Tongue embracing oral retention device

A tongue attachment assembly includes a sheath designed for attachment to a patient's tongue using a vacuum. An accessory attachment feature comprising a groove located between a flange and the distal end of the body of the sheath. Vacuum can be drawn through a valve or an external vacuum source. The tongue attachment assembly can be adapted for any of a variety of applications by selecting an appropriate accessory and attaching the accessory to the sheath by the accessory attachment feature. Accessories can include a sleep apnea attachment, a gas delivery mask retention attachment, and the like. A tongue shape restoration device can be employed to restore the tongue from a shape that is deformed by the tongue attachment assembly to a natural shape. The tongue shape restoration device can be a pair of cantilevered arms, an orbital shaped device, or any other suitable component.

FIELD OF THE INVENTION

The present disclosure relates to an oral medical apparatus used for multiple purposes. More particularly, the oral medical apparatus comprises an attachment feature carried by a tongue engaging sheath. Any of a variety of accessories is supported by the attachment feature, wherein each accessory provides a function such as prevention of snoring and sleep apnea, retention of an upper or lower lip, positioning of a tongue, and the like.

BACKGROUND OF THE INVENTION

The present invention provides an oral medical apparatus used in the prevention of snoring and sleep apnea. Snoring is the vibration of respiratory structures and the resulting sound due to obstructed air movement when a human breathes during sleep. Generally, the uvula and soft palate are the anatomical structures that cause the sound of snoring if a human's tongue drops to the back of their mouth during sleep.

Sleep apnea is a sleep disorder characterized by having one or more pauses in breathing, or shallow breaths during sleep, and is typically accompanied by snoring. Each pause or cessation is generally referred to as an apnea, and can last from a few seconds to minutes. Additionally, each apnea may occur from five to thirty or more times per hour of sleep. Although most humans do experience some level of sleep apnea during their lifetime, a relatively smaller percentage (approximately 20%) of humans, suffer with chronic, severe sleep apnea. A combination of factors causes sleep apnea or snoring. One factor is the relaxation of muscle tone that results from sleep. Another factor is the vibration of soft, collapsible tissue surrounding the human airway, which causes snoring.

There are several snoring control devices known in the art. These devices provide for reception of the tongue in a hollow tongue-retained holder. One problem presented by these devices, however, is the inadequate fit between the tongue-retained holder and the user's tongue. In particular, the device determines the position of the tongue. Consequently, a relatively long tongue is not properly or comfortably accommodated within the socket. Different sized devices or custom fabricated devices can be provided to help overcome this shortcoming, wherein the variety and custom fit devices are provided at a higher cost.

Another known device provides a tongue sleeve configured for reception and retention of the outer extent of the user's tongue, and includes a shield shaped to be received and retained outside of the user's lip, as well as a component that allows the user to attach and adjust the shield to the tongue sleeve. This component permits for selective adjustment of the shield's position relative to the tongue, reducing snoring and airway obstruction.

Another device, known as the aveoTSD, provides suction between the device and the user's tongue. This suction prevents the tongue from moving toward the back of the mouth, thereby, keeping the airway open during sleep to prevent snoring. This device is known to slip and some wearer's have felt that it is uncomfortable.

During a dental or other oral medical procedure, it is desirous to retain the patient's lip and/or tongue in a desired position.

Oral devices are commonly designed to be dedicated to a single function. More specifically, tongue sleeves are used in conjunction with a respective teeth attachment component for sleeve apnea. The tongue sleeve and the respective teeth attachment component are specifically designed to function with one another for a single use. What is desired is a system that is adaptable to a variety of applications.

Unfortunately, with all of the attempted improvements that have been made in sleep apnea prevention devices, there remains a need for a device that is more comfortable to wear and provides more effective results.

Additionally, there are benefits to creating a series of accessories for a variety of applications based upon the use of a tongue embracing member.

SUMMARY OF THE INVENTION

The present disclosure is generally directed to a sleep apnea control device, the device comprising:

a tongue attachment subassembly comprising:a sheath shaped to conform to a surface of an individual's tongue, the sheath having a tongue receiving cavity defining an opening for receiving the individual's tongue provided at a proximal end thereof, the sheath having an orientation defined by a dorsal side and a ventral side, and

a sheath interlock member extending outward from the dorsal side of the sheath; and

a maxilla attachment subassembly comprising:a maxilla tray shaped to conform to and removably engage with an individual's upper dental arch, the maxilla tray defined having an engagement side and an interlock side, anda tray interlock member extending from the interlock side of the maxilla tray and positioned to interlock with the sheath interlock member, which, when interlocked, extends an individual's tongue during use.

In one aspect, the sheath interlock member is fabricated of a rigid material and the tongue attachment subassembly is fabricated of a pliant material.

In another aspect, the device further includes an air extraction system. An embodiment of the air extraction assembly is provided, which comprises an air extraction valve integrated into the tongue attachment subassembly, wherein the valve is in fluid communication with the tongue receiving cavity. The air extraction device may include an air extraction pipette in fluid communication with an air extraction bulb, where the air extraction pipette is in fluid communication with the air extraction valve to remove air from within the tongue receiving cavity. The air extraction device can be retained or integrated with the air extraction valve or removable therefrom.

In yet another aspect, the air extraction valve may be a separate component and assembled to the sheath.

In yet another aspect, the air extraction valve may be integrally fabricated with the sheath.

In yet another aspect, the sheath interlock member further comprises a sheath interlock ridge, and the tray interlock member further comprises a tray interlock ridge, the ridge having an interlock interface to removably engage the sheath interlock ridge and the tray interlock ridge.

In yet another aspect, the interlock interface is fabricated having a series of teeth and teeth-receiving receptacles.

In yet another aspect, the interlock teeth are disposed at an acute angle.

In yet another aspect, the tongue attachment subassembly further includes a tongue base clearance defined by a U-shaped recession in the ventral side, which extends inward from an opening of the tongue receiving cavity opening.

In yet another aspect, the tongue attachment subassembly is fabricated having a bladder formed within the main body walls, wherein the air extraction valve is provided in fluid communication with the bladder. The user extracts air from the bladder, securing the tongue attachment subassembly to the individual's tongue.

In yet another aspect, the sheath interlock member further comprises a sheath interlock array, and the tray interlock member further comprises a tray interlock array, wherein the sheath interlock array and the tray interlock array removably engage with one another in a manner enabling both lateral and longitudinal adjustments. In a preferred embodiment, the arrays comprise a series of interlocking pins and pin receiving cavities.

In a second embodiment, the present disclosure further comprises an accessory to be adapted to the tongue attachment subassembly to create a lip positioning appliance, the appliance comprising:

a tongue attachment subassembly comprising:a sheath shaped to conform to a surface of an individual's tongue, the sheath having a tongue receiving cavity defining an opening for receiving the individual's tongue provided at a proximal end thereof, the sheath having an orientation defined by a dorsal side and a ventral side, and

a sheath interlock member extending outward from the dorsal side of the sheath; and

a maxilla lip retention subassembly comprising:a lip retention section having an arched shape to follow a contour of a patient's lip,a maxilla lip retention positioning arm extending from the lip retention section,a tray interlock member located at an attachment end of the maxilla lip retention positioning arm and located to interlock with the sheath interlock member,wherein when interlocked and installed, retains the lip retention section in engagement with an individual's lip, and

a tray interlock member extending from the interlock side of the maxilla tray and positioned to interlock with the sheath interlock member, which, when interlocked, extends an individual's tongue during use.

In one aspect, the sheath interlock member can be adapted to a maxilla lip retention subassembly to retain a patient's maxilla lip and tongue in a desired position during a procedure.

In another aspect, the sheath interlock member and maxilla lip retention subassembly further comprising a longitudinally adjusting interface between the two members.

In yet another aspect, the sheath interlock member and maxilla lip retention subassembly further comprising a longitudinally adjusting interface between the two members. The longitudinal adjustment can be used to control the position of the patient's tongue during a procedure.

In yet another aspect, the sheath interlock member and maxilla lip retention subassembly the longitudinally adjusting interface between the two members is provided by a series of interconnecting elements. The feature can introduce lateral adjustments with a laterally arranged series of interconnecting elements.

In yet another aspect, the sheath interlock member and maxilla lip retention subassembly the longitudinally adjusting interface between the two members is provided by a series of pins and mating series of receptacles.

In yet another aspect, the sheath interlock member and maxilla lip retention subassembly the longitudinally adjusting interface between the two members is provided by a slideably engaging interface.

In yet another aspect, the sheath interlock member and maxilla lip retention subassembly the longitudinally adjusting interface between the two members is provided by slideably engaging interface comprising a rail slideably engaging with a mating channel. The engagement can include a locking mechanism to retain the rail in a longitudinal relation with the mating channel.

In yet another aspect, the sheath interlock member and maxilla lip retention subassembly the longitudinally adjusting interface between the two members is provided by slideably engaging interface comprising a first arm in slide-able communication with a second arm. The two arms can be retained to one another using any inter-arm retaining feature. The inter-arm retaining feature can be integrated into either arm or provided as a separate component.

In yet another aspect, at least one of the sheath interlock member arm and maxilla lip retention subassembly arm can include a position locking feature, wherein the position locking feature can be a series of ridges, teeth, scalloping, and the like. The position locking feature would engage with a position retaining member to retain the axial position relation between the sheath interlock member arm and maxilla lip retention subassembly arm.

In yet another aspect, the sheath interlock member arm and maxilla lip retention subassembly arm can are provided in a parallel relationship with a primary plane of the tongue attachment subassembly bladder.

In yet another aspect, a sheath interlock member arm of the sheath interlock member is fabricated of a substantially rigid material, whereas the tongue embracing member is fabricated of a material having substantially elastic properties.

In yet another aspect, the sheath interlock member is assembled to the tongue embracing member by an overmolding process.

In yet another aspect, the sheath interlock member is assembled to the tongue embracing member by slideably inserting a sheath interlock member base of the sheath interlock member into a receiving channel formed in the exterior surface of the dorsal side of the tongue embracing member.

In yet another aspect, the receiving channel formed in the exterior surface of the dorsal side of the tongue embracing member includes a first channel segment and a second channel segment located opposite the first channel segment.

In yet another aspect, the receiving channel formed in the exterior surface of the dorsal side of the tongue embracing member includes a first channel segment and a second channel segment located opposite the first channel segment, wherein the first channel segment and the second channel segment are generally perpendicular to a longitudinal axis of the tongue embracing member.

In yet another aspect, the receiving channel formed in the exterior surface of the dorsal side of the tongue embracing member includes a first channel segment and a second channel segment located opposite the first channel segment, wherein the first channel segment and the second channel segment are parallel to one another.

In yet another aspect, the receiving channel formed in the exterior surface of the dorsal side of the tongue embracing member further comprises a third channel segment, wherein the third channel segment spans between like ends of the first channel segment and the second channel segment, wherein the first channel segment, the third channel segment and the second channel segment collectively form a “U” shaped channel.

In yet another aspect, the receiving channel is spaced from the exterior surface of the dorsal side of the tongue embracing member by a channel riser feature, wherein the channel riser feature reduces transfer of torsional and/or sheer forces from the sheath interlock member to the tongue embracing member. The reduction in transfer of forces reduces a potential scenario which can separate an interior surface of the tongue embracing member from the user's tongue, which can result in separation and dislodgement of the tongue embracing member from the user's tongue, resulting in an ineffective device.

In yet another aspect, the sheath interlock member arm and the maxilla lip retention subassembly arm are assembled positioning mating surfaces contacting or against one another.

In yet another aspect, at least one of the sheath interlock member arm and the maxilla lip retention subassembly arm is formed having a changing thickness defining a tapering distal or outer surface.

In yet another aspect, the changing thickness of the at least one of the sheath interlock member arm and the maxilla lip retention subassembly arm is linear along at least a portion of a length of the respective at least one arm.

In yet another aspect, the changing thickness of the at least one of the sheath interlock member arm and the maxilla lip retention subassembly arm forms a curved or arched surface along at least a portion of a length of the respective at least one arm.

In yet another aspect, a position retaining member at least partially circumscribes an external periphery defined by an assembly of the sheath interlock member arm and the maxilla lip retention subassembly arm. The position retaining member can be formed having a tubular rectangle shape, a tubular oblong shape, an elliptical shape, and the like, wherein the preferred shape would mimic the cross sectional shape of the assembly of the sheath interlock member arm and the maxilla lip retention subassembly arm. An interior distance spanning between an interior transverse or upper surface and an interior opposite transverse or lower surface of the position retaining member is sized enabling a sliding motion between the sheath interlock member arm and the maxilla lip retention subassembly arm when positioned at a location of the assembly having a narrow thickness and restraining any sliding motion between the sheath interlock member arm and the maxilla lip retention subassembly arm when positioned at a location of the assembly having a wider thickness.

In yet another aspect, the mating surfaces of the sheath interlock member arm and the maxilla lip retention subassembly arm are smooth.

In yet another aspect, the mating surfaces of the sheath interlock member arm and the maxilla lip retention subassembly arm are textured to increase a frictional force generated therebetween.

In yet another aspect, the mating surfaces of the sheath interlock member arm and the maxilla lip retention subassembly arm are co-planar.

