12-6 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with another embodiment of the invention, including a front elevation view (FIG. 12-1 ), side elevation views (FIGS. 12-2 and 12-3), a top view (FIG. 12-4 ) and rear and top perspective views (FIGS. 12-5 and 12-6, respectively); -
FIGS. 13-1 to 13-7 show various views of an embodiment of a slider bar subassembly that may be employed in the facial mask assembly depicted inFIGS. 12-1 to 12-6, including a top elevation view (FIG. 13-1 ), a front view (FIG. 13-2 ), a bottom view (FIG. 13-3 ), a right side elevation view (FIG. 13-4 ), bottom perspective views (FIGS. 13-5 and 13-6), and a top perspective view (FIG. 13 -7); -
FIGS. 14-1 to 14-3 show various views of a position adjustment knob that may be employed operatively with the slider bar subassembly depicted inFIGS. 13-1 to 13-7, including a side perspective view (FIG. 14-1 ), a front elevation view (FIG. 14-2 ), and a bottom plan view (FIG. 14 -3); -
FIGS. 15-1 TO 15-8 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with another embodiment of the invention, including a front elevation view (FIG. 15-1 ), a side elevation view (FIG. 15-2 ), a top view (FIG. 15-3 ), rear perspective views (FIGS. 15-4 and 15-5), top perspective views (FIGS. 15-6 and 15-7), and an exploded view (FIG. 15 -8); -
FIGS. 16-1 to 16-7 show various views of an embodiment of a slider bar subassembly that may be employed in the facial mask assembly depicted inFIGS. 15-1 to 15-8, including a top elevation view (FIG. 16-1 ), a front view (FIG. 16-2 ), right and left side elevation views (FIGS. 16-3 and 16-4, respectively), top perspective views (FIGS. 16-5 and 16-6), and a bottom perspective view (FIG. 16 -7); -
FIGS. 17-1 to 17-7 show various views of an embodiment of a facial mask frame that may be employed with the slider bar subassembly depicted inFIGS. 16-1 to 16-7 including front and side elevation views (FIGS. 17-1 and 17-2, respectively), a top view (FIG. 17-3 ), top perspective views (FIGS. 17-4 and 17-5), and bottom perspective views (FIGS. 17-6 and 17-7); -
FIGS. 18-1 to 18-5 show various views of a position adjustment knob that may be employed operatively with the slider bar subassembly depicted inFIGS. 16-1 to 16-7, including a side perspective view (FIG. 18-1 ), a bottom perspective view (FIG. 18-2 ), a front elevation view (FIG. 18-3 ), a top plan view (FIG. 18-4 ), and a bottom plan view (FIG. 18 -5); -
FIGS. 19-1 to 19-2 show various views of position markings that may be employed on an adjustment knob (FIG. 19-1 ) and/or a slider bar subassembly (FIG. 19 -2); -
FIGS. 20-1 to 20-2 show various views of employing a variable rate of motion in a slider bar subassembly; -
FIG. 21 shows a side view of a “standard” facial profile superimposed onto a grid of vertical and horizontal distances centered substantially on the nasion region, together with superimposed circular ranges of movement of forehead supports according to a prior art mask and a facial mask in accordance with another aspect of the invention; -
FIGS. 22-1 to 22-5 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with yet another embodiment of the invention, including front and side elevation views (FIGS. 22-1 and 22-2, respectively), a top view (FIG. 22-3 ) and rear and top perspective views (FIG. 22-4 and 22-5, respectively); -
FIGS. 23-1 to 23-5 show various views of an embodiment of a slider bar subassembly that may be employed in the facial mask assembly depicted inFIGS. 22-1 to 22-5, including a front elevation view (FIG. 23-1 ), a top view (FIG. 23-2 ), a left side elevation views (FIG. 23-3 ), and top and bottom perspective views (FIGS. 23-4 and 23-5, respectively); -
FIGS. 24-1 to 24-5 show various views of an embodiment of a facial mask frame that may be employed with the slider bar subassembly depicted inFIGS. 23-1 to 23-5 including front and side elevation views (FIGS. 24-1 and 24-2, respectively), a top view (FIG. 24-3 ), and top and rear perspective views (FIGS. 24-4 and 24-5, respectively); -
FIG. 25 is a perspective view of a spiral screw mechanism according to an embodiment of the present invention; -
FIGS. 26-1 to 26-4 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with yet another embodiment of the invention; -
FIGS. 27-1 to 27-6 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with yet another embodiment of the invention; -
FIGS. 28-1 to 28-3 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with yet another embodiment of the invention; -
FIGS. 29-1 to 29-3 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with yet another embodiment of the invention; -
FIGS. 30-1 to 30-3 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with yet another embodiment of the invention; -
FIGS. 31-1 to 31-8 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with yet another embodiment of the invention; -
FIGS. 32-1 to 32-6 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with yet another embodiment of the invention; -
FIGS. 33-1 to 33-6 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with yet another embodiment of the invention; -
FIGS. 34-1 to 34-5 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with yet another embodiment of the invention; -
FIG. 35 is an exploded view of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with yet another embodiment of the invention; -
FIGS. 36-1 to 36-5 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with still another embodiment of the invention; -
FIGS. 37-1 to 37-11 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with still another embodiment of the invention; -
FIGS. 37-12 to 37-15 show various sizes of a frame for the mask assembly shown inFIGS. 37-1 to 37-11; -
FIGS. 38-1 to 38-18 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with still another embodiment of the invention; -
FIGS. 39-1 to 39-9 show various views of a thread form for a forehead support in accordance with an embodiment of the present invention and showing exemplary dimensions of an embodiment; -
FIGS. 40-1 to 40-3 show various views of a forehead cushion for a forehead support in accordance with an embodiment of the present invention and showing exemplary dimensions of an embodiment; -
FIGS. 41-1 to 41-2 show various views of a forehead cushion support for a forehead support in accordance with an embodiment of the present invention and showing exemplary dimensions of an embodiment; -
FIG. 41-3 is a perspective view illustrating the forehead cushion shown inFIGS. 40-1 to 40-3 assembled to the forehead cushion support shown inFIGS. 41-1 to 41-2; -
FIGS. 42-1 to 42-8 show various views of a forehead cushion support for a forehead support in accordance with an embodiment of the present invention; -
FIGS. 43-1 to 43-21 show various views of a full facial mask assembly providing patient interface for respiratory therapy with a forehead support in accordance with still another embodiment of the invention; -
FIGS. 44-1 to 44-8 show various views of a forehead cushion support for a forehead support in accordance with an embodiment of the present invention; -
FIGS. 45-1 to 45-19 show various views of a forehead support in accordance with still another embodiment of the invention; -
FIGS. 46-1 to 46-16 show various views of a forehead support in accordance with still another embodiment of the invention; -
FIGS. 47-1 to 47-16 show various views of a forehead support in accordance with still another embodiment of the invention; -
FIGS. 48-1 to 48-16 show various views of a forehead support in accordance with still another embodiment of the invention; -
FIGS. 49-1 to 49-16 show various views of a forehead support in accordance with still another embodiment of the invention; -
FIGS. 50-1 to 50-15 show various views of a forehead support in accordance with still another embodiment of the invention; -
FIGS. 51-1 to 51-24 show various views of a forehead support in accordance with still another embodiment of the invention; -
FIGS. 52-1 and 52-2 show forehead cushion supports for a forehead support in accordance with alternative embodiments of the present invention; -
FIGS. 53-1 to 53-5 show various views of a forehead cushion support for a forehead support in accordance with another embodiment of the present invention; -
FIGS. 54-1 to 54-5 show various views of a forehead cushion support for a forehead support in accordance with another embodiment of the present invention; -
FIGS. 55-1 to 55-2 show various views of a forehead support in accordance with still another embodiment of the invention; -
FIGS. 56-1 to 56-3 show various views of a forehead support in accordance with still another embodiment of the invention; and -
FIGS. 57-1 to 57-15 show various views of a forehead support in accordance with still another embodiment of the invention. - An exemplary embodiment of a full facial mask assembly (“FMA”) which includes a
forehead support 10 according to one embodiment of the present invention is depicted in accompanyingFIGS. 1-1 to 1-4. The FMA includes amask frame 12 provided with aconnection port 14 to which an elbow connector (not shown) associated with a gas supply conduit may be coupled to allow gas under pressure to be supplied to the FMA. Afacial cushion 16 is attached to a rear portion of themask frame 12 so as to cushion the FMA against the face of the wearer.Strap connectors 18 extend laterally from themask frame 12 so as to allow attachment of straps associated with a conventional headgear assembly (not shown) and thereby permit the FMA to be secured to a wearer's head when in use. - A. Slider Bar
- According to the present invention, the
mask frame 12 includes areceiver 20 defining a channel 20-1 (seeFIG. 1-4 ) which is sized and configured to slidably receive therein anarcuate slider bar 22. Theslider bar 22 includes a series of transverse apertures (a representative few of which are identified by reference number 22-1) which are spaced apart from one another in the general lengthwise direction of theslider bar 22.Slider bar 22 includes 2-9 transverse apertures 22-1, and preferably about 7-8 transverse apertures 22-1. The apertures 22-1 are adapted to receive aposition pin 24 associated with thereceiver 20 and thereby establish a respective position of theslider bar 22 relative to themask frame 12. - B. Forehead Cushion Support Plate
- The distal end of the
slider bar 22 is connected pivotally to a generally V-shaped foreheadcushion support plate 26 which carries a pair of forehead cushions 28 for placement against a wearer's forehead region. Thecushions 28 depicted inFIGS. 1-1 to 1-4 are hollow structures which present an essentially convexly curved cushion surface to the patient's forehead. The cushions are removably attached by thesupport plates 26 by means of retaining clips 26-1 (FIGS. 1-3 , 1-4, and 5) thereof which extend into the hollow of thecushions 28 and thereby positionally retain thecushions 28 against theirrespective support plate 26. - As is perhaps best depicted in
FIG. 1-4 , thesupport plate 26 is coupled to the distal end of theslider bar 22 by means of apivot pin 30 or another arrangement (e.g., slider, ball joint, etc.) which allows movement to occur therebetween as shown by arrows A1. Also, since theslider bar 22 is itself arcuately shaped, its arcuate sliding movement between a retracted position (shown generally in solid line inFIGS. 1-4 ) and an extended position (shown generally in dashed line inFIG. 1-4 ) as shown by arrows A2 allows thecushion support plate 26 to be positioned at various angular orientations relative to themask frame 12. Pivotal movement of thecushion support frame 26 thereby allows the forehead cushions 28 to be positioned flat against a wearer's forehead. In such a manner, therefore, theforehead support 10 may be adjustable over a wide range of dimensions and angular orientations to fit various facial profiles of a wearer. The amount of pivotal movement in a clockwise direction as viewed inFIG. 1-4 is limited by means of thestop surface 27 formed at the distal end of theslider bar 22. In the example ofFIG. 1-4 ,plate 26 may pivot in about a 90° range (and preferably about 10°-50° or more or less) relative toslider bar 22. - C. Range of Adjustments
- The universality and wide range of adjustments achieved by the
forehead support 10 according to the present invention is graphically represented in accompanyingFIG. 2 . In order for the advantages of the present invention to be better understood, a co-ordinate system is defined with respect to the facial profile of a patient. When a patient is sitting upright, the x-axis is horizontal, the y-axis is vertical and the z-axis is into the plane of the face (i.e., leftward as viewed fromFIG. 1-4 ). The travel path CRP for a prior art forehead support is depicted graphically inFIG. 2 . With this support, some patients may end up with forehead pads positioned at or above their hair-line. In contrast, theforehead support 10 of an embodiment of the present invention provides a generally more appropriate range of relative movement in the z-direction as depicted graphically by the circular range of travel designated CRI shown inFIG. 2 . - According to an embodiment of the present invention, a target window TW is defined for the
forehead pads 28 in the z- and y-directions. The target window TW has upper and lower (y-axis) limits, as well as inner and outer (z-axis) limits. The window has been determined on the basis of anthropometric data from a range of sources including Anthropometry of the Head and Face, Leslie Farkas, Raven Press NY, N.Y. 1994. From this data, average and standard deviations for hairline, glabella (the smooth prominence on the forehead between the eyebrows and just above the nose) and forehead position were determined. The target window TW for theforehead support 10 according to the present invention may therefore be defined as follows: - (i) the upper Y-axis limit (Yu) is average hairline minus two standard deviations minus 15 mm;
- (ii) the lower y-axis limit (Yl) is 15 mm above the average glabella (G);
- (iii) the inner z-axis limit (Zi) is half the cushion-gusset travel (GT) plus two standard deviations from the mean forehead position;
- (iv) the outer z-axis limit (Zo) is the mean forehead position minus two standard deviations, minus half the cushion-gusset travel (GT).
- Advantageously, the cushion-gusset travel (GT) ranges between about 20 to about 40 mm, preferably about 30 mm (the gusset has about 16 mm of travel and the cushion membrane has about 15 mm of travel, therefore together the cushion-gusset travel is about 30 mm). With a coordinate system with the zero point superimposed substantially on a patient's nasion (N), the average hairline is between about 60 to about 70 mm, the average glabella is about 10 mm, and the mean forehead position varies between about −2 to about +2 in the z-direction within the target window.
