Patent Abstract:
According to one embodiment, an apparatus for coupling an oral appliance to a gas delivery device includes a post, a swivel, and first and second opposing clamps. The post includes a base configured to couple to the oral appliance; a first arm extending from the base and defining a channel extending along a portion of the first arm; and a second arm extending from the base, extending substantially parallel to the first arm, the second arm defining a channel extending along a portion of the second arm. The swivel is substantially spherical and is configured to position the gas delivery device. The first clamp is configured to engage and slide along the channel defined by the first arm and the second clamp is configured to engage and slide along the channel defined by the second arm. The first and second opposing clamps are together configured to position and secure the location and orientation of the swivel relative to the post.

Full Description:
RELATED APPLICATIONS 
       [0001]    This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application Ser. No. 61/156,323 filed Feb. 27, 2009. 
     
    
     TECHNICAL FIELD OF THE INVENTION 
       [0002]    This disclosure relates generally to oral appliances, and more particularly to an apparatus and method for coupling an oral appliance to a gas delivery device. 
       BACKGROUND OF THE INVENTION 
       [0003]    Many people experience breathing problems, which may result in difficulty sleeping, in snoring, or in other more serious conditions such as obstructive sleep apnea. One treatment for such breathing disorders involves the use of devices that are inserted into a user&#39;s mouth for extending the user&#39;s lower jaw forward. These devices open the airway (i.e., breathing passageway) more fully to allow easier breathing through the nose and mouth. Certain of these devices include upper and lower arches that are connected together using a mechanism that may be adjusted to pull the lower arch, and thus the user&#39;s lower jaw, forward to open the airway more fully. Certain devices include masks that deliver air, oxygen, or other gases to a user through their mouth and/or nasal passages. 
       SUMMARY OF THE INVENTION 
       [0004]    According to one embodiment, an apparatus for improved breathing includes an oral appliance, a gas delivery device, and a coupler. The gas delivery device is configured to direct gas to the breathing passages of a user. The coupler includes a swivel, a clamp, and a post with two arms. The clamp is configured to engage the post and to slide along the length of the post. The clamp is also configured to position and secure the swivel to define its position and orientation relative to the post. The gas delivery device is coupled to the oral appliance utilizing the swivel. 
         [0005]    According to one embodiment, an apparatus for coupling an oral appliance to a gas delivery device includes a post, a swivel, and first and second opposing clamps. The post includes a base configured to couple to the oral appliance; a first arm extending from the base and defining a channel extending along a portion of the first arm; and a second arm extending from the base, extending substantially parallel to the first arm, the second arm defining a channel extending along a portion of the second arm. The swivel is substantially spherical and is configured to position the gas delivery device. The first clamp is configured to engage and slide along the channel defined by the first arm and the second clamp is configured to engage and slide along the channel defined by the second arm. The first and second opposing clamps are together configured to position and secure the location and orientation of the swivel relative to the post. In certain embodiments, the first and second opposing clamps may include protrusions shaped to engage and slide along the channels defined by the first and second arms. 
         [0006]    According to one embodiment, a method for coupling an oral appliance to a gas delivery device includes coupling the gas delivery device to the oral appliance using a coupler. The coupler includes a post, a first clamp, a second clamp, and a substantially spherical swivel. The post includes a base, a first arm extending from the base, a second arm extending from the base. The first arm defines a first channel extending along a portion of the first arm. The second arm extends substantially parallel to the first arm and defines a second channel extending along a portion of the second arm. The first clamp is configured to engage and slide along the first channel and the second clamp is configured to engage and slide along the second channel. The method includes positioning the gas delivery device relative to the oral appliance. Positioning the gas delivery device includes adjusting the location of the gas delivery device along the first and second channels utilizing the first and second clamps. Positioning the gas delivery device also includes adjusting the orientation of the gas delivery device utilizing the swivel. The method further includes securing the position of the gas delivery device relative to the oral appliance utilizing the first and second clamps. 