In yet another aspect, the mating surfaces of the sheath interlock member arm and the maxilla lip retention subassembly arm include a series of mating mechanically engaging features.

In yet another aspect, the mating surfaces of the sheath interlock member arm and the maxilla lip retention subassembly arm include a series of mating mechanically engaging features, wherein (a) in a condition where the series of mating mechanically engaging features are engaged with one another, the sheath interlock member arm and the maxilla lip retention subassembly arm are restrained from a sliding motion therebetween and (b) in a condition where the series of mating mechanically engaging features are disengaged or separated from one another, the sheath interlock member arm and the maxilla lip retention subassembly arm are capable of a sliding or linear repositioning motion between one another.

In yet another aspect, a position retaining member can be positioned against external surfaces of the sheath interlock member arm and the maxilla lip retention subassembly arm at a position having a thickness that is approximately equal to an distance between opposite, internal transverse surfaces of the position retaining member to retain engagement between mating mechanically engaging features, thus retaining an axial relationship between the sheath interlock member arm and the maxilla lip retention subassembly arm.

In yet another aspect, the mating surfaces of the sheath interlock member arm and the maxilla lip retention subassembly arm include a series of mating mechanically engaging features comprising a series of peaks and valleys.

In yet another aspect, the mating surfaces of the sheath interlock member arm and the maxilla lip retention subassembly arm include a series of mating mechanically engaging features comprising a series of peaks and valleys, wherein the peaks and valleys are linear and spatially arranged.

In yet another aspect, the mating surfaces of the sheath interlock member arm and the maxilla lip retention subassembly arm include a series of mating mechanically engaging features comprising a series of peaks and valleys, wherein are linear, oriented substantially parallel to one another, and spatially arranged.

In yet another aspect, the mating surfaces of the sheath interlock member arm and the maxilla lip retention subassembly arm include a series of mating mechanically engaging features comprising a series of peaks and valleys, wherein the peaks and valleys are linear, oriented substantially perpendicular to a longitudinal axis of each arm, and spatially arranged.

In yet another aspect, the mating surfaces of the sheath interlock member arm and the maxilla lip retention subassembly arm include a series of mating mechanically engaging features comprising a series of peaks and valleys, wherein the peaks and valleys are linear and equally spaced arranged.

In yet another aspect, at least one of the sheath interlock member arm and the maxilla lip retention subassembly arm further comprises a position retaining member retention feature.

In yet another aspect, at least one of the sheath interlock member arm and the maxilla lip retention subassembly arm further comprises a position retaining member retention feature, wherein the position retaining member retention feature is a boss or other outwardly extending feature located proximate a distal end of the associated arm.

In yet another aspect, the maxilla lip retention subassembly comprises a lip retention feature. The lip retention feature can formed in any suitable shape for comfortably retaining the patient's maxilla lip.

In yet another aspect, the lip retention feature is fabricated inclusive of a pliant material. The pliant material may be silicone, nylon, rubber, plastic, wax, and the like.

In yet another aspect, the lip retention feature can be shaped to engage with a gum line of the patient.

In yet another aspect, the tongue embracing member comprises an air extraction valve.

In yet another aspect, the air extraction valve includes a valve seal that opens outward from a sealing feature.

In yet another aspect, the sealing feature is a flange circumscribing an interior circumference of an air extraction tube comprising the air extraction valve.

In yet another aspect, the air extraction valve includes a valve seal that pivotally opens outward from the sealing feature.

In yet another aspect, the valve seal is in operational communication with a valve operational handle.

In yet another aspect, the valve operational handle is operated by a mechanical interference with a feature and/or surface of a bulb air extraction tube of an air extraction device.

In yet another aspect, the valve operational handle includes at least one of a magnet and a magnetically attracting material and the bulb air extraction tube of an air extraction device comprises a mating at least one of a magnet and a magnetically attracting material, thus resulting in a magnetic attraction between the two elements. The magnetic attraction draws the valve seal into a closed or sealed configuration when the bulb air extraction tube of the air extraction device is slideably removed from the tongue embracing member air extraction tube.

In yet another aspect, at least one of the valve operational handle and the valve seal is in operational communication with a biasing element. The biasing element can be any form of a biasing element, including a coil spring, a cantilever spring, and the like.

In yet another aspect, the bulb air extraction tube further comprises a lead in feature, wherein one exemplary lead in feature is chamfered interior surface.

In yet another aspect, the bulb air extraction tube further comprises a valve insertion stop seat, wherein the valve insertion stop seat limits the sliding motion between the tongue embracing member air extraction tube and the interior surface of the bulb air extraction tube of the air extraction device.

In yet another aspect, the valve insertion stop seat is formed as an internal ridge at least partially circumscribing the interior surface of the bulb air extraction tube of the air extraction device.

In yet another aspect, the tongue embracing member air extraction tube includes an air extraction valve clearance, providing a clearance for the valve flap when the valve flap is rotated into an open configuration.

In yet another aspect, a vacuum formed within the tongue embracing member retains the valve flap in a closed configuration.

In yet another aspect, a sheath tongue sealing ridge is formed along at least a portion of a contacting circumferential surface of an interior surface of the tongue embracing member.

In yet another embodiment, the present disclosure further comprises a tongue attachment subassembly comprising:a sheath having a body shaped to conform to a surface of an individual's tongue, the sheath having an orientation defined by a proximal end and a distal end;a tongue receiving cavity extending inward from an opening in the proximal end of the sheath, the tongue receiving cavity having a size and a shape for receiving and engaging with the individual's tongue;a vacuum passageway passing through the distal end of the sheath into the tongue receiving cavity; andan accessory attachment feature comprising a groove located between a flange and the distal end of the body of the sheath.

In a second aspect, the tongue attachment subassembly further comprises a check valve integrally provided with the vacuum passageway.

In another aspect, the check valve is provided in a form of a duck bill valve. The duckbill valve comprising a flexible upper member and a flexible lower member mating at a slit. An applied vacuum draws the flexible upper member and the flexible lower member towards one another, sealing the slit.

In yet another aspect, the duck bill valve is integrally formed with the vacuum passageway.

In yet another aspect, the accessory attachment groove and the accessory attachment flange are annular in shape.

In yet another aspect, the accessory attachment groove and the accessory attachment flange are formed along a neck segment of the check valve.

In another aspect, the accessory attachment feature comprises groove and a flange, the groove being located between the flange and the distal end of the body of the sheath.

In yet another aspect, the tongue attachment subassembly further comprises a tongue protection insert located within the vacuum passageway.

In yet another aspect, the tongue protection insert comprises an insert interior flange located at an interior end of a tubular body. The tubular body is preferably sized and shaped for insertion into and sealing against an interior surface of the vacuum passageway of the sheath.

In yet another aspect, the tongue protection insert comprises at least one small vacuum passage orifice.

In yet another aspect, the tongue protection insert comprises a plurality of small, spatially arranged, vacuum passage orifices.

In yet another aspect, the insert interior flange is formed having a concave shaped tongue contacting surface.

In yet another aspect, the tubular body is cylindrically shaped.

In yet another aspect, the insert interior flange further comprises an orientation feature.

In yet another aspect, the insert interior flange further comprises an orientation feature, wherein the orientation feature is provided to properly align the concave shaped tongue contacting surface and the adjacent interior surface of the sheath.

In yet another aspect, the tongue protection insert comprises a central passageway extending from an inlet end thereof to the insert interior flange.

In yet another aspect, vacuum communication is provided through the tongue protection insert central passageway and small vacuum passage orifice(s).

In yet another aspect, the tongue protection insert comprises a central passageway extending from an inlet end thereof to an insert interior flange.

In yet another aspect, the tongue protection insert further comprises an exterior sealing flange, the exterior sealing flange being located proximate the inlet end of the tubular body.

In yet another aspect, the tongue attachment subassembly is designed for easy removal of the check valve.

In yet another aspect, the tongue attachment subassembly is designed for easy removal of the check valve by shearing the check valve from the vacuum passageway.

In yet another aspect, the tongue attachment subassembly is designed for easy removal of the check valve by shearing the check valve from the vacuum passageway along an outward surface of the accessory attachment flange.

In yet another embodiment, the present disclosure further comprises an assembly for treatment of sleep apnea, the assembly comprising:

a tongue attachment subassembly including:a sheath having a body shaped to conform to a surface of an individual's tongue, the sheath having an orientation defined by a proximal end and a distal end;a tongue receiving cavity extending inward from an opening in the proximal end of the sheath, the tongue receiving cavity having a size and a shape for receiving and engaging with the individual's tongue;a vacuum passageway passing through the distal end of the sheath into the tongue receiving cavity; andan accessory attachment feature; and

a tongue position retention subassembly comprising:a tongue position retention body,a face engaging surface formed on the tongue position retention body, anda tongue position retention bracket assembly clip adapted to support the tongue position retention body and engage with the accessory attachment feature,the tongue position retention subassembly being assembled to the tongue attachment subassembly by assembling the tongue position retention bracket assembly clip and the accessory attachment feature to one another.

In another aspect, the tongue position retention body is formed having an “S” shape.

In yet another aspect, the tongue position retention body is formed having a concave “S” shape.

In yet another aspect, the tongue position retention body is designed to engage with at least one of lips of a patient and a chin of the patient.

In yet another aspect, the tongue position retention body is designed to engage with cheeks of the patient.

In yet another aspect, the tongue position retention bracket assembly clip is formed having a “C” shape engaging surface, wherein the clip is sized and shaped to mate with the accessory attachment feature groove and seat against the accessory attachment feature flange.

In yet another aspect, the “C” shaped tongue position retention bracket assembly clip further comprises a clip retention feature formed on at least one end of the “C” shaped engaging surface of the clip.

In yet another aspect, the tongue position retention subassembly further comprises a valve guard.

In yet another aspect, the valve guard is formed having a generally “C” shape extending outward from an exterior surface of the tongue position retention body.

In another aspect, in use, the tongue attachment subassembly is secured to a tongue of a patient by slipping the sheath over the tongue and applying a vacuum to the sheath through the vacuum passageway, the face engaging surface of the position retention bracket assembly is placed against face of a patient, and the position retention bracket assembly is assembled to the tongue attachment subassembly by assembling the tongue position retention bracket assembly clip and the accessory attachment feature to one another.

In yet another aspect, a tongue compression component can be used in conjunction with the tongue attachment subassembly.

In yet another aspect, the tongue compression component includes an upper tongue compression arm, a lower tongue compression arm, and an assembly clip.

In yet another aspect, the tongue compression component includes an upper tongue compression arm, a lower tongue compression arm, and an assembly clip formed having a “C” shape engaging surface, wherein the clip is sized and shaped to mate with the accessory attachment feature groove and seat against the accessory attachment feature flange.

In yet another aspect, the upper tongue compression arm and the lower tongue compression arm are formed as cantilevered elements extending rearward from the tongue compression component assembly clip.

In yet another aspect, the upper tongue compression arm and the lower tongue compression arm are formed as cantilevered elements having a convex contacting surface and a concave exposed surface.

In yet another aspect, the upper tongue compression arm and the lower tongue compression arm are spaced to apply a compression force upon the tongue attachment subassembly. The spacing is such to apply a suitable compression force upon the dorsal side and ventral side of the tongue.

In yet another aspect, the compression force applied by the tongue compression component is provided to retain a patient's tongue in a natural shape. When worn, the tongue attachment subassembly could tend to draw the tongue into a rounded shape. The tongue compression component restores the tongue to the tongue's natural oval shape.

In yet another aspect, the tongue compression component is utilized in accordance with the following steps:

installing a tongue compression component onto a tongue attachment subassembly,

sliding the tongue attachment subassembly onto a patient's tongue, and

extracting air from the tongue attachment subassembly.

In yet another aspect, the tongue compression component is utilized in accordance with the following additional steps:

adjusting the tongue compression component for comfort.

In yet another aspect, the tongue compression component is utilized in accordance with the following additional steps:

selecting a properly sized tongue compression component for use.

In yet another aspect, the tongue compression component is utilized in accordance with the following additional steps:

adjusting the tongue compression component to become the proper size for use.

In yet another aspect, the adjusting process can be accomplished by heating the tongue compression component (fabricated of a plastic, nylon, or the like) and adjusting an angle of each of the cantilevered arms.

In yet another aspect, the tongue compression component can further include at least one tooth locating projection; each at least one tooth locating projection extending outward from the exposed surface of at least one of the upper tongue compression arm and the lower tongue compression arm.

In yet another aspect, the tongue compression component can further include at least one pair of teeth locating projections; each teeth locating projection of the pair of teeth locating projections extending outward from the exposed surfaces of the respective upper tongue compression arm and the respective lower tongue compression arm. The pair of teeth locating projections is preferably in substantial axial registration with one another.

In yet another aspect, the tongue compression component can further include at least two pairs of teeth locating projections; each pair of teeth locating projection of the two pair of teeth locating projections extending outward from the exposed surfaces of the respective upper tongue compression arm and the respective lower tongue compression arm. The pair of teeth locating projections is preferably in substantial axial registration with one another. Adjacent teeth locating projections of each pair of teeth locating projections are spaced from one another to receive a patient's tooth or teeth.