- In accordance with especially preferred embodiments of the invention, the target window TW, also referred to as a target plane, which the forehead pads may assume by virtue of their pivotal connection with the distal end of the
slider bar 22 and the range or arcuate movement provided by the adjustable positioning of theslider bar 22 within thereceiver 20 is preferably an area bounded by the following approximate y,z points (+/−) of a coordinate system depicted inFIG. 2 (i.e., with the zero point being located substantially coincident with a patient's nasion region): 37,28; 30,20; 30,−22 and 37,−22. - In order for the
forehead support 10 to achieve the required movement, the arc of the slider bar 22 (and corresponding channel 20-1 of the receiver 20) establish the generatrices of a circle having a radius of about 35-70 mm, and most preferably in the range of about 50-60 mm. In this example, the radius is about 54 mm (+/−2 mm). - D. Alternative Embodiment of Slider Bar Subassembly
- Accompanying
FIGS. 3-1 to 3-8 show various views of an alternative embodiment of a slider bar subassembly that may be employed in the facial mask assembly of the present invention depicted inFIGS. 1-1 to 1-4. In this regard, the embodiment of the slider bar subassembly depicted inFIGS. 3-1 to 3-8 differs principally from the slider bar subassembly embodiment discussed previously in the structural features of the foreheadcushion support plates 50 and the forehead cushions 52 carried thereby. Thus, as compared to the general V-shapedsupport plates 26, thesupport plates 50 depicted inFIGS. 3-1 to 3-8 extend generally transversely relative to theslider bar 22 and thus are more generally T-shaped. - More specifically, the
support plates 50 include a relatively narrow width medial end 50-1 and a relatively larger width lateral end 50-2. The medial ends 50-1 are joined to acentral support 54 which is in turn joined pivotally to theslider bar 22 by means ofpivot pin 56. Thus, thesupport plates 50 and thecushions 52 carried thereby are capable of pivotal movements relative to theslider bar 22 about a pivot axis defined by thepivot pin 56 so that thecushions 52 can assume a range of angular positions relative to the patient's forehead. As is perhaps best shown inFIGS. 3-2 and 3-4, thesupport plates 50 are gently curved so as to conform more closely to the contour of a patient's forehead. If desired, the forehead cushion supports 50 may be attached to straps associated with a headgear assembly (not shown) by inserting such straps throughslots 58 defined in the lateral ends 50-2 thereof. - The
cushions 52 are generally conformably shaped to thesupport plates 50. The interior surfaces 52-1 of thecushions 52 have a general “concave” contour and thus be adapted for conformable shaping relative to a patient's forehead profile. Eachcushion 52 has an attachment head 52-2 protruding rearwardly therefrom which is inserted into and through a respective aperture (not shown) formed in thesupport plates 50 so as to physically attach thecushions 52 to thesupport plates 50. The attachment head 52-2 is joined to the back of the cushion by a flexible accordion-style connector 52-3 which serves to allow compliant movement of thecushions 50 so they may be comfortably positioned in contact with the patient's forehead. Thecushions 52 are most preferably joined to one another with a one-piece bridge 52-4. - In another variant, the forehead pads can take the form of a single member that extends over the upper “T” of the forehead support. In still another variant, the forehead support may have the shape of a lower case “1”, instead of being T-shaped. In this variant, the upper portion of the slider bar would include
slots 58 to directly receive headgear straps, in which case folded-over portions of the headgear straps could engage the forehead of the patient, thereby rendering forehead pads unnecessary. - E. Mask Frame
- As noted previously, the
slider bar 22 is sized and configured so as to be slidably received within a conformably shaped channel 20-1 formed inreceiver 20 associated with themask frame 12. AccompanyingFIGS. 4-1 to 4-6 depict in greater detail an embodiment of themask frame 12 that may be employed with the FMA shown inFIGS. 1-1 to 1-4 discussed previously. In this regard, themask frame 12 includes areceiver 20 which as discussed previously is a component part of theforehead support 10 in accordance with the present invention as it receives theslider bar 22. Thereceiver 20 is mounted toward the upper extent of themask frame 12 and is preferably formed as a unitary (one piece) molded structure therewith. The channel 20-1 defined by thereceiver 20 is itself arcuately shaped in conformance with the arcuate shape of theslider 22 which it receives. - The
receiver 20 includes a pair ofopposed openings 60 through which thepin 24 may be inserted when aligned with a respective one of the slider apertures 22-1. Thus, when one of the apertures 22-1 is aligned with theopenings 60, thepin 24 may be inserted therethrough so as to maintain theslider 22 in the position established by the selected aperture 22-1. - A plurality of
vents 64 which penetrate themask frame 12 to its inside surface (seeFIG. 4-5 ) may be provided to allow venting of the interior of the FMA and prevent build-up of patient-exhaled gas (e.g., carbon dioxide). - The
cushion support plate 26 that may be employed in accordance with theforehead support 10 shown inFIGS. 1-1 to 1-4 according to the present invention is depicted in greater detail in accompanyingFIG. 5 . In this regard, thesupport plate 26 includes a pair of retaining clips 26-1 so as to retain thecushions 28 to theplates 26 in the manner described previously. Theplates 26 also define at their terminal ends a slot 26-2 for receiving a strap associated with a conventional headgear assembly (not shown) as may be desired. A pair of parallel edge channels 26-3 is provided so as to accept respective side edges of thecushion 28. - F. Alternative Form of a Forehead Cushion
- An alternative form of a
forehead cushion 70 that may be employed with thesupport plates 26 for the forehead supports 10 in accordance with the present invention is depicted inFIGS. 6-1 to 6-2. Specifically, theforehead cushion 70 includes a generallyconcave cushion flange 72 which most preferably defines the generatrices of a cylindrical surface. Thecushion flange 72 is supported by acushion body portion 74 having anopen channel 76 therethrough and a pair of rearwardly protrudingelongate foot pads 78. Theopen channel 76 is sized and configured so as to accept therein the retaining clips 26-1 so as to retain thecushion 70 against thesupport plate 26. On the other hand, theelongate foot pads 78 are sized and configured to be accepted in the channels 26-3. - G. Alternative Forms of Slider Members
- Alternative forms of
slider members forehead support 10 of the present invention are depicted inFIGS. 7-1 to 7-3, respectively. In this regard, theslider member 22A shown inFIG. 7-1 is molded such that it has a side wall 22A1 that extends along a centerline of a perimeter wall 22A2. Individual aperture walls 22A3 define each of the individual position apertures 22-1 while an individual aperture wall defines the aperture 22-2 adapted to receive thepivot pin 30. Theslider bar 22B shown inFIG. 7-2 includes connecting channels 22-3 which connect adjacent ones of the position apertures 22-1. The connecting channels 22-3 serve to allow a narrowed diameter portion of thepin 24 to be accepted therein so that theslider bar 22B may be moved within thereceiver 20 without the need to fully remove thepin 24. In a similar manner, the slider bar 22C includes an entrance channel 22-4 to allow theslider bar 22 to be snap fit onto thepin 24. An entrance channel 22-5 is similarly provided with the aperture 22-2 so as to allow it to be snap fit onto thepivot pin 30. The entrance channels 22-4, 22-5 and connecting channels 22-3 may be formed using a manufacturing method, e.g., laser cutting, in which a continuous path is cut to form the channels and apertures. - Accompanying
FIGS. 8-1 to 8-5 depict a FMA provided with another embodiment of aforehead support 10A according to the present invention.FIGS. 9-1 to 9-6 andFIGS. 10-1 to 10-5 depict in greater detail aslider bar 122 and amask frame 112 that may be employed in theforehead support 10A. In this regard, structural components that are similar to those discussed previously have been shown with the same reference numerals. Thus, a detailed discussion of such similar structural components will not be repeated. - A. Slider Bar
- The
forehead support 10A generally comprises areceiver 120 which defines an arcuately shaped channel 120-1 (seeFIGS. 10-5 ) for receiving a corresponding arcuately shapedslider bar 122. As is perhaps best shown inFIGS. 9-1 to 9-6, theslider bar 122 includes at its distal end aconnector portion 126 which defines an aperture 126-1 for receiving the pivot pin 30 (seeFIG. 8-3 ). Thepivot pin 30 thus serves to pivotally join the central support 54 (seeFIG. 8-5 ) of the foreheadcushion support plates 50 to the distal end of theslider bar 122 and thereby permit pivotal movements of the former relative to the latter. - B. Adjustment Knob
- An adjustment knob 150 (see
FIG. 11-1 ) operatively carried at a distal end of thereceiver 120. As will be discussed in greater detail below, theadjustment knob 150 is capable of being turned manually in both clockwise and counterclockwise directions so as to adjust the position of theslider bar 122 between its retracted and extended positions. As shown more clearly inFIGS. 11-1 to 11-3, theadjustment knob 150 includes anupper head portion 152 and alower pinion gear 154. Thehead portion 152 andpinion gear 154 are connected to one another by acylindrical post member 156. Thepost member 156 is positioned in opening 157 of thereceiver 120 so that thepinion gear 154 can engage operatively thegear rack 130 of theslider bar 122. - As shown in
FIGS. 9-1 to 9-6, theslider bar 122 defines a centralelongate slot 128 extending from near its proximal end to near its distal end. Theslot 128 is provided with an enlarged diameter portion 128-1 near the proximal end which is sized so as to allow thepinion gear 154 of theadjustment knob 150 to pass therethrough and thus permit theslider bar 122 to be assembled within thereceiver 120. Agear rack 130 is provided on an underside of theslider bar 122 extending substantially the entire length of theslot 128 on a lateral side thereof. Thegear rack 130 is intermeshed with thepinion gear 154 of theadjustment knob 150. Thus, when theadjustment knob 150 is turned in a clockwise direction as viewed from the front of the FMA, theslider bar 122 will be adjustably moved toward its extended position (i.e., in a direction toward a patient's forehead). Conversely, when theadjustment knob 150 is turned in a counterclockwise direction as viewed from the front of the FMA, theslider bar 122 will be adjustably moved toward its retracted position (i.e., in a direction away from the patient's forehead). Thereceiver 120 includes a circular raised bearing surface 153 (seeFIGS. 10-1 , 10-3 and 10-4) which bears against thehead portion 152 of theadjustment knob 150. In an alternative embodiment, an adjustment knob is provided that tightens by turning anti-clockwise. - C. Detent Assembly
- The
slider bar 122 includes aresilient detent button 132 carried at the end of aresilient arm 134. Thedetent button 132 is adapted to be received within respective ones of theposition apertures 136 provided along a lateral edge region of the receiver 120 (seeFIGS. 10-1 to 10-5). As theslider bar 122 is moved between its extended and retracted positions within the channel 120-1 by turning movements applied to the adjustment knob 150 (FIG. 11-1 ), the detent button 132 (FIG. 9-5 ) will be moved resiliently and sequentially into and out of engagement with the position apertures 136 (FIG. 10-1 ). As such, thedetent button 132 will be seated within one of theapertures 136 to assist in restraining the slider bar 122 (FIG. 8-5 ) at the desired position. However, turning movement applied to theadjustment knob 150 will cause thedetent button 132 to be resiliently unseated from theaperture 136 by virtue of thearm 134 to allow sliding movement of theslider bar 122 until thenext aperture 136 is aligned with the button, whereby the button is again seated therewithin. - As shown in
FIGS. 10-2 and 10-5 thereceiver 120 includes apin 140 which extends into the channel 120-1. Thepin 140 acts as an endstop to prevent theslider bar 122 from being wound all the way to the end of thegear rack 130. Thepin 140 is cantilevered to provide a detent release to allow full disassembly of theslider bar 122 from the channel 120-1. - Accompanying
FIGS. 12-1 to 12-6 depict a FMA provided with another embodiment of aforehead support 10B according to the present invention.FIGS. 13-1 to 13-7 andFIGS. 14-1 to 14-3 depict in greater detail aslider bar 322 and anadjustment knob 350 that may be employed in theforehead support 10B. In this regard, structural components that are similar to those discussed previously have been shown with the same reference numerals. Thus, a detailed discussion of such similar structural components will not be repeated. - A. Slider Bar
- The
forehead support 10B generally comprises areceiver 320 which defines an arcuately shaped channel 320-1 (seeFIG. 12-5 ) for receiving a corresponding arcuately shapedslider bar 322. As is perhaps best shown inFIGS. 13-1 to 13-7, the distal end of theslider bar 322 is joined to the central support 355 (FIG. 12-1 ) of the foreheadcushion support plates 351. The distal end may be joined to thecentral support 355 in any suitable manner, e.g., fixedly. - B. Adjustment Knob
- An
adjustment knob 350 is operatively carried at a distal end of thereceiver 320. Theadjustment knob 350 is capable of being turned manually in both clockwise and counterclockwise directions so as to adjust the position of theslider bar 322 between its retracted and extended positions. As shown more clearly inFIGS. 14-1 to 14-3, theadjustment knob 350 includes anupper head portion 352 and alower pinion gear 354. Thehead portion 352 andpinion gear 354 are connected to one another by acylindrical post member 356. Thepost member 356 is positioned in an opening of thereceiver 320 so that thepinion gear 354 can engage operatively thegear rack 330 of theslider bar 322. Also, theadjustment knob 350 includes a bearingportion 353 that is adapted to engage thereceiver 320 with a snap fit. The bearingportion 353 provides a sturdy connection between the mask frame and theadjustment knob 350 thereby reducing potential play which will affect the smooth running of therack 330. - As shown in
FIGS. 13-1 to 13-7, theslider bar 322 defines a centralelongate slot 328 extending from near its proximal end to near its distal end. Theslot 328 is provided with an enlarged diameter portion 328-1 near the proximal end which is sized so as to allow thepinion gear 354 of theadjustment knob 350 to pass therethrough and thus permit theslider bar 322 to be assembled within thereceiver 320. Agear rack 330 is provided on an underside of theslider bar 322 extending substantially the entire length of theslot 328 on a lateral side thereof. Thegear rack 330 is intermeshed with thepinion gear 354 of theadjustment knob 350. Thus, when theadjustment knob 350 is turned in a clockwise direction as viewed from the front of the FMA, theslider bar 322 will be adjustably moved toward its extended position (i.e., in a direction toward a patient's forehead). Conversely, when theadjustment knob 350 is turned in a counterclockwise direction as viewed from the front of the FMA, theslider bar 322 will be adjustably moved toward its retracted position (i.e., in a direction away from the patient's forehead). However, the direction of movement of the slider bar as the adjustment knob is turned clockwise may be designed to extend or retract by moving the gear rack onto the other side of the slider bar. Thus, the direction of rotation of the adjustment knob may be swapped, e.g., clockwise movement could extend or retract the slider bar. - C. Helical Teeth on Gear Rack and/or Pinion Gear
- In this embodiment, at least one of the
gear rack 330 of theslider bar 322 and thepinion gear 354 of theadjustment knob 350 is a helical gear including helical teeth, i.e., a gear having teeth cut at an angle to the face of the gear. The use of helical teeth on at least one of thegear rack 330 and thepinion gear 354 provides a self-locking feature so that thegear rack 330 and thepinion gear 354 will not move when force is applied from either the forehead support or the mask. That is, helical teeth are configured such that theadjustment knob 350 can easily move theslider bar 322, but theslider bar 322 cannot move theadjustment knob 350. This arrangement prevents inadvertent movement of the forehead support during use. Also, because thegears slider bar 322 and position apertures on thereceiver 320 are not required. - In the illustrated embodiment, the
gear rack 330 includes helical teeth having a helix angle at 40 degrees, and thepinion gear 354 includes a helix angle of 20 degrees and the pinion is angled at 20 degrees to the gear rack 330 (seeFIG. 12-2 ). The helix of 20 degrees on the pinion and the 20 degree angle of the pinion to the gear rack results in the gear rack helix angle of 40 degrees. However, thepinion gear 354 may be angled 20 degrees in the other direction (i.e., counter-clockwise) to improve the angle of theadjustment knob 350 relative to the patient and hence ease of adjustment. Also, the teeth of thegears - Further, there are other potential design options to provide the self-locking feature. For example, helical teeth may be provided on the
gear rack 330 only, helical teeth may be provided on thegear rack 330 with angled teeth on thepinion gear 354, or straight teeth may be provided on thegear rack 330 with angled teeth on thepinion gear 354. All of these options will help to lock thegear rack 330 andpinion gear 354 when force is applied from either the forehead support or mask. - In an alternative embodiment, the gear rack and pinion gear may be designed such that sufficient friction is provided to lock the slider bar into position when in use. This arrangement prevents the gear rack and the gear from moving when force is applied from either the forehead support or the mask. This friction may be achieved through the use of surface texture, particular materials, and/or a reduction in the clearance between gear teeth.
