APPARATUS FOR GRADUATED LATERAL ROTATION OF A SLEEP SURFACE

BACKGROUND

The subject matter disclosed herein relates generally to adverse event mitigation devices, systems, and methods and, more particularly, but not exclusively, to devices, systems, and methods for the prevention and treatment of sleep apnea. These devices, systems, and methods may include an active intervention, a passive intervention, or a continuous intervention. The embodiments described herein may also be effective in reducing snoring.

While various adverse event mitigation devices, systems, and methods have been developed, there is still room for improvement. Thus, a need persists for further contributions in this area of technology.

SUMMARY

The present disclosure includes one or more of the features recited in the appended claims and/or the following features which, alone or in any combination, may comprise patentable subject matter.

In one aspect, a lateral rotation apparatus includes a person support surface comprising head, torso and leg segments each having an independently rotatable person support plane. A first adjustable frame is positioned below the head segment and operable to rotate the head segment of the person support surface to a head tilt angle. The first adjustable frame includes an upper frame, a lower frame, and a linkage assembly connecting the upper frame of the first adjustable frame to the lower frame of the first adjustable frame. The linkage assembly includes at least one link that is operable to rotate the upper frame of the first adjustable frame with respect to the lower frame of the first adjustable frame such that the upper frame of the first adjustable frame is angled with respect to the lower frame of the first adjustable frame to provide a head tilt angle approximately at a centerline of the head segment that is in the range of about 7 to about 30 degrees relative to a horizontal support plane. A second adjustable frame is positioned below the torso segment and operable to rotate the torso segment of the person support surface to a torso tilt angle. The second adjustable frame includes an upper frame, a lower frame, and a linkage assembly connecting the upper frame of the second adjustable frame to the lower frame of the second adjustable frame. The linkage assembly of the second adjustable frame includes at least one link that is operable to rotate the upper frame of the second adjustable frame with respect to the lower frame of the second adjustable frame such that the upper frame of the second adjustable frame is angled with respect to the lower frame of the second adjustable frame to provide a torso tilt angle approximately at a centerline of the torso segment that is in the range of about 5 to about 10 degrees less than the head tilt angle. The first adjustable frame and the second adjustable frame provide a graduated lateral rotation of the person support surface.

In some embodiments, the first adjustable frame and the second adjustable frame are not connected. In some embodiments, the lower frame of the first adjustable frame and the lower frame of the second adjustable frame are integrally formed, and the upper frame of the first adjustable frame moves independently of the upper frame of the second adjustable frame. In some embodiments, the upper frame of the first adjustable frame and the upper frame of the second adjustable frame are in contact with the person support surface.

In some embodiments, a jack is coupled to the upper frame and lower frame of the first adjustable frame and is operable to actuate the linkage assembly of the first adjustable frame. In some embodiments, the jack includes a lock to maintain a rotational angle of the upper frame of the first adjustable frame with respect to the lower frame of the first adjustable frame. In some embodiments, a jack is coupled to the upper frame and lower frame of the second adjustable frame and is operable to actuate the linkage assembly of the second adjustable frame. In some embodiments, the jack includes a lock to maintain a rotational angle of the upper frame of the second adjustable frame with respect to the lower frame of the second adjustable frame.

In some embodiments, the lower frame of the first adjustable frame includes a plurality of slots. The at least one link of the first adjustable frame is coupled to the upper frame of the first adjustable frame at a first end such that a second end of the at least one link is positionable within one of the plurality of slots of the lower frame of the first adjustable frame. In some embodiments, an angle of the upper frame of the first adjustable frame with respect to the lower frame of the first adjustable frame is determined by a position of a slot of the plurality of slots in which the second end of the at least one link of the first adjustable frame is positioned. In some embodiments, the lower frame of the second adjustable frame includes a plurality of slots. The at least one link of the second adjustable frame is coupled to the upper frame of the second adjustable frame at a first end such that a second end of the at least one link is positionable within one of the plurality of slots of the lower frame of the second adjustable frame. In some embodiments, an angle of the upper frame of the second adjustable frame with respect to the lower frame of the second adjustable frame is determined by a position of a slot of the plurality of slots in which the second end of the at least one link of the second adjustable frame is positioned.

In some embodiments, the at least one link of the first adjustable frame includes a four-bar linkage. In some embodiments, the at least one link of the second adjustable frame includes a four-bar linkage. In some embodiments, the at least one link of the first adjustable frame includes a gas spring. In some embodiments, the at least one link of the second adjustable frame includes a gas spring.

In some embodiments, an actuator connects the upper frame of the first adjustable frame to the lower frame of the first adjustable frame. The actuator actuates the at least one link of the first adjustable frame. In some embodiments, the actuator includes an electromechanical device. In some embodiments, an actuator connects the upper frame of the second adjustable frame to the lower frame of the second adjustable frame. The actuator actuates the at least one link of the second adjustable frame. In some embodiments, the actuator includes an electromechanical device.

In some embodiments, the torso segment is rotated to a torso tilt angle approximately at a centerline of the torso segment in the range of about zero to about 25 degrees.

In some embodiments, the head segment is rotated to a head tilt angle approximately at a centerline of the head segment in the range of about 10 to about 15 degrees. In such an embodiment, the torso segment is rotated to a torso tilt angle approximately at a centerline of the torso segment in the range of about 5 to about 10 degrees.

In some embodiments, a third adjustable frame is positioned below the leg segment and is operable to rotate the leg segment to a leg tilt angle approximately at a centerline of the leg segment in the range of about 0 to about 5 degrees.

In some embodiments, the person support surface includes a support material having a density. The head tilt angle is a function of the density of the support material. In some embodiments, the torso tilt angle is a function of the density of the support material.

In another aspect, a lateral rotation apparatus includes a first adjustable frame positioned under a head segment of a person support surface and operable to rotate the head segment of the person support surface to a head tilt angle approximately at a centerline of the head segment in the range of about 7 to about 30 degrees relative to a horizontal support plane. A second adjustable frame is positioned under a torso segment of the person support surface and is operable to rotate the torso segment of the person support surface to a torso tilt angle approximately at a centerline of the torso segment that is within a range of about 5 degrees to about 10 degrees less than the head tilt angle. The first adjustable frame and the second adjustable frame provide a graduated lateral rotation of the person support surface. Each of the first adjustable frame and the second adjustable frame includes an upper frame, a lower frame, and a linkage assembly connecting the upper frame to the lower frame. The linkage assembly includes at least one link that is operable to rotate the upper frame with respect to the lower frame.