In yet another aspect, a variety of tongue compression components, each tongue compression component can be offered having a different distance from the assembly clip for the teeth locating projections, wherein the position of the teeth locating projections locates the tongue position respective to the teeth.

In yet another aspect, the tongue compression component is designed where each tongue compression arm having a convex contacting surface, where an apex of the convex surface is positioned rearward of an end of the tongue.

In yet another aspect, the tongue compression component assembly clip has a thickness or a dimension spanning between a first flange engaging surface and a second flange engaging surface is substantially proximate a dimension spanning between a first flange surface and a second flange surface defining the interlock coupling groove.

In yet another aspect, the thickness of the tongue compression component assembly clip can be reduced to a dimension that is shorter than the span of the interlock coupling groove. The oral appliance assembly can further include a spacer having a thickness that is the difference between the thickness of the tongue compression component assembly clip and the span of the interlock coupling groove. The spacer and the tongue compression component assembly clip can have a like shape and size.

In yet another aspect, the arrangement can employ a plurality of spacers, where the sum of the thicknesses of the plurality of spacers equals the difference between the thickness of the tongue compression component assembly clip and the span of the interlock coupling groove. The positioning of the teeth engaging tongue compression component would be adjusted by varying a placement of the spacer or plurality of spacers.

In yet another aspect, the spacer can be inserted between the tongue compression component assembly clip and the forward or outer flange surface within the interlock coupling groove, positioning the teeth engaging tongue compression component rearward.

In yet another aspect, the spacer can be inserted between the tongue compression component assembly clip and the rearward or inner flange surface within the interlock coupling groove, positioning the teeth engaging tongue compression component forward.

In yet another aspect, a position of the accessory can be adjusted by inserting one or more spacers between at least one of:(a) between the first flange engaging surface of the accessory clip body and the respective first flange surface of the tongue attachment assembly, and(b) between the second flange engaging surface of the accessory clip body and the respective second flange surface of the tongue attachment assembly.

In yet another aspect, a orbital tongue shaping device can be used for sleep apnea, where the orbital tongue shaping device is formed in a loop, including a generally linear dorsal segment having a slight arch between a forward edge and a rearward edge, a tightly arched left side segment, a generally linear ventral segment having a slight arch between the forward edge and the rearward edge, and a tightly arched left side segment, each segment being contiguous with an adjacent segment.

In yet another aspect, at least one of the segments of the orbital tongue shaping device can be shaped having a convex surface formed on a contacting surface and a concave surface formed on an exposed surface.

In yet another aspect, an opposite pair of the segments of the orbital tongue shaping device can be shaped having a convex surface formed on a contacting surface and a concave surface formed on an exposed surface.

In yet another aspect, all four segments of the orbital tongue shaping device can be shaped having a convex surface formed on a contacting surface and a concave surface formed on an exposed surface.

In yet another aspect, the dorsal segment and the ventral segment of the orbital tongue shaping device includes a leading edge wherein the leading edge is shaped having a central portion of a leading edge forward of each respective side region.

In yet another aspect, the leading edge has an arched shape, where a center of the arched shape extends forward of the body of the orbital tongue shaping device.

In yet another aspect, the trailing edge has an arched shape, where a center of the arched shape extends inward towards the body of the orbital tongue shaping device.

In yet another aspect, the dorsal segment and the ventral segment of the orbital tongue shaping device includes a trailing edge wherein the trailing edge is shaped having a central portion of the trailing edge forward of each respective side region.

In yet another aspect, the leading edge has an arched shape, where a center of the arched shape extends inward towards the body of the orbital tongue shaping device.

In yet another aspect, the trailing edge has an arched shape, where a center of the arched shape extends forward of the body of the orbital tongue shaping device.

In yet another aspect, the orbital tongue shaping device can be used independently or in conjunction with the tongue attachment subassembly.

In yet another aspect, the orbital tongue shaping device is of a size and shape to compress a patient's tongue in both a direction compressing a thickness of the tongue and a direction compressing a width of the tongue.

In yet another aspect, in use the orbital tongue shaping device compresses the patient's tongue in both a direction compressing a thickness of the tongue and a direction compressing a width of the tongue; the resulting reaction of the tongue is an expansion forward and an expansion in thickness of a segment of the tongue that is forward of the placement of the orbital tongue shaping device on the patient's tongue.

In yet another embodiment, the present disclosure further comprises an assembly for delivery of a gas, the assembly comprising:

a tongue attachment subassembly including:a sheath having a body shaped to conform to a surface of an individual's tongue, the sheath having an orientation defined by a proximal end and a distal end;a tongue receiving cavity extending inward from an opening in the proximal end of the sheath, the tongue receiving cavity having a size and a shape for receiving and engaging with the individual's tongue;a vacuum passageway passing through the distal end of the sheath into the tongue receiving cavity; andan accessory attachment feature; and

a mask retention subassembly comprising:a mask position retention body including a,a mask engaging surface formed on the mask position retention body, anda mask position retention bracket assembly clip adapted to support the mask position retention body and engage with the accessory attachment feature,the mask position retention subassembly being assembled to the tongue attachment subassembly by assembling the mask position retention bracket assembly clip and the accessory attachment feature to one another.

In another aspect, the tongue position retention body is formed having a pair of wings extending outward from a centrally located mask position retention bracket assembly clip.

In yet another aspect, each of the wings is formed having a convex curved exterior surface and a concave curved mask-contacting interior surface.

In yet another aspect, the tongue position retention body is designed to engage with a feature of a gas management mask.

In yet another aspect, the tongue position retention body is designed to engage an exterior surface of the gas management mask.

In yet another aspect, the mask position retention bracket assembly clip is formed having a “C” shape engaging surface, wherein the clip is sized and shaped to mate with the accessory attachment feature groove and seat against the accessory attachment feature flange.

In yet another aspect, the “C” shaped mask position retention bracket assembly clip further comprises a clip retention feature formed on at least one end of the “C” shaped engaging surface of the clip.

In yet another aspect, the mask position retention subassembly adequately supports the mask, exclusive of any additional securing elements (such as a strap and the like).

In yet another aspect, in use the orbital tongue shaping device compresses the patient's tongue in a first lateral direction, compressing a lateral thickness of the tongue; the resulting reaction of the tongue is an expansion forward and an expansion in vertical thickness of a segment of the tongue that is forward of the placement of the orbital tongue shaping device side regions on the patient's tongue, the orbital tongue shaping device dorsal segment and the ventral segment compressing the patient's tongue in a second vertical direction, vertically compressing the segment of the tongue that is forward of the placement of the orbital tongue shaping device side regions; the resulting reaction of the tongue is an expansion in lateral thickness in the segment of the tongue that is forward of the placement of the orbital tongue shaping device side regions, securing the orbital tongue shaping device on the tongue.

In yet another aspect, the orbital tongue shaping device can be made in an over-molding process, where the orbital tongue shaping device is fabricated of an internal rigid material and an external pliant material, where the internal rigid material provides structural support and the external pliant material provides patient comfort.

DETAILED DESCRIPTION OF THE INVENTION

A sleep apnea control device is provided for the prevention of snoring and sleep apnea. The sleep apnea control device includes a tongue attachment subassembly100and a maxilla attachment subassembly200, as illustrated inFIG. 11.

The tongue attachment subassembly100is detailed inFIGS. 1 through 9. The maxilla attachment subassembly200is detailed inFIG. 10. The tongue attachment subassembly100includes a sheath110, wherein the sheath110is defined having a tongue receiving cavity112for insertion of an individual's tongue300. The tongue attachment subassembly100can be defined having a dorsal side114and a ventral side116. The sheath110can also be defined having an exterior surface122and a tongue engagement surface120. An air extraction valve140is integrated into the sheath110at a sheath distal end118. The illustrated air extraction valve140is only exemplary and it is understood that it can include any unidirectional valve known by those skilled in the art. The device may be fabricated from any of a plethora of known, non-toxic materials. The sheath110is fabricated of a pliant material, such as latex, silicone, rubber, and the like. The sheath110can be molded, thermally formed, or constructed using similarly known fabrication techniques.

A sheath interlock member130is integrated into a dorsal side114portion of the sheath110. Details of the sheath interlock member130are presented inFIG. 6. The sheath interlock member130includes an interlock ridge132having a series of interlock teeth134and interlock teeth-receiving receptacle136extending outward from the tongue engagement surface120of the dorsal side114. The preferred design orients the interlock teeth134and interlock teeth-receiving receptacle136such that a base of each interlock teeth134is slightly forward of its top of the respective interlock teeth134. The sheath interlock member130can be integrated into the sheath110during the fabrication of the tongue attachment subassembly100using the same material, using a different material, or joined in a post fabrication assembly step. The sheath interlock member130can include an optional interlock base portion138for attachment to the sheath110. The interlock base portion138can be formed having an arched shape with a downward apex, wherein the apex applies additional pressure to the individual's tongue300. The interlock ridge132is inserted through an aperture formed in the dorsal side114and attached using any adequate attachment means. An exemplary attachment bonds the interlock base portion138to the exterior surface122using a bonding media, as illustrated inFIG. 7. The sheath interlock member130is preferably constructed from a rigid material, such as plastic, hard rubber, nylon, and the like. The sheath interlock member130is preferably fabricated using a molding process, but it is recognized that the sheath interlock member130can be fabricated using any reasonable process respective to the material selection. The bonding can be provided using any bonding medium, using a heat staking process, using an ultrasonic welding process, and the like.

The tongue attachment subassembly100is placed over and secured to an individual's tongue300as illustrated in aFIGS. 8 and 11. A tongue base clearance117can be formed within the ventral side116of the sheath110, providing a clearance for a tongue base306. The tongue base clearance117is a recess in the ventral side116of the sheath110, extending inward from an opening for the tongue receiving cavity112. A securing seal is created by evacuating air from a gap304formed between a tongue surface302of the individual's tongue300and the tongue engagement surface120. As the sheath110is placed upon the individual's tongue300, air within the tongue receiving cavity112is displaced and a seal is created between the tongue surface302and a rear portion of sheath110. A majority of the remaining air is removed using an air removal system. The air removal system includes an air extraction valve140and an air extraction device150. The air extraction device150engages with the air extraction valve140to extract air from the gap304. Details of the air removal system are illustrated inFIG. 4. The air extraction device150includes an air extraction bulb152in fluid communication with an air extraction pipette154. In the exemplary embodiment, the air extraction pipette154is inserted through a unidirectional valve orifice146separating a unidirectional valve flap142from a unidirectional valve seal144. This creates an airflow passage between the gap304and the air extraction bulb152. The user would preferably squeeze the air extraction bulb152to discharge air from within the air extraction bulb152prior to insertion of the air extraction pipette154through the unidirectional valve orifice146. Once inserted, the user would release the pressure from the air extraction bulb152, thus causing the air extraction bulb152to extract air from the gap304. The user then removes the air extraction device150from the air extraction valve140. The unidirectional valve flap142naturally retracts to a sealed configuration, seating against the unidirectional valve seal144. The removal of air from the gap304creates a vacuum, which secures the sheath110onto the individual's tongue300. It is understood that although the illustrations present a removable air extraction device150, the air extraction device150can alternately be integrated into the air extraction valve140. The air extraction device150can be used to aid in the return of air into the air-extracted region to aid in removal of the tongue attachment subassembly100from the individual's tongue300.

The maxilla attachment subassembly200is formed of a resilient material and shaped to be removably attached to a maxilla (upper jaw)320. The maxilla attachment subassembly200includes a maxilla tray210, which is formed in a “U-shape”, contouring to the maxilla (upper jaw)320. The maxilla tray210is defined having a maxilla tray's attachment side220and a maxilla tray's interlock side222. The maxilla tray's interlock side222includes a recession formed into the maxilla tray210for receiving individual's teeth. The maxilla attachment subassembly200is fabricated having a tray interlock member230disposed upon the maxilla tray's interlock side222of the maxilla tray210. The maxilla tray210is shaped to be removably attached to the maxilla (upper jaw)320.

The maxilla tray210is secured by its shape and can optionally include one or more features to aid in the engagement with the individual's teeth. The maxilla tray210can be formed to mate with the maxilla (upper jaw)320by placing the maxilla attachment subassembly200into hot water, inserting the maxilla attachment subassembly200into the individual's mouth, and placing with finger pressure into an interior recession. This will shape the interior portion of the maxilla tray210to mate with the maxilla (upper jaw)320. Another technique to form the maxilla tray210is to have a custom maxilla tray210fabricated by the individual's dentist or other oral health care professional. This technique allows the maxilla tray210to be custom fit for the user. The custom version of the maxilla attachment subassembly200would be fabricated in a manner similar to that for teeth whitening trays from their dentist. A tray interlock member230is positioned onto the maxilla tray210to interlock with the sheath interlock member130as illustrated inFIGS. 11 and 12. An interlock is formed by an engagement between the interlock teeth134of the sheath interlock member130and the interlock tooth receptacle236of the tray interlock member230, and similarly with the engagement between the interlock tooth234of the tray interlock member230and the interlock teeth-receiving receptacle136of the sheath interlock member130. The interlock between the sheath interlock member130and the tray interlock member230draws and maintains the individual's tongue300forward, to an extended tongue310. The teeth engage by the angled relation of the between the interlock tooth234and the interlock teeth-receiving receptacle136. The extended tongue310is positioned, resting upon teeth and/or gums of an individual's mandible (lower jaw)322. The extended tongue310and the fixed position of the jaw will reduce or eliminate snoring and sleep apnea.