         [0007]    Certain embodiments of the present invention may provide one or more technical advantages For example, certain embodiments may provide for precise positioning of a gas delivery device. As another example, certain embodiments may provide for coupling a gas delivery device to an oral appliance in a manner that allows for positioning of the gas delivery device as well as adjustment of the oral appliance. Certain embodiments may provide some, none, or all of these advantages. Certain embodiments may provide one or more other technical advantages, one or more of which may be readily apparent to those skilled in the art from the figures, description, and claims included herein. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]    Reference is now made to the following description taken in conjunction with the accompanying drawings, wherein like reference numbers represent like parts, in which: 
           [0009]      FIG. 1  illustrates an example oral appliance for improving a user&#39;s breathing; 
           [0010]      FIGS. 2A through 5B  illustrate an example adjustment mechanism; 
           [0011]      FIGS. 6A through 6C  illustrate example hooks with varying lengths, for use with an example adjustment mechanism; 
           [0012]      FIGS. 7A through 7C  illustrate example receivers with varying dimensions; 
           [0013]      FIGS. 8A through 10  illustrate an example adjustment mechanism utilizing an example extender; 
           [0014]      FIGS. 11A and 11B  illustrate an example extender; 
           [0015]      FIGS. 12A and 12B  illustrate example receivers; 
           [0016]      FIGS. 13 through 16  illustrate an example adjustment mechanism utilizing an example adjustment key; 
           [0017]      FIGS. 17 through 19B  illustrate an example adjustment mechanism utilizing an example extension post; 
           [0018]      FIGS. 20A through 20B  illustrate transverse cross-sectional views of example extension posts; and 
           [0019]      FIGS. 21 through 23  illustrate an example housing, for use with an example adjustment mechanism; 
           [0020]      FIGS. 24A through 25C  illustrate example receivers, for use with an example housing; 
           [0021]      FIG. 26  illustrates an example coupler, an example gas delivery device, and an example body; 
           [0022]      FIGS. 27A-D  illustrate various examples of a post; 
           [0023]      FIGS. 28A-29D  illustrate example clamps, for use with an example post; 
           [0024]      FIGS. 30A-D  illustrate examples of a swivel, for use with an example post; 
           [0025]      FIGS. 31A-B  illustrate examples of a post, for use with an example oral appliance; 
           [0026]      FIG. 32  illustrates an example method of improving a user&#39;s breathing; and 
           [0027]      FIG. 33  illustrates an example method of coupling a gas delivery device and an oral appliance. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0028]      FIG. 1  illustrates an example oral appliance  100  coupled to an example gas delivery device  110 . In general, oral appliance  100  may be used to treat sleep disordered breathing, such as snoring or obstructive sleep apnea, through forward adjustment of the user&#39;s lower jaw relative to the upper jaw. This forward adjustment opens the breathing passage more fully and facilitates improved breathing through the user&#39;s nose and mouth. In certain embodiments, oral appliance  100  remains entirely within the user&#39;s mouth and surfaces of oral appliance  100  that may contact the interior of the user&#39;s mouth are smooth to prevent injury or discomfort. Although not intended to be exclusive, example oral appliances are described in one or more of U.S. Pat. Nos. 5,427,117; 5,566,683; 5,755,219; 6,516,805; 5,954,048; 5,983,892; 6,374,824; 6,325,064; 6,247,926; and 6,405,729 each of which is incorporated herein by reference. 
         [0029]    Oral appliance  100  includes an upper arch  102  configured to receive at least some of a user&#39;s upper teeth, a lower arch  104  configured to receive at least some of the user&#39;s lower teeth, and an adjustment mechanism  10 . Upper arch  102  and lower arch  104  may include molds of at least some of the user&#39;s upper and lower teeth, respectively, for improved performance and comfort. Adjustment mechanism  10  couples lower arch  104  to upper arch  102  and may be adjusted to pull lower arch  104  forward to facilitate improved breathing. In certain embodiments, adjustment mechanism  10  may also vertically position lower arch  104  relative to upper arch  102  to determine the opening of the user&#39;s lower jaw. The components of adjustment mechanism  10  may be made from any suitable material such as, for example, a biocompatible metal or hard plastic. 
         [0030]    Gas delivery device  110  may fit over the patient&#39;s nose and other portions of the patient&#39;s face or may be nasal inserts or nose pillows to direct gas directly into the patient&#39;s nasal passages. Although not intended to be exclusive, example gas delivery devices are described in one or more of U.S. Patent Publication Nos. 2007/0006879; 2008/0006273; and 2008/0060648 each of which is incorporated herein by reference. Gas delivery device  110  may be coupled to a system for providing one or more gases. For example, gas delivery device  110  may be coupled to a positive air pressure device, such as a constant positive air pressure (CPAP) system or bi-level positive air pressure (BiPAP) system. Although CPAP and BiPAP are used as examples, other systems for delivering air or other gases at constant or varying pressure may be used. Such systems may deliver any breathable gas, such as air or oxygen. It should be understood that the term “gas” is intended to include air. 