In some embodiments, the first adjustable frame and the second adjustable frame are not connected. In some embodiments, the lower frame of the first adjustable frame and the lower frame of the second adjustable frame are integrally formed. The upper frame of the first adjustable frame moves independently of the upper frame of the second adjustable frame. In some embodiments, the upper frame is in contact with the person support surface.

In some embodiments, a jack is coupled to the upper frame and lower frame and is operable to actuate the linkage assembly. In some embodiments, the jack includes a lock to maintain a rotational angle of the upper frame with respect to the lower frame.

In some embodiments, the lower frame includes a plurality of slots. The at least one link is coupled to the upper frame at a first end such that a second end of the at least one link is positionable within one of the plurality of slots of the lower frame. In some embodiments, an angle of the upper frame with respect to the lower frame is determined by a position of a slot of the plurality of slots in which the second end of the at least one link is positioned.

In some embodiments, the at least one link includes a four-bar linkage. In some embodiments, the at least one link includes a gas spring. In some embodiments, an actuator connects the upper frame to the lower frame. The actuator actuates the at least one link. In some embodiments, the actuator includes an electromechanical device.

In some embodiments, the torso segment is rotated to a torso tilt angle approximately at a centerline of the torso segment in the range of about zero to about 25 degrees.

Additional features, which alone or in combination with any other feature(s), such as those listed above and/or those listed in the claims, can comprise patentable subject matter and will become apparent to those skilled in the art upon consideration of the following detailed description of various embodiments exemplifying the best mode of carrying out the embodiments as presently perceived.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the accompanying figures in which:

FIG. 1 is a perspective view of a patient support surface illustrated as a mattress;

FIG. 2 is a perspective view of a lateral rotation apparatus in accordance with an embodiment and positioned between the patient support apparatus and a horizontal support plane illustrated as a box spring;

FIG. 3 is a side view of the lateral rotation apparatus positioned between the patient support apparatus and a horizontal support plane illustrated as a box spring;

FIG. 4 is a head view of the lateral rotation apparatus positioned between the patient support apparatus and a horizontal support plane illustrated as a box spring;

FIG. 5 is a perspective view of a lateral rotation apparatus in accordance with an embodiment and in a first position;

FIG. 6 is a perspective view of a lateral rotation apparatus in accordance with an embodiment and in a second position;

FIG. 7 is a perspective view of a lateral rotation apparatus in accordance with another embodiment;

FIG. 8 is a perspective view of a lateral rotation apparatus in accordance with yet another embodiment;

FIG. 9 is a perspective view of a lateral rotation apparatus in accordance with a further embodiment;

FIG. 10 is a perspective view of a lateral rotation apparatus in accordance with an embodiment;

FIG. 11 is a perspective view of a lateral rotation apparatus in accordance with another embodiment;

FIG. 12 is a perspective view of a lateral rotation apparatus in accordance with a further embodiment and in a collapsed configuration;

FIG. 13 is a perspective view of the lateral rotation apparatus of FIG. 11 in an extended configuration.

FIG. 14 is an MRI of a user laying on a support system in accordance with an embodiment.

FIG. 15 is a graph showing a minimum airway area in relation to various tilt angles.

FIG. 16 is a graph of sleep surface orientations versus a minimum sagittal distance taken in a retroglossal region of a user positioned on the sleep surface;

FIG. 17 is a graph of sleep surface orientations versus an average sagittal distance taken in a retroglossal region of a user positioned on the sleep surface;

FIG. 18 is a graph of sleep surface orientations versus a minimum airway area taken in a retroglossal region of a user positioned on the sleep surface; and

FIG. 19 is a graph of sleep surface orientations versus a minimum airway area taken in a retropalatal region of a user positioned on the sleep surface.

FIGS. 20A-20C illustrate an exemplary matrix of torso angles versus head angles that may be used to improve POSA and reduce the number of Apnea-Hypopnea Index events.

DETAILED DESCRIPTION

While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific exemplary embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

The embodiments described herein relate to devices, systems and methods to reduce the occurrence and/or duration of or prevent sleep apnea events and/or snoring. The embodiments demonstrate efficacy in preventing mild to moderate obstructive sleep apnea, with improved tolerability relative to current therapy (i.e., CPAP).

The described devices, systems and methods are not limited to the specific embodiments described herein. In addition, components of each device, system and/or steps of each method may be practiced independent and separate from other components and method steps, respectively, described herein. Each component and method also can be used in combination with other systems and methods.

Referring to FIG. 1, a support system 100 includes a support surface having one or more support sections that are angled to form a lateral support plane that prevents or restricts the user from sleeping in a supine position, and, more specifically, reduces a time duration that the user sleeps with his/her upper respiratory tract oriented vertically or at an undesirable lateral rotational angle with respect to a vertical plane substantially perpendicular to a horizontal plane of the support surface. In certain embodiments, the lateral rotational angle of the user's head with respect to the vertical plane is at least 30 degrees and, more specifically, at least 45 degrees. In an alternative embodiment, the lateral rotational angle of the user's head with respect to the vertical plane may be less than 30 degrees. In one embodiment, the support sections provide multiple support planes for supporting the user's body.

In one embodiment as shown in FIG. 1, a support system 100 suitable for supporting a user, such as a person, for example, includes plurality of support sections, namely a first or leg support section 102 forming a first support plane 104, a second or torso support section 106 forming a second support plane 108, and a third or head support section 110 forming a third support plane 112 that collectively define a multi-plane, sleep surface 114 that may be progressively angled along a longitudinal axis 115 of support system 100, from a first or bottom edge 116 of sleep surface 114 to an opposing second or top edge 118 of sleep surface 114, resulting in relatively greater rotation of the upper respiratory tract of the user (as necessary for efficacy in preventing obstructive apnea) and relatively lesser rotation in the lower body of the user (resulting in greater comfort and perceived stability by avoiding rotation of a majority of the user's body mass).