The sleep apnea control device can be removed from the individual's mouth by opening the individual's mouth, which separates the engaged sheath interlock member130and tray interlock member230, removing the maxilla attachment subassembly200, then releasing the vacuum holding the tongue attachment subassembly100and removing the tongue attachment subassembly100from the individual's tongue300. The vacuum can be removed by squeezing the two sides of the tongue attachment subassembly100together to separate the rear edge from the individual's tongue300or by inserting the air extraction pipette154into the air extraction valve140, which separates the unidirectional valve flap142from the unidirectional valve seal144, and squeezing the air extraction bulb152to inject air into the tongue receiving cavity112. Upon combining the fixed, forward location310of a user's tongue300with adequate, uniform suction between the user's tongue300and the sheath310, a comfortable and efficient oral medical apparatus used in the prevention of snoring and sleep apnea is realized.

Although the exemplary embodiments include the air extraction valve140, it is understood that the tongue attachment subassembly100can be fabricated excluding the air extraction valve140. The user would manually remove the air within the tongue surface302by sucking the air therefrom.

An exemplary sleep apnea control method flow diagram400is presented inFIG. 13. The method initiates with a step of the individual obtaining the sleep apnea control device (step402), the device comprising the tongue attachment member100and the maxilla attachment subassembly200. The user places their tongue300into the tongue receiving cavity112in accordance with a tongue attachment subassembly installation step (step404). The user removes a majority of the residual air remaining between the tongue engagement surface120of the tongue receiving cavity112and the individual's tongue300in accordance with an air removal step (step406). The maxilla attachment subassembly200is positioned, placing the maxilla tray's attachment side220against the individual's maxilla (upper jaw)320in accordance with a maxilla attachment subassembly installation step (step408). The process continues with the user extending their tongue300(tongue extending step410) and engaging the sheath interlock member130and the tray interlock member230together, referred to as an interlock engagement step (step412). At this point, the device is ready for use and the individual can enjoy a night's sleep (step414). Upon completion of use, the individual disengages the interlock provided between the sheath interlock member130and the tray interlock member230. The user opens their mouth and removes the vacuum provided between the tongue receiving cavity112and the individual's tongue300in accordance with a vacuum removal step (step416). Once released, the user removes the tongue attachment subassembly100from their tongue300per a tongue attachment subassembly removal step (step418). The use is concluded with the removal of the maxilla attachment subassembly200from the individual's maxilla (upper jaw)320in accordance with a maxilla attachment subassembly removal step (step420). The user then stores the sleep apnea control device for future use.

An alternate embodiment of the tongue embracing member100is presented as a tongue embracing member500illustrated inFIG. 14. Like features of tongue embracing member500and tongue embracing member100are numbered the same except preceded by the numeral ‘5’. The tongue embracing member500utilizes an internally provided suction compared to the tongue embracing member100, which utilizes an externally applied suction. The tongue embracing member500is fabricated having a bladder air chamber564formed therein. The bladder air chamber564is defined by a bladder interior wall562formed on the tongue-contacting portion of the tongue embracing member500and a bladder exterior wall560formed on the external portion of the tongue embracing member500. The user would remove the air from within the bladder air chamber564drawing and securing the tongue embracing member500onto the individual's tongue300. The tongue embracing member500would be shaped to include a tongue base clearance117.

The tongue embracing member100can be adapted to include an array arrangement of interlocking pins634, wherein the adapted assembly is referred to as a tongue embracing member600and is illustrated inFIGS. 15 through 18. Like features of tongue embracing member600and tongue embracing member100are numbered the same except preceded by the numeral ‘6’. Although the tongue embracing member600is illustrated formed having a solid material, it is understood that the tongue embracing member600can be formed having a bladder similar to the tongue embracing member500.

The array arrangement of interlocking pins634extends perpendicularly from an interlock base portion638. The array arrangement of interlocking pins634provides longitudinal and axial adjustments between the tongue embracing member600and another component. One exemplary component for use in conjunction with the tongue embracing member600would be a maxilla lip retention subassembly800, which is introduced inFIG. 19. The maxilla lip retention subassembly800includes a lip retention subassembly interlock member830distally attached to a lip retention section810by a maxilla lip retention positioning arm820. The maxilla lip retention positioning arm820can be designed having any suitable shape to appropriately position the lip retention section810when the maxilla lip retention subassembly800is attached to the tongue embracing member600. The exemplary maxilla lip retention positioning arm820is shaped to include a positioning arm lateral arm822extending forward from the interlock base portion638and a positioning arm riser arm824extending downward from the lip retention section810. The lip retention subassembly interlock member830can be provided in any configuration to detachably mate with the selected design of the sheath interlock member630.

The lip retention subassembly interlock member830includes an array of interlock pin receptacles836extending inward from an interlocking member contact surface834of an interlock base portion838. The array of interlock pin receptacles836is arranged to detachably engage with the array of interlock pins634. The array enables the user to positionally adjust the maxilla lip retention subassembly800in either or both a longitudinal and/or a lateral direction. The user would align the array of interlock pin receptacles836with the array of interlock pins634at the desired position and engage them accordingly as illustrated inFIG. 21.

Although the exemplary embodiment of the lip retention section810contacts the upper lip330of the individual, it is understood that the lip retention section810can be shaped to contact a gum line of the individual for applications where the goal is to govern a position of the tongue310.

It is understood that the maxilla attachment device200can be adapted for use with the tongue embracing member600by replacing the tray interlock member230with the lip retention subassembly interlock member830.

The tongue embracing member100can be adapted to include a sheath interlock member730, wherein the adapted device is referred to as a tongue embracing member700and is illustrated inFIGS. 22 through 25. Like features of tongue embracing member700and tongue embracing member100are numbered the same except preceded by the numeral ‘7’. Although the tongue embracing member700is illustrated formed having a solid material, it is understood that the tongue embracing member700can be formed having a bladder similar to the tongue embracing member500.

The tongue embracing member700provides a sheath interlock member730in a form of a cantilevered member that extends forward above an exterior surface722of a dorsal side714of a sheath710. The sheath interlock member730includes an interlock member riser segment732preferably extending generally perpendicular from the exterior surface722. The interlock member riser segment732transitions into an interlock member engagement segment734, which is preferably oriented in a parallel arrangement with a longitudinal axis of the sheath710. An interlock member positioning feature736comprises a series of notches along at least one of an edge, an upper surface, and a lower surface of the interlock member engagement segment734. The interlock member positioning feature736is provided to engage with a mating feature to axially position a mating member.

The maxilla lip retention subassembly800can be modified to include a variation of the lip retention subassembly interlock member830, wherein the modified assembly is referred to as a maxilla lip retention subassembly900and is illustrated inFIGS. 26 through 28. Like features of the maxilla lip retention subassembly900and maxilla lip retention subassembly800numbered the same except preceded by the numeral ‘9’. The maxilla lip retention subassembly900is one exemplary component for use in conjunction with the tongue embracing member700. The maxilla lip retention subassembly900includes a maxilla lip retention positioning arm930extending from a lower edge of a lip retention section910. The maxilla lip retention positioning arm930can be designed having any suitable shape to appropriately position the lip retention section910when the maxilla lip retention subassembly900is attached to the tongue embracing member700. The exemplary maxilla lip retention positioning arm930is shaped to include a positioning arm riser arm932extending downward from the lip retention section910transitioning into a positioning arm lateral arm934which extends rearward and substantially perpendicular to the positioning arm riser arm932. The maxilla lip retention positioning arm930can be provided in any configuration to adjustably and/or detachably mate with the selected design of the sheath interlock member730.

The positioning arm lateral arm934would be positioned parallel to the interlock member engagement segment734and secured to one another using a position retaining member950. The position retaining member950can be a separate member or integrated into one of the interlock member engagement segment734or the positioning arm lateral arm934. The position retaining member950comprises a position retaining member body952formed having a series of walls defining a position retaining member body interior surface954, wherein the position retaining member body interior surface954at least partially circumscribes the combined positioning arm lateral arm934and interlock member engagement segment734. A position retaining member position locking element956can be integrated along one or more sides of the position retaining member950, wherein the position retaining member position locking element956releasably engages with at least one of the interlock member positioning feature736and notched or ridged surface936to secure the maxilla lip retention positioning arm930in an axial positional relation with the sheath interlock member730. The position retaining member position locking element956can be designed and operate in conjunction with any locking device known by those skilled in the art.

The exemplary embodiment presents two planar arms arranged in slideable contact with one another. It is understood that one arm can be provided in a form of a channel and the mating arm can be provided in a form of a rail, wherein the rail is slideably assembled within an interior portion of the channel. One of the two members can include a series of recessions that would engage with one or more position locking bosses.

The exemplary maxilla lip retention subassembly900is shown in use inFIG. 27. The user can positionally adjust the maxilla lip retention subassembly900respective to the tongue embracing member700by adjusting the longitudinal relation between the positioning arm lateral arm934and the interlock member engagement segment734. The longitudinal position between the positioning arm lateral arm934and the interlock member engagement segment734would be retained by the position retaining member950. The exemplary position retaining member950includes a pair of position retaining member position locking element956, each position retaining member position locking element956being located on each side thereof. The position retaining member position locking element956engages with each of the interlock member positioning feature736and interlocking member contact surface982to limit any axial motion between the two arms982,934. The tongue embracing member700would be secured to the tongue310of the patient as previously described. The positioning between the interlock member engagement segment734and the positioning arm lateral arm934either prior to or subsequent to attachment of the tongue embracing member700to the tongue310. The lip retention section910would retain the upper lip330of the patient in the desired position. The assembly between the maxilla lip retention subassembly900and the tongue embracing member700would additionally retain the tongue310in a desired position. The lip retention section910would be fabricated in a similar manner to the fabrication of the lip retention section810as previously described.

A tongue embracing member1000, illustrated inFIGS. 29 through 33, introduces advantages over the tongue embracing member700. Like features of the tongue embracing member1000and tongue embracing member700are numbered the same except preceded by the numeral ‘10’. The sheath interlock member1030is fabricated of a substantially rigid material, such as a rigid plastic. The sheath1010is fabricated of a pliant material, such as silicone. The differences in material properties deviates options for manufacturing from a single injection molding process. In the exemplary embodiment, the sheath interlock member1030includes a sheath interlock member base1031for assembly to the sheath1010. The sheath interlock member1030, more specifically, the sheath interlock member base1031, can be assembled to the sheath1010using a two step process. The sheath interlock member1030would be fabricated using a first molding process; forming a substantially rigid material into the sheath interlock member1030. The sheath interlock member1030would be assembled to the sheath1010by overmolding the sheath interlock member base1031onto the dorsal side1014of the sheath1010. A sheath interlock member overmolded retention feature1024would encapsulate the sheath interlock member base1031over the sheath1010, or in an alternative, the sheath interlock member base1031would be sandwiched between the sheath interlock member overmolded retention feature1024and a main body of the sheath1010. This is best shown in the cross sectioned views illustrated inFIGS. 30 and 31.

The sheath interlock member1030includes additional features similar to the sheath interlock member730adapted for an adjustable assembly between the sheath interlock member1030and a maxilla lip retention device1300(introduced inFIGS. 37 through 41). An interlock member riser segment1032extends generally perpendicular from an upper surface of the sheath interlock member base1031. An interlock member engagement segment1034extends generally perpendicular to the interlock member riser segment1032or generally parallel to the sheath interlock member base1031. The sheath interlock member1030would be oriented having the interlock member engagement segment1034extending in a forward direction and located above, parallel to, and in alignment with a longitudinal axis of the sheath1010. An interlock member positioning feature1036can be formed on a surface of the interlock member engagement segment1034, wherein the surface of the interlock member engagement segment1034is designed to engage with a mating surface of a positioning arm lateral segment1334(introduced inFIGS. 37 through 41) of the maxilla lip retention positioning arm1330. Details of the interlock member positioning feature1036will be introduced when describing an interlock member positioning feature1236of a sheath interlock member1230(introduced inFIGS. 37 through 41) later herein.

The tongue embracing member1000introduces a unique air extraction valve1040, which is best shown inFIGS. 32 and 33. The tongue embracing member1000is retained upon the individual's tongue300by creating a vacuum in the space between an interior surface1020of the sheath1010and a tongue surface302of the individual's tongue300. The air extraction valve1040must be designed with considerations of the vacuum. A common valve configuration pivots the unidirectional valve flap142inward, as shown inFIG. 4. It is noted that the employment of the vacuum could introduce a force that may draw the unidirectional valve flap142inward. This could introduce an unwarranted leak through the valve. The air extraction valve1040introduces an alternative valve configuration that is adapted with considerations of the implied vacuum forces.