         [0031]    Coupler  120  may couple oral appliance  100  to gas delivery device  110 . Coupler  120  allows for adjustable movement of gas delivery device  110  relative to oral appliance  100  in multiple directions. In particular embodiments, coupler  120  allows gas delivery device  110  to be adjusted along a substantially anterior-posterior axis and rotated about multiple axes. 
         [0032]      FIGS. 2A through 5B  illustrate an example adjustment mechanism  10  for use with oral appliance  100 . In certain embodiments, adjustment mechanism  10  may include body  12 , hook  28 , adjustor  36 , and receiver  50 . Body  12  may be integrated into or coupled to upper arch  102 . Body  12  may include a rear plate  14 , one or more rear fasteners  16 , a front plate  18 , and one or more front fasteners  20 . In certain embodiments, body  12  may further include one or more fastener passages  22 , one or more guides  32 , and one or more adjustment indicators  44 . Hook  28  may include flange  30 , adjustor passage  34 , and arm  46 . 
         [0033]    When assembled, rear plate  14  may be coupled to body  12  through the use of one or more fasteners  16 . Fasteners  16  may be threaded fasteners, pins, or any other appropriate fastener to couple rear plate  14  to body  12 . Hook  28  may be coupled to body  12  through the use of one or more flanges  30  engaged within the one or more guides  32 . Adjustor  36  may include pin  38  and opening  42 . Opening  42  may be square, hexagonal, or any other appropriate shape to allow for a rotational force to be applied to adjustor  36 . Adjustor  36  may be positioned within adjustor passage  34  of hook  28  and pin  38  may be aligned with and inserted into hole  40  of rear plate  14 . Front plate  18  may be coupled to body  12  through the use of one or more fasteners  20 . Fasteners  20  may include threaded fasteners, pins, or any other appropriate fastener to couple front plate  18  to body  12 . In certain embodiments, front plate  18  may include one or more structures to lock or secure one or more fasteners  20 . For example, in embodiments utilizing a threaded fastener  20  as shown, front plate  18  may include one or more grooves and associated projections  26  to better secure fastener  20  in place. 
         [0034]    In certain embodiments, front plate  18  may include an opening  19  that substantially aligns with opening  42  of adjustor  36 . In operation, opening  19  may provide access to opening  42  of adjustor  36  for locational adjustment of hook  28 . In certain embodiments, adjustor  36  may be threaded and may engage cooperative threads of adjustor passage  34  of hook  28  such that rotation of adjustor  36  moves hook  28  forward or rearward relative to body  12 . 
         [0035]    Receiver  50  is configured to receive arm  46  of hook  28  such that forward adjustment of hook  28  pulls lower arch  104  forward. Receiver  50  may be fully integrated into, permanently coupled to, or separate and removable from lower arch  104 . In certain embodiments, receiver  50  may include one or more openings  52  that may be used to couple receiver  50  to lower arch  104  through the use of any appropriate fastener. In certain embodiments, receiver  50  may also include slot  48  separating front shelf  54  from rear shelf  56 . In operation, hook  28  may engage either front shelf  54  or rear shelf  56 . In certain embodiments, the use of rear shelf  56  may provide additional extension of lower arch  104  in the forward direction relative to the use of front shelf  54 . 
         [0036]    Receiver  50  may be modified according to particular needs to provide increased flexibility. For example, the vertical location of front shelf  54  and/or rear shelf  56  relative to lower arch  104  may be adjusted or otherwise modified, either during or after initial construction of receiver  50 . As another example, receivers  50  with varying vertical dimensions may be provided, such that the use of a particular receiver  50  may be selected to define a prescribed vertical separation between upper arch  102  and lower arch  104  and thus a prescribed opening of the user&#39;s lower jaw. As another example, the vertical location of front shelf  54  and/or rear shelf  56  may be selected by coupling receiver  50  to lower arch  104  in either of two possible orientations (i.e., with a particular horizontal surface facing up or facing down). As another example, receivers  50  with varying horizontal dimensions may be provided, such that the use of a particular receiver  50  may be selected to define a prescribed forward location (or range of locations) for lower arch  104  relative to upper arch  102 . 
         [0037]    Slot  48  may allow horizontal movement of lower arch  104  relative to upper arch  102  when lower arch  104  is coupled to upper arch  102 . Similarly, the posterior surface of front shelf  54  and/or rear shelf  56  may be shaped to guide the horizontal movement of lower arch  104  relative to upper arch  102  in an arc-shaped or other desirable path. 