- Accompanying
FIGS. 15-1 to 15-8 depict a FMA provided with another embodiment of aforehead support 10C according to the present invention.FIGS. 16-1 to 16-7,FIGS. 17-1 to 17-7, andFIGS. 18-1 to 18-5 depict in greater detail aslider bar 422, amask frame 412, and anadjustment knob 450 that may be employed in theforehead support 10C. In this regard, structural components that are similar to those discussed previously have been shown with the same reference numerals. Thus, a detailed discussion of such similar structural components will not be repeated. It is noted that themask frame 412 includesconnection structures 418 that are adapted to connect to headgear clips associated with a headgear assembly. - A. Slider Bar
- The
forehead support 10C generally comprises areceiver 420 which defines an arcuately shaped channel 420-1 (seeFIG. 17-6 ) for receiving a corresponding arcuately shapedslider bar 422. As illustrated, thereceiver 420 is relatively stronger and wider to provide more support to the forehead support and to prevent any cracking or fracture. As is perhaps best shown inFIGS. 16-1 to 16-7, the distal end of theslider bar 422 is joined to thecentral support 455 of the foreheadcushion support plates 451. In the illustrated embodiment, the forehead support does not have a hinge, which results in the angle of the pad against the forehead changing about 20 degrees with the motion of theslider bar 422. This arrangement helps keep the pad flat against the forehead. However, theslider bar 422 may be joined to thecentral support 455 in any other suitable manner, e.g., via a pivot pin. - B. Adjustment Knob
- An
adjustment knob 450 is operatively carried at a distal end of thereceiver 420. Theadjustment knob 450 is capable of being turned manually in both clockwise and counterclockwise directions so as to adjust the position of theslider bar 422 between its retracted and extended positions. As shown more clearly inFIGS. 18-1 to 18-5, theadjustment knob 450 includes anupper head portion 452 and alower pinion gear 454. Thehead portion 452 andpinion gear 454 are connected to one another by acylindrical post member 456. Thepost member 456 extends through opening 457 of thereceiver 420 so that thepinion gear 454 can engage operatively thegear rack 430 of theslider bar 422. Specifically, thereceiver 420 provides rampedportions 431 adjacent to theopening 457. The rampedportions 431 assist with assembly so that thepost member 456 can engage within theopening 457 with a snap fit. The rampedportions 431 also provide shoulders to prevent easy disassembly. Also, the receiver includes an elongatedstress relief opening 433 adjacent theopening 457. Theopening 433 allows the opposing arms of thereceiver 420 to open to accommodate theadjustment knob 450 within theopening 457. As illustrated, theupper head portion 452 has a gear-like configuration around its perimeter to provide a tactile grip. - As shown in
FIGS. 16-1 to 16-7, agear rack 430 is provided on an upper surface of theslider bar 422 extending substantially the entire length thereof. Thegear rack 430 is intermeshed with thepinion gear 454 of theadjustment knob 450. Thus, when theadjustment knob 450 is turned in a counter-clockwise direction as viewed from the front of the FMA, theslider bar 422 will be adjustably moved toward its extended position (i.e., in a direction toward a patient's forehead). Conversely, when theadjustment knob 450 is turned in a clockwise direction as viewed from the front of the FMA, theslider bar 422 will be adjustably moved toward its retracted position (i.e., in a direction away from the patient's forehead). As illustrated, substantially large teeth are provided on thegears - C. Detent Assembly
- In this embodiment, a detent assembly is provided in order to provide tactile feedback with the motion of the
slider bar 422. In the illustrated embodiment, the detent assembly is provided by raisedtriangular position markers 432 on thereceiver 420 that interact withapertures 436 on theadjustment knob 450. As theadjustment knob 450 is turned to extend or retract theslider bar 422, the raisedtriangular position markers 432 will move into and out of engagement withapertures 436 provided onadjustment knob 450. As such, the raisedtriangular position markers 432 will be seated withinrespective apertures 436 to assist in restraining theslider bar 422 at the desired position. However, turning movement applied to theadjustment knob 450 will cause the raisedtriangular position markers 432 to be resiliently unseated fromrespective apertures 436 to allow sliding movement of theslider bar 422 until thenext apertures 436 are aligned with respective raisedtriangular position markers 432, whereby the raisedtriangular position markers 432 are again seated therewithin. This detent assembly provides the user with a means of measuring the amount of adjustment one makes to the forehead support position. - The spacing of the
apertures 436 may or may not align to provide feedback that corresponds to the position of the gear teeth. Also, the detent assembly may be structured to provide a locking feature. - In an embodiment, position markings may be provided on the
adjustment knob slider bar FIG. 19-1 , numbers may be provided on anadjustment knob 550 that align with aposition arrow 551 provided on thereceiver 520 to indicate the forehead support's position. As illustrated, the numbers range from 1-13. In embodiments, the numbers may range from a minimum of 1-4 and a maximum of 1-30. However, any suitable range and marking may be provided on the adjustment knob. As shown inFIG. 19-2 , spacedmarkings 651, which may be color-coded and/or numbered, may be provided on aslider bar 622 to indicate the forehead support's position as theslider bar 622 is extended and retracted during use. However, any other suitable marking may be provided on the slider bar. - In a further embodiment, the
adjustment knob - In yet another embodiment, the rack and pinion gearing as described above may be configured to provide a variable rate of motion of the slider bar. That is, the rack and pinion gearing may be configured to provide finer adjustment along portions of the range of motion, and coarser adjustment along other portions of the range of motion. For example, as shown in
FIG. 20-1 , agear rack 730 may be configured such that finer adjustment, e.g., slower motion, of the forehead support position per rotation of the adjustment knob may be provided at the ends of the range of motion as an indication that the extremes of motion have been reached. In an alternative embodiment, as shown inFIG. 20-2 , agear rack 830 may be configured such that finer adjustment of the forehead support position per rotation of the adjustment knob may be provided at the middle of the range of motion to provide fine control at the position where the majority of patients will fit the forehead support. - In the embodiments of forehead supports 10B and 10C, the design target for the center of the forehead pad is a substantially straight line defined by the line TL in
FIG. 21 . The end points of the line TL have the coordinates (40.3, −13.7; 40.3, 16.9). In general, the line TL may be described as a 30 mm horizontal distance that allows about 15 mm clearance between the bottom of a forehead pad (assuming the pad has a height of about 28 mm) and G (Glabella). - The horizontal coordinates are calculated from the intersection of the 40.3 mm height with a line drawn from G to FB (most forward forehead position at the average hairline measurement minus two standard deviations) and G to FD (most rear forehead position at the average hairline measurement minus two standard deviations) plus 7.5 mm travel either side. While the target in these embodiments is a horizontal line, the movement of the forehead support will be arcuate due to its construction.
- Accompanying
FIGS. 22-1 to 22-5 depict a FMA provided with another embodiment of aforehead support 10D according to the present invention.FIGS. 23-1 to 23-5 andFIGS. 24-1 to 24-5 depict in greater detail aslider bar 222 and amask frame 212 that may be employed in theforehead support 10D. In this regard, structural components that are similar to those discussed previously have been shown with the same reference numerals. Thus, a detailed discussion of such similar structural components will not necessarily be repeated, although some mention thereof may be to ensure clarity of discussion. - A. Slider Bar
- The
forehead support 10D generally comprises areceiver 220 fixed to themask frame 212. Thereceiver 220 defines an arcuately shaped channel 220-1 (seeFIGS. 24-5 ) for receiving a corresponding arcuately shapedslider bar 222. Thereceiver 220 also defines an elongatecentral slot 224 through which the raisedpush button 240 associated with theslider bar 222 protrudes. As is perhaps best shown inFIGS. 23-1 to 23-6, theslider bar 222 includes at its distal end aconnector portion 226 which defines an aperture 246-1 for receiving the pivot pin 30 (seeFIG. 22-3 ). Thepivot pin 30 thus serves to pivotally join thecentral support 54 of the foreheadcushion support plates 50 to the distal end of theslider bar 222 and thereby permit pivotal movements of the former relative to the latter. In an alternative embodiment, the central support may be rigidly connected to the distal end of the slider bar. - B. Receiver with Ratchet Teeth
- The
receiver 220 includes a series of pairedratchet teeth 230 protruding into the channel 220-1 (FIG. 24-5 ) along the lateral sides of the central slot 224 (seeFIGS. 24-2 and 24-5) from the proximal end of thereceiver 220 to the distal end thereof. As is perhaps best shown inFIG. 24-2 , theratchet teeth 230 are angled in a generally downward direction when themask frame 212 is in an upright condition. - C. Tongue Member on Slider Bar
- As shown in
FIGS. 23-1 to 23-5, a pair of elongateparallel slots 242 is provided near respective lateral sides of theslider bar 222. Theslots 242 extend substantial one-fourth to about one-half the circumferential distance of thearcuate slider bar 222 starting at the distal end thereof so as to establish a resilientcentral tongue member 244. Thetongue member 240 also carries a pair of fixedengagement pawls 248 which are sized and configured to be engaged with a respective pair ofratchet teeth 230 of thereceiver 220. - In use, the
slider bar 222, and hence the forehead cushions 52 carried thereby, may be positionally adjusted so as to assume a desired position by pressing against thepush button 240. Pressure against thepush button 240 thereby causes theresilient tongue 244 to be flexed downwardly so as to release engagement between thepawls 248 and a pair of theratchet teeth 230. While thepawls 248 andteeth 230 are disengaged, therefore, theslider bar 222 may be slid along the channel 220-1 of thereceiver 220 between its retracted and extended positions so as to assume a desired position. Upon reaching such desired position, thepush button 240 may be released which causes theresilient tongue 244 to return to its normal condition thereby bringing thepawls 248 into engagement with another pair ofratchet teeth 230. - It should be understood that other suitable mechanisms may be utilized to secure the slider bar with respect to the receiver. For example, the slider bar may be secured with respect to the receiver by, e.g., a fastener such as a screw, friction, etc. Also, the slider bar may be attached to the receiver by a loose pivoting arrangement, or a spring arrangement.