The air extraction valve1040includes a valve flap1070that is pivotally assembled to the primary tubular structure of the air extraction valve1040by a valve hinge pin1072. The valve flap1070is designed to pivot outward, or away from the vacuum cavity or tongue receiving cavity1012of the sheath1010. The valve flap1070seats against an air extraction valve seal flange1046provided annually about an air extraction valve interior surface1044of the primary tubular structure of the air extraction valve1040. The valve flap1070toggles between a closed configuration (FIG. 32), sealing an air extraction valve seal flange orifice1047and an opened configuration (FIG. 33), exposing the air extraction valve seal flange orifice1047for airflow therethrough.

A valve operational handle1074extends outward from the valve flap1070. The valve flap1070and the valve operational handle1074are preferably located on opposite sides of the valve hinge pin1072. The valve operational handle1074is preferably located externally to the primary tubular structure of the air extraction valve1040, while the valve flap1070is located within an interior of the primary tubular structure of the air extraction valve1040. The valve flap1070is shaped and sized to seal against the air extraction valve seal flange1046within the interior of the primary tubular structure of the air extraction valve1040.

Details of an air extraction device1050in use are presented inFIGS. 32 and 33. The air extraction device1050includes a bulb air extraction tube1060extending outward from and in fluid communication with a bulb air extraction orifice1054of an air extraction bulb1052. The air extraction bulb1052is fabricated of a pliant material, such as rubber, silicone, soft plastic, and the like. The pliant material enables compression of the air extraction bulb1052to expel air from within an interior thereof. Elastic properties of the pliant material enable the air extraction bulb1052to return to a natural shape. As the air extraction bulb1052returns from a collapsed condition to a natural shape, the air extraction bulb1052draws air through an interior of the bulb air extraction tube1060, wherein the interior is defined by a bulb air extraction tube hollow interior1061. The air drawn by the air extraction bulb1052removes air from the tongue receiving cavity1012generating a vacuum.

The illustrations inFIGS. 32 and 33additionally present operation of the air extraction valve1040. The bulb air extraction tube1060includes features to rotate the valve flap1070, exposing the air passageway defined by the air extraction valve seal flange orifice1047. An air extraction tube lead-in1064is formed at a distal end of the bulb air extraction tube hollow interior1061. The air extraction tube lead-in1064can be a linear chamfer, a curved chamfer or of any other suitable shape. The air extraction tube lead-in1064extends between an initial opening having a diameter that is greater than a diameter of an air extraction valve exterior surface1042of the tongue bladder air extraction tube and a diameter of an air extraction tube seal surface1062, wherein the air extraction tube seal surface1062is of a shape and size to create a snug, airtight seal about the air extraction valve exterior surface1042of the tongue bladder air extraction tube. An optional valve insertion stop seat1066can be formed between the air extraction tube seal surface1062and a balance of the bulb air extraction tube hollow interior1061, wherein the valve insertion stop seat1066is a slight reduction in an interior diameter providing a stop placed against a distal end of the tongue bladder air extraction tube. The bulb air extraction tube hollow interior1061ensures against over insertion of the tongue bladder air extraction tube into the air extraction tube seal surface1062and could provide an additional seal between the tongue bladder air extraction tube and the bulb air extraction tube1060. As the bulb air extraction tube1060is slideably placed over the tongue bladder air extraction tube, the surface of the bulb air extraction tube1060engages with the valve operational handle1074. The relative motion between the tongue bladder air extraction tube and the air extraction valve1040pushes the valve operational handle1074forward, causing the valve assembly to pivot or rotate accordingly about the valve hinge pin1072. The rotation pivots the valve flap1070away from the air extraction valve seal flange1046, exposing the air extraction valve seal flange orifice1047defined by the air extraction valve seal flange1046, and enabling air to pass therethrough. As the tongue bladder air extraction tube is slideably positioned onto the air extraction valve exterior surface1042, the surfaces of the air extraction tube seal surface1062and the air extraction valve exterior surface1042contact one another forming an airtight seal. The user would compress the air extraction bulb1052either prior to the slideable insertion process or subsequent to the slideable insertion process. The compression forces air from the interior of the air extraction bulb1052. This is in preparation for a step of drawing a vacuum from the tongue receiving cavity1012. Once the air extraction device1050is secured to the air extraction valve1040, with the valve flap1070in an open configuration, the user would release the applied compression, the air extraction bulb1052expands, returning to its original shape, and the expansion draws air from the tongue receiving cavity1012, through an air extraction valve interior surface1044of the tongue bladder air extraction tube, through the air extraction valve seal flange orifice1047, and into the bulb air extraction orifice1054creating a vacuum between the interior surface1020and the tongue surface302. The vacuum generated retains the sheath1010in position on the tongue300of the user. The sheath interlock member1030would be assembled to a maxilla lip retention device1300(FIGS. 37 through 41) to draw the tongue300forward within the user's mouth to a desired position and retain the tongue300in the desired position. Details of this process will be described later herein.

The air extraction valve1040can include one or more features to aid in returning the valve flap1070to a sealed position. One such feature could be a biasing member, such as a cantilever spring. A second feature, presented inFIGS. 32 and 33, employs a magnetic force. One portion of a magnetically attracting pair of materials is a valve return control magnet1079. The valve return control magnet1079is carried by the valve operational handle1074. A second portion of a magnetically attracting pair of materials is a valve return control magnet1069. The valve return control magnet1069is carried by a distal end of the bulb air extraction tube1060. The magnetic attraction between the valve return control magnet1069and the valve return control magnet1079draws the valve operational handle1074away from the sheath1010as the bulb air extraction tube1060is separated from the tongue bladder air extraction tube, causing the valve operational handle1074to rotate, drawing the valve flap1070into a closed configuration against the air extraction valve seal flange1046. The vacuum generated within the tongue receiving cavity1012retains the valve flap1070in a closed configuration. Although the exemplary embodiment employs a magnetic attraction, it is understood that any temporary coupling can be utilized, including an adhesive grip, a mechanical engagement such as a snap feature, and the like.

An air extraction valve clearance1048can be formed within the tongue bladder air extraction tube, wherein the air extraction valve clearance1048provides a clearance for the valve flap1070as shown inFIG. 33. Since the air extraction valve clearance1048is formed on a portion of the tongue bladder air extraction tube outside of the airtight boundary defined by the tongue receiving cavity1012and the air extraction valve1040.

In the tongue embracing member1000, the sheath interlock member1030is assembled to the sheath1010by an overmolding process. The sheath interlock member1030can be assembled to the sheath1010using any suitable method. A tongue embracing member1100presents an alternative configuration for assembling a sheath interlock member1130to a sheath1110, as shown inFIGS. 34 through 36. The tongue embracing member1100is similar to the tongue embracing member1000, whereby the distinguishing features are described herein. Like features of the tongue embracing member1100and tongue embracing member1000are numbered the same except preceded by the numeral ‘11’. A sheath interlock member base1131of the sheath interlock member1130is shaped to contour to a surface associated with a dorsal side1114of a sheath1110of the tongue embracing member1100. The sheath interlock member base1131is defined by a peripheral boundary, more specifically a pair of sheath interlock member base longitudinal edges1133and a pair of sheath interlock member base lateral edges1135. An arrangement of channels1124,1126is formed on the portion of an exterior surface1122associated with the dorsal side1114of the sheath1110, wherein the arrangement of channels1124,1126are shaped and sized to receive and retain the sheath interlock member base1131on the exterior surface1122of the sheath1110. The arrangement of channels1124,1126includes a pair of lateral channels1126transversely arranged upon the exterior surface1122and a longitudinal channel1124extending between like ends of the pair of lateral channel1126, wherein the first channel segment1126, the third channel segment1124and the second channel segment1126collectively form a “U” shaped channel. Each lateral channel1126defines a lateral channel groove1125. The longitudinal channel1124defines a longitudinal channel groove1123. The sheath interlock member base lateral edge1135slides into the lateral channel groove1125. The lateral channel1126constrains the sheath interlock member1130against any longitudinal movement. The sheath interlock member base1131slides into the longitudinal channel groove1123. The longitudinal channel1124provides an insertion stop in a transverse direction to ensure proper alignment between an interlock member engagement segment1134and a longitudinal centerline of the sheath1110. This configuration enables low cost manufacturing of the tongue embracing member1100compared to the costs of a two part overmolding process by avoiding a step of inserting the sheath interlock member1030into the mold cavity used for fabricating the sheath1010and the additional machine costs for the additional movements of mold sections to accommodate the inserted sheath interlock member1030.

As previously described, the tongue embracing member1100is temporarily secured to the individual's tongue300by created a vacuum between the interior surface1120and the tongue surface302. The tongue embracing member1100introduces a sheath tongue sealing ridge1121, wherein the preferred design includes a sheath tongue sealing ridge1121circumscribing a peripheral edge of the interior surface1120. The sheath tongue sealing ridge1121acts as a gasket, enhancing the seal between the interior surface1120and the tongue surface302when subjected to the vacuum.

In the tongue embracing member1100, the sheath interlock member base1131is assembled to the sheath1110by sliding the sheath interlock member base1131into recessions1123,1125formed by channels1124,1126. The channel configuration positions a lower surface of the sheath interlock member base1131against the exterior surface1122of the sheath1110. In certain circumstance, this arrangement can potentially cause the interior surface1120to dislodge from the tongue surface302of the tongue300, resulting in a breach of the vacuum therein. A tongue embracing member1200presents an alternative channel configuration to accommodate this potential risk by including a channel riser feature1227, as shown inFIGS. 37 through 39. The tongue embracing member1200is similar to the tongue embracing member1100, whereby the distinguishing feature is the channel riser feature1227. Like features of the tongue embracing member1200and tongue embracing member1100are numbered the same except preceded by the numeral ‘12’. The channel riser feature1227introduces a space between the exterior surface1222of a sheath1210and a lower surface of a sheath interlock member base1231of a sheath interlock member1230. Properties of the channel riser feature1227introduces flexure thereof, reducing transfer of any torsional forces generated by a motion of the maxilla lip retention device1300translating through the sheath interlock member1230onto the sheath1210. This reduction in transfer of any generated torsional forces reduces any potential risk of breaching the vacuum forces between the interior surface1220and the tongue surface302of the tongue300.

The tongue embracing member1200is designed to draw the tongue300of the user forward. This positioning retention system can be employed for sleep apnea, during a surgical procedure to ensure the patient's tongue300does not become lodge in the patient's throat. The positioning retention system utilizes a position adjusting system created by features of the sheath interlock member1230, features of the maxilla lip retention positioning arm1330, and a position retaining member1350. The interlock member positioning feature1236of the interlock member engagement segment1234can be of any suitable grip enhancing feature. This can include a friction enhancing surface (adding texture, adding a material having a higher coefficient of friction, and the like), forming the surface of the interlock member engagement segment1234into a desired shape (such as a series of interlock member locking surface projection (peak)1284and interlock member locking surface recession (valley)1286as illustrated inFIGS. 40 and 41) and the like. In the exemplary embodiment, the interlock member positioning feature1236includes a series of interlock member locking surface projection (peak)1284and interlock member locking surface recession (valley)1286. The interlock member locking surface projections (peaks)1284and interlock member locking surface recessions (valleys)1286can be formed in any design to matingly engage with like positioning arm locking surface projections (peaks)1384and positioning arm locking surface recessions (valleys)1386formed on a mating surface of the positioning arm lateral segment1334. In the exemplary embodiment, the interlock member locking surface projections (peaks)1284and interlock member locking surface recessions (valleys)1286and the mating positioning arm locking surface projections (peaks)1384and positioning arm locking surface recessions (valleys)1386are linear in formation and equally spaced arranged. The interlock member locking surface projections (peaks)1284and interlock member locking surface recessions (valleys)1286and the mating positioning arm locking surface projections (peaks)1384and positioning arm locking surface recessions (valleys)1386can be formed at any angle respective to a longitudinal axis of the respective interlock member engagement segment1234, positioning arm lateral segment1334. In the exemplary embodiment, the interlock member locking surface projections (peaks)1284and interlock member locking surface recessions (valleys)1286and the mating positioning arm locking surface projections (peaks)1384and positioning arm locking surface recessions (valleys)1386are perpendicular to a longitudinal axis of the respective interlock member engagement segment1234, positioning arm lateral segment1334. More specifically, the interlock member locking surface projections (peaks)1284and interlock member locking surface recessions (valleys)1286and the mating positioning arm locking surface projections (peaks)1384and positioning arm locking surface recessions (valleys)1386are linear, oriented substantially parallel to one another, and equally spaced arranged.

Although the interlock member locking surface projections (peaks)1284and interlock member locking surface recessions (valleys)1286and the mating positioning arm locking surface projections (peaks)1384and positioning arm locking surface recessions (valleys)1386are shown as having a linear arrangement, it is understood that the interlock member locking surface projections (peaks)1284and interlock member locking surface recessions (valleys)1286and the mating positioning arm locking surface projections (peaks)1384and positioning arm locking surface recessions (valleys)1386can be of any suitable design, including a cross hatching, a series of bosses and embosses, a series of dimples and recessions, and the like.

The interlock member engagement segment1234and the associated positioning arm lateral segment1334are assembled together orienting mating surfaces contacting one another, as best shown inFIGS. 40 and 41.