         [0038]      FIGS. 6A through 6C  illustrate example hooks  28  with varying lengths, for use with adjustment mechanism  10 . In operation, the use of a particular hook  28  may be selected to define a prescribed vertical separation between upper arch  102  and lower arch  104  and thus a prescribed opening of the user&#39;s lower jaw. For example, in the embodiments shown, the use of hook  28   c  may allow for greater vertical separation between upper arch  102  and lower arch  104  than the vertical separation allowed with the use of hooks  28   a  or  28   b.  In particular embodiments, the use of hooks  28  with varying lengths, together with the use of receivers  50  with varying vertical dimensions, may provide an increased range and/or precision for selection of a prescribed opening of the user&#39;s lower jaw. 
         [0039]      FIGS. 7A through 7C  illustrate example receivers with varying dimensions, for use with adjustment mechanism  10 . In operation, the use of a particular receiver may be selected to define a prescribed forward location (or range of forward locations) for lower arch  104  relative to upper arch  102  and thus a prescribed forward location (or range of forward locations) for the user&#39;s lower jaw. For example, in the embodiments shown, the use of receiver  50   c  may allow for lower arch  104  to be positioned further forward with respect to upper arch  102  than with the use of receivers  50   a  or  50   b.  In particular embodiments, the use of receivers  50  with varying dimensions may provide an increased range and/or precision for adjusting the forward location of lower arch  104  relative to upper arch  102 . 
         [0040]      FIGS. 8A through 10  illustrate an example adjustment mechanism  10  utilizing an example extender  60 . In certain embodiments, extender  60  couples to receiver  50  and operates to receive arm  46  of hook  28  such that the forward positioning of lower arch  104  is greater than that provided without extender  60 . 
         [0041]      FIGS. 11A and 11B  illustrate an example extender  60  for use with an example adjustment mechanism  10 . In certain embodiments, extender  60  may include a shelf  68  that engages arm  46  of hook  28 . In certain embodiments, extender  60  may also include one or more projections  66  that may cooperatively engage slot  48  of receiver  50 . In certain embodiments, extender  60  may also include one or more openings  64  that may cooperate with one or more fasteners  62  to couple extender  60  to receiver  50 , such as via slot  48 . Fastener  62  may be a threaded fastener, pin, or any other appropriate fastener for coupling extender  60  to receiver  50 . 
         [0042]      FIGS. 12A and 12B  illustrate example receivers  50  for use with example adjustment mechanisms  10 . As shown in  FIG. 12A , in certain embodiments, receiver  50  may include only a single shelf  54 , in which case slot  48  may be fully or partially exposed in the rearward direction. As shown in  FIG. 12B , receiver  50  may include notch  70  in slot  48 . In operation, the use of receiver  50  including only a single shelf  54  or including notch  70  may allow hook  28  to engage or disengage from shelf  54  of receiver  50  after oral appliance  100  has been inserted into a user&#39;s mouth. 
         [0043]      FIG. 13  illustrates an example oral appliance  100  with an example adjustment key  80 . Adjustment key  80  may have a cross-section that is hexagonal, square, or any other appropriate shape. In certain embodiments, adjustment key  80  may be used to exert a rotational force on adjustor  36  causing adjustor  36  to turn and thereby provide adjustment of hook  28 , forward or rearward. 
         [0044]      FIGS. 14 through 16  illustrate example adjustment mechanisms  10  utilizing example adjustment keys  80 . In certain embodiments, adjustment key  80  may be coupled to adjustment mechanism  10  through the use of retainer ring  82  and notch  84 . In operation, retainer ring  82  may engage notch  84 , thus preventing removal of adjustment key  80 . In operation, embodiments of adjustment mechanism  10  including adjustment key  80  and retaining ring  82  may be used by a particular user during a trial period for oral appliance  100 . During this trial period, the user and/or a clinician may make periodic adjustments to adjustment mechanism  10  through the use of adjustment key  80  to achieve the desired positioning of lower arch  104  relative to upper arch  102 . In these embodiments, once the desired positioning has been achieved, adjustment key  80  and retaining ring  82  may be removed. In these embodiments, once the desired positioning has been achieved, front plate  18  may be replaced with a front plate  18  that does not include an opening  19 . 
         [0045]      FIGS. 17 through 19B  illustrate an example oral appliance  100  with an example extension post  90 . Extension post  90  may be formed of any suitable material, such as a metal or hard plastic. In certain embodiments, extension post  90  may be used to couple oral appliance  100  to one or more other devices and/or to orient one or more other devices relative to oral appliance  100 . For example, extension post  90  may be used to couple oral appliance  100  to a venting seal or a gas delivery device, such as a face mask or a nose mask. In a particular embodiment, extension post may be used to couple oral appliance  100  to a mask associated with a continuous positive airway pressure (CPAP) system. 