Unlike conventional positional therapies for the prevention of obstructive sleep apnea, which attempt to manipulate the user's sleep position and/or orientation using rotation of one plane, in certain embodiments the system described herein uses multiple support planes formed by one or more support sections to laterally rotate the user. For example, in one embodiment, two support sections provide two separate support planes, with a first support plane defined by the first support section configured to support the torso and the legs of the user, and a second support plane defined by the second support section configured to support the neck and the head of the user.

In an alternative embodiment, three support sections provide three separate support planes, with a first support plane defined by the first support section configured to support the legs of the user, a second support plane defined by the second support section configured to support the torso of the user, and a third support plane defined by the third support section configured to support the head of the user.

In a further alternative embodiment, more than three support sections, for example, numerous independent support sections having a length in a longitudinal direction of sleep surface 114 of 2-18 inches or, more specifically, 4-12 inches, or, even more specifically, 6 inches, provide a corresponding number of separate support planes. Each support section can be laterally rotated independently of other support sections to collectively form sleep surface 114. In a particular embodiment, the numerous support sections can be combined to form separate support sections, for example, creating a first support section having a length of 18 inches in the longitudinal direction at the foot of the support surface, an adjacent second support section having a length of 12 inches in the longitudinal direction, and a third support section adjacent the second support section having a length in the longitudinal direction of 6 inches. In these embodiments, the support sections forming the support planes can be rotated as necessary or desired to achieve an optimal configuration that is clinically effective (i.e., prevents apnea) and demonstrates acceptable tolerance (i.e., allows the user to sleep comfortably). In an alternative embodiment, a continuously sloped sleep surface is formed by a plurality of support sections without step increases in lateral rotational angle; this is illustrated as a sleep surface with an infinite number of support sections.

In the embodiments described herein, the length in the longitudinal direction of each support section and defined support plane (and the resulting location of transitions between support planes) is designed to achieve clinical efficacy and tolerability. Therefore, a specific length can be defined in a number of configurations, including without limitations: (a) generic plane dimensions (e.g., based on average body geometry, a length of a torso section of the user defined so that when an average user's head is supported by a head support section, a transition between the torso support section and the leg support section occurs below the user's S3 vertebrae); (b) customized plane dimensions (e.g., a torso support plane has a suitable length in the longitudinal direction appropriate to the user's leg length, torso length, and/or a distance from the user's shoulder to his/her inseam); or (c) dynamic plane dimensions (e.g., transitions selected on dynamic surface appropriate to user, selection being either user-selected, care-giver defined, or automatically calculated).

Referring to FIGS. 2-4, a lateral rotation apparatus 200 is provided in the form of a frame positioned between the support system 100 and a horizontal support plane 124 to provide a gradual lateral rotation of the support system 100. In the illustrative embodiment, the lateral rotation apparatus 200 includes a first adjustable frame 202, a second adjustable frame 204, and a third adjustable frame 206. The frames 202, 204, 206 are illustrated as individual separate frames that are not connected. In one embodiment, the frames 202, 204, 206 may be joined by a linkage assembly or the like that enables each frame 202, 204, 206 to be individually adjusted. Additionally or alternatively, the frames 202, 204, 206 may be secured together, for example at a base of each frame 202, 204, 206 such that each frame 202, 204, 206 is independently adjustable. The frames 202, 204, 206 may be formed from metal, plastic, or any other material suitable for supporting the support system 100.

The first frame 202 is positioned below the support section 110. The first frame 202 is operable to rotate the support section 110 to position the support section 110 at a head tilt angle relative to the horizontal support plane 124. For example, the first frame 202 may rotate the support section 110 to a head tilt angle approximately at a centerline of the head segment in the range of about 7 to about 30 degrees relative to a horizontal support plane. The second frame 204 is positioned below the support section 106. The second frame 204 is operable to rotate the support section 106 to a torso tilt angle relative to the horizontal support plane 124. For example, the second frame 204 may rotate the support section 106 to a torso tilt angle approximately at a centerline of the torso segment that is within a range of about 5 degrees to about 10 degrees less than the head tilt angle. The third frame 206 is positioned below the support section 102. The third frame 206 is operable to rotate the support section 102 to a leg tilt angle relative to the horizontal support plane 124. For example, the third frame 206 may rotate the support section 102 to a leg tilt angle approximately at a centerline of the leg segment in the range of about 0 to about 5 degrees. It should be noted that the measured rotation of the corresponding support section 102, 106, 110 is measured approximately at a centerline of the support section 102, 106, 110. A remainder of the support section 102, 106, 110 may have a different slope due to a weight of the support system 100, e.g. the mattress, a density of the support system 100, and/or a weight of an individual on the support surface. That is, the tilt angle within a particular support section 102, 106, 110 may vary throughout the support system 100. Generally, the frames 202, 204, 206 slope the support system 100 such that gradual lateral rotation is achieved between the support sections 102, 106, and 110.

Each of the frames 202, 204, 206 includes a lower frame 208 and an upper frame 210. The lower frame 208 is positioned on the horizontal support plane 124 with the upper frame 210 positioned thereabove. The support system 100 is positioned on the upper frame 210. The upper frame 210 is coupled to the lower frame 208 and rotatable with respect thereto. In one example, the upper frame 210 may be hingedly coupled to the lower frame 208. In such an embodiment, the upper frame 210 rotates about the hinge. The upper frame 210 rotates with respect to the lower frame 208 to create the desired head tilt angle, torso tilt angle, and leg tilt angle, respectively.

In one embodiment, the support system 100 is a mattress, wherein each of the support sections 102, 106, 110 are integrally formed. Alternatively, the support sections 102, 106, 110 may be separately formed. In yet another embodiment, only some of the support sections 102, 106, 110 may be integrally formed, for example support sections 102, 106 may be integrally formed or support sections 106, 110 may be integrally formed. The mattress may be any conventional mattress, i.e. spring mattress, pillow top mattress, foam mattress, air mattress, etc. or any suitable mattress utilized in a healthcare setting. The horizontal support plane 124 may be formed along a box spring, frame, or any other suitable device for retaining a mattress.

In certain embodiments, each support section defining the corresponding support surface is independently rotatable about an axis extending parallel with a longitudinal axis of the support system. The independent rotation of each support section allows the caregiver or the user ability to focus on progressively increasing an angle of rotation in one or more support sections having support planes positioned to support the torso of the user, and the neck and/or the head of the user. In certain embodiments, a rotational angle at which the one or more support planes defined by the support sections configured to support the neck and/or the head of the user is positioned is greater that a rotational angle of the one or more support planes defined by the support sections configured to support the torso of the user, which is greater than a rotational angle at which the one or more support planes defined by the support sections configured to support the legs of the user is positioned.