-
FIG. 25 schematically illustrates aspiral screw mechanism 1020 according to an embodiment of the present invention. Thespiral screw mechanism 1020 may be employed in a forehead support of a FMA such as those discussed above. - As illustrated, the
spiral screw mechanism 1020 includes aknob 1050 with a number of pins 1052 (or spiral ribs) and astrap 1022 with a number of spiral-shapedgrooves 1030. Thepins 1052 of theknob 1050 are adapted to engage with the spiral-shapedgrooves 1030 on thestrap 1022. As theknob 1050 is turned, thepins 1052 push or pull thestrap 1022 towards or away from the knob axis. In the flat configuration shown, thepins 1052 could potentially interfere with thestrap 1022 as they rotate back over it. However, this should not be an issue if thestrap 1022 is curved (e.g., provided on a curved receiver of the mask frame) so that thestrap 1022 misses the backside trajectory of thepins 1052. Advantages of this concept include simplicity, strength, and the ability to provide a pull/push force that is closely aligned with the axis of theknob 1050 which reduces jamming issues with the slide action. -
FIGS. 26-1 to 26-4 illustrate a FMA including aforehead support 10E according to another embodiment of the present invention. Theforehead support 10E includes areceiver 1120 provided to themask frame 1112 for receiving aslider bar 1122. Theslider bar 1122 is joined to foreheadcushion support plates 1151 that carry forehead cushions 1152. - The
receiver 1120 has a split track including spaced-apart arcuately shaped channels 1120-1 and 1120-2 (FIG. 26-4 ) that define an elongatedcentral finger 1121 and outer guide rails 1123 (seeFIGS. 26-2 and 26-4). Thecentral finger 1121 includes a slot 1125 (FIG. 26-4 ) that retains anadjustment knob 1150. In the illustrated embodiment, the split track is molded into themask frame 1112 and is designed so as to be molded in a single line of draw (without complex sliding cores). - The slider bar 1122 (
FIG. 26-4 ) is fed into thereceiver 1120 so that theupper wall 1127 is supported on thecentral finger 1121 and theside walls 1129 are guided by the outer guide rails 1123 (seeFIGS. 26-2 , 26-3, and 26-4). Thus, thecentral finger 1121 provides restraint against downward movement of theslider bar 1122. - The
slider bar 1122 defines a centralelongate slot 1128. Theadjustment knob 1150 is fed into theslider bar 1122 via a void at one end of theslot 1128 adjacent the forehead end. Thepost member 1156 of theadjustment knob 1150 then clips into theslot 1125 of the central finger 1121 (FIG. 26-4 ). When coupled, thegear 1154 provided on theadjustment knob 1150 engages gear teeth positioned on the underside of theslider bar 1122. Thus, turning of theadjustment knob 1150 causes adjustable movement of theslider bar 1122. As illustrated, thehead 1147 of theadjustment knob 1150 includes grooves orfinger grips 1149, e.g., 2, 4, or 6, that make theknob 1150 easier to operate (seeFIGS. 26-1 and 26-4). - Advantages of the
forehead support 10E include ease of manufacture and strength. Also, the decoupling of thecentral finger 1121 from theouter guide rails 1123 enables the mechanism to flex and come apart under abuse loads instead of fracturing. Further, theforehead support 10E has good overall aesthetics. -
FIGS. 27-1 to 27-6 illustrate a FMA including aforehead support 10F according to another embodiment of the present invention. Theforehead support 10F includes areceiver 1220 provided to themask frame 1212 for receiving aslider bar 1222. Theslider bar 1222 is joined to forehead cushion support plates 1251 (seeFIG. 27-1 ) that carry forehead cushions. - Similar to the
receiver 1120, thereceiver 1220 has a split track including spaced-apart arcuately shaped channels 1220-1 and 1220-2 that define an elongatedcentral finger 1221 and outer guide rails 1223 (seeFIGS. 27-2 and 27-3). Thecentral finger 1221 includes aslot 1225 that retains an adjustment knob 1250 (seeFIG. 27-1 ). In the illustrated embodiment, the split track is molded into themask frame 1212 and is designed so as to be molded in a single line of draw (without complex sliding cores). - The
slider bar 1222 is fed into thereceiver 1220 so that theupper wall 1227 is supported on thecentral finger 1221 and theside walls 1229 are guided by theouter guide rails 1223. Thus, thecentral finger 1221 provides restraint against downward movement of theslider bar 1222. - The
slider bar 1222 defines a central elongate slot 1228 (seeFIGS. 27-4 and 27-5). Theadjustment knob 1250 is fed into theslider bar 1222 via a void at one end of theslot 1228 adjacent the forehead end. The post member of theadjustment knob 1250 then clips into theslot 1225 of thecentral finger 1221. When coupled, thegear 1254 provided on theadjustment knob 1250 engagesgear teeth 1230 positioned on the underside of the slider bar 1222 (seeFIG. 27-6 ). Thus, turning of theadjustment knob 1250 causes adjustable movement of theslider bar 1222. As illustrated, thehead 1247 of theadjustment knob 1250 includes grooves orfinger grips 1249, e.g., 2, 4, or 6, that make theknob 1250 easier to operate (seeFIG. 27-1 ). - Also, the
forehead support 10F includes a detent assembly or ratchet arrangement that is self-locking to lock theforehead support 10F in position. Specifically, thecentral finger 1221 may include a protrusion or detent button 1270 (seeFIGS. 27-2 and 27-3) that is adapted to interact with a series of teeth orribs 1272 provided on the underside of the slider bar 1222 (seeFIG. 27-4 ). Alternatively, eachguide rail 1223 may include a protrusion or detent button 1274 (seeFIGS. 27-2 and 27-3) that is adapted to interact with a series of teeth orribs 1276 provided on sides of the slider bar 1222 (seeFIGS. 27-1 and 27-5). Thus, the ratchet arrangement may include either one of theprotrusion 1270/teeth 1272 or theprotrusion 1274/teeth 1276. As theadjustment knob 1250 is turned to extend or retract theslider bar 1222, theprotrusion 1270 will move into and out of engagement with theteeth 1272 on the underside of theslider bar 1222, or theprotrusions 1274 will move into and out of engagement with theteeth 1276 on sides of theslider bar 1222. As such, theprotrusions respective teeth 1272, 1276 (FIGS. 27-4 and 27-5) to assist in restraining theslider bar 1222 at the desired position. However, turning movement applied to theadjustment knob 1250 will cause theprotrusions respective teeth slider bar 1222 until thenext teeth respective protrusions protrusions guide rails 1223 may flex outwardly during the ratcheting movement. This ratchet arrangement provides the user with a means of measuring the amount of adjustment one makes to the forehead support position. Theteeth - Advantages of the
forehead support 10F include ease of manufacture and strength. Also, the decoupling of thecentral finger 1221 from theouter guide rails 1223 enables the mechanism to flex and come apart under abuse loads instead of fracturing. Further, theforehead support 10F has good overall aesthetics. -
FIGS. 28-1 to 28-3 illustrate a FMA including aforehead support 10G according to another embodiment of the present invention. Theforehead support 10G includes areceiver 1320 provided to themask frame 1312 for receiving aslider bar 1322. Theslider bar 1322 is joined to foreheadcushion support plates 1351 that carry forehead cushions 1352. - The
receiver 1320 defines an arcuately shaped channel 1320-1 for receiving the correspondingly arcuately shaped slider bar 1322 (seeFIG. 28-3 ). The receiver also includes aslot 1325 that retains anadjustment knob 1350. In the illustrated embodiment, thereceiver 1320 is molded into themask frame 1312 and is designed so as to be molded with a pivoting core and provide sufficient space for cooling of the core. - The
slider bar 1322 is fed into the channel 1320-1 of thereceiver 1320, and theadjustment knob 1350 is fed into thereceiver 1320 via a void at a bottom end of theslot 1325 opposite the forehead end. Thepost member 1356 of theadjustment knob 1350 then clips into a top end of theslot 1325. Theadjustment knob 1350 clips into place from the bottom rather than the top to prevent theknob 1350 from being directed towards the user if it detaches. Also, theknob 1350 is self-contained. - When coupled, the
gear 1354 provided on theadjustment knob 1350 engages gear teeth positioned on the top side of theslider bar 1322. Thus, turning of theadjustment knob 1350 causes adjustable movement of theslider bar 1322. As illustrated, thehead 1347 of theadjustment knob 1350 includes grooves orfinger grips 1349, e.g., 2, 4, or 6, that make theknob 1350 easier to operate (seeFIG. 28-1 ). - As illustrated, the
slider bar 1322 has generally c-shaped cross-section configuration, and theside walls 1329 of theslider bar 1322 are supported onouter guide flanges 1323 that provide restraint against downward movement of theslider bar 1322. - Advantages of the
forehead support 10G include ease of molding and good overall aesthetics. -
FIGS. 29-1 to 29-3 illustrate a FMA including aforehead support 10H according to another embodiment of the present invention. Theforehead support 10H includes areceiver 1420 provided to themask frame 1412 for receiving aslider bar 1422. Theslider bar 1422 is joined to foreheadcushion support plates 1451 that carry forehead cushions 1452. - The
receiver 1420 defines an arcuately shaped channel 1420-1 for receiving the correspondingly arcuately shaped slider bar 1422 (seeFIG. 29-3 ). The receiver also includes aslot 1425 that retains anadjustment knob 1450. - The
slider bar 1422 is fed into the channel 1420-1 of thereceiver 1420, and theadjustment knob 1450 is fed into thereceiver 1420 via a void at a top end of theslot 1425 adjacent the forehead end. Thepost member 1456 of theadjustment knob 1450 then clips into theslot 1425. In contrast to theforehead support 10G, theadjustment knob 1450 clips into place from the top of thereceiver 1420 rather than the bottom. Also, thereceiver 1420 is fully enclosed at its bottom, whereas thereceiver 1320 described above had an open configuration at its bottom. - When coupled, the
gear 1454 provided on theadjustment knob 1450 engages gear teeth positioned on the topside of theslider bar 1422. Thus, turning of theadjustment knob 1450 causes adjustable movement of theslider bar 1422. As illustrated, thehead 1447 of theadjustment knob 1450 includes grooves orfinger grips 1449, e.g., 2, 4, or 6, that make theknob 1450 easier to operate (seeFIG. 29-1 ). - As illustrated, the
slider bar 1422 has generally c-shaped cross-section configuration, and theside walls 1429 of theslider bar 1422 are supported onouter guide flanges 1423 that provide restraint against downward movement of theslider bar 1422. - Advantages of the
forehead support 10H include ease of molding and good overall aesthetics. -
FIGS. 30-1 to 30-3 illustrate a FMA including aforehead support 10J according to another embodiment of the present invention. In this embodiment, the forehead support 10I uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the forehead support 10I includes a
support 1520 provided to themask frame 1512 for supporting anadjustment knob 1550. Theadjustment knob 1550 includesinternal threads 1554 and clips onto thesupport 1520 with a snap-fit. Specifically, thesupport 1520 includes opposingresilient arm members 1521 that each provide aprotrusion 1523 on a free end thereof. Theadjustment knob 1550 includes anannular groove 1555. When theadjustment knob 1550 is assembled to thesupport 1520, theresilient arm members 1521 deflect outwardly until theprotrusions 1523 snap into the groove 1555 (seeFIGS. 30-2 and 30-3). Theadjustment knob 1550 receives a threadedshaft 1522 therein such that theinternal threads 1554 are intermeshed with the threadedshaft 1522. The threadedshaft 1522 is joined to foreheadcushion support plates 1551 that carry forehead cushions 1552. In the illustrated embodiment, the threadedshaft 1522 has a tubular cross-section with D-shaped ends. This arrangement of theshaft 1522 providesflat surfaces flat surfaces support 1520. Theflat surfaces support 1520 guide theflat surfaces shaft 1522 in use and also prevent rotation of thesupport plates 1551 as theadjustment knob 1550 is rotated. However, other cross-sectional configurations are possible, e.g., circular. - When the
knob 1550 is rotated, the threadedshaft 1522 extends from or retracts into theknob 1550 which causes adjustable movement of the forehead cushions 1552. As illustrated, theadjustment knob 1550 includes grooves orfinger grips 1549 that make theknob 1550 easier to operate (seeFIGS. 30-1 and 30-3). In the illustrated embodiment, the forehead support 10I has a straight line of motion. However, the forehead support 10I may include a worm drive with slight curvature as an alternative embodiment. - Advantages of the forehead support 10I include ease of molding, strength, a straightforward adjustment mechanism, and good overall aesthetics.