         [0046]    In certain embodiments, extension post  90  may be substantially rigid, to provide for sufficiently precise positioning of one or more devices relative to upper arch  102 . For example, in certain embodiments, extension post  90  may be used to provide substantially precise and repeatable positioning of a face mask or nose mask relative to upper arch  102 . The length of extension post  90  may vary depending upon its intended use. For example, extension post  90  may be substantially shorter if it is intended to be used to couple a venting seal to oral appliance  100  than if it is intended to couple a nose mask to oral appliance  100 . The invention contemplates any reasonable length of extension post  90 , so long as the length is appropriate to perform the intended function. 
         [0047]    In certain embodiments, extension post  90  may include one or more features that can operate to index or assist in securing one or more devices to extension post  90 . For example, as shown in  FIG. 19B , extension post  90  may include one or more locators  92  at one or more positions along the length of extension post  90 . In operation, a device coupled to or guided by extension post  90  may include one or more structures that can cooperate with the one or more locators  92  to index or assist in securing the device. In the embodiment shown, locator  92  is in the form of a notch, however, in alternative embodiments, locator  92  may be in the form of a ridge, protrusion, or any other appropriate shape or structure. In particular embodiments, the position of locator  92  may be adjustable. 
         [0048]    In certain embodiments, extension post  90  may be coupled to front plate  18 . 
         [0049]    In these embodiments, extension post  90  may be coupled through the use of any appropriate means, such as welding or threaded coupling. In alternative embodiments, extension post  90  may be integrally formed with front plate  18 . In certain embodiments, extension post  90  may be substantially hollow and may couple to front plate  18  such that the hollow interior of extension post  90  substantially aligns with an opening  19 . In operation, the hollow portion of extension post  90  may provide access to adjustor  36  through opening  19 . The cross-sectional shape of extension post  90  may take any appropriate form, so long as it remains reasonable for the intended function. 
         [0050]      FIGS. 20A through 20C  illustrate transverse cross-sectional views of example extension posts  90 . As shown, extension post  90  may have a cross sectional shape that is a circle, oval, or diamond. In certain embodiments, non-circular cross-sections may function to more precisely position a device coupled to oral-appliance  100  through the use of extension post  90 , by substantially limiting the likelihood that the device will rotate about the extension post  90 . 
         [0051]    In certain embodiments, receiver  50  may be removable. For example, lower arch  104  may include a recess that allows receiver  50  to be positioned within, and then removed from, lower arch  104 . In embodiments including a removable receiver  50  and a recess in lower arch  104 , the recess may be integrally formed in lower arch  104 . In alternative embodiments, the recess may be formed in or by a housing that is included in lower arch  104 . 
         [0052]      FIGS. 21 through 23  illustrate an example housing  94 , for use with an example adjustment mechanism  10 . In certain embodiments, adjustment mechanism  10  may include housing  94  to position and secure receiver  50 . Housing  94  may be made of any appropriate material, such as metal or hard plastic. In certain embodiments, housing  94  may be integrally formed with lower arch  104 . As shown, housing  94  may define recess  95  to accept receiver  50  within housing  94 . In certain embodiments, housing  94  may include one or more fasteners  96  to secure receiver  50  within recess  95 . In a particular embodiment, fastener  96  may be a threaded set-screw. 
         [0053]    In certain embodiments, housing  94  may include one or more projections  98  that may be used to orient and/or secure housing  94  to lower arch  104 . In particular embodiments, as in the example shown in  FIG. 23 , one or more projections  98  may be used to orient housing  94  to lower arch  104 . In these embodiments, once housing  94  is properly oriented, housing  94  may be luted to (or otherwise secured to) lower arch  104 . In certain embodiments, some or all of projections  98  may be removed before or after housing  94  is completely secured to lower arch  104 . 
         [0054]      FIGS. 24A through 25C  illustrate example receivers  50 , for use with an example housing  94 . As shown, receiver  50  may have varying dimensions and the location of certain features of receiver  50  may vary. In operation, the use of a particular receiver  50  may be selected to define a prescribed forward location (or range of locations) for lower arch  104  relative to upper arch  102 . For example, in the embodiments shown, the use of receiver  50   f  may allow for lower arch  104  to be positioned further forward with respect to upper arch  102  than with the use of receivers  50   d  and  50   e.  In particular embodiments, the use of receivers  50  with varying dimensions may provide an increased range and/or precision for adjusting the forward location of lower arch  104  relative to upper arch  102 . 