The position retaining member1350at least partially circumscribes an external periphery defined by an assembly of the sheath interlock member arm1234and the maxilla lip retention subassembly segment1334. The position retaining member1350includes a position retaining member body1352preferably shaped as a tubular member. The position retaining member1350can be formed having a tubular rectangle shape, a tubular oblong shape, an elliptical shape, and the like, wherein the preferred shape would mimic the cross sectional shape of the assembly of the sheath interlock member arm1234and the maxilla lip retention subassembly segment1334. It is understood that the position retaining member1350can be fabricated in any suitable cross sectional shape, including a “C” channel shape, a “U” channel shape, any tubular shape, an “I” beam shape, or having any other suitable cross sectional design.

An interior distance1454spanning between an interior transverse or upper surface1354and an interior opposite transverse or lower surface1354of the position retaining member1350is sized enabling a sliding motion between the sheath interlock member arm1234and the maxilla lip retention subassembly segment1334when positioned at a location of the assembly having a narrow thickness (illustrated as the position retaining member1350presented in broken lines onFIG. 41) and restraining any sliding motion between the sheath interlock member arm and the maxilla lip retention subassembly arm when positioned at a location of the assembly having a wider thickness (illustrated as the position retaining member1350presented in solid lines onFIG. 41).

The position retaining member internal span1454would be of a dimension enabling separation between the interlock member engagement segment1234and the positioning arm lateral segment1334, thus disengaging the interlock member positioning feature1236(the interlock member locking surface projection (peak)1284and the interlock member locking surface recession (valley)1286) and the interlock member positioning feature1336(the positioning arm locking surface projection (peak)1384and the positioning arm locking surface recession (valley)1386) from one another, enabling a sliding motion1430. The interlock member engagement segment1234and the positioning arm lateral segment1334separates sufficiently enabling the interlock member locking surface projection (peak)1284and the positioning arm locking surface projection (peak)1384to slide over one another. The minimum dimension is identified as a teeth disengaged configuration assembly thickness1451(the distance between the interlock member position retaining member support surface1282and the position retaining member support surface1382when the interlock member engagement segment1234and the positioning arm lateral segment1334are separated from one another in a positionable configuration), as shown inFIG. 40. The position retaining member internal span1454must be at least equal to or greater than the teeth disengaged configuration assembly thickness1451.

The sliding motion1430enables positioning of the interlock member engagement segment1234and the positioning arm lateral segment1334relative to one another. This positioning properly locates the sheath1210, thus properly positioning and retaining the tongue300of the user as desired. It is noted that the design of the interlock member locking surface projection (peak)1284and the interlock member locking surface recession (valley)1286as well as the positioning arm locking surface projection (peak)1384and the positioning arm locking surface recession (valley)1386define a pitch, or the limitations for the change in a locked position. The finer the pitch (smaller the spatial gap between like features), the greater the adjustability of the position between the interlock member engagement segment1234and the positioning arm lateral segment1334.

Once the interlock member engagement segment1234and the positioning arm lateral segment1334are located in a desired position respective to one another, they are brought together, seating the interlock member locking surface projection (peak)1284into the respective positioning arm locking surface recession (valley)1386and similarly, seating the positioning arm locking surface projection (peak)1384into the respective interlock member locking surface recession (valley)1286. This reduces the dimension between the interlock member position retaining member support surface1282and the position retaining member support surface1382from the teeth disengaged configuration assembly thickness1451to a teeth engaged configuration assembly thickness1452(the distance between the interlock member position retaining member support surface1282and the position retaining member support surface1382when the interlock member engagement segment1234and the positioning arm lateral segment1334are brought together in a locked configuration), introduced inFIG. 41. Once the interlock member engagement segment1234and the positioning arm lateral segment1334are brought together, seating the interlock member locking surface projection (peak)1284into the respective positioning arm locking surface recession (valley)1386and similarly, seating the positioning arm locking surface projection (peak)1384into the respective interlock member locking surface recession (valley)1286, the position retaining member1350is repositioned in accordance with a position retaining member sliding motion1450from the adjustment position (shown in broken line) to a locked or retention position (shown in solid line). The position retaining member1350is moved into a region of the sheath interlock member1230having an interlock member thickness wedge shaped segment1283. The interlock member thickness wedge shaped segment1283is formed along a segment of at least one of the sheath interlock member arm1234and the maxilla lip retention subassembly segment1334. The interlock member thickness wedge shaped segment1283is formed as a changing thickness of the sheath interlock member arm1234(as shown) and/or the maxilla lip retention subassembly segment1334defining a tapering distal or outer surface. The interlock member thickness wedge shaped segment1283creates a wedge, increasing a dimension between opposite outer surfaces1382,1283, (referenced as a teeth engaged configuration assembly wedge section thickness1453), securing the position retaining member1350in position. The position retaining member1350retains engagement between the interlock member positioning feature1236and the interlock member positioning feature1336, thus retaining the positional relationship between the interlock member engagement segment1234and the positioning arm lateral segment1334. A position retaining member retention feature1289can be formed at a distal end of the interlock member engagement segment1234. The introduction of the position retaining member retention feature1289defines a position retaining member retention thickness1489. The position retaining member retention thickness1489is greater than the position retaining member internal span1454, thus keeping the position retaining member1350from becoming separated from the assembly. Similarly, a position retaining member retention feature1389can be formed at a distal end of the positioning arm lateral segment1334. The position retaining member retention feature1389provides the same function as the position retaining member retention feature1289, but at an opposite end of the assembly, thus ensuring against separation of the position retaining member1350from the assembly.

A tongue attachment subassembly1500, illustrated inFIGS. 42, 43, and 46 through 48, is yet another variant of the tongue attachment subassembly100. The exemplary tongue attachment subassembly1500is another variant adapted for treatment of sleep apnea. The tongue attachment subassembly1500and the tongue attachment subassembly100include a number of like elements. Like elements of the tongue attachment subassembly1500and the tongue attachment subassembly100are numbered the same, preceded by the numeral “15”. Orientation of sides of the tongue attachment subassembly1500is referenced by a dorsal side1514and a ventral side1516. Orientation of ends of the tongue attachment subassembly1500is referenced by a sheath distal end1518and a sheath proximal end1519.

Deviations between the tongue attachment subassembly1500and the tongue attachment subassembly100are identified herein. A sheath shape retention feature1528is formed extending rearward from the sheath distal end1518of a sheath1510. The sheath shape retention feature1528can be of any suitable size and shape to retain a structural and shape integrity during use. The sheath shape retention feature1528is preferably fabricated of the same material as the sheath1510. However, the sheath shape retention feature1528can be fabricated of a different material compared to the sheath1510. Similarly, a sheath proximal edge reinforcement feature1529is provided about the proximal edge of the sheath1510. The sheath proximal edge reinforcement feature1529increases the reliability of the sheath1510as well as a vacuum seal of a tongue receiving cavity1512when the tongue attachment subassembly1500is placed upon the patient's tongue300.

An air extraction valve1540is formed at a distal end of a tubular element1543extending forward from a distal end1518of the sheath1510. The air extraction valve1540includes a duckbill valve1542. A duck valve slit1546is cut through the end of the duckbill valve1542providing the resealing vacuum passageway. In use, the outer edges of the duckbill valve1542are compressed towards one another, causing the planar sections to arch, opening the duck valve slit1546. A vacuum is applied, drawing air from a volume between the individual's tongue300and the tongue engagement surface1520. The sheath proximal edge reinforcement feature1529provides a seal against a proximal end of the individual's tongue300. Upon removal of the vacuum draw, the remaining vacuum would draw the planar segments of the duckbill valve1542towards one another, sealing the duck valve slit1546.

A tongue protection insert1570, illustrated inFIGS. 44 and 45, can be included providing a feature which protects the tongue during the vacuum drawing process. The exemplary tongue protection insert1570includes a tongue protection insert interior or proximal flange1574formed at a proximal end of a tongue protection insert tubular body1572. The tongue protection insert interior or proximal flange1574is shaped having a tongue protection insert interior flange arched surface1575. A tongue protection insert orientation feature1579can be included in any portion of the tongue protection insert1570to provide guidance for an orientation of the tongue protection insert1570during installation of the tongue protection insert1570into the sheath1510. The exemplary tongue protection insert1570includes a pair of tongue protection insert orientation features1579, each tongue protection insert orientation feature1579formed at semicircular quadrants of the tongue protection insert interior or proximal flange1574. A tongue protection insert distal flange1576can be formed at a distal end of the tongue protection insert tubular body1572. The tongue protection insert interior or proximal flange1574and the tongue protection insert distal flange1576provides seals between the tongue protection insert1570and the valve passageway1543. Vacuum draw is provided through a tongue protection insert tubular body vacuum passageway1577and each of a series of tongue protection insert interior flange vacuum orifice1578. The series of tongue protection insert interior flange vacuum orifice1578segment the vacuum draw into smaller cross sectional areas to reduce the draw onto the individual's tongue300.

The tongue protection insert1570can be inserted into a valve passageway1543formed through the sheath distal end1518of the sheath1510. Orientation of the tongue protection insert1570can be provided by seating the tongue protection insert orientation feature1579against a tongue insert orientation feature1539provided within a flange receiving recess formed within the tongue engagement surface1520.

An accessory attachment feature can be provided at a sheath distal end1518of the sheath1510. The exemplary accessory attachment feature includes an interlock coupling groove1532located between an interlock coupling flange1530and a distal end of the sheath1510.

The tongue attachment subassembly1500is preferably fabricated of a uniform material and of a unitary construction. The duck valve slit1546would be formed using a secondary slitting process.

The tongue attachment subassembly1500can be combined with a tongue position retention bracket1600to create a sleep apnea treatment system, as illustrated inFIGS. 47 and 48.

The tongue position retention bracket1600includes a tongue position retention bracket assembly clip1632formed within a tongue position retention bracket body1610. A tongue position retention bracket assembly clip interior surface1634is formed as a C-shaped groove engaging surface of the tongue position retention bracket assembly clip1632. The tongue position retention bracket assembly clip interior surface1634circumscribes a circumference of greater than 180 degrees about the tongue position retention bracket assembly clip1632. A tongue position retention bracket assembly clip retention feature1636is formed at each end of the tongue position retention bracket assembly clip interior surface1634. The pair of tongue position retention bracket assembly clip retention feature1636is designed to retain the tongue position retention bracket assembly clip interior surface1634about the interlock coupling groove1532. The tongue position retention bracket body1610is shaped to comfortably contact a portion of a face of the patient with the tongue position retention bracket face contacting surface1612. This can include a lip, a chin, a cheek, or any other facial feature. In the exemplary embodiment, the tongue position retention bracket body1610is fabricated having an “S” shape in a radial direction. The exemplary “S” shape initially extends radially outward, then turning towards a proximal axial direction, and returning to a radially outward direction. The tongue position retention bracket body1610can additionally have a concave shape on a tongue position retention bracket face contacting surface1612and a convex shape on the exposed or exterior surface.

A tongue position retention bracket valve guard1640can extend forward from the exterior surface of the tongue position retention bracket body1610. The tongue position retention bracket valve guard1640would be shaped to guard the air extraction valve1540against inadvertent contact with other objects which might accidentally open the duck valve slit1546and disrupt the retained vacuum within the tongue receiving cavity1512.

The sleep apnea treatment system is assembled by inserting the tongue protection insert1570is inserted into the valve passageway1543of the tongue attachment subassembly1500, to a position where the tongue protection insert interior or proximal flange1574is seated within the respective cavity within the tongue receiving cavity1512, as best shown inFIG. 46.

The tongue attachment subassembly1500is placed onto the patient's tongue300in a manner similar to process described for the tongue attachment subassembly100. Air is removed from the tongue receiving cavity1512by drawing a vacuum through the duck valve slit1546of the air extraction valve1540and the series of tongue protection insert interior flange vacuum orifices1578, sealing the tongue receiving cavity1512against the individual's tongue300. The tongue protection insert interior flange arched surface1575in combination with the series of tongue protection insert interior flange vacuum orifices1578protects the tongue from being drawn into the tongue protection insert tubular body vacuum passageway1577. Once a sufficient vacuum is generated within the tongue receiving cavity1512, the vacuum is retained by closure of the duck valve slit1546by the duckbill valve1542, retaining the tongue attachment subassembly1500in position on the patient's tongue300.

The tongue position retention bracket1600is assembled to the tongue attachment subassembly1500by extending the patient's tongue300forward, then sliding the tongue position retention bracket assembly clip interior surface1634into the interlock coupling groove1532. The tongue position retention bracket assembly clip interior surface1634circumscribes a circumference of greater than 180 degrees about the tongue position retention bracket assembly clip1632. A tongue position retention bracket assembly clip retention feature1636is formed at each end of the tongue position retention bracket assembly clip interior surface1634. The two tongue position retention bracket assembly clip retention features1636are designed to retain the tongue position retention bracket assembly clip interior surface1634about the interlock coupling groove1532. When the tongue position retention bracket1600is assembled to the tongue attachment subassembly1500, the tongue position retention bracket valve guard1640is positioned to guard the air extraction valve1540against accidentally releasing the contained vacuum within the tongue receiving cavity1512.

After securing the tongue position retention bracket1600to the tongue attachment subassembly1500, the patient would relax their tongue300, drawing the patient's tongue300rearward until the tongue position retention bracket face contacting surface1612rests against the patient's face.