-
FIGS. 31-1 to 31-8 illustrates a FMA including aforehead support 10J according to another embodiment of the present invention. Theforehead support 10J includes areceiver 1620 provided to themask frame 1612 for receiving aslider bar 1622. Theslider bar 1622 is joined to foreheadcushion support plates 1651 that carry forehead cushions 1652. - Similar to the
forehead support 10E, thereceiver 1620 has a split track including spaced-apart arcuately shaped channels 1620-1 and 1620-2 that define an elongatedcentral finger 1621 and outer guide rails 1623 (seeFIGS. 31-5 and 31-6). In contrast, thereceiver 1620 is squarer in shape and includes abridge 1680 between theouter guide rails 1623 that provides aslot 1625 for retaining anadjustment knob 1650. Thebridge 1680 may improve the strength of thereceiver 1620. In the illustrated embodiment, the split track is molded into themask frame 1612 and may be molded in a single line of draw. - The
slider bar 1622 is fed into thereceiver 1620 so that theupper wall 1627 is supported on thecentral finger 1621 and theside walls 1629 are guided by theouter guide rails 1623. Thus, thecentral finger 1621 provides restraint against downward movement of theslider bar 1622. - The
slider bar 1622 defines a central elongate slot 1628 (seeFIGS. 31-7 and 31-8). Theadjustment knob 1650 is fed into theslider bar 1622 via a void at one end of theslot 1628 adjacent the forehead end. The post member of theadjustment knob 1650 then clips into theslot 1625 of thebridge 1680. When coupled, thegear 1654 provided on theadjustment knob 1650 engagesgear teeth 1630 positioned on the underside of the slider bar 1622 (seeFIG. 31-3 ). Thus, turning of theadjustment knob 1650 causes adjustable movement of theslider bar 1622. As illustrated, thehead 1647 of theadjustment knob 1650 includes grooves orfinger grips 1649, e.g., 2, 4, or 6, that make theknob 1650 easier to operate. -
FIGS. 32-1 to 32-6 illustrate a FMA including aforehead support 10K according to another embodiment of the present invention. In this embodiment, theforehead support 10K uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the
forehead support 10K includes asupport 1720 provided to themask frame 1712. Thesupport 1720 includes an internally threadedtube portion 1721. Theadjustment knob 1750 includes a threadedshaft 1754 that engages within the internally threadedtube portion 1721 such that the threadedshaft 1754 is intermeshed with the internally threaded tube portion 1721 (seeFIG. 32-5 ). Theadjustment knob 1750 also engages atube 1722 joined to foreheadcushion support plates 1751 that carry forehead cushions 1752. Specifically, thetube 1722 has a loweropen portion 1723 that allows thetube 1722 to fit around the internally threaded tube portion 1721 (seeFIG. 32-6 ). In addition, the end of thetube 1722 has anannular flange 1725 that engages within anannular groove 1745 provided in thehead 1747 of the adjustment knob 1750 (seeFIG. 32-5 and 32-6). - When the
knob 1750 is rotated, theknob 1750 and thetube 1722 extend or retract from the internally threadedtube portion 1721 of thesupport 1720 which allows adjustment of the forehead cushions 1752 relative to theframe 1712. Thus, theknob 1750 doesn't move relative to the patient in use. Rather, theframe 1712 is moved relative to the forehead support. As illustrated, thehead 1747 of theadjustment knob 1750 includes grooves orfinger grips 1749 that make theknob 1750 easier to operate. -
FIGS. 33-1 to 33-6 illustrate a FMA including aforehead support 10L according to another embodiment of the present invention. In this embodiment, theforehead support 10L uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the
forehead support 10L includes asupport 1820 provided to themask frame 1812 for supporting anadjustment knob 1850. Theadjustment knob 1850 includes a threadedshaft 1854 that extends through atube portion 1821 of thesupport 1820. The threadedshaft 1854 also engages within an internally threadedtube 1822 such that the threadedshaft 1854 is intermeshed with the internally threadedtube 1822. The internally threadedtube 1822 is joined to foreheadcushion support plates 1851 that carry forehead cushions 1852. - When the
knob 1850 is rotated, the internally threadedtube 1822 extends or retracts from the threadedshaft 1854 of theknob 1850 which causes adjustable movement of the forehead cushions 1852. Thus, theknob 1850 does not move relative to theframe 1812 but does move relative to the patient. In an embodiment, thehead 1847 of theadjustment knob 1850 may include one or more markings, e.g., company name. - As illustrated, the
support plates 1851 may include a recessedcentral support 1855 to conserve space. Also, the nut and bolt type assembly allows easy cleaning and assembly/disassembly. In an embodiment, thesupport 1820 may include a more enclosed configuration (such as thesupport 1820 shown inFIG. 33-6 ) to facilitate cleaning of thesupport 1820. -
FIGS. 34-1 to 34-5 illustrate a FMA including aforehead support 10M according to another embodiment of the present invention. In this embodiment, theforehead support 10M uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the
forehead support 10M includes asupport 1920 provided to themask frame 1912 for supporting anadjustment ring 1950. Theadjustment ring 1950 includes internal threads and has a reduced diameter that extends into atube portion 1921 of thesupport 1920. A threaded shaft 1922 (FIG. 34-4 ) extends through thetube portion 1921 and theadjustment ring 1950 such that the internal threads of theadjustment ring 1950 are intermeshed with the threadedshaft 1922. The threadedshaft 1922 is joined to foreheadcushion support plates 1951 that carry forehead cushions 1952. - When the
adjustment ring 1950 is rotated, the threadedshaft 1922 extends or retracts from theadjustment ring 1950 which causes adjustable movement of the forehead cushions 1952. Thus, thering 1950 does not move relative to theframe 1912. As shown inFIGS. 34-1 and 34-3, the threadedshaft 1922 may emerge at the front. - As illustrated, the
support plates 1951 may include a recessedcentral support 1955 to conserve space. Also, this nut and bolt type arrangement makes the assembly compact and reduces the actual and visual bulk. -
FIG. 35 illustrates a FMA including aforehead support 10N according to another embodiment of the present invention. In this embodiment, theforehead support 10N uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the
forehead support 10N includes asupport 2020 provided to themask frame 2012 for supporting anadjustment knob 2050. Theadjustment knob 2050 includes a threadedshaft 2054 that extends through atube portion 2021 of thesupport 2020. The threadedshaft 2054 also engages within an internally threadedtube 2022 such that the threadedshaft 2054 is intermeshed with the internally threadedtube 2022. The internally threadedtube 2022 is joined to foreheadcushion support plates 2051 that carry forehead cushions 2052. - When the
knob 2050 is rotated, the internally threadedtube 2022 extends or retracts from the threadedshaft 2054 of theknob 2050 which causes adjustable movement of the forehead cushions 2052. Thus, theknob 2050 does not move relative to theframe 2012. - As illustrated, the
support plates 2051 include a contouredcentral support 2055 that matches the contour of thetube portion 2021 of thesupport 2020. Also, thehead 2047 of theknob 2050 includes a contour that matches the contour of thetube portion 2021. This arrangement allows the assembly to be retracted into a compact position. - In an embodiment, portions of the
knob 2050 may be opaque. Also, thehead 2047 of theknob 2050 and the threadedshaft 2054 may be constructed in two parts and permanently or semi-permanently assembled. -
FIGS. 36-1 to 36-5 illustrate a FMA including aforehead support 10P according to another embodiment of the present invention. In this embodiment, theforehead support 10P uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the
forehead support 10P includes asupport 2120 provided to themask frame 2112 for supporting anadjustment knob 2150. Theadjustment knob 2150 includes internal threads and has a reduceddiameter portion 2154 that clips onto retainingarms 2121 of thesupport 2120 with a snap-fit. Theadjustment knob 2150 receives a threadedshaft 2122 therein such that the internal threads of theknob 2150 are intermeshed with the threadedshaft 2122. The threadedshaft 2122 is joined to foreheadcushion support plates 2151 that carry forehead cushions. - When the
knob 2150 is rotated, the threadedshaft 2122 extends from or retracts into theknob 2150 which causes adjustable movement of the forehead cushions. As illustrated, aprong 2180 may be positioned into a keyway of the threadedshaft 2122 to prevent spinning and hence lock the threadedshaft 2122 in place. Also, the end of theadjustment knob 2150 includes a series ofteeth 2145 that engage abase 2147 of the prong 2180 (seeFIGS. 36-2 and 36-4). As theknob 2150 is rotated, theteeth 2145 ratchet or click against thebase 2147 which provides tactile feedback during rotation. - The
knob 2150/threadedshaft 2122 subassembly may be easily assembled/disassembled to thesupport 2120 with a snap-fit. This allows for easy cleaning. Also, since theknob 2150/threadedshaft 2122 subassembly may be easily disassembled without movement of the threads, the original forehead position may be maintained even when theknob 2150/threadedshaft 2122 subassembly is disassembled from thesupport 2120. -
FIGS. 37-1 to 37-15 illustrate a FMA including aforehead support 10Q according to another embodiment of the present invention. In this embodiment, the forehead supports 10Q uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the
forehead support 10Q includes asupport 2220 provided to themask frame 2212 for supporting anadjustment knob 2250. Theadjustment knob 2250 clips onto thesupport 2220 with a snap-fit. Specifically, thesupport 2220 includes aresilient arm member 2221 that provides aprotrusion 2223 on a free end thereof. Theadjustment knob 2250 includes anannular groove 2255. When theadjustment knob 2250 is assembled to thesupport 2220, theresilient arm member 2221 deflects outwardly until theprotrusion 2223 snaps into the groove 2255 (seeFIGS. 37-1 and 37-4 to 37-7). - A threaded
shaft 2254 is provided to theadjustment knob 2250. In the illustrated embodiment, the threadedshaft 2254 and theadjustment knob 2250 are constructed in two parts and permanently or semi-permanently assembled. Specifically, thehead 2257 of the threadedshaft 2254 includes a non-circular outer perimeter, e.g.,head 2257 has at least one flat edge, that engages within a correspondingnon-circular opening 2259 provided in theadjustment knob 2250. This mechanically interlocks theadjustment knob 2250 and the threadedshaft 2254. Theknob 2250 andshaft 2254 may be further secured with an adhesive. However, theadjustment knob 2250 and the threadedshaft 2254 may be integrally formed as a one-piece structure. - The threaded
shaft 2254 engages within an internally threadedtube 2222 such that the threadedshaft 2254 is intermeshed with the internally threadedtube 2222. The internally threadedtube 2222 is joined to foreheadcushion support plates 2251 that carry forehead cushions 2252. The internally threadedtube 2222 includes aresilient arm 2290 that engages thesupport 2220 with a snap-fit to prevent disassembly. Also, the internally threadedtube 2222 includes akeyway 2292 that engages a protrusion 2229 (e.g., seeFIGS. 37-12 to 37-15) provided to thesupport 2220 to prevent thetube 2222 and hence the forehead cushions 2252 from twisting relative to theframe 2212. - When the
knob 2250 is rotated, the internally threadedtube 2222 extends or retracts from the threadedshaft 2254 provided to theknob 2250 which causes adjustable movement of the forehead cushions 2252. - As illustrated, the
knob 2250 includes grooves orfinger grips 2249 that make theknob 2250 easier to operate. Thegrips 2249 are relatively large to assist patients with relatively large hands. Preferably, theknob 2050 is opaque to hide the inner mechanisms and provide a sense of simple design reflecting ease of use. Theknob 2250 may be manufactured from TPE (thermoplastic elastomer) which is tactile for the patient. However, other suitable materials may be used. - In the illustrated embodiment, the forehead
cushion support plates 2251 include slots for attaching headgear straps. However, the foreheadcushion support plates 2251 may include clip receiving structures for engaging headgear clips. Also, thetube 2222 is recessed into thesupport plates 2251 which allows maximum extension with minimum protrusion from the forehead, thereby reducing actual and visual bulk. Further, as best shown inFIGS. 37-1 and 37-4, thetube 2222 may be labeled, e.g., spaced apartgrooves 2280, to allow the forehead support position to be remembered. Moreover, thetube 2222 may be frosted so that the internal threads are less visible, thereby reducing the technological/mechanical look of the forehead support and making it appear more user friendly and simple. - In an embodiment, the forehead support provides movement of about 24 mm+/−10 mm. This range of movement may vary, e.g., depending on the characteristics and structure of the mask cushion.