         [0055]    As shown in  FIG. 24D , in certain embodiments, receiver  50  may include only a single shelf  54 , in which case slot  48  may be fully or partially exposed in the rearward direction. In operation, the use of receiver  50  including only a single shelf  54  (or including notch  70 ) may allow hook  28  to engage or disengage from shelf  54  of receiver  50  after oral appliance  100  has been inserted into a user&#39;s mouth. 
         [0056]    As shown in  FIGS. 25A through 25C , receiver may have varying vertical dimensions. In operation, the use of a particular receiver  50  may be selected to define a prescribed vertical separation between upper arch  102  and lower arch  104  and thus a prescribed opening of the user&#39;s lower jaw. For example, in the embodiments shown, the use of receiver  50   j  may allow for greater vertical separation between upper arch  102  and lower arch  104  than the vertical separation allowed with the use of receivers  50   h  and  50   i.  In particular embodiments, the use of receivers  50  with varying vertical dimensions may provide an increased range and/or precision for selection of a prescribed opening of the user&#39;s lower jaw. 
         [0057]      FIG. 26  illustrates an example coupler  120 , an example gas delivery device  110 , and example components of oral appliance  100 . In the embodiment shown, coupler  120  includes post  131 , clamps  128 , fasteners  126 , and swivel  122 . 
         [0058]    In the depicted embodiment, post  131  includes base  136  and arms  132  configured such that post  131  is substantially U-shaped. Other suitable shapes may be used in various embodiments. For example, post  131  may be substantially V-shaped.  FIGS. 27A-D  illustrate an example embodiment of post  131 . As shown in  FIG. 27B , arms  132  in the example embodiment extend at a substantially non-perpendicular angle to base  136 . The depicted embodiment in  FIG. 27B  illustrates that angle  137  (relative to plane  138  extending substantially along the mating surface of base  136 ) is formed between the junction of base  136  and arms  132 . The positioning of arms  132  may provide for a variety of suitable configurations for post  131 . In various embodiments, for example, arms  132  may extend at an angle  137  between 60 and 80 degrees. Although any suitable angle  137  may be used, in a particular embodiment, arms  132  may extend substantially perpendicularly from base  136 . In the depicted embodiments, arms  132  include channels  130 . Channels  130  may be smooth as depicted in  FIGS. 26 and 27B . In various embodiments, other suitable shapes may be used. For example, channels  130  may include one or more structures (e.g., notches) to facilitate positioning of clamps  128 . Post  131  may be formed of any suitable material, including suitable plastics or metals as examples. In certain embodiments, post  131  may be formed of 304 stainless steel. 
         [0059]      FIGS. 28A-29D  show several perspectives of one embodiment of clamps  128 . In such embodiments, clamps  128  comprise protrusions  129 . Protrusions  129  may be used to engage channels  130 , as described further below. Protrusions  129  may be configured differently in various embodiments. For example, protrusions  129  may be configured to engage one or more structures in channels  130  to facilitate positioning of clamps  128 . Clamps  128  may also include threaded portions that facilitate advancement along channels  130 . Clamps  128  may be formed of any suitable material, including suitable plastics or metals as examples. In certain embodiments, clamps  128  may be formed of 304 stainless steel. 
         [0060]    In some embodiments, fasteners  126  may be configured in a variety of manners such that fasteners  126  may be suitable for coupling to clamps  128 . Fasteners  126  may be threaded and the heads of fasteners  126  may be square, hexagonal, or any other appropriate shape to allow for a rotational force to be applied in order to secure fasteners  126  to clamps  128 . In some embodiments, fasteners  126  may not be threaded. The ends of fasteners  126  may have notches or other structures that allow fasteners  126  to lock into place with clamps  128 . Fasteners  126  may be formed of any suitable material, including suitable plastics or metals as examples. In certain embodiments, fasteners  126  may be formed of 304 stainless steel. 