In a particular embodiment, the support plane defined by the support section configured to support the legs and the torso of the user is positioned at a rotational angle of approximately 10° with respect to a base plane of the support section, while the support plane defined by the support section configured to support the head of the user is positioned at a rotational angle of approximately 20° with respect to a base plane of the support section. In an alternative embodiment, a first support plane defined by the support section configured to support the legs of the user is positioned at a rotational angle of approximately 10° with respect to a base plane of the first support section, a second support plane defined by a second support section configured to support the torso of the user is positioned at a rotational angle of approximately 15° with respect to a base plane of the second support section, and a third support plane defined by the third support section configured to support the head of the user is positioned at a rotational angle of approximately 20° with respect to a base plane of the third support section. In alternative embodiments, the support planes can be positioned at any suitable rotational angle including any suitable lateral rotational angle and/or any suitable longitudinal rotational angle.

In a particular embodiment, first support section 102 defines support plane 104 positioned at a lateral rotational angle a of approximately 20° to approximately 30° approximately at a centerline of the first support section 102, or more specifically, approximately 20° to approximately 25°, or, even more specifically, approximately 25° with respect to the horizontal support plane 124. Second support section 106 defines support plane 108 positioned at a lateral rotational angle β of approximately 10° to approximately 20° approximately at a centerline of the support section 106, or more specifically, approximately 10° to approximately 15°, or, even more specifically, approximately 15°, with respect to the horizontal support plane 124. Third support section 110 defines support plane 112 positioned at a lateral rotational angle γ of approximately 5° to approximately 15° approximately at a centerline of the third support section 110, or more specifically, approximately 10°, with respect to the horizontal support plane 124. Other lateral rotational angles and step increases in lateral rotational angles between each support section may also be used to achieve a progressive lateral rotational angle.

Each of first support section 102, second support section 106, and third support section 110 has a respective height in a direction perpendicular to longitudinal axis 115 of support system 100. In one embodiment, first support section 102 has a maximum height from the horizontal support plane 124 to support plane 104 in a direction perpendicular to longitudinal axis 115 of 14 to 18 inches approximately at a centerline of the first support section 102, or more specifically, 16 to 17 inches; second support section 106 has a maximum height from the horizontal support plane 124 to support plane 108 in a direction perpendicular to longitudinal axis 115 of 8 to 12 inches approximately at a centerline of the second support section 106, or more specifically, 9 to 10 inches; and third support section 110 has a maximum height from the horizontal support plane 124 to support plane 112 in a direction perpendicular to longitudinal axis 115 of 4 to 8 inches approximately at a centerline of the third support section 110, or more specifically, 6 to 7 inches. As a result, the support sections can be designed with desired heights and defining support planes positioned at desired rotational angles such that support system 100 provides a composite longitudinal plane angle (e.g., reverse Trendelenburg angle), to facilitate the prevention and/or treatment of sleep apnea as well as to improve tolerability.

In one embodiment, each of support sections 102, 106, 110 are rotatable about longitudinal axis 115 to provide sleep surface 114 having a right side slope or, alternatively, a left side slope to allow the user to sleep on his/her right side or left side, respectively. In certain embodiments, support sections 102, 106, 110 are formed of more than one material, for example, two or more materials, such as two foam materials, having different densities, with the less dense material covering the denser material.

In this embodiment, support system 100 allows the user to sleep on either his/her right side or left side, based on the user's sleeping preference. This sleeping preference may not be static. For example, if the user has an injury, an ache, or a desire to change his/her sleeping preference, the orientation of sleep surface 114 can be changed at any time to accommodate the user's sleeping preference. The orientation can be changed from day to day or during the night. Moreover, from a manufacturing standpoint, a versatile support system 100 prevents having to manufacture and distribute a sleep surface 114 having a right side slope and a separate sleep surface 114 having a left side slope, which would increase production and distribution costs. Finally, a potential purchaser would not have to commit to a sleep side before purchasing the product, which might be a deterrent to purchasing the product.

As described herein, sleep surface 114 is customizable to anthropometric dimensions of the individual user to facilitate support surface performance that optimizes or matches the design intent—the body position of the user will prevent or limit undesirable sleep apnea episodes and provide improved comfort. As illustrated in FIG. 3, the support sections 102, 106, 110 are not sloped evenly, e.g. the support sections 102, 106, 110 do not slope in a straight line. Rather the support sections 102, 106, 110 slope at different angles when sloping from head to foot or side to side.

Referring to FIG. 5 an exemplary adjustable frame 300 includes a lower frame 302 and an upper frame 304. The frame 300 may be positioned under any one of the support section 102, the support section 106, or the support section 110. The lower frame 302 includes a fixed end 306 that is coupled to a fixed end 308 of the upper frame 304 at a hinge 310. The upper frame 304 rotates with respect to the lower frame 302 about the hinge 310 so that an end 312 of the upper frame 304 that is opposite the fixed end 308 moves with respect to an end 314 of the lower frame 302 that is opposite the fixed end 306. The upper frame 304 rotates with respect to the lower frame 302 to create a desired angle as described above. For example, the frame 300 may be utilized to create a desired head tilt angle, torso tilt angle, or leg tilt angle.

The lower frame 302 includes a plurality of ribs 320 defining a plurality of slots 322 between adjacent ribs 320. The upper frame 304 includes a leg 324 coupled thereto at a pivot point 326. A fixed end 328 of the leg 324 rotates about the pivot point 326 so that a free end 330 of the leg 324 moves with respect to the upper frame 304. The free end 330 of the leg 324 is configured to be positioned within one of the slots 322 such that an angle of the upper frame 304 with respect to the lower frame 302 is fixed. As shown in FIG. 5, by positioning the leg 324 is a slot 322 adjacent the end 314 of the lower frame 302 a first angle is formed between the upper frame 304 and the lower frame 302.