- The threads for the threaded
shaft 2254 and the internally threadedtube 2222 are preferably designed such that sufficient extension is provided for a particular rotation. In addition, the threads may be designed to be self-locking. In an embodiment, the threads may have a pitch of about 12 mm. However, the pitch may be in the range of 4-15 mm. It is noted that a lower thread size may be better for self-locking but may require more turns to set the desired forehead support distance. Also, in an embodiment, the threads may be 3 start LH threads. However, the threads may be RH threads. It is noted that a LH thread may feel more intuitively correct for the patient in that as they tighten the thread, the forehead support moves towards their face. Also, the threads may have any suitable number of starts and may be chosen for strength, moldability and friction characteristics. Further, in an embodiment, the threads have a 29 degree ACME thread angle. However, the thread angle may be in the range of 10-60 degrees. Also, other thread profiles may be used. Additionally, in an embodiment, the threads may have a 1.3 mm thread height. However, the thread height may be in the range of 0.5-2 mm and may be chosen for strength and moldability. - As shown in
FIGS. 37-12 to 37-15, themask frame 2212 may be provided in various sizes, e.g., extra small, small, medium, and large, to accommodate a wide range of patients. Any suitable number of sizes may be provided. -
FIGS. 38-1 to 38-18 illustrate a FMA including aforehead support 10R according to another embodiment of the present invention. In this embodiment, theforehead support 10R uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the
forehead support 10R includes asupport 2320 provided to themask frame 2312 for supporting anadjustment knob 2350. Theadjustment knob 2350 clips onto thesupport 2320 with a snap-fit. Specifically, thesupport 2320 includes afirst protrusion 2325 and aresilient arm member 2321 that provides asecond protrusion 2323 on a free end thereof. Theadjustment knob 2350 includes anannular groove 2355. When theadjustment knob 2350 is assembled to thesupport 2320, theresilient arm member 2321 deflects outwardly until the first andsecond protrusions FIGS. 38-1 , 38-4, 38-5, 38-9, and 38-10 to 38-13). As illustrated, thesupport 2320 is relatively wide and covers or shrouds a portion of theknob 2350, e.g., about half of theknob 2350, to reduce the visual bulk of theknob 2250 and improve the aesthetics of the design. - As best shown in
FIGS. 38-5 and 38-10 to 38-13, a threadedshaft 2354 is provided to theadjustment knob 2350. In the illustrated embodiment, the threadedshaft 2354 and theadjustment knob 2350 are integrally formed, e.g., integrally molded, as a one-piece structure. However, theadjustment knob 2350 and the threadedshaft 2354 may be constructed in two parts and permanently or semi-permanently assembled, e.g., by an adhesive. - The threaded
shaft 2354 engages within an internally threadedtube 2322 such that the threadedshaft 2354 is intermeshed with the internally threadedtube 2322. The internally threadedtube 2322 is joined to foreheadcushion support plates 2351 that carryforehead cushions 2352 as shown inFIGS. 38-1 , 38-3, 38-4, 38-5, and 38-14 to 38-18. As best shown inFIGS. 38-6 , 38-7, 38-9, 38-16, and 38-18, the internally threadedtube 2322 includes a non-circular outer profile or exterior surface that is adapted to extend through anon-circular opening 2345 provided to thesupport 2320 to prevent thetube 2322 and hence the forehead cushions 2352 from twisting or rotating relative to theframe 2312. - When the
knob 2350 is rotated, the internally threadedtube 2322 extends or retracts from the threadedshaft 2354 provided to theknob 2350 which causes adjustable movement of the forehead cushions 2352. - As illustrated, the
knob 2350 includes scallops orfinger grips 2349, e.g., fourfinger grips 2349, that reduce the visual and actual bulk of theknob 2350. In addition, the finger grips 2349 make theknob 2350 easier to operate. - In the illustrated embodiment, the forehead
cushion support plates 2351 include clip receiving structures orclip receptacles 2390 for engaging headgear clips associated with headgear straps. The headgear clips may be structured like those disclosed in U.S. Pat. No. 6,374,826 and/or PCT Application No. PCT/AU04/01834, filed Dec. 24, 2004, the entireties of both being incorporated herein by reference. However, the foreheadcushion support plates 2351 may include other suitable structures for engaging headgear straps, e.g., slots. Also, thetube 2322 is recessed into thesupport plates 2351 which allows maximum extension with minimum protrusion from the forehead, thereby reducing actual and visual bulk. -
FIGS. 39-1 to 39-9 illustrate a thread form for a forehead support according to an embodiment of the present invention. The thread form may be implemented or employed in a forehead support of a FMA such as those discussed above. -
FIGS. 39-1 to 39-6 illustrate a threaded shaft orbolt 2454 andFIGS. 39-7 to 39-9 illustrate an internally threadedtube 2422 that is adapted to be intermeshed with the threadedshaft 2454. The threadedshaft 2454 may be permanently or semi-permanently assembled to an adjustment knob such as those discussed above (e.g., seeFIG. 37-5 ), and the internally threadedtube 2422 may be joined to forehead cushion support plates that carry forehead cushions or form a portion of the support provided to the mask frame for supporting the adjustment knob andshaft 2454. - As illustrated, the
head 2457 of the threadedshaft 2454 includes a non-circular outer perimeter that provides aflat edge 2495. Thenon-circular head 2457 may be engaged within a corresponding non-circular opening provided in the adjustment knob to mechanically interlock the adjustment knob and the threaded shaft 2454 (e.g., seeFIG. 37-5 ). However, threadedshaft 2454 may be interlocked with an adjustment knob in other suitable manners. For example, thehead 2457 may include more than one flat edge, e.g., hexagon-shaped. - The threads for the threaded
shaft 2454 and the internally threadedtube 2422 may be designed to provide sufficient extension for a particular rotation, to be self-locking, and/or to facilitate manufacturing. In an embodiment, the threads may have a pitch P of about 12 mm. However, the pitch may be in the range of 4-15 mm. It is noted that a lower thread size may be better for self-locking but may require more turns to set the desired forehead support distance. Also, in an embodiment, the threads may be 3 start threads and may be LH or RH threads. However, the threads may have any suitable number of starts and may be chosen for strength, moldability and friction characteristics. Further, in an embodiment, the threads have an included angle A of 90-110°, preferably 100°, and a radius R of 0.8-1.5 mm, preferably 1.1 mm. However, other suitable angles and radiuses are possible depending on application. Additionally, in an embodiment, the threads of theshaft 2454 may have a diameter D of 8-10 mm, preferably 9 mm, and a diameter D2 of 10-13 mm, preferably 11.6 mm. In an embodiment, the threads of thetube 2422 may have a diameter D1 of 8-11 mm, preferably 9.7 mm, and a diameter D2 of 11-13 mm, preferably 12 mm. - Further, the threads of the threaded
shaft 2454 may include threeflat edges 2497 that may be molded with a three-way split block. However, the threads may be devoid of flat edges or may include other suitable numbers of flat edges. -
FIGS. 40-1 to 40-3 illustrate aforehead cushion 2580 for a forehead support according to an embodiment of the present invention. Theforehead cushion 2580 may be implemented or employed in a forehead support of a FMA such as those discussed above. In addition, theforehead cushion 2580 may be employed in a forehead support including attachment members with one or more slots such as the forehead support shown and described below inFIGS. 41-1 to 41-3. - The
forehead cushion 2580 is formed of an elastomeric material, e.g., silicone, and includes a pair ofcushions 2552 that are joined to one another with a one-piece bridge 2560. The interior surfaces or forehead contacting surfaces of thecushions 2552 may have a general “concave” contour and thus be adapted for conformable shaping relative to a patient's forehead profile. - Each
cushion 2552 has anattachment head 2562 protruding rearwardly therefrom which is inserted into and through a respective aperture formed in support plates of a forehead cushion support so as to physically attach thecushions 2552 to the support plates. - The
attachment head 2562 is joined to the back of eachcushion 2552 by aflexible connector 2564 which serves to allow compliant movement of thecushions 2552 so they may be comfortably positioned in contact with the patient's forehead. As illustrated, theconnector 2564 has a cored-out or hollow interior 2565 to provide a cylindricalconnector side wall 2566. Theconnector side wall 2564 has a plurality ofslots 2570 therethrough that allow theconnector wall 2564 and hence thecushions 2552 to compress, and thus provide additional adjustment that may be required for some users to extend the range of theforehead cushion 2580. - In the illustrated embodiment, the
slots 2570 are provided in two rows with each row including two spaced-apart slots. Eachslot 2570 has an elongated, generally rectangular configuration with a longitudinal axis that extends generally transverse to a longitudinal axis of theconnector 2564. Theslots 2570 each have a width W of 1-5 mm, preferably 3 mm, which allows theforehead cushion 2580 to compress, e.g., in folds like those of a concertina. In the illustrated embodiment, the length of compression C may be 2-10 mm, preferably 6 mm. However, the slots may be arranged, configured, and/or dimensioned in other suitable manners to adjust the range or manner of compression. In addition, the slots may be provided in other cushion arrangements in a similar manner in order to provide additional adjustment or compression in such cushion arrangements. -
FIGS. 41-1 to 41-3 illustrate aforehead cushion support 2653 for a forehead support according to an embodiment of the present invention. Theforehead cushion support 2653 is adapted for use with aforehead cushion 2580 as described above. - As illustrated, the
forehead cushion support 2653 includes foreheadcushion support plates 2651 and a tube orslider 2622 joined to thesupport plates 2651, e.g., formed of a rigid polymer material. Thesupport plates 2651 extend generally transversely relative to theslider 2622 and thus define a general T-shaped support. - Each
support plate 2651 has anattachment member 2662 protruding rearwardly therefrom which is adapted to receive arespective attachment head 2562 of theforehead cushion 2580 so as to physically attach theforehead cushion 2580 to the support plates 2651 (seeFIG. 41-3 ). In use, theslider 2622 is extended or retracted with respect to the mask frame which causes adjustable movement of the forehead cushions 2552. - As illustrated, each
attachment member 2662 has a cylindricalconnector side wall 2666. Theside wall 2666 has a plurality ofslots 2670 therethrough that allow theside wall 2666 and hence theforehead cushion support 2653 to compress, and thus extend the range of movement of theforehead cushion support 2653 to provide additional adjustment. Theattachment members 2662 may be made from polycarbonate, polypropylene, or silicone, for example. Also, theattachment members 2662 may be integrally formed in one-piece with thesupport plates 2651 andslider 2622, or formed separately and attached thereto. Theattachment members 2662 may be manufactured from any suitable flexible material and the slots orapertures 2670 in theattachment members 2662 allow compression of theattachment members 2662. - In the illustrated embodiment, the
slots 2670 are provided in two rows with each row including two spaced-apart slots. Eachslot 2670 has an elongated, generally rectangular configuration with a longitudinal axis that extends generally transverse to a longitudinal axis of theattachment member 2662. As illustrated, theslots 2670 each have a width W of 1-5 mm, preferably 3 mm, which allows theforehead cushion support 2653 to compress, e.g., in folds like those of a concertina. In the illustrated embodiment, the length of compression C may be 2-10 mm, preferably 6 mm. However, the slots may be arranged, configured, and/or dimensioned in other suitable manners to adjust the range or manner of compression. In addition, the slots may be provided in other cushion support arrangements in a similar manner in order to provide additional adjustment or compression in such cushion support arrangements. - When the
forehead cushion 2580 is attached to theforehead cushion support 2653, theslots 2570 of theforehead cushion 2580 may align withcorresponding slots 2670 of theforehead cushion support 2653. However, one ormore slots 2570 may be offset from theslots 2670. In addition, the slot arrangement, configuration, and/or dimension of one or more of theslots 2570 may be similar to and/or different than the slot arrangement, configuration, and/or dimension of one or more of theslots 2670. -
FIGS. 42-1 to 42-8 illustrate aforehead cushion support 2753 for a forehead support according to an embodiment of the present invention. Theforehead cushion support 2753 is adapted for use with a forehead cushion such as those described above, e.g. seeforehead cushion 1752 inFIG. 32-6 . - As illustrated, the
forehead cushion support 2753 includes foreheadcushion support plates 2751 and a tube orslider 2722 joined to thesupport plates 2751. Thesupport plates 2751 extend generally transversely relative to theslider 2722 and thus define a general T-shaped support. - The
slider 2722 includes integrally molded male threads (used for forehead support depth adjustment). The male threadedslider 2722 has flats at the top and bottom thereof (seeFIG. 42-6 ) to improve moldability and to provide keyed assembly with the mask frame (to prevent rotation). Also, recessedslots 2785 are provided at the bottom of theslider 2722 to provide indexed tactile feedback on adjustment position. In addition, aresilient tab 2787 is provided to theslider 2722 to provide quick-release assembly to the mask frame. - Each
support plate 2751 has a generallycircular attachment recess 2755 to receive a respective attachment head of the forehead cushion, e.g., formed of flexible silicone, so as to physically attach the forehead cushion to thesupport plates 2751. In use, theslider 2722 is extended or retracted with respect to the mask frame which causes adjustable movement of the forehead cushion. - The forehead
cushion support plates 2751 include clip receiving structures orclip receptacles 2790 for engaging headgear clips associated with headgear straps. The headgear clips may be structured like those disclosed in U.S. Pat. No. 6,374,826 and/or PCT Application No. PCT/AU04/01834, filed Dec. 24, 2004, the entireties of both being incorporated herein by reference. However, the foreheadcushion support plates 2751 may include other suitable structures for engaging headgear straps, e.g., slots. Also, thetube 2722 is recessed into thesupport plates 2751 which allows maximum extension with minimum protrusion from the forehead, thereby reducing actual and visual bulk. - In the illustrated embodiment, the
clip receptacles 2790 are integrally molded with theplates 2751 andslider 2722. Also, theclip receptacles 2790 are molded in front of the attachment recesses 2755, thereby reducing the overall width of the T-shapedforehead cushion support 2753. -
FIGS. 43-1 to 43-21 illustrate a FMA including aforehead support 10S according to another embodiment of the present invention. In this embodiment, theforehead support 10S incorporates theforehead cushion support 2753 described above inFIGS. 42-1 to 42-8, and uses a screw-type actuator to move theforehead cushion support 2753 along a generally linear path. - As illustrated, the