         [0061]      FIGS. 30A-D  illustrate various embodiments of swivel  122 . In the depicted embodiments, swivel  122  is substantially spherical and includes opening  123 . In the example of  FIG. 30A , opening  123  is substantially cylindrical while in the example of  FIG. 30B , opening  123  includes a D-shaped passageway that may operate to index or orient gas delivery device  110 . Additionally, the D-shaped passageway may prevent rotation of swivel  122  relative to a post inserted into opening  123 . Other suitable configurations or shapes for opening  123  may be used.  FIG. 30B  illustrates an embodiment of swivel  122  wherein swivel  122  is substantially spherical with a flat top and bottom portion. Swivel  122  may, in various embodiments, take on other shapes, such as being substantially egg-shaped, and may or may not have a flat top and bottom. Swivel  122  may be formed of any suitable material, including suitable plastics or metals as examples. In particular embodiments, swivel  122  may be formed of acrylonitrile butadiene styrene (ABS) plastic or polycarbonate plastic. 
         [0062]    In operation, in various embodiments, coupler  120  may be coupled to body  12  through post  131 . In particular embodiments, base  136  may be fastened to body  12  through fastener passages  22  of body  12  and fastener passages  133  of base  136  using fasteners  20 . Although two threaded fasteners  20  are illustrated, any suitable technique may be used to couple post  131  to oral appliance  100 . For example, post  131  may be integrally formed with one or more components of oral appliance  100 . As another example, pins may be used to couple post  131  to oral appliance  100 . 
         [0063]    Clamps  128  may be used, in some embodiments, to secure swivel  122  to post  131 . Clamps  128  may be configured to slideably engage each arm  132  using channels  130  and protrusions  129 . Clamps  128  may be secured to arms  132  using fasteners  126  that, for example, pass through clamp  128   a,  extend across the gap between arms  132   a  and  132   b,  and terminate at clamp  128   b.  In such a manner, the position of swivel  122  relative to base  136  may be determined by the location of clamps  128  along channels  130 . Swivel  122  may be positioned between arms  132  and further secured by fasteners  126 . 
         [0064]    Swivel  122 , in various embodiments, may be secured by clamps  128  and fasteners  126  (as depicted in  FIGS. 31A-B ) in a manner that allows swivel  122  to rotate along at least one axis. Swivel  122  may be configured to engage gas delivery device  110 . For example, gas delivery device  110  may include coupling platform  112 . In some embodiments, platform  112  and opening  123  may use the same shapes so as to facilitate coupling platform  112  to swivel  122 . In particular embodiments, coupling platform  112  may be shaped substantially cylindrically such that it may engage a substantially cylindrical opening  123  of swivel  122 . In alternative embodiments, swivel  122  may be integrally formed with gas delivery device  110  or with other components such that no opening is required. In the embodiment shown, swivel  122  includes a notch to allow swivel  122  to be compressed to adjust the diameter of opening  123 . Rotating swivel  122  while it is secured to post  131  and platform  112  may allow gas delivery device to be positioned in a suitable manner to properly fit to a patient&#39;s face. The freedom of movement allowed by coupler  120  allows gas delivery device  110  to be comfortably and effectively fitted to the patient&#39;s unique facial features and preferences. Once they are so fitted, fasteners  126  are tightened so as to maintain this comfortable and effective orientation between gas delivery device  110  and oral appliance  100 . In some embodiments, gas delivery device  110  may be further positioned while being secured to platform  112  by moving swivel  122  closer to or away from base  136  of post  131 . This, in some embodiments, may be accomplished by sliding clamps  128  along channels  130 . During use, oral appliance  100  will be securely in place in the patient&#39;s mouth. Because it is connected to gas delivery device  110  through coupler  120 , oral appliance  100  acts as an anchor, maintaining the orientation and fit of gas delivery device  110 . 
         [0065]    Although the described embodiment is with an oral appliance that extends the lower jaw forward to more fully open the breathing passageway of the patient, coupler  120  may also be used with oral appliances that do not perform this function. As discussed above, example oral appliance  100  is used with coupler  120  to anchor gas delivery device  110 . In alternative embodiments, other oral appliances may be used to anchor a gas delivery device. For example, an upper arch alone could be used with coupler  120  to connect to gas delivery device  110 . Furthermore, oral appliances not shaped as arches could also be used with coupler  120 . Indeed, in the context of an oral appliance coupled to a gas delivery device, the term oral appliance is meant to include any device which can fit within the oral cavity and serve as an anchor for the gas delivery device. 
         [0066]    The components of coupler  120  may be formed of any suitable material, including suitable plastics or metals as examples. In certain embodiments, post  131  and clamps  128  may be formed of 304 stainless steel. Fasteners  126  may include threaded fasteners, pins, or any other appropriate fastener to couple clamps  128  to arms  132 . 