Although the above described process installs the tongue attachment subassembly1500onto the patient's tongue300prior to assembly of the tongue position retention bracket1600to the tongue attachment subassembly1500, it is understood that the tongue position retention bracket1600can be assembled to the tongue attachment subassembly1500prior to installing the tongue attachment subassembly1500onto the patient's tongue300. When using this process, the step of drawing a vacuum from the tongue receiving cavity1512requires added attention due to the installed tongue position retention bracket valve guard1640.

Once assembled and properly placed upon the patient, the sleep apnea treatment system would significantly reduce any potential effects of sleep apnea.

The sleep apnea treatment system would be removed by separating the tongue position retention bracket1600from the tongue attachment subassembly1500and compressing the sides of the duckbill valve1542, opening the duck valve slit1546, and releasing the vacuum from within the tongue receiving cavity1512.

As previously stated, the tongue positioning retention system can be employed for any of a number of applications that would benefit placement and retention of the individual's tongue300. This includes sleep apnea; during any medical procedure, such as those requiring delivery of a gas to a patient, delivery of oxygen to the patient, conscience sedation anesthesia, and the like; or any other application to ensure the patient's tongue300does not become lodged in the patient's throat, and the like.

For example, a tongue attachment subassembly1700can be adapted for use for in conjunction with a medical procedure to retain the patient's tongue from becoming lodged in the patient's throat, as illustrated inFIGS. 49 through 53. The tongue attachment subassembly1700can include features to cooperate with a gas management mask. The tongue attachment subassembly1700is a modified variant of the tongue attachment subassembly1500. Like features of the tongue attachment subassembly1700and the tongue attachment subassembly1500are numbered the same, except preceded by the numeral “17”. The tongue attachment subassembly1700is fabricated by removing the air extraction valve1540from the tongue attachment subassembly1500. The air extraction valve1540would be removed by shearing the material along the exterior surface of the interlock coupling flange1530to form the tongue attachment subassembly1700. The shearing can be accomplished using any suitable tool, such as a knife, a razor blade, a razor knife, scissors, and the like. After removing the air extraction valve1540from the tongue attachment subassembly1500, the function of the duck valve slit1546is replaced by a vacuum passageway1746.

A tongue protection insert1770is a modified version of the tongue protection insert1570. The tongue protection insert1770includes a tongue protection insert tubular vacuum tube retention barb1773formed along a portion of the tongue protection insert tubular body1772that extends outward from a distal or exterior surface of the interlock coupling flange1730.

A mask retention bracket1800is assembled to the tongue attachment subassembly1700forming a sedation procedure tongue retention system. The mask retention bracket1800and the tongue position retention bracket1600have like elements. The like elements of the mask retention bracket1800and the tongue position retention bracket1600are numbered the same, except preceded by the numeral “18”. The mask retention bracket1800includes an attachment feature for attaching the mask retention bracket1800to the tongue attachment subassembly1700. The exemplary attachment feature is a mask retention bracket assembly clip1832, which is like the tongue position retention bracket assembly clip1632. In the exemplary embodiment, the mask retention bracket1800includes a pair of mask retention bracket bodies1810, each mask retention bracket body1810extends radially outward from the mask retention bracket assembly clip1832, one mask retention bracket body1810mirroring the other mask retention bracket body1810. Each mask retention bracket body1810can be of any suitable shape to engage with and retain a gas management mask1900(FIGS. 52 and 53) in position. The exemplary mask retention bracket bodies1810are formed having an arched shape. The arch is formed having a convex outer or exposed surface and an opposite, concave inner or mask contacting surface1812.

The gas management mask1900is provided to aid in delivery of anesthetic gases and other gases, as well as to provide other management functions. The gas management mask1900includes a gas management mask body1910having a shape for covering a nose and mouth of a patient. Most gas management masks1900are commonly fabricated of a clear, transparent, or translucent flexible gas impervious material. A few gas management masks1900designs are of a frame styled structure and use a diffuser to deliver the gas. A rear edge of the gas management mask face seal1913defines a gas management mask face seal1913. A series of openings are provided passing through the gas management mask body1910for functional applications. A first opening is a vacuum delivery aperture (not identified, but understood as being provided for insertion of the tongue protection insert1770therethrough). A second opening is a gas delivery hose connection1920. The gas delivery hose connection1920retains a gas delivery hose1954in a desired position.

The gas management mask retention system is assembled by removing the air extraction valve1540from the tongue attachment subassembly1500to create the tongue attachment subassembly1700. The tongue protection insert1770is inserted into the valve passageway1743of the tongue attachment subassembly1700, to a position where the tongue protection insert interior flange1774is seated within the respective cavity within the tongue receiving cavity1712and a section of the tongue protection insert tubular body1772containing the tongue protection insert tubular vacuum tube retention barb1773extends forward from the exposed surface of the interlock coupling flange1730, as best shown inFIG. 51.

The tongue attachment subassembly1700is placed onto the patient's tongue300in a manner similar to process described for the tongue attachment subassembly100. Air is removed from the tongue receiving cavity1712by drawing a vacuum through the tongue protection insert tubular body vacuum passageway1777and the series of tongue protection insert interior flange vacuum orifices1778, sealing the tongue receiving cavity1712against the individual's tongue300. The tongue protection insert interior flange arched surface1775in combination with the series of tongue protection insert interior flange vacuum orifices1778protects the tongue from being drawn into the tongue protection insert tubular body vacuum passageway1777. A continuous vacuum flow would be provided by an external vacuum source drawn through a tongue protection insert vacuum supply line1754(FIG. 53), retaining the tongue attachment subassembly1700in position on the patient's tongue300.

The gas management mask1900is placed onto the tongue attachment subassembly1700by sliding the exposed portion of the tongue protection insert1770through an aperture formed through the gas management mask body1910. Once the gas management mask face seal1913is positioned against the patient's face, the mask retention bracket1800is assembled to the tongue attachment subassembly1700by sliding the mask retention bracket assembly clip interior surface1834into the interlock coupling groove1732. The mask retention bracket assembly clip interior surface1834circumscribes a circumference of greater than 180 degrees about the mask retention bracket assembly clip1832. A mask retention bracket assembly clip retention feature1836is formed at each end of the mask retention bracket assembly clip interior surface1834. The pair of mask retention bracket assembly clip retention feature1836is designed to retain the mask retention bracket assembly clip interior surface1834about the interlock coupling groove1732. The mask retention bracket body1810retains the gas management mask1900against the patient's face by applying a pressure from the mask contacting surface1812onto the surface of the gas management mask body1910. In turn, the gas management mask face seal1913creates a gas impervious seal against the patient's face.

The gas management mask1900can be inserted into the tongue protection insert vacuum supply line1754before installing the tongue attachment subassembly1700onto the patient's tongue300or the completed assembly can be placed upon the patient subsequent to the assembly process.

At some point during the assembly process a gas delivery hose1954is assembled to or inserted through the gas delivery hose connection1920of the gas management mask1900.

Once assembled and properly placed upon the patient, the gas management mask retention system can be used for delivery of any desired gas. It is recognized that the same gas management mask retention system can be adapted for use in delivering any desired gas, such as nitrous-oxide, oxygen, and the like, while maintaining the tongue in a forward position. The gas management mask retention system can be used with or without any other attachment mechanism, such as a mask strap. The configuration of the delivery system can be used to retain the gas management mask1900in position throughout any suitable procedure. It is understood that a common mask with a strap or any other suitable retention mechanism can be used, allowing the tongue attachment subassembly1700to be secured or removed while the mask is still on the patient. The inclusion of a strap will also reduce any stresses on the patient's tongue300.

The gas management mask retention y system would be removed by ceasing the vacuum from the external vacuum source. The removal of the vacuum from the tongue receiving cavity1712will release the tongue attachment subassembly1700from the patient's tongue300, allowing for removal of the gas management mask retention system from the patient. Once removed, the gas management mask retention delivery system can be disassembled.

Although the illustrations present versions of tongue embracing members having different features, it is understood that features of any exemplary tongue embracing members can be adapted to any of the other exemplary tongue embracing members.

As previously introduced, the interlock coupling groove1532enables the adaptation of the tongue attachment subassembly1500to any of a variety of applications. The interlock coupling groove1532is provided as an accessory attachment interface; being employed to receive and retain the accessory attachment. In the previous example, the tongue position retention bracket1600is attached to the tongue attachment subassembly1500by seating the interlock coupling groove1532of the tongue attachment subassembly1500into the tongue position retention bracket assembly clip interior surface1634of the tongue position retention bracket1600.

Another example is introduced inFIGS. 54 through 56. A tongue compression component2000is provided to retain a natural shape of a patient's tongue while wearing the tongue attachment subassembly1500. The tongue compression component2000utilizes the same scheme for assembly of the tongue compression component2000to the tongue attachment subassembly1500. The tongue compression component2000includes a pair of tongue compression arms2050,2060extending in a same direction, substantially parallel with one another from a tongue compression arm cantilever transition section2053. A tongue compression arm cantilever transition section2053,2063provides a transition between the tongue compression component assembly clip2032and each respective tongue compression arm2050,2060. Each exemplary tongue compression arm2050,2060is formed having an exposed tongue compression arm surface (identified by example as reference numeral2052for the upper tongue compression arm2050) and a contacting tongue compression arm surface (identified by example as reference numeral2061for the lower tongue compression arm2060).

The attachment scheme of the tongue compression component2000includes a tongue compression component assembly clip interior surface2034formed within a tongue compression component assembly clip2032. The tongue compression component assembly clip interior surface2034is preferably shaped having a circumference that is greater than 180 degrees; extending between a pair of tongue compression component assembly clip retention features2036. The shape of the tongue compression component assembly clip interior surface2034retains the tongue compression component2000upon the interlock coupling groove1532of the tongue attachment subassembly1500in a lateral direction. The two surfaces (outer and interior surfaces) of the tongue compression component assembly clip2032seat against each respective surface of the interlock coupling flange1530and the opposite surface defined by a body of the sheath1510. The flanged surfaces retain the tongue compression component2000in a longitudinal direction. The tongue compression component2000is assembled to the tongue attachment subassembly1500by sliding the tongue compression component assembly clip interior surface2034over the interlock coupling groove1532, in accordance with a tongue compression component assembly direction2098or restated in an opposite manner, by sliding the interlock coupling groove1532into the tongue compression component assembly clip interior surface2034. The tongue compression component assembly clip interior surface2034is seated onto the interlock coupling groove1532and secured with the tongue compression component assembly clip retention features2036, as shown inFIGS. 55 and 56.

As illustrated in the exemplary embodiment, each tongue compression arm2050,2060is formed having an arched shape. Each contacting tongue compression arm surface2061is formed having a convex shaped surface. Subsequently, each exposed tongue compression arm surface2052is formed having a concave surface. Each tongue compression arm2050,2060can have a constant thickness along a substantial portion of a length of the tongue compression arm2050,2060or the thickness can vary along the respective length. The thickness of a cantilevered element contributes to the bending properties of the element. By varying the thickness, the designer can control the bending properties of the tongue compression arms2050,2060, thus tailoring the force applied by the tongue compression component2000onto the patient's tongue310. In one example, the thickness of the tongue compression arms2050,2060can decrease in relation to a distance from the tongue compression arm cantilever transition section2053,2063.

Another contributor to the bending properties includes the modulus of elasticity of the material used to fabricate the tongue compression component2000.

The shape of the curve of the tongue compression arms2050,2060defines the point of contact or location of application of pressure upon the patient's tongue310, as shown inFIG. 58.

When worn, the tongue attachment subassembly1500has a tendency to reshape the patient's tongue from an oval shape into an unnatural, more rounded shape. The tongue compression component2000restores the patient's tongue310to the tongue's natural shape. Additionally, the combination of the tongue attachment subassembly1500and the tongue compression component2000can be utilized to treat sleep apnea.

The tongue compression component2000can be used with a tongue attachment subassembly1500inclusive of the sheath shape retention feature1528, as shown, or exclusive of the sheath shape retention feature1528. It is desirable to include the tongue protection insert1570within the valve passageway1543(FIG. 46) of the tongue attachment subassembly1500when using the tongue compression component2000with the tongue attachment subassembly1500. The tongue protection insert1570ensures a tip of the patient's tongue310is not drawn into the valve passageway1543by the vacuum formed within the tongue receiving cavity1512(FIG. 46) of the tongue attachment subassembly1500.

The tongue compression component2000can be modified by introducing a tooth/teeth engaging arrangement, as introduced as a teeth engaging tongue compression component2100illustrated inFIG. 57, and shown in use inFIG. 58. The teeth engaging tongue compression component2100is similar to the tongue compression component2000, with like elements of the teeth engaging tongue compression component2100being numbered in a similar manner as the tongue compression component2000, with a prefix of the numeral “21”.

The exemplary teeth engaging tongue compression component2100includes three pair of locating projections2154,2164;2156,2166;2158,2168. Each locating projection includes a first tooth contacting surface and a second tooth contacting surface. The exemplary teeth engaging tongue compression component2100includes an outer pair of locating projections2154,2164; a central pair of locating projections2156,2166; and an inner pair of locating projections2158,2168.