forehead support 10S includes asupport 2720 provided to themask frame 2712 for supporting anadjustment knob 2750. Theadjustment knob 2750 clips onto thesupport 2720 with a snap-fit. Specifically, the front of thesupport 2720 includes aresilient arm member 2721 that provides afirst protrusion 2723 on a free end thereof, and a resilient quick-release button 2725 that provides asecond protrusion 2727 on a free end thereof. Theadjustment knob 2750 includes anannular groove 2755. When theadjustment knob 2750 is assembled to thesupport 2720, theresilient arm member 2721 andbutton 2725 deflect outwardly until the first andsecond protrusions FIGS. 43-12 to 43-16). Theknob 2750 may be quickly released from thesupport 2720 by depressing the quick-release button 2725. -
FIG. 43-6 illustrates an alternative embodiment of asupport 2720B provided to the mask frame. As illustrated, a quick-release detail is integrally molded with the frame to retain theknob 2750. Specifically, upper andlower protrusions 2723B (only lower protrusions visible) are provided to engage theknob 2750, and theknob 2750 may be released by squeezing the sides of thesupport 2720B. - The
adjustment knob 2750 includes internal threads and receives the threadedslider 2722 of theforehead cushion support 2753 therein such that the internal threads of theknob 2750 are intermeshed with the threadedslider 2722. - As best shown in
FIGS. 43-1 , 43-2, 43-17, 43-18, and 43-20, the threadedslider 2722 includes a non-circular outer profile or exterior surface (i.e., flats at the top and bottom thereof) that is adapted to extend through anon-circular opening 2745 provided to thesupport 2720 to prevent theslider 2722 and hence theforehead cushion support 2753 from twisting or rotating relative to theframe 2712. Also, theresilient tab 2787 of theforehead cushion support 2753 engages theopening 2745 with a snap-fit, and may be quickly released from thesupport 2720 by depressing thetab 2787. - When the
knob 2750 is rotated, the threadedslider 2722 extends or retracts from the internally threadedknob 2750 which causes adjustable movement of the forehead cushions. - As shown in
FIG. 43-2 , aridge 2792 is integrally molded inside theopening 2745 of thesupport 2720. Theridge 2792 engages the recessedslots 2785 provided at the bottom of the slider 2722 (seeFIG. 42-1 and 42-8) to provide indexed tactile feedback on adjustment position. As theknob 2750 is rotated, theridge 2792 ratchets or clicks against theslots 2785. -
FIGS. 43-1 to 43-5 are exploded views of theforehead support 10S,FIGS. 43-7 to 43-11 are partial assembled views of theforehead cushion support 2753 engaged with thesupport 2720,FIGS. 43-12 to 43-16 are assembled views of theforehead support 10S, andFIGS. 43-17 to 43-21 are isolated views of theframe 2712. -
FIGS. 44-1 to 44-8 illustrate aforehead cushion support 2853 for a forehead support according to an embodiment of the present invention. Theforehead cushion support 2853 is adapted for use with a forehead cushion such as those described above, e.g. seeforehead cushion 1752 inFIG. 32-6 . - As illustrated, the
forehead cushion support 2853 includes foreheadcushion support plates 2851 and a tube orslider 2822 joined to thesupport plates 2851. Thesupport plates 2851 extend generally transversely relative to theslider 2822 and thus define a general T-shaped support. - The
slider 2822 includes integrally molded 3-lug female threads (for better moldability). Only a 3-lug thread form is needed to engage the mating male thread provided on the adjustment knob (described below). However, other thread forms are possible. The female or internally threadedslider 2822 has flats at the top and bottom thereof (seeFIG. 44-1 and 44-5) to improve moldability and to provide keyed assembly with the mask frame (to prevent rotation). Also, recessed slots 2885 (of varying width and depth) are provided at the top of theslider 2822 to provide indexed and visual feedback on adjustment position. In addition,resilient tabs 2887 are provided to the top and bottom of theslider 2822 to provide quick-release assembly to the mask frame. Theresilient tabs 2887 prevent theforehead cushion support 2853 from falling out of the frame when fully extended. The presence of the threadedshaft 2854 of the adjustment knob 2850 (see FIGS. 4501 to 45-19 below) prevents theresilient tabs 2887 from deflecting. - Each
support plate 2851 has a generallycircular attachment recess 2855 to receive a respective attachment head of the forehead cushion, e.g., formed of flexible silicone, so as to physically attach the forehead cushion to thesupport plates 2851. In use, theslider 2822 is extended or retracted with respect to the mask frame which causes adjustable movement of the forehead cushion. - The forehead
cushion support plates 2851 include integrally moldedslots 2858 for engaging headgear straps. -
FIGS. 45-1 to 45-19 illustrate aforehead support 10T according to another embodiment of the present invention. In this embodiment, theforehead support 10T incorporates theforehead cushion support 2853 described above inFIGS. 44-1 to 44-8, and uses a screw-type actuator to move theforehead cushion support 2853 along a generally linear path. - As illustrated, the
forehead support 10T includes asupport 2820 provided to themask frame 2812 for supporting anadjustment knob 2850. Theadjustment knob 2850 clips onto thesupport 2820 with a snap-fit. Specifically, theadjustment knob 2850 includes multipleresilient arm members 2835, e.g., six finger quick-release feature, integrally molded therewith. When theadjustment knob 2850 is assembled to thesupport 2820, theresilient arm members 2835 snap into the support 2820 (seeFIGS. 45-15 to 45-19). - As illustrated, a threaded
shaft 2854 is provided to theadjustment knob 2850. In the illustrated embodiment, the threadedshaft 2854 and theadjustment knob 2850 are integrally formed, e.g., integrally molded, as a one-piece structure. However, theadjustment knob 2850 and the threadedshaft 2854 may be constructed in two parts and permanently or semi-permanently assembled, e.g., by an adhesive. For example,FIGS. 45-4 to 45-6 illustrate a twopart knob 2850 and threadedshaft 2854 for improved moldability. As shown inFIG. 45-6 , the male threadedshaft 2854 includes a three-start design and features three flats (i.e., trilobial cross-section) for improved moldability. - The threaded
shaft 2854 engages within the internally threadedslider 2822 of theforehead cushion support 2853 such that the threadedshaft 2854 is intermeshed with the internally threadedslider 2822. - The internally threaded
slider 2822 includes a non-circular outer profile or exterior surface (i.e., flats at the top and bottom thereof) that is adapted to extend through anon-circular opening 2845 or key feature (seeFIG. 45-2 ) provided to thesupport 2820 to prevent theslider 2822 and hence theforehead cushion support 2853 from twisting or rotating relative to theframe 2812. Also, theresilient tabs 2887 of theforehead cushion support 2853 engage theopening 2845 with a snap-fit to provide quick-release assembly. - When the
knob 2850 is rotated, the internally threadedtube 2822 extends or retracts from the threadedshaft 2854 provided to theknob 2850 which causes adjustable movement of the forehead cushions. -
FIG. 45-3 illustrates an alternative embodiment of asupport 2820B provided to the mask frame. As illustrated,ridges 2823B are integrally molded inside theopening 2845B to retain thearm members 2835 of theadjustment knob 2850. Also, aridge 2823C is integrally molded inside theopening 2845B to provide indexed incremental adjustment of the forehead support and to provide tactile feedback. The ridge or ratchet 2823C will act against thegrooves 2827 between theresilient arm members 2835 of theadjustment knob 2850 to provide indexed incremental adjustment of the forehead support and to provide tactile feedback. -
FIGS. 45-1 , 45-2, and 45-7 to 45-9 are exploded views of theforehead support 10T,FIGS. 45-10 to 45-14 are partial assembled views of theforehead cushion support 2853 engaged with thesupport 2820, andFIGS. 45-15 to 45-19 are assembled views of theforehead support 10T. -
FIGS. 46-1 to 46-16 illustrate aforehead support 10U according to another embodiment of the present invention. In this embodiment, theforehead support 10U uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the
forehead support 10U includes asupport 2920 provided to themask frame 2912 for supporting anadjustment knob 2950. Theadjustment knob 2950 includes a threadedshaft 2954 that extends through thesupport 2920. The threadedshaft 2954 engages within an internally threadedtube 2922 such that the threadedshaft 2954 is intermeshed with the internally threadedtube 2922. The internally threadedtube 2922 is joined to foreheadcushion support plates 2951 that carry forehead cushions. - When the
knob 2950 is rotated, the internally threadedtube 2922 extends or retracts from the threadedshaft 2954 which causes adjustable movement of the forehead cushions. - The internally threaded
tube 2922 has flats at the top and bottom thereof to improve moldability and to provide keyed assembly with the mask frame (to prevent rotation). The internally threadedtube 2922 is adapted to extend through anon-circular opening 2945 or key feature (seeFIG. 46-1 ) provided to thesupport 2920 to prevent thetube 2922 and hence the forehead cushions from twisting or rotating relative to theframe 2912. In addition, resilient tabs 2987 (seeFIGS. 46-1 and 46-2) are provided to the top and bottom of thetube 2922 to provide quick-release assembly to the mask frame. - In the illustrated embodiment, the
knob 2950 has a male threadedshaft 2954 with a three-start design and features three flats (i.e., trilobial cross-section) for improved moldability (seeFIG. 46-6 ). In an embodiment, thehead 2947 andshaft 2954 of theknob 2950 are integrally molded in one piece to simplify tooling. - The
head 2947 of theknob 2950 clips onto thesupport 2920 with a snap-fit. As shown inFIG. 46-5 , thehead 2947 of theknob 2950 is slotted so it can be squeezed for disassembly from thesupport 2920. -
FIGS. 46-1 to 46-5 are exploded views of theforehead support 10U,FIGS. 46-7 to 46-11 are partial assembled views of the forehead cushion support engaged with thesupport 2920, andFIGS. 46-12 to 46-16 are assembled views of theforehead support 10U. -
FIGS. 47-1 to 47-16 illustrate aforehead support 10V according to another embodiment of the present invention. In this embodiment, theforehead support 10V uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the
forehead support 10V includes asupport 3020 provided to themask frame 3012 for supporting an adjustment knob ordial 3050. Theadjustment dial 3050 includes internal threads (female threads) and is trapped between the frame geometry. A threadedshaft 3022 extends through thesupport 3020 and theadjustment dial 3050 such that the internal threads of theadjustment dial 3050 are intermeshed with the threadedshaft 3022. The threadedshaft 3022 is joined to foreheadcushion support plates 3051 that carry forehead cushions. - When the
adjustment dial 3050 is rotated, the threadedshaft 3022 extends or retracts from theadjustment dial 3050 which causes adjustable movement of the forehead cushions. - The threaded
shaft 3022 has flats on both sides thereof to improve moldability and to provide keyed assembly with the mask frame (to prevent rotation). The threadedshaft 3022 includeselongated slots 3087 that receiverespective protrusions 3089 provided to thesupport 3020. Theprotrusions 3089 are integrally molded with thesupport 3020 and provide a key feature to prevent rotation of the forehead cushion support. - In the illustrated embodiment, the threaded
shaft 3022 has a three-start design and features two flats for improved moldability (seeFIG. 47-3 ). -
FIGS. 47-1 , 47-2, and 47-4 to 47-6 are exploded views of theforehead support 10V,FIGS. 47-7 to 47-11 are partial assembled views of theadjustment dial 3050 engaged with thesupport 3020, andFIGS. 47-12 to 47-16 are assembled views of theforehead support 10V. -
FIGS. 48-1 to 48-16 illustrate aforehead support 10W according to another embodiment of the present invention. In this embodiment, theforehead support 10W uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the
forehead support 10W includes asupport 3120 provided to themask frame 3112 for supporting an adjustment knob ordial 3150. Theadjustment dial 3150 includes internal threads (female threads) and is attached to the front of thesupport 3120, e.g., with a snap-fit. A threadedshaft 3122 extends through theadjustment dial 3150 and into thesupport 3120 such that the internal threads of theadjustment dial 3150 are intermeshed with the threadedshaft 3122. The threadedshaft 3122 is joined to foreheadcushion support plates 3151 that carry forehead cushions. - When the
adjustment dial 3150 is rotated, the threadedshaft 3122 extends or retracts from theadjustment dial 3150 which causes adjustable movement of the forehead cushions. - The threaded
shaft 3122 has flats on both sides thereof to improve moldability and to provide keyed assembly with the mask frame (to prevent rotation). The interior of thesupport 3120 may include integrally molded key features to prevent rotation of the forehead cushion support in use. - In the illustrated embodiment, the threaded
shaft 3122 has a three-start design and features two flats for improved moldability (seeFIG. 48-3 ). -
FIGS. 48-1 , 48-2, and 48-4 to 48-6 are exploded views of theforehead support 10W,FIGS. 48-7 to 48-11 are partial assembled views of theadjustment dial 3150 engaged with thesupport 3120, andFIGS. 48-12 to 48-16 are assembled views of theforehead support 10W. -
FIGS. 49-1 to 49-16 illustrate aforehead support 10X according to another embodiment of the present invention. In this embodiment, theforehead support 10X uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the
forehead support 10X includes asupport 3220 provided to themask frame 3212 for supporting an adjustment knob ordial 3250. Theadjustment dial 3250 includes internal threads (female threads) and is attached to a front of thesupport 3220. In the illustrated embodiment, thesupport 3220 includes anannular ring 3221 that engages anannular channel 3223 integrally molded with thedial 3250 to retain thedial 3250 on thesupport 3220. - A threaded
shaft 3222 extends through thesupport 3220 andadjustment dial 3250 such that the internal threads of theadjustment dial 3250 are intermeshed with the threadedshaft 3222. The threadedshaft 3222 is joined to foreheadcushion support plates 3251 that carry forehead cushions. - When the
adjustment dial 3250 is rotated, the threadedshaft 3222 extends or retracts from theadjustment dial 3250 which causes adjustable movement of the forehead cushions. - The threaded
shaft 3222 has flats on both sides thereof to improve moldability and to provide keyed assembly with the mask frame (to prevent rotation). The threadedshaft 3222 is adapted to extend through anon-circular opening 3245 or key feature (seeFIG. 49-1 ) provided to thesupport 3220 to prevent thetube 3222 and hence the forehead cushions from twisting or rotating relative to theframe 3212. - In the illustrated embodiment, the threaded
shaft 3222 has a single-start design and features two flats for improved moldability (seeFIG. 49-3 ). -
FIGS. 49-1 , 49-2, and 49-4 to 49-6 are exploded views of theforehead support 10X,FIGS. 49-7 to 49-11 are partial assembled views of the forehead cushion support engaged with thesupport 3220, andFIGS. 49-12 to 49-16 are assembled views of theforehead support 10X. -
FIGS. 50-1 to 50-15 illustrate aforehead support 10Y according to another embodiment of the present invention. In this embodiment, theforehead support 10Y uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the