As shown in FIG. 6, moving the leg 324 to the slot 322 adjacent the fixed end 306 of the lower frame 302 positions the upper frame 304 at a second angle with respect to the lower frame 302, wherein the second angle is smaller than the first angle. Intermediate angles between the first angle and the second angle may be achieved by positioning the leg 324 in a slot 322 between the slot 322 adjacent the fixed end 306 and the slot 322 adjacent the end 314. Accordingly, the angle of the upper frame 304 with respect to the lower frame 302 is adjustable to any of the above-referenced angles by positioning the leg 324 in one of the plurality of slots 322.

Referring to FIG. 7, an exemplary adjustable frame 350 includes a lower frame 352 and an upper frame 354. The frame 350 may be positioned under any one of the support section 102, the support section 106, or the support section 110. The lower frame 352 includes a first end 356 and a second end 358. The upper frame 354 includes a first end 360 and a second end 362. A first rotating arm 364 is pivotally coupled to both the first end 356 of the lower frame 352 and the first end 360 of the upper frame 354. A second rotating arm 366 is pivotally coupled to both the second end 358 of the lower frame 352 and an intermediate position of the upper frame 354 between the first end 360 and the second end 362. A telescoping arm 368 extends from the rotating arm 366 to another intermediate position of the upper frame 354 between the second end 362 and the coupling position of the rotating arm 366 on the upper frame 354.

The telescoping arm 368 includes a base arm 370 that is pivotally coupled to the rotating arm 366 and a movable arm 372 that is pivotally coupled to the upper frame 354. The moveable arm 372 extends and retracts with respect to the base arm 370. The base arm 370 includes a biasing mechanism (not shown) therein that retains a position of the moveable arm 372 with respect to the base arm 370. For example, the biasing mechanism may be a gas or a spring. The moveable arm 372 is configured to move between a plurality of extended and retracted positions with respect to the base arm 370. The moveable arm 372 is retained in position by the biasing mechanism.

As the moveable arm 372 extends, the upper frame 354 is rotated with respect to the lower frame 352. The rotating arms 364, 366 each rotate with respect to both the lower frame 352 and the upper frame 354 so that the second end 360 of the upper frame 354 is moved away from the second end 358 of the lower frame 352. That is, a height of the second end 360 of the upper frame 354 relative to the lower frame 352 is increased, thereby increasing an angle of the upper frame 354 relative to the lower frame 352. The biasing mechanism retains the moveable arm 372 to retain the angle of the upper frame 352 relative to the lower frame 354.

As the moveable arm 372 retracts, the upper frame 354 is rotated with respect to the lower frame 352. The rotating arms 364, 366 each rotate with respect to both the lower frame 352 and the upper frame 354 so that the second end 360 of the upper frame 354 is moved toward the second end 358 of the lower frame 352. That is, a height of the second end 360 of the upper frame 354 relative to the lower frame 352 is decreased, thereby decreasing an angle of the upper frame 354 relative to the lower frame 352. The biasing mechanism retains the moveable arm 372 to retain the angle of the upper frame 352 relative to the lower frame 354.

The moveable arm 372 may be retained by the biasing mechanism at any position between fully retracted and fully extended. Accordingly, the upper frame 354 may be retained at a plurality of angles relative to the lower frame 352, wherein the range of angles is dependent on the length of the telescoping arm 368. Particularly, the telescoping arm 368 may be selected to extend and retract within a first range of lengths, thereby provided a first range of angles. Likewise, the telescoping arm 368 may be selected to extend and retract within a second range of lengths that is greater or less than the first range of lengths to provide a second ranges of angles that are greater or less than the first range of angles, respectively. Accordingly, the angle of the upper frame 354 with respect to the lower frame 352 is adjustable to any of the above-referenced angles by adjusting a length of the telescoping arm 368 by extending and retracting the moveable arm 372.

Referring to FIG. 8, an exemplary adjustable frame 400 includes a lower frame 402 and an upper frame 404. The frame 400 may be positioned under any one of the support section 102, the support section 106, or the support section 110. The lower frame 402 includes a pair of tracks 406 extending a length of the lower frame 402. Another pair of tracks 408 extends a length of the upper frame 404. A pair of rotating arms 410 couple the lower frame 402 to the upper frame 404. A rotating end 412 of each rotating arm 410 is secured to a corner 414 of the lower frame 402. A sliding end 416 of each rotating arm 410 is secured to a track 408 of the upper frame 404. The sliding end 416 of each rotating arm 410 is configured to move laterally within the respective track 408. A second pair or rotating arms 418 also couples the lower frame 402 to the upper frame 404. A rotating end 420 of each rotating arm 418 is secured to a corner 422 of the upper frame 404. A sliding end 424 of each rotating arm 418 is secured to a track 406 of the lower frame 402. The sliding end 424 of each rotating arm 418 is configured to move laterally within the respective track 406.

In a collapsed position (not shown), the upper frame 404 is positioned on top of and aligned with the lower frame 402. The upper frame 404 rotates with respect to the lower frame 402 to an extended position, shown in FIG. 8. To rotate into the extended position, the rotating arms 410 are rotated about the rotating end 412, while the rotating arms 418 are rotated about the rotating end 420. Rotation of the rotating arms 410 causes the sliding end 416 of the rotating arms 410 to move or slide within the respective track 408. Likewise, rotation of the rotating arms 418 causes the sliding end 424 of the rotating arms 418 to move or slide within the respective track 406. Because the arms 418 are greater in length than the arms 410, the upper frame 404 is angled with respect to the lower frame 402 when the lateral rotation apparatus 400 is in the extended position, as illustrated in FIG. 8.

In some embodiments, adjustable frames 400 may be provided in various sizes. For example, the lower frame 402 and the upper frame 404 may be provided in various sizes. Likewise, the rotating arms 410 and 418 may be provided in various lengths. The sizes may be configured to provide a particular distance between the upper frame 404 and the lower frame 402, when the adjustable frame 400 is in the extended position. Accordingly, the distance between the upper frame 404 and the lower frame 402 and the angle of the upper frame 404 relative to the lower frame 402 are adjustable to achieve any of the above-referenced angles. For example, the frame 400 may be utilized to create a desired head tilt angle, torso tilt angle, or leg tilt angle.