The outer locating projection2154provides a first and second outer locating projection tooth contacting surface2155. The outer locating projection2164provides a first and second outer locating projection tooth contacting surface2165. The central locating projection2156provides a first and second central locating projection tooth contacting surface2157. The central locating projection2166provides a first and second central locating projection tooth contacting surface2167. The inner locating projection2158provides a first and second inner locating projection tooth contacting surface2159. The inner locating projection2168provides a first and second inner locating projection tooth contacting surface2169.

The teeth engaging tongue compression component2100can be arranged comprising any of the following configurations or combinations thereof:(a) one tooth locating projection2154,2156,2158,2164,2166,2168on either the upper tongue compression arm2150or the lower tongue compression arm2160;(b) a pair of tooth/teeth locating projections extending outward from the same tongue compression arm2050,2060, more specifically any pair of tooth/teeth locating projections2154,2156,2158extending outward from the upper tongue compression arm2150or any pair of tooth/teeth locating projections2164,2166,2168extending outward from the lower tongue compression arm2160;(c) multiple tooth/teeth locating projections extending outward from the same tongue compression arm2150,2160, more specifically multiple tooth/teeth locating projections2154,2156,2158extending outward from the upper tongue compression arm2150or multiple tooth/teeth locating projections2164,2166,2168extending outward from the lower tongue compression arm2160;(d) a pair of tooth/teeth locating projections (2154,2164); (2156,2166); (2158,2168), a first respective tooth/teeth locating projection (2154,2156,2158) of the pair of tooth/teeth locating projections (2154,2164); (2156,2166); (2158,2168) extending outward from the upper tongue compression arm2150and a second respective tooth/teeth locating projection (2164,2166,2168) of the pair of tooth/teeth locating projections (2154,2164); (2156,2166); (2158,2168) extending outward from the lower tongue compression arm2160, or(e) any combination of the above.

Adjacent pairs of tooth/teeth locating projections on a same respective tongue compression arm2150,2160would be suitably spaced apart from one another to receive an anticipated tooth size.

It is understood that the same function can be obtained with a teeth engaging tongue compression component2100having a modified design. In an alternative configuration, the tooth/teeth locating projections and the respective tongue compression arm2150,2160can be formed as a single, unitary element, such as having a serpentine shape.

In use, the teeth engaging tongue compression component2100would be assembled to the tongue attachment subassembly1500in a manner as previously described for assembling of the tongue compression component2000onto the tongue attachment subassembly1500. The tongue attachment subassembly1500would be placed upon the patient's tongue310. As the tongue attachment subassembly1500is slid onto the patient's tongue310, the pair of tongue compression arms2150,2160applies a restoration and retention force to the patient's tongue310. The convex shaped surfaces2161of the tongue compression arms2150,2160applies a pressure to the patient's tongue310at a location proximate or slightly inward of a distal end of the patient's tongue310.

Air can be extracted from within the tongue receiving cavity1512or the volume/space between the surface of the patient's tongue310and the tongue engagement surface1520of the tongue attachment subassembly1500using any suitable method. The exemplary method utilizes the air extraction valve1540. The tongue protection insert1570protects the tip of the patient's tongue310from being drawn into the valve passageway1543.

The application of the tongue attachment subassembly1500upon the patient's tongue310can cause the patient's tongue310to be drawn inward from the sides and thicken or increase in dimension between the dorsal and ventral sides of the tongue. Conversely, the teeth engaging tongue compression component2100applies a restoring force to the patient's tongue310, where the compression force generated by the contacting surfaces2161of the pair of tongue compression arms2150,2160reduces the thickness between the dorsal and ventral sides of the tongue and broadens the width of the tongue, thus restoring the patient's tongue310to its natural shape.

The tooth/teeth locating projections2154,2156,2158,2164,2166,2168are located respective to the tongue compression component assembly clip2132to position the patient's tongue at a desired position within the patient's mouth respective to the patient's teeth320,322. The natural biting position of the patient's jaw retains the patient's teeth320,322within the gap between adjacent tooth/teeth locating projections2154,2156,2158,2164,2166,2168. The patient's teeth320,322would be restrained between two adjacent and facing locating projection tooth contacting surfaces (2155,2157)(2157,2159)(2165,2167)(2167,2169).

The position of the patient's tongue can be adjusted to optimize treatment for sleep apnea. The combination of the tongue attachment subassembly1500and the teeth engaging tongue compression component2100can include any of a number of options to modify the retained position of the patient's tongue310during use.

For example, several tongue compression components2100, each teeth engaging tongue compression component2100having a configuration that differs from the others, can be provided to adjust the position of the patient's tongue310.

In another example, the tongue compression component assembly clip2132can be adjustable respective to the tooth locating projections. The tongue compression arms2150,2160can be slideably assembled to the tongue compression component assembly clip2132, repositionably coupled to the tongue compression component assembly clip2132, or any other suitable adjusting process.

In yet another example, a wax material can be provided upon the exposed tongue compression arm surface2152of each of the tongue compression arms2150,2160. The patient would heat the wax material, install the assembly comprising the tongue attachment subassembly1500and the teeth engaging tongue compression component2100, place the patient's tongue at the desired position, than the patient would bite into the heated and softened wax. This process creates a mold of the patient's teeth320,322within the wax. The wax can be supported by one or more features to isolate any flexing of the tongue compression arms2150,2160from the wax formations.

The exemplary illustrations present a tongue compression component assembly clip2132having a thickness or a dimension spanning between a first flange engaging surface and a second flange engaging surface is substantially proximate a dimension spanning between a first (rearward or inner) flange surface1534and a second (forward or outer) flange surface1536defining the interlock coupling groove1532. This arrangement can be modified to accommodate an adjustment scheme. In a modified arrangement, the thickness of the tongue compression component assembly clip2132can be reduced to a dimension2133that is shorter than the span1533of an interlock coupling groove1532aor the span1533aof the interlock coupling groove1532acan be extended. A spacer ring2180,2182having a thickness2181,2183that is the difference between the thickness2133of the tongue compression component assembly clip2132and the span1533of the interlock coupling groove1532a. Alternatively, the arrangement can employ a plurality of spacers2180,2182, where the sum of the thicknesses2181,2183of the plurality of spacers2180,2182equals the difference between the thickness2133of the tongue compression component assembly clip2132and the span1533of the interlock coupling groove1532, as illustrated inFIGS. 59 and 60. The positioning of the teeth engaging tongue compression component2100is adjusted by varying a placement of the spacer2180,2182or plurality of spacers2180,2182. For example, in one arrangement illustrated inFIG. 59, the at least one spacer2180,2182can be inserted between the tongue compression component assembly clip2132and the forward or outer flange surface1536within the interlock coupling groove1532a. This positions the teeth engaging tongue compression component2100rearward. In an alternative arrangement illustrated inFIG. 60, a first set comprising at least one spacer2180,2182can be inserted between the tongue compression component assembly clip2132and the rearward or inner flange surface1534within the interlock coupling groove1532and a second set comprising at least one spacer2180,2182can be inserted between the tongue compression component assembly clip2132and the forward or outer flange surface1536within the interlock coupling groove1532. This positions the teeth engaging tongue compression component2100centrally within the groove1532a. In yet another alternative arrangement (not illustrated, but well understood based uponFIGS. 59 and 60), the at least one spacer2180,2182can be inserted between the tongue compression component assembly clip2132and the rearward or inner flange surface1534within the interlock coupling groove1532. This positions the teeth engaging tongue compression component2100forward.

Once the assembly comprising the tongue attachment subassembly1500and the teeth engaging tongue compression component2100are properly secured in the patient's mouth, the patient can go to sleep and being treatment for sleep apnea.

Although the details presented herein, as illustrated inFIG. 58, utilize the teeth engaging tongue compression component2100to maintain the patient's tongue at a desired position, sleep apnea may be treated simply using the tongue compression component2000. The uses of the combination of the tongue attachment subassembly1500and tongue compression component2000could sufficiently reposition and comfortably retain the patient's tongue in a position to provide the same affect and treatment for sleep apnea.

The advantages of the tongue compression component2000can be adapted to another beneficial component: an orbital tongue shaping device2200, as illustrated inFIGS. 61 through 63. The orbital tongue shaping device2200is designed to provide the same reshaping of the patient's tongue310as the tongue compression component2000. The orbital tongue shaping device2200applies the reshaping forces reward of the position where the reshaping forces are applied by the tongue compression component2000.

The orbital tongue shaping device2200is formed having an oval cross-sectioned shape, the section being taken along a transverse direction. The orbital tongue shaping device2200includes a orbital tongue shaping device body2210, wherein the orbital tongue shaping device body2210can be described as having a plurality of segments, including: a orbital tongue shaping device body dorsal segment2212extending between and contiguous with upper portions of a orbital tongue shaping device body left side segment2216and a orbital tongue shaping device body right side segment2218and a orbital tongue shaping device body ventral segment2214(being similar to the orbital tongue shaping device body dorsal segment2212) extending between and contiguous with lower portions of the orbital tongue shaping device body left side segment2216and the orbital tongue shaping device body right side segment2218.

One or more of the segments2212,2214,2216,2218can be shaped having an arch extending in along a longitudinal axis (extending between a leading edge2222and a trailing edge2224). Each segment would include a concave surface on an orbital tongue shaping device body interior surface2230of the orbital tongue shaping device2200. In a design where the thickness of each segment is consistent there-across, the orbital tongue shaping device body exterior surface2220of each segment would have a concave shape extending between the leading edge2222and the reward edge or trailing edge2224of each respective segment2212,2214,2216,2218. The leading edge2222of at least one and preferably both of the orbital tongue shaping device body dorsal segment2212and the orbital tongue shaping device body ventral segment2214is shaped having a forward leaning arch, where the central portion of the leading edge2222is forward of each respective left and right edges thereof or extending away from a center of the orbital tongue shaping device2200. The trailing or rearward edge2224of at least one and preferably both of the orbital tongue shaping device body dorsal segment2212and the orbital tongue shaping device body ventral segment2214is shaped having a forward leaning arch, where the central portion of the trailing or rearward edge2224is forward of each respective left and right edges thereof or extending towards the center of the orbital tongue shaping device2200.

The orbital tongue shaping device2200is sized to generate or apply a dorsal tongue compression force2242inward from an interior surface of the orbital tongue shaping device body dorsal segment2212, a ventral tongue compression force2244inward from an interior surface of the orbital tongue shaping device body ventral segment2214, a left side tongue compression force2246inward from an interior surface of the orbital tongue shaping device body left side segment2216, and a right side tongue compression force2248inward from an interior surface of the orbital tongue shaping device body right side segment2218. The dorsal tongue compression force2242and the ventral tongue compression force2244are provided as equal and opposite forces. Similarly, the left side tongue compression force2246and the right side tongue compression force2248are provided as equal and opposite forces. The result of the applied forces2242,2244,2246,2248, as illustrated inFIG. 63, cause the patient's tongue to extend forward in accordance with a resulting tongue forward expansion2250and thicken (increase in a distance between the dorsal and ventral sides of the patient's tongue310), in accordance with a resulting tongue thickening2252.

The orbital tongue shaping device2200can be used in conjunction with the tongue attachment subassembly1500or used independently. When the orbital tongue shaping device2200is used in conjunction with the tongue attachment subassembly1500, the orbital tongue shaping device2200would be slideably assembled onto the sheath1510of the tongue attachment subassembly1500in accordance with an orbital tongue shaping device assembly direction2298, as illustrated inFIG. 61. The leading edge2222would be oriented towards the air extraction valve1540and the trailing edge2224would be oriented towards the sheath proximal end1519. The tongue attachment subassembly1500can include or exclude the sheath shape retention feature1528. The shape of the orbital tongue shaping device2200would take into considerations the inclusion or exclusion of the sheath shape retention feature1528on the tongue attachment subassembly1500. Considerations for the presence of the sheath shape retention feature1528can include a shaping of the arches of the segments2212,2214,2216,2218, by including a recess within the respective orbital tongue shaping device body interior surface2230of the orbital tongue shaping device body dorsal segment2212and/or the orbital tongue shaping device body ventral segment2214to accommodate for the shape and size of the sheath shape retention feature1528.

Since the orbital tongue shaping device2200is designed to provide restoration forces2242,2244,2246,2248at a more central position on the patient's tongue, compared to the more forward position of the restoration forces applied by the tongue compression component2000, it is understood that the tongue compression component2000, the orbital tongue shaping device2200, and the tongue attachment subassembly1500can be used together if so desired.

The exemplary embodiment of the orbital tongue shaping device2200illustrated herein is a separate element and slideably assembled onto the sheath1510of the tongue attachment subassembly1500. The exemplary tongue attachment subassembly1500includes a sheath shape retention feature1528. In an alternative arrangement, the features of the orbital tongue shaping device2200can be integrally formed with the sheath1510of the tongue attachment subassembly1500. More specifically, the body of the sheath1510can be increased in thickness in a shape modeled after the orbital tongue shaping device2200. In another alternative arrangement, a shape resembling the orbital tongue shaping device2200can be formed of a stiffer material on the sheath1510using a two shot molding process or any other suitable manufacturing process for molding a component of two different materials.

REFERENCE ELEMENT DESCRIPTIONS

Ref No. Description