forehead support 10Y includes asupport 3320 provided to themask frame 3312 for supporting an adjustment knob ordial 3350. Theadjustment dial 3350 includes internal threads (female threads) and is retained to thesupport 3320 by aremovable locking ring 3390. In the illustrated embodiment, thelocking ring 3390 engages thesupport 3320 with a snap-fit and includes anannular channel 3321 that engages anannular ring 3323 integrally molded with thedial 3350 to retain thedial 3350 on thesupport 3320. - A threaded
shaft 3322 extends through theadjustment dial 3350 such that the internal threads of theadjustment dial 3350 are intermeshed with the threadedshaft 3322. The threadedshaft 3322 is joined to foreheadcushion support plates 3351 that carry forehead cushions. - When the
adjustment dial 3350 is rotated, the threadedshaft 3322 extends or retracts from theadjustment dial 3350 which causes adjustable movement of the forehead cushions. - The threaded
shaft 3322 has flats on both sides thereof to improve moldability and to provide keyed assembly with the mask frame (to prevent rotation). The threadedshaft 3322 is adapted to extend through anon-circular opening 3345 or key feature (seeFIG. 50-2 ) provided to thelocking ring 3390 to prevent thetube 3322 and hence the forehead cushions from twisting or rotating relative to theframe 3312. This embodiment has similar benefits to the fifteenth illustrated embodiment of theforehead support 10P. That is,forehead support 10Y maintains the forehead support position as the subassembly may be removed as one piece once thelocking ring 3390 is removed. - In the illustrated embodiment, the threaded
shaft 3322 passes through theadjustment dial 3350 to reduce the overall visual length and bulk of the assembly (seeFIG. 50-11 to 50-15). -
FIGS. 50-1 to 50-5 are exploded views of theforehead support 10Y,FIGS. 50-6 to 50-10 are partial assembled views of the forehead cushion support engaged with theadjustment dial 3350, andFIGS. 50-11 to 50-15 are assembled views of theforehead support 10Y. -
FIGS. 51-1 to 51-24 illustrate a forehead support 10Z according to another embodiment of the present invention. In this embodiment, the forehead support 10Z uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the forehead support 10Z includes a
support 3420 provided to themask frame 3412 for supporting anadjustment knob 3450. Theadjustment knob 3450 clips onto thesupport 3420 with a snap-fit. Specifically, the front of thesupport 3420 includes aresilient arm member 3421 that provides afirst protrusion 3423 on a free end thereof, and asecond protrusion 3427 opposite thefirst protrusion 3423. Theadjustment knob 3450 includes anannular groove 3455. When theadjustment knob 3450 is assembled to thesupport 3420, theresilient arm member 3421 deflects outwardly until the first andsecond protrusions groove 3455. - The
adjustment knob 3450 includes internal threads and receives a threadedinsert 3490 provided to theforehead cushion support 3453 such that the internal threads of theknob 3450 are intermeshed with the threadedinsert 3490. Specifically, theforehead cushion support 3453 includes ashaft 3422 that is joined to foreheadcushion support plates 3451 that carry forehead cushions. The threadedinsert 3490 is attached to theshaft 3422, e.g., with a snap-fit. When theadjustment knob 3450 is rotated, the threadedinsert 3490 extends or retracts from theadjustment knob 3450 which causes adjustable movement of the forehead cushions. - The threaded
insert 3490 has flats on both sides thereof to improve moldability and to provide keyed assembly with the mask frame (to prevent rotation). The threadedinsert 3490 is adapted to extend through anon-circular opening 3445 or key feature (seeFIG. 51-1 and 51-2) integrally molded with thesupport 3420 to prevent theinsert 3490 and hence theforehead cushion support 3453 from twisting or rotating relative to theframe 3412. - In the illustrated embodiment, the threaded
insert 3490 has a single-start design and features two flats for improved moldability (seeFIG. 51-3 ). - As shown in
FIG. 51-22 , the threadedinsert 3490 may be rotated for positioning in two ways, i.e.,orientation 1 ororientation 2, onto theshaft 3422 of theforehead cushion support 3453 to change the limit of travel of theforehead cushion support 3453.Orientation 1 provides a lower limit of travel L1 (seeFIG. 51-23 ), andorientation 2 provides an upper limit of travel L2 (seeFIG. 51-24 ). In an embodiment,orientation 1 may be designed to cater to the majority of the patient population, and may be minimal in its aesthetic bulk. -
FIGS. 51-1 , 51-2, and 51-4 to 51-6 are exploded views of the forehead support 10Z,FIGS. 51-7 to 51-11 are partial assembled views of the forehead cushion support engaged with the threadedinsert 3490,FIGS. 51-12 to 51-16 are partial assembled views of the forehead cushion support and insert 3490 engaged with thesupport 3420, andFIGS. 51-17 to 51-21 are assembled views of the forehead support 10Z. -
FIGS. 52-1 and 52-2 illustrate forehead cushion supports 3553A and 3553B for a forehead support according to alternative embodiments of the present invention. The forehead cushion supports 3553A and 3553B are adapted for use with a forehead cushion such as those described above, e.g. seeforehead cushion 1752 inFIG. 32-6 . - As illustrated, each
forehead cushion support cushion support plates 3551 and a tube orslider 3522 joined to thesupport plates 3551. Thesupport plates 3551 extend generally transversely relative to theslider 3522 and thus define a general T-shaped support. - The forehead
cushion support plates 3551 of theforehead cushion support 3553A include integrally moldedslots 3558 for engaging headgear straps, and the foreheadcushion support plates 3551 of theforehead cushion support 3553B include clip receiving structures orclip receptacles 3590 for engaging headgear clips associated with headgear straps. - Also, each
forehead cushion support more ribs 3580 on theslider 3522 to ensure correct orientation on assembly and to prevent rotation of each forehead cushion support in use, especially at maximum extension. As illustrated, theslider 3522 of theforehead cushion support 3553A includes tworibs 3580 on a bottom thereof, and theslider 3522 of theforehead cushion support 3553B includes arib 3580 on at least one side thereof. However, other rib arrangements are possible. -
FIGS. 53-1 to 53-5 illustrate forehead cushion supports 3653 for a forehead support according to another embodiment of the present invention. Theforehead cushion support 3653 is adapted for use with a forehead cushion such as those described above, e.g. seeforehead cushion 1752 inFIG. 32-6 . - As illustrated, the
forehead cushion support 3653 includes foreheadcushion support plates 3651 and a tube orslider 3622 joined to thesupport plates 3651. Thesupport plates 3651 extend generally transversely relative to theslider 3622 and thus define a general T-shaped support. - The forehead
cushion support plates 3651 include integrally moldedslots 3658 for engaging headgear straps. As illustrated, the bottom of theslots 3658 are open. This arrangement allows headgear straps to be inserted and removed via the open end of theslots 3658 without the need for releasing or undoing an attachment structure, e.g., Velcro® tabs, at the end of the headgear straps. Therefore, it is not necessary to adjust headgear fit each time the mask is worn. The open slots or slottedholes 3658 negate the need for quick-release headgear clips on theforehead cushion support 3653, thereby minimizing the overall width of theforehead cushion support 3653. -
FIGS. 54-1 to 54-5 illustrate forehead cushion supports 3753 for a forehead support according to another embodiment of the present invention. Theforehead cushion support 3753 is adapted for use with a forehead cushion such as those described above, e.g. seeforehead cushion 1752 inFIG. 32-6 . - As illustrated, the
forehead cushion support 3753 includes foreheadcushion support plates 3751 and a tube orslider 3722 joined to thesupport plates 3751. Thesupport plates 3751 extend generally transversely relative to theslider 3722 and thus define a general T-shaped support. - The forehead
cushion support plates 3751 include integrally moldedslots 3758 with cross-bars 3759 for engaging headgear straps. As illustrated, the top of theslots 3758 are open. This arrangement allows headgear straps to be inserted onto and removed off thecross-bars 3759 via the open end of theslots 3758 without the need for releasing or undoing an attachment structure, e.g., Velcro® tabs, at the end of the headgear straps. Therefore, it is not necessary to adjust headgear fit each time the mask is worn. The open slots or slottedholes 3758 negate the need for quick-release headgear clips on theforehead cushion support 3753, thereby minimizing the overall width of theforehead cushion support 3753. -
FIGS. 55-1 and 55-2 illustrate a forehead support 10AA according to another embodiment of the present invention. In this embodiment, the forehead support 10AA uses a rack and pinion type actuator to move or adjust the forehead support along a generally linear path. - As illustrated, the forehead support 10AA includes a
support 3820 provided to themask frame 3812 for supporting an adjustment knob ordial 3850. Theadjustment dial 3850 is removably positioned into an opening provided on top of thesupport 3820 with a snap-fit. Theadjustment dial 3850 includes agear 3854 and adjustment heads 3856 on both sides of thegear 3854. This arrangement allows adjustment of thegear 3854 from both sides of thesupport 3820 to cater to both left and right hand use. - The
forehead cushion support 3853 includes agear rack 3830 that extends through thesupport 3820 such that thegear 3854 of thedial 3850 is intermeshed with thegear rack 3830. Thegear rack 3830 is joined to foreheadcushion support plates 3851 that carry forehead cushions. When theadjustment dial 3850 is rotated, thegear rack 3830 extends or retracts from theadjustment dial 3850 which causes adjustable movement of the forehead cushions. - Locking of the
forehead cushion support 3853 into a desired position may be achieved by friction between thegear 3854 and thegear rack 3830 and/or by other mechanical means. -
FIGS. 56-1 to 56-3 illustrate a forehead support 10BB according to another embodiment of the present invention. In this embodiment, the forehead support 10BB uses a screw-type actuator to move the forehead support along a generally linear path. - As illustrated, the forehead support 10BB includes a
support 3920 provided to themask frame 3912 for supporting anadjustment dial 3950. Theadjustment dial 3950 includes a threadedshaft 3954 that extends through thesupport 3920. The threadedshaft 3954 threadably engages an intermediate threaded tube orscrew nut 3956. Theintermediate tube 3956 is internally and externally threaded. The threadedshaft 3954 engages the internal threads of theintermediate tube 3956. The external threads of theintermediate tube 3956 engage an internally threadedtube 3922 that is joined to foreheadcushion support plates 3951 that carry forehead cushions. - This arrangement provides telescopic forehead support adjustment. Specifically, the threaded
tube 3922 andintermediate tube 3956 provide a linear two-stage screw mechanism. In use, the threadedshaft 3954 of theadjustment dial 3950 drives theintermediate tube 3956 which when fully extended will in turn engage the threadedtube 3922 of theforehead cushion support 3953. The telescopic design allows the overall length of the forehead support mechanism (and hence the visual bulk) to be further reduced. - Although a two-stage telescopic arrangement is illustrated, other multiple stage, e.g., greater than two-stage, telescopic arrangements are possible.
-
FIGS. 57-1 to 57-15 illustrate a forehead support 10CC according to another embodiment of the present invention. In this embodiment, the forehead support 10CC uses a screw-type actuator to move the forehead support along a generally linear path. - Similar to the embodiment of
FIGS. 37-1 to 37-15, the forehead support 10CC includes an adjustment knob 4050 (seeFIGS. 57-12 to 57-15) with anon-circular opening 4055, e.g., generally hexagonal, that engages anon-circular head 4057, e.g., generally hexagonal, provided to a threaded shaft 4054 (seeFIGS. 57-5 to 57-11). This interlocks theknob 4050 and threadedshaft 4054 and prevents relative movement. Theadjustment knob 4050 clips onto thesupport 4020 offrame 4012 with a snap-fit, and the threadedshaft 4054 engages within an internally threaded tube of aforehead cushion support 4053. When theknob 4050 is rotated, theforehead cushion support 4053 extends or retracts with respect to theframe 4012. - In each of the above embodiments, the forehead support may or may not include headgear clip receptacles for engaging headgear clips associated with headgear straps. The forehead supports may include other suitable structures for engaging headgear straps, e.g., slots.
- The forehead supports and/or forehead support cushions described above may be used on different masks, and accordingly the amount of travel of the adjustment mechanism may be altered depending on the mask configuration.
- In each of the above embodiments, one method of fitting the FMA to a patient may include starting with the forehead support “tightened”, i.e., forehead cushions compressed against the patient, and then moving the forehead support outwardly from the patient to achieve patient comfort while maintaining a seal. However, the FMA may be fit to a patient in other suitable manners.
- 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. 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, bariatric surgery, etc.) can derive benefit from the above teachings. Moreover, the above teachings have applicability with patients and non-patients alike.
Claims (89)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US11/793,055 US20100071700A2 (en) | 2005-01-12 | 2006-01-12 | Forehead supports for facial masks |
Applications Claiming Priority (6)
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US73582305P | 2005-11-14 | 2005-11-14 | |
PCT/AU2006/000037 WO2006074517A1 (en) | 2005-01-12 | 2006-01-12 | Forehead supports for facial masks |
US11/793,055 US20100071700A2 (en) | 2005-01-12 | 2006-01-12 | Forehead supports for facial masks |
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PCT/AU2006/000037 A-371-Of-International WO2006074517A1 (en) | 2005-01-12 | 2006-01-12 | Forehead supports for facial masks |
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US13/920,834 Active 2028-05-01 US10076627B2 (en) | 2005-01-12 | 2013-06-18 | Forehead supports for facial masks |
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US (2) | US20100071700A2 (en) |
EP (5) | EP2786775A3 (en) |
JP (1) | JP5213455B2 (en) |
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AU (1) | AU2006206044B2 (en) |
DE (5) | DE202006021247U1 (en) |
ES (1) | ES2572167T3 (en) |
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- 2006-01-12 JP JP2007550640A patent/JP5213455B2/en not_active Expired - Fee Related
- 2006-01-12 EP EP14175767.4A patent/EP2789360B1/en not_active Not-in-force
- 2006-01-12 US US11/793,055 patent/US20100071700A2/en not_active Abandoned
- 2006-01-12 EP EP14175778.1A patent/EP2786776A3/en not_active Withdrawn
- 2006-01-12 CN CN201210377725.3A patent/CN103007406B/en not_active Expired - Fee Related
- 2006-01-12 WO PCT/AU2006/000037 patent/WO2006074517A1/en active Application Filing
- 2006-01-12 EP EP14175770.8A patent/EP2789361A3/en not_active Withdrawn
- 2006-01-12 NZ NZ592219A patent/NZ592219A/en not_active Application Discontinuation
- 2006-01-12 DE DE202006021261.2U patent/DE202006021261U1/en not_active Expired - Lifetime
- 2006-01-12 CN CN201010508994XA patent/CN101947345B/en not_active Expired - Fee Related
- 2006-01-12 AU AU2006206044A patent/AU2006206044B2/en not_active Ceased
- 2006-01-12 DE DE202006021250.7U patent/DE202006021250U1/en not_active Expired - Lifetime
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- 2006-01-12 ES ES06704773T patent/ES2572167T3/en active Active
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2013
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