Referring to FIG. 9, an exemplary adjustable frame 500 is configured as a four-bar linkage. The frame 500 may be positioned under any one of the support section 102, the support section 106, or the support section 110. The adjustable frame 500 includes a lower frame 502 and an upper frame 404. A pair of rotating arms 510 couple the lower frame 502 to the upper frame 504. An end 512 of each rotating arm 510 is secured to the lower frame 502. An end 516 of each rotating arm 510 is secured to an intermediate position 508 of the upper frame 504. A second pair or rotating arms 518 also couples the lower frame 502 to the upper frame 504. An end 520 of each rotating arm 518 is secured to the upper frame 504. An end 524 of each rotating arm 518 is secured to an intermediate position 506 of the lower frame 502.

In a collapsed position (not shown), the upper frame 504 is positioned on top of and aligned with the lower frame 502. The upper frame 504 rotates with respect to the lower frame 502 to an extended position, shown in FIG. 9. To rotate into the extended position, the rotating arms 510 are rotated about both ends 512 and 516, while the rotating arms 518 are rotated about the both ends 520 and 524. A stabilizing arm 530 extends between the ends 512 of the rotating arms 510 and the ends 520 of the rotating arms 518 to retain the adjustable 500 in the extended position. Because the arms 518 are greater in length than the arms 510, the upper frame 504 is angled with respect to the lower frame 502 when the lateral rotation apparatus 500 is in the extended position, as illustrated in FIG. 9.

In some embodiments, adjustable frames 500 may be provided in various sizes. For example, the lower frame 502 and the upper frame 504 may be provided in various sizes. Likewise, the rotating arms 510 and 518 may be provided in various lengths. The sizes may be configured to provide a particular distance between the upper frame 504 and the lower frame 502, when the adjustable frame 500 is in the extended position. Accordingly, the distance between the upper frame 504 and the lower frame 502 and the angle of the upper frame 504 relative to the lower frame 502 are adjustable to achieve any of the above-referenced angles. For example, the frame 500 may be utilized to create a desired head tilt angle, torso tilt angle, or leg tilt angle.

Referring to FIG. 10, an exemplary adjustable frame 600 includes a lower frame 602 and an upper frame 604. The frame 600 may be positioned under any one of the support section 102, the support section 106, or the support section 110. The lower frame 602 includes a fixed end 606 that is coupled to a fixed end 608 of the upper frame 604 at a hinge 610. The upper frame 604 rotates with respect to the lower frame 602 about the hinge 610 so that an end 612 of the upper frame 604 that is opposite the fixed end 608 moves with respect to an end 614 of the lower frame 602 that is opposite the fixed end 606. Movement of the upper frame 604 with respect to the lower frame 602 may be controlled by any one of a telescoping arm, a hydraulic arm, an actuator, a jack, a gas spring, or the like. The upper frame 604 rotates with respect to the lower frame 602 to create a desired angle as described above. For example, the frame 600 may be utilized to create a desired head tilt angle, torso tilt angle, or leg tilt angle.

Referring to FIG. 11, an exemplary adjustable frame 700 includes a lower frame 702 and an upper frame 704. The frame 700 may be positioned under any one of the support section 102, the support section 106, or the support section 110. The lower frame 702 includes a fixed end 706 that is coupled to a fixed end 708 of the upper frame 704 at a hinge 710. The upper frame 704 rotates with respect to the lower frame 702 about the hinge 710 so that an end 712 of the upper frame 704 that is opposite the fixed end 708 moves with respect to an end 714 of the lower frame 702 that is opposite the fixed end 706. Movement of the upper frame 704 with respect to the lower frame 702 is controlled by a telescoping hydraulic arm 718 that may be spring powered, gas powered, or the like. A pair of rotating arms 716 is coupled to both the upper frame 704 and the lower frame 702. The rotating arms 716 rotated about both the lower frame 702 and the upper frame 704 to control a motion of the upper frame 704 with respect to the lower frame 702. The rotating arms 716 may also provide stability to the upper frame 704 when the upper frame 704 is extended from the lower frame 702. The upper frame 704 rotates with respect to the lower frame 702 to create a desired angle as described above. For example, the frame 700 may be utilized to create a desired head tilt angle, torso tilt angle, or leg tilt angle.

Referring to FIGS. 11 and 12, an exemplary adjustable frame 900 includes a lower frame 902 and an upper frame 904. The frame 900 may be positioned under any one of the support section 102, the support section 106, or the support section 110. The lower frame 902 includes a pair of tracks 906. A slide 908 extends between the pair of tracks 906 and is movably coupled to each of the pair of tracks 906. The slide 908 is configured to move along the pair of tracks 906. A pair of first arms 910 is fixed to the lower frame 902 at an end 911 and the upper frame 904. A pair of second arms 912 is fixed to the slide 908 and the upper frame 904. The first arm 910 and the second arm 912 are crossed in an X-configuration.

A screw 914 extends through one of the first arms 910 and is secured to one of the second arms 912. A screw 916 extends through the other of the first arms 910 and is secured to the other of the second arms 912. The screws 94 and 916 may be manually operated or operated by a motor 918. The screws 914 and 916 are actuated to move the slide 908 along the tracks 906. Moving the slide 908 causes the arms 910 and 912 to operate in a scissor motion. Particularly, when the slide 908 away from the end 911, the arms 910 and 912 are opened so that the upper frame 904 is positioned substantially adjacent to the lower frame 902 in a collapsed position, as illustrated in FIG. 12. As the slide 908 moves toward the end 911, the arms 910 and 912 are closed so that the upper frame 904 moves upward from the lower frame 902 to an extended position, as illustrated in FIG. 13. Accordingly, the upper frame 904 is raised with respect to the lower frame 902 by adjusting a position of the slide 908 to achieve any of the above-referenced angles. Additionally, an angle of the upper frame 904 relative to the lower frame 902 is increased as the upper frame 904 is raised relative to the lower frame 902. The frame 900 may be utilized to create a desired head tilt angle, torso tilt angle, or leg tilt angle as described above.

It should be appreciated that any of the adjustable frames described above may be operable with an actuator, for example, a motor, a jack, a screw jack, a hydraulic cylinder, a crank, or the like.

Referring to FIG. 14, a sagittal distance 998 is defined in the airway of a user. The sagittal distance 998 is defined as an area of the user's esophagus that is opened while the user is laying on the support system 100. As illustrated in the graphs described below, the head tilt angle, the torso tilt angle and the leg tilt angle affects the sagittal distance 998 of the user.