         [0067]      FIG. 27C  illustrates passageway  134  which may allow items such as key  80  and post  90  to pass through so that oral appliance  10  may be adjusted while coupled to coupler  120 . For example, adjustment key  80  may be inserted through passageway  134  while swivel  122  is engaged or disengaged from post  131  in order to adjust oral appliance  10  (as described above) even though post  131  is secured to body  12 . 
         [0068]      FIG. 31  illustrate embodiments of coupler  120  including sleeve  140 . Sleeve  140 , in the depicted embodiments, covers a portion of coupler  120 . In various embodiments, sleeve  140  may be made out of rubber, silicon, or other suitable materials. Sleeve  140  may be used to enhance the comfort and/or safety of a user of oral appliance  100  and gas delivery device  110 . For example, sleeve  140  may help protect portions of a user&#39;s mouth or face from being irritated by the use of coupler  120 . 
         [0069]      FIG. 32  illustrates an example method of improving a user&#39;s breathing, indicated generally at  200 . At step  202 , upper arch  102  is inserted into the user&#39;s mouth. At step  204 , lower arch  104  is inserted into the user&#39;s mouth. At step  206 , upper arch  102  is coupled to lower arch  104  by adjustment mechanism  10 . In certain embodiments, adjustment mechanism  10  includes a body  12  coupled to upper arch  102 , an adjustor  36 , a hook  28 , and a receiver  50  coupled to lower arch  104 . In certain embodiments, upper arch  102  is coupled to lower arch  104  by engaging shelf  54  of receiver  50  with arm  46  of hook  28 . In particular embodiments, the initial forward position of lower arch  104  relative to upper arch  102  is determined by engaging a particular one of multiple shelves  54  of receiver  50 . In alternative embodiments, the initial forward position of lower arch  104  relative to upper arch  102  is determined by engaging shelf  68  of extender  60  coupled to receiver  50 . At step  208 , the forward position of lower arch  104  relative to upper arch  102  is adjusted to facilitate improved breathing by the user. In certain embodiments, the forward position is adjusted by rotating adjustor  36  using adjustment key  80  or in any other appropriate manner. 
         [0070]      FIG. 33  illustrates an example method of coupling a gas delivery device to an oral appliance, indicated generally at  210 . At step  212 , gas delivery device  110  is coupled to oral appliance  100 . In certain embodiments, gas delivery device  110  may be coupled to oral appliance  100  using coupler  120  with arms  132 , clamps  128 , and swivel  122 . In particular embodiments, swivel  122  may couple to gas delivery device  110  at mounting platform  112 . 
         [0071]    At step  214 , gas delivery device  110  is positioned. This may be done by adjusting clamps  128  along channels  130 . In addition, in some embodiments, swivel  122  may be adjusted in order to further refine the position of gas delivery device  110 . In certain embodiments, this may include rotating swivel  122  about at least one axis while swivel  122  is positioned between clamps  128 . 
         [0072]    At step  216 , gas delivery device  110  is secured. This may be accomplished by tightening fasteners  126  so that clamps  128  are secured to arms  132 . Tightening fasteners  126  may also secure the position of swivel  122 , thus securing the orientation of gas delivery device  110 . In some embodiments, this may cause gas delivery device  110  to be positioned appropriately for the user by orienting swivel  122  to post  131 . In certain embodiments, post  131  may be coupled to oral appliance  100  at body  12 . 
         [0073]    Although example methods are described, the steps may be accomplished in any appropriate order. For example, in method  200 , inserting the upper and lower arches can be accomplished sequentially, in any order, or simultaneously. As another example, upper arch  102  and lower arch  104  may be coupled subsequent to or prior to inserting upper arch  102  and lower arch  104  into the user&#39;s mouth. As another example, the adjustment of the forward position of lower arch  104  relative to upper arch  102  may be performed in measured increments interspersed with trial periods to test the effectiveness of the oral appliance in improving the user&#39;s breathing. Method  200  may include checking or verifying the forward position of lower arch  104  relative to upper arch  102  and then repeating step  208  as needed. In certain embodiments, method  200  may include checking or verifying the position of gas delivery device  110  relate to the user and then repeating steps  208  and  210  as needed. The present invention contemplates using methods with additional steps, fewer steps, or different steps, so long as the methods remain appropriate for improving a user&#39;s breathing. 
         [0074]    Although the present invention has been described in connection with several embodiments, it should be understood that a variety of changes, substitutions, variations, alterations, transformations, and modifications may be suggested to one of skill in the art, and it is intended that the present invention encompass such changes, substitutions, variations, alterations, transformations, and modifications as fall within the spirit and scope of the appended claims.

Technology Classification (CPC): 0