Referring to FIG. 15, a graph is provided showing a minimum airway area in relation to various tilt angles. Based on prior research in the field of sleep medicine, it was believed that a subject with Positional Obstructive Sleep Apnea (POSA) will suffer a disproportionate number of Apnea-Hypopnea Index events (or number of airway obstructions) when in the supine position than in the non-supine positon (i.e., upper airway rotated 90 degrees away from vertical). It has been assumed that changes in the airway would be either linear as the upper airway is rotated from vertical to 90 degrees from vertical, or more likely that the relationship be more binary, and that changes in the upper airway would be primarily seen once the upper airway was rotated to at or about 90 degrees from vertical.

However, based on research using Magnetic Resonance Imaging of the upper airways of patient previously diagnosed with POSA, this was not the case. Rather, in relevant measurements of the upper airway (for example, measurement of the minimum airway area in the retroglossal region), the relationship between head/torso support and minimum airway area was neither linear nor binary between 0 degree and 90 degree positons. As illustrated in FIG. 15, the research found that minimum airway area increased much more rapidly than a linear relationship and reached that level of improvement far before the 90 degree positon.

From point 950 (head angle at 0 degrees, torso angle at 0 degrees), head angle increases by 2.5 degrees until it is 5 degrees greater than the torso angle, so at point 952 the head angle is at 5 degrees and the torso angle is at 0 degrees, after which the head and torso angles each increase by 2.5 degrees until the head degree reaches 90 degrees at point 960, after which the torso angle increases by 2.5 degrees until both the head and torso angles are at 90 degrees at point 962. In FIG. 15, minimum airway area is plotted at point 950 (head angle at 0 degrees, torso angle at 0 degrees), point 954 (head angle at 15 degrees, torso angle at 10 degrees), point 956 (head angle at 20 degrees, torso angle at 15 degrees), point 958 (head angle at 22.5 degrees, torso angle at 17.5 degrees) and point 962 (head angle at 90 degrees, torso angle at 90 degrees), with the linear extrapolation between the measurements at point 950 and point 962 shown as line 964.

Referring to FIGS. 16-19, specific examples of measured sagittal distances 998 are represented through a series of graphs. It should be noted that the examples and data represented in the graphs of FIGS. 16-19 are exemplary only and non-limiting. It will be appreciated that various studies may be provided that result in other examples of data.

Referring to FIG. 16, the graph 1000 illustrates sleep orientations on the x- axis versus a minimum sagittal distance on the y-axis in the retroglossal region of a user positioned on the sleep surface 114. As illustrated by line 1002, the minimum sagittal distance for a user in the supine position with the head at 0° with respect to the horizontal support plane 124 and the torso at 0° with respect to the horizontal support plane 124 is between approximately 6.25 mm²and approximately 7.75 mm²with a mean minimum sagittal distance of approximately 7 mm². As illustrated by line 1004, the minimum sagittal distance for a user with the lateral rotation apparatus rotating the head at 15° with respect to the horizontal support plane 124 and rotating the torso at 10° with respect to the horizontal support plane 124 is between approximately 8 mm²and approximately 9.5 mm²with a mean minimum sagittal distance of approximately 8.75 mm². As illustrated by line 1006, the minimum sagittal distance for a user with the lateral rotation apparatus rotating the head at 20° with respect to the horizontal support plane 124 and rotating the torso at 15° with respect to the horizontal support plane 124 is between approximately 7.75 mm²and approximately 9 mm²with a mean minimum sagittal distance of approximately 8.5 mm². As illustrated by line 1008, the minimum sagittal distance for a user with the lateral rotation apparatus rotating the head at 22.5° with respect to the horizontal support plane 124 and rotating the torso at 17.5° with respect to the horizontal support plane 124 is between approximately 8 mm²and approximately 9.75 mm²with a mean minimum sagittal distance of approximately 8.75 mm². As illustrated by line 1010, the minimum sagittal distance for a user lying on their side is between approximately 7.75 mm²and approximately 9.5 mm²with a mean minimum sagittal distance of approximately 8.5 mm². Accordingly, the user of the sleep surface 114 has a greater minimum sagittal distance when lying with the head at 22.5° with respect to the horizontal support plane 124 and rotating the torso at 17.5° with respect to the horizontal support plane 124 or when lying with the head at 15° with respect to the horizontal support plane 124 and rotating the torso at 10° with respect to the horizontal support plane 124. In all positions on the lateral rotation apparatus 200, the user has a greater minimum sagittal distance when compared to lying supine.

Referring to FIG. 17, the graph 1100 illustrates sleep orientations on the x- axis versus an average sagittal distance on the y-axis taken in a retroglossal region of a user positioned on the sleep surface 114. As illustrated by line 1102, the average sagittal distance for a user in the supine position with the head at 0° with respect to the horizontal support plane 124 and the torso at 0° with respect to the horizontal support plane 124 is between approximately 10.25 mm²and approximately 11.75 mm²with a mean average sagittal distance of approximately 11.25 mm². As illustrated by line 1104, the average sagittal distance for a user with the lateral rotation apparatus rotating the head at 15° with respect to the horizontal support plane 124 and rotating the torso at 10° with respect to the horizontal support plane 124 is between approximately 11.75 mm²and approximately 13.5 mm²with a mean average sagittal distance of approximately 12.5 mm². As illustrated by line 1106, the average sagittal distance for a user with the lateral rotation apparatus rotating the head at 20° with respect to the horizontal support plane 124 and rotating the torso at 15° with respect to the horizontal support plane 124 is between approximately 11.75 mm²and approximately 13.5 mm²with a mean average sagittal distance of approximately 12.5 mm². As illustrated by line 1108, the average sagittal distance for a user with the lateral rotation apparatus rotating the head at 22.5° with respect to the horizontal support plane 124 and rotating the torso at 17.5° with respect to the horizontal support plane 124 is between approximately 12.25 mm²and approximately 13.75 mm²with a mean average sagittal distance of approximately 13.25 mm². As illustrated by line 1110, the average sagittal distance for a user lying on their side is between approximately 12 mm²and approximately 13.75 mm²with a mean average sagittal distance of approximately 12.75 mm². Accordingly, the user of the sleep surface 114 has a greater average sagittal distance when lying with the head at 22.5° with respect to the horizontal support plane 124 and rotating the torso at 17.5° with respect to the horizontal support plane 124. In all positions on the lateral rotation apparatus 200, the user has a greater average sagittal distance when compared to lying supine.

Referring to FIG. 18, the graph 1200 illustrates sleep orientations on the x-axis versus a minimum airway area on the y-axis taken in the retroglossal region of a user positioned on the sleep surface 114. As illustrated by line 1202, the minimum airway area in the retroglossal region for a user in the supine position with the head at 0° with respect to the horizontal support plane 124 and the torso at 0° with respect to the horizontal support plane 124 is between approximately 105 mm²and approximately 150 mm²with a mean minimum airway area in the retroglossal region of approximately 130 mm². As illustrated by line 1204, the minimum airway area in the retroglossal region for a user with the lateral rotation apparatus rotating the head at 15° with respect to the horizontal support plane 124 and rotating the torso at 10° with respect to the horizontal support plane 124 is between approximately 140 mm²and approximately 180 mm²with a mean minimum airway area in the retroglossal region of approximately 160 mm². As illustrated by line 1206, the minimum airway area in the retroglossal region for a user with the lateral rotation apparatus rotating the head at 20° with respect to the horizontal support plane 124 and rotating the torso at 15° with respect to the horizontal support plane 124 is between approximately 140 mm²and approximately 185 mm²with a mean minimum airway area in the retroglossal region of approximately 185 mm². As illustrated by line 1208, the minimum airway area in the retroglossal region for a user with the lateral rotation apparatus rotating the head at 22.5° with respect to the horizontal support plane 124 and rotating the torso at 17.5° with respect to the horizontal support plane 124 is between approximately 130 mm²and approximately 175 mm²with a mean minimum airway area in the retroglossal region of approximately 155 mm². As illustrated by line 1210, the minimum airway area in the retroglossal region for a user lying on their side is between approximately 130 mm²and approximately 180 mm²with a mean minimum airway area in the retroglossal region of approximately 155 mm². In all positions on the lateral rotation apparatus 200, the user has a greater average sagittal distance when compared to lying supine. For example, the user of the sleep surface 114 has a 24.6% greater mean minimum airway area than lying supine when lying with the head at 15° with respect to the horizontal support plane 124 and the torso at 10° with respect to the horizontal support plane 124 or when lying with the head at 20° with respect to the horizontal support plane 124 and the torso at 15° with respect to the horizontal support plane 124.

Referring to FIG. 19, the graph 1300 illustrates sleep orientations on the x- axis versus a minimum airway area on the y-axis taken in the retropalatal region of a user positioned on the sleep surface 114. As illustrated by line 1302, the minimum airway area in the retropalatal region for a user in the supine position with the head at 0° with respect to the horizontal support plane 124 and the torso at 0° with respect to the horizontal support plane 124 is between approximately 62.5 mm²and approximately 85 mm²with a mean minimum airway area in the retropalatal region of approximately 72.5 mm². As illustrated by line 1304, the minimum airway area in the retropalatal region for a user with the lateral rotation apparatus rotating the head at 15° with respect to the horizontal support plane 124 and rotating the torso at 10° with respect to the horizontal support plane 124 is between approximately 57.5 mm²and approximately 77.5 mm²with a mean minimum airway area in the retropalatal region of approximately 67.5 mm². As illustrated by line 1306, the minimum airway area in the retropalatal region for a user with the lateral rotation apparatus rotating the head at 20° with respect to the horizontal support plane 124 and rotating the torso at 15° with respect to the horizontal support plane 124 is between approximately 65 mm²and approximately 87.5 mm²with a mean minimum airway area in the retropalatal region of approximately 75 mm². As illustrated by line 1308, the minimum airway area in the retropalatal region for a user with the lateral rotation apparatus rotating the head at 22.5° with respect to the horizontal support plane 124 and rotating the torso at 17.5° with respect to the horizontal support plane 124 is between approximately 57.5 mm²and approximately 82.5 mm²with a mean minimum airway area in the retropalatal region of approximately 70 mm². As illustrated by line 1310, the minimum airway area for a user lying on their side is between approximately 55 mm²and approximately 82.5 mm²with a mean minimum airway area in the retropalatal region of approximately 70 mm². The user of the sleep surface 114 has a greater mean minimum airway area in the retropalatal region than lying supine when lying with the head at 20° with respect to the horizontal support plane 124 and the torso at 15° with respect to the horizontal support plane 124.

FIGS. 20A-20C illustrate an exemplary matrix 1400 of torso angles 1402 versus head angles 1404 that may be used to improve POSA and reduce the number of Apnea-Hypopnea Index events. The area 1406 illustrates combinations of torso angles 1402 and head angles 1404 that are generally considered unacceptable for improving POSA and reducing the number of Apnea-Hypopnea Index events. The area 1408 illustrates combinations of torso angles 1402 and head angles 1404 that are generally considered suboptimal for improving POSA and reducing the number of Apnea-Hypopnea Index events. The area 1410 illustrates combinations of torso angles 1402 and head angles 1404 that are generally considered good or fair for improving POSA and reducing the number of Apnea-Hypopnea Index events. The area 1412 illustrates combinations of torso angles 1402 and head angles 1404 that are generally considered very good for improving POSA and reducing the number of Apnea-Hypopnea Index events. The area 1414 illustrates combinations of torso angles 1402 and head angles 1404 that are generally considered excellent for improving POSA and reducing the number of Apnea-Hypopnea Index events.

Following from the above description and invention summaries, it should be apparent to those of ordinary skill in the art that, while the methods and apparatuses herein described constitute exemplary embodiments of the present invention, the invention contained herein is not limited to this precise embodiment and that changes may be made to such embodiments without departing from the scope of the invention as defined by the claims. Additionally, it is to be understood that the invention is defined by the claims and it is not intended that any limitations or elements describing the exemplary embodiments set forth herein are to be incorporated into the interpretation of any claim element unless such limitation or element is explicitly stated. Likewise, it is to be understood that it is not necessary to meet any or all of the identified advantages or objects of the invention disclosed herein in order to fall within the scope of any claims, since the invention is defined by the claims and since inherent and/or unforeseen advantages of the present invention may exist even though they may not have been explicitly discussed herein.

APPARATUS FOR GRADUATED LATERAL ROTATION OF A SLEEP SURFACE

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